HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 186/20
EN
Official Journal of the European Union
14.7.2012
COMMISSION IMPLEMENTING REGULATION (EU) No 637/2012
of 13 July 2012
amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the
active substances iron sulphate, repellents by smell of animal or plant origin/tall oil crude and
repellents by smell of animal or plant origin/tall oil pitch
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
origin/tall oil pitch ( 8 ) on 16 December 2011. The draft
review reports and the views of the Authority were
reviewed by the Member States and the Commission
Having regard to the Treaty on the Functioning of the European
within the Standing Committee on the Food Chain and
Union,
Animal Health and finalised on 1 June 2012 in the
format of the Commission review reports for iron
sulphate, repellents by smell of animal or plant origin/tall
oil crude and repellents by smell of animal or plant
Having regard to Regulation (EC) No 1107/2009 of the
origin/tall oil pitch.
European Parliament and of the Council of 21 October 2009
concerning the placing of plant protection products on the
market and repealing Council Directives 79/117/EEC and
91/414/EEC (
(3) The
Authority
communicated
its
views
on
iron
sulphate,

1 ), and in particular Article 13(2)(c) thereof,
repellents by smell of animal or plant origin/tall oil crude
and repellents by smell of animal or plant origin/tall oil
pitch to the notifiers, and the Commission invited them
Whereas:
to submit comments on the review reports.
(1) The
active
substances
iron
sulphate,
repellents
by
smell (4) It
is
confirmed
that
the
active
substances
iron
sulphate,
of animal or plant origin/tall oil crude and repellents by
repellents by smell of animal or plant origin/tall oil crude
smell of animal or plant origin/tall oil pitch were
and repellents by smell of animal or plant origin/tall oil
included in Annex I to Council Directive 91/414/EEC ( 2 )
pitch are to be deemed to have been approved under
by Commission Directive 2008/127/EC ( 3 ) in accordance
Regulation (EC) No 1107/2009.
with the procedure provided for in Article 24b of
Commission Regulation (EC) No 2229/2004 of
3 December 2004 laying down further detailed rules
for the implementation of the fourth stage of the
(5) In
accordance
with
Article
13(2)
of
Regulation
(EC)
No
programme of work referred to in Article 8(2) of
1107/2009 in conjunction with Article 6 thereof and in
Council Directive 91/414/EEC (
the light of current scientific and technical knowledge, it

4 ). Since the replacement
of Directive 91/414/EEC by Regulation (EC) No
is necessary to amend the conditions of approval of iron
1107/2009, these substances are deemed to have been
sulphate, repellents by smell of animal or plant origin/tall
approved under that Regulation and are listed in Part A
oil crude and repellents by smell of animal or plant
of the Annex to Commission Implementing Regulation
origin/tall oil pitch. It is, in particular, appropriate to
(EU) No 540/2011 of 25 May 2011 implementing Regu
require further confirmatory information as regards
lation (EC) No 1107/2009 of the European Parliament
those active substances.
and of the Council as regards the list of approved active
substances ( 5 ).
(6) The
Annex
to
Regulation
(EU)
No
540/2011
should
therefore be amended accordingly.
(2) In
accordance
with
Article
25a
of
Regulation
(EC)
No
2229/2004, the European Food Safety Authority, here
inafter ‘the Authority’, presented to the Commission its
(7) A
reasonable
period
of
time
should
be
allowed
before
the
views on the draft review reports for iron sulphate ( 6 ),
application of this Regulation in order to allow Member
repellents by smell of animal or plant origin/tall oil
States, notifiers and holders of authorisations for plant
crude ( 7 ) and repellents by smell of animal or 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 344, 20.12.2008, p. 89.
( 4 ) OJ L 379, 24.12.2004, p.13.
(8) The
measures
provided
for
in
this
Regulation
are
in
( 5 ) OJ L 153, 11.6.2011, p. 1.
accordance with the opinion of the Standing
( 6 ) Conclusion on the peer review of the pesticide risk assessment of the
Committee on the Food Chain and Animal Health,
active substance iron sulfate. EFSA Journal 2012;10(1):2521.
Available online: www.efsa.europa.eu/efsajournal.htm
( 7 ) Conclusion on the peer review of the pesticide risk assessment of the
( 8 ) Conclusion on the peer review of the pesticide risk assessment of the
active substance tall oil crude. EFSA Journal 2012;10(2):2543.
active substance tall oil pitch. EFSA Journal 2012;10(2):2544.
Available online: www.efsa.europa.eu/efsajournal.htm
Available online: www.efsa.europa.eu/efsajournal.htm

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EN
14.7.2012 Official
Journal
of
the
European
Union L
186/21
HAS ADOPTED THIS REGULATION:
smell of animal or plant origin/tall oil crude as active substances
in order to comply with the Annex to this Regulation by 1 May
Article 1
2013.
Part A of the Annex to Implementing Regulation (EU) No
540/2011 is amended in accordance with the Annex to this
Article 3
Regulation.
This Regulation shall enter into force on the twentieth day
Article 2
following that of its publication in the Official Journal of the
European Union.
Member States shall in accordance with Regulation (EC) No
1107/2009, where necessary, amend or withdraw existing auth
orisations for plant protection products containing repellents by
It shall apply from 1 November 2012.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 13 July 2012.
For the Commission
The President
José Manuel BARROSO

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L 186/22
ANNEX
Part A of the Annex to Implementing Regulation (EU) No 540/2011 is amended as follows:
(1) Row 235 on the active substance iron sulphate is replaced by the following:
EN
Number Common Name, Identification
Numbers
IUPAC Name Purity
(*) Date
of
approval Expiration
of
approval Specific
provisions

'235 Iron
sulphate:
Iron(II)sulphate
Iron(II)sulfate anhydrous: 1 September 2009 31
August
2019 PART
A
or
≥ 350 g/kg total iron.
Iron(II)sulfate anhydrous:
iron(2+) sulfate
Only uses as herbicide may be authorised.
CAS No 7720-78-7
Relevant impurities:
PART B
Iron(II)sulfate
arsenic, 18 mg/kg
monohydrate:
For the implementation of the uniform principles, as referred to in
CAS No 17375-41-6
Off
cadmium, 1,8 mg/kg
Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of
the amended review report on iron sulphate (SANCO/2616/2008) and
icial
Iron(II)sulfate heptahydrate:
chromium, 90 mg/kg
in particular Appendices I and II thereof, as finalised in the Standing
CAS No 7782-63-0
Committee on the Food Chain and Animal Health on 1 June 2012
Jour
shall be taken into account.
lead, 36 mg/kg
nal
CIPAC No 837
of
In this overall assessment Member States shall pay particular attention
mercury, 1,8 mg/kg
the
to:
European
expressed on the basis of
— the risk for operator;
the anhydrous variant
— the risk to children/residents playing on treated turf;
Union
— the risk to surface waters and to aquatic organisms.
Conditions of use shall include, where appropriate, risk mitigation
measures and the application of adequate personal protective
equipment. The notifier shall submit to the Member States, the
Commission and the Authority, confirmatory information as regards
the equivalence between the specifications of the technical material, as
commercially manufactured, and those of the test material used in the
toxicity dossiers.
The Member States concerned shall ensure that the notifier submits to
the Commission such information by 1 May 2013.'
(*) Further details on identity and specification of active substance are provided in their review report.
14.7.2012

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14.7.2012 Off
(2) Row 250 on the active substance Repellents by smell of animal or plant origin/tall oil crude is replaced by the following:
Number Common Name, Identification
Numbers
IUPAC Name Purity
(*) Date
of
approval Expiration
of
approval Specific
provisions
'250 Repellents
by
smell
of
animal
Not available The
qualitative
parameters
1 September 2009 31
August
2019 PART
A
or plant origin/tall oil crude:
below comprise the specifi
EN
cation of repellents by smell
Only uses as repellent applied by glove or brush may be authorised.

CAS No 8002-26-4
of animal or plant
origin/tall oil crude:
PART B
CIPAC No 911
acid number: min.
For the implementation of the uniform principles, as referred to in
125 mgKOH/g
Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of
the amended review report on repellents by smell of animal or plant
water content: max. 2 %
origin/tall oil crude (SANCO/2631/2008) and in particular Appendices
I and II thereof, as finalised in the Standing Committee on the Food
rosin acid content: min.
Chain and Animal Health on 1 June 2012 shall be taken into account.
35 % (proposed)
In assessing applications to authorise plant protection products
icial
ash content: max. 0,2 %
containing Repellents by smell of animal or plant origin/tall oil crude
for uses other than as a repellent in forestry, Member States shall pay
Jour
pH: approx. min. 5,5
particular attention to the criteria in Article 4(3) of Regulation (EC)
nal
No 1107/2009, and shall ensure that any necessary information is
of
unsaponifiables: max. 12 %
provided before such an authorisation is granted.
the
free mineral acids: max.
In this overall assessment Member States shall pay particular attention
European
0,02 %
to:
— the protection of operator, worker and bystander;
Union
— the risk to non target species.
Conditions of use shall include, where appropriate, risk mitigation
measures.
The Member States concerned shall request the submission of
confirmatory information as regards:
(a) the equivalence between the specifications of the technical material,
as commercially manufactured, and those of the test material used
in the toxicity dossiers;
(b) the toxicological profile of repellents by smell of animal or plant
origin/tall oil crude.
The Member States concerned shall ensure that the notifier submits to
the Commission the information set out in point (a) by 1 May 2013
L
and the information set out in point (b) by 31 May 2014.'
186/23
(*) Further details on identity and specification of active substance are provided in their review report.

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L 186/24
(3) Row 251 on the active substance Repellents by smell of animal or plant origin/tall oil pitch is replaced by the following:
Number Common Name, Identification
Numbers
IUPAC Name Purity
(*) Date
of
approval Expiration
of
approval Specific
provisions
'251 Repellents
by
smell
of
animal
Not available Complex
mixture
of
esters
1 September 2009 31
August
2019 PART
A
or plant origin/tall oil pitch:
of fatty acids, rosin and
small amounts of dimers
Only uses as repellent may be authorised.
EN
CAS No 8016-81-7
and trimers of resin acids

and fatty acids.
PART B
CIPAC No 912
For the implementation of the uniform principles, as referred to in
Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of
the amended review report on repellents by smell of animal or plant
origin/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 on 1 June 2012 shall be taken into account.
Off
In assessing applications to authorise plant protection products
containing repellents by smell of animal or plant origin/tall oil pitch
icial
for uses other than as a repellent in forestry applied by glove or brush,
Member States shall pay particular attention to the criteria in
Jour
Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that
nal
any necessary information is provided before such an authorization is
granted.
of
the
In this overall assessment Member States shall pay particular attention
European
to:
— the protection of operator, worker and bystander;
Union
— the risk to non target species.
Conditions of use shall include risk mitigation measures, where appro
priate.
The Member States concerned shall request the submission of
confirmatory information as regards:
(a) the equivalence between the specifications of the technical material,
as commercially manufactured, and those of the test material used
in the toxicity dossiers;
(b) the toxicological profile of repellents by smell of animal or plant
origin/tall oil pitch.
The Member States concerned shall ensure that the notifier submits to
the Commission the information set out in point (a) by 1 May 2013
and the information set out in point (b) by 31 May 2014.'
14.7.2012

(*) Further details on identity and specification of active substance are provided in their review report.

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