Commission Implementing Directive 2011/49/EU
of
18 April 2011
amending Council Directive 91/414/EEC to include
pencycuron as
active substance and amending Commission Decision 2008/934/EC
(Text with EEA
relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the
Functioning of the European Union,
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,
Whereas:
(1)
Commission Regulations (EC) No 451/2000 [2] and (EC) No 1490/2002 [3] lay down
the detailed rules for the implementation of the third stage of the programme of
work referred to in Article 8(2) of Directive 91/414/EEC and establish a list of
active substances to be assessed, with a view to their possible inclusion in
Annex I to Directive 91/414/EEC. That list included
pencycuron.
(2) In
accordance with Article 11e of Regulation (EC) No 1490/2002 the notifier
withdrew its support of the inclusion of that active substance in Annex I to
Directive 91/414/EEC within 2 months from receipt of the draft assessment
report. Consequently, Commission Decision 2008/934/EC of 5 December 2008
concerning the non-inclusion of certain active substances in Annex I to Council
Directive 91/414/EEC and the withdrawal of authorisations for plant protection
products containing these substances [4] was adopted on the non-inclusion of
pencycuron.
(3) 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 be applied, as provided for in Articles 14 to 19 of
Commission Regulation (EC) No 33/2008 of 17 January 2008 laying down detailed
rules for the application of Council Directive 91/414/EEC as regards a regular
and an accelerated procedure for the assessment of active substances 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].
(4) The application was
submitted to the Netherlands, which had been designated rapporteur Member State
by 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 as were the subject of Decision 2008/934/EC. That application also
complies with the remaining substantive and procedural requirements of Article
15 of Regulation (EC) No 33/2008.
(5) The Netherlands evaluated the
additional data submitted by the applicant and prepared an additional report. It
communicated that report to the European Food Safety Authority (hereinafter "the
Authority") and to the Commission on 4 December 2009. The Authority communicated
the additional report to the other Member States and the applicant for comments
and forwarded the comments it had received to the Commission. In accordance with
Article 20(1) of Regulation (EC) No 33/2008 and at the request of the
Commission, the Authority presented its conclusion on pencycuron to the
Commission on 24 September 2010 [6]. The draft assessment report, the additional
report and the conclusion of the Authority were reviewed by the Member States
and the Commission within the Standing Committee on the Food Chain and Animal
Health and finalised on 11 March 2011 in the format of the Commission review
report for pencycuron.
(6) It has appeared from the various examinations made
that plant protection products containing pencycuron may be expected to satisfy,
in general, the requirements laid down in Article 5(1)(a) and (b) of Directive
91/414/EEC, in particular with regard to the uses which have been examined and
detailed in the Commission review report. It is therefore appropriate to include
pencycuron in Annex I, in order to ensure that in all Member States the
authorisations of plant protection products containing this active substance can
be granted in accordance with the provisions of that Directive.
(7) Without
prejudice to that conclusion, it is appropriate to obtain further information on
certain specific points. Article 6(1) of Directive 91/414/EEC provides that
inclusion of a substance in Annex I may be subject to conditions. Therefore, it
is appropriate to require that the applicant submit confirmatory information as
regards the fate and behaviour in soil of the chlorophenyl and cyclopentyl
portions of pencycuron, the fate and behaviour in natural surface water and
sediment systems of the chlorophenyl and phenyl portions of pencycuron, the
long-term risk to large omnivorous mammals.
(8) A reasonable period should be
allowed to elapse before an active substance is included in Annex I in order to
permit Member States and the interested parties to prepare themselves to meet
the new requirements which will result from the inclusion.
(9) Without
prejudice to the obligations defined by Directive 91/414/EEC as a consequence of
including an active substance in Annex I, Member States should be allowed a
period of 6 months after inclusion to review existing authorisations of plant
protection products containing pencycuron to ensure that the requirements laid
down by Directive 91/414/EEC, in particular in its Article 13 and the relevant
conditions set out in Annex I, are satisfied. Member States should vary, replace
or withdraw, as appropriate, existing authorisations, in accordance with the
provisions of Directive 91/414/EEC. By derogation from the above deadline, a
longer period should be provided for the submission and assessment of the
complete Annex III dossier of each plant protection product for each intended
use in accordance with the uniform principles laid down in Directive
91/414/EEC.
(10) The experience gained from previous inclusions in Annex I to
Directive 91/414/EEC of active substances assessed in the framework of
Commission Regulation (EEC) No 3600/92 of 11 December 1992 laying down the
detailed rules for the implementation of the first stage of the programme of
work referred to in Article 8(2) of Council Directive 91/414/EEC concerning the
placing of plant protection products on the market [7] has shown that
difficulties can arise in interpreting the duties of holders of existing
authorisations in relation to access to data. In order to avoid further
difficulties it therefore appears necessary to clarify the duties of the Member
States, especially the duty to verify that the holder of an authorisation
demonstrates access to a dossier satisfying the requirements of Annex II to that
Directive. However, this clarification does not impose any new obligations on
Member States or holders of authorisations compared to the directives which have
been adopted until now amending Annex I.
(11) It is therefore appropriate to
amend Directive 91/414/EEC accordingly.
(12) Decision 2008/934/EC provides
for the non-inclusion of pencycuron and the withdrawal of authorisations for
plant protection products containing that substance by 31 December 2011. It is
necessary to delete the line concerning pencycuron in the Annex to that
Decision.
(13) It is therefore appropriate to amend Decision 2008/934/EC
accordingly.
(14) The measures provided for in this Directive are in
accordance with the opinion of the Standing Committee on the Food Chain and
Animal Health,
HAS ADOPTED THIS DIRECTIVE:
Article 1
Annex I to
Directive 91/414/EEC is amended as set out in the Annex to this
Directive.
Article 2
The line concerning pencycuron in the Annex to
Decision 2008/934/EC is deleted.
Article 3
Member States shall adopt and
publish by 30 November 2011 at the latest the laws, regulations and
administrative provisions necessary to comply with this Directive. They shall
forthwith communicate to the Commission the text of those provisions and a
correlation table between those provisions and this Directive.
They shall
apply those provisions from 1 December 2011.
When Member States adopt those
provisions, they shall contain a reference to this Directive or be accompanied
by such a reference on the occasion of their official publication. Member States
shall determine how such reference is to be made.
Article 4
1. Member
States shall in accordance with Directive 91/414/EEC, where necessary, amend or
withdraw existing authorisations for plant protection products containing
pencycuron as an active substance by 30 November 2011.
By
that date they shall in particular verify that the conditions in Annex I to that
Directive relating to pencycuron are met, with the exception of those identified
in part B of the entry concerning that active substance, and that the holder of
the authorisation has, or has access to, a dossier satisfying the requirements
of Annex II to that Directive in accordance with the conditions of Article 13 of
that Directive.
2. By way of derogation from paragraph 1, for each authorised
plant protection product containing pencycuron as either the only active
substance or as one of several active substances all of which were listed in
Annex I to Directive 91/414/EEC by 31 May 2011 at the latest, Member States
shall re-evaluate the product in accordance with the uniform principles provided
for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying
the requirements of Annex III to that Directive and taking into account part B
of the entry in Annex I to that Directive concerning pencycuron. On the basis of
that evaluation, they shall determine whether the product satisfies the
conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive
91/414/EEC.
Following that determination Member States shall:
(a) in the
case of a product containing pencycuron as the only active substance, where
necessary, amend or withdraw the authorisation by 31 May 2015 at the latest;
or
(b) in the case of a product containing pencycuron as one of several
active substances, where necessary, amend or withdraw the authorisation by 31
May 2015 or by the date fixed for such an amendment or withdrawal in the
respective Directive or Directives which added the relevant substance or
substances to Annex I to Directive 91/414/EEC, whichever is the
latest.
Article 5
This Directive shall enter into force on 1 June
2011.
Article 6
This Directive is addressed to the Member States.
Done
at Brussels, 18 April 2011.
For the Commission
The President
José
Manuel Barroso
[1] OJ L 230, 19.8.1991, p. 1.
[2] OJ L 55, 29.2.2000, p.
25.
[3] OJ L 224, 21.8.2002, p. 23.
[4] OJ L 333, 11.12.2008, p.
11.
[5] OJ L 15, 18.1.2008, p. 5.
[6] European Food Safety Authority;
Conclusion on the peer review of the pesticide risk assessment of the active
substance pencycuron. Summary: EFSA Journal 2010; 8(10):1828. [53 pp.].
doi:10.2903/j.efsa.2010.1828. Available online: www.efsa.europa.eu
[7] OJ L
366, 15.12.1992, p.
10.
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ANNEX
The
following entry shall be added at the end of the table in Annex I to Directive
91/414/EEC:
No | Common name, identification numbers | IUPAC name | Purity
[1] | Entry into force | Expiration of inclusion | Specific provisions |
"354
| Pencycuron CAS No 66063-05-6 CIPAC No 402 |
1-(4-chlorobenzyl)-1-cyclopentyl-3-phenylurea | ≥ 980 g/kg | 1 June 2011 | 31
May 2021 | PART AOnly uses as fungicide may be authorised.PART BFor the
implementation of the uniform principles of Annex VI, the conclusions of the
review report on pencycuron, and in particular Appendices I and II thereof, as
finalised in the Standing Committee on the Food Chain and Animal Health on 11
March 2011 shall be taken into account.In this overall assessment Member States
shall pay particular attention to the protection of large omnivorous
mammals.Conditions of use shall include risk mitigation measures, where
appropriate.The Member States concerned shall request the submission of
confirmatory information as regards:(1)the fate and behaviour in soil of the
chlorophenyl and cyclopentyl portions of pencycuron;(2)the fate and behaviour in
natural surface water and sediment systems of the chlorophenyl and phenyl
portions of pencycuron;(3)the long-term risk to large omnivorous mammals.The
Member States concerned shall ensure that the applicant submits to the
Commission the information set out in points (1), (2) and (3) by 31 May 2013."
|
[1] Further details on identity and specification of active substance are
provided in the review report.
