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22.2.2011 Official
Journal
of
the
European
Union L
47/19
COMMISSION DECISION
of 21 February 2011
concerning the non-inclusion of methyl bromide in Annex I to Council Directive 91/414/EEC
(notified under document C(2011) 950)
(Text with EEA relevance)
(2011/120/EU)
THE EUROPEAN COMMISSION,
which were part of the programme of work referred to in
Article 8(2) of that Directive but have not been included
into its Annex I ( 5 ).
Having regard to the Treaty on the Functioning of the European
Union,
(4) The
application
was
submitted
to
the
United
Kingdom,
which had been designated rapporteur Member State by
Regulation (EC) No 1490/2002. The time period for the
Having regard to Council Directive 91/414/EEC of 15 July
accelerated procedure was respected. The specification of
1991 concerning the placing of plant protection products on
the active substance and the supported uses are the same
the market ( 1 ), and in particular Article 6(1) thereof,
as were the subject of Decision 2008/753/EC. That appli
cation also complies with the remaining substantive and
procedural requirements of Article 15 of Regulation (EC)
No 33/2008.
Whereas:
(5) The
United
Kingdom
evaluated
the
additional
data
(1) Commission
Regulations
(EC)
No
451/2000
( 2 ) and (EC)
submitted by the applicant and prepared an additional
No 1490/2002 ( 3 ) lay down the detailed rules for the
report. It communicated that report to the European
implementation of the second and third stages of the
Food Safety Authority (hereinafter ‘the Authority’) and
programme of work referred to in Article 8(2) of
to the Commission on 26 November 2009. The
Directive 91/414/EEC and establish a list of active
Authority communicated the additional report to the
substances to be assessed, with a view to their possible
other Member States and the applicant for comments
inclusion in Annex I to Directive 91/414/EEC. That list
and forwarded the comments it had received to the
included methyl bromide.
Commission. In accordance with Article 20(1) of Regu
lation (EC) No 33/2008 and at the request of the
Commission, the Authority presented its conclusion on
methyl bromide to the Commission on 3 November
(2) In
accordance
with
Article
11f
of
Regulation
(EC)
2010 ( 6 ). The draft assessment report, the additional
No 1490/2002 and Article 12(1)(a) and
report and the conclusion of the Authority were
Article 12(2)(b) of that Regulation Commission
reviewed by the Member States and the Commission
Decision 2008/753/EC of 18 September 2008
within the Standing Committee on the Food Chain and
concerning the non-inclusion of methyl bromide in
the Animal Health and finalised on 28 January 2011 in
Annex I to Council Directive 91/414/EEC and the with
the format of the Commission review report for methyl
drawal of authorisations for plant protection products
bromide.
containing that substance ( 4 ) was adopted.
(6) The
additional
report
by
the
rapporteur
Member
State
(3) In
agreement
with
the
original
notifier,
another
person
and the conclusion by the Authority concentrate on
(hereinafter ‘the applicant’) submitted a new application
the concerns that lead to the non-inclusion. Those
pursuant to Article 6(2) of Directive 91/414/EEC
concerns were harmful effects on human health in
requesting the accelerated procedure to be applied, as
particular on bystanders, because the exposure was
provided for in Articles 14 to 19 of Commission Regu
greater than 100 % of the AOEL, and on consumers,
lation (EC) No 33/2008 of 17 January 2008 laying down
because the exposure was greater than 100 % of the
detailed rules for the application of Council Directive
ADI and the ARfD. More concerns were identified in
91/414/EEC as regards a regular and an accelerated
the review report for methyl bromide.
procedure for the assessment of active substances
( 5 ) OJ L 15, 18.1.2008, p. 5.
( 1 ) OJ L 230, 19.8.1991, p. 1.
( 6 ) European Food Safety Authority; Conclusion on the peer review of
( 2 ) OJ L 55, 29.2.2000, p. 25.
the pesticide risk assessment of the active substance methyl bromide.
( 3 ) OJ L 224, 21.8.2002, p. 23.
EFSA Journal 2011;9(1):1893. [32 pp.]. doi:10.2903/j.efsa.
( 4 ) OJ L 258, 26.9.2008, p. 68.
2011.1893. Available online: www.efsa.europa.eu/efsajournal

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L 47/20
EN
Official Journal of the European Union
22.2.2011
(7) Additional
information
was
submitted
by
the
applicant, (12) Methyl
bromide
should
therefore
not
be
included
in
in particular as regards reducing exposure by applying a
Annex I to Directive 91/414/EEC.
recapture technology. In order to reduce the risk to
consumers and non-target species, the applicant has
limited its support to uses on wood packaging material
(13) Decision
2008/753/EC
should
be
repealed.
in containers.
(14) This
Decision
does
not
prejudice
the
submission
of
a
(8) However,
the
additional
information
provided
by
the
further application for methyl bromide pursuant to
applicant did not permit to eliminate all of the specific
Article 6(2) of Directive 91/414/EEC and Chapter II of
concerns arising in respect of methyl bromide.
Regulation (EC) No 33/2008.
(9) In
particular,
the
information
available
was
not
sufficient (15) The measures provided for in this Decision are in
to conduct a quantitative exposure assessment for
accordance with the opinion of the Standing
bystanders. Furthermore, the information available was
Committee on the Food Chain and Animal Health,
insufficient to estimate the possible air concentrations
of methyl bromide around containers with wood
packaging material on which methyl bromide was used
HAS ADOPTED THIS DECISION:
and to finalise the risk assessment for non-target
organisms. In addition, data were not available to
address the risk of indirect exposure of soil, surface
Article 1
water and groundwater.
Methyl bromide shall not be included as active substance in
Annex I to Directive 91/414/EEC.
(10) The
Commission invited
the
applicant
to
submit
its
comments on the conclusion by the Authority.
Furthermore, in accordance with Article 21(1) to Regu
Article 2
lation (EC) No 33/2008, the Commission invited the
applicant to submit comments on the draft review
Decision 2008/753/EC is repealed.
report. The applicant submitted its comments, which
have been carefully examined.
Article 3
This Decision is addressed to the Member States.
(11) However,
despite
the
arguments
put
forward
by
the
applicant, the concerns identified could not be elim
inated, and assessments made on the basis of the
Done at Brussels, 21 February 2011.
information submitted and evaluated during the expert
meetings of the Authority have not demonstrated that it
may be expected that, under the proposed conditions of
For the Commission
use, plant protection products containing methyl
bromide satisfy in general the requirements laid down
John DALLI
in Article 5(1)(a) and (b) of Directive 91/414/EEC.
Member of the Commission

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