II
(Acts adopted under the EC Treaty/Euratom Treaty whose publication is not obligatory)
DECISIONS
COMMISSION
COMMISSION DECISION
of 8 December 2008
concerning the non-inclusion of nicotine in Annex I to Council Directive 91/414/EEC and the
withdrawal of authorisations for plant protection products containing that substance
(notified under document number C(2008) 7714)
(Text with EEA relevance)
(2009/9/EC)
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European
Community,
Having regard to Council Directive 91/414/EEC of 15 July 1991
concerning the placing of plant protection products on themarket (
1), and in particular the fourth subparagraph of
Article 8(2) thereof,
Whereas:
(1) Article 8(2) of Directive 91/414/EEC provides that a
Member State may, during a period of 12 yearsfollowing the notification of that Directive, authorisethe placing on the market of plant protection productscontaining active substances not listed in Annex I to thatDirective that are already on the market two years afterthe date of notification, while those substances aregradually being examined within the framework of aprogramme of work.
(2) Commission Regulations (EC) No 1112/2002 (2) and (EC)
No 2229/2004 (3) lay down the detailed rules for the
implementation of the fourth stage of the programmeof work referred to in Article 8(2) of Directive91/414/EEC and establish a list of active substances tobe assessed with a view to their possible inclusion inAnnex I to Directive 91/414/EEC. That list includes
nicotine.
(3) For nicotine the effects on human health and the envi­ronment have been assessed in accordance with theprovisions laid down in Regulations (EC) No1112/2002 and (EC) No 2229/2004 for a range ofuses proposed by the notifier. Moreover, those Regu­
lations designate the rapporteur Member States which
have to submit the relevant assessment reports andrecommendations to the European Food SafetyAuthority (EFSA) in accordance with Article 20 of Regu­lation (EC) No 2229/2004. For nicotine the rapporteurMember State was the United Kingdom and all relevantinformation was submitted in January 2008.
(4) The Commission examined nicotine in accordance withArticle 24a of Regulation (EC) No 2229/2004. A draftreview report for that substance was reviewed by theMember States and the Commission within theStanding Committee on the Food Chain and AnimalHealth and finalised on 26 September 2008 in theformat of the Commission review report.
(5) During the examination of this active substance by theCommittee, it was concluded, taking into accountcomments received from Member States, that theexisting evidence is not sufficient to demonstrate a safeuse with respect to operators, workers, bystanders andconsumers. Moreover, other concerns which were iden­tified by the rapporteur Member State in its assessmentreport are included in the review report for thesubstance.EN 9.1.2009 Official Journal of the European Union L 5/7
(1) OJ L 230, 19.8.1991, p. 1.
(2) OJ L 168, 27.6.2002, p. 14.
(3) OJ L 379, 24.12.2004, p. 13.(6) The Commission invited the notifier to submit its
comments on the results of the peer review and on itsintention or not to further support the substance. Thenotifier submitted its comments which have beencarefully examined. However, despite the arguments putforward by the notifier, the concerns identified could notbe eliminated, and assessments made on the basis of theinformation submitted have not demonstrated that it
may be expected that, under the proposed conditions
of use, plant protection products containing nicotinesatisfy in general the requirements laid down inArticle 5(1)(a) and (b) of Directive 91/414/EEC.
(7) Nicotine should therefore not be included in Annex I toDirective 91/414/EEC.
(8) Measures should be taken to ensure that authorisationsgranted for plant protection products containing nicotineare withdrawn within a fixed period of time and are notrenewed and that no new authorisations for suchproducts are granted.
(9) Any period of grace granted by a Member State for thedisposal, storage, placing on the market and use ofexisting stocks of plant protection products containingnicotine should be limited to 12 months in order toallow existing stocks to be used in one further growingseason, which ensures that plant protection productscontaining nicotine remain available to farmers for 18months from the adoption of this Decision.
(10) This Decision does not prejudice the submission of anapplication for nicotine in accordance with Article 6(2)of Directive 91/414/EEC and 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 acceleratedprocedure for the assessment of active substanceswhich were part of the programme of work referred toin Article 8(2) of that Directive but have not beenincluded into its Annex I (
1), in view of a possible
inclusion in its Annex I.(11) The measures provided for in this Decision are inaccordance with the opinion of the StandingCommittee on the Food Chain and Animal Health,
HAS ADOPTED THIS DECISION:
Article 1
Nicotine shall not be included as active substance in Annex I to
Directive 91/414/EEC.
Article 2
Member States shall ensure that:
(a) authorisations for plant protection products containing
nicotine are withdrawn by 8 June 2009;
(b) no authorisations for plant protection products containing
nicotine are granted or renewed from the date of publi­cation of this Decision.
Article 3
Any period of grace granted by Member States in accordance
with the provisions of Article 4(6) of Directive 91/414/EEC,shall be as short as possible and shall expire on 8 June 2010at the latest.
Article 4
This Decision is addressed to the Member States.
Done at Brussels, 8 December 2008.
For the Commission
Androulla VASSILIOU
Member of the CommissionEN L 5/8 Official Journal of the European Union 9.1.2009
(1) OJ L 15, 18.1.2008, p. 5.