Council Directive 2009/116/EC of 25 June 2009 amending Directive 91/414/EEC to include paraffin oils CAS No 64742-46-7, CAS No 72623-86-0 and CAS No 97862-82-3 as active substances (Text with EEA relevance)

Published date09 September 2009
Official Gazette PublicationOfficial Journal of the European Union, L 237, 09 September 2009
L_2009237EN.01000701.xml
9.9.2009 EN Official Journal of the European Union L 237/7

COUNCIL DIRECTIVE 2009/116/EC

of 25 June 2009

amending Directive 91/414/EEC to include paraffin oils CAS No 64742-46-7, CAS No 72623-86-0 and CAS No 97862-82-3 as active substances

(Text with EEA relevance)

THE COUNCIL OF THE EUROPEAN UNION,

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 the market (1), and in particular Article 6(1) thereof,

Whereas:

(1) Article 8(2) of Directive 91/414/EEC provides that a Member State may, during a period of 12 years following the notification of that Directive, authorise the placing on the market of plant protection products containing active substances not listed in Annex I to that Directive that are already on the market 2 years after the date of notification, while those substances are gradually being examined within the framework of a programme 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 programme of 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 in Annex I to Directive 91/414/EEC. That list includes paraffin oils CAS No 64742-46-7, CAS No 72623-86-0 and CAS No 97862-82-3.
(3) For paraffin oils CAS No 64742-46-7, CAS No 72623-86-0 and CAS No 97862-82-3 the effects on human health and the environment have been assessed in accordance with the provisions laid down in Regulations (EC) No 1112/2002 and (EC) No 2229/2004 for a range of uses proposed by the notifier. Moreover, those Regulations designate the rapporteur Member States which have to submit the relevant assessment reports and recommendations to the European Food Safety Authority (EFSA) in accordance with Article 10(1) of Regulation (EC) No 2229/2004. For paraffin oils CAS No 64742-46-7, CAS No 72623-86-0 and CAS No 97862-82-3 the rapporteur Member State was Greece and all relevant information was submitted on 6 May 2008.
(4) The assessment report has been peer reviewed by the Member States and the EFSA and presented to the Commission on 19 December 2008 in the format of the EFSA Scientific Report for paraffin oils CAS No 64742-46-7, CAS No 72623-86-0 and CAS No 97862-82-3. This report has been reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 12 April 2009 in the format of the Commission review report for paraffin oils CAS No 64742-46-7, CAS No 72623-86-0 and CAS No 97862-82-3.
(5) During the evaluation of these active substances, a number of concerns have been identified. In particular, the evidence produced during this evaluation was not sufficient to demonstrate a safe use with respect to operators, workers, bystanders and consumers. Consequently, it was not possible to conclude, on the basis of the information made available at that stage, that paraffin oils CAS No 64742-46-7, CAS No 72623-86-0 and CAS No 97862-82-3 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 its intention or not to further support the substances. The notifier submitted its comments which have been carefully examined. However, despite the arguments put forward by the notifier, the Commission initially found that the concerns identified could not be completely eliminated.
(7) However, in the light of the information before the Council it appears that the concerns are related to the lack of specifications and should be solved when the purity of the substances is demonstrated. In particular, as stated in the EFSA scientific report if it can be demonstrated that paraffin oils are of high purity (i.e. 100 %) no toxicological concern should be raised. For
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