21.9.2011 Official Journal of the European Union L 2437 DIRECTIVES COMMISSION DIRECTIVE 2011/78/EU of 20 September 2011 amending Directive 98/8/EC of the European Parliament and of the Council to include Bacillus thuringiensis subsp. israelensis Serotype H14, Strain AM65-52 as an active substance in Annex I thereto (Text with EEA relevance) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (!), and in particular the second subparagraph of Article 16(2) thereof, Whereas: () ) 0] 0] Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (%) establishes a list of active substances to be assessed, with a view to their possible inclusion in Annex I, IA or IB to Directive 98/8/EC. That list includes Bacillus thuringiensis subsp. israelensis Serotype H14. Pursuant to Regulation (EC) No 1451/2007, Strain AMG65-52  of Bacillus thuringiensis subsp. israelensis Serotype H14, has been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product- type 18, insecticides, acaricides and products to control other arthropods, as defined in Annex V to that Directive. Strain SA3A of Bacillus thuringiensis subsp. israelensis Serotype H14 is still under evaluation for use in that product-type. Italy was designated as Rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 11 July 2008 in accordance with Article 14(4) and (6) of Regu- lation (EC) No 1451/2007. L 123, 24.4.1998, p. 1. L 325, 11.12.2007, p. 3. ) The competent authority report was reviewed by the Member States and the Commission. In accordance with Article 15(4) of Regulation (EC) No 1451/2007, the findings of the review were incorporated, within the Standing Committee on Biocidal Products on 6 May 2011, in an assessment report. It appears from the evaluations that biocidal products used as insecticides, acaricides and products to control other arthropods and containing Bacillus thuringiensis subsp. israelensis Serotype H14, Strain AM65-52, may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC. It is therefore appropriate to include Bacillus thuringiensis subsp. israelensis Serotype H14, Strain AM65-52 in Annex I to that Directive. Not all potential uses have been evaluated at Union level. It is therefore appropriate that Member States assess those uses or exposure scenarios and those risks to human populations and to environmental compartments that have not been representatively addressed in the Union level risk assessment and, when granting product  authorisations, —ensure that appropriate measures are taken or specific conditions imposed in order to reduce the identified risks to acceptable levels. In the light of the potential risks identified for profes- sional use without personal protective equipment, it is appropriate to require that product authorisations for professional use are granted only for use with appro- priate personal protective equipment, unless it can be demonstrated in the application for product authori- sation that risks to professional users can be reduced to an acceptable level by others means. In the light of the possible indirect human exposure via consumption of food as a result of those uses repre- sented in the assessment, it is appropriate to require, where relevant, verification of the need to set new or to amend existing maximum residue levels according to Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying