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EN
Official Journal of the European Union
23.12.2011
COMMISSION IMPLEMENTING REGULATION (EU) No 1381/2011
of 22 December 2011
concerning the non-approval of the active substance chloropicrin, 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 Decision 2008/934/EC
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Annex I to Directive 91/414/EEC within 2 months from
entry into force of Regulation (EC) No 1095/2007.
Having regard to the Treaty on the Functioning of the European
Consequently, Commission Decision 2008/934/EC of
Union,
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 these
concerning the placing of plant protection products on the
substances ( 7 ) was adopted on the non-inclusion of
market and repealing Council Directives 79/117/EEC and
chloropicrin.
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
(5) The
application
was
submitted
to
Italy,
which
had
been
approval, to active substances for which completeness
designated rapporteur Member State by Regulation (EC)
has been established in accordance with Article 16 of
No 1490/2002. The time period for the accelerated
Commission Regulation (EC) No 33/2008 of
procedure was respected. The specification of the active
17 January 2008 laying down detailed rules for the
substance and the supported uses are the same as were
application of Council Directive 91/414/EEC as regards
the subject of Decision 2008/934/EC. That application
a regular and an accelerated procedure for the assessment
also complies with the remaining substantive and
of active substances which were part of the programme
procedural requirements of Article 15 of Regulation
of work referred to in Article 8(2) of that Directive but
(EC) No 33/2008.
have not been included into its Annex I ( 3 ). Chloropicrin
is an active substance for which completeness has been
established in accordance with that Regulation.
(6) Italy evaluated the additional data submitted by the
applicant and prepared an additional report. It
communicated that report to the European Food Safety
(2) Commission
Regulations
(EC)
No
451/2000
( 4 ) and (EC)
No 1490/2002 (
Authority (hereinafter ‘the Authority’) and to the

5 ) lay down the detailed rules for the
implementation of the second and third stages of the
Commission on 11 March 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. These lists
Commission. In accordance with Article 20(1) of Regu
included chloropicrin.
lation (EC) No 33/2008 and at the request of the

Commission, the Authority presented its conclusion on
the risk assessment of chloropicrin to the Commission
(3) In
accordance
with
Article
3(2)
of
Commission
Regu
on 23 February 2011 ( 8 ). The draft assessment report, the
lation (EC) No 1095/2007 of 20 September 2007
additional report and the conclusion of the Authority
amending Regulation (EC) No 1490/2002 laying down
were reviewed by the Member States and the
further detailed rules for the implementation of the third
Commission within the Standing Committee on the
stage of the programme of work referred to in
Food Chain and Animal Health and finalised on
Article 8(2) of Council Directive 91/414/EEC and Regu
11 October 2011 in the format of the Commission
lation (EC) No 2229/2004 laying down further detailed
review report for chloropicrin.
rules for the implementation of the fourth stage of the
programme of work referred to in Article 8(2) of Council
Directive 91/414/EEC
( 6 ) the notifier withdrew its
(7) During
the
evaluation
of
this
active
substance,
concerns
support of the inclusion of that active substance in
were identified. Those concerns were, in particular, the
following. There is an unacceptable risk to operators. It
( 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 chloropicrin.
( 5 ) OJ L 224, 21.8.2002, p. 23.
EFSA Journal 2011;9(3):2084. [58 pp.] doi:10.2903/j.efsa.2011.
( 6 ) OJ L 246, 21.9.2007, p. 19.
2084. Available online: www.efsa.europa.eu/efsajournal.htm

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EN
23.12.2011 Official
Journal
of
the
European
Union L
343/27
was not possible to perform a reliable groundwater
(14) In the interest of clarity, the entry for chloropicrin in the
exposure assessment as data were missing concerning
Annex to Decision 2008/934/EC should be deleted.
the metabolite dichloronitromethane and impurities of
the active substance as manufactured. Insufficient data
(15) It is therefore appropriate to amend Decision
were available to conclude on the risks to sediment
2008/934/EC accordingly.
dwellers, bees, earthworms and non-target plants. A
high risk to aquatic organisms, birds and mammals was
(16) The
Standing
Committee
on
the
Food
chain
and
Animal
identified. It was not possible to perform a reliable
Health did not deliver an opinion. An implementing act
surface water and sediment exposure assessment as
was deemed to be necessary and the chair submitted the
data were missing for chloropicrin and the metabolite
draft implementing act to the appeal committee for
dichloronitromethane. No reliable assessment of
further deliberation. The measures provided for in this
exposure concentrations in air of phosgene could be
Regulation are in accordance with the opinion of the
performed. A high potential for long-range atmospheric
appeal committee,
transport 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) to Regu
lation (EC) No 33/2008, the Commission invited the
Non-approval of active substance
applicant to submit comments on the draft review
report. The applicant submitted its comments, which
The active substance chloropicrin is not approved.
have been carefully examined.
Article 2
(9) However,
despite
the
arguments
put
forward
by
the
Transitional measures
applicant, the concerns referred to in recital 7 could
not be eliminated. Consequently, it has not been demon
By way of derogation from Article 12(3) of Regulation (EC) No
strated that it may be expected that, under the proposed
1490/2002, Member States shall ensure that authorisations for
conditions of use, plant protection products containing
plant protection products containing chloropicrin are
chloropicrin satisfy in general the requirements laid down
withdrawn by 23 June 2012.
in Article 5(1)(a) and (b) of Directive 91/414/EEC.
Article 3
(10) Chloropicrin
should
therefore
not
be
approved
pursuant
Period of grace
to Article 13(2) of Regulation (EC) No 1107/2009.
Any period of grace granted by Member States in accordance
with Article 46 of Regulation (EC) No 1107/2009 shall be as
(11) To
provide
Member
States
with
time
to
withdraw
auth
short as possible and shall expire 12 months after withdrawal of
orisations for plant protection products containing chlor
the respective authorisation at the latest.
ipicrin, Regulation (EC) No 1490/2002 should be
derogated from.
Article 4
Amendments to Decision 2008/934/EC
(12) For
plant
protection
products
containing
chloropicrin,
where Member States grant any period of grace in
In the Annex to Decision 2008/934/EC, the entry for
accordance with Article 46 of Regulation (EC) No
‘chloropicrin’ is deleted.
1107/2009, this period should expire at the latest 1
year after the withdrawal of the respective authorisation.
Article 5
Entry into force and date of application
(13) This
Regulation
does
not
prejudice
the
submission
of
a
further application for chloropicrin pursuant to Article 7
This Regulation shall enter into force on the day following its
of Regulation (EC) No 1107/2009.
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, 22 December 2011.
For the Commission
The President
José Manuel BARROSO

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