HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 289/26
EN
Official Journal of the European Union
8.11.2011
COMMISSION IMPLEMENTING REGULATION (EU) No 1127/2011
of 7 November 2011
concerning the non-approval of the active substance 2-naphthyloxyacetic acid, 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
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
91/414/EEC and the withdrawal of authorisations for
plant protection products containing that substance ( 6 )
was adopted.
Having regard to the Treaty on the Functioning of the European
Union,
(4) Pursuant
to
Article
6(2)
of
Directive
91/414/EEC
the
original notifier (hereinafter ‘the applicant’) submitted a
new application requesting the accelerated procedure to
Having regard to Regulation (EC) No 1107/2009 of the
be applied, as provided for in Articles 14 to 19 of Regu
European Parliament and of the Council of 21 October 2009
lation (EC) No 33/2008.
concerning the placing of plant protection products on the
market and repealing Council Directives 79/117/EEC and
91/414/EEC ( 1 ), and in particular Article 13(2) thereof,
(5) The
application
was
submitted
to
Italy,
replacing
France
which had originally been designated rapporteur Member
State by Regulation (EC) No 2229/2004. The time period
Whereas:
for the accelerated procedure was respected. The specifi
cation of the active substance and the supported uses are
the same as were the subject of Decision 2009/65/EC.
That application also complies with the remaining
(1) In
accordance
with
Article
80(1)(c)
of
Regulation
(EC)
No 1107/2009, Council Directive 91/414/EEC (
substantive and procedural requirements of Article 15

2 ) is to
apply, with respect to the procedure and the conditions
of Regulation (EC) No 33/2008.
for approval, to active substances for which completeness
has been established in accordance with Article 16 of
Commission Regulation (EC) No 33/2008 of
(6) Italy evaluated the additional data submitted by the
17 January 2008 laying down detailed rules for the
applicant and prepared an additional report. It
application of Council Directive 91/414/EEC as regards
communicated that report to the European Food Safety
a regular and an accelerated procedure for the assessment
Authority (hereinafter ‘the Authority’) and to the
of active substances which were part of the programme
Commission on 21 May 2010. The Authority
of work referred to in Article 8(2) of that Directive but
communicated the additional report to the other
have not been included into its Annex I ( 3 ). 2-naphthy
Member States and the applicant for comments and
loxyacetic acid is an active substance for which
forwarded the comments it had received to the
completeness has been established in accordance with
Commission. In accordance with Article 20(1) of Regu
that Regulation.
lation (EC) No 33/2008 and at the request of the
Commission, the Authority presented its conclusion on
the risk assessment of 2-naphthyloxyacetic acid to the
Commission on 28 April 2011 ( 7 ). The draft assessment
(2) Commission
Regulations
(EC)
No
1112/2002
( 4 ) and (EC)
report, the additional report and the conclusion of the
No 2229/2004 ( 5 ) lay down detailed rules for the imple
Authority were reviewed by the Member States and the
mentation of the fourth stage of the programme of work
Commission within the Standing Committee on the Food
referred to in Article 8(2) of Directive 91/414/EEC and
Chain and Animal Health and finalised on 27 September
establish a list of active substances to be assessed, with a
2011 in the format of the Commission review report for
view to their possible inclusion in Annex I to Directive
2-naphthyloxyacetic acid.
91/414/EEC. That list included 2-naphthyloxyacetic acid.
(7)
Based on the new data submitted by the applicant and
(3) In
accordance
with
Article
24f
of
Regulation
(EC)
included in the additional report an acceptable daily
No 2229/2004 and Article 25(1)(a) and (2)(b) of that
intake could be set. However, during the evaluation of
Regulation, Commission Decision 2009/65/EC of
this active substance, a number of other concerns have
26 January 2009 concerning the non-inclusion of 2-
been identified. In particular, it was not possible to
Naphthyloxyacetic acid in Annex I to Council Directive
( 6 ) OJ L 23, 27.1.2009, p. 33.
( 1 ) OJ L 309, 24.11.2009, p. 1.
( 7 ) European Food Safety Authority; Conclusion on the peer review of
( 2 ) OJ L 230, 19.8.1991, p. 1.
the pesticide risk assessment of the active substance 2-naphthylo
( 3 ) OJ L 15, 18.1.2008, p. 5.
xyacetic acid. EFSA Journal 2011; 9(5):2152 [52 pp.]. doi:10.2903/
( 4 ) OJ L 168, 27.6.2002, p. 14.
j.efsa.2011.2152. Available online: www.efsa.europa.eu/efsajournal.
( 5 ) OJ L 379, 24.12.2004, p. 13.
htm

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EN
8.11.2011 Official
Journal
of
the
European
Union L
289/27
perform a consumer exposure assessment, as necessary
(12) This
Regulation
does
not
prejudice
the
submission
of
a
information was missing as regards livestock exposure,
further application for 2-naphthyloxyacetic acid pursuant
plant metabolism, residue trials, processing studies and
to Article 7 of Regulation (EC) No 1107/2009.
plant residue definition. Furthermore, data were also
missing to conclude on the risk to bees, earthworms
and soil macro-organisms.
(13) The
measures
provided
for
in
this
Regulation
are
in
accordance with the opinion of the Standing
(8) The
Commission
invited
the
applicant
to
submit
its
Committee on the Food Chain and Animal Health,
comments on the conclusion of the Authority.
Furthermore, in accordance with Article 21(1) of Regu
lation (EC) No 33/2008, the Commission invited the
HAS ADOPTED THIS REGULATION:
applicant to submit comments on the draft review
report. The applicant submitted its comments, which
have been carefully examined.
Article 1
Non-approval of active substance
(9) However,
despite
the
arguments
put
forward
by
the
applicant, the concerns referred to in recital 7 could
The active substance 2-naphthyloxyacetic acid is not approved.
not be eliminated. Consequently, it has not been demon
strated that it may be expected that, under the proposed
conditions of use, plant protection products containing
Article 2
2-naphthyloxyacetic acid satisfy in general the
requirements laid down in Article 5(1)(a) and (b) of
Repeal
Directive 91/414/EEC.
Decision 2009/65/EC is repealed.
(10) 2-naphthyloxyacetic acid should therefore not be
approved pursuant to Article 13(2) of Regulation (EC)
Article 3
No 1107/2009.
Entry into force
(11) In
the
interest
of
clarity,
Decision
2009/65/EC
should
be
This Regulation shall enter into force on the 20th day following
repealed.
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, 7 November 2011.
For the Commission
The President
José Manuel BARROSO

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