Directive 98/8/EC of the European Parliament and of the Council (repealed)Show full title

Article 15 Derogation from the requirements

1. By way of derogating from Articles 3 and 5, a Member State may authorise temporarily for a period not exceeding 120 days, the placing on the market of biocidal products not complying with the provisions of this Directive for a limited and controlled use if such a measure appears necessary because of an unforseen danger which cannot be contained by other means. In this case, the Member State concerned shall immediately inform the other Member States and the Commission of its action and the justification for it. The Commission shall make a proposal and it shall be decided without delay, in accordance with the procedure laid down in Article 28(2), whether, and, if so, under what conditions, the action taken by the Member State may be extended for a period to be determined, be repeated, or be revoked.

2. By way of derogation from Article 5(1)(a) and until an active substance is listed in Annex I or IA, a Member State may authorise provisionally, for a period not exceeding three years, the placing on the market of a biocidal product containing an active substance not listed in Annex I or IA and not yet available on the market on the date referred to in Article 34(1) for purposes other than those defined in Article 2(2)(c) and (d). Such an authorisation may be issued only if, after dossiers have been evaluated in accordance with Article 11, the Member State believes that:

• the active substance satisfies the requirements of Article 10 and,

• the biocidal product may be expected to satisfy the conditions of Articles 5(l)(b), (c) and (d),

and no other Member State, on the basis of the summary it receives, makes legitimate objection, in accordance with Article 18(2), to the completeness of the dossiers. Where an objection is made, a decision on the completeness of dossiers shall be taken in accordance with the procedure laid down in Article 28(2) without undue delay.

If, following the procedures laid down in Articles 27 and 28(2), it is decided that the active substance does not satisfy the requirements specified in Article 10, the Member State shall ensure that the provisional authorisation is cancelled.

In cases where evaluation of dossiers for the purposes of inclusion of an active substance in Annex I or IA is not completed when the period of three years expires, the competent authority may further provisionally authorise the product for a period not exceeding one year, providing there are good reasons to believe the active substance will satisfy the requirements of Article 10. Member States shall inform other Member States and the Commission of such action.