19.12.2009 Official Journal of the European Union L 338/83 COMMISSION DIRECTIVE 2009/160/EU of 17 December 2009 amending Council Directive 91/414/EEC to include 2-phenylphenol as active substance (Text with EEA relevance) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market ('), and in particular Article 6(1) thereof, Whereas: (1)  Commission Regulations (EC) No 1112/2002 (?) and (EC) No 2229/2004 (}) 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. (2)  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. (3)  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 (*). 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. (4) It has appeared from the various examinations made that plant protection products containing 2-phenylphenol ) OJ L 230, 19.8.1991, p. 1. () O () OJ L 168, 27.6.2002, p. 14. () OJ L 379, 24.12.2004, p. 13. (*) EFSA Scientific Report (2008) 217, Conclusion regarding the peer review of the pesticide risk assessment of the active substance 2- phenylphenol (finalised 19 December 2008). 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. (5)  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-phenylhydro- quinone (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. (6) 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 products. (7 Until MRLs have been set in accordance with Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414[EEC (°), European Parliament and Council Directive 95/2/EC of 20 February 1995 on food additives other than colours and sweeteners (°) continues to apply to 2-phenylphenol. For the sake of clarity and to avoid an overlap, it is therefore necessary that the date of application of this Directive is such that the same date may be set for the application of the MRLs adopted for 2-phenylphenol, pursuant to Regulation (EC) No 396/2005. () O] L 70, 16.3.2005, p. 1. (6 OJ L 61, 18.3.1995, p. 1.