COMMISSION DECISION
of 12 December 2008
concerning the non-inclusion of bone oil 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) 8083)
(Text with EEA relevance)
(2008/943/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 includesbone oil.
(3) For bone oil acid 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. Forbone oil the rapporteur Member State was Belgium and
all relevant information was submitted in October 2006.
(4) The Commission examined bone oil 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, 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) and acute reference dose (ARfD) andsuch values are necessary to conduct the risk assessment.In addition, the operator exposure is greater than 100 %of the acceptable operator exposure level (AOEL) in allmodelled scenarios. Moreover, other concerns whichwere identified by the rapporteur Member State in itsassessment report are included in the review report forthe substance.
(6) The Commission invited the notifier to submit itscomments on the results of the examination of boneoil and on its intention or not to further support thesubstance. The notifier submitted its comments whichhave been carefully examined. However, despite thearguments put forward by the notifier, the concerns iden­tified could not be eliminated, and assessments made onthe basis of the information submitted have not demon­strated that it may be expected that, under the proposed
conditions of use, plant protection products containing
bone oil satisfy in general the requirements laid down inArticle 5(1)(a) and (b) of Directive 91/414/EEC.
(7) Bone oil 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 bone oilare withdrawn within a fixed period of time and are notrenewed and that no new authorisations for suchproducts are granted.EN 13.12.2008 Official Journal of the European Union L 335/97
(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 containingbone oil should be limited to 12 months in order toallow existing stocks to be used in one further growingseason, which ensures that plant protection productscontaining bone oil remain available for 18 monthsfrom the adoption of this Decision.
(10) This Decision does not prejudice the submission of anapplication for bone oil in accordance with Article 6(2)of Directive 91/414/EEC and Commission Regulation(EC) No 33/2008 of 17 January 2008 laying downdetailed rules for the application of Council Directive91/414/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 Standing
Committee on the Food Chain and Animal Health,
HAS ADOPTED THIS DECISION:
Article 1
Bone oil 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
bone oil are withdrawn by 12 June 2009;
(b) no authorisations for plant protection products containing
bone oil 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 12 June2010 at the latest.
Article 4
This Decision is addressed to the Member States.
Done at Brussels, 12 December 2008.
For the Commission
Androulla VASSILIOU
Member of the CommissionEN L 335/98 Official Journal of the European Union 13.12.2008
(1) OJ L 15, 18.1.2008, p. 5.