The Biocidal Products Regulations 2001

Modification and review of authorisations and registrations

20.—(1) The Ministers shall modify the conditions of use, subject to which an authorisation or a registration is granted under these Regulations, where they consider that, on the basis of developments in scientific and technical knowledge, such modification is necessary to protect human or animal health or the environment.

(2) Subject to regulation 39(3), the Ministers may modify the conditions of use, subject to which an authorisation or a registration is granted under these Regulations, at the written request of the holder, who shall state the reasons for that request.

(3) The Ministers may review an authorisation of a biocidal product granted under regulation 9, 11 or 13 or a registration of a biocidal product granted under regulation 10, 12 or 14 at any time if there are indications that—

(a) the biocidal product in question no longer satisfies one or more of the requirements referred to in paragraphs 1(a)–(d) or 4(b) of Schedule 3;

(b) there is a change in the classification of the biocidal product; or

(c) the conditions or restrictions, subject to which the biocidal product has been authorised or registered, as the case may be, and imposed to ensure that the requirements referred to in paragraphs 1(a)–(d) or 4(b) of Schedule 3 remain satisfied, are no longer appropriate for ensuring that such requirements remain satisfied.

(4) Where a Commission decision confirms the refusal of a member State to register a biocidal product in respect of which the Ministers have granted a registration under regulation 10, if considered appropriate by the Standing Committee, the Ministers shall review that registration, taking the refusal of the member State into consideration.

(5) Where the Ministers review an authorisation or a registration under paragraph (3), or a registration under paragraph (4), the Ministers—

(a) may extend the authorisation or registration in question for the period necessary to enable them to complete the review; and

(b) may require the holder to provide further information necessary for the review.

(6) Where the Ministers require further information in accordance with paragraph (5), the Ministers shall extend the authorisation or registration for the period necessary to enable the holder to provide such information.

(7) In this regulation—

(a) “holder” has the same meaning as it has in regulation 19;

(b) “the conditions of use” means the conditions relating to the use of a biocidal product, including, but without prejudice to the generality of the foregoing, the manner of use and the amounts used; and

(c) “the Standing Committee” means the Standing Committee on Biocidal Products referred to in Article 28(1).