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11.6.2011 Official
Journal
of
the
European
Union L
153/1
II
(Non-legislative acts)
REGULATIONS
COMMISSION IMPLEMENTING REGULATION (EU) No 540/2011
of 25 May 2011
implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as
regards the list of approved active substances
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
containing the list of active substances included in Annex
I to Directive 91/414/EEC at the moment of the
Having regard to the Treaty on the Functioning of the European
adoption of this Regulatation,
Union,
(3) In
this
context
it
is
to
be
borne
in
mind
that,
as a consequence of Article 83 of Regulation (EC)
Having regard to Regulation (EC) No 1107/2009 of the
No 1107/2009 having repealed Directive 91/414/EEC,
European Parliament and of the Council of 21 October 2009
the Directives which included the active substances in
concerning the placing of plant protection products on the
Annex I to Directive 91/414/EEC have become obsolete
market and repealing Council Directives 79/117/EEC and
to the extent that they amend that Directive. However,
91/414/EEC ( 1 ), and in particular Article 78(3) thereof,
the autonomous provisions of these Directives continue
to apply,
After consulting the Standing Committee on the Food Chain
and Animal Health,
HAS ADOPTED THIS REGULATION:
Whereas:
Article 1

The active substances as set out in the Annex to this Regulation
shall be deemed to have been approved under Regulation (EC)
(1) In
accordance
with
Regulation
(EC)
No
1107/2009
active
substances included in Annex I to Council Directive
No 1107/2009.
91/414/EEC of 15 July 1991 concerning the placing of
plant protection products on the market (
Article 2

2 ) are to be
deemed to have been approved under that Regulation.
This Regulation shall enter into force on the day following that
of its publication in the Official Journal of the European Union.
(2) It
is
therefore
necessary
for
the
implementation
of
Regu
lation (EC) No 1107/2009 to adopt a Regulation
It shall apply from 14 June 2011.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 25 May 2011.
For the Commission
The President
José Manuel BARROSO
( 1 ) OJ L 309, 24.11.2009, p. 1.
( 2 ) OJ L 230, 19.8.1991, p. 1.

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L 153/2
ANNEX
ACTIVE SUBSTANCES APPROVED FOR USE IN PLANT PROTECTION PRODUCTS
General provisions applying to all substances listed in this Annex:
— for the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009 in relation to each substance, the conclusions of the review report on it, and in particular
EN
the Appendices I and II thereof, shall be taken into account;

— Member States shall keep available all review reports (except for confidential information within the meaning of Article 63 of Regulation (EC) No 1107/2009) for consultation by any interested parties or
shall make it available to them on specific request.
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
1 Imazalil
(+)-1-(β-allyloxy-2,4-di
975 g/kg 1
January
31 December Only uses as fungicide may be authorized.
chlorophenylethyl)
1999
2011
CAS No 73790-28-0, imidazole or (+)-allyl 1-
For the following uses the following particular conditions apply:
35554-44-0
Off
(2,4-dichlorophenyl)-2-
— post-harvest fruit, vegetable and potato treatments may only be authorised when
CIPAC No 335
imidazol-1-ylethyl ether
an appropriate decontamination system is available or a risk assessment has
icial
demonstrated to the authorizing Member State that the discharge of the
Jour
treatment solution does not have an unacceptable risk to the environment and
in particular to aquatic organisms,
nal
— post-harvest treatment of potatoes may only be authorised when a risk
of
assessment has demonstrated to the authorizing Member State that the
the
discharge of the processing waste from treated potatoes does not have an unac
European
ceptable risk to aquatic organisms,
— outdoor foliar uses may only be authorised when a risk assessment has demon
strated to the authorizing Member State that the use has no unacceptable effects
on human and animal health and the environment.
Union
Date of Standing Committee on Plant Health at which the review report was
finalised: 11 July 1997.
2 Azoxystrobin
Methyl (E)-2-{2[6-(2-
930 g/kg (Z isomer 1 July 1998 31
December Only uses as fungicide may be authorised.
cyanophenoxy)pyrimidin-
max. 25 g/kg)
2011
CAS No 131860-33-8
4-yloxy] phenyl}-3-metho
In the decision making according to the uniform principles as referred to in
Article 29(6) of Regulation (EC) No 1107/2009, particular attention should be
CIPAC No 571
xyacrylate
given to the impact on aquatic organisms. Authorisation conditions should
include appropriate risk mitigation measures.
Date of Standing Committee on Plant Health at which the review report was
finalised: 22 April 1998.
3 Kresoxim-Methyl
Methyl (E)-2-
910 g/kg 1
February
31 December Only uses as fungicide may be authorised.
methoxyimino-2-[2-(o-toly
1999
2011
CAS No 143390-89-0
loxymethyl) phenyl]acetate
In their decision making according to the uniform principles as referred to in
Article 29(6) of Regulation (EC) No 1107/2009, Member States shall pay particular
CIPAC No 568
11.6.2011
attention to the protection of groundwater under vulnerable conditions.
Date of Standing Committee on Plant Health at which the review report was
finalised: 16 October 1998.

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11.6.2011 Off
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
4 Spiroxamine
(8-tert-Butyl-1,4-dioxa-
940 g/kg
(diaste 1 September 31 December Only uses as a fungicide may be authorised.
spiro [4.5] decan-2-
reomers A and B
1999
2011
CAS No 1181134-30-8 ylmethyl)-ethyl-propyl-
combined)
In their decision making according to the uniform principles as referred to in
Article 29(6) of Regulation (EC) No 1107/2009, Member States:
CIPAC No 572
amine
EN
— must pay particular attention to operator safety and must ensure that the

conditions of authorisation include appropriate protective measures,
— must pay particular attention to the impact on aquatic organisms and must
ensure that the conditions of authorisation include, where appropriate, risk
mitigation measures.
Date of Standing Committee on Plant Health at which the review report was
finalised: 12 May 1999.
5 Azimsulfuron
1-(4,6-dimethoxy
980 g/kg 1
October
31 December Only uses as herbicide may be authorised.
icial
pyrimidin-2-yl)-3-[1-
1999
2011
CAS No 120162-55-2
methyl-4-(2-methyl-2H-
Aerial applications may not be authorised.
Jour
CIPAC No 584
tetrazol-5-yl)-pyrazol-5-
In their decision making according to the uniform principles as referred to in
ylsulfonyl]-urea
nal
Article 29(6) of Regulation (EC) No 1107/2009, Member States must pay particular
attention to the impact on aquatic organisms and terrestrial non-target plants and
of
must ensure that the conditions of authorisation include, where appropriate, risk
the
mitigation measures (e.g. in rice cultivation minimum holding periods for water
European
prior to discharge).
Date of Standing Committee on Plant Health at which the review report was
finalised: 2 July 1999.
Union
6 Fluroxypyr
4-amino-3,5-dichloro-6-
950 g/kg 1
December
31 December Only uses as herbicide may be authorised.
fluoro-2-pyridyloxyacetic
2000
2011
CAS No 69377-81-7
acid
In their decision making according to the Uniform principles as referred to in
Article 29(6) of Regulation (EC) No 1107/2009 Member States:
CIPAC No 431
— shall take into account the additional information requested in point 7 of the
Review Report,
— must pay particular attention to the protection of groundwater,
— must pay particular attention to the impact on aquatic organisms and must
ensure that the conditions of authorisation include, where appropriate, risk
mitigation measures.
Member States shall inform the Commission if the requested additional trials and
information as outlined in point 7 of the Review Report were not submitted by
1 December 2000.
Date of Standing Committee on Plant Health at which the review report was
L
153/3
finalised: 30 November 1999.

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L 153/4
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
7 Metsulfuron
methyl Methyl-2-(4-methoxy-6-
960 g/kg 1
July
2001 31
December Only uses as herbicide may be authorised.
methyl-1,3,5,-triazin-2-
2015
CAS No 74223-64-6
ylcarbamoylsul
In their decision making according to the uniform principles as referred to in
famoyl)benzoate
Article 29(6) of Regulation (EC) No 1107/2009, Member States
— must pay particular attention to the protection of groundwater;
EN

— must pay particular attention to the impact on aquatic organisms and must
ensure that the conditions of authorisation include, where appropriate, risk
mitigation measures.
Date of Standing Committee on Plant Health at which the review report was
finalised: 16 June 2000.
8 Prohexadione
Calcium
Calcium 3,5-dioxo-4-
890 g/kg 1
October
31 December Only uses as plant growth regulator may be authorised.
propionylcyclohexanecar
2000
2011
CAS No 127277-53-6
boxylate
Date of Standing Committee on Plant Health at which the review report was
finalised: 16 June 2000.
Off
CIPAC No 567
icial
9 Triasulfuron
1-[2-(2-chloro
940 g/kg 1
August
31 December Only uses as herbicide may be authorised.
Jour
ethoxy)phenylsulfonyl]-3-
2001
2015
CAS No 82097-50-5
nal
(4-methoxy-6-methyl-
In their decision making according to the uniform principles as referred to in
Article 29(6) of Regulation (EC) No 1107/2009, Member States:
CIPAC No 480
1,3,5-triazin-2-yl)urea
of
— must pay particular attention to the protection of groundwater;
the
— must pay particular attention to the impact on aquatic organisms and must
European
ensure that the conditions of authorisation include, where appropriate, risk
mitigation measures.
Date of Standing Committee on Plant Health at which the review report was
Union
finalised: 13 July 2000.
10 Esfenvalerate
(S)-α-Cyano-3-phenoxy
830 g/kg 1
August
31 December Only uses as insecticide may be authorised.
benzyl-(S)-2-(4-chloro
2001
2015
CAS No 66230-04-4
phenyl)-3-methylbutyrate
In their decision making according to the uniform principles as referred to in
Article 29(6) of Regulation (EC) No 1107/2009, Member States:
CIPAC No 481
— must pay particular attention to the potential impact on aquatic organisms and
non-target arthropods and must ensure that the conditions of authorisation
include, where appropriate, risk mitigation measures.
Date of Standing Committee on Plant Health at which the review report was
finalised: 13 July 2000.
11 Bentazone
3-isopropyl-(1H)-2,1,3-
960 g/kg 1
August
31 December Only uses as herbicide may be authorised.
benzothiadiazin-4-(3H)-
2001
2015
CAS No 25057-89-0
one-2,2-dioxide
In their decision making according to the uniform principles as referred to in
Article 29(6) of Regulation (EC) No 1107/2009, Member States must pay particular
CIPAC No 366
11.6.2011
attention to the protection of groundwater.
Date of Standing Committee on Plant Health at which the review report was
finalised: 13 July 2000.

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11.6.2011 Off
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
12 Lambda-cyhalothrin A 1:1 mixture of:
810 g/kg 1
January
31 December Only uses as insecticide may be authorised.
2002
2015
CAS No 91465-08-6
(S)-α-cyano-3-phenoxy
In their decision making according to the uniform principles as referred to in
benzyl (Z)-(1R,3R)-3-(2-
CIPAC No 463
Article 29(6) of Regulation (EC) No 1107/2009, Member States:
chloro-3,3,3-trifluo
EN
ropropenyl)-2,2-dimethyl
— must pay particular attention to operator safety;

cyclopropanecarboxylate,
and
— must pay particular attention to the potential impact on aquatic organisms and
non-target arthropods including bees and must ensure that the conditions of
(R)-α-cyano-3-phenoxy
authorisation include, where appropriate, risk mitigation measures;
benzyl (Z)-(1S,3S)-3-(2-
chloro-3,3,3-trifluo
— must pay particular attention to the residues in food and especially the acute
ropropenyl)-2,2-dimethyl
effects thereof.
cyclopropanecarboxylate
Date of Standing Committee on Plant Health at which the review report was
finalised: 19 October 2000.
icial
13 Fenhexamid
N-(2,3-dichloro-4-hydro
≥ 950 g/kg 1
June
2001 31
December Only uses as a fungicide may be authorized.
Jour
xyphenyl)-1-methylcyclo
2015
CAS No 126833-17-8
hexanecarboxamide
In decision making according to the uniform principles as referred to in
nal
CIPAC No 603
Article 29(6) of Regulation (EC) No 1107/2009, Member States must pay particular
of
attention to the potential impact on aquatic organisms and must ensure that the
the
conditions of authorisation include, where appropriate, risk mitigation measures.
European
Date of Standing Committee on Plant Health at which the review report was
finalised: 19 October 2000.
Union
14 Amitrole
H-[1,2,4]-triazole-3-
900 g/kg 1
January
31 December Only uses as herbicide may be authorised
ylamine
2002
2015
CAS No 61-82-5
For the implementation of the uniform principles as referred to in Article 29(6) of
CIPAC No 90
Regulation (EC) No 1107/2009, the conclusions of the review report on amitrole,
and in particular Appendices I and II thereof, as finalised in the Standing Committee
on Plant Health on 12 December 2000 shall be taken into account. In this overall
assessment Member States:
— must pay particular attention to the protection of operators;
— must pay particular attention to the protection of the groundwater in vulnerable
areas, in particular with respect to non-crop uses;
— must pay particular attention to the protection of beneficial arthropods;
— must pay particular attention to the protection of birds and wild mammals. Use
of amitrole during the breeding season may only be authorised when an appro
priate risk assessment has demonstrated that there is no unacceptable impact and
L
when the conditions of authorisation include, where appropriate, risk mitigation
153/5
measures.

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L 153/6
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
15 Diquat
9,10-Dihydro-8a,10a-
950 g/kg 1
January
31 December On the basis of currently available information, only uses as terrestrial herbicide and
diazoniaphenanthrene ion
2002
2015
desiccant may be authorised. Uses in aquatic weed control shall not be authorised.
CAS No 2764-72-9 (dibromide)
(ion), 85-00-7
For the implementation of the uniform principles as referred to in Article 29(6) of
(dibromide)
Regulation (EC) No 1107/2009, the conclusions of the Review report on diquat, and
EN
in particular Appendices I and II thereof, as finalised in the Standing Committee on

CIPAC No 55
Plant Health on 12 December 2000 shall be taken into account. In this overall
assessment Member States:
— must pay particular attention to the potential impact on aquatic organisms and
must ensure that the conditions of authorisation include, where appropriate, risk
mitigation measures;
— must pay particular attention to operator safety as related to non-professional
use and must ensure that the conditions of authorisation include, where appro
priate, risk mitigation measures.
Off
icial
16 Pyridate
6-Chloro-3-
900 g/kg 1
January
31 December Only uses as herbicide may be authorized.
Jour
phenylpyridazin-4-yl
2002
2015
CAS No 55512-33.9
nal
S-octyl thiocarbonate
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the Review report on Pyridate,
of
CIPAC No 447
and in particular Appendices I and II thereof, as finalised in the Standing Committee
the
on Plant Health on 12 December 2000 shall be taken into account. In this overall
European
assessment Member States:
— must pay particular attention to the protection of groundwater;
— must pay particular attention to the potential impact on aquatic organisms and
Union
must ensure that the conditions of authorisation include, where appropriate, risk
mitigation measures.
17 Thiabendazole
2-Thiazol-4-yl-1H-ben
985 g/kg 1
January
31 December Only uses as fungicide may be authorised. Foliar spray applications shall not be
zimidazole
2002
2015
authorised.
CAS No 148-79-8
For the implementation of the uniform principles as referred to in Article 29(6) of
CIPAC No 323
Regulation (EC) No 1107/2009, the conclusions of the Review report on thiaben
dazole, and in particular Appendices I and II thereof, as finalised in the Standing
Committee on Plant Health on 12 December 2000 shall be taken into account. In
this overall assessment Member States:
— must pay particular attention to the protection of aquatic and sediment-dwelling
organisms and must ensure that the conditions of authorisation include, where
appropriate, risk mitigation measures.
11.6.2011
Suitable risk mitigation measures (e.g. depuration with diatom earth or activated
carbon) have to be implemented to protect surface waters from unacceptable levels
of contamination via wastewater.

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11.6.2011 Off
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
18 Paecilomyces
fumoso Not applicable The
absence
of
1 July 2001 31
December Only uses as an insecticide may be authorised.
roseus
secondary metabolites
2015
should be checked in
Each fermentation broth should be checked by HPLC to ensure that no secondary
Apopka strain 97, PFR
each fermentation
metabolites are present.
97 or CG 170,
EN
broth by HPLC
ATCC20874
Date of Standing Committee on Plant Health at which the review report was

finalised: 27 April 2001.
19 DPX
KE
459
(flupyr 2-(4,6-dimethoxy
903 g/kg 1
July
2001 31
December Only uses as a herbicide may be authorised.
sulfuron-methyl)
pyrimidin-2-ylcarba
2015
moylsulfamoyl)-6-trifluro
In decision making according to the Uniform Principles Member States must pay
CAS No 144740-54-5
methylnicotinate mono
particular attention to the protection of groundwater.
CIPAC No 577
sodium salt
Date of Standing Committee on Plant Health at which the review report was
finalised: 27 April 2001.
icial
Jour
20 Acibenzolar-s-methyl Benzo[1,2,3]thiadiazole-7-
970 g/kg 1
November
31 December Only uses as a plant activator may be authorised.
carbothioic acid S-methyl
2001
2015
nal
CAS No 135158-54-2
ester
Date of Standing Committee on Plant Health at which the review report was
finalised: 29 June 2001
of
CIPAC No 597
the
European
21 Cyclanilide
Not available 960
g/kg 1
November
31 December Only uses as a plant growth regulator may be authorised.
2001
2015
CAS No 113136-77-9
The maximum content of the impurity 2,4-dichloroaniline (2,4-DCA) in the active
Union
substance as manufactured should be 1 g/kg.
CIPAC No 586
Date of Standing Committee on Plant Health at which the review report was
finalised: 29 June 2001.
22 Ferric
phosphate
Ferric phosphate 990
g/kg 1
November
31 December Only uses as a molluscicide may be authorised.
2001
2015
CAS No 10045-86-0
Date of Standing Committee on Plant Health at which the review report was
finalised: 29 June 2001.
CIPAC No 629
23 Pymetrozine
(E)-6-methyl-4-[(pyridin-3-
950 g/kg 1
November
31 December Only uses as an insecticide may be authorised.
ylmetylene)amino]-4,5-
2001
2015
CAS No 123312-89-0
dihydro-2H-[1,2,4]-triazin-
In decision making according to the Uniform Principles Member States must pay
particular attention to the protection of aquatic organisms.
CIPAC No 593
3 one
L
Date of Standing Committee on Plant Health at which the review report was
153/7
finalised: 29 June 2001.

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L 153/8
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
24 Pyraflufen-ethyl
Ethyl-2-chloro-5-(4-chloro- 956 g/kg 1
November
31 December Only uses as a herbicide may be authorised.
5-difluoromethoxy-1-
2001
2015
CAS No 129630-19-9
mhypyrazol-3-yl)-4-fluo
In decision making according to the Uniform Principles Member States must pay
particular attention to the protection of algae and aquatic plants and should apply,
CIPAC No 605
rophenoxyacetate
where appropriate, risk mitigation measures.
EN
Date of Standing Committee on Plant Health at which the review report was

finalised: 29 June 2001.
25 Glyphosate
N-(phosphonomethyl)-
950 g/kg 1
July
2002 31
December Only uses as herbicide may be authorised
glycin
2015
CAS No 1071-83-6
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on glyphosate,
CIPAC No 284
and in particular Appendices I and II thereof, as finalised in the Standing Committee
on Plant Health on 29 June 2001 shall be taken into account. In this overall
assessment Member States:
Off
— must pay particular attention to the protection of the groundwater in vulnerable
icial
areas, in particular with respect to non-crop uses.
Jour
26 Thifensulfuron-methyl Methyl 3-(4-methoxy-6-
960 g/kg 1
July
2002 31
December Only uses as herbicide may be authorised
nal
methyl-1,3,5-triazin-2-
2015
of
CAS No 79277-27-3
ylcarbamoyl-sulfamoyl)
For the implementation of the uniform principles as referred to in Article 29(6) of
the
Regulation (EC) No 1107/2009, the conclusions of the review report on thifen
CIPAC No 452
thiophene-2-carboxylate
sulfuron-methyl, and in particular Appendices I and II thereof, as finalised in the
European
Standing Committee on Plant Health on 29 June 2001 shall be taken into account.
In this overall assessment Member States:
— must pay particular attention to the protection of groundwater;
Union
— must pay particular attention to the impact on aquatic plants and must ensure
that the conditions of authorisation include, where appropriate, risk mitigation
measures.
27 2,4-D
(2,4-dichlorophenoxy)
960 g/kg 1
October
31 December Only uses as herbicide may be authorised
acetic acid
2002
2015
CAS No 94-75-7
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on 2,4-D, and
CIPAC No 1
in particular Appendices I and II thereof, as finalised in the Standing Committee on
Plant Health on 2 October 2001 shall be taken into account. In this overall
assessment Member States:
— must pay particular attention to the protection of the groundwater, when the
active substance is applied in regions with vulnerable soil and/or climatic
conditions;
— must pay particular attention to the dermal absorption;
11.6.2011
— must pay particular attention to the protection of non-target arthropods and
must ensure that the conditions of authorisation include, where appropriate, risk
mitigation measures.

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11.6.2011 Off
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
28 Isoproturon
3-(4-isopropylphenyl)-1,1-
970 g/kg 1
January
31 December Only uses as herbicide may be authorised
dimethylurea
2003
2015
CAS No 34123-59-6
For the implementation of the uniform principles as referred to in Article 29(6) of
CIPAC No 336
Regulation (EC) No 1107/2009, the conclusions of the review report on
EN
isoproturon, and in particular Appendices I and II thereof, as finalised in the

Standing Committee on Plant Health on 7 December 2001 shall be taken into
account. In this overall assessment Member States:
— must pay particular attention to the protection of the groundwater, when the
active substance is applied in regions with vulnerable soil and/or climatic
conditions or at use rates higher than those described in the review report
and must apply risk mitigation measures, where appropriate;
— must pay particular attention to the protection of aquatic organisms and must
ensure that the conditions of authorisation include, where appropriate, risk
mitigation measures.
icial
Jour
nal
29 Ethofumesate
(±)-2-ethoxy-2,3-dihydro-
960 g/kg 1
March
28 February Only uses as herbicide may be authorised
3,3-dimethylbenzofuran-5-
2003
2013
of
CAS No 26225-79-6
ylmethanesulfonate
For the implementation of the uniform principles as referred to in Article 29(6) of
the
CICAP No 223
Regulation (EC) No 1107/2009, the conclusions of the review report on etho
European
fumesate, and in particular Appendices I and II thereof, as finalised in the
Standing Committee on the Food Chain and Animal Health on 26 February 2002
shall be taken into account. In this overall assessment Member States may pay
particular attention to the protection of the groundwater, when the active
Union
substance is applied in regions with vulnerable soil and/or climatic conditions and
must apply risk mitigation measures, where appropriate.
30 Iprovalicarb
{2-Methyl-1-[1-(4-methyl
950 g/kg (provisional 1 July 2002 31
December Only uses as fungicide may be authorised.
phenyl)ethylcarbonyl]
specification)
2015
CAS No 140923-17-7
propyl}-carbamic acid
For the implementation of the uniform principles as referred to in Article 29(6) of
isopropylester
CICAP No 620
Regulation (EC) No 1107/2009, the conclusions of the review report on ipro
valicarb, and in particular Appendices I and II thereof, as finalised in the Standing
Committee on the Food Chain and Animal Health on 26 February 2002 shall be
taken into account. In this overall assessment:
— the specification of the technical material as commercially manufactured must be
confirmed and supported by appropriate analytical data. The test material used in
the toxicity dossier should be compared and verified against this specification of
the technical material;
L
153/9
— Member States must pay particular attention to the protection of operators.

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L 153/10
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
31 Prosulfuron
1-(4-methoxy-6-methyl-
950 g/kg 1
Juli
2002 31
December Only uses as herbicide may be authorised.
1,3,5-triazin-2-yl)-3-[2-
2015
CAS No 94125-34-5
(3,3,3-trifluoropropyl)-
For the implementation of the uniform principles as referred to in Article 29(6) of
phenylsulfonyl]-urea
Regulation (EC) No 1107/2009, the conclusions of the review report on
CICAP No 579
prosulfuron, and in particular Appendices I and II thereof, as finalised in the
EN
Standing Committee on the Food Chain and Animal Health on 26 February 2002

shall be taken into account. In this overall assessment Member States:
— must carefully consider the risk to aquatic plants if the active substance is applied
adjacent to surface waters. Risk mitigation measures should be applied where
appropriate;
— must pay particular attention to the protection of groundwater, when the active
substance is applied in regions with vulnerable soil and/or climate conditions.
Risk mitigation measures should be applied where appropriate.
Off
icial
32 Sulfosulfuron
1-(4,6-dimethoxy
980 g/kg 1
July
2002 31
December Only uses as a herbicide may be authorised.
pyrimidin-2-yl)-3-[2-
2015
Jour
CAS No 141776-32-1
ethanesulfonyl-
For the implementation of the uniform principles as referred to in Article 29(6) of
nal
imidazo[1,2-a]pyridine)
Regulation (EC) No 1107/2009, the conclusions of the review report on sulfo
CICAP No 601
sulfonyl]urea
sulfuron, and in particular Appendices I and II thereof, as finalised in the
of
Standing Committee on the Food Chain and Animal Health on 26 February 2002
the
shall be taken into account. In this overall assessment:
European
— Member States must pay particular attention to the protection of aquatic plants
and algae. Where appropriate, risk mitigation measures should be applied;
— Member States must pay particular attention to the protection of the
Union
groundwater, when the active substance is applied in regions with vulnerable
soil and/or climatic conditions.
33 Cinidon-ethyl
(Z)-ethyl 2-chloro-3-[2-
940 g/kg 1
October
31 December Only uses as herbicide may be authorised.
chloro-5-(cyclohex-1-ene-
2002
2015
CAS No 142891-20-1
1,2-dicarboximido)phenyl]
For the implementation of the uniform principles as referred to in Article 29(6) of
acrylate
Regulation (EC) No 1107/2009, the conclusions of the review report on cinidon-
CIPAC No 598
ethyl, and in particular Appendices I and II thereof, as finalised in the Standing
Committee on the Food Chain and Animal Health on 19 April 2002 shall be taken
into account. In this overall assessment Member States:
— should pay particular attention to the potential for ground water contamination,
when the active substance is applied in regions with vulnerable soil (e.g. soils
with neutral or high pH values) and/or climatic conditions;
— should pay particular attention to the protection of aquatic organisms.
11.6.2011
Conditions of authorisation must include risk mitigation measures, where appro
priate.

---

11.6.2011 Off
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
34 Cyhalofop
butyl
Butyl-(R)-2-[4(4-cyano-2-
950 g/kg 1
October
31 December Only uses as herbicide may be authorised.
fluorophenoxy) phenoxy]
2002
2015
CAS No 122008-85-9
propionate
For the implementation of the uniform principles as referred to in Article 29(6) of
CIPAC No 596
Regulation (EC) No 1107/2009, the conclusions of the review report on cyhalofop
butyl, and in particular Appendices I and II thereof, as finalised in the Standing
EN
Committee on the Food Chain and Animal Health on 19 April 2002 shall be taken

into account. In this overall assessment:
— Member States must carefully consider the potential impact of aerial applications
to non-target organisms and in particular to aquatic species. Conditions of au
thorisation must include restrictions or risk mitigation measures, where appro
priate.
— Member States must carefully consider the potential impact of terrestrial appli
cations on aquatic organisms within paddy fields. Conditions of authorisation
must include risk mitigation measures, where appropriate.
icial
35 Famoxadone
3-anilino-5-methyl-5-(4-
960 g/kg 1
October
31 December Only uses as fungicide may be authorised.
Jour
phenoxyphenyl)-1,3-
2002
2015
nal
CAS No 131807-57-3
oxazolidine-2,4-dione
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on
of
CIPAC No 594
famoxadone, and in particular Appendices I and II thereof, as finalised in the
the
Standing Committee on the Food Chain and Animal Health on 19 April 2002
European
shall be taken into account. In this overall assessment:
— Member States must pay particular attention to potential chronic risks of the
parent substance or metabolites to earthworms;
Union
— Member States must pay particular attention to the protection of aquatic
organisms and must ensure that the conditions of authorisation include, where
appropriate, risk mitigation measures;
— Member States should pay particular attention to the protection of operators.
36 Florasulam
2′, 6′, 8-Trifluoro-5-
970 g/kg 1
October
31 December Only uses as herbicide may be authorised.
methoxy-[1,2,4]-triazolo
2002
2015
CAS No 145701-23-1
[1,5-c] pyrimidine-2-
For the implementation of the uniform principles as referred to in Article 29(6) of
sulphonanilide
Regulation (EC) No 1107/2009, the conclusions of the review report on florasulam,
CIPAC No 616
and in particular Appendices I and II thereof, as finalised in the Standing Committee
on the Food Chain and Animal Health on 19 April 2002 shall be taken into
account. In this overall assessment Member States:
— should pay particular attention to the potential for ground water contamination,
when the active substance is applied in regions with vulnerable soil and/or
L
153/11
climatic conditions. Conditions of authorisation must include risk mitigation
measures, where appropriate.

---

L 153/12
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
37 Metalaxyl-M
Methyl(R)-2-{[(2,6-
910 g/kg 1
October
31 December Only uses as fungicide may be authorised.
dimethylphenyl)methoxy-
2002
2015
CAS No 70630-17-0
acetyl] amino} propionate
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on Metalaxyl-
CIPAC No 580
M, and in particular Appendices I and II thereof, as finalised in the Standing
EN
Committee on the Food Chain and Animal Health on 19 April 2002 shall be

taken into account. In this overall assessment:
— particular attention should be given to the potential for groundwater contami
nation by the active substance or its degradation products CGA 62826, and CGA
108906 when the active substance is applied in regions with vulnerable soil
and/or climatic conditions. Risk mitigation measures should be applied, where
appropriate.
38 Picolinafen
4′-Fluoro-6-[(α,α,α-
970 g/kg 1
October
31 December Only uses as herbicide may be authorised.
Off
trifluoro-m-tolyl)oxy]pico
2002
2015
icial
CAS No 137641-05-5
linanilide
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on picolinafen,
Jour
CIPAC No 639
and in particular Appendices I and II thereof, as finalised in the Standing Committee
on the Food Chain and Animal Health on 19 April 2002 shall be taken into
nal
account. In this overall assessment Member States:
of
the
— must pay particular attention to the protection of aquatic organisms. Conditions
of authorisation should include risk mitigation measures, where appropriate.
European
39 Flumioxazine
N-(7-fluoro-3,4-dihydro-3-
960 g/kg 1
January
31 December Only uses as herbicide may be authorised.
Union
oxo-4-prop-2-ynyl-2H-1,4-
2003
2015
CAS No 103361-09-7
benzoxazin-6-yl)cyclohex-
For the implementation of the uniform principles as referred to in Article 29(6) of
1-ene-1,2-dicarboximide
Regulation (EC) No 1107/2009, the conclusions of the review report on flumio
CICAP No 578
xazine, and in particular Appendices I and II thereof, as finalised in the Standing
Committee on the Food Chain and Animal Health on 28 June 2002 shall be taken
into account. In this overall assessment Member States:
— must carefully consider the risk to aquatic plants and algae. Conditions of au
thorisation must include risk mitigation measures, where appropriate.
40 Deltamethrin
(S)-α-cyano-3-phenoxy
980 g/kg 1
November
31 October Only uses as insecticide may be authorised
benzyl (1R,3R)-3-(2,2-
2003
2013
CAS No 52918-63-5
dibromovinyl)-2,2-
For the implementation of the uniform principles as referred to in Article 29(6) of
dimethylcyclopropane
Regulation (EC) No 1107/2009, the conclusions of the review report on delta
CIPAC No 333
carboxylate
methrin, and in particular Appendices I and II thereof, as finalised in the Standing
Committee on Plant Health on 18 October 2002 shall be taken into account. In this
overall assessment Member States:
11.6.2011
— must pay particular attention to the operator safety and must ensure that the
conditions of authorisation include appropriate protective measures,

---

11.6.2011 Off
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
— should observe the acute dietary exposure situation of consumers in view of
future revisions of maximum residue levels,
— must pay particular attention to the protection of aquatic organisms, bees and
non-target arthropods and must ensure that the conditions of authorisation
EN
include risk mitigation measures, where appropriate.

41 Imazamox
(±)-2-(4-isopropyl-4-
950 g/kg 1
July
2003 30
June Only uses as herbicide may be authorised.
methyl-5-oxo-2-imid
2013
CAS No 114311-32-9
azolin-2-yl)-5-(methoxy
For the implementation of the uniform principles as referred to in Article 29(6) of
methyl) nicotinic acid
Regulation (EC) No 1107/2009, the conclusions of the review report on imazamox,
CIPAC No 619
and in particular Appendices I and II thereof, as finalised in the Standing Committee
on the Food Chain and Animal Health on 3 December 2002 shall be taken into
account.
In this overall assessment Member States should pay particular attention to the
icial
potential for groundwater contamination, when the active substance is applied in
regions with vulnerable soil and/or climate conditions. Risk mitigation measures
Jour
should be applied where appropriate.
nal
of
the
42 Oxasulfuron
Oxetan-3-yl 2[(4,6-
930 g/kg 1
July
2003 30
June Only uses as herbicide may be authorised.
dimethylpyrimidin-2-yl)
2013
European
CAS No 144651-06-9
carbamoyl-sulfamoyl]
For the implementation of the uniform principles as referred to in Article 29(6) of
benzoate
Regulation (EC) No 1107/2009, the conclusions of the review report on
CIPAC No 626
oxasulfuron, and in particular Appendices I and II thereof, as finalised in the
Standing Committee on the Food Chain and Animal Health on 3 December 2002
Union
shall be taken into account.
Member States must pay particular attention to the protection of groundwater, when
the active substance is applied in regions with vulnerable soil and/or climate
conditions.
Risk mitigation measures should be applied, where appropriate.
43 Ethoxysulfuron
3-(4,6-dimethoxy
950 g/kg 1
July
2003 30
June Only uses as herbicide may be authorised.
pyrimidin-2-yl)-1-(2-etho
2013
CAS No 126801-58-9
xyphenoxy-sulfonyl)urea
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on ethoxy
CIPAC No 591
sulfuron, and in particular Appendices I and II thereof, as finalised in the Standing
Committee on the Food Chain and Animal Health on 3 December 2002 shall be
taken into account.
Member States should pay particular attention to the protection of non-target
L
aquatic plants and algae in drainage canals. Risk mitigation measures should be
153/13
applied where appropriate.

---

L 153/14
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
44 Foramsulfuron
1-(4,6-dimethoxy
940 g/kg 1
July
2003 30
June Only uses as herbicide may be authorised.
pyrimidin-2-yl)-3-(2-
2013
CAS No 173159-57-4
dimethylcarbamoyl-5-form
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on foram
CIPAC No 659
amidophenylsulfonyl)urea
sulfuron, and in particular Appendices I and II thereof, as finalised in the Standing
EN
Committee on the Food Chain and Animal Health on 3 December 2002 shall be

taken into account.
In this overall assessment Member States should pay particular attention to the
protection of aquatic plants. Risk mitigation measures should be applied, where
appropriate.
45 Oxadiargyl
5-tert-butyl-3-(2,4-
980 g/kg 1
July
2003 30
June Only uses as herbicide may be authorised.
dichloro-5-propargylo
2013
CAS No 39807-15-3
xyphenyl)-1,3,4 oxadiazol-
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on oxadiargyl,
CIPAC No 604
2-(3H)-one
Off
and in particular Appendices I and II thereof, as finalised in the Standing Committee
on the Food Chain and Animal Health on 3 December 2002 shall be taken into
icial
account.
Jour
In this overall assessment Member States should pay particular attention to the
protection of algae and aquatic plants. Risk mitigation measures should be applied
nal
where appropriate.
of
the
46 Cyazofamid
4-chloro-2cyano-N,N-
935 g/kg 1
July
2003 30
June Only uses as fungicide may be authorised.
European
dimethyl-5-P-tolylimidazole
2013
CAS No 120116-88-3
-1-sulfonamide
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on cyazofamid,
CIPAC No 653
and in particular Appendices I and II thereof, as finalised in the Standing Committee
Union
on the Food Chain and Animal Health on 3 December 2002 shall be taken into
account. In this overall assessment:
— Member States must pay particular attention to the protection of aquatic
organisms;
— Member States must pay particular attention to the degradation kinetics of the
metabolite CTCA in soil, especially for Northern European regions.
Risk mitigation measures or use restrictions should be applied where appropriate.
47 2,4-DB
4-(2,4-dichlorophenoxy)
940 g/kg 1
January
31 December Only use as herbicide may be authorised
butyric acid
2004
2013
CAS No 94-82-6
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on 2,4-DB, and
CIPAC No 83
in particular Appendices I and II thereof, as finalised in the Standing Committee on
the Food Chain and Animal Health on 3 December 2002 shall be taken into
account. In this overall assessment Member States:
11.6.2011
— must pay particular attention to the protection of groundwater when the active
substance is applied in regions with vulnerable soil and/or climatic conditions.
Risk mitigation measures should be applied, where appropriate.

---

11.6.2011 Off
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
48 Beta-cyfluthrin
(1RS,3RS;1RS,3SR)-3- (2,2- 965 g/kg 1
January
31 December Only use as insecticide may be authorised
dichlorovinyl)-2,2-
2004
2013
CAS No 68359-37-5 dimethylcyclopropanecar
Uses other than ornamental in greenhouses and seed treatment are currently not
(unstated stereo boxylic acid (SR)-α-cyano-
adequately supported and have not shown to be acceptable under the criteria
chemistry)
(4-fluoro-3-phenoxy-
required by the uniform principles as referred to in Article 29(6) of Regulation
EN
(EC) No 1107/2009. To support authorisations for such uses, data and information
CIPAC No 482
phenyl)methyl ester

to prove their acceptability to human consumers and the environment will have to
be generated and submitted to the Member States. This will be the case in particular
for data to assess in all detail the risks of outdoor foliar uses and the dietary risks of
foliar treatment in edible crops.
For the implementation of the uniform principles, the conclusions of the review
report on beta-cyfluthrin, and in particular Appendices I and II thereof, as finalised
in the Standing Committee on the Food Chain and Animal Health on 3 December
2002 shall be taken into account. In this overall assessment:
— Member States must pay particular attention to the protection of non-target
arthropods. Conditions of authorisation should include adequate risk mitigation
icial
measures.
Jour
49 Cyfluthrin
(RS),-α-cyano-4-fluoro-3-
920 g/kg 1
January
31 December Only use as insecticide may be authorised
nal
phenoxybenzyl-
2004
2013
CAS No 68359-37-5 (1RS,3RS;1RS,3SR)-3-(2,2-
Uses other than ornamental in greenhouses and seed treatment are currently not
of
(unstated stereo dichlorovinyl)-2,2-dimethy
adequately supported and have not shown to be acceptable under the criteria
the
chemistry)
cyclopropanecarboxylate
required by the uniform principles as referred to in Article 29(6) of Regulation
(EC) No 1107/2009. To support authorisations for such uses, data and information
European
CIPAC No 385
to prove their acceptability to human consumers and the environment will have to
be generated and submitted to the Member States. This will be the case in particular
for data to assess in all detail the risks of outdoor foliar uses and the dietary risks of
Union
foliar treatment in edible crops.
For the implementation of the uniform principles, the conclusions of the review
report on cyfluthrin, and in particular Appendices I and II thereof, as finalised in the
Standing Committee on the Food Chain and Animal Health on 3 December 2002
shall be taken into account. In this overall assessment:
— Member States must pay particular attention to the protection of non-target
arthropods. Conditions of authorisation should include adequate risk mitigation
measures.
50 Iprodione
3-(3,5-dichlorophenyl)-
960 g/kg 1
January
31 December Only uses as fungicide and nematicide may be authorised.
Nisopropyl-2,4-dioxo-imid
2004
2013
CAS No 36734-19-7
azolidine-1-carboximide
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on iprodione,
CIPAC No 278
and in particular Appendices I and II thereof, as finalised in the Standing Committee
on the Food Chain and Animal Health on 3 December 2002 shall be taken into
account. In this overall assessment, Member States:
L
— should pay particular attention to the potential for groundwater contamination
153/15
when the active substance is applied at high use rates (in particular use in turf)
on acidic soils (pH below 6) under vulnerable climatic conditions,

---

L 153/16
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
— must carefully consider the risk to aquatic invertebrates if the active substance is
applied directly adjacent to surface waters. Risk mitigation measures should be
applied, where appropriate.
51 Linuron
3-(3,4-dichlorophenyl)-1-
900 g/kg 1
January
31 December Only use as herbicide may be authorised
EN
methoxy-1-methylurea
2004
2013

CAS No 330-55-2
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on linuron,
CIPAC No 76
and in particular Appendices I and II thereof, as finalised in the Standing Committee
on the Food Chain and Animal Health on 3 December 2002 shall be taken into
account. In this overall assessment Member States:
— must pay particular attention to the protection of wild mammals, non-target
arthropods and aquatic organisms. Conditions of authorisation should include
risk mitigation measures, where appropriate,
Off
— must pay particular attention to the protection of operators.
icial
52 Maleic
hydrazide
6-hydroxy-2H-pyridazin-3- 940 g/kg. 1
January
31 December Only use as growth regulator may be authorised
Jour
one
2004
2013
nal
CAS No 123-33-1
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on maleic
of
CIPAC No 310
hydrazide, and in particular Appendices I and II thereof, as finalised in the
the
Standing Committee on the Food Chain and Animal Health on 3 December 2002
European
shall be taken into account. In this overall assessment Member States:
— must pay particular attention to the protection of non-target arthropods and
must ensure that the conditions of authorisation include risk mitigation
Union
measures, where appropriate,
— must pay particular attention to the potential for groundwater contamination,
when the active substance is applied in regions with vulnerable soil and/or
climatic conditions. Risk mitigation measures should be applied, where appro
priate.
53 Pendimethalin
N-(1-ethylpropyl)-2,6-
900 g/kg 1
January
31 December Only use as herbicide may be authorised
dinitro-3,4-xylidene
2004
2013
CAS No 40487-42-1
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on pendime
CIPAC No 357
thalin, and in particular Appendices I and II thereof, as finalised in the Standing
Committee on the Food Chain and Animal Health 3 December 2002 shall be taken
into account. In this overall assessment Member States:
— must pay particular attention to the protection of aquatic organisms and non-
target terrestrial plants. Conditions of authorisation must include risk mitigation
measures, where appropriate,
11.6.2011
— must pay particular attention to the possibility of short-range transport of the
active substance in air.

---

11.6.2011 Off
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
54 Propineb
Polymeric zinc 1,2-pro The technical active
1 April
31 March
Only uses as fungicide may be authorised
pylenebis(dithiocarbamate)
substance should 2004
2014
CAS No 12071-83-9
comply with the FAO
For the implementation of the uniform principles as referred to in Article 29(6) of
(monomer), 9016-72-2
specification
Regulation (EC) No 1107/2009, the conclusions of the review report on propineb,
(homopolymer)
and in particular Appendices I and II thereto, as finalised in the Standing Committee
EN
on the Food Chain and Animal Health on 26 February 2003 shall be taken into

CIPAC No 177
account. In this overall assessment:
— Member States should pay particular attention to the potential for ground water
contamination when the active substance is applied in regions with vulnerable
soils and/or extreme climatic conditions
— Member States should pay particular attention to the protection of small
mammals, aquatic organisms and non-target arthropods. Conditions of authori
sation should include risk mitigation measures, where appropriate
— Member States should observe the acute dietary exposure situation of consumers
in view of future revisions of maximum residue levels
icial
Jour
55 Propyzamide
3,5-dichloro-N-(1,1-
920 g/kg 1
April
31 March
Only uses as herbicide may be authorised
dimethyl-prop-2-
2004
2014
nal
CAS No 23950-58-5
ynyl)benzamide
For the implementation of the uniform principles as referred to in Article 29(6) of
of
Regulation (EC) No 1107/2009, the conclusions of the review report on propy
the
CIPAC No 315
zamide, and in particular Appendices I and II thereof, as finalised in the Standing
Committee on Plant Health 26 February 2003 shall be taken into account. In this
European
overall assessment, Member States:
— must pay particular attention to the protection of operators and must ensure that
conditions of authorisation include risk mitigation measures, where appropriate
Union
— must pay particular attention to the protection of birds and wild mammals in
particular if the substance is applied during the breeding season. Conditions of
authorisation should include risk mitigation measures, where appropriate
56 Mecoprop
(RS)-2-(4-chloro-o-
930 g/kg 1
June
2004 31
May Only uses as herbicide may be authorised.
tolyloxy)-propionic acid
2014
CAS No 7085-19-0
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on mecoprop,
CIPAC No 51
and in particular Appendices I and II thereof, as finalised in the Standing Committee
on the Food Chain and Animal Health on 15 April 2003 shall be taken into
account. In this overall assessment:
— Member States should pay particular attention to the potential for groundwater
contamination, when the active substance is applied in regions with vulnerable
soil and/or climatic conditions. Conditions of authorisation should include risk
mitigation measures, where appropriate,
L
153/17
— Member States should pay particular attention to the protection of non-target
arthropods. Risk mitigation measures should be applied, where appropriate.

---

L 153/18
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
57 Mecoprop-P
(R)-2-(4-chloro-o-tolyloxy)- 860 g/kg 1
June
2004 31
May Only uses as herbicide may be authorised.
propionic acid
2014
CAS No 16484-77-8
For the implementation of the uniform principles as referred to in Article 29(6) of
CIPAC No 475
Regulation (EC) No 1107/2009, the conclusions of the review report on mecoprop-
EN
P, and in particular Appendices I and II thereof, as finalised in the Standing

Committee on the Food Chain and Animal Health on 15 April 2003 shall be
taken into account. In this overall assessment:
— Member States should pay particular attention to the potential for groundwater
contamination, when the active substance is applied in regions with vulnerable
soil and/or climatic conditions. Conditions of authorisation should include risk
mitigation measures, where appropriate.
58 Propiconazole
(±)-1-[2-(2,4-dichlo
920 g/kg 1
June
2004 31
May Only uses as fungicide may be authorised.
Off
rophenyl)-4-propyl-1,3-
2014
icial
CAS No 60207-90-1
dioxolan-2-ylmethyl]-1H-
For the implementation of the uniform principles as referred to in Article 29(6) of
1,2,4-triazole
Jour
CIPAC No 408
Regulation (EC) No 1107/2009, the conclusions of the review report on propi
conazole, and in particular Appendices I and II thereof, as finalised in the
nal
Standing Committee on the Food Chain and Animal Health on 15 April 2003
shall be taken into account. In this overall assessment:
of
the
— Member States should pay particular attention to the protection of non-target
European
arthropods and aquatic organisms. Conditions of authorisation should include
risk mitigation measures, where appropriate,
— Member States should pay particular attention to the protection of soil
Union
organisms for applications rates exceeding 625 g a.i./ha (e.g. uses in lawn).
Conditions of authorisation should include risk mitigation measures (e.g.
spotwise application scheme), where appropriate.
59 Trifloxystrobin
Methyl (E)-methoxyimino- 960 g/kg 1
October
30 September Only use as fungicide may be authorised.
{(E)-a-[1-a-(a,a,a-trifluoro-
2003
2013
CAS No 141517-21-7
m-tolyl)ethylideneami
For the implementation of the uniform principles as referred to in Article 29(6) of
nooxyl]-o-tolyl}acetate
CIPAC No 617
Regulation (EC) No 1107/2009, the conclusions of the review report on tri
floxystrobin, and in particular Appendices I and II thereof, as finalised in the
Standing Committee on the Food Chain and Animal Health on 15 April 2003
shall be taken into account. In this overall assessment:
— Member States should pay particular attention to the protection of groundwater,
when the active substance is applied in regions with vulnerable soil and/or
climate conditions.
11.6.2011
Risk mitigation measures should be applied and/or monitoring programs may be
initiated where appropriate.

---

11.6.2011 Off
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
60 Carfentrazone
ethyl Ethyl (RS)-2-chloro-3-[2- 900 g/kg 1
October
30 September Only use as herbicide may be authorised.
chloro-5-(4-difluoro
2003
2013
CAS No 128639-02.1
methyl-4,5-dihydro-3-
For the implementation of the uniform principles as referred to in Article 29(6) of
CIPAC No 587
methyl-5oxo-1H 1,2,4-
Regulation (EC) No 1107/2009, the conclusions of the review report on carfen
EN
triazol-1-yl)-4-fluoro
trazone-ethyl, and in particular Appendices I and II thereof, as finalised in the

phenyl]propionate
Standing Committee on the Food Chain and Animal Health on 15 April 2003
shall be taken into account. In this overall assessment:
— Member States should pay particular attention to the protection of groundwater,
when the active substance is applied in regions with vulnerable soil and/or
climate conditions.
Risk mitigation measures should be applied where appropriate.
icial
61 Mesotrione
2-(4-mesyl-2-nitrobenzoyl) 920 g/kg
1 October
30 September Only use as herbicide may be authorised.
cyclohexane -1,3-dione
2003
2013
Jour
CAS No 104206-8
The manufacturing
For the implementation of the uniform principles as referred to in Article 29(6) of
impurity 1-cyano-6-
nal
CIPAC No 625
Regulation (EC) No 1107/2009, the conclusions of the review report on mesotrione,
(methylsulfonyl)-7-
and in particular Appendices I and II thereof, as finalised in the Standing Committee
of
nitro-9H-xanthen-9-
on the Food Chain and Animal Health on 15 April 2003 shall be taken into
the
one is considered to
account.
be of toxicological
European
concern and must
remain below
0,0002 % (w/w) in
the technical product.
Union
62 Fenamidone
(S)-5-methyl-2-methylthio-
975 g/kg 1
October
30 September Only use as fungicide may be authorised.
5-phenyl-3-phenylamino-
2003
2013
CAS No 161326-34-7
3,5-dihydroimidazol-4-one
For the implementation of the uniform principles as referred to in Article 29(6) of
CIPAC No 650
Regulation (EC) No 1107/2009, the conclusions of the review report on fenamidone,
and in particular Appendices I and II thereof, as finalised in the Standing Committee
on the Food Chain and Animal Health on 15 April 2003 shall be taken into
account. In this overall assessment Member States:
— should pay particular attention to the protection of groundwater, when the active
substance is applied in regions with vulnerable soil and/or climate conditions,
— should pay particular attention to the protection of non-target arthropods,
— should pay particular attention to the protection of aquatic organisms.
L
153/19
Risk mitigation measures should be applied where appropriate.

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L 153/20
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
63 Isoxaflutole
5-cyclopropyl-4-(2-methyl
950 g/kg 1
October
30 September Only use as herbicide may be authorised.
sulfonyl-4-trifluoromethyl
2003
2013
CAS No 141112-29-0
benzoyl) isoxazole
For the implementation of the uniform principles as referred to in Article 29(6) of
CIPAC No 575
Regulation (EC) No 1107/2009, the conclusions of the review report on isoxaflutole,
and in particular Appendices I and II thereof, as finalised in the Standing Committee
EN
on the Food Chain and Animal Health on 15 April 2003 shall be taken into

account. In this overall assessment Member States:
— must pay particular attention to the protection of groundwater, when the active
substance is applied in regions with vulnerable soil and/or climate conditions.
Risk mitigation measures or monitoring programs should be applied where
appropriate.
64 Flurtamone
(RS)-5-methylamino-2-
960 g/kg 1
January
31 December Only uses as herbicide may be authorised.
Off
phenyl-4-(a,a,a-trifluoro-m-
2004
2013
CAS No 96525-23-4
tolyl) furan-3 (2H)-one
icial
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on flurtamone,
Jour
and in particular Appendices I and II thereof, as finalised in the Standing Committee
on the Food Chain and Animal Health on 4 July 2003 shall be taken into account.
nal
In this overall assessment Member States:
of
the
— should pay particular attention to the protection of groundwater, when the active
substance is applied in regions with vulnerable soil and/or climate conditions,
European
— should pay particular attention to the protection of algae and other aquatic
plants.
Union
Risk mitigation measures should be applied where appropriate.
65 Flufenacet
4′-fluoro-N-isopropyl-2-[5- 950 g/kg 1
January
31 December Only uses as herbicide may be authorised.
(trifluoromethyl)-1,3,4-thia
2004
2013
CAS No 142459-58-3
diazol-2-yloxy]acetanilide
For the implementation of the uniform principles as referred to in Article 29(6) of
CIPAC No 588
Regulation (EC) No 1107/2009, the conclusions of the review report on flufenacet,
and in particular Appendices I and II thereof, as finalised in the Standing Committee
on the Food Chain and Animal Health on 4 July 2003 shall be taken into account.
In this overall assessment Member States:
— should pay particular attention to the protection of groundwater, when the active
substance is applied in regions with vulnerable soil and/or climate conditions,
— should pay particular attention to the protection of algae and aquatic plants,
11.6.2011
— should pay particular attention to the protection of operators.
Risk mitigation measures should be applied where appropriate.

---

11.6.2011 Off
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
66 Iodosulfuron
4-iodo-2-[3-(4-methoxy-6-
910 g/kg 1
January
31 December Only uses as herbicide may be authorised.
methyl-1,3,5-triazin-2-yl)-
2004
2013
CAS No 185119-76-0 ureidosulfonyl]benzoate
For the implementation of the uniform principles as referred to in Article 29(6) of
(parent)
Regulation (EC) No 1107/2009, the conclusions of the review report on iodo
sulfuron, and in particular Appendices I and II thereof, as finalised in the
EN
144550-36-7 (iodo
Standing Committee on the Food Chain and Animal Health on 4 July 2003 shall

sulfuron-methyl-
be taken into account. In this overall assessment Member States:
sodium)
— should pay particular attention to the potential of iodosulfuron and its meta
CIPAC No 634 (parent)
bolites for groundwater contamination, when the active substance is applied in
634.501 (iodosulfuron-
regions with vulnerable soil and/or climate conditions,
methyl-sodium)
— should pay particular attention to the protection of aquatic plants.
Risk mitigation measures should be applied where appropriate.
icial
67 Dimethenamid-p
S-2-chloro-N-(2,4-
890 g/kg (preliminary
1 January
31 December Only uses as herbicide may be authorised.
dimethyl-3-thienyl)-N-(2-
value based on a
2004
2013
CAS No 163515-14-8
Jour
methoxy-1-methylethyl)-
pilot plant)
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on
CIPAC No 638
acetamide
nal
dimethenamid-p, and in particular Appendices I and II thereof, as finalised in the
Standing Committee on the Food Chain and Animal Health on 4 July 2003 shall be
of
taken into account. In this overall assessment Member States:
the
— should pay particular attention to the potential of the metabolites of
European
dimethenamid-p for groundwater contamination, when the active substance is
applied in regions with vulnerable soil and/or climate conditions,
— should pay particular attention to the protection of aquatic ecosystems, especially
Union
of aquatic plants.
Risk mitigation measures should be applied where appropriate.
The Member States shall inform the Commission in accordance with Article 38 of
Regulation (EC) No 1107/2009 on the specification of the technical material as
commercially manufactured.
68 Picoxystrobin
Methyl (E)-3-methoxy-2-{2- 950 g/kg (preliminary
1 January
31 December Only uses as fungicide may be authorised.
[6-(trifluoromethyl) -2-
value based on a
2004
2013
CAS No 117428-22-5
pyridyloxymethyl]phenyl}
pilot plant)
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on pi
CIPAC No 628
acrylate
coxystrobin, and in particular Appendices I and II thereof, as finalised in the
Standing Committee on the Food Chain and Animal Health on 4 July 2003 shall
be taken into account. In this overall assessment Member States:
— should pay particular attention to the protection of groundwater, when the active
L
substance is applied in regions with vulnerable soil and/or climate conditions,
153/21
— should pay particular attention to the protection of soil organisms,

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L 153/22
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
— should pay particular attention to the protection of aquatic ecosystems.
Risk mitigation measures should be applied where appropriate.
The Member States shall inform the Commission in accordance with Article 38 of
EN
Regulation (EC) No 1107/2009 on the specification of the technical material as

commercially manufactured.
69 Fosthiazate
(RS)-S-sec-butyl O-ethyl 2- 930 g/kg 1
January
31 December Only uses as insecticide or nematicide may be authorised.
oxo-1,3-thiazolidin-3-
2004
2013
CAS No 98886-44-3
ylphosphonothioate
For the implementation of the uniform principles as referred to in Article 29(6) of
CIPAC No 585
Regulation (EC) No 1107/2009, the conclusions of the review report on fosthiazate,
and in particular Appendices I and II thereof, as finalised in the Standing Committee
on the Food Chain and Animal Health on 4 July 2003 shall be taken into account.
In this overall assessment Member States
Off
icial
— should pay particular attention to the protection of groundwater, when the active
substance is applied in regions with vulnerable soil and/or climate conditions;
Jour
— should pay particular attention to the protection of birds and wild mammals in
nal
particular if the substance is applied during the breeding season;
of
the
— should pay particular attention to the protection of non-target soil organisms.
European
Risk mitigation measures should be applied where appropriate. In order to mitigate
the potential risk to small birds, product authorisations must require that a very high
level of incorporation of granules into soil is achieved.
Union
The Member States shall inform the Commission in accordance with Article 38 of
Regulation (EC) No 1107/2009 on the specification of the technical material as
commercially manufactured.
70 Silthiofam
N-allyl-4,5-dimethyl-2-
950 g/kg 1
January
31 December Only uses as fungicide may be authorised.
(trimethylsilyl)thiophene-3-
2004
2013
CAS No 175217-20-6
carboxamide
Uses other than seed treatments are currently not adequately supported by data. To
CIPAC No 635
support authorisations for such uses, data and information to prove their accepta
bility for consumers, operators and the environment will have to be generated and
submitted to the Member States.
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on silthiofam,
and in particular Appendices I and II thereof, as finalised in the Standing Committee
on the Food Chain and Animal Health on 4 July 2003 shall be taken into account.
11.6.2011
In this overall assessment Member States must pay particular attention to the
protection of operators. Risk mitigation measures must be applied, where appro
priate.

---

11.6.2011 Off
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
71 Coniothyrium
minitans
Not applicable For
details
on
purity
1 January
31 December Only uses as fungicide may be authorised.
and production
2004
2013
Strain CON/M/91-08
control see Review
(DSM 9660)
When granting authorisations, the conclusions of the review report on Conio
Report
thyrium minitans, and in particular Appendices I and II thereof, as finalised in the
EN
CIPAC No 614
Standing Committee on the Food Chain and Animal Health on 4 July 2003 shall be

taken into account.
In this overall assessment:
— Member States must pay particular attention to the operator and worker safety
and must ensure that the conditions of authorisation include appropriate
protective measures.
72 Molinate
S-ethyl azepane-1-carbo 950 g/kg 1
August
31 July 2014 Only
uses
as
herbicide
may
be
authorised.
thioate;
2004
icial
CAS No 2212-67-1
For the implementation of the uniform principles as referred to in Article 29(6) of
S-ethyl perhydroazepine-1-
Jour
CIPAC No 235
Regulation (EC) No 1107/2009, the conclusions of the review report on molinate,
carbothioate;
and in particular Appendices I and II thereof, as finalised in the Standing Committee
nal
S-ethyl perhydroazepine-1-
on the Food Chain and Animal Health on 4 July 2003 shall be taken into account.
of
thiocarboxilate
In this overall assessment:
the
European
— Member States should pay particular attention to the potential for groundwater
contamination, when the active substance is applied in regions with vulnerable
soil and/or climatic conditions. Conditions of authorisation should include risk
mitigation measures, where appropriate,
Union
— Member States should pay particular attention to the possibility of short-range
transport of the active substance in air.
73 Thiram
tetramethylthiuram
960 g/kg 1
August
31 July 2014 Only uses as fungicide or as repellent may be authorised.
disulfide;
2004
CAS No 137-26-8
For the implementation of the uniform principles as referred to in Article 29(6) of
bis (dimethylthiocar
CIPAC No 24
Regulation (EC) No 1107/2009, the conclusions of the review report on thiram, and
bamoyl)-disulfide
in particular Appendices I and II thereof, as finalised in the Standing Committee on
the Food Chain and Animal Health on 4 July 2003 shall be taken into account. In
this overall assessment:
— Member States should pay particular attention to the protection of aquatic
organisms. Risk mitigation measures should be applied, where appropriate,
— Member States should pay particular attention to the protection of small
L
mammals and birds when the substance is used as a seed treatment in spring
153/23
uses. Risk mitigation measures should be applied, where appropriate.

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L 153/24
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
74 Ziram
Zinc bis (dimethyldithio 950 g/kg (FAO-specifi
1 August
31 July 2014 Only uses as fungicide or as repellent may be authorised.
carbamate)
cation)
2004
CAS No 137-30-4
For the implementation of the uniform principles as referred to in Article 29(6) of
Arsenic: maximum
Regulation (EC) No 1107/2009, the conclusions of the review report on ziram, and
CIPAC No 31
250 mg/kg
in particular Appendices I and II thereof, as finalised in the Standing Committee on
EN

the Food Chain and Animal Health on 4 July 2003 shall be taken into account. In
Water: maximum
this overall assessment:
1,5 %
— Member States should pay particular attention to the protection of non-target
arthropods and aquatic organisms. Risk mitigation measures should be applied,
where appropriate,
— Member States should observe the acute dietary exposure situation of consumers
in view of future revisions of Maximum Residue Levels.
Off
icial
75 Mesosulfuron
2-[(4,6-dimethoxy
930 g/kg 1
April
31 March
Only use as herbicide may be authorised.
pyrimidin-2-ylcar
2004
2014
Jour
CAS No 400852-66-6
bamoyl)sulfamoyl]-α-
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on meso
nal
CIPAC No 441
(methanesulfonamido)-p-
toluic acid
sulfuron, and in particular Appendices I and II thereof, as finalised in the
of
Standing Committee on the Food Chain and Animal Health on 3 October 2003
the
shall be taken into account. In this overall assessment Member States:
European
— should pay particular attention to the protection of aquatic plants;
— should pay particular attention to the potential of mesosulfuron and its meta
bolites for groundwater contamination, when the active substance is applied in
regions with vulnerable soil and/or climate conditions.
Union
Risk mitigation measures should be applied where appropriate.
76 Propoxycarbazone
2-(4,5-dihydro-4-methyl-5- ≥ 950 g/kg (expressed
1 April
31 March
Only uses as herbicide may be authorised.
oxo-3-propoxy-1H-1,2,4-
as propoxy-
2004
2014
CAS No 145026-81-9
triazol-1-yl) carboxami carbazone-sodium)
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on propoxy
CIPAC No 655
dosulfonylbenzoicacid-
methylester
carbazone, and in particular Appendices I and II thereto, as finalised in the Standing
Committee on the Food Chain and Animal Health on 3 October 2003 shall be taken
into account. In this overall assessment Member States:
— should pay particular attention to the potential of propoxycarbazone and its
metabolites for groundwater contamination, when the active substance is
applied in regions with vulnerable soil and/or climate conditions,
— should pay particular attention to the protection of aquatic ecosystems, especially
11.6.2011
of aquatic plants.
Risk mitigation measures should be applied where appropriate.

---

11.6.2011 Off
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
77 Zoxamide
(RS)-3,5-Dichloro-N-(3-
950 g/kg 1
April
31 March
Only use as fungicide may be authorised.
chloro-1-ethyl-1-methyl
2004
2014
CAS No 156052-68-5
acetonyl)-p-toluamide
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on zoxamide,
CIPAC No 640
and in particular Appendices I and II thereof, as finalised in the Standing Committee
EN
on the Food Chain and Animal Health on 3 October 2003 shall be taken into

account.
78 Chlorpropham
Isopropyl 3-chlorophe 975 g/kg 1
February
31 January Only uses as herbicide and sprout suppression may be authorised.
nylcarbamate
2005
2015
CAS No 101-21-3
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on chlor
CIPAC No 43
propham, and in particular Appendices I and II thereof, as finalised in the
Standing Committee on the Food Chain and Animal Health on 28 November
2003 shall be taken into account. In this overall assessment Member States
should pay particular attention to the protection of operators, consumers and
icial
non-target arthropods. Conditions of authorisation should include risk mitigation
measures, where appropriate.
Jour
nal
of
79 Benzoic
acid
benzoic acid 990
g/kg 1
June
2004 31
May Only uses as disinfectant may be authorised.
the
2014
CAS No 65-85-0
For the implementation of the uniform principles as referred to in Article 29(6) of
European
Regulation (EC) No 1107/2009, the conclusions of the review report on benzoic
CIPAC No 622
acid, and in particular Appendices I and II thereof, as finalised in the Standing
Committee on the Food Chain and Animal Health on 28 November 2003 shall
be taken into account.
Union
80 Flazasulfuron
1-(4,6-dimethoxy
940 g/kg 1
June
2004 31
May Only uses as herbicide may be authorised.
pyrimidin-2-yl)-3-(3-triflu
2014
CAS No 104040-78-0
oromethyl-2-pyridylsul
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on flaza
CIPAC No 595
phonyl)urea
sulfuron, and in particular Appendices I and II thereto, as finalised in the
Standing Committee on the Food Chain and Animal Health on 28 November
2003 shall be taken into account. In this overall assessment Member States
— should pay particular attention to the potential for groundwater contamination,
when the active substance is applied in regions with vulnerable soil and/or
climate conditions,
— should pay particular attention to the protection of aquatic plants.
Risk mitigation measures should be applied where appropriate.
The Member States shall inform the Commission in accordance with Article 38 of
L
Regulation (EC) No 1107/2009 on the specification of the technical material as
153/25
commercially manufactured.

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L 153/26
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
81 Pyraclostrobin
methyl N-(2-{[1-(4-chloro 975 g/kg
1 June 2004 31
May Only uses as fungicide or plant growth regulator may be authorised.
phenyl)-1H-pyrazol-3-
2014
CAS No 175013-18-0
yl]oxymethyl}phenyl) N- The manufacturing
For the implementation of the uniform principles as referred to in Article 29(6) of
impurity dimethyl
Regulation (EC) No 1107/2009, the conclusions of the review report on pyra
CIPAC No 657
methoxy carbamate
sulfate (DMS) is
clostrobin, and in particular Appendices I and II thereof, as finalised in the
EN
condidered to be of
Standing Committee on the Food Chain and Animal Health on 28 November

toxicological concern
2003 shall be taken into account. In this overall assessment Member States:
and must not exceed
a concentration of
— should pay particular attention to the protection of aquatic organisms, especially
0,0001 %
in
the
fish,
technical product.
— should pay particular attention to the protection of terrestrial arthropods and
earthworms.
Risk mitigation measures should be applied where appropriate.
The Member States shall inform the Commission in accordance with Article 38 of
Off
Regulation (EC) No 1107/2009 on the specification of the technical material as
commercially manufactured.
icial
Jour
nal
82 Quinoxyfen
5, 7-dichloro-4 (ρ-fluo 970 g/kg 1
September
31 August
Only uses as fungicide may be authorised.
of
rophenoxy) quinoline
2004
2014
CAS No 124495-18-7
For the implementation of the uniform principles as referred to in Article 29(6) of
the
Regulation (EC) No 1107/2009, the conclusions of the review report on quinoxyfen,
CIPAC No 566
European
and in particular Appendices I and II thereto, as finalised in the Standing Committee
on the Food Chain and Animal Health on 28 November 2003, shall be taken into
account.
Member States should pay particular attention to the protection of aquatic
Union
organisms. Risk mitigation measures must be applied and monitoring programmes
must be initiated in vulnerable zones where appropriate.
83 Alpha-cypermethrin Racemate comprising
930 g/kg CIS-2 1
March
28 February Only uses as insecticide may be authorised.
2005
2015
CAS No 67375-30-8
(S)-α- cyano-3 phenoxy
For the implementation of the uniform principles as referred to in Article 29(6) of
benzyl-(1R)-cis-3-(2,2-di
Regulation (EC) No 1107/2009, the conclusions of the review report on alpha-
CIPAC No
chlorovinyl)-2,2-dimethyl
cypermethrin, and in particular Appendices I and II thereof, as finalised in the
cyclopropane carboxylate
Standing Committee on the Food Chain and Animal Health on 13 February 2004
shall be taken into account. In this overall assessment:
and
— Member States must pay particular attention to the protection of aquatic
(R)-α- cyano-3 phenoxy
organisms, bees and non-target arthropods and must ensure that the conditions
benzyl-(1S)-cis-3-(2,2-di
of authorisation include risk mitigation measures.
chlorovinyl)-2,2-dimethyl
cyclopropane carboxylate
— Member States must pay particular attention to the operator safety and must
11.6.2011
ensure that the conditions of authorisation include appropriate protective
(= cis-2 isomer pair of
measures.
cypermethrin)

---

11.6.2011 Off
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
84 Benalaxyl
Methyl N-phenylacetyl–N- 960 g/kg 1
March
28 February Only uses as fungicide may be authorised.
2, 6–xylyl–DL-alaninate
2005
2015
CAS No 71626-11-4
For the implementation of the uniform principles as referred to in Article 29(6) of
CIPAC No 416
Regulation (EC) No 1107/2009, the conclusions of the review report on benalaxyl,
EN
and in particular Appendices I and II thereto, as finalised in the Standing Committee

on the Food Chain and Animal Health on 13 February 2004 shall be taken into
account. In this overall assessment Member States should pay particular attention to
the potential for groundwater contamination, when the active substance is applied in
regions with vulnerable soil and/or climatic conditions. Conditions of authorisation
should include risk mitigation measures, where appropriate.
85 Bromoxynil
3,5 dibromo – 4- hydroxy 970 g/kg 1
March
28 February Only uses as herbicide may be authorised.
benzonitrile
2005
2015
CAS No 1689-84-5
For the implementation of the uniform principles as referred to in Article 29(6) of
icial
CIPAC No 87
Regulation (EC) No 1107/2009, the conclusions of the review report on bromoxynil,
and in particular Appendices I and II thereto, as finalised in the Standing Committee
Jour
on the Food Chain and Animal Health on 13 February 2004 shall be taken into
account. In this overall assessment Member States must pay particular attention to
nal
the protection of birds and wild mammals, in particular if the substance is applied in
of
winter, and of aquatic organisms. Conditions of authorisation should include risk
the
mitigation measures, where appropriate.
European
86 Desmedipham
ethyl 3′-phenylcarbamoy Min. 970 g/kg 1
March
28 February Only uses as herbicide may be authorised.
loxycarbanilate
2005
2015
Union
CAS No 13684-56-5
For the implementation of the uniform principles as referred to in Article 29(6) of
ethyl 3-phenylcarbamoylo
CIPAC No 477
Regulation (EC) No 1107/2009, the conclusions of the review report on
xyphenylcarbamate
desmedipham, and in particular Appendices I and II thereto, as finalised in the
Standing Committee on the Food Chain and Animal Health on 13 February 2004
shall be taken into account. In this overall assessment Member States should pay
particular attention to the protection of aquatic organisms and earthworms. Risk
mitigation measures should be applied if appropriate
87 Ioxynil
4- hydroxy- 3,5- di-iodo 960 g/kg 1
March
28 February Only uses as herbicide may be authorised.
benzonitrile
2005
2015
CAS No 13684-83-4
For the implementation of the uniform principles as referred to in Article 29(6) of
CIPAC No 86
Regulation (EC) No 1107/2009, the conclusions of the review report on ioxynil, and
in particular Appendices I and II thereto, as finalised in the Standing Committee on
the Food Chain and Animal Health on 13 February 2004 shall be taken into
account. In this overall assessment Member States must pay particular attention to
the protection of birds and wild mammals in particular if the substance is applied in
L
winter and to aquatic organisms. Conditions of authorisation should include risk
153/27
mitigation measures, where appropriate.

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L 153/28
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
88 Phenmedipham
methyl 3-(3-methylcarb Min. 970 g/kg 1
March
28 February Only uses as herbicide may be authorised.
aniloyloxy)carbanilate;
2005
2015
CAS No 13684-63-4
For the implementation of the uniform principles as referred to in Article 29(6) of
3-methoxycarbonylamin
Regulation (EC) No 1107/2009, the conclusions of the review report on phen
CIPAC No 77
ophenyl 3′-methylcarb
medipham, and in particular Appendices I and II thereto, as finalised in the
EN
anilate
Standing Committee on the Food Chain and Animal Health on 13 February 2004

shall be taken into account. In this overall assessment Member States should pay
particular attention to the protection of aquatic organisms. Conditions of authori
sation should include risk mitigation measures, where appropriate.
89 Pseudomonas
chloro Not applicable The
amount
of
the
1 October
30 September Only uses as fungicide for seed dressing in closed seed dressing machinery may be
raphis
secondary metabolite
2004
2014
authorised.
2,3-deepoxy-2,3-
Strain: MA 342
didehydro-rhizoxin
When granting authorisations, the conclusions of the review report on Pseudomonas
chlororaphis, and in particular Appendices I and II thereof, as finalised in the
CIPAC No 574
(DDR) in the
Off
fermentate at the
Standing Committee on the Food Chain and Animal Health on 30 March 2004
icial
point of formulation
shall be taken into account.
of the product must
In this overall assessment, Member States should pay particular attention to the
Jour
not exceed the LOQ
safety of operators and workers. Risk mitigation measures should be applied
nal
(2 mg/l).
where appropriate.
of
the
90 Mepanipyrim
N-(4-methyl-6-prop-1-
960 g/kg 1
October
30 September Only uses as fungicide may be authorised.
European
ynylpyrimidin-2-yl)aniline
2004
2014
CAS No 110235-47-7
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on
CIPAC No 611
mepanipyrim, and in particular Appendices I and II thereof, as finalised in the
Union
Standing Committee on the Food Chain and Animal Health on 30 March 2004
shall be taken into account.
In this overall assessment Member States should pay particular attention to the
protection of aquatic organisms. Risk mitigation measures should be applied
where appropriate.
91 Acetamiprid
(E)-N1-[(6-chloro-3-
≥ 990 g/kg 1
January
31 December Only uses as insecticide may be authorised.
pyridyl)methyl]-N2-cyano-
2005
2014
CAS No 160430-64-8
N1-methylacetamidine
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on Acet
CIPAC No Not yet
amiprid, and in particular Appendices I and II thereof, as finalised in the Standing
allocated
Committee on the Food Chain and Animal Health on 29 June 2004 shall be taken
into account.
In this overall assessment Member States
— should pay particular attention to worker exposure,
11.6.2011
— should pay particular attention to the protection of aquatic organisms.
Risk mitigation measures should be applied where appropriate.

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11.6.2011 Off
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
92 Thiacloprid
(Z)-N-{3-[(6-Chloro-3-
≥ 975 g/kg 1
January
31 December Only uses as insecticide may be authorised.
pyridinyl)methyl]-1,3-
2005
2014
CAS No 111988-49-9
thiazolan-2-
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on Thiacloprid,
CIPAC No 631
yliden}cyanamide
and in particular Appendices I and II thereof, as finalised in the Standing Committee
EN
on the Food Chain and Animal Health on 29 June 2004 shall be taken into account.

In this overall assessment Member States:
— should pay particular attention to the protection of non-target arthropods,
— should pay particular attention to the protection of aquatic organisms,
— should pay particular attention to the potential for groundwater contamination,
when the active substance is applied in regions with vulnerable soil and/or
climatic conditions.
Risk mitigation measures should be applied where appropriate.
icial
93 Ampelomyces quis Not applicable 1
April
31 March
Only uses as fungicide may be authorised.
Jour
qualis
2005
2015
When granting authorisations, the conclusions of the review report on Ampe
nal
Strain: AQ 10
lomyces quisqualis, and in particular Appendices I and II thereof, as finalised in
of
the Standing Committee on the Food Chain and Animal Health on 8 October
Culture collection No
2004 shall be taken into account.
the
CNCM I-807
European
CIPAC No
Not allocated
Union
94 Imazosulfuron
1-(2-chloroimidazo[1,2-
≥ 980 g/kg 1
April
31 March
Only uses as herbicide may be authorised.
α]pyridin-3-ylsul-phonyl)-
2005
2015
CAS No 122548-33-8
3-(4,6-dimethoxy
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on imazo
CIPAC No 590
pyrimidin-2-yl)urea
sulfuron, and in particular Appendices I and II thereof, as finalised in the Standing
Committee on the Food Chain and Animal Health on 8 October 2004 shall be taken
into account.
In this overall assessment Member States should pay particular attention to the
protection of aquatic and terrestrial non-target plants. Risk mitigation measures
should be applied where appropriate.
95 Laminarin
(1→3)-β-D-glucan
≥ 860 g/kg on dry
1 April
31 March
Only uses as elicitor of the crop's self-defence mechanisms may be authorised.
matter
2005
2015
CAS No 9008-22-4
(according to IUPAC-IUB
For the implementation of the uniform principles as referred to in Article 29(6) of
Joint Commission on
Regulation (EC) No 1107/2009, the conclusions of the review report on laminarin,
CIPAC No 671
Biochemical Nomenclature)
and in particular Appendices I and II thereof, as finalised in the Standing Committee
L
on the Food Chain and Animal Health on 8 October 2004 shall be taken into
153/29
account.

---

L 153/30
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
96 Methoxyfenozide
N-tert-Butyl-N′-(3-
≥ 970 g/kg 1
April
31 March
Only uses as insecticide may be authorised.
methoxy-o-toluoyl)-3,5-
2005
2015
CAS No 161050-58-4
xylohydrazide
For the implementation of the uniform principles as referred to in Article 29(6) of
CIPAC No 656
Regulation (EC) No 1107/2009, the conclusions of the review report on methoxyfe
EN
nozide, and in particular Appendices I and II thereof, as finalised in the Standing

Committee on the Food Chain and Animal Health on 8 October 2004 shall be taken
into account.
In this overall assessment Member States should pay particular attention to the
protection of terrestrial and aquatic non-target arthropods.
Risk mitigation measures should be applied where appropriate.
Off
97 S-metolachlor
Mixture of:
≥ 960 g/kg 1
April
31 March
Only uses as herbicide may be authorised.
icial
2005
2015
CAS No 87392-12-9
(aRS, 1 S)-2-chloro-N-(6-
For the implementation of the uniform principles as referred to in Article 29(6) of
Jour
ethyl-o-tolyl)-N-(2-
(S-isomer)
Regulation (EC) No 1107/2009, the conclusions of the review report on s-meto
methoxy-1-
nal
lachlor, and in particular Appendices I and II thereof, as finalised in the Standing
methylethyl)acetamide
178961-20-1
Committee on the Food Chain and Animal Health on 8 October 2004 shall be taken
of
(80-100 %)
(R-isomer)
into account.
the
and:
European
CIPAC No 607
In this overall assessment Member States:
(aRS, 1 R)-2-chloro-N-(6-
ethyl-o-tolyl)-N-(2-
— should pay particular attention to the potential for groundwater contamination,
methoxy-1-
particularly of the active substance and its metabolites CGA 51202 and CGA
Union
methylethyl)acetamide
354743, when the active substance is applied in regions with vulnerable soil
(20-0 %)
and/or climatic conditions,
— should pay particular attention to the protection of aquatic plants.
Risk mitigation measures should be applied where appropriate.
98 Gliocladium
Not applicable 1
April
31 March
Only uses as fungicide may be authorised.
catenulatum
2005
2015
When granting authorisations, the conclusions of the review report on Gliocladium
Strain: J1446
catenulatum, and in particular Appendices I and II thereof, as finalised in the
Culture collection No
Standing Committee on the Food Chain and Animal Health on 30 March 2004
DSM 9212
shall be taken into account.
CIPAC No
In this overall assessment, Member States should pay particular attention to the
11.6.2011
protection of operators and workers. Risk mitigation measures should be applied
Not allocated
where appropriate.

---

11.6.2011 Off
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
99 Etoxazole
(RS)-5-tert-butyl-2-[2-(2,6-
≥ 948 g/kg 1
June
2005 31
May Only uses as acaricide may be authorised.
difluorophenyl)-4,5-
2015
CAS No 153233-91-1
dihydro-1,3-oxazol-4-yl]
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on etoxazole,
CIPAC No 623
phenetole
and in particular Appendices I and II thereof, as finalised in the Standing Committee
EN
on the Food Chain and Animal Health on 3 December 2004 shall be taken into

account.
In this overall assessment Member States should pay particular attention to the
protection of aquatic organisms.
Risk mitigation measures should be applied where appropriate.
100 Tepraloxydim
(EZ)-(RS)-2-{1-[(2E)-3-
≥ 920 g/kg 1
June
2005 31
May Only uses as herbicide may be authorised.
chloroally
2015
CAS No 149979-41-9
loxyimino]propyl}-3-
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on tepral
icial
CIPAC No 608
hydroxy-5-perhydropyran-
4-ylcyclohex-2-en-1-one
oxydim, and in particular Appendices I and II thereof, as finalised in the Standing
Committee on the Food Chain and Animal Health on 3 December 2004 shall be
Jour
taken into account.
nal
In this overall assessment, Member States should pay particular attention to the
of
protection of terrestrial non-target arthropods.
the
Risk mitigation measures should be applied where appropriate.
European
101 Chlorothalonil
Tetrachloroisophtha
985 g/kg
1 March
28 February PART A
Union
lonitrile
2006
2016
CAS No 1897-45-6
— Hexachloro
Only uses as fungicide may be authorised.
benzene: not more
CIPAC No 288
than 0,04 g/kg
PART B
— Decachloro
biphenyl: not
For the implementation of the uniform principles as referred to in Article 29(6) of
more than
Regulation (EC) No 1107/2009, the conclusions of the review report on chloro
0,03 g/kg
thalonil, and in particular Appendices I and II thereof, as finalised in the Standing
Committee onthe Food Chain and Animal Health on 15 February 2005 shall be
taken into account.
In this overall assessment Members States must pay particular attention to the
protection of:
— aquatic organisms,
— groundwater, in particular with regards to the active substance and its meta
bolites R417888 and R611965 (SDS46851), when the substance is applied in
regions with vulnerable soil and/or climate conditions.
L
153/31
Conditions of use should include risk mitigation measures, where appropriate.

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L 153/32
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
102 Chlorotoluron
(unstated
3-(3-chloro-p-tolyl)-1,1-
975 g/kg 1
March
28 February PART A
stereochemistry)
dimethylurea
2006
2016
Only uses as herbicide may be authorised
CAS No 15545-48-9
PART B
EN
CIPAC No 217

For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on chloro
toluron, and in particular Appendices I and II thereof, as finalised in the Standing
Committee on the Food Chain and Animal Health on 15 February 2005 shall be
taken into account. In this overall assessment Member States must pay particular
attention to the protection of groundwater, when the active substance is applied in
regions with vulnerable soil and/or climate conditions. Conditions of authorisation
should include risk mitigation measures, where appropriate
Off
103 Cypermethrin
(RS)-α-cyano-3 phenoxy 900 g/kg 1
March
28 February PART A
icial
benzyl-(1RS)-cis, trans-3-
2006
2016
CAS No 52315-07-8
(2,2-dichlorovinyl)-2,2-
Only uses as insecticide may be authorised
Jour
dimethylcyclopropane
CIPAC No 332
nal
carboxylate
PART B
of
(4 isomer pairs: cis-1, cis-2,
For the implementation of the uniform principles as referred to in Article 29(6) of
the
trans-3, trans-4)
Regulation (EC) No 1107/2009, the conclusions of the review report on cyper
methrin, and in particular Appendices I and II thereof, as finalised in the Standing
European
Committee on the Food Chain and Animal Health on 15 February 2005 shall be
taken into account. In this overall assessment:
— Member States must pay particular attention to the protection of aquatic
Union
organisms, bees and non-target arthropods. Conditions of authorisation should
include risk mitigation measures, where appropriate,
— Member States must pay particular attention to the operator safety. Conditions of
authorisation should include protective measures, where appropriate
104 Daminozide
N-dimethylaminosuc
990 g/kg
1 March
28 February PART A
cinamic acid
2006
2016
CAS No 1596-84-5
Impurities:
Only uses as growth regulator in non-edible crops may be authorised
CIPAC No 330
— N-nitrosodi
PART B
methylamine: not
more than
For the implementation of the uniform principles as referred to in Article 29(6) of
2,0 mg/kg
Regulation (EC) No 1107/2009, the conclusions of the review report on daminozide,
and in particular Appendices I and II thereof, as finalised in the Standing Committee
— 1,1-dimethyl
on the Food Chain and Animal Health on 15 February 2005 shall be taken into
11.6.2011
hydrazide: not
account. In this overall assessment Member States must pay particular attention to
more than
the safety of operators and workers after re-entry. Conditions of authorisation should
30 mg/kg
include protective measures, where appropriate

---

11.6.2011 Off
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
105 Thiophanate-methyl Dimethyl 4,4′-(o-
950 g/kg 1
March
28 February PART A
(unstated stereo
phenylene)bis(3-thioal
2006
2016
chemistry)
lophanate)
Only uses as fungicide may be authorised
CAS No 23564-05-8
PART B
EN

CIPAC No 262
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on
thiophanate-methyl, and in particular Appendices I and II thereof, as finalised in
the Standing Committee on the Food Chain and Animal Health on 15 February
2005 shall be taken into account. In this overall assessment Member States must pay
particular attention to the protection of aquatic organisms, earthworms and other
soil macro-organisms. Conditions of authorisation should include risk mitigation
measures, where appropriate
icial
106 Tribenuron
2-[4-methoxy-6-methyl-
950 g/kg (expressed as
1 March
28 February PART A
1,3,5-triazin-2-
tribenuron-methyl)
2006
2016
Jour
CAS No 106040-48-6 yl(methyl)carbamoylsul
Only uses as herbicide may be authorised.
(tribenuron)
famoyl]benzoic acid
nal
PART B
of
CIPAC No 546
For the implementation of the uniform principles as referred to in Article 29(6) of
the
Regulation (EC) No 1107/2009, the conclusions of the review report on tribenuron,
European
and in particular Appendices I and II thereof, as finalised in the Standing Committee
on the Food Chain and Animal Health on 15 February 2005 shall be taken into
account. In this overall assessment Member States must pay particular attention to
the protection of non-target terrestrial plants, higher aquatic plants and groundwater
Union
in vulnerable situations. Conditions of authorisation should include risk mitigation
measures, where appropriate.
107 MCPA
4-chloro-o-tolyloxyacetic
≥ 930 g/kg 1
May
2006 30
April PART A
acid
2016
CAS No 94-74-6
Only uses as herbicide may be authorised
CIPAC No 2
PART B
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on MCPA, and
in particular Appendices I and II thereof, as finalised in the Standing Committee on
the Food Chain and Animal Health on 15 April 2005 shall be taken into account
Member States should pay particular attention to the potential for groundwater
contamination, when the active substance is applied in regions with vulnerable
L
soil and/or climatic conditions. Conditions of authorisation should include risk
153/33
mitigation measures, where appropriate

---

L 153/34
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
Member States must pay particular attention to the protection of aquatic organisms
and must ensure that the conditions of authorisation include risk mitigation
measures, where appropriate, such as buffer zones
EN

108 MCPB
4-(4-chloro-o-
≥ 920 g/kg 1
May
2006 30
April PART A
tolyloxy)butyric acid
2016
CAS No 94-81-5
Only uses as herbicide may be authorised
CIPAC No 50
PART B
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on MCPB, and
Off
in particular Appendices I and II thereof, as finalised in the Standing Committee on
icial
the Food Chain and Animal Health on 15 April 2005 shall be taken into account
Jour
Member States should pay particular attention to the potential for groundwater
contamination, when the active substance is applied in regions with vulnerable
nal
soil and/or climatic conditions. Conditions of authorisation should include risk
of
mitigation measures, where appropriate
the
European
Member States must pay particular attention to the protection of aquatic organisms
and must ensure that the conditions of authorisation include risk mitigation
measures, where appropriate, such as buffer zones
Union
109 Bifenazate
Isopropyl 2-(4-methoxy ≥ 950 g/kg 1
December
30 November PART A
biphenyl-3-yl)hydrazino
2005
2015
CAS No 149877-41-8
formate
Only uses as acaricide may be authorised.
CIPAC No 736
PART B
In assessing applications to authorise plant protection products containing bifenazate
for uses other than on ornamental plants in greenhouses, Member States shall pay
particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009,
and shall ensure that any necessary data and information is provided before such an
authorization is granted.
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on bifenazate,
11.6.2011
and in particular Appendices I and II thereof, as finalised in the Standing Committee
on the Food Chain and Animal Health on 3 June 2005 shall be taken into account.

---

11.6.2011 Off
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
110 Milbemectin
M.A3:
≥ 950 g/kg 1
December
30 November PART A
(10E,14E,16E,22Z)-
2005
2015
Milbemectin is a
(1R,4S,5′S,6R,6′R,8R,13R,
mixture of M.A3 and
Only uses as acaricide or insecticide may be authorised.
20R,21R,24S)-21,24-
M.A4
EN
dihydroxy-5′,6′,11,13,22-

CAS No
pentamethyl-3,7,19-trioxa
PART B
tetracyclo[15.6.1.14,8.020,
M.A3: 51596-10-2
24] pentacosa-10,14,16,
For the implementation of the uniform principles as referred to in Article 29(6) of
M.A4: 51596-11-3
22-tetraene-6-spiro-2′-
Regulation (EC) No 1107/2009, the conclusions of the review report on milbe
tetrahydropyran-2-one
mectin, and in particular Appendices I and II thereof, as finalised in the Standing
CIPAC No 660
Committee on the Food Chain and Animal Health on 3 June 2005 shall be taken
M.A4:
into account.
(10E,14E,16E,22Z)-
(1R,4S,5′S,6R,6′R,8R,13R,
20R,21R,24S)-6′-ethyl-
In this overall assessment Member States should pay particular attention to the
21,24-dihydroxy-
protection of aquatic organisms.
5′,11,13,22-tetramethyl-
icial
3,7,19-trioxatet
Risk mitigation measures should be applied where appropriate.
racyclo[15.6.1.
Jour
14,8020,24] pentacosa-
10,14,16,22-tetraene-6-
nal
spiro-2′-tetrahydropyran-2-
of
one
the
European
111 Chlorpyrifos
O,O-diethyl-O-3,5,6-
≥ 970 g/kg
1 July 2006 30
June PART A
trichloro-2-pyridyl phos
2016
CAS No 2921-88-2
phorothioate
The impurity
Union
O,O,O,O-tetraethyl
Only uses as insecticide may be authorised.
CIPAC No 221
dithiopyrophosphate
(Sulfotep) was
PART B
considered of toxico
logical concern and a
For the implementation of the uniform principles as referred to in Article 29(6) of
maximum level of
Regulation (EC) No 1107/2009, the conclusions of the review report on chlor
3 g/Kg is established.
pyrifos, and in particular Appendices I and II thereof, as finalised in the Standing
Committee on the Food Chain and Animal Health on 3 June 2005 shall be taken
into account.
Member States must pay particular attention to the protection of birds, mammals,
aquatic organisms, bees and non-target arthropods and must ensure that the
conditions of authorisation include risk mitigation measures, where appropriate,
such as buffer zones.
Member States shall request the submission of further studies to confirm the risk
assessment for birds and mammals. They shall ensure that the notifiers at whose
L
request chlorpyrifos has been included in this Annex provide such studies to the
153/35
Commission within two years from the approval.

---

L 153/36
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
112 Chlorpyrifos-methyl O,O-dimethyl-O-3,5,6-
≥ 960 g/kg
1 July 2006 30
June PART A
trichloro-2-pyridyl phos
2016
CAS No 5598-13-0
phorothioate
The impurities
O,O,O,O-tetramethyl
Only uses as insecticide may be authorised.
CIPAC No 486
dithiopyrophosphate
EN
(Sulfotemp) and

OOO-trimethyl-O-
PART B
(3,5,6-trichloro-2-
pyridinyl) diphospho
For the implementation of the uniform principles as referred to in Article 29(6) of
rodithioate (Sulfotemp
Regulation (EC) No 1107/2009, the conclusions of the review report on chlor
-ester) were
pyrifos-methyl, and in particular Appendices I and II thereof, as finalised in the
considered of toxico
Standing Committee on the Food Chain and Animal Health on 3 June 2005 shall
logical concern and a
be taken into account.
maximum level of
5 g/Kg is established
for each impurity.
Member States must pay particular attention to the protection of birds, mammals,
aquatic organisms, bees and non-target arthropods and must ensure that the
Off
conditions of authorisation include risk mitigation measures, where appropriate,
icial
such as buffer zones.
Jour
Member States shall request the submission of further studies to confirm the risk
nal
assessment for birds and mammals in case of outdoor uses. They shall ensure that
of
the notifiers at whose request chlorpyrifos-methyl has been included in this Annex
the
provide such studies to the Commission within two years from the approval.
European
113 Maneb
manganese ethylenebis
≥ 860 g/kg
1 July 2006 30
June PART A
(dithiocarbamate)
2016
CAS No 12427-38-2
(polymeric )
The manufacturing
Union
impurity ethylene
Only uses as fungicide may be authorised.
CIPAC No 61
thiourea is considered
to be of toxicological
PART B
concern and must
not exceed 0,5 % of
the maneb content.
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on maneb, and
in particular Appendices I and II thereof, as finalised in the Standing Committee on
the Food Chain and Animal Health on 3 June 2005 shall be taken into account.
Member States must pay particular attention to the potential for groundwater
contamination when the active substance is applied in regions with vulnerable
soils and/or extreme climatic conditions.
Member States must pay particular attention to the residues in food and evaluate the
dietary exposure of consumers.
11.6.2011
Member States must pay particular attention to the protection of birds, mammals,
aquatic organisms and non-target arthropods and ensure that the conditions of
authorisation include risk mitigation measures.

---

11.6.2011 Off
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
Member States shall request the submission of further studies to confirm the risk
assessment for birds and mammals and for developmental toxicity.
They shall ensure that the notifiers at whose request maneb has been included in this
EN
Annex provide such studies to the Commission within two years from the approval.

114 Mancozeb
Manganese ethylenebis
≥ 800 g/kg
1 July 2006 30
June PART A
(dithiocarbamate)
2016
CAS No 8018-01-7 (polymeric) complex with The manufacturing
Only uses as fungicide may be authorised.
(formerly 8065-67-5)
zinc salt
impurity ethylene
thiourea is considered
CIPAC No 34
PART B
to be of toxicological
concern and must
not exceed 0,5 % of
For the implementation of the uniform principles as referred to in Article 29(6) of
the mancozeb
Regulation (EC) No 1107/2009, the conclusions of the review report on mancozeb,
content.
and in particular Appendices I and II thereof, as finalised in the Standing Committee
on the Food Chain and Animal Health on 3 June 2005 shall be taken into account.
icial
Jour
Member States must pay particular attention to the potential for groundwater
contamination when the active substance is applied in regions with vulnerable
nal
soils and/or extreme climatic conditions.
of
the
Member States must pay particular attention to the residues in food and evaluate the
dietary exposure of consumers.
European
Member States must pay particular attention to the protection of birds, mammals,
aquatic organisms and non-target arthropods and ensure that the conditions of
authorisation include risk mitigation measures.
Union
Member States shall request the submission of further studies to confirm the risk
assessment for birds and mammals and for developmental toxicity.
They shall ensure that the notifiers at whose request mancozeb has been included in
this Annex provide such studies to the Commission within two years from the
approval.
115 Metiram
Zinc ammoniate ethyl ≥ 840 g/kg
1 July 2006 30
June PART A
enebis(dithiocarbamate) —
2016
CAS No 9006-42-2
poly[ethylenebis(thiuram
The manufacturing
Only uses as fungicide may be authorised.
disulfide)]
impurity ethylene
CIPAC No 478
thiourea is considered
PART B
to be of toxicological
concern and must
not exceed 0,5 % of
For the implementation of the uniform principles as referred to in Article 29(6) of
L
the metiram content.
Regulation (EC) No 1107/2009, the conclusions of the review report on metiram,
153/37
and in particular Appendices I and II thereof, as finalised in the Standing Committee
on the Food Chain and Animal Health on 3 June 2005 shall be taken into account.

---

L 153/38
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
Member States must pay particular attention to the potential for ground water
contamination when the active substance is applied in regions with vulnerable
soils and/or extreme climatic conditions.
EN
Member States must pay particular attention to the residues in food and evaluate the

dietary exposure of consumers.
Member States must pay particular attention to the protection of birds, mammals,
aquatic organisms and non target arthropods and must ensure that the conditions of
authorisation include risk mitigation measures.
Member States shall request the submission of further studies to confirm the risk
assessment for birds and mammals. They shall ensure that the notifiers at whose
request metiram has been included in this Annex provide such studies to the
Off
Commission within two years from the approval.
icial
Jour
116 Oxamyl
N,N-dimethyl-2-methylcar
970 g/kg 1
August
31 July 2016 PART
A
bamoyloxyimino-2-
2006
nal
CAS No 23135-22-0
(methylthio) acetamide
Only uses as nematicide and insecticide may be authorised.
of
CIPAC No 342
the
PART B
European
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on oxamyl,
and in particular Appendices I and II thereto, as finalised in the Standing Committee
Union
on the Food Chain and Animal Health on 15 July 2005 shall be taken into account.
In this overall assessment,
— Member States must pay particular attention to the protection of birds and
mammals, earthworms, aquatic organisms, surface water, and groundwater in
vulnerable situations.
Conditions of authorisation should include risk mitigation measures, where appro
priate.
— Member States must pay particular attention to the operator safety. Conditions of
authorisation should include protective measures, where appropriate.
The concerned Member States shall request the submission of further studies to
confirm the risk assessment for ground water contamination in acidic soils, birds
and mammals and earthworms. They shall ensure that the notifiers at whose request
11.6.2011
oxamyl has been included in this Annex provide such studies to the Commission
within two years from the approval.

---

11.6.2011 Off
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
117 1-methylcyclopropene 1-methylcyclopropene
≥ 960 g/kg
1 April
31 March
PART A
(an ISO Common Name
2006
2016
will not be considered
The manufacturing
Only uses as plant growth regulator for post harvest storage in sealable warehouse
for this active
impurities 1-chloro-2-
may be authorised.
substance)
methylpropene and 3-
EN
chloro-2-methyl
PART B

CAS No 3100-04-7
propene are of toxico
logical concern and
CIPAC No not allocated
For the implementation of the uniform principles as referred to in Article 29(6) of
each of them must
Regulation (EC) No 1107/2009, the conclusions of the review report on 1-methyl
not exceed 0,5
g/kg
cyclopropene, and in particular Appendices I and II thereof, as finalised in the
in the technical
Standing Committee on the Food Chain and Animal Health on 23 September
material.
2005 shall be taken into account.
118 Forchlorfenuron
1-(2-chloro-4-pyridinyl)-3-
≥ 978 g/kg 1
April
31 March
PART A
phenylurea
2006
2016
CAS No 68157-60-8
Only uses as plant growth regulator may be authorised.
icial
CIPAC No 633
PART B
Jour
In assessing applications to authorise plant protection products containing forchlor
nal
fenuron for uses other than in kiwi plants, Member States shall pay particular
attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and
of
shall ensure that any necessary data and information is provided before such an
the
authorization is granted.
European
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on forchlor
fenuron, and in particular Appendices I and II thereof, as finalised in the Standing
Union
Committee on the Food Chain and Animal Health on 23 September 2005 shall be
taken into account.
In this overall assessment Member States must pay particular attention to the
potential for groundwater contamination, when the active substance is applied in
regions with vulnerable soil and/or climatic conditions.
Risk mitigation measures should be applied where appropriate.
119 Indoxacarb
methyl (S)-N-[7-chloro-
TC (Technical
1 April
31 March
PART A
2,3,4a,5-tetrahydro-4a-
Material): ≥ 628 g/kg
2006
2016
CAS No 173584-44-6
(methoxycarbonyl)indeno
indoxacarb
Only uses as insecticide may be authorised.
[1,2-e][1,3,4]oxadiazin-2-
CIPAC No 612
ylcarbonyl]-4′-(trifluoro
PART B
methoxy)carbanilate
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on indoxacarb,
L
and in particular Appendices I and II thereof, as finalised in the Standing Committee
153/39
on the Food Chain and Animal Health on 23 September 2005 shall be taken into
account.

---

L 153/40
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
In this overall assessment Member States must pay particular attention to the
protection of aquatic organisms.
Conditions of use should include risk mitigation measures, where appropriate.
EN
120 Warfarin
(RS)-4-hydroxy-3-(3-oxo-1- ≥ 990 g/kg 1
October
30 September PART A

phenylbutyl)coumarin 3-(α-
2006
2013
CAS No 81-81-2
acetonyl-benzyl)-4-
Only uses as rodenticide in the form of pre-prepared bait, if appropriate, placed in
hydroxycoumarin
specially constructed hoppers, are authorised.
CIPAC No 70
PART B
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on warfarin,
Off
and in particular Appendices I and II thereto, as finalised in the Standing Committee
on the Food Chain and Animal Health on 23 September 2005, shall be taken into
icial
account. In this overall assessment Member States should pay particular attention to
the protection of operators, birds and non-target mammals.
Jour
nal
Risk mitigation measures should be applied where appropriate.
of
the
121 Clothianidin
(E)-1-(2-chloro-1,3-thiazol- ≥ 960 g/kg 1
August
31 July 2016 PART
A
European
5-ylmethyl)-3-methyl-2-
2006
CAS No 210880-92-5
nitroguanidine
Only uses as insecticide may be authorised.
Union
CIPAC No 738
For the protection of non-target organisms, in particular honey bees, for use as seed
treatment:
— the seed coating shall only be performed in professional seed treatment facilities.
Those facilities must apply the best available techniques in order to ensure that
the release of dust during application to the seed, storage, and transport can be
minimised,
— adequate seed drilling equipment shall be used to ensure a high degree of incor
poration in soil, minimisation of spillage and minimisation of dust emission.
Member States shall ensure that:
— the label of the treated seed includes the indication that the seeds were treated
with clothianidin and sets out the risk mitigation measures provided for in the
authorisation,
11.6.2011
— the conditions of the authorisation, in particular for spray applications, include,
where appropriate, risk mitigation measures to protect honey bees,

---

11.6.2011 Off
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
— monitoring programmes are initiated to verify the real exposure of honey bees to
clothianidin in areas extensively used by bees for foraging or by beekeepers,
where and as appropriate.
PART B
EN

For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on cloth
ianidin, and in particular Appendices I and II thereof, as finalised in the Standing
Committee on the Food Chain and Animal Health on 27 January 2006 shall be
taken into account.
In this overall assessment Member States
— must pay particular attention to the protection of groundwater, when the active
substance is applied in regions with vulnerable soil and/or climate conditions,
icial
Jour
— must pay particular attention to the risk to granivorous birds and mammals
when the substance is used as a seed dressing.
nal
of
Conditions of use shall include risk mitigation measures, where appropriate.
the
European
122 Pethoxamid
2-chloro-N-(2-ethoxyethyl)- ≥ 940 g/kg 1
August
31 July 2016 PART
A
N-(2-methyl-1-phenylprop-
2006
CAS No 106700-29-2
1-enyl) acetamide
Only uses as herbicide may be authorised.
Union
PART B
CIPAC No 655
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on
pethoxamid, and in particular Appendices I and II thereof, as finalised in the
Standing Committee on the Food Chain and Animal Health on 27 January 2006
shall be taken into account.
In this overall assessment Member States
— must pay particular attention to the protection of groundwater, when the active
substance is applied in regions with vulnerable soil and/or climate conditions,
— must pay particular attention to the protection of the aquatic environment, in
particular higher aquatic plants.
Conditions of use shall include risk mitigation measures, where appropriate.
The Member States shall inform the Commission in accordance with Article 38 of
L
153/41
Regulation (EC) No 1107/2009 on the specification of the technical material as
commercially manufactured.

---

L 153/42
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
123 Clodinafop
(R)-2-[4-(5-chloro-3-fluoro- ≥ 950 g/kg (expressed
1 February
31 January PART A
2 pyridyloxy)-phenoxy]-
as clodinafop-
2007
2017
CAS No 114420-56-3
propionic acid
propargyl)
Only uses as herbicide may be authorised.
CIPAC No 683
PART B
EN

For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on clodinafop,
and in particular Appendices I and II thereof, as finalised in the Standing Committee
on the Food Chain and Animal Health on 27 January 2006 shall be taken into
account.
124 Pirimicarb
2-dimethylamino-5,6-
≥ 950 g/kg 1
February
31 January PART A
dimethylpyrimidin-4-yl
2007
2017
CAS No 23103-98-2
dimethylcarbamate
Only uses as insecticide may be authorised.
Off
CIPAC No 231
PART B
icial
For the implementation of the uniform principles as referred to in Article 29(6) of
Jour
Regulation (EC) No 1107/2009, the conclusions of the review report on pirimicarb,
and in particular Appendices I and II thereof, as finalised in the Standing Committee
nal
on the Food Chain and Animal Health on 27 January 2006 shall be taken into
of
account.
the
Member States must pay particular attention to the safety of operators and ensure
European
that conditions of use prescribe the application of adequate personal protective
equipment.
Member States must pay particular attention to the protection of aquatic organisms
Union
and must ensure that the conditions of authorisation include risk mitigation
measures, where appropriate, such as buffer zones.
The concerned Member States shall request the submission of further studies to
confirm the long term risk assessment for birds and for potential groundwater
contamination, in particular concerning metabolite R35140. They shall ensure
that the notifiers at whose request pirimicarb has been included in this Annex
provide such studies to the Commission within two years from the approval.
125 Rimsulfuron
1-(4-6 dimethoxypyrimidin- ≥ 960 g/kg (expressed
1 February
31 January PART A
2-yl)-3-(3-ethylsulfonyl-2-
as rimsulfuron)
2007
2017
CAS No 122931-48-0 pyridylsulfonyl) urea
Only uses as herbicide may be authorised.
(rimsulfuron)
PART B
CIPAC No 716
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on
11.6.2011
rimsulfuron, and in particular Appendices I and II thereof, as finalised in the
Standing Committee on the Food Chain and Animal Health on 27 January 2006
shall be taken into account.

---

11.6.2011 Off
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
Member States must pay particular attention to the protection of non target plants
and groundwater in vulnerable situations. Conditions of authorisation should include
risk mitigation measures, where appropriate.
EN
126 Tolclofos-methyl
O-2,6-dichloro-p-tolyl
≥ 960 g/kg 1
February
31 January PART A

O,O-dimethyl phosphoro
2007
2017
CAS No 57018-04-9
thioate
Only uses as fungicide may be authorised.
CIPAC No 479
O-2,6-dichloro-4-methyl
PART B
phenyl O,O-dimethyl phos
phorothioate
In assessing applications to authorise plant protection products containing tolclofos-
methyl for uses other than pre-planting tuber (seed) treatment in potato and soil
treatment in lettuce within greenhouses, Member States shall pay particular attention
to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure
that any necessary data and information is provided before such an authorisation is
icial
granted.
Jour
For the implementation of the uniform principles as referred to in Article 29(6) of
nal
Regulation (EC) No 1107/2009, the conclusions of the review report on tolclofos-
methyl, and in particular Appendices I and II thereof, as finalised in the Standing
of
Committee on the Food Chain and Animal Health on 27 January 2006 shall be
the
taken into account.
European
127 Triticonazole
(±)-(E)-5-(4-chloro
≥ 950 g/kg 1
February
31 January PART A
benzylidene)-2,2-dimethyl-
2007
2017
Union
CAS No 131983-72-7
1-(1H-1,2,4-triazol-1-
Only uses as fungicide may be authorised.
ylmethyl)cyclopentanol
CIPAC No 652
PART B
In assessing applications to authorise plant protection products containing triti
conazole for uses other than seed treatment, Member States shall pay particular
attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and
shall ensure that any necessary data and information is provided before such an
authorisation is granted.
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on triti
conazole, and in particular Appendices I and II thereof, as finalised in the
Standing Committee on the Food Chain and Animal Health on 27 January 2006
shall be taken into account. In this overall assessment Member States:
L
153/43
— must pay particular attention to the operator safety. Conditions of authorisation
should include protective measures, where appropriate,

---

L 153/44
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
— must pay particular attention to the potential for groundwater contamination, in
particular from the highly persistent active substance and its metabolite RPA
406341, in vulnerable zones,
— must pay particular attention to the protection of granivorous birds (long term
EN
risk).

Conditions of authorisation should include risk mitigation measures, where appro
priate.
The concerned Member States shall request the submission of further studies to
confirm the risk assessment for granivorous birds. They shall ensure that the
notifier at whose request triticonazole has been included in this Annex provide
such studies to the Commission within two years from the approval.
Off
128 Dimoxystrobin
(E)-o-(2,5-dimethylphe
≥ 980 g/kg 1
October
30 September PART A
icial
noxymethyl)-2-
2006
2016
Jour
CAS No 149961-52-4
methoxyimino-N-methyl
Only uses as fungicide may be authorised.
phenylacetamide
nal
CIPAC No 739
PART B
of
the
In assessing applications to authorise plant protection products containing dimoxy
strobin for indoor uses, Member States shall pay particular attention to the criteria in
European
Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary
data and information is provided before such an authorisation is granted.
Union
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on dimoxy
strobin, and in particular Appendices I and II thereof, as finalised in the Standing
Committee on the Food Chain and Animal Health on 27 January 2006 shall be
taken into account.
In this overall assessment Member States
— must pay particular attention to the protection of groundwater, when the active
substance is applied in a situation with a low crop interception factor, or in
regions with vulnerable soil and/or climate conditions;
— must pay particular attention to the protection of aquatic organisms.
Conditions of use shall include risk mitigation measures, where appropriate.
The concerned Member States shall request the submission of
11.6.2011
— a refined risk assessment for birds and mammals considering the formulated
active substance;

---

11.6.2011 Off
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
— a comprehensive aquatic risk assessment considering the high chronic risk to fish
and the effectiveness of potential risk mitigation measures, particularly taking
into account run-off and drainage.
They shall ensure that the notifiers at whose request dimoxystrobin has been
EN
included in this Annex provide such studies to the Commission within two years

from the approval.
129 Clopyralid
3,6-dichloropyridine-2-
≥ 950 g/kg 1
May
2007 30
April PART A
carboxylic acid
2017
CAS No 1702-17-6
Only uses as herbicide may be authorised.
CIPAC No 455
PART B
In assessing applications to authorise plant protection products containing clopyralid
for uses other than spring applications, Member States shall pay particular attention
to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure
icial
that any necessary data and information is provided before such an authorisation is
granted.
Jour
nal
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on clopyralid,
of
and in particular Appendices I and II thereof, as finalised in the Standing Committee
the
on the Food Chain and Animal Health on 4 April 2006 shall be taken into account.
European
In this overall assessment Member States must pay particular attention to:
— the protection of non target plants and groundwater under vulnerable
Union
conditions. Conditions of authorisation should include risk mitigation
measures and monitoring programmes should be initiated to verify potential
groundwater contamination in vulnerable zones, where appropriate.
The concerned Member States shall request the submission of further studies to
confirm the results on animal metabolism. They shall ensure that the notifiers at
whose request clopyralid has been included in this Annex provide such studies to the
Commission within two years from the approval.
130 Cyprodinil
(4-cyclopropyl-6-methyl-
≥ 980 g/kg 1
May
2007 30
April PART A
pyrimidin-2-yl)-phenyl-
2017
CAS No 121522-61-2
amine
Only uses as fungicide may be authorised.
CIPAC No 511
PART B
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on cyprodinil,
L
and in particular Appendices I and II thereof, as finalised in the Standing Committee
153/45
on the Food Chain and Animal Health on 4 April 2006 shall be taken into account.

---

L 153/46
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
In this overall assessment Member States:
— must pay particular attention to the safety of operators and ensure that
conditions of use prescribe the application of adequate personal protective
equipment,
EN

— must pay particular attention to the protection of birds, mammals and aquatic
organisms. Conditions of authorisation should include risk mitigation measures,
such as buffer zones.
The concerned Member States shall request the submission of further studies to
confirm the risk assessment for birds and mammals and for possible presence of
residues of metabolite CGA 304075 in food of animal origin. They shall ensure that
the notifiers at whose request cyprodinil has been included in this Annex provide
such studies to the Commission within two years from the approval.
Off
131 Fosetyl
Ethyl hydrogen phos ≥ 960 g/kg (expressed 1 May 2007 30
April PART A
icial
phonate
as fosetyl-Al)
2017
CAS No 15845-66-6
Only uses as fungicide may be authorised.
Jour
CIPAC No 384
PART B
nal
of
For the implementation of the uniform principles as referred to in Article 29(6) of
the
Regulation (EC) No 1107/2009, the conclusions of the review report on fosetyl, and
in particular Appendices I and II thereof, as finalised in the Standing Committee on
European
the Food Chain and Animal Health on 4 April 2006 shall be taken into account.
In this overall assessment Member States:
Union
— must pay particular attention to the protection of birds, mammals, aquatic
organisms and non-target arthropods.
Conditions of authorisation should include risk mitigation measures, where appro
priate, such as buffer zones.
The concerned Member States shall request the submission of further studies to
confirm the risk assessment for non-target arthropods, in particular with regard to
in-field recovery, and for herbivorous mammals. They shall ensure that the notifier at
whose request fosetyl has been included in this Annex provide such studies to the
Commission within two years from the approval.
132 Trinexapac
4-(cyclopropyl-hydroxy
≥ 940 g/kg (expressed 1 May 2007 30
April PART A
methylene)-3,5-dioxo-
as trinexapac-ethyl)
2017
CAS No 104273-73-6
cyclohexanecarboxylic acid
Only uses as plant growth regulator may be authorised.
CIPAC No 732
PART B
11.6.2011
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on trinexapac,

---

11.6.2011 Off
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
and in particular Appendices I and II thereof, as finalised in the Standing Committee
on the Food Chain and Animal Health on 4 April 2006 shall be taken into account.
In this overall assessment Member States:
EN
— must pay particular attention to the protection of birds and mammals.

Conditions of authorisation should include risk mitigation measures, where appro
priate.
133 Dichlorprop-P
(R)-2-(2,4-dichloro
≥ 900 g/kg 1
June
2007 31
May PART A
phenoxy) propanoic acid
2017
CAS No 15165-67-0
Only uses as herbicide may be authorised.
CIPAC No 476
PART B
For the implementation of the uniform principles as referred to in Article 29(6) of
icial
Regulation (EC) No 1107/2009, the conclusions of the review report on di
chlorprop-P, and in particular Appendices I and II thereof, as finalised in the
Jour
Standing Committee on the Food Chain and Animal Health on 23 May 2006
shall be taken into account.
nal
of
In this overall assessment Member States:
the
— must pay particular attention to the protection of birds, mammals, aquatic
European
organisms and non-target plants. Conditions of authorisation should include
risk mitigation measures, where appropriate.
The Member States concerned shall request the submission of further studies to
Union
confirm the results on animal metabolism and the risk assessment on acute and
short-term exposure for birds and on acute exposure for herbivorous mammals.
They shall ensure that the notifiers at whose request dichlorprop-P has been included
in this Annex provide such studies to the Commission within two years of the
approval.
134 Metconazole
(1RS,5RS:1RS,5SR)-5-(4-
≥ 940 g/kg
1 June 2007 31
May PART A
chlorobenzyl)-2,2-
2017
CAS No 125116-23-6 dimethyl-1-(1H-1,2,4-
(sum of cis-and trans-
Only uses as fungicide and plant growth regulator may be authorised.
(unstated stereo-
triazol-1-ylmethyl) cyclo isomers)
chemistry)
pentanol
PART B
CIPAC No 706
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on
metconazole, and in particular Appendices I and II thereof, as finalised in the
L
Standing Committee on the Food Chain and Animal Health on 23 May 2006
153/47
shall be taken into account.

---

L 153/48
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
In this overall assessment:
— Member States must pay particular attention to the protection of aquatic
organisms, birds and mammals. Conditions of authorisation should include
risk mitigation measures, where appropriate,
EN

— Member States must pay particular attention to the operator safety. Conditions of
authorisation should include protective measures, where appropriate.
135 Pyrimethanil
N-(4,6-dimethylpyrimidin-
≥ 975 g/kg
1 June 2007 31
May PART A
2-yl) aniline
2017
CAS No 53112-28-0
(the manufacturing
Only uses as fungicide may be authorised.
impurity cyanamide is
CIPAC No not allocated
considered to be of
PART B
toxicological concern
Off
and must not exceed
For the implementation of the uniform principles as referred to in Article 29(6) of
icial
0,5 g/kg
in
the
Regulation (EC) No 1107/2009, the conclusions of the review report on pyrime
technical material)
thanil, and in particular Appendices I and II thereof, as finalised in the Standing
Jour
Committee on the Food Chain and Animal Health on 23 May 2006 shall be taken
nal
into account.
of
In this overall assessment Member States:
the
European
— must pay particular attention to the protection of aquatic organisms. Conditions
of authorisation should include risk mitigation measures, where appropriate, such
as buffer zones,
Union
— must pay particular attention to the operator safety and ensure that conditions of
use prescribe the application of adequate personal protective equipment.
The Member States concerned shall request the submission of further studies to
confirm the risk assessment to fish. They shall ensure that the notifiers at whose
request pyrimethanil has been included in this Annex provide such studies to the
Commission within two years from the approval.
136 Triclopyr
3,5,6-trichloro-2-pyridylo
≥ 960 g/kg
1 June 2007 31
May PART A
xyacetic acid
2017
CAS No 055335-06-3
(as Triclopyr
Only uses as herbicide may be authorised.
butoxyethyl ester)
CIPAC No 376
PART B
In assessing applications to authorise plant protection products containing triclopyr
for uses other than spring applications in pasture and grassland, Member States shall
11.6.2011
pay particular attention to the criteria in Article 4(3) of Regulation (EC) No
1107/2009, and shall ensure that any necessary data and information is provided
before such an authorisation is granted.

---

11.6.2011 Off
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on triclopyr,
and in particular Appendices I and II thereof, as finalised in the Standing Committee
on the Food Chain and Animal Health on 23 May 2006 shall be taken into account.
EN
In this overall assessment Member States:

— must pay particular attention to the protection of groundwater under vulnerable
conditions. Conditions of authorisation should include risk mitigation measures
and monitoring programmes should be initiated in vulnerable zones, where
appropriate,
— must pay particular attention to the safety of operators and ensure that
conditions of use prescribe the application of adequate personal protective
equipment,
icial
— must pay particular attention to the protection of birds, mammals, aquatic
Jour
organisms and non-target plants. Conditions of authorisation should include
risk mitigation measures, where appropriate.
nal
of
The Member States concerned shall request the submission of further studies to
the
confirm the acute and long-term risk assessment for birds and mammals and the
European
risk to aquatic organisms from exposure to the metabolite 6-chloro-2-pyridinol.
They shall ensure that the notifiers at whose request triclopyr has been included
in this Annex provide such studies to the Commission within two years from the
approval.
Union
137 Metrafenone
3′-bromo-2,3,4,6′-
≥ 940 g/kg 1
February
31 January PART A
tetramethoxy-2′,6-
2007
2017
dimethylbenzophenone
CAS No 220899-03-6
Only uses as fungicide may be authorised.
CIPAC No 752
PART B
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on
metrafenone, and in particular Appendices I and II thereof, as finalised in the
Standing Committee on the Food Chain and Animal Health on 14 July 2006
shall be taken into account.
The Member States shall inform the Commission in accordance with Article 38 of
L
Regulation (EC) No 1107/2009 on the specification of the technical material as
153/49
commercially manufactured.

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L 153/50
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
138 Bacillus
subtilis
Not applicable 1
February
31 January PART A
2007
2017
(Cohn 1872)
Only uses as fungicide may be authorised.
Strain QST 713,
EN
identical with strain
PART B

AQ 713
For the implementation of the uniform principles as referred to in Article 29(6) of
Culture collection No:
Regulation (EC) No 1107/2009, the conclusions of the review report on Bacillus
NRRL B -21661
subtilis, and in particular Appendices I and II thereof, as finalised in the Standing
Committee on the Food Chain and Animal Health on 14 July 2006 shall be taken
CIPAC No not allocated
into account.
139 Spinosad
Spinosyn A:
≥ 850 g/kg 1
February
31 January PART A
Off
2007
2017
CAS No 131929-60-7 (2R,3aS,5aR,5bS,9S,13S,
Only uses as insecticide may be authorised.
icial
(Spinosyn A)
14R,16aS,16bR)-2-(6-
Jour
deoxy-2,3,4-tri-O-methyl-
PART B
131929-63-0 (Spinosyn α-L-mannopyranosyloxy)-
nal
D)
13-(4-dimethylamino-
For the implementation of the uniform principles as referred to in Article 29(6) of
2,3,4,6-tetradeoxy--D-
Regulation (EC) No 1107/2009, the conclusions of the review report on spinosad,
of
CIPAC No 636
erythropyranosyloxy)-9-
and in particular Appendices I and II thereof, as finalised in the Standing Committee
the
ethyl-2,3,3a,5a,5b,6,7,9,10,
on the Food Chain and Animal Health on 14 July 2006 shall be taken into account.
European
11,12,13,14,15,16a,16b-
hexadecahydro-14-methyl-
In this overall assessment Member States
1H-8-oxacyclododeca[b]as-
indacene-7,15-dione
— must pay particular attention to the protection of aquatic organisms;
Union
Spinosyn D:
— must pay particular attention to the risk to earthworms when the substance is
used in glasshouses.
(2S,3aR,5aS,5bS,9S,13S,
14R,16aS,16bS)-2-(6-
Conditions of use shall include risk mitigation measures, where appropriate.
deoxy-2,3,4-tri-O-methyl-
α-L-mannopyranosyloxy)-
13-(4-dimethylamino-
2,3,4,6-tetradeoxy--D-
erythropyranosyloxy)-9-
ethyl-2,3,3a,5a,5b,6,7,9,10,
11,12,13,14,15,16a,16b-
hexadecahydro-4,14-
dimethyl-1H-8-oxacyclo
dodeca[b]as-indacene-7,15-
dione
Spinosad is a mixture of
11.6.2011
50-95 % spinosyn A and
5-50 % spinosyn D

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11.6.2011 Off
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
140 Thiamethoxam
(E,Z)-3-(2-chloro-thiazol-5- ≥ 980 g/kg 1
February
31 January PART A
ylmethyl)-5-methyl-
2007
2017
CAS No 153719-23-4
[1,3,5]oxadiazinan-4-
Only uses as insecticide may be authorised.
CIPAC No 637
ylidene-N-nitroamine
EN
For the protection of non-target organisms, in particular honey bees, for use as seed

treatment:
— the seed coating shall only be performed in professional seed treatment facilities.
Those facilities must apply the best available techniques in order to ensure that
the release of dust during application to the seed, storage, and transport can be
minimised,
— adequate seed drilling equipment shall be used to ensure a high degree of incor
poration in soil, minimisation of spillage and minimisation of dust emission.
Member States shall ensure that:
icial
— the label of the treated seed includes the indication that the seeds were treated
with thiamethoxam and sets out the risk mitigation measures provided for in the
Jour
authorisation,
nal
— the conditions of the authorisation, in particular for spray applications, include,
of
where appropriate, risk mitigation measures to protect honey bees,
the
— monitoring programmes are initiated to verify the real exposure of honey bees to
European
thiamethoxam in areas extensively used by bees for foraging or by beekeepers,
where and as appropriate.
PART B
Union
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on thiame
thoxam, and in particular Appendices I and II thereof, as finalised in the Standing
Committee on the Food Chain and Animal Health on 14 July 2006 shall be taken
into account.
In this overall assessment Member States:
— must pay particular attention to the potential for groundwater contamination,
particularly of the active substance and its metabolites NOA 459602, SYN
501406 and CGA 322704, when the active substance is applied in regions
with vulnerable soil and/or climatic conditions,
— must pay particular attention to the protection of aquatic organisms,
— must pay particular attention to the long-term risk to small herbivorous animals
if the substance is used for seed treatment.
L
153/51
Conditions of use shall include risk mitigation measures, where appropriate.

---

L 153/52
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
141 Fenamiphos
(RS)-ethyl 4-methylthio-m- ≥ 940 g/kg 1
August
31 July 2017 PART
A
tolyl isopropyl-phosphor
2007
CAS No 22224-92-6
amidate
Only uses as nematicide applied by drip irrigation in greenhouses with permanent
CIPAC No 692
structure may be authorised.
EN
PART B

For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on fenamiphos,
and in particular Appendices I and II thereof, as finalised in the Standing Committee
on the Food Chain and Animal Health on 14 July 2006 shall be taken into account.
In this overall assessment:
— Member States must pay particular attention to the protection of aquatic
organisms, soil non-target organisms and groundwater in vulnerable situations.
Off
Conditions of authorisation should include risk mitigation measures and monitoring
icial
programmes should be initiated to verify potential groundwater contamination in
Jour
vulnerable zones, where appropriate.
nal
142 Ethephon
2-chloroethyl-phosphonic
≥ 910 g/kg (technical
1 August
31 July 2017 PART
A
of
acid
material — TC)
2007
the
CAS No 16672-87-0
Only uses as plant growth regulator may be authorised.
European
The manufacturing
CIPAC No 373
impurities MEPHA
PART B
(Mono 2-chloroethyl
ester, 2-chloroethyl
For the implementation of the uniform principles as referred to in Article 29(6) of
Union
phosphonic acid) and
Regulation (EC) No 1107/2009, the conclusions of the review report on ethephon,
1,2-Dichloroethane
and in particular Appendices I and II thereof, as finalised in the Standing Committee
are of toxicological
on the Food Chain and Animal Health on 14 July 2006 shall be taken into account.
concern and must
not exceed
respectively 20
g/kg
and 0,5 g/kg in the
technical material.
143 Flusilazole
(2 )
Bis(4-fluorophenyl)(methyl) 925 g/kg 1
January
30 June
PART A
(1H-1,2.4-triazol-1-
2007
2008 (2 )
CAS No 85509-19-9
ylmethyl)silane
Only uses as fungicide on the following crops may be authorised:
CIPAC No 435
— cereals other than rice (2 ),
— maize (2 ),
11.6.2011
— rape seed (2 ),
— sugar beet (2 ),

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11.6.2011 Off
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
at rates not exceeding 200 g active substance per hectare per application.
The following uses must not be authorised:
— air application,
EN

— knapsack and hand-held applications, neither by amateur nor by professional
users,
— home gardening.
Member States shall ensure that all appropriate risk mitigation measures are applied.
Particular attention must be paid to the protection of:
— aquatic organisms. An appropriate distance must be kept between treated areas
and surface water bodies. This distance may depend on the application or not of
icial
drift reducing techniques or devices,
Jour
— birds and mammals. Conditions of authorisation shall include risk mitigation
nal
measures, such as a judicious timing of the application and the selection of
those formulations which, as a result of their physical presentation or the
of
presence of agents that ensure an adequate avoidance, minimise the exposure
the
of the concerned species,
European
— operators, who must wear suitable protective clothing, in particular gloves,
coveralls, rubber boots and face protection or safety glasses during mixing,
loading, application and cleaning of the equipment, unless the exposure to the
Union
substance is adequately precluded by the design and construction of the
equipment itself or by the mounting of specific protective components on
such equipment.
PART B
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on flusilazole,
and in particular Appendices I and II thereof, shall be taken into account.
Member States must ensure that the authorisation holders report at the latest on 31
December of each year on incidences of operator health problems. Member States
may require that elements, such as sales data and a survey of use patterns, are
provided so that a realistic picture of the use conditions and the possible toxico
logical impact of flusilazole can be obtained.
Member States shall request the submission of further studies to address the
L
potential endocrine disrupting properties of flusilazole within two years after the
153/53
adoption of the Test Guidelines on endocrine disruption by the Organisation for

---

L 153/54
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
Economic Cooperation and Development (OECD). They shall ensure that the notifier
at whose request flusilazole has been included in this Annex provide such studies to
the Commission within two years of the adoption of the above test guidelines.
EN
144 Carbendazim
(unstated
Methyl benzimidazol-2-
980 g/kg 1
January
13 June
PART A

stereochemistry)
ylcarbamate
2007
2011
Only uses as fungicide on the following crops may be authorised:
CAS No 10605-21-7
— cereals
CIPAC No 263
— rapeseed
— sugar beet
— maize
Off
at rates not exceeding
icial
— 0,25 kg active substance per hectare per application for cereals and rapeseed,
Jour
— 0,075 kg active substance per hectare per application for sugar beet,
nal
of
— 0,1 kg active substance per hectare per application for maize.
the
The following uses must not be authorised:
European
— air application,
— knapsack and hand-held applications neither by amateur nor by professional
Union
users,
— home gardening.
Member States shall ensure that all appropriate risk mitigation measures are applied.
Particular attention must be paid to the protection of:
— aquatic organisms. An appropriate distance must be kept between treated areas
and surface water bodies. This distance may depend on the application or not of
drift reducing techniques or devices,
— earthworms and other soil macro-organisms. Conditions of authorisation shall
include risk mitigation measures, such as the selection of the most appropriate
combination of numbers and timing of application, rates of application, and, if
necessary, the degree of concentration of the active substance,
— birds and mammals. Conditions of authorisation shall include risk mitigation
measures, such as a judicious timing of the application and the selection of
11.6.2011
those formulations which, as a result of their physical presentation or the
presence of agents that ensure an adequate avoidance, minimise the exposure
of the concerned species,

---

11.6.2011 Off
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
— operators, who must wear suitable protective clothing, in particular gloves,
coveralls, rubber boots and face protection or safety glasses during mixing,
loading, application and cleaning of the equipment, unless the exposure to the
substance is adequately precluded by the design and construction of the
equipment itself or by the mounting of specific protective components on
EN
such equipment.

PART B
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on
carbendazim, and in particular Appendices I and II thereof, shall be taken into
account.
Member States must ensure that the authorisation holders report at the latest on 31
December of each year on incidences of operator health problems. Member States
may require that elements, such as sales data and a survey of use patterns, are
provided so that a realistic picture of the use conditions and the possible toxico
icial
logical impact of carbendazim can be obtained.
Jour
nal
145 Captan
N-(trichloromethylthio)
≥ 910 g/kg
1 October
30 September PART A
cyclohex-4-ene-1,2-dicar
2007
2017
of
CAS No 133-06-02
boximide
Impurities:
the
Only uses as fungicide can be authorised.
European
CIPAC No 40
Perchloromethylmer
captan (R005406):
PART B
not more than 5 g/kg
Union
Folpet: not more than
In assessing applications to authorise plant protection products containing captan
10 g/kg
for uses other than tomatoes Member States shall pay particular attention to the
criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any
Carbon tetrachloride
necessary data and information is provided before such an authorisation is granted.
not more than
0,1 g/Kg
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on captan, and
in particular Appendices I and II thereof, as finalised in the Standing Committee on
the Food Chain and Animal Health on 29 September 2006 shall be taken into
account.
In this overall assessment Member States must pay particular attention to:
— the operators and workers safety. Authorised conditions of use must prescribe
the application of adequate personal protective equipment and risk mitigation
measures to reduce the exposure;
L
— the dietary exposure of consumers in view of future revisions of Maximum
153/55
Residue Levels;

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L 153/56
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
— the protection of groundwater under vulnerable conditions. Conditions of au
thorisation should include risk mitigation measures and monitoring programmes
should be initiated in vulnerable zones, where appropriate;
— the protection of birds, mammals and aquatic organisms. Conditions of au
EN
thorisation should include risk mitigation measures.

The Member States concerned shall request the submission of further studies to
confirm the long term risk assessment for birds and mammals, as well as the
toxicological assessment on metabolites potentially present in groundwater under
vulnerable conditions. They shall ensure that the notifiers at whose request captan
has been included in this Annex provide such studies to the Commission within two
years from the approval.
146 Folpet
N-(trichloromethylthio)
≥ 940 g/kg
1 October
30 September PART A
Off
phthalimide
2007
2017
icial
CAS No 133-07-3
Impurities:
Only uses as fungicide can be authorised.
Jour
CIPAC No 75
Perchloromethylmer
PART B
nal
captan (R005406):
not more than
of
In assessing applications to authorise plant protection products containing folpet for
3,5 g/kg
uses other than winter wheat Member States shall pay particular attention to the
the
criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any
European
Carbon tetrachloride
necessary data and information is provided before such an authorisation is granted.
not more than 4 g/kg
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on folpet, and
Union
in particular Appendices I and II thereof, as finalised in the Standing Committee on
the Food Chain and Animal Health on 29 September 2006 shall be taken into
account.
In this overall assessment Member States must pay particular attention to:
— operators and workers safety. Authorised conditions of use must prescribe the
application of adequate personal protective equipment;
— the dietary exposure of consumers in view of future revisions of Maximum
Residue Levels;
— the protection of birds, mammals, aquatic and soil organisms. Conditions of
authorisation should include risk mitigation measures.
The Member States concerned shall request the submission of further studies to
confirm the risk assessment for birds, mammals and earthworms. They shall
11.6.2011
ensure that the notifiers at whose request folpet has been included in this Annex
provide such studies to the Commission within two years from the approval.

---

11.6.2011 Off
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
147 Formetanate
3-dimethylaminomethyl
≥ 910 g/kg 1
October
30 September PART A
eneaminophenyl methyl
2007
2017
CAS No 23422-53-9
carbamate
Only uses as insecticide and acaricide may be authorised.
CIPAC No 697
PART B
EN

In assessing applications to authorise plant protection products containing form
etanate for uses other than in field tomatoes and ornamental shrubs Member States
shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No
1107/2009, and shall ensure that any necessary data and information is provided
before such an authorisation is granted.
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on form
etanate, and in particular Appendices I and II thereof, as finalised in the Standing
Committee on the Food Chain and Animal Health on 29 September 2006 shall be
taken into account.
icial
In this overall assessment Member States:
Jour
— must pay particular attention to the protection of birds, mammals, non-target
nal
arthropods and bees and must ensure that the conditions of authorisation
of
include, where appropriate, risk mitigation measures;
the
— must pay particular attention to the operator safety and ensure that conditions of
European
use prescribe the application of adequate personal protective equipment;
— must pay particular attention to the dietary exposure of consumers in view of
future revisions of Maximum Residue Levels.
Union
The Member States concerned shall request the submission of further studies to
confirm the risk assessment for birds, mammals and non-target arthropods. They
shall ensure that the notifier at whose request formetanate has been included in this
Annex provide such studies to the Commission within two years from the approval.
148 Methiocarb
4-methylthio-3,5-xylyl
≥ 980 g/kg 1
October
30 September PART A
methylcarbamate
2007
2017
CAS No 2032-65-7
Only uses as repellent in seed treatment, insecticide and molluscicide may be au
thorised.
CIPAC No 165
PART B
In assessing applications to authorise plant protection products containing
methiocarb for uses other than seed treatment in maize Member States shall pay
particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009,
L
and shall ensure that any necessary data and information is provided before such an
153/57
authorisation is granted.

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L 153/58
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on methiocarb,
and in particular Appendices I and II thereof, as finalised in the Standing Committee
on the Food Chain and Animal Health on 29 September 2006 shall be taken into
account.
EN

In this overall assessment Member States:
— must pay particular attention to the protection of birds, mammals and non-target
arthropods and must ensure that the conditions of authorisation include, where
appropriate, risk mitigation measures;
— must pay particular attention to the operator and bystander safety and ensure
that conditions of use prescribe the application of adequate personal protective
equipment;
Off
— must pay particular attention to the dietary exposure of consumers in view of
icial
future revisions of Maximum Residue Levels.
Jour
The Member States concerned shall request the submission of further studies to
nal
confirm the risk assessment for birds, mammals and non-target arthropods, as
well as to confirm the toxicological assessment on metabolites potentially present
of
in crops. They shall ensure that the notifier at whose request methiocarb has been
the
included in this Annex provide such studies to the Commission within two years
European
from the approval.
149 Dimethoate
O,O-Dimethyl-S-(N-methyl ≥ 950 g/kg
1 October
30 September PART A
Union
carbamoylmethyl) phos
2007
2017
CAS No 60-51-5
phorodithioate; 2-
Impurities:
Only uses as insecticide may be authorised.
Dimethoxy-phosphino
CIPAC No 59
thioylthio-N-methyl
— omethoate:
not
PART B
acetamide
more than 2 g/kg
For the implementation of the uniform principles as referred to in Article 29(6) of
— isodimethoate: not
Regulation (EC) No 1107/2009, the conclusions of the review report on dimethoate,
more than 3 g/kg
and in particular Appendices I and II thereof, as finalised in the Standing Committee
on the Food Chain and Animal Health on 24 November 2006 shall be taken into
account.
In this overall assessment Member States:
— must pay particular attention to the protection of birds, mammals, aquatic
organisms and other non-target arthropods. Conditions of authorisation should
include risk mitigation measures, where appropriate, such as buffer zones and
reduction of run-off and drainage inputs to surface water;
11.6.2011
— must pay particular attention to the dietary exposure of consumers;

---

11.6.2011 Off
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
— must pay particular attention to the operator safety and ensure that conditions of
use prescribe the application of adequate personal protective equipment.
The Member States concerned shall request the submission of further studies to
confirm the risk assessment for birds, mammals and non-target arthropods, as
EN
well as to confirm the toxicological assessment on metabolites potentially present

in crops.
They shall ensure that the notifier at whose request dimethoate has been included in
this Annex provides such studies to the Commission within two years from the
approval.
150 Dimethomorph
(E,Z) 4-[3-(4-chloro ≥ 965 g/kg 1
October
30 September PART A
phenyl)-3-(3,4-dimetho
2007
2017
CAS No 110488-70-5
xyphenyl)acryloyl]morpho
Only uses as fungicide may be authorised.
line
icial
CIPAC No 483
PART B
Jour
For the implementation of the uniform principles as referred to in Article 29(6) of
nal
Regulation (EC) No 1107/2009, the conclusions of the review report on di
methomorph, and in particular Appendices I and II thereof, as finalised in the
of
Standing Committee on the Food Chain and Animal Health on 24 November
the
2006 shall be taken into account.
European
In this overall assessment Member States must pay particular attention to:
— the operators and workers safety. Authorised conditions of use must prescribe
the application of adequate personal protective equipment;
Union
— to the protection of birds, mammals and aquatic organisms.
Conditions of authorisation should include risk mitigation measures, where appro
priate.
151 Glufosinate
ammonium(DL)-
950 g/kg 1
October
30 September PART A
homoalanin-4-
2007
2017
CAS No 77182-82-2
yl(methyl)phosphinate
Only uses as herbicide may be authorised.
CIPAC No 437.007
PART B
In assessing applications to authorise plant protection products containing
glufosinate for uses other than in apple orchards, notably as regards the operator
and consumer exposure, Member States shall pay particular attention to the criteria
L
in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any
153/59
necessary data and information is provided before such an authorisation is granted.

---

L 153/60
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on glufosinate,
and in particular Appendices I and II thereof, as finalised in the Standing Committee
on the Food Chain and Animal Health on 24 November 2006 shall be taken into
account. In this overall assessment Member States must pay particular attention to:
EN

— the operators, workers and bystanders safety. Conditions of authorisation should
include protective measures, where appropriate;
— the potential for groundwater contamination, when the active substance is
applied in regions with vulnerable soil and/or climatic conditions;
— the protection of mammals, non-target arthropods and non-target plants.
Conditions of authorisation should include risk mitigation measures, where appro
priate.
Off
The Member States concerned shall request the submission of further studies to
icial
confirm the risk assessment for mammals and non-target arthropods in apple
orchards. They shall ensure that the notifier at whose request glufosinate has been
Jour
included in this Annex provide such studies to the Commission within two years
nal
from the approval.
of
the
152 Metribuzin
4-amino-6-tert-butyl-3-
≥ 910 g/kg 1
October
30 September PART A
European
methylthio-1,2,4-triazin-
2007
2017
CAS No 21087-64-9
5(4H)-one
Only uses as herbicide may be authorised.
CIPAC No 283
Union
PART B
In assessing applications to authorise plant protection products containing
metribuzin for uses other than in post-emergence selective herbicide in potatoes
Member States shall pay particular attention to the criteria in Article 4(3) of Regu
lation (EC) No 1107/2009, and shall ensure that any necessary data and information
is provided before such an authorisation is granted.
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on metribuzin,
and in particular Appendices I and II thereof, as finalised in the Standing Committee
on the Food Chain and Animal Health on 24 November 2006 shall be taken into
account.
In this overall assessment Member States:
— must pay particular attention to the protection of algae, aquatic plants, non-
11.6.2011
target plants outside the treated field and must ensure that the conditions of
authorisation include, where appropriate, risk mitigation measures.

---

11.6.2011 Off
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
— must pay particular attention to the operator safety and ensure that conditions of
use prescribe the application of adequate personal protective equipment.
The Member States concerned shall request the submission of further data to
confirm the risk assessment for groundwater. They shall ensure that the notifiers
EN
at whose request metribuzin has been included in this Annex provide such studies to

the Commission within two years from the approval.
153 Phosmet
O,O-dimethyl S-phthali ≥ 950 g/kg
1 October
30 September PART A
midomethyl phosphorodi
2007
2017
CAS No 732-11-6
thioate; N-(dimethoxy Impurities:
Only uses as insecticide and acaricide may be authorised.
phosphinothioylthio
CIPAC No 318
methyl)phatalimide
— phosmet oxon: not
PART B
more than
0,8 g/kg
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on phosmet,
— iso phosmet: not
and in particular Appendices I and II thereof, as finalised in the Standing Committee
icial
more than
on the Food Chain and Animal Health on 24 November 2006 shall be taken into
0,4 g/kg
account.
Jour
In this overall assessment Member States:
nal
of
— must pay particular attention to the protection of birds, mammals, aquatic
the
organisms, bees and other non-target arthropods. Conditions of authorisation
should include risk mitigation measures, where appropriate, such as buffer zones
European
and reduction of run-off and drainage inputs to surface water,
— must pay particular attention to the operator safety and ensure that conditions of
use prescribe the application of adequate personal and respiratory protective
Union
equipment.
The Member States concerned shall request the submission of further studies to
confirm the risk assessment for birds (acute risk) and herbivorous mammals (long
term risk). They shall ensure that the notifier at whose request phosmet has been
included in this Annex provides such studies to the Commission within two years
from the approval.
154 Propamocarb
Propyl 3-(dimethylamino) ≥ 920 g/kg 1
October
30 September PART A
propylcarbamate
2007
2017
CAS No 24579-73-5
Only uses as fungicide may be authorised.
CIPAC No 399
PART B
In assessing applications to authorise plant protection products containing propa
mocarb for uses other than foliar applications, Member States shall pay particular
attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, as regards
L
153/61
worker exposure and shall ensure that any necessary data and information is
provided before such an authorisation is granted.

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L 153/62
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on propa
mocarb, and in particular Appendices I and II thereof, as finalised in the Standing
Committee on the Food Chain and Animal Health on 24 November 2006 shall be
taken into account.
EN

In this overall assessment Member States must pay particular attention to:
— the operators and workers safety. Conditions of authorisation should include
protective measures, where appropriate;
— the transfer of soil residues for rotating or succeeding crops;
— the protection of surface and groundwater in vulnerable zones;
— the protection of birds, mammals and aquatic organisms. Conditions of auth
Off
orisation should include risk mitigation measures, where appropriate.
icial
Jour
155 ethoprophos
O-ethyl S,S-dipropyl phos > 940 g/kg 1
October
30 September PART A
phorodithioate
2007
2017
nal
CAS No 13194-48-4
Only uses as nematicide and insecticide in soil application can be authorised.
of
the
CIPAC No 218
Authorisations should be limited to professional users.
European
PART B
In assessing applications to authorise plant protection products containing etho
Union
prophos for uses other than potatoes not cultivated for human or animal
consumption, Member States shall pay particular attention to the criteria in
Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any
necessary data and information is provided before such an authorisation is granted.
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on etho
prophos, and in particular Appendices I and II thereof, as finalised in the
Standing Committee on the Food Chain and Animal Health on 16 March 2007
shall be taken into account.
In this overall assessment Member States must pay particular attention to:
— the residues and evaluate the dietary exposure of consumers in view of future
revisions of Maximum Residue Levels,
— the operator safety. Authorised conditions of use must prescribe the application
11.6.2011
of adequate personal and respiratory protective equipment and other risk miti
gation measures such as the use of closed transfer system for the distribution of
the product,

---

11.6.2011 Off
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
— he protection of birds, mammals, aquatic organisms, surface and groundwater
under vulnerable conditions. Conditions of authorisation should include risk
mitigation measures, such as buffer zones and the achievement of complete
incorporation of granules in the soil.
EN
The concerned Member States shall request the submission of further studies to

confirm the short and long term risk assessment for birds and for earthworms
eating mammals. They shall ensure that the notifiers at whose request ethoprophos
has been included in this Annex provide such studies to the Commission within two
years from the approval.
156 Pirimiphos-methyl
O-2-diethylamino-6-
> 880 g/kg 1
October
30 September PART A
methylpyrimidin-4-yl
2007
2017
CAS No 29232-93-7
Only uses as insecticide for post harvest storage can be authorised.
O,O-dimethylphosphoro
CIPAC No 239
thioate
Hand-held applications shall not be authorised.
icial
PART B
Jour
In assessing applications to authorise plant protection products containing piri
nal
miphos-methyl for uses other than applications with automated systems in empty
of
cereals storehouses, Member States shall pay particular attention to the criteria in
the
Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary
data and information is provided before such an authorisation is granted.
European
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on pirimiphos-
methyl, and in particular Appendices I and II thereof, as finalised in the Standing
Union
Committee on the Food Chain and Animal Health on 15 March 2007 shall be taken
into account.
In this overall assessment Member States must pay particular attention to:
— the operators safety. Authorised conditions of use must prescribe the application
of adequate personal protective equipment including respiratory protective
equipment and risk mitigation measures to reduce the exposure;
— the dietary exposure of consumers in view of future revisions of Maximum
Residue Levels.
157 Fipronil
(±)-5-amino-1-(2,6-
≥ 950 g/kg 1
October
30 September PART A
dichloro-α,α,α-trifluoro-
2007
2017
CAS No 120068-37-3
para-tolyl)-4-trifluoro
Only uses as insecticide for use as seed treatment may be authorised.
L
methylsulfinylpyrazole-3-
153/63
CIPAC No 581
carbonitrile
For the protection of non-target organisms, in particular honey bees:

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L 153/64
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
— the seed coating shall only be performed in professional seed treatment facilities.
Those facilities must apply the best available techniques in order to ensure that
the release of dust during application to the seed, storage, and transport can be
minimised,
EN
— adequate seed drilling equipment shall be used to ensure a high degree of incor

poration in soil, minimisation of spillage and minimisation of dust emission.
Member States shall ensure that:
— the label of the treated seed includes the indication that the seeds were treated
with fipronil and sets out the risk mitigation measures provided for in the
authorisation,
— monitoring programmes are initiated to verify the real exposure of honey bees to
fipronil in areas extensively used by bees for foraging or by beekeepers, where
and as appropriate.
Off
icial
PART B
Jour
For the implementation of the uniform principles as referred to in Article 29(6) of
nal
Regulation (EC) No 1107/2009, the conclusions of the review report on fipronil,
and in particular Appendices I and II thereof, as finalised in the Standing Committee
of
on the Food Chain and Animal Health on 16 March 2007 shall be taken into
the
account. In this overall assessment Member States must pay particular attention to:
European
— the packaging of the marketed products to avoid the generation of photo-degra
dation products of concern,
— the potential for groundwater contamination, especially from metabolites which
Union
are more persistent than the parent compound, when the active substance is
applied in regions with vulnerable soil and/or climatic conditions,
— the protection of granivorous birds and mammals, aquatic organisms, non-target
arthropods and honey bees.
Conditions of authorisation should include risk mitigation measures, where appro
priate.
The concerned Member States shall request the submission of further studies to
confirm the risk assessment for granivorous birds and mammals, and honey bees,
especially bee brood. They shall ensure that the notifier at whose request fipronil has
been included in this Annex provide such studies to the Commission within one
year from the approval.
158 Beflubutamid
(RS)-N-benzyl-2-(4-fluoro-
≥ 970 g/kg 1
December
30 November PART A
3-trifluoromethylphenoxy)
2007
2017
11.6.2011
CAS No 113614-08-7
butanamide
Only uses as herbicide may be authorised.
CIPAC No 662

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11.6.2011 Off
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
PART B
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on
beflubutamid, and in particular Appendices I and II thereof, as finalised in the
EN
Standing Committee on the Food Chain and Animal Health on 15 May 2007

shall be taken into account.
In this overall assessment Member States:
— must pay particular attention to the risk to aquatic organisms.
Conditions of use shall include risk mitigation measures, where appropriate.
159 Spodoptera exigua
Not applicable 1
December
30 November PART A
nuclear polyhedrosis
2007
2017
icial
virus
Only uses as insecticide may be authorised.
Jour
CIPAC No
PART B
nal
Not allocated
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on Spodoptera
of
exigua NPV, and in particular Appendices I and II thereof, as finalised in the
the
Standing Committee on the Food Chain and Animal Health on 15 May 2007
European
shall be taken into account.
Union
160 Prosulfocarb
S-benzyl dipropyl(thio 970 g/kg 1
November
31 October PART A
carbamat)
2008
2018
CAS No 52888-80-9
Only uses as herbicide may be authorised.
CIPAC No 539
PART B
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on prosul
focarb, and in particular Appendices I and II thereof, as finalised in the Standing
Committee on the Food Chain and Animal Health on 9 October 2007 shall be taken
into account.
In this overall assessment Member States must pay particular attention to:
— the operator safety and ensure that conditions of use prescribe the application of
adequate personal protective equipment,
— the protection of aquatic organisms and must ensure that the conditions of
L
authorisation include, where appropriate, risk mitigation measures such as
153/65
buffer zone,

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L 153/66
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
— the protection of non-target plants and must ensure that the conditions of
authorisation include, where appropriate, risk mitigation measures such as an
in-field no spray buffer zone.
EN
161 Fludioxonil
4-(2,2-difluoro-1,3-benzo
950 g/kg 1
November
31 October PART A

dioxol-4-yl)-1H-pyrrole-3-
2008
2018
CAS No 131341-86-1
carbonitrile
Only uses as fungicide may be authorised.
CIPAC No 522
PART B
In assessing applications to authorise plant protection products containing
fludioxonil for uses other than seed treatment, Member States shall pay particular
attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall
ensure that any necessary data and information is provided before such an au
thorisation is granted and:
Off
— must pay particular attention to the potential for groundwater contamination, in
icial
particular from the soil photolysis metabolites CGA 339833 and CGA 192155,
in vulnerable zones,
Jour
nal
— must pay particular attention to the protection of fish and aquatic invertebrates.
of
Conditions of authorisation should include risk mitigation measures, where appro
the
priate.
European
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on fludioxonil,
and in particular Appendices I and II thereof, as finalised in the Standing Committee
Union
on the Food Chain and Animal Health on 9 October 2007 shall be taken into
account.
162 Clomazone
2-(2-chlorobenzyl)-4,4-
960 g/kg 1
November
31 October PART A
dimethyl-1,2-oxazolidin-3-
2008
2018
CAS No 81777-89-1
one
Only uses as herbicide may be authorised.
CIPAC No 509
PART B
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on clomazone,
and in particular Appendices I and II thereof, as finalised in the Standing Committee
on the Food Chain and Animal Health on 9 October 2007 shall be taken into
account.
In this overall assessment Member States must pay particular attention to:
11.6.2011
— the operator safety and ensure that conditions of use prescribe the application of
adequate personal protective equipment,

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11.6.2011 Off
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
— the protection of non-target plants and must ensure that the conditions of
authorisation include, where appropriate, risk mitigation measures such as
buffer zones.
EN
163 Benthiavalicarb
[(S)-1-{[(R)-1-(6-fluoro-1,3- ≥ 910 g/kg
1 August
31 July 2018 PART
A

benzothiazol-2-
2008
CAS No 413615-35-7
yl)ethyl]carbamoyl}-2-
The following manu
Only uses as fungicide may be authorised.
methylpropyl]carbamic
facturing impurities
CIPAC No 744
acid
are of toxicological
PART B
concern and each of
them must not
For the implementation of the uniform principles as referred to in Article 29(6) of
exceed a certain
Regulation (EC) No 1107/2009, the conclusions of the review report on benthia
amount in the
valicarb, and in particular Appendices I and II thereof, as finalised in the Standing
technical material:
Committee on the Food Chain and Animal Health on 22 January 2008 shall be
taken into account.
6,6′-difluoro-2,2′-
icial
dibenzothiazole: < 3,5
In this overall assessment Member States must pay particular attention to:
mg/kg
Jour
— the operator safety,
bis(2-amino-5-fluo
nal
rophenyl) disulfide:
— the protection of non-target arthropods.
of
< 14 mg/kg
Conditions of use shall include adequate risk mitigation measures, where appro
the
priate.
European
In assessing applications to authorise plant protection products containing benthia
valicarb for uses other than in glasshouses, Member States shall pay particular
attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and
Union
shall ensure that any necessary data and information is provided before such an
authorisation is granted.
The Member States shall inform the Commission in accordance with Article 38 of
Regulation (EC) No 1107/2009 on the specification of the technical material as
commercially manufactured.
164 Boscalid
2-Chloro-N-(4′-chloro
≥ 960 g/kg 1
August
31 July 2018 PART
A
biphenyl-2-yl)nicotinamide
2008
CAS No 188425-85-6
Only uses as fungicide may be authorised.
CIPAC No 673
PART B
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on boscalid,
and in particular Appendices I and II thereof, as finalised in the Standing Committee
L
on the Food Chain and Animal Health on 22 January 2008 shall be taken into
153/67
account.

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L 153/68
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
In this overall assessment Member States must pay particular attention
— to the operator safety,
— to the long term risk to birds and soil organisms,
EN

— to the risk of accumulation in soil if the substance is used in perennial crops or
in succeeding crops in crop rotation.
Conditions of use shall include adequate risk mitigation measures, where appro
priate.
165 Carvone
5-isopropenyl-2-methyl
≥ 930 g/kg with a d/l
1 August
31 July 2018 PART
A
cyclohex-2-en-1-one
ratio of at least 100:1
2008
CAS No 99-49-0 (d/l
Only uses as plant growth regulator may be authorised.
Off
mixture)
PART B
icial
CIPAC No 602
For the implementation of the uniform principles as referred to in Article 29(6) of
Jour
Regulation (EC) No 1107/2009, the conclusions of the review report on carvone,
nal
and in particular Appendices I and II thereof, as finalised in the Standing Committee
on the Food Chain and Animal Health on 22 January 2008 shall be taken into
of
account.
the
European
In this overall assessment Member States must pay particular attention to the
operator safety.
Conditions of use shall include risk mitigation measures, where appropriate.
Union
166 Fluoxastrobin
(E)-{2-[6-(2-chloro
≥ 940 g/kg 1
August
31 July 2018 PART
A
phenoxy)-5-fluoro
2008
CAS No 361377-29-9 pyrimidin-4-
Only uses as fungicide may be authorised.
yloxy]phenyl}(5,6-dihydro-
CIPAC No 746
1,4,2-dioxazin-3-
PART B
yl)methanone
O-methyloxime
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on fluox
astrobin, and in particular Appendices I and II thereof, as finalised in the
Standing Committee on the Food Chain and Animal Health on 22 January 2008
shall be taken into account.
In this overall assessment Member States must pay particular attention to:
— the operator safety, in particular when handling the undiluted concentrate.
11.6.2011
Conditions of use shall include adequate protective measures, such as wearing
a face shield,

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11.6.2011 Off
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
— the protection of aquatic organisms. Risk mitigation measures such as buffer
zones shall be applied, where appropriate,
— the levels of residues of the metabolites of fluoxastrobin, when straw from
treated areas is used as animal feeding stuff. Conditions of use shall include
EN
restrictions for feeding to animals, where appropriate,

— the risk of accumulation in the soil surface, if the substance is used in perennial
crops or in succeeding crops in crop rotation.
Conditions of use shall include risk mitigation measures, where appropriate.
The concerned Member States shall request the submission of:
— data to allow a comprehensive aquatic risk assessment to be made taking into
account spray drift, run-off, drainage and the effectiveness of potential risk
mitigation measures,
icial
— data on toxicity of non-rat metabolites if straw from treated areas is to be used
as feedstuff.
Jour
They shall ensure that the notifier at whose request fluoxastrobin has been included
nal
in this Annex provide such studies to the Commission within two years from the
of
approval.
the
European
167 Paecilomyces
lilacinus
Not applicable 1
August
31 July 2018 PART
A
(Thom)
2008
Samson 1974 strain
Only uses as nematicide may be authorised.
Union
251 (AGAL:
No 89/030550)
PART B
CIPAC No 753
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on Paeci
lomyces lilacinus, and in particular Appendices I and II thereof, as finalised in the
Standing Committee on the Food Chain and Animal Health on 22 January 2008
shall be taken into account.
In this overall assessment Member States must pay particular attention to:
— the operator safety (although there was no need to set an AOEL, as a general
rule, microorganisms should be considered as potential sensitisers),
— the protection of leaf dwelling non-target arthropods.
L
153/69
Conditions of use shall include risk mitigation measures, where appropriate.

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L 153/70
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
168 Prothioconazole
(RS)-2-[2-(1-chlorocyclo
≥ 970 g/kg
1 August
31 July 2018 PART
A
propyl)-3-(2-chlorophenyl)-
2008
CAS No 178928-70-6
2-hydroxypropyl]-2,4-
The following manu
facturing impurities
Only uses as fungicide may be authorised.
CIPAC No 745
dihydro-1,2,4-triazole-3-
EN
thione
are of toxicological
concern and each of

them must not
PART B
exceed a certain
amount in the
For the implementation of the uniform principles as referred to in Article 29(6) of
technical material:
Regulation (EC) No 1107/2009, the conclusions of the review report on prothio
— Toluene: < 5 g/kg
conazole, and in particular Appendices I and II thereof, as finalised in the Standing
Committee on the Food Chain and Animal Health on 22 January 2008 shall be
— Prothioconazole-
taken into account.
desthio (2-(1-
chlorocyclo
Off
propyl)1-(2-
In this overall assessment Member States must pay particular attention to:
chlorophenyl)-3-
icial
(1,2,4-triazol-1-yl)-
— the operator safety in spray applications. Conditions of use shall include adequate
Jour
propan-2-ol): <
protective measures,
0,5 g/kg (LOD)
nal
— the protection of aquatic organisms. Risk mitigation measures such as buffer
of
zones shall be applied, where appropriate,
the
European
— the protection of birds and small mammals. Risk mitigation measures shall be
applied, where appropriate.
Union
Conditions of use shall include risk mitigation measures, where appropriate.
The concerned Member States shall request the submission of:
— information to allow the assessment of consumer exposure to triazole metabolite
derivatives in primary crops, rotational crops, and products of animal origin,
— a comparison of the mode of action of prothioconazole and the triazole meta
bolite derivatives to allow the assessment of the toxicity resulting from the
combined exposure to these compounds,
— information to further address the long-term risk to granivorous birds and
mammals arising from the use of prothioconazole as a seed treatment.
They shall ensure that the notifier at whose request prothioconazole has been
11.6.2011
included in this Annex provide such studies to the Commission within two years
from the approval.

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11.6.2011 Off
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
169 Amidosulfuron
3-(4,6-dimethoxy
≥ 970 g/kg 1
January
31 December PART A
pyrimidin-2-yl)-1-(N-
2009
2018
CAS No 120923-37-7
methyl-N-methylsulfonyl-
Only uses as herbicide may be authorised.
CIPAC No 515
aminosulfonyl)urea
PART B
EN
or

1-(4,6-dimethoxy
In assessing applications to authorise plant protection products containing ami
pyrimidin-2-yl)-3-
dosulfuron for uses other than meadows and pasture, Member States shall pay
mesyl(methyl) sulfa
particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009,
moylurea
and shall ensure that any necessary data and information is provided before such an
authorisation is granted.
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on ami
dosulfuron, and in particular Appendices I and II thereof, as finalised in the
Standing Committee on the Food Chain and Animal Health on 22 January 2008
shall be taken into account.
icial
In this overall assessment Member States must pay particular attention to:
Jour
— the protection of groundwater due to a potential for groundwater contamination
nal
by some of the degradation products when it is applied in regions with
of
vulnerable soil and/or climatic conditions,
the
— the protection of aquatic plants.
European
In relation to these identified risks, risk mitigation measures, such as buffer zones,
should be applied where appropriate.
Union
170 Nicosulfuron
2-[(4,6-dimethoxy
≥ 910 g/kg 1
January
31 December PART A
pyrimidin-2-ylcar
2009
2018
CAS No 111991-09-4
bamoyl)sulfamoyl]-N,N-
Only uses as herbicide may be authorised.
dimethylnicotinamide
CIPAC No 709
PART B
or
For the implementation of the uniform principles as referred to in Article 29(6) of
1-(4,6-dimethoxy
Regulation (EC) No 1107/2009, the conclusions of the review report on nico
pyrimidin-2-yl)-3-(3-
sulfuron, and in particular Appendices I and II thereof, as finalised in the
dimethylcarbamoyl-2-pyri
Standing Committee on the Food Chain and Animal Health on 22 January 2008
dylsulfonyl)urea
shall be taken into account.
In this overall assessment Member States must pay particular attention to:
— the potential exposure of the aquatic environment to metabolite DUDN when is
applied in regions with vulnerable soil conditions,
L
— the protection of aquatic plants and must ensure that the conditions of au
153/71
thorisation include, where appropriate, risk mitigation measures such as buffer
zones,

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L 153/72
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
— the protection of non-target plants and must ensure that the conditions of
authorisation include, where appropriate, risk mitigation measures such as an
in-field no-spray buffer zone,
— the protection of groundwater and surface water under vulnerable soil and
EN
climatic conditions.

171 Clofentezine
3,6-bis(2-chlorophenyl)-
≥ 980 g/kg
(dry
1 January
31 December PART A
1,2,4,5-tetrazine
material)
2009
2018
CAS No 74115-24-5
Only uses as acaricide may be authorised.
CIPAC No 418
PART B
For the implementation of the uniform principles as referred to in Article 29(6) of
Off
Regulation (EC) No 1107/2009, the conclusions of the review report on clofen
icial
tezine, and in particular Appendices I and II thereof, as finalised in the Standing
Committee on the Food Chain and Animal Health on 11 May 2010 shall be taken
Jour
into account.
nal
of
In this overall assessment Member States must pay particular attention to:
the
European
— the specification of the technical material as commercially manufactured, which
must be confirmed and supported by appropriate analytical data. The test
material used in the toxicity dossiers shall be compared and verified against
this specification of the technical material;
Union
— the operator and worker safety and ensure that conditions of use prescribe the
application of adequate personal protective equipment, where appropriate;
— the potential for long range transport via air;
— the risk to non target organisms. Conditions of authorisation shall include risk
mitigation measures, where appropriate.
The Member States concerned shall ensure that the notifier presents to the
Commission a monitoring programme to assess the potential for long-range atmo
spheric transport of clofentezine and the related environmental risks by 31 July
2011. The results of that monitoring programme shall be submitted as a monitoring
report to the rapporteur Member State and to the Commission by 31 July 2013.
The Member States concerned shall ensure that the notifier submits to the
11.6.2011
Commission confirmatory studies on clofentezine metabolites relating to their toxi
cological and environmental risk assessment by 30 June 2012.

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11.6.2011 Off
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
172 Dicamba
3,6-dichloro-2-methoxy
≥ 850 g/kg 1
January
31 December PART A
benzoic acid
2009
2018
CAS No 1918-00-9
Only uses as herbicide may be authorised.
CIPAC No 85
PART B
EN

For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on dicamba,
and in particular Appendices I and II thereof, as finalised in the Standing Committee
on the Food Chain and Animal Health shall be taken into account.
173 Difenoconazole
3-chloro-4-
≥ 940 g/kg 1
January
31 December PART A
[(2RS,4RS;2RS,4SR)-4-
2009
2018
CAS No 119446-68-3
methyl-2-(1H-1,2,4-triazol-
Only uses as fungicide may be authorised.
1-ylmethyl)-1,3-dioxolan-
CIPAC No 687
2-yl]phenyl 4-chlorophenyl
PART B
icial
ether
For the implementation of the uniform principles as referred to in Article 29(6) of
Jour
Regulation (EC) No 1107/2009, the conclusions of the review report on difeno
conazole, and in particular Appendices I and II thereof, as finalised in the Standing
nal
Committee on the Food Chain and Animal Health shall be taken into account.
of
the
In this overall assessment Member States must pay particular attention to:
European
— the protection of aquatic organisms.
Conditions of use shall include adequate risk mitigation measures, where appro
priate.
Union
174 Diflubenzuron
1-(4-chlorophenyl)-3-(2,6-
≥ 950 g/kg impurity:
1 January
31 December PART A
difluorobenzoyl) urea
max. 0,03
g/kg 4-
2009
2018
CAS No 35367-38-5
chloroaniline
Only uses as insecticide may be authorised.
CIPAC No 339
PART B
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on diflu
benzuron, and in particular Appendices I and II thereof, as finalised in the
Standing Committee on the Food Chain and Animal Health on 11 May 2010
shall be taken into account.
In this overall assessment Member States must pay particular attention to:
— the specification of the technical material as commercially manufactured, which
must be confirmed and supported by appropriate analytical data. The test
L
material used in the toxicity dossiers shall be compared and verified against
153/73
this specification of the technical material;

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L 153/74
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
— the protection of aquatic organisms;
— the protection of terrestrial organisms;
— the protection of non-target arthropods including bees.
EN

Conditions of use shall include adequate risk mitigation measures, where appro
priate.
The Member States concerned shall ensure that the notifier submits to the
Commission further studies to address the potential toxicological relevance of the
impurity and metabolite 4-chloroaniline (PCA) by 30 June 2011.
175 Imazaquin
2-[(RS)-4-isopropyl-4-
≥ 960 g/kg (racemic
1 January
31 December PART A
methyl-5-oxo-2-imid
mixture)
2009
2018
Off
CAS No 81335-37-7
azolin-2-yl]quinoline-3-
Only uses as plant growth regulator may be authorised.
carboxylic acid
icial
CIPAC No 699
PART B
Jour
nal
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on imazaquin,
of
and in particular Appendices I and II thereof, as finalised in the Standing Committee
the
on the Food Chain and Animal Health shall be taken into account.
European
176 Lenacil
3-cyclohexyl-1,5,6,7-
≥ 975 g/kg 1
January
31 December PART A
tetrahydrocyclopentapyri
2009
2018
CAS No 2164-08-1
midine-2,4(3H)-dione
Only uses as herbicide may be authorised.
Union
CIPAC No 163
PART B
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on lenacil, and
in particular Appendices I and II thereof, as finalised in the Standing Committee on
the Food Chain and Animal Health on 11 May 2010 shall be taken into account.
In this overall assessment Member States must pay particular attention to:
— the risk to aquatic organisms, especially algae and aquatic plants. Conditions of
authorisation shall include risk mitigation measures, such as bufferzones between
treated areas and surface water bodies;
— the protection of the groundwater, where the active substance is applied in
regions with vulnerable soil or climatic conditions. Conditions of authorisation
11.6.2011
shall include risk mitigation measures and monitoring programmes shall be
initiated to verify potential groundwater contamination from the metabolites
IN-KF 313, M1, M2 and M3 in vulnerable zones, where appropriate.

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11.6.2011 Off
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
The Member States concerned shall ensure that the notifier submits to the
Commission confirmatory information on the identity and characterisation of soil
metabolites Polar B and Polars and metabolites M1, M2 and M3 which occurred in
lysimeter studies and confirmatory data on rotational crops, including possible
phytotoxic effects. They shall ensure that the notifier provides such information to
EN
the Commission by 30 June 2012.

If a decision on the classification of lenacil under Regulation (EC) No 1272/2008 of
the European Parliament and of the Council (3 ) identifies the need for further
information on the relevance of the metabolites IN-KE 121, IN-KF 313, M1; M2,
M3, Polar B and Polars, the Member States concerned shall request the submission of
such information. They shall ensure that the notifier provides that information to the
Commission within six months from the notification of such a classification
decision.
177 Oxadiazon
5-tert-butyl-3-(2,4-
≥ 940 g/kg 1
January
31 December PART A
dichloro-5-isopro
2009
2018
icial
CAS No 19666-30-9
poxyphenyl)-1,3,4-
Only uses as herbicide may be authorised.
oxadiazol-2(3H)-one
Jour
CIPAC No 213
PART B
nal
of
For the implementation of the uniform principles as referred to in Article 29(6) of
the
Regulation (EC) No 1107/2009, the conclusions of the review report on oxadiazon,
and in particular Appendices I and II thereof, as finalised in the Standing Committee
European
on the Food Chain and Animal Health on 11 May 2010 shall be taken into account.
In this overall assessment Member States must pay particular attention to:
Union
— the specification of the technical material as commercially manufactured, which
must be confirmed and supported by appropriate analytical data. The test
material used in the toxicity dossiers shall be compared and verified against
this specification of the technical material;
— the potential for ground water contamination by the metabolite AE0608022
where the active substance is applied in situations for which prolonged
anaerobic conditions may be expected to occur or in regions with vulnerable
soil or climatic conditions. Conditions of authorisation must include risk miti
gation measures, where appropriate.
The Member States concerned shall ensure that the notifier submits to the
Commission:
— further studies to address the potential toxicological relevance of an impurity in
the proposed technical specification;
L
153/75
— information to further clarify the occurrence of metabolite AE0608033 in
primary crops and rotational crops;

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L 153/76
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
— further trials on rotational crops (namely root crops and cereals) and a
metabolism study on ruminants to confirm the consumer risk assessment;
— information to further address the risk to earthworm-eating birds and mammals,
and the long-term risk to fish.
EN

They shall ensure that the notifier provides such information to the Commission by
30 June 2012.
178 Picloram
4-amino-3,5,6-trichloro
≥ 920 g/kg 1
January
31 December PART A
pyridine-2-carboxylic acid
2009
2018
CAS No 1918-02-1
Only uses as herbicide may be authorised.
CIPAC No 174
PART B
For the implementation of the uniform principles as referred to in Article 29(6) of
Off
Regulation (EC) No 1107/2009, the conclusions of the review report on picloram,
icial
and in particular Appendices I and II thereof, as finalised in the Standing Committee
on the Food Chain and Animal Health on 11 May 2010 shall be taken into account.
Jour
In the overall assessment Member States must pay particular attention to:
nal
of
— the potential for ground water contamination where picloram is applied in
the
regions with vulnerable soil or climatic conditions. Conditions of authorisation
must include risk mitigation measures, where appropriate;
European
The Member States concerned shall ensure that the notifier submits to the
Commission:
Union
— further information to confirm that the monitoring analytical method applied in
residue trials correctly quantifies the residues of picloram and its conjugates;
— a soil photolysis study to confirm the evaluation of picloram degradation.
They shall ensure that the notifier provides such information to the Commission by
30 June 2012.
179 Pyriproxyfen
4-phenoxyphenyl (RS)-2- ≥ 970 g/kg 1
January
31 December PART A
(2-pyridyloxy)propyl ether
2009
2018
CAS No 95737-68-1
Only uses as insecticide may be authorised.
CIPAC No 715
PART B
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on pyri
11.6.2011
proxyfen, and in particular Appendices I and II thereof, as finalised in the
Standing Committee on the Food Chain and Animal Health on 11 May 2010
shall be taken into account.

---

11.6.2011 Off
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
In the overall assessment Member States must pay particular attention to:
— the operator safety and ensure that conditions of use prescribe the application of
adequate personal protective equipment, where appropriate;
EN
— the risk to aquatic organisms. Conditions of use shall include adequate risk

mitigation measures, where appropriate.
The Member States concerned shall ensure that the notifier submits to the
Commission further information confirming the risk assessment in respect of two
points, namely the risk posed to aquatic insects by pyriproxfen and the metabolite
DPH-pyr and the risk posed by pyriproxfen to pollinators. They shall ensure that the
notifier provides such information to the Commission by 30 June 2012.
180 Bifenox
Methyl 5-(2,4-dichloro ≥ 970 g/kg impurities:
1 January
31 December PART A
phenoxy)-2-nitrobenzoate
2009
2018
CAS No 42576-02-3
max. 3
g/kg 2,4-di
icial
chlorophenol
Only uses as herbicide may be authorised.
CIPAC No 413
Jour
max. 6
g/kg 2,4-di
PART B
chloroanisole
nal
of
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on bifenox,
the
and in particular Appendices I and II thereof, as finalised in the Standing Committee
European
on the Food Chain and Animal Health on 14 March 2008 shall be taken into
account.
Union
In this overall assessment Member States must pay particular attention to:
— the operator safety and ensure that conditions of use prescribe the application of
adequate personal protective equipment where appropriate,
— the dietary exposure of consumers to bifenox residues in products of animal
origin and in succeeding rotational crops.
The Member States concerned shall request the submission of:
— information on residues of bifenox and its metabolite hydroxy bifenox acid in
food of animal origin and on residues of bifenox in rotational crops,
— information to further address the long-term risk to herbivorous mammals
arising from the use of bifenox.
L
153/77
They shall ensure that the notifier provides such confirmatory data and information
to the Commission within two years from the approval.

---

L 153/78
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
181 Diflufenican
2′,4′-difluoro-2-(α,α,α-
≥ 970 g/kg 1
January
31 December PART A
trifluoro-m-tolyloxy) nico
2009
2018
CAS No 83164-33-4
tinanilide
Only uses as herbicide may be authorised.
CIPAC No 462
EN
PART B

For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on diflufenican,
and in particular Appendices I and II thereof, as finalised in the Standing Committee
on the Food Chain and Animal Health on 14 March 2008 shall be taken into
account.
In this overall assessment Member States must pay particular attention to:
— the protection of aquatic organisms. Risk mitigation measures such as buffer
zones shall be applied, where appropriate,
Off
icial
— the protection of non-target plants. Risk mitigation measures such as an in-field
no spray buffer zones shall be applied, where appropriate.
Jour
nal
of
182 Fenoxaprop-P
(R)-2[4-[(6-chloro-2-ben
≥ 920 g/kg 1
January
31 December PART A
the
zoxazolyl)oxy]-phenoxy]-
2009
2018
European
CAS No 113158-40-0
propanoic acid
Only uses as herbicide may be authorised.
CIPAC No 484
PART B
For the implementation of the uniform principles as referred to in Article 29(6) of
Union
Regulation (EC) No 1107/2009, the conclusions of the review report on fenoxaprop-
P, and in particular Appendices I and II thereof, as finalised in the Standing
Committee on the Food Chain and Animal Health on 14 March 2008 shall be
taken into account.
In this overall assessment Member States must pay particular attention to:
— the operator safety and ensure that conditions of use prescribe the application of
adequate personal protective equipment,
— the protection of non target plants,
— the presence of the safener mefenpyr-diethyl in formulated products as regards
operator, worker and bystander exposure,
— the persistence of the substance and of some of its degradation products in
colder zones and areas where anaerobic conditions may occur.
11.6.2011
Conditions of authorisation should include risk mitigation measures, where appro
priate.

---

11.6.2011 Off
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
183 Fenpropidin
(R,S)-1-[3-(4-tert-
≥ 960 g/kg (racemate) 1
January 31 December PART A
butylphenyl)-2-methyl
2009
2018
CAS No 67306-00-7
propyl]-piperidine
Only uses as fungicide may be authorised.
CIPAC No 520
PART B
EN

For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on fenpropidin,
and in particular Appendices I and II thereof, as finalised in the Standing Committee
on the Food Chain and Animal Health on 14 March 2008 shall be taken into
account.
In this overall assessment Member States must pay particular attention to:
— the operator and worker safety and ensure that conditions of use prescribe the
application of adequate personal protective equipment,
— the protection of aquatic organisms and must ensure that the conditions of
icial
authorisation include, where appropriate, risk mitigation measures such as
buffer zone.
Jour
The Member States concerned shall request the submission of:
nal
of
— information to further address the long-term risk to herbivorous and insec
the
tivorous birds arising from the use of fenpropidin.
European
They shall ensure that the notifier provides such confirmatory data and information
to the Commission within two years from the approval.
Union
184 Quinoclamine
2-amino-3-chloro-1,4-
≥ 965 g/kg impurity:
1 January
31 December PART A
naphthoquinone
2009
2018
CAS No 2797-51-5
dichlone (2,3-
Only uses as herbicide may be authorised.
dichloro-1,4-naphtho
CIPAC No 648
quinone) max. 15 g/kg
PART B
In assessing applications to authorise plant protection products containing quino
clamine for uses other than ornamentals or nursery plants, Member States shall pay
particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009,
and shall ensure that any necessary data and information is provided before such an
authorisation is granted.
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on quino
clamine, and in particular Appendices I and II thereof, as finalised in the Standing
Committee on the Food Chain and Animal Health on 14 March 2008 shall be taken
into account.
In this overall assessment Member States must pay particular attention to:
L
153/79
— the operator, worker and bystander safety and ensure that conditions of use
prescribe the application of adequate personal protective equipment,

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L 153/80
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
— the protection of aquatic organisms,
— the protection of birds and small mammals.
Conditions of use shall include adequate risk mitigation measures, where appro
EN
priate.

185 Chloridazon
5-amino-4-chloro-2-
920 g/kg
1 January
31 December PART A
phenylpyridazin-3(2H)-one
2009
2018
CAS No 1698-60-8
The manufacturing
Only uses as herbicide in application max. of 2,6 kg/ha only every third year on the
impurity 4-amino-5-
same field may be authorised.
CIPAC No 111
chloro-isomer is
considered to be of
PART B
toxicological concern
and a maximum level
For the implementation of the uniform principles as referred to in Article 29(6) of
of 60 g/kg is estab
Regulation (EC) No 1107/2009, the conclusions of the review report on chlo
Off
lished.
ridazon, and in particular Appendices I and II thereof, as finalised in the Standing
Committee on the Food Chain and Animal Health on 4 December 2007 shall be
icial
taken into account.
Jour
In this overall assessment Member States must pay particular attention to:
nal
— the operator safety and ensure that conditions of use prescribe the application of
of
adequate personal protective equipment,
the
European
— the protection of aquatic organisms,
— the protection of the groundwater, when the active substance is applied in
regions with vulnerable soil and/or climatic conditions.
Union
Conditions of authorisation should include risk mitigation measures and monitoring
programmes should be initiated to verify potential groundwater contamination from
metabolites B and B1 in vulnerable zones, where appropriate.
186 Tritosulfuron
1-(4-methoxy-6-trifluoro
≥ 960 g/kg
1 December 30 November PART A
methyl-1,3,5-triazin-2-yl)-
2008
2018
CAS No 142469-14-5
3-(2-trifluoromethyl-
The following manu
Only uses as herbicide may be authorised.
benzenesulfonyl)urea
facturing impurity is
CIPAC No 735
of toxicological
PART B
concern and must
not exceed a certain
For the implementation of the uniform principles as referred to in Article 29(6) of
amount in the
Regulation (EC) No 1107/2009, the conclusions of the review report on trito
technical material:
sulfuron, and in particular Appendices I and II thereof, as finalised in the
Standing Committee on the Food Chain and Animal Health on 20 May 2008
2-Amino-4-methoxy-
shall be taken into account.
6-(trifluormethyl)-
1,3,5-triazine:
In this overall assessment Member States must pay particular attention to:
11.6.2011
<0,2 g/kg
— the potential for groundwater contamination, when the active substance is
applied in regions with vulnerable soil and/or climatic conditions,

---

11.6.2011 Off
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
— the protection of aquatic organisms,
— the protection of small mammals.
Conditions of use shall include risk mitigation measures, where appropriate.
EN

187 Flutolanil
α,α,α-trifluoro-3′-
≥ 975 g/kg 1
March
28 February PART A
isopropoxy-o-toluanilide
2009
2019
CAS No 66332-96-5
Only uses as fungicide may be authorised.
CIPAC No 524
PART B
In assessing applications to authorise plant protection products containing flutolanil
for uses other than potato tuber treatment, Member States shall pay particular
attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and
shall ensure that any necessary data and information is provided before such an
authorisation is granted.
icial
For the implementation of the uniform principles as referred to in Article 29(6) of
Jour
Regulation (EC) No 1107/2009, the conclusions of the review report on flutolanil,
nal
and in particular Appendices I and II thereof, as finalised in the Standing Committee
on the Food Chain and Animal Health on 20 May 2008 shall be taken into account.
of
the
In this overall assessment Member States must pay particular attention to:
European
— the protection of groundwater, when the active substance is applied in regions
with vulnerable soil and/or climatic conditions.
Union
Conditions of authorisation should include risk mitigation measures, where appro
priate.
188 Benfluralin
N-butyl-N-ethyl-α,α,α-
≥ 960 g/kg
1 March
28 February PART A
trifluoro-2,6-dinitro-p-
2009
2019
CAS No 1861-40-1
toluidine
Impurities:
Only uses as herbicide may be authorised.
CIPAC No 285
— ethyl-butyl-nitro
PART B
samine: max.
0,1 mg/kg
In assessing applications to authorise plant protection products containing
benfluralin for uses other than lettuce and endive, Member States shall pay particular
attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall
ensure that any necessary data and information is provided before such an au
thorisation is granted.
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on benfluralin,
L
153/81
and in particular Appendices I and II thereof, as finalised in the Standing Committee
on the Food Chain and Animal Health on 20 May 2008 shall be taken into account.

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L 153/82
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
In this overall assessment Member States must pay particular attention to:
— the protection of the operators’ safety. Authorised conditions of use must
prescribe the application of adequate personal protective equipment and risk
mitigation measures to reduce the exposure,
EN

— the residues in food of plant and animal origin and evaluate the dietary exposure
of consumers,
— the protection of birds, mammals, surface waters and aquatic organisms. In
relation to these identified risks, risk mitigation measures, such as buffer
zones, should be applied where appropriate.
The Member States concerned shall request the submission of further studies on
rotational crops metabolism and to confirm the risk assessment for metabolite B12
and for aquatic organisms. They shall ensure that the notifiers at whose request
benfluralin has been included in this Annex provide such studies to the Commission
Off
within two years from the approval.
icial
Jour
189 Fluazinam
3-chloro-N-(3-chloro-5-
≥ 960 g/kg
1 March
28 February PART A
trifluoromethyl-2-pyridyl)-
2009
2019
nal
CAS No 79622-59-6
α,α,α-trifluoro-2, 6-dinitro- Impurities:
Only uses as fungicide may be authorised.
of
p-toluidine
the
CIPAC No 521
5-chloro-N-(3-chloro-
5-trifluoromethyl-2-
PART B
European
pyridyl)-α,α,α-trifluoro-
4,6-dinitro-o-toluidine
In assessing applications to authorise plant protection products containing fluazinam
for uses other than potatoes, Member States shall pay particular attention to the
— not more than
Union
criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any
2 g/kg
necessary data and information is provided before such an authorisation is granted.
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on fluazinam,
and in particular Appendices I and II thereof, as finalised in the Standing Committee
on the Food Chain and Animal Health on 20 May 2008 shall be taken into account.
In this overall assessment Member States must pay particular attention to:
— the protection of the operators’ and workers’ safety. Authorised conditions of use
must prescribe the application of adequate personal protective equipment and
risk mitigation measures to reduce the exposure,
— the residues in food of plant and animal origin and evaluate the dietary exposure
of consumers,
11.6.2011
— the protection of aquatic organisms. In relation to this identified risk, risk miti
gation measures, such as buffer zones, should be applied where appropriate.

---

11.6.2011 Off
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
The Member States concerned shall request the submission of further studies to
confirm the risk assessment for aquatic organisms and soil macro-organisms. They
shall ensure that the notifiers at whose request fluazinam has been included in this
Annex provide such studies to the Commission within two years from the approval.
EN

190 Fuberidazole
2-(2′-furyl)benzimidazole
≥ 970 g/kg 1
March
28 February PART A
2009
2019
CAS No 3878-19-1
Only uses as fungicide may be authorised.
CIPAC No 525
PART B
In assessing applications to authorise plant protection products containing fuberi
dazole for uses other than seed dressing, Member States shall pay particular attention
to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure
that any necessary data and information is provided before such an authorisation is
granted.
icial
For the implementation of the uniform principles as referred to in Article 29(6) of
Jour
Regulation (EC) No 1107/2009, the conclusions of the review report on fuberi
dazole, and in particular Appendices I and II thereof, as finalised in the Standing
nal
Committee on the Food Chain and Animal Health on 20 May 2008 shall be taken
of
into account.
the
In this overall assessment Member States must pay particular attention to:
European
— the operator safety and ensure that conditions of use prescribe the application of
adequate personal protective equipment,
Union
— long-term risk to mammals and must ensure that the conditions of authorisation
include, where appropriate, risk mitigation measures.In such case the use of
adequate equipment ensuring a high degree of incorporation in soil and a mini
misation of spillage during application should apply.
Conditions of use shall include adequate risk mitigation measures, where appro
priate.
191 Mepiquat
1,1-dimethylpiperidinium
≥ 990 g/kg 1
March
28 February PART A
chloride (mepiquat
2009
2019
CAS No 15302-91-7
chloride)
Only uses as plant growth regulator may be authorised.
CIPAC No 440
PART B
In assessing applications to authorise plant protection products containing mepiquat
L
for uses other than in barley, Member States shall pay particular attention to the
153/83
criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any
necessary data and information is provided before such an authorisation is granted.

---

L 153/84
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on mepiquat,
and in particular Appendices I and II thereof, as finalised in the Standing Committee
on the Food Chain and Animal Health on 20 May 2008 shall be taken into account.
EN
The Member States must pay particular attention to the residues in food of plant and

animal origin and evaluate the dietary exposure of consumers.
192 Diuron
3-(3,4-dichlorophenyl)-1,1- ≥ 930 g/kg 1
October
30 September PART A
dimethylurea
2008
2018
CAS No 330-54-1
Only uses as herbicide at rates not exceeding 0,5 kg/ha (areic average) may be
authorised.
CIPAC No 100
PART B
Off
For the implementation of the uniform principles as referred to in Article 29(6) of
icial
Regulation (EC) No 1107/2009, the conclusions of the review report on diuron, and
in particular Appendices I and II thereof, as finalised in the Standing Committee on
Jour
the Food Chain and Animal Health on 11 July 2008 shall be taken into account.
nal
of
In this overall assessment Member States must pay particular attention to:
the
European
— the operator safety; conditions of use shall prescribe the use of personal
protective equipment, if appropriate,
— the protection of aquatic organisms and non-target plants.
Union
Conditions of authorisation shall include risk mitigation measures, where appro
priate.
193 Bacillus thuringiensis
Not applicable No
relevant
impurities 1
May
2009 30
April PART A
subsp. aizawai
2019
Only uses as insecticide may be authorised.
STRAIN: ABTS-1857
PART B
Culture collection: No
SD-1372,
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on Bacillus
STRAIN: GC-91
thuringiensis subsp.Aizawai ABTS-1857 (SANCO/1539/2008) and GC-91
(SANCO/1538/2008) and in particular Appendices I and II thereof, as finalised in
Culture collection: No
the Standing Committee on the Food Chain and Animal Health shall be taken into
11.6.2011
NCTC 11821
account.
Conditions of use shall include, where appropriate, risk mitigation measures.

---

11.6.2011 Off
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
194 Bacillus thuringiensis
Not applicable No
relevant
impurities 1
May
2009 30
April PART A
subsp. israeliensis
2019
(serotype H-14)
Only uses as insecticide may be authorised.
STRAIN: AM65-52
PART B
EN
Culture collection: No

ATCC-1276
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on Bacillus
thuringiensis subsp. israeliensis (serotype H-14) AM65-52 (SANCO/1540/2008) and
in particular Appendices I and II thereof, as finalised in the Standing Committee on
the Food Chain and Animal Health shall be taken into account.
Conditions of use shall include, where appropriate, risk mitigation measures.
195 Bacillus thuringiensis
Not applicable No
relevant
impurities 1
May
2009 30
April PART A
subsp. kurstaki
2019
Only uses as insecticide may be authorised.
icial
STRAIN: ABTS 351
PART B
Jour
Culture collection: No
ATCC SD-1275
For the implementation of the uniform principles as referred to in Article 29(6) of
nal
Regulation (EC) No 1107/2009, the conclusions of the review report on Bacillus
of
STRAIN: PB 54
thuringiensis subsp. kurstaki ABTS 351 (SANCO/1541/2008), PB 54
the
(SANCO/1542/2008), SA 11, SA 12 and EG 2348 (SANCO/1543/2008) and in
Culture collection: No
particular Appendices I and II thereof, as finalised in the Standing Committee on the
European
CECT 7209
Food Chain and Animal Health shall be taken into account.
STRAIN: SA 11
Conditions of use shall include, where appropriate, risk mitigation measures.
Union
Culture collection: No
NRRL B-30790
STRAIN: SA 12
Culture collection: No
NRRL B-30791
STRAIN: EG 2348
Culture collection: No
NRRL B-18208
196 Bacillus thuringiensis
Not applicable No
relevant
impurities 1
May
2009 30
April PART A
subsp. Tenebrionis
2019
Only uses as insecticide may be authorised.
STRAIN: NB 176 (TM
141)
PART B
L
153/85
Culture collection: No
For the implementation of the uniform principles as referred to in Article 29(6) of
SD-5428
Regulation (EC) No 1107/2009, the conclusions of the review report on Bacillus

---

L 153/86
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
thuringiensis subsp. tenebrionis NB 176 (SANCO/1545/2008) and in particular
Appendices I and II thereof, as finalised in the Standing Committee on the Food
Chain and Animal Health shall be taken into account.
Conditions of use shall include, where appropriate, risk mitigation measures.
EN

197 Beauveria
bassiana
Not applicable Max
level
of
beau 1 May 2009 30
April PART A
vericin: 5 mg/kg
2019
STRAIN: ATCC 74040
Only uses as insecticide may be authorised.
Culture collection: No
PART B
ATCC 74040
For the implementation of the uniform principles as referred to in Article 29(6) of
STRAIN: GHA
Regulation (EC) No 1107/2009, the conclusions of the review report on Beauveria
bassiana ATCC 74040 (SANCO/1546/2008) and GHA (SANCO/1547/2008) and in
Culture collection: No
particular Appendices I and II thereof, as finalised in the Standing Committee on the
Off
ATCC 74250
Food Chain and Animal Health shall be taken into account.
icial
Conditions of use shall include, where appropriate, risk mitigation measures.
Jour
nal
198 Cydia
pomonella
Not applicable Contaminating
micro-
1 May 2009 30
April PART A
of
Granulovirus (CpGV)
organisms (Bacillus
2019
the
cereus) < 1 × 106
Only uses as insecticide may be authorised.
European
CFU/g
PART B
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on Cydia
Union
pomonella Granulovirus (CpGV) (SANCO/1548/2008) and in particular Appendices
I and II thereof, as finalised in the Standing Committee on the Food Chain and
Animal Health shall be taken into account.
Conditions of use shall include, where appropriate, risk mitigation measures.
199 Lecanicillium
Not applicable No
relevant
impurities 1
May
2009 30
April PART A
muscarium
2019
Only uses as insecticide may be authorised.
(formerly Verticilium
lecanii)
PART B
STRAIN: Ve 6
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on Lecani
Culture collection: No
cillium muscarium (formerly Verticilium lecanii) Ve 6 (SANCO/1861/2008) and in
CABI (=IMI) 268317,
particular Appendices I and II thereof, as finalised in the Standing Committee on the
11.6.2011
CBS 102071, ARSEF
Food Chain and Animal Health shall be taken into account.
5128
Conditions of use shall include, where appropriate, risk mitigation measures.

---

11.6.2011 Off
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
200 Metarhizium
anisopliae
Not applicable No
relevant
impurities 1
May
2009 30
April PART A
var. anisopliae
2019
(formerly Metarhizium
Only uses as insecticide and acaricide may be authorised.
anisopliae)
EN

STRAIN: BIPESCO
PART B
5/F52
For the implementation of the uniform principles as referred to in Article 29(6) of
Culture collection: No
Regulation (EC) No 1107/2009, the conclusions of the review report on Meta
M.a. 43; No 275-86
rhizium anisopliae var. anisopliae (formerly Metarhizium anisopliae) BIPESCO 5
(acronyms V275 or
and F52 (SANCO/1862/2008) and in particular Appendices I and II thereof, as
KVL 275); No KVL 99-
finalised in the Standing Committee on the Food Chain and Animal Health shall
112 (Ma 275 or V
be taken into account.
275); No DSM 3884;
No ATCC 90448; No
ARSEF 1095
Conditions of use shall include, where appropriate, risk mitigation measures.
icial
Jour
201 Phlebiopsis
gigantea Not applicable No
relevant
impurities 1
May
2009 30
April PART A
2019
nal
Only uses as fungicide may be authorised.
STRAIN: VRA 1835
of
PART B
the
Culture collection: No
European
For the implementation of the uniform principles as referred to in Article 29(6) of
ATCC 90304
Regulation (EC) No 1107/2009, the conclusions of the review report on Phlebiopsis
gigantea (SANCO/1863/2008) and in particular Appendices I and II thereof, as
STRAIN: VRA 1984
finalised in the Standing Committee on the Food Chain and Animal Health shall
Union
be taken into account.
Culture collection: No
Conditions of use shall include, where appropriate, risk mitigation measures.
DSM16201
STRAIN: VRA 1985
Culture collection: No
DSM 16202
STRAIN: VRA 1986
Culture collection: No
DSM 16203
STRAIN: FOC PG B20/5
L
Culture collection: No
153/87
IMI 390096

---

L 153/88
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
STRAIN: FOC PG SP
log 6
Culture collection: No
EN
IMI 390097

STRAIN: FOC PG SP
log 5
Culture collection: No
IMI 390098
STRAIN: FOC PG BU 3
Culture collection: No
IMI 390099
Off
icial
STRAIN: FOC PG BU 4
Jour
Culture collection: No
nal
IMI 390100
of
STRAIN: FOC PG 410.3
the
Culture collection: No
European
IMI 390101
STRAIN: FOC PG97/
1062/116/1.1
Union
Culture collection: No
IMI 390102
STRAIN: FOC PG B22/
SP1287/3.1
Culture collection: No
IMI 390103
STRAIN: FOC PG SH 1
Culture collection: No
IMI 390104
STRAIN: FOC PG B22/
SP1190/3.2
11.6.2011
Culture collection: No
IMI 390105

---

11.6.2011 Off
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
202 Pythium
oligandrum Not applicable No
relevant
impurities 1
May
2009 30
April PART A
2019
STRAINS: M1
Only uses as fungicide may be authorised
Culture collection No
EN
ATCC 38472
PART B

For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on Pythium
oligandrum M1 (SANCO/1864/2008) and in particular Appendices I and II thereof,
as finalised in the Standing Committee on the Food Chain and Animal Health shall
be taken into account.
Conditions of use shall include, where appropriate, risk mitigation measures.
203 Streptomyces K61
Not applicable No
relevant
impurities 1
May
2009 30
April PART A
icial
(formerly S. griseo
2019
viridis)
Only uses as fungicide may be authorised.
Jour
STRAIN: K61
PART B
nal
of
Culture collection: No
For the implementation of the uniform principles as referred to in Article 29(6) of
DSM 7206
Regulation (EC) No 1107/2009, the conclusions of the review report on Strep
the
tomyces (formerly Streptomyces griseoviridis) K61 (SANCO/1865/2008), and in
European
particular Appendices I and II thereof, as finalised in the Standing Committee on
the Food Chain and Animal Health shall be taken into account.
Conditions of use shall include, where appropriate, risk mitigation measures.
Union
204 Trichoderma
atroviride Not applicable No
relevant
impurities 1
May
2009 30
April PART A
2019
(formerly T. harzianum)
Only uses as fungicide may be authorised.
STRAIN: IMI 206040
PART B
Culture collection No
For the implementation of the uniform principles as referred to in Article 29(6) of
IMI 206040, ATCC
Regulation (EC) No 1107/2009, the conclusions of the review reports on
20476;
Trichoderma atroviride (formerly T. harzianum) IMI 206040 (SANCO/1866/2008)
and T-11 (SANCO/1841/2008) respectively, and in particular Appendices I and II
STRAIN: T11
thereof, as finalised in the Standing Committee on the Food Chain and Animal
Health shall be taken into account.
Culture collection: No
Conditions of use shall include, where appropriate, risk mitigation measures.
Spanish type culture
collection CECT
L
20498, identical with
153/89
IMI 352941

---

L 153/90
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
205 Trichoderma poly Not applicable No
relevant
impurities 1
May
2009 30
April PART A
sporum
2019
Only uses as fungicide may be authorised.
STRAIN: Trichoderma
polysporum IMI
PART B
EN
206039

Culture collection No
For the implementation of the uniform principles as referred to in Article 29(6) of
IMI 206039, ATCC
Regulation (EC) No 1107/2009, the conclusions of the review report on
20475
Trichoderma polysporum IMI 206039 (SANCO/1867/2008), and in particular
Appendices I and II thereof, as finalised in the Standing Committee on the Food
Chain and Animal Health shall be taken into account.
Conditions of use shall include, where appropriate, risk mitigation measures.
Off
206 Trichoderma
harzianum
Not applicable No
relevant
impurities 1
May
2009 30
April PART A
icial
Rifai
2019
Only uses as fungicide may be authorised.
Jour
STRAIN:
PART B
nal
Trichoderma harzianum
of
T-22;
For the implementation of the uniform principles as referred to in Article 29(6) of
the
Regulation (EC) No 1107/2009, the conclusions of the review reports on
Culture collection No
Trichoderma harzianum T-22 (SANCO/1839/2008) and ITEM 908
European
ATCC 20847
(SANCO/1840/208) respectively and in particular Appendices I and II thereof, as
finalised in the Standing Committee on the Food Chain and Animal Health shall be
STRAIN: Trichoderma
taken into account.
harzianum ITEM 908;
Union
Conditions of use shall include, where appropriate, risk mitigation measures.
Culture collection No
CBS 118749
207 Trichoderma
asperellum
Not applicable No
relevant
impurities 1
May
2009 30
April PART A
2019
(formerly T. harzianum)
Only uses as fungicide may be authorised.
STRAIN: ICC012
PART B
Culture collection No
For the implementation of the uniform principles as referred to in Article 29(6) of
CABI CC IMI 392716
Regulation (EC) No 1107/2009, the conclusions of the review reports on
Trichoderma asperellum (formerly T. harzianum) ICC012 (SANCO/1842/2008)
STRAIN: Trichoderma
and Trichoderma asperellum (formerly T. viride T25 and TV1) T25 and TV1
asperellum
(SANCO/1868/2008) and in particular Appendices I and II thereof, as finalised in
11.6.2011
the Standing Committee on the Food Chain and Animal Health shall be taken into
(formerly T. viride T25)
account.
T25

---

11.6.2011 Off
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
Culture collection No
Conditions of use shall include, where appropriate, risk mitigation measures.
CECT 20178
STRAIN: Trichoderma
asperellum
EN

(formerly T. viride TV1)
TV1
Culture collection No
MUCL 43093
208 Trichoderma gamsii
Not applicable No
relevant
impurities 1
May
2009 30
April PART A
(formerly T. viride)
2019
STRAINS:
Only uses as fungicide may be authorised.
icial
ICC080
Jour
PART B
Culture collection No
nal
IMI CC number
of
392151 CABI
For the implementation of the uniform principles as referred to in Article 29(6) of
the
Regulation (EC) No 1107/2009, the conclusions of the review report on
Trichoderma viride (SANCO/1868/2008), and in particular Appendices I and II
European
thereof, as finalised in the Standing Committee on the Food Chain and Animal
Health shall be taken into account.
Union
Conditions of use shall include, where appropriate, risk mitigation measures.
209 Verticillium
albo-atrum Not applicable No
relevant
impurities 1
May
2009 30
April PART A
2019
(formerly Verticillium
Only uses as fungicide may be authorised.
dahliae)
PART B
STRAIN: Verticillium
albo-atrum isolate
WCS850
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on Verticillium
albo-atrum (formerly Verticillium dahliae) WCS850 (SANCO/1870/2008), and in
Culture collection No
particular Appendices I and II thereof, as finalised in the Standing Committee on
CBS 276.92
the Food Chain and Animal Health shall be taken into account.
L
153/91
Conditions of use shall include, where appropriate, risk mitigation measures.

---

L 153/92
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
210 Abamectin
AvermectinB1a
≥ 850 g/kg 1
May
2009 30
April PART A
2019
CAS No 71751-41-2
(10E,14E,16E,22Z)-
(1R,4S,5′S,6S,6′R,8R,12S,
Only uses as insecticide, acaricide may be authorised.
avermectin B1a
13S,20R,21R,24S)-6′-[(S)-
EN
CAS No 65195-55-3
sec-butyl]-21,24-
PART B

dihydroxy-5′,11.13,22-
Avermectin B1b
tetramethyl-2-oxo-3.7,19-
In assessing applications to authorise plant protection products containing
CAS No 65195-56-4
trioxatetracyclo[15.6.1.14,8
abamectin for uses other than citrus, lettuce and tomatoes, Member States shall
020,24]pentacosa-
abamectin
pay particular attention to the criteria in Article 4(3) of Regulation (EC)
10.14,16,22-tetraene-6-
No 1107/2009, and shall ensure that any necessary data and information are
CIPAC No 495
spiro-2′-(5′,6′-dihydro-
provided before such an authorisation is granted.
2′H-pyran)-12-yl 2,6-
dideoxy-4-O-(2,6-dideoxy-
3-O-methyl-α-L-arabino-
For the implementation of the uniform principles as referred to in Article 29(6) of
hexopyranosyl)-3-O-
Regulation (EC) No 1107/2009, the conclusions of the review report on (abamectin),
Off
methyl-α-L-arabino-
and in particular Appendices I and II thereof, as finalised in the Standing Committee
icial
hexopyranoside
on the Food Chain and Animal Health on 11 July 2008 shall be taken into account.
Jour
AvermectinB1b
In this overall assessment Member States must pay particular attention to:
nal
(10E,14E,16E,22Z)-
(1R,4S,5′S,6S,6′R,8R,12S,
of
— the operator safety and ensure that conditions of use prescribe the application of
13S,20R,21R,24S)-21,24-
the
adequate personal protective equipment,
dihydroxy-6′-isopropyl-
European
5′,11.13,22-tetramethyl-2-
oxo-3.7,19-trioxatet
— the residues in food of plant origin and evaluate the dietary exposure of
racyclo[15.6.1.14,8
consumers,
020,24]pentacosa-
Union
10.14,16,22-tetraene-6-
— the protection of bees, non-target arthropods, birds, mammals and aquatic
spiro-2′-(5′,6′-dihydro-
organisms. In relation to these identified risks risk mitigation measures, such
2′H-pyran)-12-yl 2,6-
as buffer zones, waiting periods, should be applied where appropriate.
dideoxy-4-O-(2,6-dideoxy-
3-O-methyl-α-L-arabino-
The Member States concerned shall request the submission of:
hexopyranosyl)-3-O-
methyl-α-L-arabino-
hexopyranoside
— further studies on the specification,
— information to further address the risk assessment for birds and mammals,
— information to address the risk to aquatic organisms with respect to the major
soil metabolites,
— information to address the risk to groundwater with respect to the metabolite
U8.
11.6.2011
They shall ensure that the notifiers provide such studies to the Commission within
two years from the approval.

---

11.6.2011 Off
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
211 Epoxiconazole
(2RS, 3SR)-1-[3-(2-chloro ≥ 920 g/kg 1
May
2009 30
April PART A
phenyl)-2,3-epoxy-2-(4-
2019
CAS No 135319-73-2
fluorophenyl)propyl]-1H-
(formerly 106325-08-0) 1.2,4-triazole
Only uses as fungicide may be authorised.
EN
CIPAC No 609

PART B
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on epox
iconazole, and in particular Appendices I and II thereof, as finalised in the
Standing Committee on the Food Chain and Animal Health on 11 July 2008
shall be taken into account.
In this overall assessment Member States must pay particular attention to:
icial
— the operator safety and ensure that conditions of use prescribe the application of
Jour
adequate personal protective equipment where appropriate,
nal
of
— the dietary exposure of consumers to the epoxiconazole (triazole) metabolites,
the
European
— the potential for long-range transport via air,
— the risk to aquatic organisms, birds and mammals. Conditions of authorisation
Union
shall include risk mitigation measures, where appropriate.
The Member States concerned shall ensure that the notifier submits to the
Commission further studies addressing the potential endocrine disrupting properties
of epoxiconazole within two years after the adoption of the OECD test guidelines on
endocrine disruption or, alternatively, of Community agreed test guidelines.
The Member States concerned shall ensure that the notifier presents to the
Commission not later than 30 June 2009 a monitoring programme to assess the
long-range atmospheric transport of epoxiconazole and related environmental risks.
The results of this monitoring shall be submitted as a monitoring report to the
Commission by 31 December 2011 at the latest.
The concerned Member States shall ensure that the notifier submits within two years
from the approval, at the latest, information on residues of epoxiconazole meta
L
bolites in primary crops, rotational crops and products of animal origin and
153/93
information to further address the long-term risk to herbivorous birds and
mammals.

---

L 153/94
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
212 Fenpropimorph
(RS)-cis-4-[3-(4-tert-
≥ 930 g/kg 1
May
2009 30
April PART A
butylphenyl)-2-methyl
2019
CAS No 67564-91-4
propyl]-2,6-dimethylmor
Only uses as fungicide may be authorised.
CIPAC No 427
pholine
PART B
EN

For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on
fenpropimorph, and in particular Appendices I and II thereof, as finalised in the
Standing Committee on the Food Chain and Animal Health on 11 July 2008 shall
be taken into account.
In this overall assessment Member States must pay particular attention to:
— the operators and workers safety. Authorised conditions of use must prescribe
Off
the application of adequate personal protective equipment and risk mitigation
icial
measures to reduce the exposure, such as restrictions of the daily work rate,
Jour
— the protection of the groundwater, when the active substance is applied in
regions with vulnerable soil and/or climatic conditions,
nal
of
— the protection of aquatic organisms. Conditions of authorisation should include
the
risk mitigation measures, where appropriate, such as buffer zones, reduction of
run-off and drift reduction nozzles.
European
The Member States concerned shall request the submission of further studies to
confirm the mobility in soil of the metabolite BF-421-7. They shall ensure that
Union
the notifiers at whose request fenpropimorph has been included in this Annex
provide such studies to the Commission within two years from the approval.
213 Fenpyroximate
tert-butyl (E)-alpha-(1,3-
> 960 g/kg 1
May
2009 30
April PART A
dimethyl-5-pheno
2019
CAS No 134098-61-6
xypyrazol-4-ylmethylene
Only uses as acaricide may be authorised.
amino-oxy)-p-toluate
CIPAC No 695
The following uses must not be authorised:
— applications in high crops with a high risk of spray drift, for example tractor
mounted air-blast sprayer and hand-held applications.
PART B
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on fenpy
11.6.2011
roximate, and in particular Appendices I and II thereof, as finalised in the
Standing Committee on the Food Chain and Animal Health on 11 July 2008
shall be taken into account.

---

11.6.2011 Off
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
In this overall assessment Member States must pay particular attention to:
— the operator and worker safety and ensure that conditions of use prescribe the
application of adequate personal protective equipment,
EN
— the impact on aquatic organisms and non-target arthropods and must ensure

that the conditions of authorisation include, where appropriate, risk mitigation
measures.
The Member States concerned shall request the submission of information to further
address:
— the risk to aquatic organisms from metabolites containing the benzyl moiety,
— the risk of biomagnification in aquatic food chains.
They shall ensure that the notifiers at whose request fenpyroximate has been
icial
included in this Annex provide such information to the Commission within two
years from the approval.
Jour
nal
214 Tralkoxydim
(RS)-2-[(EZ)-1-
≥ 960 g/kg 1
May
2009 30
April PART A
(ethoxyimino)propyl]-3-
2019
of
CAS No 87820-88-0
hydroxy-5-mesitylcyclohex-
Only uses as herbicide may be authorised.
the
2-en-1-one
European
CIPAC No 544
PART B
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on tralk
oxydim, and in particular Appendices I and II thereof, as finalised in the Standing
Union
Committee on the Food Chain and Animal Health on 11 July 2008 shall be taken
into account.
In this overall assessment Member States must pay particular attention to:
— the protection of the groundwater, in particular from the soil metabolite
R173642 when the active substance is applied in regions with vulnerable soil
and/or climatic conditions,
— the protection of herbivorous mammals.
Conditions of use shall include risk mitigation measures, where appropriate.
The Member States concerned shall request the submission of:
— information to further address the long-term risk to herbivorous mammals
arising from the use of tralkoxydim.
L
They shall ensure that the notifiers at whose request tralkoxydim has been included
153/95
in this Annex provide such information to the Commission within two years from
the approval.

---

L 153/96
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
215 Aclonifen
2-chloro-6-nitro-3-phe
≥ 970 g/kg
1 August
31 July 2019 PART
A
noxyaniline
2009
CAS No 74070-46-5
The impurity phenol
is of toxicological
CIPAC No 498
Only uses as herbicide may be authorised.
concern and a
EN
maximum level of

5 g/kg is established.
PART B
In assessing applications to authorise plant protection products containing aclonifen
for uses other than sunflower, Member States shall pay particular attention to the
criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any
necessary data and information is provided before such an authorisation is granted.
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on aclonifen,
Off
and in particular Appendices I and II thereof, as finalised in the Standing Committee
icial
on the Food Chain and Animal Health on 26 September 2008 shall be taken into
account.
Jour
nal
In this overall assessment Member States must pay particular attention to:
of
the
— the specification of the technical material as commercially manufactured, which
European
must be confirmed and supported by appropriate analytical data. The test
material used in the toxicity dossiers should be compared and verified against
this specification of the technical material,
Union
— the protection of the operators safety. Authorised conditions of use must
prescribe the application of adequate personal protective equipment and risk
mitigation measures to reduce the exposure,
— the residues in rotational crops and evaluate the dietary exposure of consumers,
— the protection of birds, mammals, aquatic organisms and non-target plants. In
relation to these identified risks, risk mitigation measures, such as buffer zones,
should be applied where appropriate.
The Member States concerned shall request the submission of further studies on
rotational crops residues and relevant information to confirm the risk assessment for
birds, mammals, aquatic organisms and non-target plants.
11.6.2011
They shall ensure that the notifier provides such confirmatory data and information
to the Commission within two years from the approval.

---

11.6.2011 Off
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
216 Imidacloprid
(E)-1-(6-Chloro-3-pyridi
≥ 970 g/kg 1
August
31 July 2019 PART
A
nylmethyl)-N-nitroimid
2009
CAS No 138261-41-3
azolidin-2-ylideneamine
Only uses as insecticide may be authorised.
CIPAC No 582
For the protection of non-target organisms, in particular honey bees and birds, for
EN
use as seed treatment:

— the seed coating shall only be performed in professional seed treatment facilities.
Those facilities must apply the best available techniques in order to ensure that
the release of dust during application to the seed, storage and transport can be
minimised,
— adequate seed drilling equipment shall be used to ensure a high degree of incor
poration in soil, minimisation of spillage and minimisation of dust emission.
Member States shall ensure that:
— the label of treated seed includes the indication that the seeds were treated with
icial
imidacloprid and sets out the risk mitigation measures provided for in the au
Jour
thorisation,
nal
— the conditions of the authorisation, in particular for spray applications, include,
where appropriate, risk mitigation measures to protect honey bees,
of
the
— monitoring programmes are initiated to verify the real exposure of honey bees to
European
imidacloprid in areas extensively used by bees for foraging or by beekeepers,
where and as appropriate.
PART B
Union
In assessing applications to authorise plant protection products containing imid
acloprid for uses other than tomatoes in glasshouses, Member States shall pay
particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009,
and shall ensure that any necessary data and information is provided before such an
authorisation is granted.
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on imid
acloprid, and in particular Appendices I and II thereof, as finalised in the Standing
Committee on the Food Chain and Animal Health on 26 September 2008 shall be
taken into account.
In this overall assessment Member States must pay particular attention to:
— the operator and worker safety and ensure that conditions of use prescribe the
application of adequate personal protective equipment,
L
— the impact on aquatic organisms, non-target arthropods, earthworms, other soil
153/97
macroorganisms and must ensure that the conditions of authorisation include,
where appropriate, risk mitigation measures.

---

L 153/98
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
The Member States concerned shall request the submission of:
— information to further address the risk assessment for operators and workers,
— information to further address the risk to birds and mammals.
EN

They shall ensure that the notifier provides such confirmatory data and information
to the Commission within two years from the approval.
217 Metazachlor
2-chloro-N-(pyrazol-1-
≥ 940 g/kg
1 August
31 July 2019 PART
A
ylmethyl)acet-2′,6′-xylidide
2009
CAS No 67129-08-2
The manufacturing
impurity toluene is
Only uses as herbicide may be authorised; application max. of 1,0 kg/ha only every
CIPAC No 411
considered to be of
third year on the same field.
toxicological concern
and a maximum level
PART B
Off
of 0,05
% is estab
icial
lished.
For the implementation of the uniform principles as referred to in Article 29(6) of
Jour
Regulation (EC) No 1107/2009, the conclusions of the review report on meta
zachlor, and in particular Appendices I and II thereof, as finalised in the Standing
nal
Committee on the Food Chain and Animal Health on 26 September 2008 shall be
of
taken into account.
the
In this overall assessment Member States must pay particular attention to:
European
— the operator safety and ensure that conditions of use prescribe the application of
adequate personal protective equipment,
Union
— the protection of aquatic organisms,
— the protection of the groundwater, when the active substance is applied in
regions with vulnerable soil and/or climatic conditions.
Conditions of authorisation shall include risk mitigation measures and monitoring
programmes shall be initiated to verify potential groundwater contamination from
the metabolites 479M04, 479M08, 479M09, 479M11 and 479M12 in vulnerable
zones, where appropriate.
If metazachlor is classified under Regularion (EC) No 1272/2008 as ‘suspected of
causing cancer’, the Member States concerned shall request the submission of further
information on the relevance of the metabolites 479M04, 479M08, 479M09,
479M11 and 479M12 with respect to cancer.
11.6.2011
They shall ensure that the notifiers provide that information to the Commission
within six months from the notification of such a classification decision.

---

11.6.2011 Off
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
218 Acetic
acid
Acetic acid
≥ 980 g/kg 1
September
31 August
PART A
2009
2019
CAS No 64-19-7
Only uses as herbicide may be authorised.
CIPAC No not allocated
EN
PART B

For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on acetic acid
(SANCO/2602/2008) and in particular Appendices I and II thereof, as finalised in
the Standing Committee on the Food Chain and Animal Health shall be taken into
account.
Conditions of use shall include, where appropriate, risk mitigation measures.
icial
219 Aluminium
ammonium
Aluminium ammonium
≥ 960 g/kg 1
September
31 August
PART A
Jour
sulphate
sulphate
2009
2019
Only uses as repellent may be authorised.
nal
CAS No 7784-26-1
of
PART B
the
CIPAC No not allocated
For the implementation of the uniform principles as referred to in Article 29(6) of
European
Regulation (EC) No 1107/2009, the conclusions of the review report on aluminium
ammonium sulphate (SANCO/2985/2008) and in particular Appendices I and II
thereof, as finalised in the Standing Committee on the Food Chain and Animal
Health shall be taken into account.
Union
Conditions of use shall include, where appropriate, risk mitigation measures.
220 Aluminium
silicate
Not available
≥ 999,8 g/kg 1
September
31 August
PART A
2009
2019
CAS No 1332-58-7
Chemical name: Kaolin
Only uses as repellent may be authorised.
CIPAC No not allocated
PART B
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on aluminium
silicate (SANCO/2603/2008) and in particular Appendices I and II thereof, as
finalised in the Standing Committee on the Food Chain and Animal Health shall
be taken into account.
L
Conditions of use shall include, where appropriate, risk mitigation measures.
153/99

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L 153/100
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
221 Ammonium
acetate Ammonium acetate
≥ 970 g/kg
1 September
31 August
PART A
2009
2019
CAS No 631-61-8
Relevant impurity:
Only uses as attractant may be authorised.
Heavy metals as Pb
CIPAC No not allocated
EN
maximum 10 ppm
PART B

For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on ammonium
acetate (SANCO/2986/2008) and in particular Appendices I and II thereof, as
finalised in the Standing Committee on the Food Chain and Animal Health shall
be taken into account.
Conditions of use shall include, where appropriate, risk mitigation measures.
Off
icial
222 Blood
meal
Not available
≥ 990 g/kg 1
September
31 August
PART A
Jour
2009
2019
CAS No not allocated
Only uses as repellent may be authorised. Blood meal must be in compliance with
nal
Regulation (EC) No 1069/2009.
CIPAC No not allocated
of
PART B
the
European
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on blood meal
(SANCO/2604/2008) and in particular Appendices I and II thereof, as finalised in
the Standing Committee on the Food Chain and Animal Health shall be taken into
Union
account.
Conditions of use shall include, where appropriate, risk mitigation measures.
223 Calcium
carbide
Calcium carbide
≥ 765 g/kg
1 September
31 August
PART A
2009
2019
CAS No 75-20-7
Calcium acetylide
Containing 0,08-
Only uses as repellent may be authorised.
0,52 g/kg
Calcium
CIPAC No not allocated
Phosphide
PART B
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on calcium
carbide (SANCO/2605/2008) and in particular Appendices I and II thereof, as
finalised in the Standing Committee on the Food Chain and Animal Health shall
be taken into account.
11.6.2011
Conditions of use shall include, where appropriate, risk mitigation measures.

---

11.6.2011 Off
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
224 Calcium
carbonate
Calcium carbonate
≥ 995 g/kg 1
September
31 August
PART A
2009
2019
CAS No 471-34-1
Only uses as repellent may be authorised.
CIPAC No not allocated
EN
PART B

For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on calcium
carbonate (SANCO/2606/2008) and in particular Appendices I and II thereof, as
finalised in the Standing Committee on the Food Chain and Animal Health shall be
taken into account.
Conditions of use shall include, where appropriate, risk mitigation measures.
icial
225 Carbon
dioxide
Carbon dioxide
≥ 99,9 % 1
September
31 August
PART A
Jour
2009
2019
CAS No 124-38-9
Only uses as fumigant may be authorised.
nal
of
PART B
the
For the implementation of the uniform principles as referred to in Article 29(6) of
European
Regulation (EC) No 1107/2009, the conclusions of the review report on carbon
dioxide (SANCO/2987/2008) and in particular Appendices I and II thereof, as
finalised in the Standing Committee on the Food Chain and Animal Health shall
be taken into account.
Union
Conditions of use shall include, where appropriate, risk mitigation measures.
226 Denathonium
benzoate Benzyldiethyl[[2,6-xylylcar ≥ 995 g/kg 1
September
31 August
PART A
bamoyl]methyl]ammonium
2009
2019
CAS No 3734-33-6
benzoate
Only uses as repellent may be authorised.
CIPAC No not allocated
PART B
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on de
nathonium benzoate (SANCO/2607/2008) and in particular Appendices I and II
thereof, as finalised in the Standing Committee on the Food Chain and Animal
Health shall be taken into account.
L
153/101
Conditions of use shall include, where appropriate, risk mitigation measures.

---

L 153/102
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
227 Ethylene
Ethene
≥ 99 % 1
September
31 August
PART A
2009
2019
CAS No 74-85-1
Only uses as plant growth regulator may be authorised.
CIPAC No not allocated
PART B
EN

For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on ethylene
(SANCO/2608/2008) and in particular Appendices I and II thereof, as finalised in
the Standing Committee on the Food Chain and Animal Health shall be taken into
account.
Conditions of use shall include, where appropriate, risk mitigation measures.
228 Extract
from
tea
tree Tee Tree Oil is a complex Main components:
1 September
31 August
PART A
Off
mixture of chemical
2009
2019
icial
CAS No Tee Tree Oil substances.
terpinen-4-ol
Only uses as fungicide may be authorised.
68647-73-4
≥ 300 g/kg
Jour
PART B
Main components:
γ-terpinene
nal
≥ 100 g/kg
For the implementation of the uniform principles as referred to in Article 29(6) of
of
terpinen-4-ol 562-74-3
Regulation (EC) No 1107/2009, the conclusions of the review report on extract
the
α-terpinene ≥ 50 g/kg
from tea tree (SANCO/2609/2008) and in particular Appendices I and II thereof, as
γ-terpinene 99-85-4
finalised in the Standing Committee on the Food Chain and Animal Health shall be
European
1,8-cineol trace
taken into account.
α-terpinene 99-86-5
Conditions of use shall include, where appropriate, risk mitigation measures.
1,8-cineol 470-82-6
Union
CIPAC No not allocated
229 Fat
destilation
residues Not available
≥ 40 % of cleaved 1 September
31 August
PART A
fatty acids
2009
2019
CAS No not allocated
Relevant impurity: Ni
Only uses as repellent may be authorised. Fat destilation residues of animal origin
CIPAC No not allocated
maximum 200 mg/kg
must be in compliance with Regulation (EC) No 1069/2009.
PART B
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on fat desti
lation residues (SANCO/2610/2008) and in particular Appendices I and II thereof, as
finalised in the Standing Committee on the Food Chain and Animal Health shall be
taken into account.
11.6.2011
Conditions of use shall include, where appropriate, risk mitigation measures.

---

11.6.2011 Off
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
230 Fatty
acids
C7
to
C20 Nonanoic acid
≥ 889 g/kg (Pelargonic 1 September
31 August
PART A
Acid)
2009
2019
CAS No 112-05-0 Caprylic Acid, Pelargonic
Only uses as insecticide, acaricide, and herbicide and plant growth regulator may be
(Pelargonic Acid)
Acid, Capric Acid, Lauric ≥ 838 g/kg fatty acids
authorised.
EN
Acid, Oleic Acid (ISO in

67701-09-1 (Fatty acids each case)
≥ 99 %
fatty
acid
PART B
C7-C18 and C18 unsa
methyl esters
For the implementation of the uniform principles as referred to in Article 29(6) of
turated potassium salts) Octanoic Acid, Nonanoic
Regulation (EC) No 1107/2009, the conclusions of the review report on fatty acids
Acid, Decanoic Acid,
(SANCO/2610/2008) and in particular Appendices I and II thereof, as finalised in
124-07-2 (Caprylic
Dodecanoic Acid, cis-9-
the Standing Committee on the Food Chain and Animal Health shall be taken into
Acid)
Octadecenoic Acid (IUPAC
account.
in each case)
334-48-5 (Capric Acid)
Conditions of use shall include, where appropriate, risk mitigation measures.
Fatty acids, C7-C10, Me
143-07-7 (Lauric Acid) esters
icial
112-80-1 (Oleic Acid)
Jour
85566-26-3 (Fatty acids
nal
C8-C10 Me esters)
of
the
111-11-5 (Methyl
octanoate)
European
110-42-9 (Methyl
decanoate)
Union
CIPAC No not allocated
231 Garlic
extract
Food grade garlic juice ≥ 99,9 % 1
September
31 August
PART A
concentrate
2009
2019
CAS No 8008-99-9
Only uses as repellent, insecticide and nematicide may be authorised.
CIPAC No not allocated
PART B
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on garlic
extract (SANCO/2612/2008) and in particular Appendices I and II thereof, as
finalised in the Standing Committee on the Food Chain and Animal Health shall
be taken into account.
L
153/103
Conditions of use shall include, where appropriate, risk mitigation measures.

---

L 153/104
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
232 Gibberellic
acid
(3S,3aS,4S,4aS,7S,9aR,9bR, ≥ 850 g/kg 1
September
31 August
PART A
12S)-7,12-dihydroxy-3-
2009
2019
CAS No 77-06-5
methyl-6-methylene-2-
Only uses as plant growth regulator may be authorised.
CIPAC No 307
oxoperhydro-4a,7-
methano-9b,3-
PART B
EN

propenol(1,2-b)furan-4-
carboxylic acid
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on gibberellic
Alt:
acid (SANCO/2613/2008) and in particular Appendices I and II thereof, as finalised
(3S,3aR,4S,4aS,6S,8aR,8b
in the Standing Committee on the Food Chain and Animal Health shall be taken
R,11S)-6,11-dihydroxy-3-
into account.
methyl-12-methylene-2-
oxo-4a,6-methano-3,8b-
Conditions of use shall include, where appropriate, risk mitigation measures.
prop-lenoperhydroindenol
(1,2-b) furan-4-carboxylic
acid
Off
icial
Jour
233 Gibberellins
GA4:
Review report
1 September
31 August
PART A
(SANCO/2614/2008).
2009
2019
nal
CAS No GA4: 468- (3S,3aR,4S,4aR,7R,9aR,9b
Only uses as plant growth regulator may be authorised.
44-0
R,12S)-12-hydroxy-3-
of
methyl-6-methylene-2-
PART B
the
GA7: 510-75-8
oxoperhydro-4a,7-
European
methano-3,9b-propa
For the implementation of the uniform principles as referred to in Article 29(6) of
GA4A7 mixture: 8030- noazuleno[1,2-b]furan-4-
Regulation (EC) No 1107/2009, the conclusions of the review report on gibberellins
53-3
carboxylic acid
(SANCO/2614/2008) and in particular Appendices I and II thereof, as finalised in
the Standing Committee on the Food Chain and Animal Health shall be taken into
Union
CIPAC No not allocated GA7:
account.
(3S,3aR,4S,4aR,7R,9aR,9b
Conditions of use shall include, where appropriate, risk mitigation measures.
R,12S)-12-hydroxy-3-
methyl-6-methylene-2-
oxoperhydro-4a,7-
methano-9b,3-propeno
azuleno[1,2-b]furan-4-
carboxylic acid
234 Hydrolysed
proteins Not available Review
report
1 September
31 August
PART A
(SANCO/2615/2008)
2009
2019
CAS No not allocated
Only uses as attractant may be authorised. Hydrolysed proteins of animal origin
must be in compliance with Regulation (EC) No 1069/2009.
CIPAC No not allocated
PART B
11.6.2011
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on hydrolysed

---

11.6.2011 Off
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
proteins (SANCO/2615/2008) and in particular Appendices I and II thereof, as
finalised in the Standing Committee on the Food Chain and Animal Health shall
be taken into account.
EN
Conditions of use shall include, where appropriate, risk mitigation measures.

235 Iron
sulphate
Iron (II) sulfate Iron(II)sulphate
1 September
31 August
PART A
anhydrous
2009
2019
Iron(II)sulphate
≥ 367,5 g/kg
Only uses as herbicide may be authorised.
anhydrous: CAS No
7720-78-7
Iron(II)sulphate
PART B
monohydrate
Iron(II)sulphate
≥ 300 g/kg
For the implementation of the uniform principles as referred to in Article 29(6) of
monohydrate: CAS No
Regulation (EC) No 1107/2009, the conclusions of the review report on iron
17375-41-6
Iron(II)sulphate
sulphate (SANCO/2616/2008) and in particular Appendices I and II thereof, as
heptahydrate
finalised in the Standing Committee on the Food Chain and Animal Health shall
Iron(II)sulphate
≥ 180 g/kg
be taken into account.
icial
heptahydrate: CAS No
Jour
7782-63-0
Conditions of use shall include, where appropriate, risk mitigation measures.
nal
CIPAC No not allocated
of
the
236 Kieselgur
(Diato Kieselgur (diatomaceous
920 ± 20 g SiO2/kg 1 September
31 August
PART A
maceous earth)
earth)
DE
2009
2019
European
Only uses as insecticide and acaricide may be authorised.
CAS No 61790-53-2
Maximum 0,1
% of
particles of Crystalline
PART B
CIPAC No 647
Silica (with diameter
Union
below 50 um.)
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on kieselgur
(SANCO/2617/2008) and in particular Appendices I and II thereof, as finalised in
the Standing Committee on the Food Chain and Animal Health shall be taken into
account.
Conditions of use shall include, where appropriate, risk mitigation measures.
237 Limestone
not available
≥ 980 g/kg 1
September
31 August
PART A
2009
2019
CAS No 1317-65-3
Only uses as repellent may be authorised.
CIPAC No not allocated
PART B
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on limestone
(SANCO/2618/2008) and in particular Appendices I and II thereof, as finalised in
L
the Standing Committee on the Food Chain and Animal Health shall be taken into
153/105
account.
Conditions of use shall include, where appropriate, risk mitigation measures.

---

L 153/106
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
238 Methyl
nonyl
ketone Undecan-2-one
≥ 975 g/kg 1
September
31 August
PART A
2009
2019
CAS No 112-12-9
Only uses as repellent may be authorised.
CIPAC No not allocated
PART B
EN

For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on
methylnonyl ketone (SANCO/2619/2008) and in particular Appendices I and II
thereof, as finalised in the Standing Committee on the Food Chain and Animal
Health shall be taken into account.
Conditions of use shall include, where appropriate, risk mitigation measures.
Off
239 Pepper
Black pepper — Piper It is a complex 1 September
31 August
PART A
icial
nigrum
mixture of chemical
2009
2019
CAS No not allocated
substances, the
Only uses as repellent may be authorised.
Jour
component piperine
CIPAC No not allocated
as marker should be
PART B
nal
minimum 4 %
For the implementation of the uniform principles as referred to in Article 29(6) of
of
Regulation (EC) No 1107/2009, the conclusions of the review report on pepper
the
(SANCO/2620/2008) and in particular Appendices I and II thereof, as finalised in
European
the Standing Committee on the Food Chain and Animal Health shall be taken into
account.
Conditions of use shall include, where appropriate, risk mitigation measures.
Union
240 Plant
oils/citronella
oil Citronella Oil is a complex Relevant impurities
1 September
31 August
PART A
mixture of chemical
methyl eugenol and
2009
2019
CAS No 8000-29-1
substances.
methyl-isoeugenol
Only uses as herbicide may be authorised.
maximum 0,1 %.
CIPAC No not allocated The main components are:
PART B
Citronellal (3,7-dimethyl-6-
For the implementation of the uniform principles as referred to in Article 29(6) of
octenal).
Regulation (EC) No 1107/2009, the conclusions of the review report on citronella
oil (SANCO/2621/2008) and in particular Appendices I and II thereof, as finalised in
Geraniol ((E)-3,7-dimethyl-
the Standing Committee on the Food Chain and Animal Health shall be taken into
2,6-octadien-1-ol).
account.
Citronellol (3,7-dimethyl-6-
Conditions of use shall include, where appropriate, risk mitigation measures.
octan-2-ol).
Geranyl acetate (3,7-
11.6.2011
dimethyl-6-octen-1yl
acetate).

---

11.6.2011 Off
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
241 Plant
oils/clove
oil
Clove Oil is a complex ≥ 800 g/kg 1
September
31 August
PART A
mixture of chemical
2009
2019
CAS No 94961-50-2 substances.
Only uses as fungicide and bactericide may be authorised.
(clove oil)
EN
The main component is
97-53-0 (Eugenol —
PART B

eugenol.
main component)
For the implementation of the uniform principles as referred to in Article 29(6) of
CIPAC No not allocated
Regulation (EC) No 1107/2009, the conclusions of the review report on clove oil
(SANCO/2622/2008) and in particular Appendices I and II thereof, as finalised in
the Standing Committee on the Food Chain and Animal Health shall be taken into
account.
Conditions of use shall include, where appropriate, risk mitigation measures.
icial
242 Plant
oils/rape
seed
oil Rape seed oil Rape
seed
oil
is
a
1 September
31 August
PART A
Jour
complex mixture of
2009
2019
CAS No 8002-13-9
nal
fatty acids
Only uses as insecticide and acaricide may be authorised.
of
CIPAC No not allocated
PART B
the
For the implementation of the uniform principles as referred to in Article 29(6) of
European
Regulation (EC) No 1107/2009, the conclusions of the review report on rape seed
oil (SANCO/2623/2008) and in particular Appendices I and II thereof, as finalised in
the Standing Committee on the Food Chain and Animal Health shall be taken into
account.
Union
Conditions of use shall include, where appropriate, risk mitigation measures.
243 Plant
oils/spear
mint
oil
Spearmint oil
≥ 550 g/kg
as
L- 1 September
31 August
PART A
Carvone
2009
2019
CAS No 8008-79-5
Only uses as plant growth regulator may be authorised.
CIPAC No not allocated
PART B
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on spearmint
oil (SANCO/2624/2008) and in particular Appendices I and II thereof, as finalised in
the Standing Committee on the Food Chain and Animal Health shall be taken into
account.
L
153/107
Conditions of use shall include, where appropriate, risk mitigation measures.

---

L 153/108
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
244 Potassium hydrogen
Potassium hydrogen
≥ 99,5 % 1
September
31 August
PART A
carbonate
carbonate
2009
2019
Only uses as fungicide may be authorised.
CAS No 298-14-6
EN
CIPAC No not allocated
PART B

For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on potassium
hydrogen carbonate (SANCO/2625/2008) and in particular Appendices I and II
thereof, as finalised in the Standing Committee on the Food Chain and Animal
Health shall be taken into account.
Conditions of use shall include, where appropriate, risk mitigation measures.
Off
icial
245 Putrescin (1,4-Diami Butane-1,4-diamine
≥ 990 g/kg 1
September
31 August
PART A
nobutane)
2009
2019
Jour
Only uses as attractant may be authorised.
CAS No 110-60-1
nal
PART B
of
CIPAC No not allocated
For the implementation of the uniform principles as referred to in Article 29(6) of
the
Regulation (EC) No 1107/2009, the conclusions of the review report on putrescin
European
(SANCO/2626/2008) and in particular Appendices I and II thereof, as finalised in
the Standing Committee on the Food Chain and Animal Health shall be taken into
account.
Union
Conditions of use shall include, where appropriate, risk mitigation measures.
246 Pyrethrins
Pyrethrins are a complex Extract A: ≥ 500 g/kg 1 September
31 August
PART A
mixture of chemical
Pyrethrins
2009
2019
CAS No (A) and (B):
substances.
Only uses as insecticide may be authorised.
Extract B: ≥ 480 g/kg
Pyrethrins: 8003-34-7
Pyrethrins
PART B
Extract A: extractives of
For the implementation of the uniform principles as referred to in Article 29(6) of
Chrysanthemum cine
Regulation (EC) No 1107/2009, the conclusions of the review report on pyrethrins
rariaefolium: 89997-
(SANCO/2627/2008) and in particular Appendices I and II thereof, as finalised in
63-7
the Standing Committee on the Food Chain and Animal Health shall be taken into
account.
pyrethrin 1: CAS 121-
21-1
Conditions of use shall include, where appropriate, risk mitigation measures.
11.6.2011
pyrethrin 2: CAS 121-
29-9

---

11.6.2011 Off
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
cinerin 1: CAS 25402-
06-6
cinerin 2: CAS 121-
20-0
EN

jasmolin 1: CAS 4466-
14-2
jasmolin 2: CAS 1172-
63-0
Extract B: pyrethrin 1:
CAS 121-21-1
pyrethrin 2: CAS 121-
29-9
icial
Jour
cinerin 1: CAS 25402-
06-6
nal
of
cinerin 2: CAS 121-
20-0
the
European
jasmolin 1: CAS 4466-
14-2
jasmolin 2: CAS 1172-
Union
63-0
CIPAC No 32
247 Quartz
sand
Quarz, Quartz, Silicium ≥ 915 g/kg
1 September
31 August
PART A
dioxid, Silica, Silicon
2009
2019
CAS No 14808-60-7
dioxide, SiO2
Maximum 0,1
% of
Only uses as repellent may be authorised.
particles of Crystalline
CIPAC No not allocated
Silica (with diameter
below 50 um.)
PART B
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on quartz sand
(SANCO/2628/2008) and in particular Appendices I and II thereof, as finalised in
the Standing Committee on the Food Chain and Animal Health shall be taken into
account.
L
153/109
Conditions of use shall include, where appropriate, risk mitigation measures.

---

L 153/110
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
248 Repellents
by
smell
of
Fish Oil
≥ 99 % 1
September
31 August
PART A
animal or plant
2009
2019
origin/fish oil
Only uses as repellent may be authorised. Fish oil must be in compliance with
Regulation (EC) No 1069/2009
EN
CAS No 100085-40-3

CIPAC No not allocated
PART B
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on fish oil
(SANCO/2629/2008) and in particular Appendices I and II thereof, as finalised in
the Standing Committee on the Food Chain and Animal Health shall be taken into
account.
Conditions of use shall include, where appropriate, risk mitigation measures.
Off
icial
249 Repellents
by
smell
of
Sheep Fat Pure
sheep
fat
1 September
31 August
PART A
Jour
animal or plant
containing a
2009
2019
nal
origin/sheep fat
maximum of 0,18 %
Only uses as repellent may be authorised. Sheep fat must be in compliance with
w/w/water.
Regulation (EC) No 1069/2009
of
CAS No 98999-15-6
the
PART B
CIPAC No not allocated
European
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on sheep fat
(SANCO/2630/2008) and in particular Appendices I and II thereof, as finalised in
the Standing Committee on the Food Chain and Animal Health shall be taken into
Union
account.
Conditions of use shall include, where appropriate, risk mitigation measures.
250 Repellents
by
smell
of
Tall Oil Crude Tall
oil
crude
is
a
1 September
31 August
PART A
animal or plant
complex mixture of
2009
2019
origin/tall oil crude
tall rosin and fatty
Only uses as repellent may be authorised.
acids
CAS No 8002-26-4
PART B
CIPAC No not allocated
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on tall oil
crude (SANCO/2631/2008) and in particular Appendices I and II thereof, as finalised
in the Standing Committee on the Food Chain and Animal Health shall be taken
into account.
11.6.2011
Conditions of use shall include, where appropriate, risk mitigation measures.

---

11.6.2011 Off
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
251 Repellents
by
smell
of
Tall Oil Pitch Complex
mixture
of
1 September
31 August
PART A
animal or plant
esters of fatty acids,
2009
2019
origin/tall oil pitch
rosin and small
Only uses as repellent may be authorised.
amounts of dimers
EN
CAS No 8016-81-7
and trimers of resin
PART B

CIPAC No not allocated
acids and fatty acids.
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on tall oil pitch
(SANCO/2632/2008) and in particular Appendices I and II thereof, as finalised in
the Standing Committee on the Food Chain and Animal Health shall be taken into
account.
Conditions of use shall include, where appropriate, risk mitigation measures.
icial
252 Sea-algae
extract
See algae extract See
algae
extract
is
a
1 September
31 August
PART A
Jour
(formerly sea algae
complex mixture. 2009
2019
nal
extract and sea weeds)
Main components as
Only uses as plant growth regulator may be authorised.
markers: mannitol,
of
CAS No not allocated
fucoidans and
PART B
the
alginates. Review
CIPAC No not allocated
European
report
For the implementation of the uniform principles as referred to in Article 29(6) of
SANCO/2634/2008
Regulation (EC) No 1107/2009, the conclusions of the review report on sea algae
extract (SANCO/2634/2008) and in particular Appendices I and II thereof, as
finalised in the Standing Committee on the Food Chain and Animal Health shall
be taken into account.
Union
Conditions of use shall include, where appropriate, risk mitigation measures.
253 Sodium aluminium
Sodium aluminium silicate: 1 000 g/kg 1
September
31 August
PART A
silicate
Nax[(AlO2)x(SiO2)y] ×
2009
2019
zH2O
Only uses as repellent may be authorised.
CAS No 1344-00-9
PART B
CIPAC No not allocated
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on sodium
aluminium silicate (SANCO/2635/2008) and in particular Appendices I and II
thereof, as finalised in the Standing Committee on the Food Chain and Animal
Health shall be taken into account.
L
153/111
Conditions of use shall include, where appropriate, risk mitigation measures.

---

L 153/112
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
254 Sodium
Hypochlorite Sodium Hypochlorite 10
%
(w/w)
expressed
1 September
31 August
PART A
as chlorine
2009
2019
CAS No 7681-52-9
Only uses as disinfectant may be authorised.
CIPAC No not allocated
PART B
EN

For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on sodium
hypochlorite (SANCO/2988/2008) and in particular Appendices I and II thereof, as
finalised in the Standing Committee on the Food Chain and Animal Health shall be
taken into account.
Conditions of use shall include, where appropriate, risk mitigation measures.
255 Straight
Chain
Lepi Acetate group: Review
report
1 September
31 August
PART A
Off
dopteran Pheromones
(SANCO/2633/2008)
2009
2019
Only uses as attractants may be authorised.
icial
Jour
PART B
(E)-5-decen-1-yl acetate (E)-5-decen-1-yl acetate
nal
For the implementation of the uniform principles as referred to in Article 29(6) of
CAS No 38421-90-8
Regulation (EC) No 1107/2009, the conclusions of the review report on straight
of
CIPAC No not allocated
chain lepidopteran pheromones (SANCO/2633/2008) and in particular Appendices I
the
and II thereof, as finalised in the Standing Committee on the Food Chain and
European
Animal Health shall be taken into account.
(E)-8-dodecen-1-yl
(E)-8-dodecen-1-yl acetate
Conditions of use shall include, where appropriate, risk mitigation measures.
acetate
Union
CAS No 38363-29-0
CIPAC No
not allocated
(E/Z)-8-dodecen-1-yl
(E/Z)-8-dodecen-1-yl
acetate
acetate as individual
isomers
CAS No not available
CIPAC No not avaiable
(Z)-8-dodecen-1-yl
(Z)-8-dodecen-1-yl acetate
acetate
11.6.2011
CAS No 28079-04-1
CIPAC No not allocated

---

11.6.2011 Off
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
(Z)-9-dodecen-1-yl
(Z)-9-dodecen-1-yl acetate
acetate
CAS No 16974-11-1
EN
CIPAC No 422

(E,Z)-7,9-dodecadien-1-
(E,Z)-7,9-dodecadien-1-yl
yl acetate
acetate
CAS No 54364-62-4
CIPAC No not allocated
icial
(E)-11-tetradecen-1-yl
(E)-11-tetradecen-1-yl
Jour
acetate
acetate
nal
CAS No 33189-72-9
of
CIPAC No not allocated
the
European
(Z)-9-tetradecen-1-yl
(Z)-9-tetradecen-1-yl
acetate
acetate
Union
CAS No 16725-53-4
CIPAC No not allocated
(Z)-11-tetradecen-1-yl
(Z)-11-tetradecen-1-yl
acetate
acetate
CAS No 20711-10-8
CIPAC No not allocated
(Z, E)-9, 12-tetrade (Z, E)-9, 12-tetradecadien-
cadien-1-yl acetate
1-yl acetate
L
CAS No 31654-77-0
153/113
CIPAC No not allocated

---

L 153/114
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
Z-11-hexadecen-1-yl
Z-11-hexadecen-1-yl
acetate
acetate
CAS No 34010-21-4
EN
CIPAC No not allocated

(Z, E)-7, 11-hexade Z, E)-7, 11-hexadecadien-
cadien-1-yl acetate
1-yl acetate
CAS No 51606-94-4
CIPAC No not allocated
Off
icial
(E, Z)-2, 13-octade (E, Z)-2, 13-octadecadien-
cadien-1-yl acetate.
1-yl acetate.
Jour
CAS No 86252-65-5
nal
CIPAC No not allocated
of
the
European
Alcohol group: Alcohol
group:
Union
(E)-5-decen-1-ol
(E)-5-decen-1-ol
CAS No 56578-18-8
CIPAC No not allocated
(Z)-8-dodecen-1-ol
(Z)-8-dodecen-1-ol
CAS No 40642-40-8
CIPAC No not allocated
(E,E)-8,10-dodecadien-
(E,E)-8,10-dodecadien-1-ol
1-ol
11.6.2011
CAS No 33956-49-9
CIPAC No not allocated

---

11.6.2011 Off
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
tetradecan-1-ol
tetradecan-1-ol
CAS No 112-72-1
CIPAC No not allocated
EN

(Z)-11-hexadecen-1-ol
(Z)-11-hexadecen-1-ol
CAS No 56683-54-6
CIPAC No not allocated
Aldehyde group: Aldehyde
group:
icial
Jour
nal
(Z)-7-tetradecenal
(Z)-7-tetradecenal
of
CAS No 65128-96-3
the
CIPAC No not allocated
European
Union
(Z)-9-hexadecenal
(Z)-9-hexadecenal
CAS No 56219-04-6
CIPAC No not allocated
(Z)-11-hexadecenal
(Z)-11-hexadecenal
CAS No 53939-28-9
CIPAC No not allocated
(Z)-13-octadecenal
(Z)-13-octadecenal
L
CAS No 58594-45-9
153/115
CIPAC No not allocated

---

L 153/116
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
Blends acetates: Blends
acetates:
(i) (Z)-8-dodecen-1-yl (i) (Z)-8-dodecen-1-yl
EN
acetate
acetate

CAS No 28079-
and
04-1
CIPAC No not
allocated
and
(ii) Dodecyl acetate
(ii) Dodecyl acetate;
Off
icial
CAS No 112-66-3
CIPAC No not
Jour
allocated;
nal
of
the
(i) (Z)-9-dodecen-1-yl (i) (Z)-9-dodecen-1-yl
acetate
acetate
European
CAS No 16974-
and
11-1
Union
CIPAC No 422
and
(ii) Dodecyl acetate
(ii) Dodecyl acetate;
CAS No 112-66-3
CIPAC No 422;
(i) (E,Z)-7,9-dode
(i) (E,Z)-7,9-dodecadien-1-
cadien-1-yl acetate
yl acetate,
CAS No 55774-
and
32-8
CIPAC No not
11.6.2011
allocated
and

---

11.6.2011 Off
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
(ii) (E,E)-7,9-dode
(ii) (E,E)-7,9-dodecadien-1-
cadien-1-yl acetate
yl acetate;
CAS No 54364-
EN
63-5

CIPAC No not
allocated;
(i) (Z,Z)-7,11-hexade
(i) (Z,Z)-7,11-hexade
cadien-1-yl acetate
cadien-1-yl acetate
and
and
icial
Jour
(ii) (Z,E)-7,11-hexade
(ii) (Z,E)-7,11-hexade
nal
cadien-1-yl acetate
cadien-1-yl acetate;
of
CAS No i) & ii)
the
53042-79-8
European
CAS No i) 52207-
99-5
CAS No ii) 51606-
Union
94-4
CIPAC No not
allocated;
Blends aldehydes: Blends
aldehydes:
(i) (Z)-9-hexadecenal
(i) (Z)-9-hexadecenal
CAS No 56219-
and
04-6
CIPAC No not
L
allocated
153/117
and

---

L 153/118
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
(ii) (Z)-11-hexadecenal
(ii) (Z)-11-hexadecenal
CAS No 53939-
and
28-9
EN
CIPAC: not allocated

and
(iii) (Z)-13-octadecenal
(iii) (Z)-13-octadecenal;
CAS No 58594-
45-9
CIPAC No not
allocated;
Off
icial
Jour
Blends mixtures: Blends
mixtures:
nal
of
the
(i) (E)-5-decen-1-yl
(i) (E)-5-decen-1-yl acetate
European
acetate
and
CAS No 38421-
90-8
Union
CIPAC No not
allocated
and
(ii) (E)-5-decen-1-ol
(ii) (E)-5-decen-1-ol;
CAS No 56578-
18-8
CIPAC No not
allocated;
(i) (E/Z)-8-dodecen-1-yl (i) (E/Z)-8-dodecen-1-yl
acetate
acetate
11.6.2011
CAS No as indi
and
vidual isomers

---

11.6.2011 Off
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
CIPAC No not
allocated;
and
EN

(i) (E)-8-dodecen-1-yl
(i) (E)-8-dodecen-1-yl
acetate
acetate
CAS No (E) 38363-
and
29-0
CIPAC No not
allocated
and
icial
(i) (Z)-8-dodecen-1-yl (i) (Z)-8-dodecen-1-yl
acetate
acetate
Jour
CAS No (Z) 28079-
and
nal
04-1
of
CIPAC No not
the
allocated
European
and
Union
(ii) (Z)-8-dodecen-1-ol
(ii) (Z)-8-dodecen-1-ol;
CAS No ii) 40642-
40-8
CIPAC No not
allocated;
(i) (Z)-11-hexadecenal (i) (Z)-11-hexadecenal
CAS No 53939-
and
28-9
CIPAC No not
allocated
and
L
153/119
(ii) (Z)-11-hexadecen-1- (ii) (Z)-11-hexadecen-1-yl
yl acetate
acetate

---

L 153/120
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
CAS No 34010-21-4
CIPAC No not allocated
EN
256 Trimethylamine
hydro Trimethylamine hydro ≥ 988 g/kg 1
September
31 August
PART A

chloride
chloride
2009
2019
Only uses as attractant may be authorised.
CAS No 593-81-7
CIPAC No not allocated
PART B
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on
trimethylamine hydrochloride (SANCO/2636/2008) and in particular Appendices I
and II thereof, as finalised in the Standing Committee on the Food Chain and
Animal Health shall be taken into account.
Off
Conditions of use shall include, where appropriate, risk mitigation measures.
icial
Jour
nal
257 Urea
Urea
≥ 98 % w/w 1
September
31 August
PART A
2009
2019
of
CAS No 57-13-6
Only uses as attractant and fungicide may be authorised.
the
European
CIPAC No 8352
PART B
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on urea
Union
(SANCO/2637/2008) and in particular Appendices I and II thereof, as finalised in
the Standing Committee on the Food Chain and Animal Health shall be taken into
account.
Conditions of use shall include, where appropriate, risk mitigation measures.
258 Z-13-hexadecen-11-yn- Z-13-hexadecen-11-yn-1-yl ≥ 75 % 1
September
31 August
PART A
1-yl acetate
acetate
2009
2019
Only uses as attractant may be authorised.
CAS No 78617-58-0
PART B
CIPAC: not allocated
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on Z-13-
hexadecen-11-yn-1-yl acetate (SANCO/2649/2008) and in particular Appendices I
and II thereof, as finalised in the Standing Committee on the Food Chain and
11.6.2011
Animal Health shall be taken into account.
Conditions of use shall include, where appropriate, risk mitigation measures.

---

11.6.2011 Off
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
259 Z,Z,Z,Z-7,13,16,19- Z,Z,Z,Z-7,13,16,19-doco
≥ 90 % 1
September
31 August
PART A
docosatetraen-1-yl
satetraen-1-yl isobutyrate
2009
2019
isobutyrate
Only uses as attractant may be authorised.
EN
CAS No 135459-81-3
PART B

CIPAC: not allocated
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on Z,Z,Z,Z-
7,13,16,19-docosatetraen-1-yl isobutyrate (SANCO/2650/2008) and in particular
Appendices I and II thereof, as finalised in the Standing Committee on the Food
Chain and Animal Health shall be taken into account.
Conditions of use shall include, where appropriate, risk mitigation measures.
icial
260 Aluminium
phosphide Aluminium phosphide
≥ 830 g/kg 1
September
31 August
PART A
2009
2019
Jour
CAS No 20859-73-8
Only uses as insecticide, rodenticide, talpicide and leporicide in the form of ready-to-
use aluminium phosphide containing products may be authorised.
nal
CIPAC No 227
of
As rodenticide, talpicide and leporicide only outdoor uses may be authorised.
the
Authorisations should be limited to professional users.
European
PART B
For the implementation of the uniform principles as referred to in Article 29(6) of
Union
Regulation (EC) No 1107/2009, the conclusions of the review report on aluminium
phosphide, and in particular Appendices I and II thereof, as finalised in the Standing
Committee on the Food Chain and Animal Health on 28 October 2008 shall be
taken into account.
In this overall assessment Member States must pay particular attention to:
— the protection of consumers and ensure that the spent ready-to-use aluminium
phosphide containing products are removed from the food commodity in uses
against storage pests and subsequently an adequate additional withholding period
is applied;
— the operator and worker safety and ensure that conditions of use prescribe the
application of adequate personal and respiratory protective equipment;
— the protection of operators and workers during fumigation for indoor uses;
— the protection of workers at re-entry (after fumigation period) for indoor uses;
L
153/121
— the protection of bystanders against leaking of gas for indoor uses;

---

L 153/122
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
— the protection of birds and mammals. Conditions of authorisation should include
risk mitigation measures, such as the closure of the burrows and the achievement
of complete incorporation of granules in the soil, where appropriate;
EN
— the protection of aquatic organisms. Conditions of authorisation should include

risk mitigation measures, such as buffer zones between treated areas and surface
water bodies, where appropriate.
261 Calcium
phosphide Calcium phosphide
≥ 160 g/kg 1
September
31 August
PART A
2009
2019
CAS No 1305-99-3
Only outdoor uses as rodenticide and talpicide in the form of ready-to-use calcium
phosphide containing products may be authorised.
CIPAC No 505
Authorisations should be limited to professional users.
Off
icial
PART B
Jour
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on calcium
nal
phosphide, and in particular Appendices I and II thereof, as finalised in the Standing
of
Committee on the Food Chain and Animal Health on 28 October 2008 shall be
the
taken into account.
European
In this overall assessment Member States must pay particular attention to:
— the operator and worker safety and ensure that conditions of use prescribe the
Union
application of adequate personal and respiratory protective equipment;
— the protection of birds and mammals. Conditions of authorisation should include
risk mitigation measures, such as the closure of the burrows and the achievement
of complete incorporation of granules in the soil, where appropriate;
— the protection of aquatic organisms. Conditions of authorisation should include
risk mitigation measures, such as buffer zones between treated areas and surface
water bodies, where appropriate.
262 Magnesium
phosphide Magnesium phosphide
≥ 880 g/kg 1
September
31 August
PART A
2009
2019
CAS No 12057-74-8
Only uses as insecticide, rodenticide, talpicide and leporicide in the form of ready-to-
use magnesium phosphide containing products may be authorised.
CIPAC No 228
As rodenticide, talpicide and leporicide only outdoor uses may be authorised.
11.6.2011
Authorisations should be limited to professional users.

---

11.6.2011 Off
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
PART B
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on magnesium
phosphide, and in particular Appendices I and II thereof, as finalised in the Standing
EN
Committee on the Food Chain and Animal Health on 28 October 2008 shall be

taken into account.
In this overall assessment Member States must pay particular attention to:
— the protection of consumers and ensure that the spent ready-to-use magnesium
phosphide containing products are removed from the food commodity in uses
against storage pests and subsequently an adequate additional withholding period
is applied;
— the operator safety and ensure that conditions of use prescribe the application of
adequate personal and respiratory protective equipment;
icial
— the protection of operators and workers during fumigation for indoor uses;
Jour
nal
— the protection of workers at re-entry (after fumigation period) for indoor uses;
of
— the protection of bystanders against leaking of gas for indoor uses;
the
European
— the protection of birds and mammals. Conditions of authorisation should include
risk mitigation measures, such as the closure of the burrows and the achievement
of complete incorporation of granules in the soil, where appropriate;
Union
— the protection of aquatic organisms. Conditions of authorisation should include
risk mitigation measures, such as buffer zones between treated areas and surface
water bodies, where appropriate.
263 Cymoxanil
1-[(E/Z)-2-cyano-2-
≥ 970 g/kg 1
September
31 August
PART A
methoxyiminoacetyl]-3-
2009
2019
CAS No 57966-95-7
ethylurea
Only uses as fungicide may be authorised.
CIPAC No 419
PART B
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on cymoxanil,
and in particular Appendices I and II thereof, as finalised in the Standing Committee
on the Food Chain and Animal Health on 28 October 2008 shall be taken into
account.
In this overall assessment Member States must pay particular attention to:
L
153/123
— the operator and worker safety and ensure that conditions of use prescribe the
application of adequate personal protective equipment;

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L 153/124
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
— the protection of the groundwater, when the active substance is applied in
regions with vulnerable soil and/or climatic conditions;
— the protection of aquatic organisms and must ensure that the conditions of
authorisation include risk mitigation measures such as buffer zones, where
EN
appropriate.

264 Dodemorph
cis/trans-[4-cyclododecyl]-
≥ 950 g/kg 1
September
31 August
PART A
2,6-dimethylmorpholine
2009
2019
CAS No 1593-77-7
Only uses as fungicide on ornamentals in glasshouse may be authorised.
CIPAC No 300
PART B
For the implementation of the uniform principles as referred to in Article 29(6) of
Off
Regulation (EC) No 1107/2009, the conclusions of the review report on dodemorph,
icial
and in particular Appendices I and II thereof, as finalised in the Standing Committee
on the Food Chain and Animal Health on 28 October 2008 shall be taken into
Jour
account.
nal
In this overall assessment Member States must pay particular attention to:
of
the
— the operator and worker safety and ensure that conditions of use prescribe the
European
application of adequate personal protective equipment where appropriate;
— the protection of the groundwater, when the active substance is applied in
Union
regions with vulnerable soil conditions;
— conditions of authorisation should include risk mitigation measures, where
appropriate.
265 2,5-Dichlorobenzoic methyl-2,5-dichloro
≥ 995 g/kg 1
September
31 August
PART A
acid methylester
benzoate
2009
2019
Only indoor uses as plant growth regulator and fungicide for grafting of grapevines
CAS No 2905-69-3
may be authorised.
CIPAC No 686
PART B
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on 2,5-Di
chlorobenzoic acid methylester, and in particular Appendices I and II thereof, as
11.6.2011
finalised in the Standing Committee on the Food Chain and Animal Health on
28 October 2008 shall be taken into account.

---

11.6.2011 Off
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
266 Metamitron
4-amino-4,5-dihydro-3-
≥ 960 g/kg 1
September
31 August
PART A
methyl-6-phenyl-1,2,4-
2009
2019
CAS No 41394-05-2
triazin-5-one
CIPAC No 381
Only uses as herbicide may be authorised.
EN

PART B
In assessing applications to authorise plant protection products containing
metamitron for uses other than on root crops, Member States shall pay particular
attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall
ensure that any necessary data and information is provided before such an au
thorisation is granted.
For the implementation of the uniform principles as referred to in Article 29(6) of
icial
Regulation (EC) No 1107/2009, the conclusions of the review report on
metamitron, and in particular Appendices I and II thereof, as finalised in the
Jour
Standing Committee on the Food Chain and Animal Health on 28 October 2008
nal
shall be taken into account.
of
the
In this overall assessment Member States must pay particular attention to:
European
— the operator safety and ensure that conditions of use prescribe the application of
personal protective equipment where appropriate;
Union
— the protection of groundwater, when the active substance is applied in regions
with vulnerable soil and/or climatic conditions;
— the risk to birds and mammals, and non-target terrestrial plants.
Conditions of authorisation shall include risk mitigation measures, where appro
priate.
The Member States concerned shall request the submission of further information on
the impact of soil metabolite M3 on groundwater, on residues in rotational crops,
on the long-term risk to insectivorous birds and the specific risk to birds and
mammals that may be contaminated by the intake of water in field. They shall
L
ensure that the notifiers at whose request metamitron has been included in this
153/125
Annex provide such information to the Commission by 31 August 2011 at the
latest.

---

L 153/126
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
267 Sulcotrione
2-(2-chloro-4-mesyl
≥ 950 g/kg
1 September
31 August
PART A
benzoyl)cyclohexane-1,3-
2009
2019
CAS No 99105-77-8
dione
Impurities:
Only uses as herbicide may be authorised.
CIPAC No 723
— hydrogen cyanide:
EN
not more than
PART B

80 mg/kg
For the implementation of the uniform principles as referred to in Article 29(6) of
— toluene: not more
Regulation (EC) No 1107/2009, the conclusions of the review report on sulcotrione,
than 4 g/kg
and in particular Appendices I and II thereof, as finalised in the Standing Committee
on the Food Chain and Animal Health on 28 October 2008 shall be taken into
account.
In this overall assessment Member States must pay particular attention to:
— the operator safety and ensure that conditions of use prescribe the application of
adequate personal protective equipment where appropriate;
Off
icial
— the risk to insectivorous birds, aquatic and terrestrial non-target plants, and non-
target arthropods.
Jour
Conditions of authorisation shall include risk mitigation measures, where appro
nal
priate.
of
the
The Member States concerned shall request the submission of further information on
the degradation in soil and water of the cyclohexadione moiety and the long-term
European
risk to insectivorous birds. They shall ensure that the notifier at whose request
sulcotrione has been included in this Annex provide such information to the
Commission by 31 August 2011 at the latest.
Union
268 Tebuconazole
(RS)-1-p-chlorophenyl-4,4- ≥ 905 g/kg 1
September
31 August
PART A
dimethyl-3-(1H-1,2,4-
2009
2019
CAS No 107534-96-3
triazol-1-ylmethyl)-pentan-
Only uses as fungicide may be authorised.
3-ol
CIPAC No 494
PART B
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on tebu
conazole, and in particular Appendices I and II thereof, as finalised in the
Standing Committee on the Food Chain and Animal Health on 28 October 2008
shall be taken into account.
In this overall assessment Member States must pay particular attention to:
— the operator and worker safety and ensure that conditions of use prescribe the
application of adequate personal protective equipment;
11.6.2011
— the dietary exposure of consumers to the tebuconazole (triazole) metabolites;

---

11.6.2011 Off
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
— the protection of granivorous birds and mammals and herbivorous mammals
and must ensure that the conditions of authorisation include, where appropriate,
risk mitigation measures.
EN
— the protection of aquatic organisms and must ensure that conditions of auth

orisation include risk mitigation measures such as buffer zones, where appro
priate.
The Member States concerned shall request the submission of further information to
confirm the risk assessment for birds and mammals. They shall ensure that the
notifier at whose request tebuconazole has been included in this Annex provide
such information to the Commission by 31 August 2011 at the latest.
The Member States concerned shall ensure that the notifier submits to the
Commission further information addressing the potential endocrine disrupting
properties of tebuconazole within two years after the adoption of the OECD test
guidelines on endocrine disruption or, alternatively, of Community agreed test
icial
guidelines.
Jour
nal
269 Triadimenol
(1RS,2RS;1RS,2SR)-1-(4-
≥ 920 g/kg
1 September
31 August
PART A
of
chlorophenoxy)-3,3-
2009
2019
the
CAS No 55219-65-3
dimethyl-1-(1H-1,2,4-
isomer A (1RS,2SR),
Only uses as fungicide may be authorised.
triazol-1-yl)butan-2-ol
isomer B (1RS,2RS)
European
CIPAC No 398
PART B
Diastereomer A, RS +
SR, range: 70 to 85 %
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on triadimenol,
Union
Diastereomer B, RR +
and in particular Appendices I and II thereof, as finalised in the Standing Committee
SS, range: 15 to 30 %
on the Food Chain and Animal Health on 28 October 2008 shall be taken into
account.
In this overall assessment Member States must pay particular attention to:
— the presence of N-methylpyrrolidone in formulated products as regards operator,
worker and bystander exposure;
— the protection of birds and mammals. In relation to these identified risks risk
mitigation measures, such as buffer zones, should be applied where appropriate.
The Member States concerned shall ensure that the notifier submits to the
Commission:
— further information on the specification;
— information to further address the risk assessment for birds and mammals.
L
153/127
— information to further address the risk of endocrine disrupting effects on fish.

---

L 153/128
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
They shall ensure that the notifier at whose request triadimenol has been included in
this Annex provide such information to the Commission by 31 August 2011 at the
latest.
EN
The Member States concerned shall ensure that the notifier submits to the

Commission further information addressing the potential endocrine disrupting
properties of triadimenol within two years after the adoption of the OECD test
guidelines on endocrine disruption or, alternatively, of Community agreed test
guidelines.
270 Methomyl
S-methyl (EZ)-N-(methyl ≥ 980 g/kg 1
September
31 August
PART A
carbamoyloxy)thioace
2009
2019
CAS No 16752-77-50
timidate
Only uses as insecticide on vegetables may be authorised at rates not exceeding
0,25 kg active substance per hectare per application and for a maximum of 2
Off
CIPAC No 264
applications per season.
icial
Authorisations shall be limited to professional users.
Jour
nal
PART B
of
For the implementation of the uniform principles as referred to in Article 29(6) of
the
Regulation (EC) No 1107/2009, the conclusions of the review report on methomyl,
European
and in particular Appendices I and II thereof, as finalised in the Standing Committee
on the Food Chain and Animal Health on 12 June 2009 shall be taken into account.
In this overall assessment Member States shall pay particular attention to:
Union
— the operator safety: conditions of use shall prescribe the use of adequate personal
protective equipment. Special attention shall be paid to the exposure of operators
using knapsacks or other hand-held application equipment,
— the protection of birds,
— the protection of aquatic organisms: conditions of authorisation shall include risk
mitigation measures, where appropriate, such as buffer zones, reduction of run-
off and drift reduction nozzles,
— the protection of non-target arthropods, in particular bees: risk mitigation
measures to avoid all contact with bees shall be applied.
Member States shall ensure that methomyl-based formulations contain effective
repelling and/or emetic agents.
11.6.2011
Where appropriate, conditions of authorisation shall include further risk mitigation
measures.

---

11.6.2011 Off
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
271 Bensulfuron
α-[(4,6-dimethoxy
≥ 975 g/kg 1
November
31 October PART A
pyrimidin-2-ylcar
2009
2019
CAS No 83055-99-6
bamoyl)sulfamoyl]-o-toluic
Only uses as a herbicide may be authorised.
CIPAC No 502.201
acid (bensulfuron)
EN
PART B
methyl α-[(4,6-dimethoxy

pyrimidin-2-ylcar
For the implementation of the uniform principles as referred to in Article 29(6) of
bamoyl)sulfamoyl]-o-
Regulation (EC) No 1107/2009, the conclusions of the review report on
toluate (bensulfuron-
bensulfuron, and in particular Appendices I and II thereof, as finalised in the
methyl)
Standing Committee on the Food Chain and Animal Health on 8 December 2008
shall be taken into account.
In this overall assessment Member States must pay particular attention to the
following:
— the protection of aquatic organisms; in relation to these identified risks, risk
mitigation measures, such as buffer zones, shall be applied where appropriate,
icial
— the protection of the groundwater, where the active substance is applied in
Jour
regions with vulnerable soil and/or climatic conditions.
nal
The Member States concerned shall ensure that the notifier submits to the
of
Commission:
the
— further studies on the specification,
European
— information to further address the route and rate of degradation of bensulfuron-
methyl under aerobic flooded soil conditions,
Union
— information to address the relevance of metabolites for the consumer risk
assessment.
They shall ensure that the notifiers provide such studies to the Commission by
31 October 2011.
272 Sodium 5-nitroguaia Sodium 2-methoxy-5-
≥ 980 g/kg 1
November
31 October PART A
colate
nitrophenolate
2009
2019
Only use as plant growth regulator may be authorised.
CAS No 67233-85-6
PART B
CIPAC number not
allocated
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on sodium 5-
nitroguaiacolate, sodium o-nitrophenolate and sodium p-nitrophenolate, and in
L
particular Appendices I and II thereof, as finalised in the Standing Committee on
153/129
the Food Chain and Animal Health on 2 December 2008 shall be taken into
account.

---

L 153/130
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
In this overall assessment Member States must pay particular attention to:
— the specification of the technical material as commercially manufactured, which
must be confirmed and supported by appropriate analytical data. The test
material used in the toxicity dossiers should be compared and verified against
EN
this specification of the technical material,

— the protection of the operators and workers safety. Authorised conditions of use
must prescribe the application of adequate personal protective equipment and
risk mitigation measures to reduce the exposure,
— the protection of the groundwater, when the active substance is applied in
regions with vulnerable soil and/or climatic conditions. Conditions of authori
sation should include risk mitigation measures, where appropriate.
The Member States concerned shall request the submission of further studies to
Off
address the risk to groundwater. They shall ensure that the notifiers provide such
icial
studies to the Commission by 31 October 2011.
Jour
273 Sodium o-nitrophe Sodium 2-nitrophenolate; ≥ 980 g/kg
1 November 31 October PART A
nal
nolate
sodium o-nitrophenolate
2009
2019
of
The following
Only use as plant growth regulator may be authorised.
the
CAS No 824-39-5
impurities are of toxi
PART B
cological concern:
European
CIPAC number not
For the implementation of the uniform principles as referred to in Article 29(6) of
allocated
Phenol
Regulation (EC) No 1107/2009, the conclusions of the review report on sodium 5-
nitroguaiacolate, sodium o-nitrophenolate and sodium p-nitrophenolate, and in
Union
Max content: 0,1 g/kg
particular Appendices I and II thereof, as finalised in the Standing Committee on
the Food Chain and Animal Health on 2 December 2008 shall be taken into
2,4 dinitrophenol
account.
max content:
In this overall assessment Member States must pay particular attention to:
0,14 g/kg
— the specification of the technical material as commercially manufactured, which
must be confirmed and supported by appropriate analytical data. The test
2,6 dinitrophenol
material used in the toxicity dossiers should be compared and verified against
this specification of the technical material,
max content:
0,32 g/kg
— the protection of the operators and workers safety. Authorised conditions of use
must prescribe the application of adequate personal protective equipment and
risk mitigation measures to reduce the exposure,
— the protection of the groundwater, when the active substance is applied in
regions with vulnerable soil and/or climatic conditions. Conditions of authori
sation should include risk mitigation measures, where appropriate.
11.6.2011
The Member States concerned shall request the submission of further studies to
address the risk to groundwater. They shall ensure that the notifiers provide such
studies to the Commission by 31 October 2011.

---

11.6.2011 Off
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
274 Sodium p-nitrophe Sodium 4-nitrophenolate; ≥ 998 g/kg
1 November 31 October PART A
nolate
sodium p-nitrophenolate
2009
2019
The following
Only use as plant growth regulator may be authorised.
CAS No 824-78-2
impurities are of toxi
cological concern:
CIPAC number not
PART B
EN
allocated
Phenol

For the implementation of the uniform principles as referred to in Article 29(6) of
max content: 0,1 g/kg
Regulation (EC) No 1107/2009, the conclusions of the review report on sodium 5-
nitroguaiacolate, sodium o-nitrophenolate and sodium p-nitrophenolate, and in
2,4 dinitrophenol
particular Appendices I and II thereof, as finalised in the Standing Committee on
max content:
the Food Chain and Animal Health on 2 December 2008 shall be taken into
0,07 g/kg
account.
2,6 dinitrophenol
In this overall assessment Member States must pay particular attention to:
max content:
0,09 g/kg
— the specification of the technical material as commercially manufactured, which
must be confirmed and supported by appropriate analytical data. The test
material used in the toxicity dossiers should be compared and verified against
icial
this specification of the technical material,
Jour
— the protection of the operators and workers safety. Authorised conditions of use
nal
must prescribe the application of adequate personal protective equipment and
risk mitigation measures to reduce the exposure,
of
the
— the protection of the groundwater, when the active substance is applied in
European
regions with vulnerable soil and/or climatic conditions. Conditions of authori
sation should include risk mitigation measures, where appropriate.
The Member States concerned shall request the submission of further studies to
Union
address the risk to groundwater. They shall ensure that the notifiers provide such
studies to the Commission by 31 October 2011.
275 Tebufenpyrad
N-(4-tert-butylbenzyl)-4-
≥ 980 g/kg 1
November
31 October PART A
chloro-3-ethyl-1-methyl
2009
2019
CAS No 119168-77-3
pyrazole-5-carboxamide
Only uses as acaricide and insecticide may be authorised.
CIPAC No 725
PART B
In assessing applications to authorise plant protection products containing tebu
fenpyrad in formulations other than water soluble bags Member States shall pay
particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009,
and shall ensure that any necessary data and information is provided before such an
authorisation is granted.
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on tebu
L
fenpyrad, and in particular Appendices I and II thereof, as finalised in the
153/131
Standing Committee on the Food Chain and Animal Health on 2 December 2008
shall be taken into account.

---

L 153/132
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
In this overall assessment Member States must pay particular attention to:
— the operator and worker safety and ensure that conditions of use prescribe the
application of adequate personal protective equipment,
EN
— the protection of aquatic organisms and must ensure that conditions of au

thorisation include risk mitigation measures such as buffer zones, where appro
priate,
— the protection of insectivorous birds and must ensure that the conditions of
authorisation include, where appropriate, risk mitigation measures.
The Member States concerned shall ensure that the notifier submits to the
Commission:
— further information confirming that no relevant impurities are present,
Off
icial
— information to further address the risk to insectivorous birds.
Jour
They shall ensure that the notifier provides such information to the Commission by
nal
31 October 2011.
of
the
276 Chlormequat
2-chloroethyltrimethyl
≥ 636 g/kg
1 December 30 November PART A
European
ammonium (chlormequat)
2009
2019
CAS No 7003-89-6
Impurities
Only uses as plant growth regulator on cereals and non edible crops may be au
(chlormequat)
2-chloroethyltrimethyl
thorised.
ammonium chloride
1,2-dichloroethane:
Union
CAS No 999-81-5
max 0,1 g/kg (on the
PART B
(chlormequat chloride)
(chlormequat chloride)
dry chlormequat
chloride content)
In assessing applications to authorise plant protection products containing chlor
CIPAC No 143 (chlor
mequat for uses other than in rye and triticale, notably as regards the exposure of
mequat)
Chloroethene (vinyl
consumers, Member States shall pay particular attention to the criteria in Article 4(3)
chloride): max
of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and
CIPAC No 143.302
0,0005 g/kg (on the
information is provided before such an authorisation is granted.
(chlormequat chloride)
dry chlormequat
chloride content)
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on chlor
mequat, and in particular Appendices I and II thereof, as finalised in the Standing
Committee on the Food Chain and Animal Health on 23 January 2009 shall be
taken into account.
In this overall assessment Member States must pay particular attention to:
— the operator safety and ensure that conditions of use prescribe the application of
11.6.2011
adequate personal protective equipment;
— the protection of birds and mammals.

---

11.6.2011 Off
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
Conditions of authorisation shall include risk mitigation measures, where appro
priate.
The Member States concerned shall request the submission of further information on
the fate and behaviour (adsorption studies to be performed at 20 °C, recalculation of
EN
the predicted concentrations in groundwater, surface water and sediment), the moni

toring methods for determination of the substance in animal products and water,
and the risk to aquatic organisms, birds and mammals. They shall ensure that the
notifier at whose request chlormequat has been included in this Annex provide such
information to the Commission by 30 November 2011 at the latest.
277 Copper
compounds: 1
December
30 November PART A
2009
2016
Only uses as bactericide and fungicide may be authorised.
Copper hydroxide
Copper (II) hydroxide
≥ 573 g/kg
PART B
CAS No 20427-59-2
icial
In assessing applications to authorise plant protection products containing copper
CIPAC No 44.305
Jour
for uses other than on tomatoes in greenhouses, Member States shall pay particular
attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall
nal
Copper oxychloride
Dicopper chloride trihy ≥ 550 g/kg
ensure that any necessary data and information is provided before such an au
of
droxide
thorisation is granted.
the
CAS No 1332-65-6 or
1332-40-7
European
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on copper
CIPAC No 44.602
compounds, and in particular Appendices I and II thereof, as finalised in the
Standing Committee on the Food Chain and Animal Health on 23 January 2009
Union
shall be taken into account.
Copper oxide
Copper oxide
≥ 820 g/kg
In this overall assessment Member States must pay particular attention to:
CAS No 1317-39-1
— the specification of the technical material as commercially manufactured which
CIPAC No 44.603
must be confirmed and supported by appropriate analytical data. The test
material used in the toxicity dossiers should be compared and verified against
Bordeaux mixture
Not allocated
≥ 245 g/kg
this specification of the technical material,
CAS No 8011-63-0
— the operator and worker safety and ensure that conditions of use prescribe the
application of adequate personal protective equipment where appropriate,
CIPAC No 44.604
— the protection of water and non-target organisms. In relation to these identified
risks risk mitigation measures, such as buffer zones, should be applied where
appropriate,
L
— the amount of active substance applied and ensure that the authorised amounts,
153/133
in terms of rates and number of applications, are the minimum necessary to
achieve the desired effects.

---

L 153/134
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
Tribasic copper sulphate Not allocated
≥ 490 g/kg
The concerned Member States shall request the submission of information to further
address:
CAS No 12527-76-3
The following
impurities are of toxi
CIPAC No 44.306
— the risk from inhalation,
cological concern and
must not exceed the
EN
— the risk assessment for non-target organisms and for soil and water.
levels below:

Lead max 0,0005 g/kg
They shall ensure that the notifier at whose request copper compounds have been
of copper content.
included in this Annex provides such information to the Commission by
30 November 2011 at the latest.
Cadmium max
0,0001 g/kg
of
Member States shall initiate monitoring programmes in vulnerable areas where the
copper content.
contamination of the soil compartment by copper is of concern, in order to set,
where appropriate, limitations such as maximum application rates.
Arsenic max
0,0001 g/kg
of
copper content.
Off
icial
278 Propaquizafop
2-isopropylidenamino-
≥ 920 g/kg
1 December 30 November PART A
oxyethyl (R)-2-[4-(6-
2009
2019
Jour
CAS No 111479-05-1
chloro-quinoxalin-2-
Toluene maximum
Only uses as herbicide may be authorised.
nal
yloxy)phenoxy]propionate
content 5 g/kg
CIPAC No 173
PART B
of
the
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on propa
European
quizafop, and in particular Appendices I and II thereof, as finalised in the
Standing Committee on the Food Chain and Animal Health on 23 January 2009
shall be taken into account.
Union
In this overall assessment Member States must pay particular attention to:
— the specification of the technical material as commercially manufactured which
must be confirmed and supported by appropriate analytical data. The test
material used in the toxicity dossiers should be compared and verified against
this specification of the technical material,
— the operator safety and ensure that conditions of use prescribe the application of
adequate personal protective equipment,
— the protection of aquatic organisms and non-target plants and ensure that
conditions of authorisation include risk mitigation measures such as buffer
zones, where appropriate,
— the protection of non-target arthropods and ensure that the conditions of au
thorisation include, where appropriate, risk mitigation measures.
The Member States concerned shall ensure that the notifier submits to the
11.6.2011
Commission:
— further information on the relevant impurity Ro 41-5259,

---

11.6.2011 Off
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
— information to further address the risk to aquatic organisms and to non-target
arthropods.
They shall ensure that the notifier provides such information to the Commission by
30 November 2011.
EN

279 Quizalofop-P: 1
December
30 November PART A
2009
2019
Only uses as herbicide may be authorised.
Quizalofop-P-ethyl
ethyl (R)-2-[4-(6-chloro ≥ 950 g/kg
quinoxalin-2-yloxy)
PART B
CAS No 100646-51-3
phenoxy]propionate
For the implementation of the uniform principles as referred to in Article 29(6) of
CIPAC No 641.202
Regulation (EC) No 1107/2009, the conclusions of the review report on quizalofop-
P, and in particular Appendices I and II thereof, as finalised in the Standing
Quizalofop-P-tefuryl
(RS)-Tetrahydrofurfuryl (R)- ≥ 795 g/kg
Committee on the Food Chain and Animal Health on 23 January 2009 shall be
2-[4-(6-chloroquinoxalin-
taken into account.
CAS No 119738-06-6
2-yloxy)phenoxy]
icial
propionate
In this overall assessment Member States must pay particular attention to:
CIPAC No 641.226
Jour
— the specification of the technical material as commercially manufactured which
nal
must be confirmed and supported by appropriate analytical data. The test
material used in the toxicity dossiers should be compared and verified against
of
this specification of the technical material,
the
European
— the operator and worker safety and ensure that conditions of use prescribe the
application of adequate personal protective equipment,
— the protection of non-target plants and ensure that conditions of authorisation
Union
include risk mitigation measures such as buffer zones, where appropriate.
Conditions of authorisation shall include risk mitigation measures, where appro
priate.
The Member States concerned shall ensure that the notifier submits to the
Commission further information on the risk to non-target arthropods.
They shall ensure that the notifier provides such information to the Commission by
30 November 2011.
280 Teflubenzuron
1-(3,5-dichloro-2,4-difluo
≥ 970 g/kg 1
December
30 November PART A
rophenyl)-3-(2,6-difluo
2009
2019
CAS No 83121-18-0
robenzoyl)urea
Only uses as insecticide in glasshouses (on artificial substrate or closed hydroponic
systems) may be authorised.
CIPAC No 450
PART B
L
153/135
In assessing applications to authorise plant protection products containing teflu
benzuron for uses other than on tomatoes in greenhouses, Member States shall
pay particular attention to the criteria in Article 4(3) of Regulation (EC)

---

L 153/136
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
No 1107/2009, and shall ensure that any necessary data and information is
provided before such an authorisation is granted.
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on teflu
EN
benzuron, and in particular Appendices I and II thereof, as finalised in the

Standing Committee on the Food Chain and Animal Health on 23 January 2009
shall be taken into account.
In this overall assessment Member States must pay particular attention to:
— the operator and workers safety and ensure that conditions of use prescribe the
application of adequate personal protective equipment, where appropriate,
— the protection of aquatic organisms. Releases from glasshouse application must
be minimised and, in any case, should not have the potential to reach in
significant levels water bodies in the vicinity,
Off
icial
— the protection of bees which should be prevented from accessing the glasshouse,
Jour
— the protection of pollinator colonies purposely placed in the glasshouse,
nal
— the safe disposal of condensation water, drain water and substrate in order to
of
preclude risks to non-target organisms and contamination of surface water and
the
groundwater.
European
Conditions of authorisation shall include risk mitigation measures, where appro
priate.
Union
281 Zeta-cypermethrin
Mixture of the
≥ 850 g/kg
1 December 30 November PART A
stereoisomers (S)-α-cyano-
2009
2019
CAS No 52315-07-8
3-phenoxybenzyl
Impurities:
(1RS,3RS;1RS,3SR)-3-(2,2-
Only uses as insecticide may be authorised.
CIPAC No 733
dichlorovinyl)-2,2
toluene: max 2 g/kg
dimethylcyclopropanecar
boxylate where the ratio of tars: max 12,5 g/kg
PART B
the (S);(1RS,3RS) isomeric
pair to the (S);(1RS,3SR)
In assessing applications to authorise plant protection products containing zeta-
isomeric pair lies in the
cypermethrin for uses other than in cereals, notably as regards the exposure of
ratio range 45-55 to 55-
consumers to mPBAldehyde, a degradation product that may be formed during
45 respectively
processing, Member States shall pay particular attention to the criteria in
Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any
necessary data and information is provided before such an authorisation is granted.
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on zeta-cyper
11.6.2011
methrin, and in particular Appendices I and II thereof, as finalised in the Standing
Committee on the Food Chain and Animal Health on 23 January 2009 shall be
taken into account.

---

11.6.2011 Off
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
In this overall assessment Member States must pay particular attention to:
— the operator safety and ensure that conditions of use prescribe the application of
adequate personal protective equipment, where appropriate,
EN
— the protection of birds, aquatic organisms, bees, non-target arthropods and non-

target soil macro-organisms.
Conditions of authorisation shall include risk mitigation measures, where appro
priate.
The Member States concerned shall request the submission of further information on
the fate and behaviour (aerobic degradation in soil), the long-term risk to birds,
aquatic organisms and non-target arthropods. They shall ensure that the notifier at
whose request zeta-cypermethrin has been included in this Annex provide such
information to the Commission by 30 November 2011 at the latest.
icial
282 Chlorsulfuron
1-(2-chlorophenylsulfonyl)- ≥ 950 g/kg
1 January
31 December PART A
Jour
3-(4-methoxy-6-methyl-
2010
2019
CAS No 64902-72-3
1,3,5-triazin-2-yl)urea
Impurities:
Only uses as herbicide may be authorised.
nal
of
CIPAC No 391
2-Chlorobenzenesul
PART B
the
fonamide (IN-A4097)
For the implementation of the uniform principles as referred to in Article 29(6) of
not more than 5 g/kg
European
Regulation (EC) No 1107/2009, the conclusions of the review report on chlor
and
sulfuron, and in particular Appendices I and II thereof, as finalised in the
Standing Committee on the Food Chain and Animal Health on 26 February 2009
4-methoxy-6-methyl-
shall be taken into account.
Union
1,3,5-triazin-2-amine
(IN-A4098) not more
In this overall assessment Member States must pay particular attention to:
than 6 g/kg
— the protection of aquatic organisms and non-target plants; in relation to these
identified risks, risk mitigation measures, such as buffer zones, shall be applied
where appropriate,
— the protection of the groundwater, when the active substance is applied in
regions with vulnerable soil and/or climatic conditions.
The Member States concerned shall:
— ensure that the notifier submits to the Commission further studies on the spec
ification by 1 January 2010.
If chlorsulfuron is classified as carcinogenic category 2 in accordance with Regu
lation (EC) No 1272/2008, the Member States concerned shall request the
submission of further information on the relevance of the metabolites IN-A4097,
L
IN-A4098, IN-JJ998, IN-B5528 and IN-V7160 with respect to cancer and ensure
153/137
that the notifier provides that information to the Commission within six months
from the notification of the classification decision concerning that substance.

---

L 153/138
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
283 Cyromazine
N-cyclopropyl-1,3,5-
≥ 950 g/kg 1
January
31 December PART A
triazine-2,4,6-triamine
2010
2019
CAS No 66215-27-8
Only uses as insecticide in greenhouses may be authorised.
CIPAC No 420
PART B
EN

In assessing applications to authorise plant protection products containing cyro
mazine for uses other than in tomatoes, notably as regards the exposure of
consumers, Member States shall pay particular attention to the criteria in
Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any
necessary data and information is provided before such an authorisation is granted.
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on cyromazine,
and in particular Appendices I and II thereof, as finalised in the Standing Committee
on the Food Chain and Animal Health on 26 February 2009 shall be taken into
Off
account.
icial
In this overall assessment Member States must pay particular attention to:
Jour
— the protection of groundwater, when the active substance is applied in regions
nal
with vulnerable soil and/or climatic conditions,
of
the
— the protection of aquatic organisms,
European
— the protection of pollinators.
Conditions of authorisation shall include risk mitigation measures, where appro
priate.
Union
The Member States concerned shall request the submission of further information on
the fate and behaviour of the soil metabolite NOA 435343 and on the risk to
aquatic organisms. They shall ensure that the notifier at whose request cyromazine
has been included in this Annex provide such information to the Commission by
31 December 2011 at the latest.
284 Dimethachlor
2-chloro-N-(2-metho
≥ 950 g/kg
1 January
31 December PART A
xyethyl)acet-2′,6′-xylidide
2010
2019
CAS No 50563-36-5
Impurity 2,6-
Only uses as herbicide in application max. of 1,0 kg/ha only every third year on the
dimethylaniline: Not
same field may be authorised.
CIPAC No 688
more than 0,5 g/kg
PART B
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on di
11.6.2011
methachlor, and in particular Appendices I and II thereof, as finalised in the
Standing Committee on the Food Chain and Animal Health on 26 February 2009
shall be taken into account.

---

11.6.2011 Off
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
In this overall assessment Member States must pay particular attention to:
— the operator safety and ensure that conditions of use prescribe the application of
adequate personal protective equipment,
EN
— the protection of aquatic organisms and non-target plants; in relation to these

identified risks, risk mitigation measures, such as buffer zones, shall be applied
where appropriate,
— the protection of the groundwater, when the active substance is applied in
regions with vulnerable soil and/or climatic conditions.
Conditions of authorisation shall include risk mitigation measures and monitoring
programmes shall be initiated to verify potential groundwater contamination from
metabolites CGA 50266, CGA 354742, CGA 102935 and SYN 528702 in
vulnerable zones, where appropriate.
icial
The Member States concerned shall:
Jour
— ensure that the notifier submits to the Commission further studies on the spec
nal
ification by 1 January 2010.
of
If dimethachlor is classified as carcinogenic category 2 in accordance with Regulation
the
(EC) No 1272/2008, the Member States concerned shall request the submission of
European
further information on the relevance of the metabolites CGA 50266, CGA 354742,
CGA 102935 and SYN 528702 with respect to cancer and ensure that the notifier
provides that information to the Commission within six months from the notifi
cation of the classification decision concerning that substance.
Union
285 Etofenprox
2-(4-ethoxyphenyl)-2-
≥ 980 g/kg 1
January
31 December PART A
methylpropyl 3-phenoxy
2010
2019
CAS No 80844-07-1
benzyl
Only uses as insecticide may be authorised.
CIPAC No 471
ether
PART B
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on etofenprox,
and in particular Appendices I and II thereof, as finalised in the Standing Committee
on the Food Chain and Animal Health on 26 February 2009 shall be taken into
account.
In this overall assessment Member States must pay particular attention to:
— the operator and worker safety and ensure that conditions of use prescribe the
application of adequate personal protective equipment,
L
153/139
— the protection of aquatic organisms; in relation to these identified risks, risk
mitigation measures, such as buffer zones, shall be applied where appropriate,

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L 153/140
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
— the protection of bees and non-target arthropods; in relation to these identified
risks, risk mitigation measures, such as buffer zones, shall be applied where
appropriate.
The Member States concerned shall:
EN

— ensure that the notifier submits to the Commission further information on the
risk to aquatic organisms including the risk to sediment dwellers and bio
magnification,
— the submission of further studies on the endocrine disruption potential in aquatic
organisms (fish full life cycle study).
They shall ensure that the notifiers provide such studies to the Commission by
31 December 2011.
Off
286 Lufenuron
(RS)-1-[2,5-dichloro-4-
≥ 970 g/kg 1
January
31 December PART A
icial
(1,1,2,3,3,3-hexafluoro-
2010
2019
CAS No 103055-07-8
propoxy)-phenyl]-3-(2,6-
Only indoor uses or use in outdoor bait stations as insecticide may be authorised.
Jour
difluorobenzoyl)-urea
CIPAC No 704
PART B
nal
For the implementation of the uniform principles as referred to in Article 29(6) of
of
Regulation (EC) No 1107/2009, the conclusions of the review report on lufenuron,
the
and in particular Appendices I and II thereof, as finalised in the Standing Committee
European
on the Food Chain and Animal Health on 26 February 2009 shall be taken into
account.
In this overall assessment Member States must pay particular attention to:
Union
— the high persistency in the environment and the high risk for bioaccumulation
and shall ensure that the use of lufenuron has no adverse long-term effects on
non-target organisms,
— the protection of birds, mammals, soil non-target organisms, bees, non-target
arthropods, surface waters and aquatic organisms in vulnerable situations.
The Member States concerned shall:
— ensure that the notifier submits to the Commission further studies on the spec
ification by 1 January 2010.
287 Penconazole
(RS) 1-[2-(2,4-dichloro-
≥ 950 g/kg 1
January
31 December PART A
phenyl)-pentyl]-1H-[1,2,4]
2010
2019
CAS No 66246-88-6
triazole
Only uses as fungicides may be authorised.
CIPAC No 446
PART B
11.6.2011
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on

---

11.6.2011 Off
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
penconazole, and in particular Appendices I and II thereof, as finalised in the
Standing Committee on the Food Chain and Animal Health on 26 February 2009
shall be taken into account.
In this overall assessment Member States must pay particular attention to:
EN

— the protection of groundwater, when the active substance is applied in regions
with vulnerable soil and/or climatic conditions.
Conditions of authorisation shall include risk mitigation measures, where appro
priate.
The Member States concerned shall request the submission of further information on
the fate and behaviour of the soil metabolite CGA179944 in acidic soils. They shall
ensure that the notifier at whose request penconazole has been included in this
Annex provide such information to the Commission by 31 December 2011 at the
latest.
icial
Jour
288 Tri-allate
S-2,3,3-trichloroallyl di-
≥ 940 g/kg
1 January
31 December PART A
isopropyl
2010
2019
nal
CAS No 2303-17-5
NDIPA (Nitroso-diiso
Only uses as herbicide may be authorised.
of
(thiocarbamate)
propylamine)
the
CIPAC No 97
PART B
max. 0,02 mg/kg
European
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on tri-allate,
and in particular Appendices I and II thereof, as finalised in the Standing Committee
Union
on the Food Chain and Animal Health on 26 February 2009 shall be taken into
account.
In this overall assessment Member States must pay particular attention to:
— the operator safety and ensure that conditions of use prescribe the application of
adequate personal protective equipment,
— the dietary exposure of consumers to residues of tri-allate in treated crops as well
as in succeeding rotational crops and in products of animal origin
— the protection of aquatic organisms and non-target plants and ensure that
conditions of authorisation include risk mitigation measures such as buffer
zones, where appropriate,
L
— the potential for ground water contamination by the degradation products
153/141
TCPSA when the active substance is applied in regions with vulnerable soil
and/or climatic conditions. Conditions of authorisation must include risk miti
gation measures, where appropriate.

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L 153/142
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
The Member States concerned shall ensure that the notifier submits to the
Commission:
— further information to assess the primary plant metabolism,
EN

— further information on the fate and behaviour of the soil metabolite diisopropyl
amine,
— further information on the potential for biomagnification in aquatic food chains,
— information to further address the risk to fish-eating mammals and the long-term
risk to earthworms.
Off
They shall ensure that the notifier provides such information to the Commission by
31 December 2011.
icial
Jour
289 Triflusulfuron
2-[4-dimethylamino-6-
≥ 960 g/kg
1 January
31 December PART A
(2,2,2-trifluoroethoxy)-
2010
2019
nal
1,3,5-triazin-2-ylcarba
CAS No 126535-15-7
Only uses as a herbicide in application on sugar and fodder beet at max 60 g/ha
of
moylsulfamoyl]-m-toluic
N,N-dimethyl-6-
only every third year on the same field may be authorised. Foliage of treated crops
the
acid
(2,2,2-trifluoro
ethoxy)-1,3,5-triazine-
may not be fed to livestock.
CIPAC No 731
European
2,4-diamine
PART B
Max. 6 g/kg
For the implementation of the uniform principles as referred to in Article 29(6) of
Union
Regulation (EC) No 1107/2009, the conclusions of the review report on triflu
sulfuron, and in particular Appendices I and II thereof, as finalised in the
Standing Committee on the Food Chain and Animal Health on 26 February 2009
shall be taken into account.
In this overall assessment Member States must pay particular attention to:
— the dietary exposure of consumers to residues of metabolites IN-M7222 and IN-
E7710 in succeeding rotational crops and in products of animal origin,
— the protection of aquatic organisms and aquatic plants from the risk arising from
triflusulfuron and the metabolite IN-66036 and ensure that conditions of au
thorisation include risk mitigation measures such as buffer zones, where appro
priate,
— the potential for ground water contamination by the degradation products IN-
11.6.2011
M7222 and IN-W6725 when the active substance is applied in regions with
vulnerable soil and/or climatic conditions. Conditions of authorisation must
include risk mitigation measures, where appropriate.

---

11.6.2011 Off
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
If triflusulfuron is classified as carcinogenic category 2 in accordance with Regulation
(EC) No 1272/2008, the Member States concerned shall request the submission of
further information on the relevance of the metabolites IN-M7222, IN-D8526 and
IN-E7710 with respect to cancer. They shall ensure that the notifier provides that
information to the Commission within six months from the notification of the
EN
classification decision concerning that substance.

290 Difenacoum
3-[(1RS,3RS;1RS,3SR)-3-
≥ 905 g/kg 1
January
30 December PART A
biphenyl-4-yl-1,2,3,4-
2010
2019
CAS No 56073-07-5
tetrahydro-1-naphthyl]-4-
Only uses as rodenticide in the form of pre-prepared baits placed in specially
hydroxycoumarin
constructed, tamper resistant and secured bait boxes are authorised.
CIPAC No 514
The nominal concentration of the active substance in the products shall not exceed
50 mg/kg.
Authorisations shall be limited to professional users.
PART B
icial
Jour
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on difenacoum,
nal
and in particular Appendices I and II thereof, as finalised in the Standing Committee
of
on the Food Chain and Animal Health on 26 February 2009 shall be taken into
account. In this overall assessment Member States shall pay particular attention to
the
the protection of birds and non-target mammals from primary and secondary
European
poisoning. Risk mitigation measures shall be applied where appropriate.
The Member States concerned shall ensure that the notifier submits to the
Commission further information on methods for the determination of residues of
Union
difenacoum in body fluids.
They shall ensure that the notifier provides such information to the Commission by
30 November 2011.
The Member States concerned shall ensure that the notifier submits to the
Commission further information on the specification of the active substance as
manufactured.
They shall ensure that the notifier provides such information to the Commission by
31 December 2009.
291 Didecyldimethylam
Didecyldimethylam
≥ 70 %
(Technical
1 January
31 December PART A
monium chloride
monium chloride is a concentrate)
2010
2019
mixture of alkyl-quaternary
Only indoor uses for ornamental plants as bactericide, fungicide, herbicide and
CAS: not allocated
ammonium salts with
algaecide may be authorised.
typical alkyl chain lengths
L
CIPAC: not allocated
of C8, C10 and C12, with
PART B
153/143
more than 90 % of C10
For the implementation of the uniform principles as referred to in Article 29(6)
of Regulation (EC) No 1107/2009, the conclusions of the review report on

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L 153/144
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
didecyldimethylammonium chloride, and in particular Appendices I and II thereof, as
finalised in the Standing Committee on the Food Chain and Animal Health on
12 March 2009 shall be taken into account.
EN
In this overall assessment Member States must pay particular attention to:

— the protection of the operator and worker safety. Authorised conditions of use
must prescribe the application of adequate personal protective equipment and
risk mitigation measures to reduce the exposure,
— the protection of aquatic organisms.
Conditions of authorisation shall include risk mitigation measures, where appro
priate.
The Member States concerned shall ensure that the notifier submits to the
Off
Commission further information on the specification of the active substance as
icial
manufactured by 1 January 2010 and on the risk to aquatic organisms by
31 December 2011.
Jour
nal
292 sulphur
sulphur
≥ 990 g/kg 1
January
31 December PART A
of
2010
2019
the
CAS No 7704-34-9
Only uses as fungicide and acaricide may be authorised.
European
CIPAC No 18
PART B
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on sulphur,
and in particular Appendices I and II thereof, as finalised in the Standing Committee
Union
on the Food Chain and Animal Health on 12 March 2009 shall be taken into
account.
In this overall assessment Member States shall pay particular attention to:
— the protection of birds, mammals, aquatic organisms and non-target arthropods.
Conditions of authorisation shall include risk mitigation measures, where appro
priate.
The Member States concerned shall ensure that the notifier submit to the
Commission further information to confirm the risk assessment for birds,
mammals, sediment dwelling organisms and non-target arthropods. They shall
ensure that the notifier at whose request sulphur has been included in this Annex
provide such data to the Commission at latest by 30 June 2011.
293 Tetraconazole
(RS)-2-(2,4-dichlo
≥ 950 g/kg (racemic
1 January
31 December PART A
rophenyl)-3-(1H-1.2,4-
mixture)
2010
2019
11.6.2011
CAS No 112281-77-3
triazol-1-yl)-propyl-1.1,2,2-
Only uses as fungicide may be authorised.
Impurity toluene: not
CIPAC No 726
tetrafluoroethyl ether
more than 13 g/kg

---

11.6.2011 Off
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
PART B
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on tetra
conazole, and in particular Appendices I and II thereof, as finalised in the
EN
Standing Committee on the Food Chain and Animal Health on 26 February 2009

shall be taken into account.
In this overall assessment Member States must pay particular attention to:
— the protection of aquatic organisms and non-target plants; in relation to these
identified risks, risk mitigation measures, such as buffer zones, shall be applied
where appropriate,
— the protection of the groundwater, when the active substance is applied in
regions with vulnerable soil and/or climatic conditions.
The Member States concerned shall request:
icial
— the submission of further information on a refined consumer risk assessment,
Jour
— further information on the specification regarding ecotoxicology,
nal
of
— further information on the fate and behaviour of potential metabolites in all
the
relevant compartments,
European
— the refined risk assessment of such metabolites to birds, mammals aquatic
organisms and non-target arthropods,
— further information on the potential for endocrine disrupting effects to birds,
Union
mammals and fish.
They shall ensure that the notifier provides such information to the Commission by
31 December 2011.
294 Paraffin
oils
paraffin oil European
Phar
1 January
31 December PART A
macopoeia 6.0
2010
2019
CAS No 64742-46-7
Only uses as insecticide and acaricide may be authorised.
PART B
CAS No 72623-86-0
For the implementation of the uniform principles as referred to in Article 29(6) of
CAS No 97862-82-3
Regulation (EC) No 1107/2009, the conclusions of the review report on paraffin oils
CAS No 64742-46-7, CAS No 72623-86-0 and CAS No 97862-82-3, and in
CIPAC No n.a.
particular Appendices I and II thereto shall be taken into account.
Conditions of use shall include, where appropriate, risk mitigation measures.
The Member States concerned shall request:
L
— the submission of the specification of the technical material as commercially
153/145
manufactured to verify the compliance with purity criteria of European Phar
macopoeia. 6.0.

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L 153/146
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
They shall ensure that the notifiers provides such information to the Commission by
30 June 2010.
295 Paraffin
oil
paraffin oil European
Phar
1 January
31 December PART A
macopoeia. 6,0
2010
2019
EN
CAS No 8042-47-5
Only uses as insecticide and acaricide may be authorised.

CIPAC No n.a.
PART B
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on paraffin oil
8042-47-5, and in particular Appendices I and II thereof, shall be taken into
account.
Conditions of use shall include, where appropriate, risk mitigation measures.
Off
The Member States concerned shall request:
icial
The submission of the specification of the technical material as commercially manu
factured to verify the compliance with purity criteria of European Pharmacopoeia.
Jour
6,0
nal
They shall ensure that the notifier provides such information to the Commission by
of
30 June 2010.
the
European
296 Cyflufenamid
(Z)-N-[α-(cyclopropylme
> 980 g/kg 1
April
31 March
PART A
thoxyimino) – 2,3-difluoro-
2010
2020
CAS No 180409-60-3
6-(trifluoromethyl)benzyl]-
Only uses as fungicide may be authorised.
2-phenylacetamide
Union
CIPAC No 759
PART B
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on
cyflufenamid, and in particular Appendices I and II thereof, as finalised in the
Standing Committee on the Food Chain and Animal Health on 2 October 2009
shall be taken into account.
In this overall assessment Member States must pay particular attention to the
protection of groundwater, when the active substance is applied in regions with
vulnerable soil and/or climatic conditions.
Conditions of authorisation shall include risk mitigation measures, where appro
priate.
297 Fluopicolide
2,6-dichloro-N-[3-chloro-
≥ 970 g/kg
1 June 2010 31
May PART A
5-(trifluoromethyl)-2-pyri
2020
CAS No
11.6.2011
dylmethyl]benzamide
The impurity toluene
Only uses as fungicide may be authorised.
must not exceed
239110-15-7
3 g/kg
in
the
CIPAC No 787
technical material.

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11.6.2011 Off
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
PART B
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on fluopicolide,
and in particular Appendices I and II thereof, as finalised in the Standing Committee
EN
on the Food Chain and Animal Health on 27 November 2009 shall be taken into

account.
In this overall assessment, Member States must pay particular attention to:
— the protection of aquatic organisms,
— the protection of groundwater when the active substance is applied in regions
with vulnerable soil and/or climatic conditions,
— to the risk to operators during application,
icial
— the potential for long range transport via air.
Jour
Conditions of authorisation shall include risk mitigation measures and monitoring
nal
programmes shall be initiated to verify potential accumulation and exposure in
of
vulnerable areas, where appropriate.
the
The Member States concerned shall ensure that the notifier submits to the
European
Commission further information on the relevance of the metabolite M15 for
groundwater by 30 April 2012 at the latest.
Union
298 Heptamaloxyloglucan Full IUPAC name in ≥ 780 g/kg
1 June 2010 31
May PART A
footnote (1)
2020
CAS No
The impurity Patulin
Only uses as plant growth regulator may be authorised.
Xyl p: xylopyranosyl
must not exceed 50
870721-81-6
μg/kg in the technical
PART B
Glc p: glucopyranosyl
material.
For the implementation of the uniform principles as referred to in Article 29(6) of
CIPAC No
Regulation (EC) No 1107/2009, the conclusions of the review report on heptamal
Fuc p: fucopyranosyl
oxyloglucan, and in particular Appendices I and II thereof, as finalised in the
Not available
Standing Committee on the Food Chain and Animal Health on 27 November
Gal p: galactopyranosyl
2009 shall be taken into account.
Glc-ol: glucitol
299 2-phenylphenol
biphenyl-2-ol
≥ 998 g/kg 1
January
31 December PART A
(including its salts such
2010
2019
as the sodium salt)
Only uses as a post-harvest fungicide for indoor use may be authorised.
L
153/147
CAS No 90-43-7
CIPAC No 246

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L 153/148
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
PART B
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on 2-
phenylphenol, and in particular Appendices I and II thereof, as finalised in the
EN
Standing Committee on the Food Chain and Animal Health on 27 November

2009, as amended in the Standing Committee on the Food Chain and Animal
Health on 28 October 2010, shall be taken into account.
In this overall assessment Member States must pay particular attention:
— to the protection of operators and workers and ensure that conditions of use
prescribe the application of adequate personal protective equipment,
— to put in place appropriate waste management practices to handle the waste
solution remaining after application, including the cleaning water of the
drenching and other application systems. Member States permitting the release
Off
of wastewater into the sewage system, shall ensure that a local risk assessment is
icial
carried out.
Jour
The Member States concerned shall ensure that the notifier submits to the
nal
Commission:
of
— further information on the potential for skin depigmentation for workers and
the
consumers due to possible exposure to the metabolite 2-phenylhydroquinone
European
(PHQ) on citrus peel,
— further information to confirm that the analytical method applied in residue
trials correctly quantifies the residues of 2-phenylphenol, PHQ and their
Union
conjugates.
They shall ensure that the notifier provides such information to the Commission by
31 December 2011.
Furthermore, the Member States concerned shall ensure that the notifier submits to
the Commission further information to confirm the residue levels occurring as a
result of application techniques other than those in drench chambers.
They shall ensure that the notifier provides such information to the Commission by
31 December 2012.
300 Malathion
diethyl (dimethoxyphosphi ≥ 950 g/kg
1 May 2010 30
April PART A
nothioylthio)succinate
2020
CAS No 121-75-5
Impurities:
Only uses as insecticide may be authorised. Authorisations shall be limited to
or
professional users.
CIPAC No 12
S-1,2-bis(ethoxy
Isomalathion: not
carbonyl)ethyl O,O-
more than 2 g/kg
11.6.2011
dimethyl phosphorodi
thioate
racemate

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11.6.2011 Off
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
PART B
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on malathion,
and in particular Appendices I and II thereof, as finalised in the Standing Committee
EN
on the Food Chain and Animal Health on 22 January 2010 shall be taken into

account.
In this overall assessment Member States shall pay particular attention to:
— the operator and worker safety: conditions of use shall prescribe the use of
adequate personal protective equipment;
— the protection of aquatic organisms: conditions of authorisation shall include risk
mitigation measures, where appropriate, such as adequate buffer zones;
— the protection of insectivorous birds and honey bees: conditions of authorisation
shall include risk mitigation measures, where appropriate. As regards bees, the
icial
necessary indications shall be provided on the labelling and the accompanying
instructions as to avoid exposure.
Jour
nal
Member States shall ensure that malathion-based formulations are accompanied by
the necessary instructions to avoid any risk of formation of isomalathion in excess
of
of the permitted maximum quantities during storage and transport.
the
Where appropriate, conditions of authorisation shall include further risk mitigation
European
measures.
The Member States concerned shall ensure that the notifier presents to the
Commission:
Union
— information confirming the consumer risk assessment and the acute and long-
term risk assessment for insectivorous birds;
— information on the quantification of the different potency of malaoxon and
malathion.
301 Penoxsulam
3-(2,2-difluoroethoxy)-N-
> 980 g/kg
1 August
31 July 2020 PART
A
(5,8-dimethoxy[1,2,4]
2010
CAS No 219714-96-2
triazolo[1,5-c]pyrimidin-2- The impurity
Only uses as herbicide may be authorised.
yl)-α,α,α-trifluorotoluene-2-
CIPAC No 758
sulfonamide
Bis-CHYMP
PART B
2-chloro-4-[2-(2-
For the implementation of the uniform principles as referred to in Article 29(6) of
chloro-5-methoxy-4-
Regulation (EC) No 1107/2009, the conclusions of the review report on
pyrimidinyl)
penoxsulam, and in particular Appendices I and II thereof, as finalised in the
L
hydrazino]-5-
Standing Committee on the Food Chain and Animal Health on 22 January 2010
153/149
methoxypyrimidine
shall be taken into account.
must not exceed

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L 153/150
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
0,1 g/kg
in
the
In this overall assessment, Member States must pay particular attention to:
technical material
— the protection of aquatic organisms,
— the dietary exposure of consumers to residues of the metabolite BSCTA in
EN
succeeding rotational crops,

— the protection of groundwater when the active substance is applied in regions
with vulnerable soil and/or climatic conditions.
Conditions of authorisation shall include risk mitigation measures, where appro
priate.
The Member States concerned shall ensure that the notifier submits to the
Commission further information to address the off-field risk to higher aquatic
plants. They shall ensure that the notifier provides such information to the
Off
Commission by 31 July 2012.
icial
The Rapporteur Member State shall inform the Commission in accordance with
Jour
Article 38 of Regulation (EC) No 1107/2009 on the specification of the technical
material as commercially manufactured.
nal
of
the
302 Proquinazid
6-iodo-2-propoxy-3-
> 950 g/kg 1
August
31 July 2020 PART
A
European
propylquinazolin-4(3H)-
2010
CAS No 189278-12-4
one
Only uses as fungicide may be authorised.
CIPAC No 764
PART B
Union
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on
proquinazid, and in particular Appendices I and II thereof, as finalised in the
Standing Committee on the Food Chain and Animal Health on 22 January 2010
shall be taken into account.
In this overall assessment, Member States must pay particular attention:
— to the long-term risk to earthworm-eating birds for uses in grapevine,
— to the risk to aquatic organisms,
— the dietary exposure of consumers to proquinazid residues in products of animal
origin and in succeeding rotational crops,
— to the operator safety.
11.6.2011
Conditions of authorisation shall include risk mitigation measures, where appro
priate.

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11.6.2011 Off
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
The Rapporteur Member State shall inform the Commission in accordance with
Article 38 of Regulation (EC) No 1107/2009 on the specification of the technical
material as commercially manufactured.
EN
303 Spirodiclofen
3-(2,4-dichlorophenyl)-2-
> 965 g/kg
1 August
31 July 2020 PART
A

oxo-1-oxaspiro[4.5]dec-3-
2010
CAS No 148477-71-8
en-4-yl 2,2-dimethyl The following
Only uses as acaricide or insecticide may be authorised.
butyrate
impurities must not
CIPAC No 737
exceed a certain
PART B
amount in the
technical material:
For the implementation of the uniform principles as referred to in Article 29(6) of
3-(2,4-dichlo
Regulation (EC) No 1107/2009, the conclusions of the review report on spirodi
rophenyl)-4-hydroxy-
clofen, and in particular Appendices I and II thereof, as finalised in the Standing
1-oxaspiro[4.5]dec-3-
Committee on the Food Chain and Animal Health on 22 January 2010 shall be
en-2-one (BAJ-2740
taken into account.
icial
enol): ≤ 6 g/kg
In this overall assessment, Member States must pay particular attention:
Jour
N,N-dimethyl
acetamide: ≤ 4 g/kg
— to the long-term risk to aquatic organisms,
nal
of
— to the operator safety,
the
— to the risk to bee brood.
European
Conditions of authorisation shall include risk mitigation measures, where appro
priate.
Union
304 Metalaxyl
Methyl N-(methoxyacetyl)- 950 g/kg
1 July 2010 30
June PART A
N-(2,6-xylyl)-DL-alaninate
2020
CAS No 57837-19-1
The impurity 2,6-
Only uses as fungicide may be authorised.
dimethylaniline was
CIPAC No 365
considered of toxico
PART B
logical concern and a
maximum level of
For the implementation of the uniform principles as referred to in Article 29(6) of
1 g/kg is established.
Regulation (EC) No 1107/2009, the conclusions of the review report on metalaxyl,
and in particular Appendices I and II thereof, as finalised in the Standing Committee
on the Food Chain and Animal Health on 12 March 2010 shall be taken into
account.
Member States must pay particular attention to the potential contamination of
groundwater by the active substance or its degradation products CGA 62826 and
L
CGA 108906 when the active substance is applied in regions with vulnerable soil
153/151
and/or climatic conditions. Risk mitigation measures should be applied where appro
priate.

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L 153/152
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
305 Flonicamid
(IKI-220) N-cyanomethyl-4-(trifluo
≥ 960 g/kg
1 September
31 August
PART A
romethyl)nicotinamide
2010
2020
CAS No 158062-67-0
The impurity toluene
must not exceed
Only uses as insecticide may be authorised.
CIPAC No 763
3 g/kg
in
the
EN
technical material.
PART B

For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on flonicamid,
and in particular Appendices I and II thereof, as finalised in the Standing Committee
on the Food Chain and Animal Health on 22 January 2010, shall be taken into
account.
In this overall assessment, Member States must pay particular attention to:
Off
— the risk to operators and re-entry workers,
icial
— the risk to bees.
Jour
nal
Conditions of authorisation shall include risk mitigation measures where appropriate.
of
the
The Member States shall inform the Commission in accordance with Article 38 of
Regulation (EC) No 1107/2009 on the specification of the technical material as
European
commercially manufactured.
306 Triflumizole
(E)-4-chloro-α,α,α-trifluoro- ≥ 980 g/kg
1 July 2010 30
June PART A
Union
N-(1-imidazol-1-yl-2-
2020
CAS No 99387-89-0
propoxyethylidene)-o-
Impurities:
Only uses as fungicide in greenhouses on artificial substrates may be authorised.
toluidine
CIPAC No 730
Toluene: not more
PART B
than 1 g/kg
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on triflumizole,
and in particular Appendices I and II thereof, as finalised in the Standing Committee
on the Food Chain and Animal Health on 12 March 2010 shall be taken into
account.
In this overall assessment Member States shall pay particular attention to:
— the operator and worker safety: conditions of use shall prescribe the use of
adequate personal protective equipment,
11.6.2011
— the potential impact on aquatic organisms and must ensure that the conditions
of authorisation include, as appropriate, risk mitigation measures.

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11.6.2011 Off
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
307 Sulfuryl
fluoride
Sulfuryl fluoride >
994
g/kg 1
November
31 October PART A
2010
2020
CAS No 002699-79-8
Only uses as insecticide/nematicide (fumigant) applied by professional users in
CIPAC No 757
sealable structures
EN
— which are empty; or

— where conditions of use ensure that consumer exposure is acceptable;
may be authorised.
PART B
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on sulfuryl
fluoride, and in particular Appendices I and II thereof, as finalised in the Standing
Committee on the Food Chain and Animal Health on 11 May 2010 shall be taken
into account.
icial
In this overall assessment, Member States must pay particular attention to:
Jour
— the risk posed by inorganic fluoride through contaminated products, such as
nal
flour and bran that remained in the mill machinery during fumigation, or grain
stored in silos in the mill. Measures are required to ensure that such products do
of
not enter the food and feed chain,
the
European
— the risk to operators and the risk to workers, such as when re-entering a
fumigated structure after aeration. Measures are required to ensure that they
wear self containing breathing apparatus or other appropriate personal protective
equipment,
Union
— the risk to bystanders by applying an appropriate exclusion zone around the
fumigated structure.
Conditions of authorisation shall include risk mitigation measures, where appro
priate.
The Member States concerned shall ensure that the notifier submits to the
Commission further information and in particular, confirmatory data on:
— the mill processing conditions necessary to ensure that residues of fluoride ion in
flour, bran and grain do not exceed the natural background levels,
— tropospheric concentrations of sulfuryl fluoride. Measured concentrations should
be updated regularly. The limit of detection for the analysis shall be at least 0,5
ppt (equivalent to 2,1 ng sulfuryl fluoride/m3 of tropospheric air),
— estimates of sulfuryl fluoride atmospheric lifetime based on worst case scenario,
with respect to the global warming potential (GWP).
L
153/153
They shall ensure that the notifier provides such information to the Commission by
31 August 2012.

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L 153/154
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
308 FEN
560
(also
called
Not applicable 100
%
fenugreek
seed
1 November 31 October PART A
fenugreek or fenugreek
powder without any
2010
2020
seed powder)
additive and no
Only uses as elicitor of the crop's self-defence mechanisms may be authorised.
extraction; the seed
CAS No
being of human food
EN
PART B

None
grade quality.
CIPAC No
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on FEN 560
None
(fenugreek seed powder), and in particular Appendices I and II thereof, as finalised in
The active substance is
the Standing Committee on the Food Chain and Animal Health on 11 May 2010
prepared from the seed
shall be taken into account.
powder of Trigonella
foenum-graecum L.
In this overall assessment, Member States must pay particular attention to the risk to
(fenugreek).
operators, workers and bystanders.
Off
Conditions of authorisation shall include risk mitigation measures where appro
icial
priate.
Jour
nal
309 Haloxyfop-P
Acid: (R)-2-[4-(3-chloro-5- ≥ 940 g/kg
1 January
31 December PART A
of
trifluoromethyl-2-
2011
2020
the
CAS No Acid: 95977- pyridyloxy)phenoxy]propa (Haloxyfop-P-methyl
Only uses as herbicide may be authorised.
29-0
noic acid
ester)
European
PART B
Ester: 72619-32-0
Ester: Methyl (R)-2-{}{4-[3-
chloro-5-(trifluoromethyl)-
For the implementation of the uniform principles as referred to in Article 29(6) of
CIPAC No Acid: 526
2-pyridyloxy]phenoxy}}
Regulation (EC) No 1107/2009, the conclusions of the review report on haloxyfop-
Union
propionate
P, and in particular Appendices I and II thereof, as finalised in the Standing
Ester: 526.201
Committee on the Food Chain and Animal Health on 28 October 2010 shall be
taken into account.
In this overall assessment Member States shall pay particular attention to:
— operator safety: conditions of use shall prescribe the use of adequate personal
protective equipment;
— protection of aquatic organisms: conditions of authorisation shall include risk
mitigation measures, where appropriate, such as adequate buffer zones;
— consumer safety as regards the occurrence in groundwater of metabolites DE-
535 pyridinol and DE-535 pyridinone.
The Member States concerned shall ensure that the applicant presents to the
11.6.2011
Commission, by 31 December 2012 at the latest, information confirming the
groundwater exposure assessment as regards the active substance and its soil meta
bolites DE-535 phenol, DE-535 pyridinol and DE-535 pyridinone.

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11.6.2011 Off
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
310 Napropamide
(RS)-N,N-diethyl-2-(1-naph ≥ 930 g/kg
1 January
31 December PART A
thyloxy)propionamide
2011
2020
CAS No 15299-99-7
(Racemic mixture)
Only uses as herbicide may be authorised.
Relevant impurity
PART B
EN
Toluene: not more

than 1,4 g/kg
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on napro
pamide, and in particular Appendices I and II thereof, as finalised in the Standing
Committee on the Food Chain and Animal Health on 28 October 2010, shall be
taken into account.
In this overall assessment Member States shall pay particular attention to:
— operator safety: conditions of use shall prescribe the use of adequate personal
protective equipment, where necessary,
— protection of aquatic organisms: conditions of authorisation shall include risk
icial
mitigation measures, where appropriate, such as adequate buffer zones,
Jour
— consumer safety as regards the occurrence in groundwater of the metabolite 2-
nal
(1-naphthyloxy)propionic acid, hereinafter ‘NOPA’.
of
The Member States concerned shall ensure that the applicant presents to the
the
Commission, by 31 December 2012 at the latest, information confirming the
European
surface water exposure assessment as regards the photolysis metabolites and the
metabolite NOPA and information for the risk assessment of aquatic plants.
Union
311 Quinmerac
7-chloro-3-methylqui
≥ 980 g/kg 1
May
2011 30
April PART A
noline-8-carboxylic acid
2021
CAS No 90717-03-6
Only uses as herbicide may be authorised.
CIPAC No 563
PART B
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on quinmerac,
and in particular Appendices I and II thereof, as finalised in the Standing Committee
on the Food Chain and Animal Health on 28 October 2010 shall be taken into
account.
In this overall assessment Member States shall pay particular attention to:
— the protection of groundwater when the active substance is applied in regions
with vulnerable soil and/or climatic conditions;
— the dietary exposure of consumers to residues of quinmerac (and its metabolites)
L
in succeeding rotational crops
153/155
— the risk to aquatic organisms and the long term risk for earthworms.

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L 153/156
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
Conditions of use shall include risk mitigation measures, where appropriate.
The Member States concerned shall request the submission of information as
regards:
EN
— the potential of plant metabolism to result in an opening of the quinoline ring;

— residues in rotational crops and the long term risk for earthworms due to the
metabolite BH 518-5.
They shall ensure that the applicant provides such confirmatory data and
information to the Commission by 30 April 2013.
312 Metosulam
2′,6′-dichloro-5,7-
≥ 980 g/kg 1
May
2011 30
April PART A
dimethoxy-3′-
2021
Off
CAS No 139528-85-1
methyl[1,2,4]triazolo
Only uses as herbicide may be authorised.
icial
CIPAC No 707
[1,5-a]pyrimidine-2-sulfon
PART B
Jour
anilide
For the implementation of the uniform principles as referred to in Article 29(6) of
nal
Regulation (EC) No 1107/2009, the conclusions of the review report on metosulam,
of
and in particular Appendices I and II thereof, as finalised in the Standing Committee
the
on the Food Chain and Animal Health on 28 October 2010 shall be taken into
account.
European
In this overall assessment Member States shall pay particular attention to:
Union
— the protection of groundwater when the active substance is applied in regions
with vulnerable soil and/or climatic conditions;
— the risk to aquatic organisms;
— the risk to non-target plants in the off-field area.
Conditions of use shall include risk mitigation measures, where appropriate.
The Member States concerned shall ensure that the applicant submits to the
Commission, by 30 October 2011, further information on the specification of the
active substance as manufactured.
The Member States concerned shall ensure that the applicant submits to the
Commission, by 30 April 2013, confirmatory information as regards:
— potential pH dependence of soil adsorption, groundwater leaching and surface
11.6.2011
water exposure for metabolites M01 and M02;
— potential genotoxicity of one impurity.

---

11.6.2011 Off
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
313 Pyridaben
2-tert-butyl-5-(4-tert-
>980 g/kg 1
May
2011 30
April PART A
butylbenzylthio)-4-
2021
CAS No 96489-71-3
chloropyrididazin-3(2H)-
Only uses as insecticide and acaricide may be authorised.
CIPAC No 583
one
EN
PART B

For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on pyridaben,
and in particular Appendices I and II thereof, as finalised in the Standing Committee
on the Food Chain and Animal Health on 28 October 2010 shall be taken into
account.
In this overall assessment Member States shall pay particular attention to:
— the operator safety and ensure that conditions of use prescribe the application of
adequate personal protective equipment where appropriate,
icial
— the risk to aquatic organisms and mammals,
Jour
nal
— the risk to non target arthropods including honeybees.
of
Conditions of authorisation should include risk mitigation measures and monitoring
the
programmes should be initiated to verify the real exposure of honeybees to
European
pyridaben in areas extensively used by such bees for foraging or by beekeepers,
where and as appropriate.
The Member States concerned shall request the submission of confirmatory
Union
information as regards:
— the risks for the water compartment resulting from the exposure to aqueous
photolysis metabolites W-1 and B-3,
— the potential long term risk for mammals,
— the assessment of fat soluble residues.
They shall ensure that the applicant provides such confirmatory information to the
Commission by 30 April 2013.
314 Zinc
phosphide
Trizinc diphosphide
≥ 800 g/kg 1
May
2011 30
April PART A
2021
CAS No 1314-84-7
Only uses as rodenticide in the form of ready-to-use baits placed in bait stations or
L
target locations may be authorised.
153/157
CIPAC No 69

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L 153/158
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
PART B
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on zinc
phosphide, and in particular Appendices I and II thereof, as finalised in the
EN

Standing Committee on the Food Chain and Animal Health on 28 October 2010
shall be taken into account.
In this overall assessment Member States should pay particular attention to:
— the protection of non target organisms. Risk mitigation measures should be
applied as appropriate in particular to avoid the spread of baits where only
part of the content has been consumed.
Off
315 Fenbuconazole
(R,S) 4-(4-chlorophenyl)-2- ≥ 965 g/kg 1
May
2011 30
April PART A
icial
phenyl-2-(1H-1,2,4-triazol-
2021
1-ylmethyl)butyronitrile
Jour
CAS No 114369-43-6
Only uses as fungicide may be authorised.
nal
PART B
CIPAC No 694
of
the
For the implementation of the uniform principles as referred to in Article 29(6) of
European
Regulation (EC) No 1107/2009, the conclusions of the review report on fenbu
conazole, and in particular Appendices I and II thereof, as finalised in the
Standing Committee on the Food Chain and Animal Health on 28 October 2010
shall be taken into account.
Union
In this overall assessment Member States shall pay particular attention to:
— the operator safety and ensure that conditions of use prescribe the application of
adequate personal protective equipment where appropriate,
— the dietary exposure of consumers to the residues of triazole derivative meta
bolites (TDMs),
— the risk to aquatic organisms and mammals.
Conditions of use shall include risk mitigation measures, where appropriate.
The Member States concerned shall request the submission of confirmatory data on
residues of triazole derivative metabolites (TDMs) in primary crops, rotational crops
and products of animal origin.
11.6.2011
They shall ensure that the applicant provides such studies to the Commission by
30 April 2013.

---

11.6.2011 Off
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
The Member States concerned shall ensure that the applicant submits to the
Commission further information addressing the potential endocrine disrupting
properties of fenbuconazole within two years after the adoption of the OECD test
guidelines on endocrine disruption or, alternatively, of Community agreed test
guidelines.
EN

316 Cycloxydim
(5RS)-2-[(EZ)-1-
≥ 940 g/kg 1
June
2011 31
May PART A
(ethoxyimino)butyl]-3-
2021
CAS No 101205-02-1
hydroxy-5-[(3RS)-thian-3-
Only uses as herbicide may be authorised.
yl]cyclohex-2-en-1-one
CIPAC No 510
PART B
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on cycloxydim,
and in particular Appendices I and II thereof, as finalised in the Standing Committee
on the Food Chain and Animal Health on 23 November 2010 shall be taken into
icial
account.
Jour
In this overall assessment Member States shall pay particular attention to the risk to
nal
non-target plants.
of
Conditions of use shall include risk mitigation measures, where appropriate.
the
European
The Member States concerned shall request the submission of further information
concerning the methods for analysis of residues of cycloxydim in plant and animal
products.
Union
The Member States concerned shall ensure that the applicant submits such methods
of analysis to the Commission by 31 May 2013.
317 6-Benzyladenine
N6-benzyladenine
≥ 973 g/kg 1
June
2011 31
May PART A
2021
CAS No 1214-39-7
Only uses as plant growth regulator may be authorised.
CIPAC No 829
PART B
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on 6-ben
zyladenine, and in particular Appendices I and II thereof, as finalised in the
Standing Committee on the Food Chain and Animal Health on 23 November
2010 shall be taken into account.
L
In this overall assessment Member States shall pay particular attention to the
153/159
protection of aquatic organisms. Risk mitigation measures such as buffer zones
shall be applied, where appropriate.

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L 153/160
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
318 Bromuconazole
1-[(2RS,4RS:2RS,4SR)-4-
≥ 960 g/kg 1
February
31 January PART A
bromo-2-(2,4-dichlo
2011
2021
CAS No 116255-48-2
rophenyl)tetrahydro
Only uses as fungicide may be authorised.
CIPAC No 680
furfuryl]-1H-1,2,4-triazole
PART B
EN

For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on bromu
conazole, and in particular Appendices I and II thereof, as finalised in the Standing
Committee on the Food Chain and Animal Health on 23 November 2010 shall be
taken into account.
In this overall assessment, Member States shall pay particular attention to:
— operator's safety and ensure that conditions of use prescribe the application of
adequate personal protective equipment where appropriate;
Off
— protection of aquatic organisms. Conditions of authorisation shall include risk
icial
mitigation measures, where appropriate, such as adequate buffer zones.
Jour
The Member States concerned shall ensure that the applicant presents to the
nal
Commission:
of
— further information on residues of triazole derivative metabolites (TDMs) in
the
primary crops, rotational crops and products of animal origin;
European
— information to further address the long term risk to herbivorous mammals.
They shall ensure that the applicant at whose request bromuconazole has been
Union
included in this Annex provides such confirmatory information to the Commission
by 31 January 2013 at the latest.
The Member States concerned shall ensure that the applicant submits to the
Commission further information addressing the potential endocrine disrupting
properties of bromuconazole within two years after the adoption of the OECD
test guidelines on endocrine disruption or, alternatively, of Community agreed test
guidelines.
319 Myclobutanil
RS)-2-(4-chlorophenyl)-2-
≥ 925 g/kg
1 June 2011 31
May PART A
(1H-1,2,4-triazol-1-
2021
CAS No 88671-89-0
ylmethyl)hexanenitrile
The impurity 1-
Only uses as fungicide may be authorised.
methylpyrrolidin-2-
CIPAC No 442
one shall not exceed
PART B
1 g/kg
in
the
technical material
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on
11.6.2011
myclobutanil, and in particular Appendices I and II thereof, as finalised in the
Standing Committee on the Food Chain and Animal Health on 23 November
2010 shall be taken into account.

---

11.6.2011 Off
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
In this overall assessment Member States shall pay particular attention to the
operator safety and ensure that conditions of use prescribe the application of
adequate personal protective equipment where appropriate.
Conditions of use shall include risk mitigation measures, where appropriate.
EN

The Member States concerned shall request the submission of confirmatory
information on the residues of myclobutanil and its metabolites in following
growing seasons and information confirming that the available residue data cover
all compounds of the residue definition.
The Member States concerned shall ensure that the applicant submits such
confirmatory information to the Commission by 31 January 2013.
320 Buprofezin
(Z)-2-tert-butylimino-3-
≥ 985 g/kg 1
February
31 January PART A
isopropyl-5-phenyl-1,3,5-
2011
2021
icial
CAS No 953030-84-7
thiadiazinan-4-one
Only uses as insecticide and acaricide may be authorised.
Jour
nal
CIPAC No 681
PART B
of
For the implementation of the uniform principles as referred to in Article 29(6) of
the
Regulation (EC) No 1107/2009, the conclusions of the review report on buprofezin,
and in particular Appendices I and II thereof, as finalised in the Standing Committee
European
on the Food Chain and Animal Health on 23 November 2010 shall be taken into
account.
Union
In this overall assessment Member States shall pay particular attention to:
— the operators’ and workers’ safety and ensure that conditions of use impose
adequate personal protective equipment where appropriate;
— the dietary exposure of consumers to the buprofezin (aniline) metabolites in
processed food;
— the application of an appropriate waiting period for rotational crops in green
houses;
— the risk to aquatic organisms and ensure that conditions of use impose adequate
risk mitigation measures, where appropriate.
The Member States concerned shall request the submission of confirmatory
information as regards the processing and conversion factors for consumer risk
assessment.
L
153/161
The Member States concerned shall ensure that the applicant submits such
confirmatory information to the Commission by 31 January 2013.

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L 153/162
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
321 Triflumuron
1-(2-chlorobenzoyl)-3-[4-
≥ 955 g/kg
1 April
31 March
PART A
trifluoromethoxyphe
2011
2021
CAS No 64628-44-0
nyl]urea
Impurities:
Only uses as insecticide may be authorised.
CIPAC No: 548
— N,N′-bis-[4-
(trifluoromethoxy)
PART B
EN
phenyl]urea: not

more than 1 g/kg
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on triflumuron,
— 4-trifluoro-metho
and in particular Appendices I and II thereof, as finalised in the Standing Committee
xyaniline: not
on the Food Chain and Animal Health on 28 January 2011 shall be taken into
more than 5 g/kg
account.
In this overall assessment, Member States shall pay particular attention to:
— the protection of the aquatic environment;
— the protection of honey bees. Conditions of authorisation shall include risk
Off
mitigation measures, where appropriate.
icial
Conditions of authorisation shall include risk mitigation measures, where appro
Jour
priate.
nal
The Member States concerned shall ensure that the applicant submits to the
of
Commission confirmatory information as regards the long-term risk to birds, the
the
risk to aquatic invertebrates and the risk to bee brood development.
European
The Member States concerned shall ensure that the applicant submits such
information to the Commission by 31 March 2013.
Union
322 Hymexazol
5-methylisoxazol-3-ol (or ≥985 g/kg 1
June
2011 31
May PART A
5-methyl-1,2-oxazol-3-ol)
2021
CAS No 10004-44-1
Only uses as fungicide for seed pelleting of sugar beets in professional seed
treatment facilities may be authorised.
CIPAC No 528
PART B
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on hymexazol,
and in particular Appendices I and II thereof, as finalised in the Standing Committee
on the Food Chain and Animal Health on 23 November 2010 shall be taken into
account.
In this overall assessment Member States shall pay particular attention to:
— the operators and workers safety. Conditions of authorisation shall include
protective measures, where appropriate,
11.6.2011
— the risk to granivorous birds and mammals.
Conditions of use shall include risk mitigation measures, where appropriate.

---

11.6.2011 Off
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
The Member States concerned shall request the submission of confirmatory
information as regards the nature of residues in root crops and the risk for grani
vorous birds and mammals.
The Member States concerned shall ensure that the applicant submits such
EN
confirmatory information to the Commission by 31 May 2013.

323 Dodine
1-dodecylguanidinium
≥ 950 g/kg 1
June
2011 31
May PART A
acetate
2021
CAS No 2439-10-3
Only uses as fungicide may be authorised.
CIPAC No 101
PART B
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on dodine, and
in particular Appendices I and II thereof, as finalised in the Standing Committee on
the Food Chain and Animal Health on 23 November 2010 shall be taken into
icial
account.
Jour
In this overall assessment Member States shall pay particular attention to:
nal
— the potential long-term risk to birds and mammals;
of
the
— the risk to aquatic organisms and ensure that conditions of use impose adequate
risk mitigation measures;
European
— the risk to non-target plants in the off-field area and ensure that conditions of
use impose adequate risk mitigation measures;
Union
— the monitoring of residue levels in pome fruit.
The Member States concerned shall request the submission of confirmatory
information as regards:
— long-term risk assessment for birds and mammals,
— risk assessment in natural surface water systems where major metabolites have
potentially formed.
The Member States concerned shall ensure that the applicant submits such
confirmatory information to the Commission by 31 May 2013.
324 Diethofencarb
isopropyl 3,4-diethoxy ≥ 970 g/kg
1 June 2011 31
May PART A
carbanilate
2021
CAS No 87130-20-9
Impurities:
Only uses as fungicide may be authorised.
L
153/163
CIPAC No 513
Toluene: not more
than 1 g/kg

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L 153/164
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
PART B
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on dietho
fencarb, and in particular Appendices I and II thereof, as finalised in the Standing
EN
Committee on the Food Chain and Animal Health on 28 January 2011 shall be

taken into account.
In this overall assessment Member States shall pay particular attention to the risk to
aquatic organisms and non-target arthropods and shall ensure that conditions of use
include the application of adequate risk mitigation measures.
The Member States concerned shall request the submission of confirmatory
information as regards:
Off
— the potential uptake of the metabolite 6-NO2-DFC in succeeding crops;
icial
Jour
— the risk assessment for non-target arthropod species.
nal
The Member States concerned shall ensure that the applicant submits such
of
information to the Commission by 31 May 2013.
the
European
325 Etridiazole
ethyl-3-trichloromethyl-
≥ 970 g/kg 1
June
2011 31
May PART A
1,2,4-thiadiazol-5-yl ether
2021
CAS No 2593-15-9
Only uses as fungicide in non-soil bound systems in greenhouse may be authorised.
Union
CIPAC No 518
PART B
In assessing applications to authorise plant protection products containing etri
diazole for uses other than on ornamental plants, Member States shall pay particular
attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall
ensure that any necessary information is provided before such an authorization is
granted.
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on etridiazole,
and in particular Appendices I and II thereof, as finalised in the Standing Committee
on the Food Chain and Animal Health on 28 January 2011 shall be taken into
account.
In this overall assessment Member States shall:
11.6.2011
— pay particular attention to the risk to operators and workers and ensure that
conditions of use include the application of appropriate risk mitigation measures;

---

11.6.2011 Off
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
— ensure that appropriate waste management practices are applied as regards waste
water from irrigation of non-soil bound growing systems; Member States
permitting the release of waste water into the sewage system or into natural
water bodies, shall ensure that an appropriate risk assessment is carried out;
EN
— pay particular attention to the risk to aquatic organisms and ensure that

conditions of use include the application of appropriate risk mitigation measures.
The Member States concerned shall request the submission of confirmatory
information as regards:
1. the specification of the technical material, as commercially manufactured, by
appropriate analytical data;
2. the relevance of the impurities;
3. the equivalence between the specifications of the technical material, as
commercially manufactured, and those of the test material used in the ecotoxicity
icial
dossiers;
Jour
4. the relevance of the plant metabolites 5-hydroxy-ethoxyetridiazole acid and 3-
nal
hydroxymethyletridiazole;
of
5. indirect exposure of groundwater and soil-dwelling organisms to etridiazole and
the
to its soil metabolites dichloro-etridiazole and etridiazole acid;
European
6. long-range and short-range transport through the atmosphere of etridiazole acid.
The Member States concerned shall ensure that the applicant submits to the
Commission the information set out in points (1), (2) and (3) by 30 November
Union
2011 and the information set out in points (4), (5) and (6) by 31 May 2013.
326 Indolylbutyric
acid
4-(1H-indol-3-yl)butyric
≥ 994 g/kg 1
June
2011 31
May PART A
acid
2021
CAS No 133-32-4
Only uses as plant growth regulator in ornamentals may be authorised.
CIPAC No 830
PART B
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on indo
lylbutyric acid, and in particular Appendices I and II thereof, as finalised in the
Standing Committee on the Food Chain and Animal Health on 28 January 2011
shall be taken into account.
In this overall assessment Member States shall pay particular attention to the
L
operators and workers safety. Conditions of authorisation shall include the appli
153/165
cation of adequate personal protective equipment and risk mitigation measures to
reduce the exposure.

---

L 153/166
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
The Member States concerned shall request the submission of further information to
confirm:
— the absence of clastogenicity potential of indolylbutyric acid;
EN

— the vapour pressure of indolylbutyric acid and, consequently, an inhalation
toxicity study;
— the natural background concentration of indolylbutyric acid in the soil.
The Member States concerned shall ensure that the applicant submits such
confirmatory information to the Commission by 31 May 2013.
327 Oryzalin
3,5-dinitro-N4,N4-dipro
≥ 960 g/kg
1 June 2011 31
May PART A
Off
pylsulfanilamide
2021
Only uses as herbicide may be authorised.
icial
CAS No 19044-88-3
N-nitrosodipropyl
amine:
PART B
Jour
CIPAC No 537
For the implementation of the uniform principles as referred to in Article 29(6) of
nal
≤ 0,1 mg/kg
Regulation (EC) No 1107/2009, the conclusions of the review report on oryzalin,
of
and in particular Appendices I and II thereof, as finalised in the Standing Committee
the
Toluene: ≤ 4 g/kg
on the Food Chain and Animal Health on 28 January 2011 shall be taken into
account.
European
In this overall assessment Member States shall pay particular attention to:
— the operator safety and ensure that conditions of use include the application of
Union
adequate personal protective equipment;
— the protection of aquatic organisms and non target plants;
— the protection of groundwater, where the active substance is applied in regions
with vulnerable soil and/or climatic conditions;
— the risk to herbivorous birds and mammals;
— the risk to bees, in the flowering season.
Conditions of authorisation shall include risk mitigation measures, where appro
priate.
The Member States concerned shall carry out monitoring programmes to verify
potential groundwater contamination from the metabolites OR13 (4 ) and OR15 (5 )
in vulnerable zones, where appropriate.The Member States concerned shall request
the submission of confirmatory information as regards:
(1) the specification of the technical material, as commercially manufactured, by
11.6.2011
appropriate analytical data, including information on the relevance of the
impurities which for confidentiality reasons are referred to as impurities 2, 6,
7, 9, 10, 11, 12;

---

11.6.2011 Off
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
(2) the relevance of the test material used in the toxicity dossiers in view of the
specification of the technical material;
(3) the risk assessment for aquatic organisms;
EN

(4) the relevance of the metabolites OR13 and OR15, and the corresponding
groundwater risk assessment, if oryzalin is classified under Regulation (EC)
No 1272/2008 as ‘suspected of causing cancer’.
The Member States concerned shall ensure that the applicant submits to the
Commission the information set out in points (1) and (2) by 30 November 2011
and the information set out in point (3) by 31 May 2013. The information set out
in point (4) shall be submitted within six month of notification of a decision
classifying oryzalin.
icial
328 Tau-fluvalinate
(RS)-α-cyano-3-phenoxy
≥ 920 g/kg
1 June 2011 31
May PART A
benzyl N-(2-chloro- α,α α-
2021
Jour
CAS No 102851-06-9
trifluoro-p-tolyl)-D-valinate (1:1 ratio of R-α-
Only uses as insecticide and acaricide may be authorised.
nal
cyano and S-α-cyano
PART B
of
CIPAC No 786
(Isomer ratio 1:1)
isomers)
the
For the implementation of the uniform principles as referred to in Article 29(6) of
Impurities:
Regulation (EC) No 1107/2009, the conclusions of the review report on tau-
European
fluvalinate, and in particular Appendices I and II thereof, as finalised in the
Toluene: not more
Standing Committee on the Food Chain and Animal Health on 28 January 2011
than 5 g/kg
shall be taken into account.
Union
In this overall assessment Member States shall pay particular attention to:
— the risk to aquatic organisms and ensure that conditions of use prescribe the
application of adequate risk mitigation measures;
— the risk to non-target arthropods and ensure that conditions of use prescribe the
application of adequate risk mitigation measures;
— the test material used in the toxicity dossiers shall be compared and verified
against the specification of the technical material commercially manufactured.
The Member States concerned shall request the submission of confirmatory
information as regards:
— the risk of bioaccumulation/biomagnification in the aquatic environment;
— the risk to non-target arthropods;
L
The Member States concerned shall ensure that the applicant submits such
153/167
confirmatory information to the Commission by 31 May 2013.

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L 153/168
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
The Member States concerned shall ensure that the applicant submits confirmatory
information, two years after the adoption of specific guidance, as regards:
— the possible impact on the environment of the potential enantio-selective degra
dation in environmental matrices.
EN

329 Clethodim
(5RS)-2-{(1EZ)-1-[(2E)-3-
≥ 930 g/kg
1 June 2011 31
May PART A
chloroally
2021
CAS No 99129-21-2
loxyimino]propyl}-5-
Impurities:
Only uses as herbicide on sugar beet may be authorised.
[(2RS)-2-(ethylthio)propyl]-
CIPAC No 508
3-hydroxycyclohex-2-en-1- toluene max. 4 g/kg
PART B
one
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on clethodim,
and in particular Appendices I and II thereof, as finalised in the Standing Committee
Off
on the Food Chain and Animal Health on 28 January 2011 shall be taken into
account.
icial
In this overall assessment Member States shall pay particular attention to the
Jour
protection to aquatic organisms, birds and mammals, and shall ensure that
nal
conditions of use include the application of adequate risk mitigation measures.
of
The Member States concerned shall request the submission of confirmatory
the
information, on the basis of most recent scientific knowledge, as regards:
European
— the soil and groundwater exposure assessments,
— the residue definition for risk assessment.
Union
The Member States concerned shall ensure that the applicant submits such
confirmatory information to the Commission by 31 May 2013.
330 Bupirimate
5-butyl-2-ethylamino-6-
≥ 945 g/kg
1 June 2011 31
May PART A
methylpyrimidine-4-yl
2021
CAS No 41483-43-6
dimethylsulfamate
Impurities:
Only uses as fungicide may be authorised.
CIPAC No 261
Ethirimol: max. 2 g/kg
PART B
Toluene: max. 3 g/kg
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on bupirimate,
and in particular Appendices I and II thereof, as finalised in the Standing Committee
on the Food Chain and Animal Health on 28 January 2011 shall be taken into
account.
In this overall assessment Member States shall pay particular attention to:
11.6.2011
— the protection of aquatic organisms. Conditions of authorisation shall include
risk mitigation measures, where appropriate,

---

11.6.2011 Off
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
— the protection of the groundwater, when the active substance is applied in
regions with vulnerable soil and/or climatic conditions. Conditions of authori
sation shall include risk mitigations, where appropriate,
— the in-field risk to non-target arthropods.
EN

The Member States concerned shall request the submission of confirmatory
information as regards:
(1) the specification of the technical material, as commercially manufactured, by
appropriate analytical data; including information on the relevance of the
impurities,
(2) the equivalence between the specifications of the technical material; as
commercially manufactured, and those of the test material used in the toxicity
dossiers,
icial
(3) the kinetic parameters, the soil degradation and the adsorption and desorption
parameter for the major soil metabolite DE-B (6 ).
Jour
nal
The Member States concerned shall ensure that the applicant submits such
confirmatory data and information to the Commission set out in point (1) and
of
(2) by 30 November 2011 and the information set out in point (3) by 31 May
the
2013.
European
331 Fenbutatin
oxide
bis[tris(2-methyl-2-
≥ 970 g/kg
1 June 2011 31
May PART A
phenylpropyl)-tin]oxide
2021
Union
CAS No 13356-08-6
Impurities:
Only uses as acaricide in greenhouses may be authorised.
CIPAC No 359
bis[hydroxybis(2-
PART B
methyl-2-
phenylpropyl)tin]oxide
For the implementation of the uniform principles as referred to in Article 29(6) of
(SD 31723): not more
Regulation (EC) No 1107/2009, the conclusions of the review report on fenbutatin
than 3 g/kg
oxide, and in particular Appendices I and II thereof, as finalised in the Standing
Committee on the Food Chain and Animal Health on 28 January 2011 shall be
taken into account.
In this overall assessment Member States shall pay particular attention to:
— the technical specification of the impurity content,
— the residue levels in small tomato varieties (cherry tomatoes),
— the operator safety. Conditions of use shall prescribe the application of adequate
L
personal protective equipment, where appropriate;
153/169
— the risk to aquatic organisms.

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L 153/170
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
Conditions of authorisation shall include risk mitigation measures, where appro
priate.
The Member States concerned shall request the submission of information
confirming the results of the risk assessment, on the basis of most recent scientific
EN
knowledge, as regards the impurity SD 31723. That information shall concern the

following points:
— genotoxicological potential;
— ecotoxicological relevance;
— spectra, storage stability and methods of analysis in the formulation.
The Member States concerned shall ensure that the applicant submits such
confirmatory information to the Commission by 31 May 2013.
Off
icial
332 Fenoxycarb
Ethyl 2-(4-phenoxy ≥ 970 g/kg
1 June 2011 31
May PART A
Jour
phenoxy)ethyl carbamate
2021
CAS No 79127-80-3
Impurities:
Only uses as insecticide may be authorised.
nal
of
CIPAC No: 425
Toluene: max. 1 g/kg
PART B
the
For the implementation of the uniform principles as referred to in Article 29(6) of
European
Regulation (EC) No 1107/2009, the conclusions of the review report on fenoxycarb,
and in particular Appendices I and II thereof, as finalised in the Standing Committee
on the Food Chain and Animal Health on 28 January 2011 shall be taken into
account.
Union
In this overall assessment Member States shall pay particular attention to:
— the protection of aquatic organisms. Conditions of authorisation shall include
risk mitigation measures, where appropriate,
— the risk to bees and non-target arthropods. Conditions of authorisation shall
include risk mitigation measures, where appropriate.
The Member States concerned shall request the submission of information
confirming the risk assessment for non-target arthropods and for bee brood.
The Member States concerned shall ensure that the applicant submits such
information to the Commission by 31 May 2013.
333 1-decanol
Decan-1-ol
≥ 960 g/kg 1
June
2011 31
May PART A
2021
11.6.2011
CAS No 112-30-1
Only uses as plant growth regulator may be authorised.
CIPAC No 831

---

11.6.2011 Off
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
PART B
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on 1-decanol,
EN
and in particular Appendices I and II thereof, as finalised in the Standing Committee

on the Food Chain and Animal Health on 28 January 2011 shall be taken into
account.
In this overall assessment Member States shall pay particular attention to:
— the risk to consumers from residues in case of use on food or feed crops;
— the risk for operator and ensure that conditions of use prescribe the application
of adequate personal protective equipment where appropriate;
— the protection of groundwater when the active substance is applied in regions
with vulnerable soil and/or climatic conditions;
icial
— the risk to aquatic organisms;
Jour
— the risk to non-target arthropods and bees that may be exposed to the active
nal
substance by visiting flowering weeds present in the crop at time of application.
of
the
Risk mitigation measures shall be applied, where appropriate.
European
The Member States concerned shall request the submission of confirmatory
information, as regards the risk to aquatic organisms and of information confirming
the groundwater, surface water and sediment exposure assessments.
Union
The Member States concerned shall ensure that the applicant submits such
confirmatory information to the Commission by 31 May 2013.
334 Isoxaben
N-[3-(1-ethyl-1-methyl
≥ 910 g/kg
1 June 2011 31
May PART A
propyl)-1,2-oxazol-5-yl]-
2021
CAS No 82558-50-7
2,6-dimethoxybenzamide
Toluene: ≤ 3 g/kg
Only uses as herbicide may be authorised.
CIPAC No 701
PART B
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on isoxaben,
and in particular Appendices I and II thereof, as finalised in the Standing Committee
on the Food Chain and Animal Health on 28 January 2011 shall be taken into
account.
In this overall assessment Member States shall pay particular attention to the risk to
aquatic organisms, the risk to non-target terrestrial plants and the potential leaching
L
of metabolites to groundwater.
153/171
Conditions of use shall include risk mitigation measures, where appropriate.

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L 153/172
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
The Member States concerned shall request the submission of confirmatory
information as regards:
(a) the specification of the technical material, as commercially manufactured,
EN
(b) the relevance of the impurities;

(c) the residues in rotational crops;
(d) the potential risk to aquatic organisms.
The Member States concerned shall ensure that the applicant submits to the
Commission the information set out in points (a) and (b) by 30 November 2011
and the information set out in points (c) and (d) by 31 May 2013.
Off
335 Fluometuron
1,1-dimethyl-3-(α,α,α
≥ 940 g/kg 1
June
2011 31
May PART A
icial
-trifluoro-m-tolyl)urea
2021
CAS No: 2164-17-2
Only uses as herbicide on cotton may be authorised.
Jour
nal
CIPAC No: 159
PART B
of
For the implementation of the uniform principles as referred to in Article 29(6) of
the
Regulation (EC) No 1107/2009, the conclusions of the review report on
fluometuron, and in particular Appendices I and II thereof, as finalised in the
European
Standing Committee on the Food Chain and Animal Health on 11 March 2011
shall be taken into account.
In this overall assessment Member States shall:
Union
— pay particular attention to the protection of the operators and workers and
ensure that conditions of use include the application of adequate personal
protective equipment;
— pay particular attention to the protection of the groundwater where the active
substance is applied in regions with vulnerable soil and/or climatic conditions;
they shall ensure that conditions of authorisation include risk mitigation
measures and the obligation to carry out monitoring programmes to verify
potential leaching of fluometuron and soil metabolites desmethyl-fluometuron
and trifluoromethylaniline in vulnerable areas, where appropriate;
— pay particular attention to the risk to non-target soil macro-organisms others
than earthworms and non-target plants, and ensure that conditions of authori
sation include risk mitigation measures, where appropriate.
The Member States concerned shall ensure that the applicants submit to the
11.6.2011
Commission confirmatory information as regards:
(a) the toxicological properties of the plant metabolite trifluoroacetic acid;

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11.6.2011 Off
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
(b) the analytical methods for the monitoring of fluometuron in air;
(c) the analytical methods for the monitoring of the soil metabolite trifluoromethyl
aniline in soil and water;
EN
(d) the relevance for ground water of the soil metabolites desmethyl-fluometuron

and trifluoromethylaniline, if fluometuron is classified under Regulation (EC)
No 1272/2008 as ‘suspected of causing cancer’.
The Member States concerned shall ensure that the applicants submit to the
Commission the information set out in points (a), (b) and (c) by 31 March 2013
and the information set out in point (d) within six months from the notification of
the decision classifying fluometuron.
336 Carbetamide
(R)-1-(Ethylcarbamoyl)ethyl ≥ 950 g/kg 1
June
2011 31
May PART A
carbanilate
2021
icial
CAS No 16118-49-3
Only uses as herbicide may be authorised.
Jour
CIPAC No 95
PART B
nal
For the implementation of the uniform principles as referred to in Article 29(6) of
of
Regulation (EC) No 1107/2009, the conclusions of the review report on carbe
the
tamide, and in particular Appendices I and II thereof, as finalised in the Standing
European
Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken
into account.
In this overall assessment Member States shall pay particular attention to:
Union
(a) the protection of groundwater, when the active substance is applied in regions
with vulnerable soil and/or climatic conditions;
(b) the risk to non-target plants;
(c) the risk to aquatic organisms.
Conditions of use shall include risk mitigation measures, where appropriate.
337 Carboxin
5,6-dihydro-2-methyl-1,4-
≥ 970 g/kg 1
June
2011 31
May PART A
oxathiine-3-carboxanilide
2021
CAS No 5234-68-4
Only uses as fungicide for seed treatment may be authorised.
CIPAC No 273
Member States shall ensure that authorisations provide that seed coating be
L
performed exclusively in professional seed treatment facilities and that these facilities
153/173
apply the best available techniques to exclude the release of dust clouds during
storage, transport and application.

---

L 153/174
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
PART B
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on carboxin,
EN
and in particular Appendices I and II thereof, as finalised in the Standing Committee

on the Food Chain and Animal Health on 11 March 2011 shall be taken into
account.
In this overall assessment Member States shall pay particular attention to:
— the risk to operators;
— the protection of groundwater, when the active substance is applied in regions
with vulnerable soil and/or climatic conditions;
Off
icial
— the risk to birds and mammals.
Jour
Conditions of use shall include risk mitigation measures, where appropriate.
nal
of
The Member States concerned shall request the submission of confirmatory
information as regards:
the
European
(a) the specification of the technical material, as commercially manufactured,
-including appropriate analytical data-;
Union
(b) the relevance of the impurities;
(c) comparison and verification of the test material used in the mammalian toxicity
and ecotoxicity dossiers against the specification of the technical material;
(d) analytical methods for the monitoring of the metabolite M6 (7 ) in soil,
groundwater and surface water and for the monitoring of metabolite M9 (8 ) in
groundwater;
(e) additional values regarding the period required for 50 percent dissipation in soil
for the soil metabolites P/V-54 (9 ) and P/V-55 (10 ),
(f) rotational crop metabolism,
(g) the long-term risk to granivorous birds, granivorous mammals and herbivorous
mammals;
11.6.2011
(h) the relevance for ground water of the soil metabolites P/V-54 (11 ), P/V-55 (12 ) and
M9 (13 ) if carboxin is classified under Regulation (EC) No 1272/2008 as
‘suspected of causing cancer’.

---

11.6.2011 Off
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
The Member States concerned shall ensure that the applicant submits to the
Commission the information set out in point (a), (b) and (c) by 30 November
2011, the information set out in points (d), (e), (f) and (g) by 31 May 2013 and
the information set out in point (h) six months after the notification of decision
classifying carboxin.
EN

338 Cyproconazole
(2RS,3RS;2RS,3SR)-2-(4-
≥ 940 g/kg 1
June
2011 31
May PART A
chlorophenyl)-3-cyclo
2021
CAS No 94361-06-5
propyl-1-(1H-1,2,4-triazol-
Only uses as fungicide may be authorised.
1-yl)butan-2-ol
CIPAC No 600
PART B
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on cypro
conazole, and in particular Appendices I and II thereof, as finalised in the
Standing Committee on the Food Chain and Animal Health on 11 March 2011
shall be taken into account.
icial
Jour
In this overall assessment Member States shall pay particular attention to:
nal
— the dietary exposure of consumers to the residues of triazole derivative meta
of
bolites (TDMs);
the
— the risk to aquatic organisms.
European
Conditions of use shall include risk mitigation measures, where appropriate.
Union
The Member States concerned shall request the submission of confirmatory
information as regards:
(a) the toxicological relevance of the impurities in the technical specification;
(b) analytical methods for the monitoring of cyproconazole in soil, body fluids and
tissues;
(c) residues of triazole derivative metabolites (TDMs) in primary crops, rotational
crops and products of animal origin;
(d) the long term risk to herbivorous mammals;
(e) the possible environmental impact of the preferential degradation and/or
conversion of the mixture of isomers.
The Member States concerned shall ensure that the applicant submits to the
L
Commission the information set out in point (a) by 30 November 2011, the
153/175
information set out in points (b), (c) and (d) by 31 May 2013 and the information
set out in point (e) two years after the adoption of specific guidance.

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L 153/176
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
339 Dazomet
3,5-dimethyl-1,3,5-thiadia
≥ 950 g/kg 1
June
2011 31
May PART A
zinane-2-thione
2021
CAS No 533-74-4
Only uses as nematicide, fungicide, herbicide and insecticide may be authorised.
or
CIPAC No 146
Only application as soil fumigant may be authorised. Use shall be limited to one
tetrahydro-3,5-dimethyl-
application every third year.
EN
1,3,5-thiadiazine-2-thione

PART B
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on dazomet,
and in particular Appendices I and II thereof, as finalised in the Standing Committee
on the Food Chain and Animal Health on 11 March 2011 shall be taken into
account.
In this overall assessment Member States shall pay particular attention to:
— the risk to operators, workers and bystanders;
Off
icial
— the protection of groundwater, when the active substance is applied in regions
with vulnerable soil and/or climatic conditions;
Jour
— the risk to aquatic organisms.
nal
of
Conditions of use shall include risk mitigation measures, where appropriate.
the
The Member States concerned shall request the submission of confirmatory
European
information as regards:
(a) the potential groundwater contamination by methyl isothiocyanate;
Union
(b) the assessment of the long range atmospheric transport potential of methyl
isothiocyanate and related environmental risks;
(c) the acute risk to insectivorous birds;
(d) the long term risk to birds and mammals.
The Member States concerned shall ensure that the applicant submits to the
Commission the information set out in points (a), (b), (c) and (d) by 31 May 2013.
340 Metaldehyde
r-2, c-4, c-6, c-8-tetra ≥ 985 g/kg
1 June 2011 31
May PART A
methyl-1,3,5,7- tetro
2021
CAS No 108-62-3 xocane
acetaldehyde max.
Only uses as molluscicide may be authorised.
(tetramer)
1,5 g/kg
PART B
9002-91-9 (homo
polymer)
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on metal
11.6.2011
CIPAC No 62
dehyde, and in particular Appendices I and II thereof, as finalised in the Standing
Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken
into account.

---

11.6.2011 Off
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
In this overall assessment Member States shall pay particular attention to:
— the risk to operators and workers;
— the dietary exposure situation of consumers in view of future revisions of
EN
maximum residue levels;

— the acute risk and long term risk to birds and mammals.
Member States shall ensure that authorisations shall contain an effective dog
repellent agent.
Conditions of use shall include risk mitigation measures, where appropriate.
341 Sintofen
1-(4-chlorophenyl)-1,4-
≥ 980 g/kg
1 June 2011 31
May PART A
dihydro-5-(2-metho
2021
CAS No 130561-48-7
xyethoxy)-4-oxocinnoline-
Impurities:
Only uses as a plant growth regulator on wheat for hybrid seed production not
icial
3-carboxylic acid
intended for human consumption may be authorised.
CIPAC No 717
2-methoxyethanol,
Jour
not more than
PART B
nal
0,25 g/kg
For the implementation of the uniform principles as referred to in Article 29(6) of
of
N,N-dimethyl
Regulation (EC) No 1107/2009, the conclusions of the review report on sintofen,
the
formamide, not more
and in particular Appendices I and II thereof, as finalised in the Standing Committee
than 1,5 g/kg
on the Food Chain and Animal Health on 11 March 2011 shall be taken into
European
account.
In this overall assessment Member States shall pay particular attention to the risk to
operators and workers and shall ensure that conditions of use include the application
Union
of adequate risk mitigation measures. They shall ensure that wheat treated with
sintofen does not enter the food and feed chain.
The Member States concerned shall request the submission of confirmatory
information as regards:
(1) the specification of the technical material, as commercially manufactured,
supported by appropriate analytical data;
(2) the relevance of the impurities present in the technical specifications, except of
the impurities 2-methoxyethanol and N,N-dimethylformamide;
(3) the relevance of the test material used in the toxicity and ecotoxicity dossiers in
view of the specification of the technical material;
(4) the metabolic profile of sintofen in rotational crops.
L
The Member States concerned shall ensure that the applicant submits to the
153/177
Commission: the information set out in points (1) (2) and (3) by 30 November
2011 and the information set out in point (4) by 31 May 2013.

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L 153/178
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
342 Fenazaquin
4-tert-butylphenethyl
≥ 975 g/kg 1
June
2011 31
May PART A
quinazolin-4-yl ether
2021
CAS No 120928-09-8
Only uses as acaricide on ornamentals in greenhouses may be authorised.
CIPAC No 693
PART B
EN

For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on fenazaquin,
and in particular Appendices I and II thereof, as finalised in the Standing Committee
on the Food Chain and Animal Health on 11 March 2011 shall be taken into
account.
In this overall assessment Member States shall:
— pay particular attention to the protection of aquatic organisms;
— pay particular attention to the risk to operators and ensure that conditions of use
Off
include the application of adequate personal protective equipment;
icial
— pay particular attention to the protection of bees and ensure that conditions of
Jour
use include risk mitigation measures, where appropriate;
nal
— provide for conditions of use which ensure that there are no residues of fena
of
zaquin in crops for human and animal consumption.
the
European
343 Azadirachtin
Azadirachtin A:
Expressed as azadi 1 June 2011 31
May PART A
rachtin A:
2021
CAS No 11141-17-6 dimethyl
Only uses as insecticide may be authorised.
(azadirachtin A)
(2aR,3S,4S,4aR,5S,7aS,8S,
≥ 111 g/kg
Union
10R,10aS,10bR)-10-
PART B
CIPAC No 627 (azadi acetoxy-3,5-dihydroxy-4-
Sum of the aflatoxins
rachtin A)
[(1aR,2S,3aS,6aS,7S,7aS)-
B1, B2, G1, G2 must
For the implementation of the uniform principles as referred to in Article 29(6) of
6a-hydroxy-7a-methyl-
not exceeding
Regulation (EC) No 1107/2009, the conclusions of the review report on azadi
3a,6a,7,7a-tetrahydro-2,7-
300 μg/kg of the
rachtin, and in particular Appendices I and II thereof, as finalised in the Standing
methanofuro[2,3-
azadirachtin A
Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken
b]oxireno[e]oxepin-1a(2H)- content.
into account.
yl]-4-methyl-8-{[(2E)-2-
methylbut-2-
In this overall assessment Member States shall pay particular attention to:
enoyl]oxy}octahydro-1H-
naphtho[1,8a-c:4,5-
— the dietary exposure of consumers in view of future revisions of Maximum
b′c′]difuran-5,10a(8H)-
Residue Levels;
dicarboxylate.
— the protection of non target arthropods and aquatic organisms. Risk mitigation
measures shall be applied where appropriate.
The Member States concerned shall request the submission of confirmatory
information as regards:
11.6.2011
— the relationship between azadirachtin A and the rest of the active components in
the neem seeds extract with respect to amount, biological activity and
persistence, in order to confirm the lead active compound approach

---

11.6.2011 Off
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
with regard to azadirachtin A and to confirm specification of the technical
material, residue definition and groundwater risk assessment.
The Member States concerned shall ensure that the applicant submits such
EN
information to the Commission by 31 December 2013.

344 Diclofop
Diclofop
≥ 980 g/kg (expressed 1 June 2011 31
May PART A
as diclofop-methyl)
2021
CAS No 40843-25-2 (RS)-2-[4-(2,4-dichloro
Only uses as herbicide may be authorised.
(parent)
phenoxy)phenoxy]propion
PART B
ic acid
CAS No 257-141-8
For the implementation of the uniform principles as referred to in Article 29(6) of
(diclofop-methyl)
Diclofop-methyl
Regulation (EC) No 1107/2009, the conclusions of the review report on diclofop,
and in particular Appendices I and II thereof, as finalised in the Standing Committee
CIPAC No 358 (parent) methyl (RS)-2-[4-(2,4-dich
on the Food Chain and Animal Health on 11 March 2011 shall be taken into
lorophenoxy)phenoxy]
account.
CIPAC No 358.201
icial
propionate
(diclofop-methyl)
In this overall assessment Member States shall:
Jour
— pay particular attention to the operators and workers safety and include as a
nal
condition for authorisation the application of adequate personal protective
equipment;
of
the
— pay particular attention to the risk to aquatic organisms and non target plants
European
and require risk mitigation measures to be applied.
The Member States concerned shall request the submission of confirmatory
information as regards:
Union
(a) a metabolism study on cereals;
(b) an update of the risk assessment concerning the possible environmental impact
of the preferential degradation/conversion of the isomers.
The Member States concerned shall ensure that the applicant submits to the
Commission the information set out in point (a) by 31 May 2013 and the
information set out in point (b) at latest two years after the adoption of a
specific guidance document on evaluation of isomers mixtures.
345 Lime
sulphur
Calcium polysulfide
≥ 290 g/Kg. 1
June
2011 31
May PART A
2021
CAS No 1344 - 81 - 6
Only uses as fungicide may be authorised.
CIPAC No 17
PART B
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on lime
L
sulphur, and in particular Appendices I and II thereof, as finalised in the Standing
153/179
Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken
into account.

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L 153/180
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
In this overall assessment Member States shall pay particular attention to:
— operator safety and shall ensure that the conditions of authorisation include
appropriate protective measures;
EN
— to the protection of aquatic organisms and non target arthropods and shall

ensure that the conditions of use include risk mitigation measures as appropriate.
346 Aluminium
sulfate
Aluminium sulfate 970
g/kg 1
June
2011 31
May PART A
2021
CAS No 10043-01-3
Only indoor uses as post-harvest bactericide for ornamental plants may be au
thorised.
CIPAC not available
PART B
Off
For the implementation of the uniform principles as referred to in Article 29(6) of
icial
Regulation (EC) No 1107/2009, the conclusions of the review report on aluminium
sulfate, and in particular Appendices I and II thereof, as finalised in the Standing
Jour
Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken
nal
into account.
of
The Member States concerned shall request the submission of confirmatory
the
information as regards the specification of the technical material, as commercially
European
manufactured, in the form of appropriate analytical data.
The Member States concerned shall ensure that the applicant submits such
information to the Commission by 30 November 2011.
Union
347 Bromadiolone
3-[(1RS,3RS;1RS,3SR)-3-
≥ 970 g/kg 1
June
2011 31
May PART A
(4′-bromobiphenyl-4-yl)-3-
2021
CAS No 28772-56-7
hydroxy-1-phenylpropyl]-
Only uses as rodenticide in the form of pre-prepared baits placed into the rodent
4-hydroxycoumarin
tunnels may be authorised.
CIPAC No 371
The nominal concentration of the active substance in the plant protection products
shall not exceed 50 mg/kg.
Authorisations shall be granted for uses by professional users only.
PART B
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on broma
11.6.2011
diolone, and in particular Appendices I and II thereof, as finalised in the Standing
Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken
into account.

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11.6.2011 Off
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
In this overall assessment Member States shall:
— pay particular attention to the risk to professional operators and ensure that
conditions of use include the application of adequate personal protective
equipment where appropriate;
EN

— pay particular attention to the risk to birds and non-target mammals from
primary and secondary poisoning.
Conditions of authorisation shall include risk mitigation measures, where appro
priate.
The Member States concerned shall request the submission of confirmatory
information as regards:
(a) the specification of the technical material, as commercially manufactured, in the
form of appropriate analytical data;
icial
Jour
(b) the relevance of the impurities;
nal
(c) the determination of bromadiolone in water with a limit of quantification of
of
0,01 μg/l;
the
(d) the effectiveness of proposed mitigation measures to reduce risk to birds and
European
non-target mammals;
(e) the groundwater exposure assessment in respect of metabolites.
Union
The Member States concerned shall ensure that the applicant submits to the
Commission the information set out in points (a), (b) and (c) by 30 November
2011 and the information set out in points (d) and (e) by 31 May 2013.
348 Paclobutrazol
(2RS,3RS)-1-(4-chloro
≥ 930 g/kg 1
June
2011 31
May PART A
phenyl)-4,4-dimethyl-2-
2021
CAS No 76738-62-0
(1H-1,2,4-triazol-1-
Only uses as plant growth regulator may be authorised.
yl)pentan-3-ol
CIPAC No 445
PART B
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on paclo
butrazol, and in particular Appendices I and II thereof, as finalised in the
Standing Committee on the Food Chain and Animal Health on 11 March 2011
shall be taken into account.
L
In this overall assessment Member States shall pay particular attention to the risk to
153/181
aquatic plants and ensure that conditions of use include the risk mitigation measures,
where appropriate.

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L 153/182
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
The Member States concerned shall request the submission of confirmatory
information as regards:
(1) the specification of the technical material, as commercially manufactured;
EN
(2) the analytical methods in soil and surface water for the metabolite NOA457654;

(3) the residues of triazole derivative metabolites (TDMs) in primary crops,
rotational crops and products of animal origin;
(4) the potential endocrine disrupting properties of paclobutrazol;
(5) the potential adverse effects of breakdown products of the different optical
structures of paclobutrazol and its metabolite CGA 149907 on the environ
mental compartments soil, water and air.
Off
The Member States concerned shall ensure that the applicant submits to the
icial
Commission the information set out in points (1) and (2) by 30 November 2011,
the information set out in points (3) by 31 May 2013, the information set out in
Jour
point (4) within two years after the adoption of the OECD test guidelines on
endocrine disruption and the information set out in point (5) within two years
nal
after the adoption of specific guidance.
of
the
349 Pencycuron
1-(4-chlorobenzyl)-1-cyclo ≥ 980 g/kg 1
June
2011 31
May PART A
European
pentyl-3-phenylurea
2021
CAS No 66063-05-6
Only uses as fungicide may be authorised.
CIPAC No 402
PART B
Union
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on pencycuron,
and in particular Appendices I and II thereof, as finalised in the Standing Committee
on the Food Chain and Animal Health on 11 March 2011 shall be taken into
account.
In this overall assessment Member States shall pay particular attention to the
protection of large omnivorous mammals.
Conditions of use shall include risk mitigation measures, where appropriate.
The Member States concerned shall request the submission of confirmatory
information as regards:
(1) the fate and behaviour in soil of the chlorophenyl and cyclopentyl portions of
pencycuron;
(2) the fate and behaviour in natural surface water and sediment systems of the
11.6.2011
chlorophenyl and phenyl portions of pencycuron;
(3) the long-term risk to large omnivorous mammals.

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11.6.2011 Off
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
The Member States concerned shall ensure that the applicant submits to the
Commission the information set out in points (1), (2) and (3) by 31 May 2013.
350 Tebufenozide
N-tert-butyl-N′-(4-
≥ 970 g/kg
1 June 2011 31
May PART A
EN
ethylbenzoyl)-3,5-dimethyl
2021

CAS No 112410-23-8
benzohydrazide
Relevant impurity
Only uses as insecticide may be authorised.
CIPAC No 724
t-butyl hydrazine
PART B
< 0,001 g/kg
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on tebufe
nozide, and in particular Appendices I and II thereof, as finalised in the Standing
Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken
into account.
In this overall assessment Member States shall:
icial
— pay particular attention to the safety of operators and workers after re-entry and
ensure that conditions of authorisation prescribe appropriate protective
Jour
equipment;
nal
— pay particular attention to the protection of groundwater, when the active
of
substance is applied in regions with vulnerable soil and/or climatic conditions;
the
European
— pay particular attention to the protection of aquatic organism and ensure that
conditions of use prescribe adequate mitigation measures;
— pay particular attention to the risk to Lepidoptera non-target insects.
Union
Conditions of authorisation shall include risk mitigation measures, where appro
priate.
The Member States concerned shall request the submission of confirmatory
information, as regards:
(1) the relevance of metabolites RH-6595, RH-2651, M2;
(2) the degradation of tebufenozide in anaerobic soils and soils of alkaline pH.
The Member States concerned shall ensure that the applicant submits to the
Commission the information set out in points (1) and (2) by 31 May 2013.
351 Dithianon
5,10-dihydro-5,10-dioxon
≥ 930 g/kg 1
June
2011 31
May PART A
aphtho[2,3-b]-1,4-dithiine-
2021
L
CAS No 3347-22-6
2,3-dicarbonitrile
Only uses as fungicide may be authorised.
153/183
CIPAC No 153

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L 153/184
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
PART B
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on dithianon,
EN
and in particular Appendices I and II thereof, as finalised in the Standing Committee

on the Food Chain and Animal Health on 11 March 2011 shall be taken into
account.
In this overall assessment Member States shall:
— pay particular attention to the protection of aquatic organisms; conditions of use
shall include risk mitigation measures, where appropriate,
— pay particular attention to the operator safety; conditions of use shall include the
application of adequate personal protective equipment, where appropriate,
Off
— pay particular attention to the long-term risks to birds; conditions of use shall
icial
include risk mitigation measures, where appropriate.
Jour
The Member States concerned shall request the submission of confirmatory
information as regards:
nal
of
— the storage stability and the nature of residues in processed products,
the
— the aquatic and groundwater exposure assessment for phthalic acid,
European
— the risk assessment for aquatic organisms with respect to phthalic acid, phthal
aldehyde and 1,2 benzenedimethanol.
Union
The Member States concerned shall ensure that the applicant submits such
information to the Commission by 31 May 2013.
352 Hexythiazox
(4RS,5RS)-5-(4-chloro
≥ 976 g/kg
1 June 2011 31
May PART A
phenyl)-N-cyclohexyl-4-
2021
CAS No 78587-05-0
methyl-2-oxo-1,3-thia
(1:1 mixture of (4R,
Only uses as acaricide may be authorised.
zolidine-3-carboxamide
5R) and (4S, 5S))
CIPAC No 439
PART B
For the implementation of the uniform principles as referred to in Article 29(6) of
Regulation (EC) No 1107/2009, the conclusions of the review report on hexy
thiazox, and in particular Appendices I and II thereof, as finalised in the Standing
Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken
into account.
In this overall assessment Member States shall pay particular attention to:
11.6.2011
— the protection of aquatic organisms. Conditions of use shall include risk miti
gation measures, where appropriate;

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11.6.2011 Off
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
— the operators and workers safety. Conditions of use shall include protective
measures, where appropriate.
The Member States concerned shall request the submission of confirmatory
information as regards:
EN

(a) the toxicological relevance of the metabolite PT-1-3 (14 );
(b) the potential occurrence of the metabolite PT-1-3 in processed commodities;
(c) the potential adverse effects of hexythiazox on bee brood;
(d) the possible impact of the preferential degradation and/or conversion of the
mixture of isomers on the worker risk assessment, the consumer risk assessment
and the environment.
The Member States concerned shall ensure that the applicant submits to the
icial
Commission the information set out in points (a), (b) and (c) by 31 May 2013
Jour
and the information set out in point (d) two years after the adoption of specific
guidance.
nal
of
353 Flutriafol
(RS)-2,4′-difluoro-α-(1H-
≥ 920 g/kg
1 June 2011 31
May PART A
the
1,2,4-triazol-1-
2021
European
CAS No 76674-21-0
ylmethyl)benzhydryl
(racemate)
Only uses as fungicide may be authorised.
alcohol
CIPAC No 436
Relevant impurities:
PART B
Union
dimethyl sulphate:
For the implementation of the uniform principles as referred to in Article 29(6) of
max content 0,1 g/kg
Regulation (EC) No 1107/2009, the conclusions of the review report on flutriafol,
and in particular Appendices I and II thereof, as finalised in the Standing Committee
dimethylformamide:
on the Food Chain and Animal Health on 11 March 2011 shall be taken into
max content 1 g/kg
account.
methanol: max
In this overall assessment Member States shall:
content 1 g/kg
— pay particular attention to the protection of the workers’ safety and ensure that
conditions of use include the application of adequate personal protective
equipment;
— pay particular attention to the protection of the groundwater, when the active
substance is applied in regions with vulnerable soil and/or climatic conditions;
— pay particular attention to the long-term risk to insectivorous birds.
L
153/185
Conditions of authorisation shall include risk mitigation measures, where appro
priate.

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L 153/186
Number
Common name,
Expiration of
identification numbers
IUPAC name Purity
(1 )
Date of
approval
approval
Specific provisions
The Member States concerned shall ensure that the applicant submits to the
Commission confirmatory information as regards:
(a) the relevance of the impurities present in the technical specifications;
EN
(b) the residues of triazole derivative metabolites (TDMs) in primary crops, rotational

crops and products of animal origin;
(c) the long-term risk to insectivorous birds.
The Member States concerned shall ensure that the applicant submits to the
Commission the information set out in point (a) by 30 November 2011, the
information set out in points (b) and (c) by 31 May 2013.
(1 ) Further details on identity and specification of active substances are provided in their review reports.
Off
(2 ) Suspended by order of the General Court of 19 July 2007 in case T-31/07 R, Du Pont de Nemours (France) SAS and others v Commission, [2007] ECR II-2767.
(3 ) OJ L 353, 31.12.2008, p. 1.
icial
(4 ) 2-ethyl-7-nitro-1-propyl-1H-benzimidazole-5-sulfonamide.
(5 ) 2-ethyl-7-nitro-1H-benzimidazole-5-sulfonamide.
Jour
(6 ) De-ethyl-bupirimate.
nal
(7 ) 2-{[anilino(oxo)acetyl]sulfanyl}ethyl acetate.
(8 ) (2RS)-2-hydroxy-2-methyl-N-phenyl-1,4-oxathiane-3-carboxamide 4-oxide.
of
(9 ) 2-methyl-5,6-dihydro-1,4-oxathiine-3-carboxamide 4-oxide.
the
(10 ) 2-methyl-5,6-dihydro-1,4-oxathiine-3-carboxamide 4,4-dioxide.
(11 ) 2-methyl-5,6-dihydro-1,4-oxathiine-3-carboxamide 4-oxide.
European
(12 ) 2-methyl-5,6-dihydro-1,4-oxathiine-3-carboxamide 4,4-dioxide.
(13 ) (2RS)-2-hydroxy-2-methyl-N-phenyl-1,4-oxathiane-3-carboxamide 4-oxide.
(14 ) (4S,5S)-5-(4-chlorophenyl)-4-methyl-1,3-thiazolidin-2-one and (4R,5R)-5-(4-chlorophenyl)-4-methyl-1,3-thiazolidin-2-one.
Union
11.6.2011

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