Directive 2009/160 - Amendment of Council Directive 91/414/EEC to include 2-phenylphenol as active substance - Main contents

EN

Official Journal of the European Union

L 338/83

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 2-phenylphenol.

For 2-phenylphenol 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 22 of Regulation (EC) No 2229/2004. For 2-phenylphenol the rapporteur Member State was Spain and all relevant information was submitted on 11 February 2008.

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 2-phenylphenol (4). 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 27 November 2009 in the format of the Commission review report for 2-phenylphenol.

It has appeared from the various examinations made that plant protection products containing 2-phenylphenol may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to include 2-phenylphenol in Annex I, in order to ensure that in all Member States the authorisations of plant protection products containing this active substance can be granted in accordance with the provisions of that Directive.

Without prejudice to that conclusion, it is appropriate to obtain further information on certain specific points. Article 6(1) of Directive 91/414/EEC provides that the inclusion of a substance in Annex I may be subject to conditions. Therefore it is appropriate to require that the notifier submit further information on the potential for skin depigmentation for workers and consumers due to possible exposure to the metabolite 2-phenylhydroquinone (PHQ) on citrus peel. In addition, the notifier should submit further information to confirm that the analytical method applied in residue trials correctly quantifies the residues of 2-phenylphenol, PHQ and their conjugates.

A reasonable period should be allowed to elapse before an active substance is included in Annex I in order to permit Member States and the interested parties to prepare themselves to meet the new requirements which will result from the inclusion. Since authorisations granted in accordance with the first subparagraph of Article 8(2) of Directive 91/414/EEC for plant protection products containing 2-phenylphenol expire on 31 December 2009 at the latest, this Directive should enter into force no later than 1 January 2010 to avoid a gap with respect to such plant protection...