Essential useN.I.
12.—(1) In this regulation—
“essential use active substance” means an active substance in respect of which the Commission has granted a derogation for essential use under Article 5 of the fifth review regulation; and
“the fifth review regulation” means Commission Regulation (EC) No 1451/2007 M1.
(2) A person shall not place on the market a biocidal product containing an essential use active substance without an authorisation under this regulation.
(3) Where a person submits an application under this regulation to the competent authority for the authorisation of a biocidal product, the competent authority may authorise the placing on the market of that product.
(4) The competent authority may only grant an authorisation under this regulation if it concludes that, taking into account all available information, it is reasonable to assume that continued use of that biocidal product does not have any unacceptable effect on human or animal health or on the environment.
(5) An authorisation granted under this regulation shall—
(a)require that the biocidal product is placed on the market only for the essential use allowed for by the derogation;
(b)impose any risk reduction measures that the competent authority considers appropriate for that product; and
(c)be granted for a period of time not exceeding that permitted by the derogation granted by the Commission.
(6) The competent authority may extend an authorisation if the Commission makes a decision or adopts a regulation to extend the derogation.
(7) An authorisation granted under this regulation may impose labelling requirements.
Marginal Citations
M1OJ L 325, 11.12.2007, p.3.