Commission Directive 2011/80/EU of 20 September 2011 amending Directive 98/8/EC of the European Parliament and of the Council to include lambda-cyhalothrin as an active substance in Annex I thereto  Text with EEA relevance

21.9.2011 EN Official Journal of the European Union L 243/13
COMMISSION DIRECTIVE 2011/80/EU
of 20 September 2011
amending Directive 98/8/EC of the European Parliament and of the Council to include lambda-cyhalothrin 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 (1), and in particular the second subparagraph of Article 16(2) thereof,
Whereas:
(1) 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 (2) 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 lambda-cyhalothrin.
(2) Pursuant to Regulation (EC) No 1451/2007, lambda-cyhalothrin 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.
(3) Sweden was designated as Rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 8 September 2008 in accordance with Article 14(4) and (6) of Regulation (EC) No 1451/2007.
(4) 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.
(5) It appears from the evaluations that biocidal products used as insecticides, acaricides and products to control other arthropods and containing lambda-cyhalothrin may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC. It is therefore appropriate to include lambda-cyhalothrin in Annex I to that Directive.
(6) 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.
(7) In the light of the risks identified for the aquatic and terrestrial ecosystems when products were emitted to a sewage treatment plant, it is appropriate to require that products are not authorised for such uses, unless data are submitted demonstrating that the product will meet the requirements of both Article 5 of and Annex VI to Directive 98/8/EC, if necessary by the application of appropriate risk mitigation measures.
(8) In the light of the risks identified for professional use without personal protective equipment, it is appropriate to require that product authorisations for professional use are granted only for use with appropriate personal protective equipment, unless it can be demonstrated in the application for product authorisation that risks to professional users can be reduced to an acceptable level by others means.
(9) In the light of the possible indirect human exposure via consumption of food as a result of those uses represented 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 down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (3) or 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 (4). Measures should be adopted ensuring that the applicable maximum residue levels are not exceeded.
(10) The provisions of this Directive should be applied at the same time in all Member States in order to ensure equal treatment on the Union market of biocidal products containing the active substance lambda-cyhalothrin and also to facilitate the proper operation of the biocidal products market in general.
(11) A reasonable period should be allowed to elapse before an active substance is included in Annex I to Directive 98/8/EC, in order to permit Member States and interested parties to prepare themselves to meet the new requirements entailed and to ensure that applicants who have prepared dossiers can benefit fully from the 10-year period of data protection, which, in accordance with Article 12(1)(c)(ii) of Directive 98/8/EC, starts from the date of inclusion.
(12) After inclusion, Member States should be allowed a reasonable period to implement Article 16(3) of Directive 98/8/EC.
(13) Directive 98/8/EC should therefore be amended accordingly.
(14) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Biocidal Products,