Commission Directive 2010/51/EU of 11 August 2010 amending Directive 98/8/EC of the European Parliament and of the Council to include N,N-diethyl-meta-toluamide as an active substance in Annex I thereto Text with EEA relevance

• Published date: 12 August 2010
• Subject Matter: Internal market - Principles,Plant health legislation,Environment
• Official Gazette Publication: Official Journal of the European Union, L 211, 12 August 2010

12.8.2010 EN Official Journal of the European Union L 211/14

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COMMISSION DIRECTIVE 2010/51/EU

of 11 August 2010

amending Directive 98/8/EC of the European Parliament and of the Council to include N,N-diethyl-meta-toluamide 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 N,N-diethyl-meta-toluamide (hereinafter ‘DEET’).

(2) Pursuant to Regulation (EC) No 1451/2007, DEET has been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product-type 19, repellents and attractants, 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 30 November 2007 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 11 March 2010, in an assessment report.

(5) It appears from the examinations made that biocidal products used as repellents or attractants and containing DEET may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC. It is therefore appropriate to include DEET in Annex I to that Directive.

(6) In the light of the findings of the assessment report, it is appropriate to require that risk mitigation measures are applied at product authorisation level to products containing DEET and used as repellents or attractants. Products intended for direct application to human skin should be labelled with instructions for use including amount and frequency of application in order to minimize primary exposure of humans. Concerns were identified during the risk assessment for human health, especially for children. Therefore, unless data is submitted to demonstrate that the product will meet the requirements of Article 5 and Annex VI when used on children, products containing DEET should not be used on children less than two years old, and use should be

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