HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 285/10
EN
Official Journal of the European Union
1.11.2011
COMMISSION IMPLEMENTING REGULATION (EU) No 1100/2011
of 31 October 2011
amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the
active substances dicamba, difenoconazole, and imazaquin
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
and imazaquin
( 8 ) on 17 December 2010. These
conclusions were reviewed by the Member States and
the Commission within the Standing Committee on the
Food Chain and Animal Health and were finalised on
Having regard to the Treaty on the Functioning of the European
27 September 2011 in the format of the Commission
Union,
review reports for difenoconazole, dicamba, and
imazaquin.
Having regard to Regulation (EC) No 1107/2009 of the
European Parliament and of the Council of 21 October 2009
concerning the placing of plant protection products on the
(3) In
accordance
with
Article
12(2)
of
Regulation
(EC)
No
1107/2009 the Commission invited the notifiers to
market and repealing Council Directives 79/117/EEC and
submit their comments on the conclusions of the
91/414/EEC ( 1 ), and in particular Article 13(2) thereof,
Authority. Furthermore, in accordance with
Article 13(1) of that Regulation, the Commission
invited the notifiers to submit comments on the draft
Whereas:
review reports for dicamba, difenoconazole and
imazaquin. The notifiers submitted their comments,
which have been carefully examined.
(1) The
active
substances
dicamba,
difenoconazole
and
imazaquin were included in Annex I to Council
Directive 91/414/EEC
( 2 ) by Commission Directive
(4) It
is
confirmed
that
the
active
substances
dicamba,
dife
2008/69/EC ( 3 ) in accordance with the procedure
noconazole and imazaquin are to be deemed to have
provided for in Article 11b of Commission Regulation
been approved under Regulation (EC) No 1107/2009.
(EC) No 1490/2002 of 14 August 2002 laying down
further detailed rules for the implementation of the
third stage of the programme of work referred to in
Article 8(2) of Council Directive 91/414/EEC and
(5) In
accordance
with
Article
13(2)
of
Regulation
(EC)
No
amending Regulation (EC) No 451/2000 ( 4 ). Since the
1107/2009 in conjunction with Article 6 thereof and in
replacement of Directive 91/414/EEC by Regulation
the light of current scientific and technical knowledge, it
(EC) No 1107/2009, these substances are deemed to
is necessary to amend the conditions of approval of
have been approved under that Regulation and are
dicamba, difenoconazole and imazaquin. It is, in
listed in Part A of the Annex to Commission Imple
particular, appropriate to require further confirmatory
menting Regulation (EU) No 540/2011 of 25 May
information.
2011 implementing Regulation (EC) No 1107/2009 of
the European Parliament and of the Council as regards
the list of approved active substances ( 5 ).
(6) The
Annex
to
Implementing
Regulation
(EU)
No
540/2011 should therefore be amended accordingly.
(2) In
accordance
with
Article
12a
of
Regulation
(EC)
No 1490/2002, the European Food Safety
Authority, hereinafter ‘the Authority’, presented
(7) A
reasonable
period
of
time
should
be
allowed
before
the
to the Commission the conclusions on the peer
application of this Regulation in order to allow Member
review for difenoconazole
( 6 ), dicamba
( 7 )
States, notifiers and holders of authorisations for plant
protection products to meet the requirements resulting
from amendment to the conditions of the approval.
( 1 ) OJ L 309, 24.11.2009, p. 1.
( 2 ) OJ L 230, 19.8.1991, p. 1.
( 3 ) OJ L 172, 2.7.2008, p. 9.
( 4 ) OJ L 224, 21.8.2002, p. 23.
( 5 ) OJ L 153, 11.6.2011, p. 1.
(8) The
measures
provided
for
in
this
Regulation
are
in
( 6 ) European Food Safety Authority; Conclusion on the peer review of
accordance with the opinion of the Standing
the pesticide risk assessment of the active substance difenoconazole.
Committee on the Food Chain and Animal Health,
EFSA Journal 2011; 9(1):1967. [71 pp.]. doi:10.2903/j.efsa.
2011.1967. Available online: www.efsa.europa.eu/efsajournal.htm
( 7 ) European Food Safety Authority; Conclusion on the peer review of
( 8 ) European Food Safety Authority; Conclusion on the peer review of
the pesticide risk assessment of the active substance dicamba. EFSA
the pesticide risk assessment of the active substance imazaquin.
Journal 2011; 9(1):1965. [52 pp.] doi:10.2903/j.efsa.2011.1965.
EFSA Journal 2011; 9(1):1968. [57 pp.]. doi:10.2903/j.efsa.
Available online: www.efsa.europa.eu/efsajournal.htm
2011.1968. Available online: www.efsa.europa.eu/efsajournal.htm

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EN
1.11.2011 Official
Journal
of
the
European
Union L
285/11
HAS ADOPTED THIS REGULATION:
Article 1
Part A of the Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with the
Annex to this Regulation.
Article 2
This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the
European Union.
It shall apply from 1 May 2012.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 31 October 2011.
For the Commission
The President
José Manuel BARROSO

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L 285/12
ANNEX
Part A of the Annex to Implementing Regulation (EU) No 540/2011 is amended as follows:
(1) Number 172 on the active substance dicamba is replaced by the following:
Number Common Name, Identifi
EN
cation Numbers
IUPAC Name Purity Date
of
approval Expiration
of
approval Specific
provisions

‘172 Dicamba
3,6-dichloro-2-
≥ 850 g/kg 1
January
2009 31
December
2018 PART
A
methoxybenzoic acid
CAS No 1918-00-9
Only uses as herbicide may be authorised.
CIPAC No 85
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 dicamba, and in particular Appendices I and II thereof, as
finalised in the Standing Committee on the Food Chain and Animal Health
Off
on 27 September 2011 shall be taken into account.
icial
In this overall assessment Member States shall pay particular attention to
Jour
the protection of non-target plants.
nal
Conditions of use shall include adequate risk mitigation measures, where
of
appropriate.
the
European
The notifier shall submit confirmatory information as regards:
(a) the identification and quantification of a group of soil transformation
products formed in a soil incubation study;
Union
(b) the potential for long range transport through the atmosphere.
The notifier shall submit this information to the Member States, the
Commission and the Authority by 30 November 2013.’
(2) Number 173 on the active substance difenoconazole is replaced by the following:
Number Common Name, Identifi
cation Numbers
IUPAC Name Purity Date
of
approval Expiration
of
approval Specific
provisions
‘173 Difenoconazole
3-chloro-4-
≥ 940g/kg
1 January 2009 31
December
2018 PART
A
[(2RS,4RS;2RS,4SR)-4-
CAS No 119446-68-3 methyl-2-(1H-1,2,4-
Toluene maximum
Only uses as fungicide may be authorised.
triazol-1-ylmethyl)-
content: 5 g/kg
CIPAC No 687
1,3-dioxolan-2-
PART B
1.11.2011
yl]phenyl 4-chloro
phenyl ether
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 difenoconazole, and in particular Appendices I

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1.11.2011 Off
Number Common Name, Identifi
cation Numbers
IUPAC Name Purity Date
of
approval Expiration
of
approval Specific
provisions
and II thereof, as finalised in the Standing Committee on the Food Chain
and Animal Health on 27 September 2011 shall be taken into account.
In this overall assessment Member States shall pay particular attention to
the protection of aquatic organisms.
EN

Conditions of use shall include adequate risk mitigation measures, where
appropriate.
The notifier shall submit confirmatory information as regards:
(a) further data on the specification of the technical material;
(b) residues of triazole derivative metabolites (TDMs) in primary crops,
rotational crops, processed commodities and products of animal origin;
icial
(c) the potential for endocrine disrupting effects on fish (fish full life cycle
Jour
study) and the chronic risk to earthworms from the active substance
and the metabolite CGA 205375 (*);
nal
of
(d) the possible impact of the variable isomer-ratio in the technical
the
material and of the preferential degradation and/or conversion of the
European
mixture of isomers on the worker risk assessment, the consumer risk
assessment and on the environment.
The notifier shall submit to the Member States, the Commission and the
Union
Authority the information set out in point (a) by 31 May 2012, the
information set out in points (b) and (c) by 30 November 2013 and
the information set out in point (d) within 2 years from the adoption
of specific guidance.’
(*) 1-[2-[2-chloro-4-(4-chloro-phenoxy)-phenyl]-2-1H-[1,2,4]triazol-yl]-ethanol.
(3) Number 175 on the active substance imazaquin is replaced by the following:
Number Common Name, Identifi
cation Numbers
IUPAC Name Purity Date
of
approval Expiration
of
approval Specific
provisions
‘175 Imazaquin
2-[(RS)-4-isopropyl-4- ≥ 960
g/kg (racemic 1 January 2009 31
December
2018 PART
A
methyl-5-oxo-2-imid
mixture)
CAS No 81335-37-7 azolin-2-yl]quinoline-
Only uses as plant growth regulator may be authorised.
3-carboxylic acid
CIPAC No 699
PART B
L
285/13
For the implementation of the uniform principles as referred to in
Article 29(6) of Regulation (EC) No 1107/2009, the conclusions

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L 285/14
Number Common Name, Identifi
cation Numbers
IUPAC Name Purity Date
of
approval Expiration
of
approval Specific
provisions
of the review report on imazaquin, and in particular Appendices I and II
thereof, as finalised in the Standing Committee on the Food Chain and
Animal Health on 27 September 2011 shall be taken into account
The notifier shall submit confirmatory information as regards:
EN

(a) further data on the specification of the technical material;
(b) the possible impact of the variable isomer-ratio in the technical
material and of the preferential degradation and/or conversion of the
mixture of isomers on the worker risk assessment, the consumer risk
assessment and on the environment.
The notifier shall submit to the Member States, the Commission and the
Authority the information set out in point (a) by 31 May 2012 and the
information set out in point (b) within 2 years from the adoption of
Off
specific guidance.’
icial
Jour
nal
of
the
European
Union
1.11.2011

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