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22.12.2011 Official
Journal
of
the
European
Union L
341/45
COMMISSION IMPLEMENTING REGULATION (EU) No 1372/2011
of 21 December 2011
concerning the non-approval of the active substance acetochlor, 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,
its support for the inclusion of that active substance in
Annex I to Directive 91/414/EEC within two months
Having regard to the Treaty on the Functioning of the European
from entry into force of Regulation (EC) No 1095/2007.
Union,
Consequently, Commission Decision 2008/934/EC of
5 December 2008 concerning the non-inclusion of
certain active substances in Annex I to Council
Having regard to Regulation (EC) No 1107/2009 of the
Directive 91/414/EEC and the withdrawal of authori
European Parliament and of the Council of 21 October 2009
sations for plant protection products containing
concerning the placing of plant protection products on the
these substances ( 7 ) was adopted on the non-inclusion
market and repealing Council Directives 79/117/EEC and
of acetochlor.
91/414/EEC ( 1 ), and in particular Article 13(2) and
Article 78(2) thereof,
(4) Pursuant
to
Article
6(2)
of
Directive
91/414/EEC
the
original notifier (hereinafter ‘the applicant’) submitted a
Whereas:
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
Spain
which
had
been
has been established in accordance with Article 16 of
designated rapporteur Member State by Regulation (EC)
Commission Regulation (EC) No 33/2008 of
No 1490/2002. The time period for the accelerated
17 January 2008 laying down detailed rules for the
procedure was respected. The specification of the active
application of Council Directive 91/414/EEC as regards
substance and the supported uses are the same as were
a regular and an accelerated procedure for the assessment
the subject of Decision 2008/934/EC. That application
of active substances which were part of the programme
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
have not been included into its Annex I (
(EC) No 33/2008.

3 ). Acetochlor is
an active substance for which completeness has been
established in accordance with that Regulation.
(6) Spain
evaluated
the
additional
data
submitted
by
the
applicant and prepared an additional report. It
(2) Commission
Regulations
(EC)
No
451/2000
(
communicated that report to the European Food Safety

4 ) and (EC)
No 1490/2002 (
Authority (hereinafter ‘the Authority’) and to the

5 ) lay down detailed rules for the imple
mentation of the second and third stages of the
Commission on 22 April 2010. The Authority
programme of work referred to in Article 8(2) of
communicated the additional report to the other
Directive 91/414/EEC and establish lists of active
Member States and the applicant for comments and
substances to be assessed, with a view to their possible
forwarded the comments it had received to the
inclusion in Annex I to Directive 91/414/EEC. One of
Commission. In accordance with Article 20(1) of Regu
these lists included acetochlor.
lation (EC) No 33/2008 and at the request of the
Commission, the Authority presented its conclusion on
the risk assessment of acetochlor to the Commission on
(3) In
accordance
with
Article
3(2)
of
Commission
Regu
18 April 2011 ( 8 ). The draft assessment report, the addi
lation (EC) No 1095/2007 of 20 September 2007
tional report and the conclusion of the Authority were
amending Regulation (EC) No 1490/2002 laying down
reviewed by the Member States and the Commission
further detailed rules for the implementation of the third
within the Standing Committee on the Food Chain and
stage of the programme of work referred to in
Animal Health and finalised on 11 October 2011 in the
Article 8(2) of Council Directive 91/414/EEC and Regu
format of the Commission review report for acetochlor.
lation (EC) No 2229/2004 laying down further detailed
rules for the implementation of the fourth stage of
the programme of work referred to in Article 8(2) of
(7) During
the
evaluation
of
this
active
substance,
concerns
Council Directive 91/414/EEC ( 6 ) the notifier withdrew
were identified. Those concerns were, in particular, the
following. A potential human exposure above the
( 1 ) OJ L 309, 24.11.2009, p. 1.
( 2 ) OJ L 230, 19.8.1991, p. 1.
( 7 ) OJ L 333, 11.12.2008, p. 11.
( 3 ) OJ L 15, 18.1.2008, p. 5.
( 8 ) European Food Safety Authority: ‘Conclusion on the peer review of
( 4 ) OJ L 55, 29.2.2000, p. 25.
the pesticide risk assessment of the active substance acetochlor’.
( 5 ) OJ L 224, 21.8.2002, p. 23.
EFSA Journal 2011; 9(5):2143. [109 pp.]. doi:10.2903/j.efsa.
( 6 ) OJ L 246, 21.9.2007, p. 19.
2011.2143. Available online: www.efsa.europa.eu/efsajournal.htm

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L 341/46
EN
Official Journal of the European Union
22.12.2011
acceptable daily intake has been identified. In addition,
(15) It is therefore appropriate to amend Decision
there is a potential for human exposure to the surface
2008/934/EC accordingly.
water metabolite t-norchloro acetochlor, the genotoxicity
of which cannot be excluded. There is a high risk of
groundwater contamination for several metabolites, a
(16) The
Standing
Committee
on
the
Food
chain
and
Animal
high risk for aquatic organisms and a high long term
Health did not deliver an opinion. An implementing act
risk for herbivorous birds. Finally, the information
was deemed to be necessary and the chair submitted the
available was not sufficient to conclude on the risk
draft implementing act to the appeal committee for
assessment for the groundwater contamination for meta
further deliberation. The measures provided for in this
bolites t-norchloracetochlor and t-hydroxyacetochlor.
Regulation are in accordance with the opinion of the
appeal committee,
(8) The
Commission
invited
the
applicant
to
submit
its
comments on the conclusion of the Authority.
HAS ADOPTED THIS REGULATION:
Furthermore, in accordance with Article 21(1) to Regu
lation (EC) No 33/2008, the Commission invited the
applicant to submit comments on the draft review
Article 1
report. The applicant submitted its comments, which
Non-approval of active substance
have been carefully examined.
The active substance acetochlor is not approved.
(9) However,
despite
the
arguments
put
forward
by
the
applicant, the concerns referred to in recital 7 could
Article 2
not be eliminated. Consequently, it has not been demon
strated that it may be expected that, under the proposed
Transitional measures
conditions of use, plant protection products containing
By way of derogation from Article 12(3) of Regulation (EC)
acetochlor satisfy in general the requirements laid down
No 1490/2002, Member States shall ensure that authorisations
in Article 5(1)(a) and (b) of Directive 91/414/EEC.
for plant protection products containing acetochlor are
withdrawn by 23 June 2012.
(10) Acetochlor
should
therefore
not
be
approved
pursuant
to
Article 13(2) of Regulation (EC) No 1107/2009.
Article 3
(11) To provide Member States with time to withdraw
Period of grace
authorisations for plant protection products containing
Any period of grace granted by Member States in accordance
acetochlor, Regulation (EC) No 1490/2002 should be
with Article 46 of Regulation (EC) No 1107/2009 shall be as
derogated from.
short as possible and shall expire 12 months after withdrawal of
the respective authorisation at the latest.
(12) For plant protection products containing acetochlor,
where Member States grant any period of grace
in accordance with Article 46 of Regulation (EC)
Article 4
No 1107/2009, this period should expire at the
Amendments to Decision 2008/934/EC
latest one year after the withdrawal of the respective
authorisation.
In the Annex to Decision 2008/934/EC, the entry for
‘acetochlor’ is deleted.
(13) This
Regulation
does
not
prejudice
the
submission
of
a
further application for acetochlor pursuant to Article 7 of
Article 5
Regulation (EC) No 1107/2009.
Entry into force
(14) In the interest of clarity, the entry for acetochlor in the
This Regulation shall enter into force on the day following its
Annex to Decision 2008/934/EC should be deleted.
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, 21 December 2011.
For the Commission
The President
José Manuel BARROSO

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