Directive 98/8/EC of the European Parliament and of the Council (repealed)Show full title

Article 11 Procedure for inclusion of an active substance in Annex I, IA or IB

1. Inclusion, or subsequent changes to the inclusion, of an active substance in Annex I, IA or IB shall be considered when:

(a) an applicant has forwarded to the competent authority of one of the Member States:

(i)

a dossier for the active substance satisfying the requirements of Annex IVA or the requirements of Annex IIA and, where specified, the relevant parts of Annex IIIA;

(ii)

a dossier for at least one biocidal product containing the active substance satisfying the requirements of Article 8, with the exception of paragraph 3 thereof;

(b) the receiving competent authority has verified the dossiers and believes them to satisfy the requirements of Annex IVA and Annex IVB or the requirements of Annex IIA and Annex IIB and, where relevant, Annexes IIIA and IIIB, accepts them and agrees to the applicant forwarding a summary of the dossiers to the Commission and the other Member States.

2. The receiving competent authority shall, within 12 months of accepting the dossiers, carry out an evaluation thereof. A copy of the evaluation shall be sent by the competent authority to the Commission, the other Member States and to the applicant, together with a recommendation for the inclusion, or otherwise, of the active substance in Annex I, IA or IB.

If, when the dossiers are evaluated, it appears that further information is necessary for full evaluation to be made, the receiving competent authority shall ask that the applicant submit such information. The 12-month period shall be suspended from the date of issue of the competent authority's request until the date the information is received. The competent authority shall inform the other Member States and the Commission of its action when it informs the applicant.

3. To avoid dossiers being evaluated by only a few Member States, the evaluation can be carried out by Member States other than the receiving one. A request for this shall be given when the dossiers are accepted, and the decision shall be taken in accordance with the procedure laid down in Article 28(2). The decision shall be taken at the latest one month after receipt by the Commission of the request.

4. On receipt of the evaluation, the Commission shall, in accordance with the procedure in Article 27, prepare a proposal without undue delay for decision in accordance with the procedure laid down in Article 28(3). The decision shall be taken at the latest 12 months after the receipt by the Commission of the evaluation referred to in paragraph 2.