Directive 2009/89 - Amendment of Directive 98/8/EC to include nitrogen as an active substance in Annex I thereto - Main contents

EN

Official Journal of the European Union

L 199/19

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 nitrogen.

Pursuant to Regulation (EC) No 1451/2007, nitrogen has been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product-type 18, insecticides, as defined in Annex V to Directive 98/8/EC.

Ireland was designated as Rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 13 November 2007 in accordance with Article 14(4) and (6) of Regulation (EC) No 1451/2007.

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 28 November 2008, in an assessment report.

It appears from the examinations made that biocidal products used as insecticides and containing nitrogen may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC. It is therefore appropriate to include nitrogen in Annex I, in order to ensure that in all Member States authorisations for biocidal products used as insecticides and containing nitrogen can be granted, modified, or cancelled in accordance with Article 16(3) of Directive 98/8/EC.

Not all potential uses have been evaluated at the Community level. It is therefore appropriate that Member States assess those risks to the compartments and populations that have not been representatively addressed in the Community level risk assessment and, when granting product authorisations, ensure that appropriate measures are taken or specific conditions imposed in order to mitigate the identified risks to acceptable levels.

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 nitrogen and used as insecticides. In particular, products should only be sold to and used by trained professionals with safe working practices and safe systems of work in place to ensure minimum risk.

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 nitrogen and also to facilitate the proper operation of the biocidal products market in general.

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...