COMMISSION DECISION
of 13 January 2009
concerning the non-inclusion of flurprimidol 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) 8967)
(Text with EEA relevance)
(2009/28/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 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/EECand establish a list of active substances to be assessedwith a view to their possible inclusion in Annex I toDirective 91/414/EEC. That list includes flurprimidol.
(3) For flurprimidol the effects on human health and theenvironment have been assessed in accordance with theprovisions laid down in Regulations (EC) No 451/2000and (EC) No 1490/2002 for a range of uses proposed bythe notifier. Moreover, those Regulations designate therapporteur Member States which have to submit therelevant assessment reports and recommendations tothe European Food Safety Authority (EFSA) in accordance
with Article 10(1) of Regulation (EC) No 1490/2002. Forflurprimidol the rapporteur Member State was Finlandand all relevant information was submitted on 20 April2007.
(4) The assessment report has been peer reviewed by theMember States and the EFSA within its Working Group
Evaluation and presented to the Commission on 31 July
2008 in the format of the EFSA conclusion regarding thepeer review of the pesticide risk assessment of the activesubstance flurprimidol (
4). This report has been reviewed
by the Member 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 for flurprimidol.
(5) During the evaluation of this active substance, a numberof concerns have been identified. In particular, based onthe available information, the operator and workerexposure exceed the AOEL (acceptable operatorexposure level) in all evaluated scenarios and conditionsof use. Moreover, no data was available on the impurityprofile of batches used in toxicological studies. Conse­quently, it was not possible to conclude on the basisof the information available that flurprimidol met the
criteria for inclusion in Annex I to Directive 91/414/EEC.
(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 and evaluated during the EFSAexpert meetings have not demonstrated that it may beexpected that, under the proposed conditions of use,plant protection products containing flurprimidol satisfyin general the requirements laid down in Article 5(1)(a)and (b) of Directive 91/414/EEC.EN 15.1.2009 Official Journal of the European Union L 10/25
(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)EFSA Scientific Report (2008) 151, Conclusion on the peer review of
flurprimidol, finalised 31 July 2008.(7) Flurprimidol should therefore not be included in Annex I
to Directive 91/414/EEC.
(8) Measures should be taken to ensure that authorisationsgranted for plant protection products containing flur­primidol are withdrawn within a fixed period of timeand are not renewed and that no new authorisationsfor such products 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 containingflurprimidol should be limited to 12 months in order toallow existing stocks to be used in one further growingseason, which ensures that plant protection productscontaining flurprimidol remain available to farmers for18 months from the adoption of this Decision.
(10) This Decision does not prejudice the submission of anapplication for flurprimidol according to the provisionsof Article 6(2) of Directive 91/414/EEC, the detailed im­plementation rules of which have been laid down inCommission Regulation (EC) No 33/2008 (
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
Flurprimidol 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 flur­
primidol are withdrawn by 13 July 2009;
(b) no authorisations for plant protection products containing
flurprimidol 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 13 July2010 at the latest.
Article 4
This Decision is addressed to the Member States.
Done at Brussels, 13 January 2009.
For the Commission
Androulla VASSILIOU
Member of the CommissionEN L 10/26 Official Journal of the European Union 15.1.2009
(1) OJ L 15, 18.1.2008, p. 5.