COMMISSION DECISION
of 15 December 2008
concerning the non-inclusion of antraquinone 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) 8133)
(Text with EEA relevance)
(2008/986/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 Directive
91/414/EEC and establish a list of active substances to
be assessed with a view to their possible inclusion inAnnex I to Directive 91/414/EEC. That list includesantraquinone.
(3) For antraquinone the effects on human health and theenvironment have been assessed in accordance with theprovisions laid down in Regulations (EC) No 1112/2002and (EC) No 2229/2004 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 20 of Regulation (EC) No 2229/2004. Forantraquinone the rapporteur Member State was Belgium
and all relevant information was submitted in September2006.
(4) The Commission examined antraquinone in accordancewith Article 24a of Regulation (EC) No 2229/2004. Adraft review report for that substance was reviewed bythe 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.
(5) During the examination of this active substance by theCommittee, taking into account comments received fromMember States, it was concluded that there are clearindications that it may be expected that it has harmfuleffects on human health and in particular the crucialmissing data does not allow to set reliable acceptabledaily intake (ADI), acute reference dose (ARfD) andacceptable operator exposure level (AOEL) and suchvalues are necessary to conduct the risk assessment.Moreover, other concerns which were identified by therapporteur Member State in its assessment report areincluded in the review report for the substance.
(6) The Commission invited the notifier to submit itscomments on the results of the examination of antra­quinone and on its intention or not to further supportthe substance. The notifier submitted its commentswhich have been carefully examined. However, despitethe arguments put forward by the notifier, theconcerns identified could not be eliminated, andassessments made on the basis of the informationsubmitted have not demonstrated that it may beexpected that, under the proposed conditions of use,
plant protection products containing antraquinone
satisfy in general the requirements laid down inArticle 5(1)(a) and (b) of Directive 91/414/EEC.
(7) Antraquinone should therefore not be included in AnnexI to Directive 91/414/EEC.
(8) Measures should be taken to ensure that authorisationsgranted for plant protection products containing antra­quinone are withdrawn within a fixed period of time andare not renewed and that no new authorisations for suchproducts are granted.EN L 352/48 Official Journal of the European Union 31.12.2008
(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.(9) Any period of grace granted by a Member State for the
disposal, storage, placing on the market and use ofexisting stocks of plant protection products containingantraquinone should be limited to 12 months in order toallow existing stocks to be used in one further growingseason, which ensures that plant protection productscontaining antraquinone remain available for 18months from the adoption of this Decision.
(10) This Decision does not prejudice the submission of anapplication for antraquinone in accordance withArticle 6(2) of Directive 91/414/EEC and CommissionRegulation (EC) No 33/2008 of 17 January 2008laying down detailed rules for the application ofCouncil Directive 91/414/EEC as regards a regular andan accelerated procedure for the assessment of activesubstances which were part of the programme of workreferred to in Article 8(2) of that Directive but have notbeen 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 in
accordance with the opinion of the Standing
Committee on the Food Chain and Animal Health,
HAS ADOPTED THIS DECISION:
Article 1
Antraquinone shall not be included as an active substance in
Annex I to Directive 91/414/EEC.Article 2
Member States shall ensure that:
(a) authorisations for plant protection products containing
antraquinone are withdrawn by 15 June 2009;
(b) no authorisations for plant protection products containing
antraquinone are granted or renewed from the date ofpublication 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 15 June2010 at the latest.
Article 4
This Decision is addressed to the Member States.
Done at Brussels, 15 December 2008.
For the Commission
Androulla VASSILIOU
Member of the CommissionEN 31.12.2008 Official Journal of the European Union L 352/49
(1) OJ L 15, 18.1.2008, p. 5.