30.7.2009   

EN

Official Journal of the European Union

L 198/28

(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 coumatetralyl.

(2)

Pursuant to Regulation (EC) No 1451/2007, coumatetralyl has been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product-type 14, rodenticides, as defined in Annex V to Directive 98/8/EC.

(3)

Denmark was designated as Rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 29 September 2005 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 20 February 2009, in an assessment report.

(5)

It appears from the examinations made that biocidal products used as rodenticides and containing coumatetralyl may be expected not to present a risk to humans except for accidental incidents with children. A risk has been identified regarding non-target animals. However, coumatetralyl is for the time being considered essential for reasons of public health and hygiene. It is therefore justified to include coumatetralyl in Annex I, in order to ensure that in all Member States authorisations for biocidal products used as rodenticides and containing coumatetralyl can be granted, modified, or cancelled in accordance with Article 16(3) of Directive 98/8/EC.

(6)

In the light of the findings of the assessment report, it is appropriate to require that specific risk mitigation measures are applied at product authorisation level to products containing coumatetralyl and used as rodenticides. Such measures should be aimed at limiting the risk of primary and secondary exposure of humans and non-target animals. To this end, certain constraints such as the maximum concentration, the prohibition on marketing the active substance in products which are not ready to use and the use of aversive agents should be imposed across the board, while other conditions should be imposed by the Member States on a case-by-case basis.

(7)

In view of the identified risks, coumatetralyl should be included in Annex I for five years only and should be made subject to a comparative risk assessment in accordance with the second subparagraph of Article 10(5)(i) of Directive 98/8/EC before its inclusion in Annex I is renewed.

(8)

It is important that the provisions of this Directive be applied simultaneously in all the Member States in order to ensure equal treatment of biocidal products on the market containing the active substance coumatetralyl and also to facilitate the proper operation of the biocidal products market in general.

(9)

A reasonable period should be allowed to elapse before an active substance is included in Annex I in order to permit Member States and the 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.

(10)

After inclusion, Member States should be allowed a reasonable period to implement Article 16(3) of Directive 98/8/EC, and in particular, to grant, modify or cancel authorisations of biocidal products in product-type 14 containing coumatetralyl to ensure that they comply with Directive 98/8/EC.

(11)

Directive 98/8/EC should therefore be amended accordingly.

(12)

The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Biocidal Products,