4.

The following Articles 4a and 4b are inserted: ‘Article 4a Essential use 1. Member States may apply to the Commission for an extension of the period laid down in Article 4(2) where they consider that an active substance listed in Annex III or VII is essential for them for reasons of health, safety, protection of cultural heritage or is critical for the functioning of society, and where there are no available technically and economically feasible alternatives or substitutes that are acceptable from the standpoint of environment and health. Applications shall be accompanied by a document stating the reasons and justifications. 2. The applications referred to in paragraph 1 shall be forwarded by the Commission to the other Member States and be made publicly available by electronic means. Member States or any person may for a period of 60 days following reception of an application submit comments in writing to the Commission. 3. Taking account of the comments received, the Commission may in accordance with Article 16(2) of Directive 98/8/EC grant an extension of the period laid down in Article 4(2) of this Regulation for placing the substance on the market of the requesting Member States until 14 May 2010 at the latest, provided that the Member States: (a) ensure that continued use is only possible under the conditions that products containing the substance are approved for the intended essential use; (b) conclude that, taking into account all available information, it is reasonable to assume that continued use does not have any unacceptable effect on human or animal health or on the environment; (c) impose all appropriate risk reduction measures when granting approval; (d) ensure that such approved biocidal products remaining on the market after 1 September 2006 are relabelled in order to match the use conditions laid down by the Member States in accordance with this paragraph; and (e) ensure that, where appropriate, alternatives for such uses are being sought by the holders of the approvals or the Member States concerned, or a dossier is being prepared for submission in accordance with the procedure laid down in Article 11 of Directive 98/8/EC by 14 May 2008 at the latest. 4. The Member States concerned shall annually inform the Commission on the application of paragraph 3 and in particular on the actions taken pursuant to point (e). 5. Member States may at any time review the approvals of biocidal products for which the period of placing on the market has been extended in accordance with paragraph 3. Whenever there is reason to believe that any of the conditions set in points (a) to (e) of that paragraph are no longer satisfied, the Member States concerned shall without undue delay take steps to remedy the situation or if that is not possible, withdraw the approvals of the biocidal products concerned. Article 4b Extension of deadline for placing on the market 1. Producers, formulators, associations or other persons may apply for an extension of the period laid down in Article 4(2) for the marketing of biocidal products containing active substances referred to in that paragraph by submitting a complete dossier for each active substance and product type combination concerned that complies with the requirements of Annex IV to the competent authority in one of the Member States by 1 March 2006 at the latest. 2. The receiving Member State shall verify whether the dossier referred to in paragraph 1 is to be accepted as complete in accordance with Article 9(1) to (4). If the dossier is accepted as complete the active substance/product type combinations shall be included into Annex II and Annex V and, where appropriate, be removed from Annex III or VII. 3. For product types other than 8 and 14, the evaluation of the dossiers shall commence at the same time as the evaluation of dossiers for other active substances in the same product type(s) as specified in Annex V.’