Part IIIBiocidal Products
Mutual recognition of registrations12
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 Executive for registration of that biocidal product for placing on the market and use under this regulation.
2
Subject to the following paragraphs and to regulation 39(2), within 60 days of the Executive receiving an application in accordance with this regulation, it 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 Executive 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 Executive shall not register a biocidal product under this regulation if it considers 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, 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 Executive, 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 Executive is 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,
it 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 Executive is satisfied that the biocidal product, in respect of which an application has been made under paragraph (1), is not a low-risk biocidal product, it—
a
may provisionally refuse to register the biocidal product; and
b
shall immediately communicate its 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 Executive communicating its concerns in accordance with paragraph 10(b), the Executive 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 Executive shall notify the Commission of the lack of agreement.
12
Notwithstanding paragraphs (10) and (11), where, under this regulation the Executive proposes 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, it 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 it proposes 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 Executive shall refuse to register the biocidal product in question;
b
confirms any of the proposed additional conditions or restrictions, the Executive 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 Executive proposes should be refused or has provisionally refused, should be granted, the Executive 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 Executive should be imposed, the Executive 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 it proposed.