L_2011034EN.01004501.xml
| 9.2.2011 | EN | Official Journal of the European Union | L 34/45 |
COMMISSION DIRECTIVE 2011/11/EU
of 8 February 2011
amending Directive 98/8/EC of the European Parliament and of the Council to include (Z,E)-tetradeca-9,12-dienyl acetate as an active substance in Annexes I and IA 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 (Z,E)-tetradeca-9,12-dienyl acetate. |
| (3) | Austria was designated as Rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 23 February 2009 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 24 September 2010, in an assessment report. |
| (5) | It appears from the evaluations that biocidal products used as attractants and containing (Z,E)-tetradeca-9,12-dienyl acetate may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC. It is therefore appropriate to include (Z,E)-tetradeca-9,12-dienyl acetate in Annex I to that Directive. |
| (6) | It also appears from the evaluations that biocidal products used as attractants and containing (Z,E)-tetradeca-9,12-dienyl acetate may be expected to present only low risk to humans, animals and the environment and to satisfy the requirements laid down in Article 5 of Directive 98/8/EC, in particular with regard to the use which was examined and detailed in the assessment report, i.e. in traps for indoor use containing a maximum of 2 mg of the active substance. It is therefore appropriate to include (Z,E)-tetradeca-9,12-dienyl acetate in Annex IA to Directive 98/8/EC. |
| (7) | Not all potential uses have been evaluated at Union level. It is therefore appropriate that Member States, when granting product authorisations, assess those uses or exposure scenarios and those risks to the environmental compartments and populations that have not been representatively addressed in the Union level risk assessment and ensure that appropriate measures are taken or specific conditions imposed in order to reduce the identified risks to acceptable levels. |
| (8) | In the light of the assumptions made during the evaluation, it is appropriate to require that (Z,E)-tetradeca-9,12-dienyl acetate is not applied where food or feed is stored unless the food or feed packaging is closed or re-closed. Labels should therefore indicate that biocidal products containing (Z,E)-tetradeca-9,12-dienyl acetate are not to be used in spaces |
...
