HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 105/28
EN
Official Journal of the European Union
21.4.2011
COMMISSION IMPLEMENTING DIRECTIVE 2011/54/EU
of 20 April 2011
amending Council Directive 91/414/EEC to include metaldehyde as active substance and amending
Commission Decision 2008/934/EC
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
(4) The
application
was
submitted
to
Austria,
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
Having regard to the Treaty on the Functioning of the European
substance and the supported uses are the same as were
Union,
the subject of Decision 2008/934/EC. That application
also complies with the remaining substantive and
procedural requirements of Article 15 of Regulation
Having regard to Council Directive 91/414/EEC of 15 July
(EC) No 33/2008.
1991 concerning the placing of plant protection products on
the market ( 1 ), and in particular Article 6(1) thereof,
(5) Austria
evaluated
the
additional
data
submitted
by
the
Whereas:
applicant and prepared an additional report. It
communicated that report to the European Food Safety
Authority (hereinafter ‘the Authority’) and to the
Commission on 5 January 2010. The Authority
(1) Commission
Regulations
(EC)
No
451/2000
( 2 ) and (EC)
communicated the additional report to the other
No 1490/2002 ( 3 ) lay down the detailed rules for the
Member States and the applicant for comments and
implementation of the second and third stages of the
forwarded the comments it had received to the
programme of work referred to in Article 8(2) of
Commission. In accordance with Article 20(1) of Regu
Directive 91/414/EEC and establish a list of active
lation (EC) No 33/2008 and at the request of the
substances to be assessed, with a view to their possible
Commission, the Authority presented its conclusion on
inclusion in Annex I to Directive 91/414/EEC. That list
metaldehyde to the Commission on 11 October 2010 ( 6 ).
included metaldehyde.
The draft assessment report, the additional report and the
conclusion of the Authority were reviewed by the
Member States and the Commission within the
(2) In
accordance
with
Article
11e
of
Regulation
(EC)
Standing Committee on the Food Chain and Animal
No 1490/2002 the notifier withdrew its support of the
Health and finalised on 11 March 2011 in the format
inclusion of that active substance in Annex I to Directive
of the Commission review report for metaldehyde.
91/414/EEC within two 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
(6)
It has appeared from the various examinations made that
to Council Directive 91/414/EEC and the withdrawal of
plant protection products containing metaldehyde may
authorisations for plant protection products containing
be expected to satisfy, in general, the requirements laid
these substances ( 4 ) was adopted on the non-inclusion
down in Article 5(1)(a) and (b) of Directive 91/414/EEC,
of metaldehyde.
in particular with regard to the uses which have been
examined and detailed in the Commission review report.
It is therefore appropriate to include metaldehyde in
Annex I, in order to ensure that in all Member States
(3)
Pursuant to Article 6(2) of Directive 91/414/EEC the
original notifier (hereinafter ‘the applicant’) submitted a
the authorisations of plant protection products
new application requesting the accelerated procedure to
containing this active substance can be granted in
be applied, as provided for in Articles 14 to 19 of
accordance with the provisions of that Directive.
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
(7) A
reasonable
period
should
be
allowed
to
elapse
before
of active substances which were part of the programme
an active substance is included in Annex I in order to
of work referred to in Article 8(2) of that Directive but
permit Member States and the interested parties to
have not been included into its Annex I ( 5 ).
prepare themselves to meet the new requirements
which will result from the inclusion.
( 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 metaldehyde.
( 4 ) OJ L 333, 11.12.2008, p. 11.
EFSA Journal 2010; 8(10):1856. [71 pp.]. doi:10.2903/j.efsa.
( 5 ) OJ L 15, 18.1.2008, p. 5.
2010.1856. Available online: www.efsa.europa.eu

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EN
21.4.2011 Official
Journal
of
the
European
Union L
105/29
(8) Without
prejudice
to
the
obligations
defined
by
Directive HAS ADOPTED THIS DIRECTIVE:
91/414/EEC as a consequence of including an active
substance in Annex I, Member States should be
allowed a period of six months after inclusion to
review existing authorisations of plant protection
Article 1
products containing metaldehyde to ensure that the
Annex I to Directive 91/414/EEC is amended as set out in the
requirements laid down by Directive 91/414/EEC, in
Annex to this Directive.
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 au-
thorisations, in accordance with the provisions of
Article 2
Directive 91/414/EEC. By derogation from the above
The line concerning metaldehyde in the Annex to Decision
deadline, a longer period should be provided for the
2008/934/EC is deleted.
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.
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
(9) The
experience
gained
from
previous
inclusions
in
Annex communicate to the Commission the text of those provisions
I to Directive 91/414/EEC of active substances assessed
and a correlation table between those provisions and this
in the framework of Commission Regulation (EEC)
Directive.
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
They shall apply those provisions from 1 December 2011.
plant protection products on the market ( 1 ) has shown
that difficulties can arise in interpreting the duties of
holders of existing authorisations in relation to access
When Member States adopt those provisions, they shall contain
to data. In order to avoid further difficulties it therefore
a reference to this Directive or be accompanied by such a
appears necessary to clarify the duties of the Member
reference on the occasion of their official publication. Member
States, especially the duty to verify that the holder of
States shall determine how such reference is to be made.
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 authori
Article 4
sations compared to the Directives which have been
1. Member States shall in accordance with Directive
adopted until now amending Annex I.
91/414/EEC, where necessary, amend or withdraw existing
authorisations for plant protection products containing metal
dehyde as an active substance by 30 November 2011.
(10) It is therefore appropriate to amend Directive
91/414/EEC accordingly.
By that date they shall in particular verify that the conditions in
Annex I to that Directive relating to metaldehyde are met, with
the exception of those identified in part B of the entry
concerning that active substance, and that the holder of the
(11) Decision
2008/934/EC
provides
for
the
non-inclusion
of
authorisation has, or has access to, a dossier satisfying the
metaldehyde and the withdrawal of authorisations for
requirements of Annex II to that Directive in accordance with
plant protection products containing that substance by
the conditions of Article 13 of that Directive.
31 December 2011. It is necessary to delete the line
concerning metaldehyde in the Annex to that Decision.
2. By way of derogation from paragraph 1, for each au-
thorised plant protection product containing metaldehyde as
either the only active substance or as one of several active
(12) It is therefore appropriate to amend Decision
substances all of which were listed in Annex I to Directive
2008/934/EC accordingly.
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
(13) The
measures provided for in this Directive are in
III to that Directive and taking into account part B of the entry
accordance with the opinion of the Standing
in Annex I to that Directive concerning metaldehyde. On the
Committee on the Food Chain and Animal Health,
basis of that evaluation, they shall determine whether the
product satisfies the conditions set out in Article 4(1)(b), (c),
( 1 ) OJ L 366, 15.12.1992, p. 10.
(d) and (e) of Directive 91/414/EEC.

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L 105/30
EN
Official Journal of the European Union
21.4.2011
Following that determination Member States shall:
Article 5
This Directive shall enter into force on 1 June 2011.
(a) in the case of a product containing metaldehyde as the only
active substance, where necessary, amend or withdraw the
Article 6
authorisation by 31 May 2015 at the latest; or
This Directive is addressed to the Member States.
(b) in the case of a product containing metaldehyde as one of
several active substances, where necessary, amend or
Done at Brussels, 20 April 2011.
withdraw the authorisation by 31 May 2015 or by the
date fixed for such an amendment or withdrawal in the
For the Commission
respective Directive or Directives which added the relevant
substance or substances to Annex I to Directive
The President
91/414/EEC, whichever is the latest.
José Manuel BARROSO

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21.4.2011 Off
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
EN
‘360 Metaldehyde
r-2, c-4, c-6, c-8-
≥ 985 g/kg
1 June 2011 31
May
2021 PART
A

tetramethyl-1,3,5,7-
CAS No:
tetroxocane
acetaldehyde max.
Only uses as molluscicide may be authorised.
1,5 g/kg
108-62-3 (tetramer)
PART B
9002-91-9
(homopolymer)
For the implementation of the uniform principles of Annex VI, the conclusions
of the review report on metaldehyde, and in particular Appendices I and II
CIPAC No: 62
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:
icial
(a) the risk to operators and workers;
Jour
(b) the dietary exposure situation of consumers in view of future revisions of
maximum residue levels;
nal
of
(c) the acute risk and long-term risk to birds and mammals.
the
Member States shall ensure that authorisations shall contain an effective dog
European
repellent agent.
Conditions of use shall include risk mitigation measures, where appropriate.’
Union
(1 ) Further details on identity and specification of active substance are provided in the review report.
L
105/31

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