šŸ”† šŸ“– āž• šŸ‘¤

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:

Article 1Subject matter

This Regulation lays down the procedure applicable where an authorisation is sought for a product (the ā€˜same productā€™) 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 in the United Kingdom in accordance with Directive 98/8/EC of the European Parliament and of the Council(2) or authorised or registered in the United Kingdom in accordance withRegulation (EU) No 528/2012, or authorised or registered in Great Britain in accordance with this Regulation, or for which an application for such authorisation has been submitted (the ā€˜related reference productā€™), 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).

Article 2Content of applications

By way of derogation from Article 20(1) of Regulation (EU) No 528/2012 ... 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, 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.

Article 3Submission and validation of applications for ... authorisation

1.Where the related reference product has been authorised by national authorisation 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 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 ....

1a.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2.By way of derogation from 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.

Article 4Submission and validation of applications for Union authorisation

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

Article 4aSubmission 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 ....

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

Article 4bGuidance on handling applications for authorisation of same products

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

Article 5Evaluation and decision on applications for ... authorisation

1,Subject to paragraph 2, by way of derogation from Article 30 of Regulation (EU) No 528/2012, the 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.

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.

Article 6Evaluation and decision on applications for Union authorisation

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

Article 6aEvaluation and decision on applications under the simplified procedure

1.Subject to paragraph 1A, by way of derogation from Article 26(3) and (4) of Regulation (EU) No 528/2012, the 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.

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.

3.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Article 7Authorisations 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 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 competent authority ... shall consider the appropriateness of cancelling or amending the authorisation of other products to which the product is linked ... as referred to in the second subparagraph of paragraph 1.

Article 8

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

...

(2)

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)

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).

(2)

[F1Directive 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)

[F1Commission 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

Status: There are currently no known outstanding effects by UK legislation for Commission Implementing Regulation (EU) No 414/2013.
Commission Implementing Regulation(EU) No 414/2013 (2013/414)

Displaying information

Status of this instrument

footnotecommentarytransitional and savingsin force statusrelated provisionsgeo extentinsert/omitsource countin force adj
F1Substituted 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).
F1Substituted 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).
F1Substituted 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).
F2Words 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)inserted, substituted
F3Words 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)inserted, substituted
F4Words 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)inserted, substituted
F5Words 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)omitted
F6Words 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)substituted
F7Word 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)omitted
F8Words 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)inserted, substituted
F9Words 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)inserted, substituted
F10Words 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)omitted, substituted
F11Art. 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)omitted, substituted
F12Words 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)substituted
F13Art. 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)omitted
F14Inserted 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).
F14Inserted 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).
F15Words 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)omitted
F16Art. 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)omitted
F17Word 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)omitted
F18Art. 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)renumbered
F19Words 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)inserted
F20Words 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)substituted
F21Art. 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)inserted
F22Art. 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)omitted
F23Words 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)inserted
F24Words 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)substituted
F25Art. 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)inserted
F26Art. 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)omitted
F27Words 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)substituted
F28Words 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)substituted
F29Words 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)omitted
F30Words 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)omitted
F31Art. 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)omitted
F31Art. 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)omitted
F32Art. 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)omitted
Defined TermSection/ArticleIDScope of Application
related reference productart. Article 1related_re_rteLWrO
same productart. Article 1(the_ā€˜_prnDFCXm

Status of changes to instrument text

The list includes made instruments, both those in force and those yet to come into force. Typically, instruments that are not yet in force (hence their changes are not incorporated into the text above) are indicated by description 'not yet' in the changes made column.