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11.4.2012 Official
Journal
of
the
European
Union L
101/15
COMMISSION IMPLEMENTING DECISION
of 4 April 2012
amending Decision 2001/861/EC as regards novaluron
(notified under document C(2012) 2164)
(Text with EEA relevance)
(2012/187/EU)
THE EUROPEAN COMMISSION,
detailed rules for the implementation of Council Directive
91/414/EEC as regards the procedure for the assessment
of active substances which were not on the market 2
Having regard to the Treaty on the Functioning of the European
years after the date of notification of that Directive (
Union,

4 )
the European Food Safety Authority (‘the Authority’)
asked the rapporteur Member State on 16 June 2011
Having regard to Council Directive 91/414/EEC of 15 July
to request additional information from the applicant.
1991 concerning the placing of plant protection products on
the market ( 1 ), and in particular Article 6(3) thereof,
(6) By
letter
of
29
February
2012
the
applicant
informed
the
United Kingdom, the Authority and the Commission of
Having regard to Regulation (EC) No 1107/2009 of the
its intention not to support the evaluation any further
European Parliament and of the Council of 21 October 2009
and not to submit further data. By the same letter the
concerning the placing of plant protection products on the
applicant withdrew its application. Since the additional
market and repealing Council Directives 79/117/EEC and
information requested by the Authority was not
91/414/EEC (
submitted, the dossier can no longer be considered to

2 ), and in particular Article 80(1)(a) thereof,
be complete.
Whereas:
(7) Decision
2001/861/EC
should
therefore
be
amended
accordingly.
(1) In
accordance
with
Article
80(1)(a)
of
Regulation
(EC)
No
1107/2009, Directive 91/414/EEC shall continue to
(8) Existing
provisional
authorisations
should,
consequently,
apply to active substances for which a decision has
be withdrawn and no new authorisations granted.
been adopted in accordance with Article 6(3) of
Directive 91/414/EEC before 14 June 2011.
(9) For
plant
protection
products
containing
novaluron,
where Member States grant any period of grace in
(2) In
accordance
with
Article
6(2)
of
Directive
91/414/EEC
accordance with Article 4(6) of Directive 91/414/EEC,
the United Kingdom received on 29 March 2001 an
this period should expire at the latest one year after
application from Makhteshim Agan Ltd, for the
the withdrawal of the respective authorisation.
inclusion of the active substance novaluron in Annex I
to Directive 91/414/EEC.
(10) The
measures provided for in this Decision are in
accordance with the opinion of the Standing
(3) By
Commission
Decision
2001/861/EC
(
Committee on the Food Chain and Animal Health,

3 ) it was
confirmed that, on preliminary examination, the dossier
was considered ‘complete’, in that it could be considered
HAS ADOPTED THIS DECISION:
as satisfying, in principle, the data and information
requirements of Annex II and Annex III to Directive
91/414/EEC.
Article 1

The Annex to Decision 2001/861/EC is replaced by the text in
the Annex to this Decision.
(4) Member
States
where
thereby
given
the
possibility
to
grant provisional authorisations, for plant protection
products containing novaluron for an initial period of
Article 2
three years, in accordance with Article 8(1) of Directive
91/414/EEC. That initial period of three years can start at
Member States shall ensure that:
any time, as soon as an application is assessed.
(a) authorisations for plant protection products containing
novaluron are withdrawn by 3 October 2012;
(5) In
accordance
with
the
second
sentence
of
the
third
subparagraph of Article 11(6) of Commission Regulation
(EU) No 188/2011 of 25 February 2011 laying down
(b) no authorisations for plant protection products containing
novaluron are granted or renewed from the date of
publication of this Decision.
( 1 ) OJ L 230, 19.8.1991, p. 1.
( 2 ) OJ L 309, 24.11.2009, p. 1.
( 3 ) OJ L 321, 6.12.2001, p. 34.
( 4 ) OJ L 53, 26.2.2011, p. 51.

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L 101/16
EN
Official Journal of the European Union
11.4.2012
Article 3
Any period of grace granted by Member States in accordance with Article 4(6) of Directive 91/414/EEC
shall be as short as possible and shall expire 12 months after withdrawal of the respective authorisation at
the latest.
Article 4
This Decision is addressed to the Member States.
Done at Brussels, 4 April 2012.
For the Commission
John DALLI
Member of the Commission

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EN
11.4.2012 Official
Journal
of
the
European
Union L
101/17
ANNEX
‘ANNEX
ACTIVE SUBSTANCES CONCERNED BY THIS DECISION
No
Common Name,
CIPAC Identification Number
Notifier Date
of
application Rapporteur
Member
State
1 Laminarin
Laboratoires Gomar SA,
29 March 2001 Belgium’
CIPAC No 671
France

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Document Outline

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