L 59/26 Official Journal of the European Union 4.3.2011 DIRECTIVES COMMISSION DIRECTIVE 2011/22/EU of 3 March 2011 amending Council Directive 91/414/EEC to include bispyribac 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 (1), and in particular Article 6(1) thereof, Whereas: (1) In accordance with Article 6(2) of Directive 91/414/EEC Italy received on 26 February 2002 an application from Bayer CropScience for the inclusion of the active substance bispyribac (also called bispyribac sodium, according to the form in which the active substance is contained in the representative formulation on which the dossier is based) in Annex I to Directive 91/414/EEC. Commission Decision 2003/305/EC (3 confirmed that the dossier was ‘complete’ in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes Il and I to Directive 91/414/EEC. For that active substance, the effects on human health and the environment have been assessed, in accordance with the provisions of Article 6(2) and (4) of Directive 91/414/[EEC, for the uses proposed by the applicant. The designated rapporteur Member State submitted a draft assessment report on 1 August 2003. The draft assessment report was peer reviewed by the Member States and the European Food Safety Authority (EFSA) in the format of the EFSA conclusion on the peer review of the pesticide risk assessment of the active substance bispyribac on 12 July 2010 (*). This report was reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and () OJ L 230, 19.8.1991, p. 1. () OJ L 112, 6.5.2003, p. 10. (}) EFSA Journal (2010) 8(1):1692, Conclusion on the peer review of the pesticide risk assessment of the active substance bispyribac (unless otherwise stated all data evaluated refer to the variant bispyribac-sodium). doi:10.2903/j.efsa.2010.1692. Available online: www.efsa.europa.eu Animal Health and was finalised on 28 January 2011 in the format of the Commission review report for bispyribac. It has appeared from the various examinations made that plant protection products containing bispyribac may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) and Article 5(3) 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 bispyribac in Annex I to that Directive, in order to ensure that in all Member States the authori- sations of plant protection products containing this active substance may be granted in accordance with the provisions of that Directive. Without prejudice to that conclusion, it is appropriate to obtain confirmatory 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 applicant submit further information to confirm the risk assessment on the potential for groundwater contamination by metabolites MO03 (), MO04 (5) and M10 (°). Without prejudice to the obligations defined by Directive 91/414[EEC as a consequence of including an active substance in Annex I, Member States should be allowed a period of 6 months after inclusion to review existing provisional authorisations of plant protection products containing bispyribac to ensure that the requirements laid down by Directive 91/414/EEC, in particular in its Article 13 and the relevant conditions set out in Annex I, are satisfied. Member States should transform existing provisional authorisations into full authorisations, amend them or withdraw them in accordance with the provisions of Directive 91/414/EEC. By derogation from the above deadline, a longer period should be provided for the submission and assessment of the complete Annex III dossier of each plant protection product for each intended use in accordance with the uniform principles laid down in Directive 91/414/EEC. (*) 2-hydroxy-4,6-dimethoxypyrimidine () 2,4-dihydroxy-6-methoxypyrimidine (%) sodium 2-hydroxy-6-(4-hydroxy-6-methoxypyrimidin-2-yl) oxybenzoate