HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 176/54
EN
Official Journal of the European Union
6.7.2012
COMMISSION IMPLEMENTING REGULATION (EU) No 597/2012
of 5 July 2012
amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the
active substances aluminium ammonium sulphate, fat distillation residues, repellents by smell of
animal or plant origin/fish oil and urea
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
plant origin/fish oil ( 8 ) and urea ( 9 ) on 16 December
2011. The draft review reports and the views of the
Authority were reviewed by the Member States and the
Having regard to the Treaty on the Functioning of the European
Commission within the Standing Committee on the Food
Union,
Chain and Animal Health and finalised on 1 June 2012
in the format of the Commission review reports for
aluminium ammonium sulphate, fat distillation residues,
repellents by smell of animal or plant origin/fish oil and
Having regard to Regulation (EC) No 1107/2009 of the
urea.
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
(3) The
Authority
communicated
its
views
on
aluminium
91/414/EEC ( 1 ), and in particular Article 13(2)(c) thereof,
ammonium sulphate, fat distillation residues, repellents
by smell of animal or plant origin/fish oil and urea to
the notifiers, and the Commission invited them to submit
Whereas:
comments on the review reports.
(4)
It is confirmed that the active substances aluminium
(1) The
active
substances
aluminium
ammonium
sulphate,
ammonium sulphate, fat distillation residues, repellents
fat distillation residues, repellents by smell of animal or
by smell of animal or plant origin/fish oil and urea are
plant origin/fish oil and urea were included in Annex I to
to be deemed to have been approved under Regulation
Council Directive 91/414/EEC
( 2 ) by Commission
(EC) No 1107/2009.
Directive 2008/127/EC
( 3 ) in accordance with the
procedure provided for in Article 24b of Commission
Regulation (EC) No 2229/2004 of 3 December 2004
(5) In
accordance
with
Article
13(2)
of
Regulation
(EC)
No
laying down further detailed rules for the implementation
1107/2009 in conjunction with Article 6 thereof and in
of the fourth stage of the programme of work referred to
the light of current scientific and technical knowledge, it
in Article 8(2) of Council Directive 91/414/EEC ( 4 ). Since
is necessary to amend the conditions of approval of
the replacement of Directive 91/414/EEC by Regulation
aluminium ammonium sulphate, fat distillation residues,
(EC) No 1107/2009, these substances are deemed to
repellents by smell of animal or plant origin/fish oil and
have been approved under that Regulation and are
urea. It is, in particular, appropriate to require further
listed in Part A of the Annex to Commission Imple
confirmatory information as regards those active
menting Regulation (EU) No 540/2011 of 25 May
substances. At the same time certain technical adap
2011 implementing Regulation (EC) No 1107/2009 of
tations should be made, in particular the name of the
the European Parliament and of the Council as regards
active substances ‘Repellents by smell of animal or plant
the list of approved active substances ( 5 ).
origin/fish oil’ and ‘fat distillation residues’ should be
replaced respectively by ‘fish oil’ and fat distillation
residues. The Annex to Implementing Regulation (EU)
(2) In
accordance
with
Article
25a
of
Regulation
(EC)
No
No 540/2011 should therefore be amended accordingly.
2229/2004, the European Food Safety Authority (here
inafter ‘the Authority’) presented to the Commission its
(6) A
reasonable
period
of
time
should
be
allowed
before
the
views on the draft review reports for aluminium
application of this Regulation in order to allow Member
ammonium sulphate ( 6 ) on 6 December 2011, for fat
States, notifiers and holders of authorisations for plant
distillation residues ( 7 ), repellents by smell of animal or
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.
(7) The
measures
provided
for
in
this
Regulation
are
in
( 4 ) OJ L 379, 24.12.2004, p. 13.
accordance with the opinion of the Standing
( 5 ) OJ L 153, 11.6.2011, p. 1.
Committee on the Food Chain and Animal Health,
( 6 ) Conclusion on the peer review of the pesticide risk assessment of the
active substance aluminium ammonium sulphate, EFSA Journal
2012;10(3):2491. Available online: www.efsa.europa.eu/efsajournal.
( 8 ) Conclusion on the peer review of the pesticide risk assessment of the
htm
active substance fish oil, EFSA Journal 2012;10(2):2546. Available
( 7 ) Conclusion on the peer review of the pesticide risk assessment of
online: www.efsa.europa.eu/efsajournal.htm
the active substance fat distillation residues, EFSA Journal
( 9 ) Conclusion on the peer review of the pesticide risk assessment of the
2012;10(2):2519. Available online: www.efsa.europa.eu/efsajournal.
active substance urea, EFSA Journal 2012;10(1):2523. Available
htm
online: www.efsa.europa.eu/efsajournal.htm

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EN
6.7.2012 Official
Journal
of
the
European
Union L
176/55
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 twentieth day following that of its publication in the Official
Journal of the European Union.
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, 5 July 2012.
For the Commission
The President
José Manuel BARROSO

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L 176/56
ANNEX
Part A of the Annex to Implementing Regulation (EU) No 540/2011 is amended as follows:
(1) Row 219 on the active substance aluminium ammonium sulphate is replaced by the following:
EN

Number
Common name,
identification numbers
IUPAC name Purity
(*) Date
of
approval Expiration
of
approval Specific
provisions
‘219 Aluminium
ammonium
Aluminium
≥ 960 g/kg (expressed as 1 September 2009 31
August
2019 PART
A
sulphate
ammonium
dodecahydrate)
sulphate
Only uses as repellent may be authorised.
CAS No 7784-26-1
≥ 502 g/kg (anhydrous)
(dodecahydrate),
PART B
7784-25-0 (anhydrous)
For the implementation of the uniform principles as referred to in
CIPAC No 840
Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the
Off
review report on aluminium ammonium sulphate (SANCO/2985/2008)
icial
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
Jour
taken into account.
nal
Conditions of use shall include, where appropriate, risk mitigation measures.
of
the
The notifier shall submit confirmatory information as regards:
European
(a) the impact on the environment of the transformation/dissociation
products of aluminium ammonium sulphate;
(b) the risk to non-target terrestrial organisms other than vertebrates and
Union
aquatic organisms.
This information shall be submitted to the Member States, the Commission
and the Authority by 1 January 2016.’
(*) Further details on identity and specification of active substance are provided in their review report.
(2) Row 229 on the active substance fat distillation residues is replaced by the following:
Number
Common name,
identification numbers
IUPAC name Purity
(*) Date
of
approval Expiration
of
approval Specific
provisions
‘229 Fat
distillation
residues
Not available
≥ 40 % of cleaved fatty
1 September 2009 31
August
2019 PART
A
acids
CAS No: not allocated
Only uses as repellent may be authorised. Fat distillation residues of animal
Relevant impurity: Ni
6.7.2012
origin must be in compliance with Regulation (EC) No 1069/2009 of the
CIPAC No 915
maximum 200 mg/kg
European Parliament and of the Council and Commission Regulation (EU)
No 142/2011 (OJ L 54, 26.2.2011, p. 1).

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6.7.2012 Off
Number
Common name,
identification numbers
IUPAC name Purity
(*) Date
of
approval Expiration
of
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
amended review report on fat distillation residues (SANCO/2610/2008)
EN
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.
Conditions of use shall include, where appropriate, risk mitigation measures.
The notifier shall submit confirmatory information as regards the specifi
cation of the technical material and the analysis of the maximum levels of
impurities and contaminants of toxicological concern. This information
shall be submitted to the Member States, the Commission and the
Authority by 1 May 2013.’
icial
(*) Further details on identity and specification of active substance are provided in their review report.
Jour
nal
(3) Row 248 on the active substance repellents by smell of animal or plant origin/fish oil is replaced by the following:
of
the
Number
Common name,
identification numbers
IUPAC name Purity
(*) Date
of
approval Expiration
of
approval Specific
provisions
European
‘248 Fish
oil
Fish oil
≥ 99 %
1 September 2009 31
August
2019 PART
A
Union
CAS No 100085-40-3
Relevant impurity:
Only uses as repellent may be authorised. Fish oil must be in compliance
Dioxine max. 6 pg/kg
with Regulation (EC) No 1069/2009 and Regulation (EU) No 142/2011.
CIPAC No 918
for animal feed
PART B
Hg max. 0,5 mg/kg feed
derived from fish and
other sea food
For the implementation of the uniform principles as referred to in
processing
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
Cd max. 2 mg/kg feed of
I and II thereof, as finalised in the Standing Committee on the Food Chain
animal origin except in
and Animal Health on 1 June 2012 shall be taken into account.
feed for domestic pets
Pb max. 10 mg/kg
Conditions of use shall include, where appropriate, risk mitigation measures.
PCBs max. 5 mg/kg
The notifier shall submit confirmatory information as regards the specifi
cation of the technical material and the analysis of the maximum levels of
impurities and contaminants of toxicological concern. This information
shall be submitted to the Member States, the Commission and the
L
Authority by 1 May 2013.’
176/57
(*) Further details on identity and specification of active substance are provided in their review report.

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L 176/58
(4) Row 257 on the active substance urea is replaced by the following:
Number
Common name,
identification numbers
IUPAC name Purity
(*) Date
of
approval Expiration
of
approval Specific
provisions
‘257 Urea
Urea
≥ 98 % w/w 1
September
2009 31
August
2019 PART
A
CAS No 57-13-6
Only uses as attractant and fungicide may be authorised.
EN

CIPAC No 913
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 (SANCO/2637/2008) 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.
Conditions of use shall include, where appropriate, risk mitigation measures.
Off
icial
The notifier shall submit confirmatory information as regards:
Jour
(a) the analysis method for urea and for the impurity biuret;
nal
(b) the risk for operators, workers and bystanders.
of
the
The information set out in point (a) and in point (b) shall be submitted to
European
the Member States, the Commission and the Authority respectively by
1 May 2013 and 1 January 2016.’
(*) Further details on identity and specification of active substance are provided in their review report.
Union
6.7.2012

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