COMMISSION DECISION
of 5 December 2008
concerning the non-inclusion of sulphuric acid 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) 7612)
(Text with EEA relevance)
(2008/937/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 includessulphuric acid.
(3) For sulphuric 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. Forsulphuric acid the rapporteur Member State was France
and all relevant information was submitted in October2007.
(4) The Commission examined sulphuric acid 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, it was concluded, taking into account
comments received from Member States, that the
existing evidence is not sufficient to finalise theconsumer risk assessment and to set a reliable AcceptableOperator Exposure Level (AOEL) and such value isnecessary to conduct the operator 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 peer review and on itsintention or not to further support the substance. Thenotifier submitted its comments which have been
carefully examined. However, despite the arguments put
forward by the notifier, the concerns identified could notbe eliminated, and assessments made on the basis of theinformation submitted have not demonstrated that itmay be expected that, under the proposed conditionsof use, plant protection products containing sulphuricacid satisfy in general the requirements laid down inArticle 5(1)(a) and (b) of Directive 91/414/EEC.
(7) Sulphuric acid 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 containingsulphuric acid are withdrawn within a fixed period oftime and are not renewed and that no new authorisationsfor such products are granted.EN L 334/88 Official Journal of the European Union 12.12.2008
(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 containingsulphuric acid should be limited to 12 months in orderto allow existing stocks to be used in one furthergrowing season, which ensures that plant protectionproducts containing sulphuric acid remain available tofarmers for 18 months from the adoption of this
Decision.
(10) This Decision does not prejudice the submission of an
application for sulphuric acid in accordance withArticle 6(2) of Directive 91/414/EEC and CommissionRegulation (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 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 inaccordance with the opinion of the StandingCommittee on the Food Chain and Animal Health,
HAS ADOPTED THIS DECISION:
Article 1
Sulphuric acid 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
sulphuric acid are withdrawn by 5 June 2009;
(b) no authorisations for plant protection products containing
sulphuric acid 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 5 June 2010at the latest.
Article 4
This Decision is addressed to the Member States.
Done at Brussels, 5 December 2008.
For the Commission
Androulla VASSILIOU
Member of the CommissionEN 12.12.2008 Official Journal of the European Union L 334/89
(1) OJ L 15, 18.1.2008, p. 5.