HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 98/14
EN
Official Journal of the European Union
13.4.2011
COMMISSION IMPLEMENTING DECISION
of 11 April 2011
concerning the non-inclusion of dichlobenil in Annex I to Council Directive 91/414/EEC
(notified under document C(2011) 2437)
(Text with EEA relevance)
(2011/234/EU)
THE EUROPEAN COMMISSION,
Regulation (EC) No 1490/2002. The time period for the
accelerated procedure was respected. The specification of
the active substance and the supported uses are the same
Having regard to the Treaty on the Functioning of the European
as were the subject of Decision 2008/754/EC. That appli
Union,
cation also complies with the remaining substantive and
procedural requirements of Article 15 of Regulation (EC)
No 33/2008.
Having regard to Council Directive 91/414/EEC of 15 July
1991 concerning the placing of plant protection products on
the market ( 1 ), and in particular Article 6(1) thereof,
(5) The
United
Kingdom
evaluated
the
additional
data
submitted by the applicant and prepared an additional
report. It communicated that report to the European
Whereas:
Food Safety Authority (hereinafter ‘the Authority’) and
to the Commission on 7 October 2009. The Authority
communicated the additional report to the other Member
(1) Commission
Regulations
(EC)
No
451/2000
( 2 ) and (EC)
States and the applicant for comments and forwarded the
No 1490/2002 ( 3 ) lay down the detailed rules for the
comments it had received to the Commission. In
implementation of the second and third stages of the
accordance with Article 20(1) of Regulation (EC)
programme of work referred to in Article 8(2) of
No 33/2008 and at the request of the Commission,
Directive 91/414/EEC and establish a list of active
the Authority presented its conclusion on dichlobenil
substances to be assessed, with a view to their possible
to the Commission on 29 July 2010 (
inclusion in Annex I to Directive 91/414/EEC. That list

6 ). The draft
assessment report, the additional report and the
included dichlobenil.
conclusion of the Authority were reviewed by the
Member States and the Commission within the
Standing Committee on the Food Chain and Animal
(2) In
accordance
with
Article
11f
of
Regulation
(EC)
Health and finalised on 11 March 2011 in the format
No 1490/2002 and Article 12(1)(a) and
of the Commission review report for dichlobenil.
Article 12(2)(b) of that Regulation, Commission
Decision 2008/754/EC of 18 September 2008
concerning the non-inclusion of dichlobenil in Annex I
to Council Directive 91/414/EEC and the withdrawal of
(6) The
additional
report
by
the
rapporteur
Member
State
authorisations for plant protection products containing
and the conclusion by the Authority concentrate on
that substance ( 4 ) was adopted.
the concerns that lead to the non-inclusion; in particular,
there was a concern with regard to the consumer
exposure from drinking water and the leaching to
(3) The
original
notifier
(hereinafter
‘the
applicant’)
submitted
groundwater. More concerns were identified in the
a new application pursuant to Article 6(2) of Directive
review report for dichlobenil.
91/414/EEC requesting the accelerated procedure to be
applied, as provided for in Articles 14 to 19 of
Commission Regulation (EC) No 33/2008 of
(7) Additional
information
was
submitted
by
the
applicant,
17 January 2008 laying down detailed rules for the
in particular as regards the leaching to groundwater, the
application of Council Directive 91/414/EEC as regards
consumer exposure from drinking water, the risks to
a regular and an accelerated procedure for the assessment
birds and mammals and methods of analysis for
of active substances which were part of the programme
impurities in the technical material and for products of
of work referred to in Article 8(2) of that Directive but
animal origin.
have not been included into its Annex I ( 5 ).
(4) The
application
was
submitted
to
the
United
Kingdom, (8) However,
the
additional
information
provided
by
the
which had been designated rapporteur Member State by
applicant did not permit to eliminate all of the specific
concerns arising in respect of dichlobenil.
( 1 ) OJ L 230, 19.8.1991, p. 1.
( 2 ) OJ L 55, 29.2.2000, p. 25.
( 6 ) European Food Safety Authority; Conclusion on the peer review of
( 3 ) OJ L 224, 21.8.2002, p. 23.
the pesticide risk assessment of the active substance dichlobenil.
( 4 ) OJ L 258, 26.9.2008, p. 70.
EFSA Journal 2010;8(8):1705. [68 pp.]. doi:10.2903/j.efsa.2010.
( 5 ) OJ L 15, 18.1.2008, p. 5.
1705. Available online: www.efsa.europa.eu/efsajournal

---

EN
13.4.2011 Official
Journal
of
the
European
Union L
98/15
(9) During
the
evaluation
of
this
active
substance,
a
number (13) In
the
interest
of
clarity,
Decision
2008/754/EC
should
of concerns have been identified. Several unacceptable
be repealed.
effects on the environment were identified. In particular,
the potential groundwater contamination by the very
persistent metabolite 2,6-dichlorobenzamide (BAM) is
(14) This
Decision does not prejudice
the submission of
expected to be very high, with concentrations well
a further application for dichlobenil pursuant to
above 10 μg/l for all modelled scenarios. There is a
Article 6(2) of Directive 91/414/EEC and Chapter II of
potential for long-range transport of the metabolite
Regulation (EC) No 33/2008.
BAM through the atmosphere. A high acute risk to
birds and a high long-term risk to earthworm-eating
birds and mammals were identified. The available data
(15) The
measures provided for in this Decision are in
were insufficient to address the nature of residues of the
accordance with the opinion of the Standing
metabolite BAM in processed commodities.
Committee on the Food Chain and Animal Health,
HAS ADOPTED THIS DECISION:
(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 1
lation (EC) No 33/2008, the Commission invited the
applicant to submit comments on the draft review
Dichlobenil shall not be included as active substance in Annex I
report. The applicant submitted its comments, which
to Directive 91/414/EEC.
have been carefully examined.
Article 2
(11) However,
despite
the
arguments
put
forward
by
the
Commission Decision 2008/754/EC is repealed.
applicant, the concerns identified could not be elim
inated, and assessments made on the basis of the
information submitted and evaluated during the expert
Article 3
meetings of the Authority have not demonstrated that it
This Decision is addressed to the Member States.
may be expected that, under the proposed conditions of
use, plant protection products containing dichlobenil
satisfy in general the requirements laid down in
Done at Brussels, 11 April 2011.
Article 5(1)(a) and (b) of Directive 91/414/EEC.
For the Commission
(12) Dichlobenil
should
therefore
not
be
included
in
Annex
I
John DALLI
to Directive 91/414/EEC.
Member of the Commission

---