The Biocidal Products Regulations 2001

Mutual recognition of registrations

12.—(1) Where a biocidal product has been registered for placing on the market and use under the Directive in a member State, a person may apply to the Ministers for registration of that biocidal product for placing on the market and use under this regulation.

(2) Subject to the following paragraphs of this regulation and subject to regulation 39(2), within 60 days of the Ministers receiving an application in accordance with this regulation, they shall register the biocidal product in question subject to the conditions and restrictions imposed on registration of that biocidal product in the member State where registration was first granted.

(3) Subject to paragraphs (10) to (13), the Ministers shall not register a biocidal product under this regulation unless—

(a) the biocidal product is a low-risk biocidal product; and

(b) any requirements set out in Annex IA relating to the active substance in the biocidal product have been fulfilled.

(4) Subject to paragraphs (12) and (13), the Ministers shall not register a biocidal product under this regulation if they consider that—

(a) the biocidal product does not satisfy the requirements referred to in paragraphs 1(a)–(d) and 4(b) of Schedule 3; or

(b) the nature and quantity of—

(i) the active substance in,

(ii) where appropriate, any toxicologically or ecotoxicologically significant impurities and co-formulants in, or

(iii) the residues of toxicological or environmental significance which result from authorised uses of,

the biocidal product cannot be determined according to the relevant requirements in Annexes IIA, IIB, IIIA, IIIB, IVA and IVB.

(5) Subject to paragraphs (6) and (7), an applicant for registration of a biocidal product under this regulation shall submit with his application—

(a) a dossier containing the information set out in Schedule 4; and

(b) a certified copy of the registration of that biocidal product in the member State in which registration was first granted.

(6) Where the applicant justifies the omission to the satisfaction of the Ministers, the applicant may omit from a dossier submitted in accordance with paragraph (5)(a) information which—

(a) is not necessary owing to the nature of—

(i) the low-risk biocidal product, or

(ii) its proposed uses;

(b) it is not scientifically necessary or technically possible to supply.

(7) The data referred to in paragraph 10 of Schedule 4 may be provided in summary form.

(8) Where the Ministers are satisfied that—

(a) the target species is not present in harmful quantities;

(b) there is unacceptable tolerance or resistance of the target organism to the biocidal product; or

(c) the relevant circumstances of use differ significantly from those in the member State where the biocidal product was first registered, such that registration without additional requirements or conditions may present unacceptable risks to humans, animals or the environment,

they may propose conditions and restrictions relating to the matters referred to in Schedule 5 concerning the placing on the market and the use of the biocidal product in addition to those conditions and restrictions imposed in the member State in which the first registration was granted.

(9) The additional conditions and restrictions proposed pursuant to paragraph (8) shall be such as to ensure—

(a) compliance with any requirements set out in Annex IA relating to the active substance in the biocidal product in question; and

(b) that the requirements referred to in paragraph 1(a)–(d) and 4(b) of Schedule 3 remain satisfied.

(10) If the Ministers are satisfied that the biocidal product, in respect of which an application has been made under paragraph (1), is not a low-risk biocidal product, they—

(a) may provisionally refuse to register the biocidal product; and

(b) shall immediately communicate their concerns to the competent authority which verified the dossier submitted in support of the application for first registration.

(11) If, within 90 days of the Ministers communicating their concerns in accordance with paragraph (10)(b), the Ministers and the competent authority which verified the dossier submitted in support of the application for first registration cannot reach an agreement as to whether a biocidal product is a low-risk biocidal product, the Ministers shall notify the Commission of the lack of agreement.

(12) Notwithstanding paragraphs (10) and (11), where, under this regulation the Ministers propose to refuse to register a biocidal product, or to impose conditions or restrictions in addition to those imposed in the member State in which the low-risk biocidal product was first registered, they shall—

(a) notify the Commission, member States and the applicant; and

(b) provide the Commission, member States and the applicant with an explanatory document setting out—

(i) the name and specification of the biocidal product, and

(ii) the grounds on which they propose to refuse registration, or to impose additional conditions or restrictions on registration.

(13) Where a Commission decision—

(a) confirms a proposed or provisional refusal, the Ministers shall refuse to register the biocidal product in question;

(b) confirms any of the proposed additional conditions or restrictions, the Ministers shall register the biocidal product in question subject to—

(i) the conditions and restrictions confirmed by the Commission decision, and

(ii) any conditions and restrictions imposed in the member State in which the biocidal product was first registered;

(c) confirms that a registration, which the Ministers propose should be refused or have provisionally refused, should be granted, the Ministers shall register the biocidal product in question subject to any conditions and restrictions imposed in the member State in which the biocidal product was first registered;

(d) confirms that none of the additional conditions and restrictions proposed by the Ministers should be imposed, the Ministers shall register the biocidal product in question subject to any conditions and restrictions imposed in the member State in which the biocidal product was first registered but without imposing the additional conditions and restrictions which they proposed.