Regulation (EU) No 528/2012 of the European Parliament and of the CouncilDangos y teitl llawn

CHAPTER V U.K. SIMPLIFIED AUTHORISATION PROCEDURE

Article 25 U.K. Eligibility for the simplified authorisation procedure

For eligible biocidal products, an application for authorisation may be made under a simplified authorisation procedure. A biocidal product shall be eligible if all the following conditions are met:

(a)

all the active substances contained in the biocidal product appear in [F1 the Simplified Active Substance List] and satisfy any restriction specified in [F2 that list];

(b)

the biocidal product does not contain any substance of concern;

(c)

the biocidal product does not contain any nanomaterials;

(d)

the biocidal product is sufficiently effective; and

(e)

the handling of the biocidal product and its intended use do not require personal protective equipment.

Textual Amendments

F1 Words in Art. 25(1)(a) substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 86(a); 2020 c. 1, Sch. 5 para. 1(1)

F2 Words in Art. 25(1)(a) substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 86(b); 2020 c. 1, Sch. 5 para. 1(1)

Article 26 U.K. Applicable procedure

1. Applicants seeking the authorisation of a biocidal product meeting the conditions of Article 25 shall submit an application to the [F3 competent authority], F4 ....

2. The F5 ... competent authority shall inform the applicant of the [F6 appropriate fees] and shall reject the application if the applicant fails to pay the fees within 30 days. It shall inform the applicant accordingly.

Upon receipt of the [F6 appropriate fees], the F5 ... competent authority shall accept the application and inform the applicant accordingly, indicating the date of the acceptance.

[F7 2A. Where the application is one to which paragraph 2B applies, paragraph 2 applies as if for “shall inform the applicant of the appropriate fees” there were substituted “shall inform the applicant before 31st December 2027 of the appropriate fees”.

2B. This paragraph applies to—

(a) an application in respect of a relevant category B product that is resubmitted by virtue of Article 95E; or

(b) an application that is resubmitted under Article 95FA.

2C. A “relevant category B product” is a product containing an active substance falling within category B of the Simplified Active Substance List that before IP completion day was—

(a) approved; or

(b) included in Annex 1 to Regulation (EU) No 528/2012 of the European Parliament and of the Council concerning the making available on the market and use of biocidal products.]

3. [F8 Subject to paragraph 3A,] within 90 days of accepting an application, the F5 ... competent authority shall authorise the biocidal product if satisfied that the product meets the conditions laid down in Article 25.

[F9 3A. Where a relevant application is accepted before 2nd October 2027, the competent authority must authorise the application before 31st December 2027 if it is satisfied that the product meets the conditions laid down in Article 25.

3B. In paragraph 3A, “relevant application” is one that is submitted in respect of a product containing an active substance that before IP completion day was—

(a) approved; or

(b) included in Annex 1 to Regulation (EU) No 528/2012 of the European Parliament and of the Council concerning the making available on the market and use of biocidal products.]

4. Where the F5 ... competent authority considers that the application is incomplete, it shall inform the applicant as to what additional information is required and shall set a reasonable time limit for the submission of that information. That time limit shall not normally exceed 90 days.

The F5 ... competent authority shall, within 90 days of receipt of the additional information, authorise the biocidal product if satisfied, on the basis of the additional information submitted, that the product meets the conditions laid down in Article 25.

[F10 Where paragraph 3A applies, the deadline of 31st December 2027 referred to in that paragraph is to be extended by a number of days equal to the number of days beginning with the date on which the competent authority requested additional information and ending with the date on which the information was received by the competent authority plus 90 days.]

The F5 ... competent authority shall reject the application if the applicant fails to submit the requested information within the deadline and shall inform the applicant accordingly. In such cases, where fees have been paid, part of the fees F11 ... shall be reimbursed.

Textual Amendments

F3 Words in Art. 26(1) substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 87(3)(a); 2020 c. 1, Sch. 5 para. 1(1)

F4 Words in Art. 26(1) omitted (31.12.2020) by virtue of The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 87(3)(b); 2020 c. 1, Sch. 5 para. 1(1)

F5 Word in Art. 26 omitted (31.12.2020) by virtue of The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 87(2); 2020 c. 1, Sch. 5 para. 1(1)

F6 Words in Art. 26(2) substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 87(4); 2020 c. 1, Sch. 5 para. 1(1)

F7 Art. 26(2A)-(2C) inserted (31.12.2022) by The Biocidal Products (Health and Safety) (Amendment) Regulations 2022 (S.I. 2022/1291), regs. 1(2), 2(2)(a)

F8 Words in Art. 26(3) inserted (31.12.2022) by The Biocidal Products (Health and Safety) (Amendment) Regulations 2022 (S.I. 2022/1291), regs. 1(2), 2(2)(b)

F9 Art. 26(3A)(3B) inserted (31.12.2022) by The Biocidal Products (Health and Safety) (Amendment) Regulations 2022 (S.I. 2022/1291), regs. 1(2), 2(2)(c)

F10 Words in Art. 26(4) inserted (31.12.2022) by The Biocidal Products (Health and Safety) (Amendment) Regulations 2022 (S.I. 2022/1291), regs. 1(2), 2(2)(d)

F11 Words in Art. 26(4) omitted (31.12.2020) by virtue of The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 87(5); 2020 c. 1, Sch. 5 para. 1(1)

F12 Article 27 U.K. Making available on the market of biocidal products authorised in accordance with the simplified authorisation procedure

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F12 Art. 27 omitted (31.12.2020) by virtue of The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 88; 2020 c. 1, Sch. 5 para. 1(1)

Article 28 U.K. Amendment of [F13 the Simplified Active Substance List]

[F14 1. The competent authority must, after receiving the decision of the Secretary of State, update the Simplified Active Substance List in order to include active substances provided that there is evidence that they do not give rise to concern according to paragraph 2 of this Article.]

2. Active substances give rise to concern where:

(a) they meet the criteria for classification according to Regulation (EC) No 1272/2008 as:

• (a) explosive/highly flammable,

• organic peroxide,

• acutely toxic of category 1, 2 or 3,

• corrosive of category 1A, 1B or 1C,

• respiratory sensitiser,

• skin sensitiser,

• germ cell mutagen of category 1 or 2;

• carcinogen of category 1 or 2,

• human reproductive toxicant of category 1 or 2 or with effects on or via lactation,

• specific target organ toxicant by single or repeated exposure, or

• toxic to aquatic life of acute category 1;

(b) they fulfil any of the substitution criteria set out in Article 10(1); or

(c) they have neurotoxic or immunotoxic properties.

Active substances also give rise to concern, even if none of the specific criteria in points (a) to (c) are met, where a level of concern equivalent to that arising from points (a) to (c) can be reasonably demonstrated based on reliable information.

[F15 3. The Secretary of State may agree to the restriction or removal of an entry of an active substance to the Simplified Active Substance List on the recommendation of the competent authority if there is evidence that biocidal products containing that substance do not, in certain circumstances, satisfy the conditions set out in paragraph 1 of this Article or in Article 25.

4. Paragraph 1 or 3 shall apply at the initiative of the Secretary of State or at the request of an economic operator or at the request of a Devolved Authority providing the necessary evidence as referred to in those paragraphs.

5. The Secretary of State may make regulations to further specify the procedures to be followed with respect to the amendment of the Simplified Active Substance List.

6. A decision issued or a function carried out under paragraph 1, 3 or 5 is subject to the consent requirement.

7. Where any of the Devolved Authorities makes proposals in relation to regulations under paragraph 5 above, the Secretary of State must have regard to such proposals when deciding whether to exercise functions under that paragraph.]

Textual Amendments

F13 Words in Art. 28 heading substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 89(a); 2020 c. 1, Sch. 5 para. 1(1)

F14 Art. 28(1) substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 89(b); 2020 c. 1, Sch. 5 para. 1(1)

F15 Art. 28(3)-(7) substituted for (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 89(c); 2020 c. 1, Sch. 5 para. 1(1)