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20.10.2011 Official
Journal
of
the
European
Union L
275/23
COMMISSION IMPLEMENTING REGULATION (EU) No 1045/2011
of 19 October 2011
concerning the non-approval of the active substance asulam, in accordance with Regulation (EC) No
1107/2009 of the European Parliament and of the Council concerning the placing of plant
protection products on the market, and amending Commission Decision 2008/934/EC
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
programme of work referred to in Article 8(2) of Council
Directive 91/414/EEC
( 6 ) the notifier withdrew its
support for the inclusion of that active substance in
Having regard to the Treaty on the Functioning of the European
Annex I to Directive 91/414/EEC within 2 months
Union,
from entry into force of Regulation (EC) No 1095/2007.
Consequently, Commission Decision 2008/934/EC of
5 December 2008 concerning the non-inclusion of
Having regard to Regulation (EC) No 1107/2009 of the
certain active substances in Annex I to Council
European Parliament and of the Council of 21 October 2009
Directive 91/414/EEC and the withdrawal of authori
concerning the placing of plant protection products on the
sations for plant protection products containing these
market and repealing Council Directives 79/117/EEC and
substances ( 7 ) was adopted on the non-inclusion of
91/414/EEC ( 1 ), and in particular Articles 13(2) and 78(2)
asulam.
thereof,
(4) Pursuant
to
Article
6(2)
of
Directive
91/414/EEC
the
Whereas:
original notifier (hereinafter ‘the applicant’) submitted a
new application requesting the accelerated procedure to
be applied, as provided for in Articles 14 to 19 of Regu
(1) In
accordance
with
Article
80(1)(c)
of
Regulation
(EC)
No
lation (EC) No 33/2008.
1107/2009, Council Directive 91/414/EEC ( 2 ) is to apply,
with respect to the procedure and the conditions for
approval, to active substances for which completeness
(5) The
application
was
submitted
to
the
United
Kingdom,
has been established in accordance with Article 16 of
which had been designated rapporteur Member State by
Commission Regulation (EC) No 33/2008 of
Regulation (EC) No 1490/2002. The time period for the
17 January 2008 laying down detailed rules for the
accelerated procedure was respected. The specification of
application of Council Directive 91/414/EEC as regards
the active substance and the supported uses are the same
a regular and an accelerated procedure for the assessment
as were the subject of Decision 2008/934/EC. That appli
of active substances which were part of the programme
cation also complies with the remaining substantive and
of work referred to in Article 8(2) of that Directive but
procedural requirements of Article 15 of Regulation (EC)
have not been included into its Annex I ( 3 ). Asulam is an
No 33/2008.
active substance for which completeness has been estab
lished in accordance with that Regulation.
(6) The
United
Kingdom
evaluated
the
additional
data
submitted by the applicant and prepared an additional
(2) Commission
Regulations
(EC)
No
451/2000
( 4 ) and (EC)
report. It communicated that report to the European
No 1490/2002 ( 5 ) lay down the detailed rules for the
Food Safety Authority (hereinafter ‘the Authority’) and
implementation of the second and third stages of the
to the Commission on 6 November 2009. The
programme of work referred to in Article 8(2) of
Authority communicated the additional report to the
Directive 91/414/EEC and establish lists of active
other Member States and the applicant for comments
substances to be assessed, with a view to their possible
and forwarded the comments it had received to the
inclusion in Annex I to Directive 91/414/EEC. These lists
Commission. In accordance with Article 20(1) of Regu
included asulam.
lation (EC) No 33/2008 and at the request of the
Commission, the Authority presented its conclusion on
the risk assessment of asulam to the Commission on
(3) In
accordance
with
Article
3(2)
of
Commission
Regu
23 September 2010 ( 8 ). The draft assessment report,
lation (EC) No 1095/2007 of 20 September 2007
the additional report and the conclusion of the
amending Regulation (EC) No 1490/2002 laying down
Authority were reviewed by the Member States and the
further detailed rules for the implementation of the third
Commission within the Standing Committee on the Food
stage of the programme of work referred to in
Chain and Animal Health and finalised on 14 July 2011
Article 8(2) of Council Directive 91/414/EEC and Regu
in the format of the Commission review report for
lation (EC) No 2229/2004 laying down further detailed
asulam.
rules for the implementation of the fourth stage of the
( 6 ) OJ L 246, 21.9.2007, p. 19.
( 1 ) OJ L 309, 24.11.2009, p. 1.
( 7 ) OJ L 333, 11.12.2008, p. 11.
( 2 ) OJ L 230, 19.8.1991, p. 1.
( 8 ) European Food Safety Authority; Conclusion on the peer review of
( 3 ) OJ L 15, 18.1.2008, p. 5.
the pesticide risk assessment of the active substance asulam. EFSA
( 4 ) OJ L 55, 29.2.2000, p. 25.
Journal 2010;8(12):1822. [71 pp.]. doi:10.2903/j.efsa.2010.1822.
( 5 ) OJ L 224, 21.8.2002, p. 23.
Available online: www.efsa.europa.eu/efsajournal.htm

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L 275/24
EN
Official Journal of the European Union
20.10.2011
(7) During
the
evaluation
of
this
active
substance,
concerns (14) It is therefore appropriate to amend Decision
were identified. Those concerns were, in particular, the
2008/934/EC accordingly.
following. It was not possible to perform a reliable
consumer exposure assessment as data were missing
concerning the presence and toxicity of the metabolite
(15) The
Standing
Committee
on
the
Food
Chain
and
Animal
sulfanilamide, as well as concerning the presence of other
Health did not deliver an opinion. An implementing act
potentially significant metabolites that were not analysed
was deemed to be necessary and the chair submitted the
in the available residue trials and processing studies.
draft implementing act to the appeal committee for
Furthermore, no data was available on the toxicological
further deliberation. The appeal committee did not
relevance of the impurities in the technical specification
deliver an opinion,
of the active substance. In addition, a high risk to birds
was identified.
HAS ADOPTED THIS REGULATION:
(8) The
Commission
invited
the
applicant
to
submit
its
comments on the conclusion of the Authority.
Article 1
Furthermore, in accordance with Article 21(1) of Regu
Non-approval of active substance
lation (EC) No 33/2008, the Commission invited the
applicant to submit comments on the draft review
The active substance asulam is not approved.
report. The applicant submitted its comments, which
have been carefully examined.
Article 2
Transitional measures
(9) However,
despite
the
arguments
put
forward
by
the
applicant, the concerns referred to in recital 7 could
Member States shall ensure that authorisations for plant
not be eliminated. Consequently, it has not been demon
protection products containing asulam are withdrawn by
strated that it may be expected that, under the proposed
31 December 2011.
conditions of use, plant protection products containing
asulam satisfy in general the requirements laid down in
Article 5(1)(a) and (b) of Directive 91/414/EEC.
Article 3
Period of grace
(10) Asulam
should
therefore
not
be
approved
pursuant
to
Any period of grace granted by Member States in accordance
Article 13(2) of Regulation (EC) No 1107/2009.
with Article 46 of Regulation (EC) No 1107/2009 shall be as
short as possible and shall expire on 31 December 2012 at the
latest.
(11) For
plant
protection
products
containing
asulam,
where
Member States grant any period of grace in accordance
with Article 46 of Regulation (EC) No 1107/2009, this
Article 4
period should expire on 31 December 2012 at the latest
as laid down in the second paragraph of Article 3 of
Amendments to Decision 2008/934/EC
Decision 2008/934/EC.
In the Annex to Decision 2008/934/EC, the entry for ‘asulam’ is
deleted.
(12) This
Regulation
does
not
prejudice
the
submission
of
a
further application for asulam pursuant to Article 7 of
Regulation (EC) No 1107/2009.
Article 5
Entry into force and date of application
(13) In the interest of clarity, the entry for asulam in the
This Regulation shall enter into force on the 20th day following
Annex to Decision 2008/934/EC should be deleted.
its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 19 October 2011.
For the Commission
The President
José Manuel BARROSO

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