Commission Implementing Regulation (EU) No 414/2013Dangos y teitl llawn

Commission Implementing Regulation (EU) No 414/2013

of 6 May 2013

specifying a procedure for the authorisation of same biocidal products in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products(1), and in particular Article 17(7) thereof,

Whereas:

(1) Regulation (EU) No 528/2012 specifies procedures for applying for and granting authorisation of biocidal products.

(2) Where applications are submitted to the same receiving competent authority or to the Agency for two or more authorisations of biocidal products with the same properties, the authorisations may be granted based on one single product evaluation and, as the case may be, comparative assessment. It is therefore appropriate to provide for an adapted authorisation procedure for such cases.

(3) The terms and conditions relating to the making available on the market and use of a biocidal product should be based on the evaluation made of the product. It is therefore appropriate to require that biocidal products authorised in accordance with this Regulation are authorised on the same terms and conditions as the evaluated biocidal products to which they refer, with the exception of the details on which the products differ.

(4) Since this Regulation specifies a procedure provided for by Regulation (EU) No 528/2012, which applies from 1 September 2013, this Regulation should also apply from that date.

(5) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,

HAS ADOPTED THIS REGULATION:

[F1 Article 1 U.K. Subject matter

This Regulation lays down the procedure applicable where an authorisation is sought for a product (the ‘same product’) which is identical to another single biocidal product, biocidal product family, or individual product of a biocidal product family which has been authorised or registered [F2 in the United Kingdom] in accordance with Directive 98/8/EC of the European Parliament and of the Council(2) or [F3 authorised or registered in the United Kingdom in accordance with] Regulation (EU) No 528/2012, [F4 or authorised or registered in Great Britain in accordance with this Regulation,] or for which an application for such authorisation has been submitted (the ‘related reference product’), with regard to all the latest information submitted in relation to the authorisation or registration, except information which can be the subject of an administrative change in accordance with Commission Implementing Regulation (EU) No 354/2013(3).]

Textual Amendments

F1 Substituted by Commission Implementing Regulation (EU) 2016/1802 of 11 October 2016 amending Implementing Regulation (EU) No 414/2013 specifying a procedure for the authorisation of same biocidal products in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (Text with EEA relevance).

F2 Words in Art. 1 inserted (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. 195(a) (as substituted by S.I. 2020/1567, reg. 1(2), Sch. 2 para. 64); 2020 c. 1, Sch. 5 para. 1(1)

F3 Words in Art. 1 inserted (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. 195(b) (as substituted by S.I. 2020/1567, reg. 1(2), Sch. 2 para. 64); 2020 c. 1, Sch. 5 para. 1(1)

F4 Words in Art. 1 inserted (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. 195(c) (as substituted by S.I. 2020/1567, reg. 1(2), Sch. 2 para. 64; 2020 c. 1, Sch. 5 para. 1(1)

Article 2 U.K. Content of applications

By way of derogation from Article 20(1) of Regulation (EU) No 528/2012 F5 ... an application for authorisation of a same product shall contain the following information:

(a)

the authorisation number or, for not yet approved related reference products, [F6 the application number of the related reference product provided by the competent authority on submission of that application];

(b)

an indication of the proposed differences between the same product and the related reference product, and evidence that the products are identical on all other aspects;

(c)

where required by Article 59(1) of Regulation (EU) No 528/2012, letters of access to all the data supporting the authorisation of the related reference product;

(d)

a draft summary of the biocidal product characteristics for the same product.

Textual Amendments

F5 Words in Art. 2 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. 196(a); 2020 c. 1, Sch. 5 para. 1(1)

F6 Words in Art. 2(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. 196(b); 2020 c. 1, Sch. 5 para. 1(1)

Article 3 U.K. Submission and validation of applications for F7 ... authorisation

1. Where the related reference product has been authorised by national authorisation [F8 in the United Kingdom (before IP completion day) or in Great Britain (from IP completion day)] or is the subject of an application for such an authorisation [F9 in Great Britain], applications for authorisation of a same product shall be submitted in accordance with Article 29(1) of Regulation (EU) No 528/2012 to the competent authority F10 ....

F11 1a. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2. By way of derogation from [F12 paragraph 2] of Article 29 of Regulation (EU) No 528/2012, the competent authority shall validate the application within 30 days of accepting it, provided that the information indicated in Article 2 has been submitted.

The validation shall include a check that the proposed differences between the same product and the related reference product concern merely information which can be the subject of an administrative change in accordance with Implementing Regulation (EU) No 354/2013.

Textual Amendments

F7 Word in Art. 3 heading 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. 197(2); 2020 c. 1, Sch. 5 para. 1(1)

F8 Words in Art. 3(1) inserted (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. 197(3)(a) (as substituted by S.I. 2020/1567, reg. 1(2), Sch. 2 para. 65); 2020 c. 1, Sch. 5 para. 1(1)

F9 Words in Art. 3(1) inserted (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. 197(3)(b) (as substituted by S.I. 2020/1567, reg. 1(2), Sch. 2 para. 65); 2020 c. 1, Sch. 5 para. 1(1)

F10 Words in Art. 3(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. 197(3)(c) (as substituted by S.I. 2020/1567, reg. 1(2), Sch. 2 para. 65); 2020 c. 1, Sch. 5 para. 1(1)

F11 Art. 3(1a) 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. 197(4) (as substituted by S.I. 2020/1567, reg. 1(2), Sch. 2 para. 65); 2020 c. 1, Sch. 5 para. 1(1)

F12 Words in Art. 3(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. 197(5) (as substituted by S.I. 2020/1567, reg. 1(2), Sch. 2 para. 65); 2020 c. 1, Sch. 5 para. 1(1)

F13 Article 4 U.K. Submission and validation of applications for Union authorisation

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

Textual Amendments

F13 Art. 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. 198; 2020 c. 1, Sch. 5 para. 1(1)

[F14 Article 4a U.K. Submission and acceptance of applications under the simplified procedure

1. Where the related reference product has been authorised in accordance with Article 26(3) of Regulation (EU) No 528/2012 or is the subject of an application for such an authorisation, applications for authorisation of a same product shall be submitted in accordance with Article 26(1) of that Regulation to the competent authority F15 ....

2. The competent authority shall accept the application in accordance with Article 26(2) of Regulation (EU) No 528/2012.]

Textual Amendments

F14 Inserted by Commission Implementing Regulation (EU) 2016/1802 of 11 October 2016 amending Implementing Regulation (EU) No 414/2013 specifying a procedure for the authorisation of same biocidal products in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (Text with EEA relevance).

F15 Words in Art. 4a(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. 199; 2020 c. 1, Sch. 5 para. 1(1)

F16 Article 4b U.K. Guidance on handling applications for authorisation of same products

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

Textual Amendments

F16 Art. 4b 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. 200; 2020 c. 1, Sch. 5 para. 1(1)

[F1 Article 5 U.K. Evaluation and decision on applications for F17 ... authorisation

[F18 1,] [F19 Subject to paragraph 2,] by way of derogation from Article 30 of Regulation (EU) No 528/2012, the [F20 competent authority] shall decide whether to grant or refuse authorisation of a same product in accordance with Article 19 of that Regulation within 60 days from the validation of the application in accordance with Article 3 of this Regulation, or, where applicable, from the subsequent date of adoption of the corresponding decision concerning the related reference product.]

[F21 2. By way of derogation from Article 30 of Regulation No 528/2012, where an application for authorisation of a same product is validated in accordance with Article 3 before 1st November 2027, or, where applicable, the subsequent date of adoption of the corresponding decision concerning the related reference product is before 1st November 2027, the competent authority must decide whether to grant or refuse the authorisation in accordance with Article 19 of that Regulation before 31st December 2027.]

Textual Amendments

F1 Substituted by Commission Implementing Regulation (EU) 2016/1802 of 11 October 2016 amending Implementing Regulation (EU) No 414/2013 specifying a procedure for the authorisation of same biocidal products in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (Text with EEA relevance).

F17 Word in Art. 5 heading 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. 201(a); 2020 c. 1, Sch. 5 para. 1(1)

F18 Art. 5 renumbered as Art. 5(1) (31.12.2022) by The Biocidal Products (Health and Safety) (Amendment) Regulations 2022 (S.I. 2022/1291), regs. 1(2), 4(2)(a)

F19 Words in Art. 5(1) inserted (31.12.2022) by The Biocidal Products (Health and Safety) (Amendment) Regulations 2022 (S.I. 2022/1291), regs. 1(2), 4(2)(b)

F20 Words in Art. 5 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. 201(b); 2020 c. 1, Sch. 5 para. 1(1)

F21 Art. 5(2) inserted (31.12.2022) by The Biocidal Products (Health and Safety) (Amendment) Regulations 2022 (S.I. 2022/1291), regs. 1(2), 4(2)(c)

F22 Article 6 U.K. Evaluation and decision on applications for Union authorisation

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

Textual Amendments

F22 Art. 6 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. 202; 2020 c. 1, Sch. 5 para. 1(1)

[F14 Article 6a U.K. Evaluation and decision on applications under the simplified procedure

1. [F23 Subject to paragraph 1A,] by way of derogation from Article 26(3) and (4) of Regulation (EU) No 528/2012, the [F24 competent authority] shall decide whether to grant or refuse authorisation of a same product in accordance with Article 25 of that Regulation within 60 days from the acceptance of the application in accordance with Article 4a(2) of this Regulation, or, where applicable, from the subsequent date of adoption of the corresponding decision concerning the related reference product.

[F25 1A. By way of derogation from Article 26(3) and (4) of Regulation No 528/2012, where an application for authorisation of a same product is accepted in accordance with Article 4a(2) before 1st November 2027, or, where applicable, the subsequent date of adoption of the corresponding decision concerning the related reference product is before 1st November 2027, the competent authority must decide whether to grant or refuse the authorisation in accordance with Article 25 of that Regulation before 31st December 2027.]

2. The evaluation shall include a check that the information indicated in Article 2 has been submitted and that the proposed differences between the same product and the related reference product concern merely information which can be the subject of an administrative change in accordance with Implementing Regulation (EU) No 354/2013.

F26 3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .]

Textual Amendments

F14 Inserted by Commission Implementing Regulation (EU) 2016/1802 of 11 October 2016 amending Implementing Regulation (EU) No 414/2013 specifying a procedure for the authorisation of same biocidal products in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (Text with EEA relevance).

F23 Words in Art. 6a(1) inserted (31.12.2022) by The Biocidal Products (Health and Safety) (Amendment) Regulations 2022 (S.I. 2022/1291), regs. 1(2), 4(3)(a)

F24 Words in Art. 6a(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. 203(a); 2020 c. 1, Sch. 5 para. 1(1)

F25 Art. 6a(1A) inserted (31.12.2022) by The Biocidal Products (Health and Safety) (Amendment) Regulations 2022 (S.I. 2022/1291), regs. 1(2), 4(3)(b)

F26 Art. 6a(3) 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. 203(b); 2020 c. 1, Sch. 5 para. 1(1)

Article 7 U.K. Authorisations and changes of same products

1. A same product shall have a different authorisation number than that of the related reference product.

On all other aspects, the content of the authorisation of a same product shall be identical with that of the related reference product except in terms of the information in respect of which the products differ. The [F27 competent authority shall record the] link between same products and related reference products.

2. Changes of a same product or of a related reference product shall be notified or applied for in accordance with Implementing Regulation (EU) No 354/2013 independently of each other.

Authorisations of a same product or of a related reference product may be changed or cancelled independently of each other.

However, in the evaluation of a proposed change of a same product or of a related reference product, the [F28 competent authority]F29 ... shall consider the appropriateness of cancelling or amending the authorisation of other products to which the product is linked F30 ... as referred to in the second subparagraph of paragraph 1.

Textual Amendments

F27 Words in Art. 7(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. 204(2); 2020 c. 1, Sch. 5 para. 1(1)

F28 Words in Art. 7(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. 204(3)(a); 2020 c. 1, Sch. 5 para. 1(1)

F29 Words in Art. 7(2) 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. 204(3)(b); 2020 c. 1, Sch. 5 para. 1(1)

F30 Words in Art. 7(2) 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. 204(3)(c); 2020 c. 1, Sch. 5 para. 1(1)

F31 Article 8 U.K.

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

Textual Amendments

F31 Art. 8 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. 205; 2020 c. 1, Sch. 5 para. 1(1)

F32 ...

Textual Amendments

F32 Art. 8 (including binding words) 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. 205; 2020 c. 1, Sch. 5 para. 1(1)

(1)

OJ L 167, 27.6.2012, p. 1.

(2)

[F1 Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market ( OJ L 123, 24.4.1998, p. 1 ).]

(3)

[F1 Commission Implementing Regulation (EU) No 354/2013 of 18 April 2013 on changes of biocidal products authorised in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council ( OJ L 109, 19.4.2013, p. 4 ).]

Textual Amendments

F1 Substituted by Commission Implementing Regulation (EU) 2016/1802 of 11 October 2016 amending Implementing Regulation (EU) No 414/2013 specifying a procedure for the authorisation of same biocidal products in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (Text with EEA relevance).