HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 169/46
EN
Official Journal of the European Union
29.6.2012
COMMISSION IMPLEMENTING REGULATION (EU) No 571/2012
of 28 June 2012
amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the
active substances aluminium silicate, hydrolysed proteins and 1,4-diaminobutane (putrescine)
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
reports and the views of the Authority were reviewed by
the Member States and the Commission within the
Standing Committee on the Food Chain and Animal
Having regard to the Treaty on the Functioning of the European
Health and finalised on 1 June 2012 in the format of
Union,
the Commission review reports for aluminium silicate,
hydrolysed proteins and 1,4-diaminobutane (putrescine).
Having regard to Regulation (EC) No 1107/2009 of the
European Parliament and of the Council of 21 October 2009
(3) The
Authority
communicated
its
views
on
aluminium
concerning the placing of plant protection products on the
silicate, hydrolysed proteins and 1,4-diaminobutane
market and repealing Council Directives 79/117/EEC and
(putrescine) to the notifiers, and the Commission
91/414/EEC (
invited them to submit comments on the review reports.

1 ), and in particular Article 13(2)(c) thereof,
Whereas:
(4)
It is confirmed that the active substances aluminium
silicate, hydrolysed proteins and 1,4-diaminobutane
(putrescine) are to be deemed to have been approved
under Regulation (EC) No 1107/2009.
(1) The
active
substances
aluminium
silicate,
hydrolysed
proteins and 1,4-diaminobutane (putrescine) were
included in Annex I to Council Directive 91/414/EEC ( 2 )
by Commission Directive 2008/127/EC (
(5) In
accordance
with
Article
13(2)
of
Regulation
(EC)
No

3 ) in accordance
with the procedure provided for in Article 24b of
1107/2009 in conjunction with Article 6 thereof and in
Commission Regulation (EC) No 2229/2004 of
the light of current scientific and technical knowledge, it
3 December 2004 laying down further detailed rules
is necessary to amend the conditions of approval of
for the implementation of the fourth stage of the
aluminium silicate, hydrolysed proteins and 1,4-diami
programme of work referred to in Article 8(2) of
nobutane (putrescine). It is, in particular, appropriate to
Council Directive 91/414/EEC (
require further confirmatory information as regards

4 ). Since the replacement
of Directive 91/414/EEC by Regulation (EC) No
aluminium silicate and hydrolysed proteins. At the
1107/2009, these substances are deemed to have been
same time certain technical adaptations should be
approved under that Regulation and are listed in Part A
made, in particular the name of the active substance
of the Annex to Commission Implementing Regulation
'putrescin (1,4-diaminobutane)' should be replaced by
(EU) No 540/2011 of 25 May 2011 implementing Regu
'1,4-diaminobutane (putrescine)'. The Annex to Regu
lation (EC) No 1107/2009 of the European Parliament
lation (EU) No 540/2011 should therefore be amended
and of the Council as regards the list of approved active
accordingly.
substances ( 5 ).
(6) A
reasonable
period
of
time
should
be
allowed
before
the
(2) In
accordance
with
Article
25a
of
Regulation
(EC)
No
application of this Regulation in order to allow Member
2229/2004, the European Food Safety Authority, here
States, notifiers and holders of authorisations for plant
inafter ‘the Authority’, presented to the Commission its
protection products to meet the requirements resulting
views on the draft review reports for aluminium sili
from amendment to the conditions of the approval.
cate ( 6 ), hydrolysed proteins ( 7 ) and 1,4-diaminobutane
(putrescine) ( 8 ) on 16 December 2011. The draft review
(7) The
measures
provided
for
in
this
Regulation
are
in
( 1 ) OJ L 309, 24.11.2009,p. 1.
accordance with the opinion of the Standing
( 2 ) OJ L 230, 19.8.1991, p. 1.
Committee on the Food Chain and Animal Health,
( 3 ) OJ L 344, 20.12.2008, p. 89.
( 4 ) OJ L 379, 24.12.2004, p. 13.
( 5 ) OJ L 153, 11.6.2011, p. 1.
( 6 ) Conclusion on the peer review of the pesticide risk assessment of the
HAS ADOPTED THIS REGULATION:
active substance aluminium silicate. EFSA Journal 2012; 10(1):2517.
Available online: www.efsa.europa.eu/efsajournal.
( 7 ) Conclusion on the peer review of the pesticide risk assessment of the
active substance hydrolysed proteins. EFSA Journal 2012;
Article 1
10(2):2545. Available online: www.efsa.europa.eu/efsajournal.
Part A of the Annex to Implementing Regulation (EU) No
( 8 ) Conclusion on the peer review of the pesticide risk assessment of the
active substance 1,4-diaminobutane (putrescine). EFSA Journal
540/2011 is amended in accordance with the Annex to this
2012;10(1):2516. Available online: www.efsa.europa.eu/efsajournal.
Regulation.

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EN
29.6.2012 Official
Journal
of
the
European
Union L
169/47
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, 28 June 2012.
For the Commission
The President
José Manuel BARROSO

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L 169/48
ANNEX
Part A of the Annex to Implementing Regulation (EU) No 540/2011 is amended as follows:
(1) Row 220 on the active substance aluminium silicate is replaced by the following:
Number Common Name, Identification
EN
Numbers
IUPAC Name Purity
(*) Date
of
approval
Expiration of
approval
Specific provisions

'220 Aluminium
silicate
Not available
≥ 999,8 g/kg 1
September
2009 31
August
2019 PART
A
CAS No 1332-58-7
Chemical name:
Only uses as repellent may be authorised.
Aluminium silicate
CIPAC No 841
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/2603/08) and in particular
Appendices I and II thereof, as finalised in the Standing Committee on the
Off
Food Chain and Animal Health on 1 June 2012 shall be taken into
icial
account.
Jour
In this overall assessment Member States shall pay particular attention to
the operator safety; conditions of use shall include the application of
nal
adequate personal and respiratory protective equipment, where appropriate.
of
Conditions of use shall include, where appropriate, risk mitigation
the
measures.
European
The Member States concerned shall ensure that the applicant submits to
the Commission confirmatory information as regards:
(a) the specification of the technical material, as commercially manufac
Union
tured, supported by appropriate analytical data;
(b) the relevance of the test material used in the toxicity dossier in view of
the specification of the technical material.
The Member States concerned shall ensure that the applicant submits such
information to the Commission by 1 May 2013.'
(*) Further details on identity and specification of active substances are provided in their review report.
(2) Row 234 on the active substance hydrolysed proteins is replaced by the following:
'Number Common Name, Identification
Numbers
IUPAC Name Purity
(*) Date
of
approval
Expiration of
approval
Specific provisions
234 Hydrolysed
proteins
Not available Review
report
1 September 2009 31
August
2019 PART
A
29.6.2012
(SANCO/2615/2008)
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 (**) and
CIPAC No 901
Commission Regulation (EU) No 142/2011 (***).

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29.6.2012 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
review report on hydrolysed proteins (SANCO/2615/08) and in particular
Appendices I and II thereof, as finalised in the Standing Committee on the
EN
Food Chain and Animal Health on 1 June 2012 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 include the appli
cation of adequate personal protective equipment, where appropriate.
Conditions of use shall include, where appropriate, risk mitigation
measures.
The Member States concerned shall ensure that the applicant submits to
the Commission confirmatory information as regards:
(a) the specifications of the technical material, as commercially manufac
icial
tured, supported by appropriate analytical data;
Jour
(b) the risk to aquatic organisms.
The Member States concerned shall ensure that the applicant submits to
nal
the Commission the information set out in point (a) by 1 May 2013, the
of
information set out in point (b) by 1 November 2013.
the
(*) Further details on identity and specification of active substances are provided in their review report.
European
(**) OJ L 300, 14.11.2009, p. 1.
(***) OJ L 54, 26.2.2011, p. 1.'
Union
(3) Row 245 on the active substance 1,4-diaminobutane (putrescine) is replaced by the following:
Number Common Name, Identification
Numbers
IUPAC Name Purity
(*) Date
of
approval
Expiration of
approval
Specific provisions
'245 1,4-diaminobutane
Butane-1,4-
≥ 990 g/kg 1
September
2009 31
August
2019 PART
A
(putrescine)
diamine
Only uses as attractant may be authorised.
CAS No 110-60-1
PART B
CIPAC No 854
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 1,4-diaminobutane (putrescine) (SANCO/2626/08) 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
L
measures.'
169/49
(*) Further details on identity and specification of active substances are provided in their review report.

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