COMMISSION DECISION
of 16 March 2009
concerning the non-inclusion of triflumuron 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(2009) 1681)
(Text with EEA relevance)
(2009/241/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 are
gradually being examined within the framework of a
programme 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 ofwork 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 triflumuron.
(3) For triflumuron 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 accordancewith Article 10(1) of Regulation (EC) No 1490/2002. Fortriflumuron the rapporteur Member State was Italy andall relevant information was submitted on 15 July 2005.(4) The assessment report has been peer reviewed by theMember States and the EFSA within its Working GroupEvaluation and presented to the Commission on30 September 2008 in the format of the EFSAconclusion regarding the peer review of the pesticiderisk assessment of the active substance triflumuron (
4).
This report has been reviewed by the Member States
and the Commission within the Standing Committeeon the Food Chain and Animal Health and finalised on2 December 2008 in the format of the Commissionreview report for triflumuron.
(5) During the evaluation of this active substance, a numberof concerns have been identified. In particular, based onthe available information, it has not been demonstratedthat the consumer exposure is acceptable due to lack ofdata in terms of nature and level of the relevant residues.In fact, it was not possible to perform an acute riskassessment for the metabolite M07, because data wasnot sufficient to allocate an acute reference dose for
this metabolite. Moreover, data were missing to
determine an appropriate residue definition and toestimate the level of residues in processed fruitcommodities. In addition, a high risk to aquaticorganisms has been identified. Consequently, it was notpossible to conclude on the basis of the informationavailable that triflumuron met the criteria for inclusionin Annex I to Directive 91/414/EEC.
(6) The Commission invited the notifier to submit itscomments 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 put
forward by the notifier, the concerns identified could not
be 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 triflumuron satisfyin general the requirements laid down in Article 5(1)(a)and (b) of Directive 91/414/EEC.
(7) Triflumuron should therefore not be included in Annex Ito Directive 91/414/EEC.EN 17.3.2009 Official Journal of the European Union L 71/59
(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) 194, Conclusion on the peer review
of triflumuron, finalised 30 September 2008.(8) Measures should be taken to ensure that authorisations
granted for plant protection products containingtriflumuron are withdrawn within a fixed period oftime and 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 containingtriflumuron should be limited to 12 months in order toallow existing stocks to be used in one further growingseason, which ensures that plant protection products
containing triflumuron remain available to farmers for
18 months from the adoption of this Decision.
(10) This Decision does not prejudice the submission of anapplication for triflumuron according to the provisions
of Article 6(2) of Directive 91/414/EEC, the detailed im­
plementation rules of which have been laid down inCommission Regulation (EC) No 33/2008 of17 January 2008 laying down detailed rules for theapplication of Council Directive 91/414/EEC as regardsa regular and an accelerated procedure for the assessmentof active substances which were part of the programmeof work referred to in Article 8(2) of that Directive buthave not been included 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
Triflumuron 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
triflumuron are withdrawn by 16 September 2009;
(b) no authorisations for plant protection products containing
triflumuron 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 on16 September 2010 at the latest.
Article 4
This Decision is addressed to the Member States.
Done at Brussels, 16 March 2009.
For the Commission
Androulla VASSILIOU
Member of the CommissionEN L 71/60 Official Journal of the European Union 17.3.2009
(1) OJ L 15, 18.1.2008, p. 5.