http://www.legislation.gov.uk/eur/2013/354/chapter/IICommission 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 (Text with EEA relevance)Commission Implementing Regulation (EU) No 354/2013Commission 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 (Text with EEA relevance)King's Printer of Acts of Parliamenthttps://webarchive.nationalarchives.gov.uk/eu-exit/https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32013R0354texttext/xmlen2025-03-05Expert Participation2022-12-31 CHAPTER II<Strong>CHANGES OF <Substitution ChangeId="key-889a29b2d030a8a337f4daf30efd5330-1736767102004" CommentaryRef="key-889a29b2d030a8a337f4daf30efd5330">AUTHORISED PRODUCTS</Substitution></Strong>Notification procedure for administrative changes of productsArticle 61The authorisation holder, or its representative, shall submit ... a notification to the competent authority complying with Article 5 and ... pay the appropriate fee.2Without prejudice to the second subparagraph, the notification shall be submitted within 12 months following the implementation of the change.In case of a change referred to in Section 1 of Title 1 of the Annex to this Regulation, the notification shall be submitted before the implementation of the change.3Within 30 days following receipt of the notification, where the competent authority disagrees with the change or the relevant fee has not been paid, the competent authority shall inform the authorisation holder, or its representative, ... that the change is rejected and the grounds for the rejection.If, within 30 days following receipt of the notification, the competent authority has not expressed its disagreement, it shall be deemed to have agreed with the change.4Where the competent authority has not rejected the change in accordance with paragraph 3 it shall, where relevant, amend the authorisation of the biocidal product in conformity with the agreed change.Procedure for minor changes of productsArticle 71The authorisation holder, or its representative, shall submit ... an application complying with Article 5.2The competent authority shall inform the applicant of the appropriate fee. If the applicant fails to pay the fee within 30 days, the competent authority shall reject the application and inform the applicant ... accordingly. Upon receipt of the fee, the competent authority shall accept the application and inform the applicant accordingly indicating the date of acceptance.2AWhere the application is one that has been resubmitted by virtue of Article 95M of Regulation (EU) No 528/2012, paragraph 2 applies as if for “shall inform the applicant of the appropriate fee” there were substituted “shall inform the applicant before 31st December 2027 of the appropriate fee”.3The competent authority shall validate the application within 30 days of its acceptance, if it complies with the requirements laid down in Article 5 and inform the applicant ... accordingly.In the context of the validation referred to in the first subparagraph, the competent authority shall not make an assessment of the quality or the adequacy of the data or justifications submitted.Where the competent authority considers that the application is incomplete, it shall inform the applicant as to what additional information is required for the application to be completed and shall set a reasonable time limit for the submission of that information. That time limit shall not normally exceed 45 days.The competent authority shall, within 30 days of receipt of the additional information, validate the application if the additional information submitted is sufficient to comply with the requirements laid down in Article 5.The competent authority shall reject the application if the applicant fails to submit the requested information within the deadline and shall inform the applicant ... accordingly.4Subject to paragraph 4A, within 90 days of validating an application, the competent authority shall evaluate the application and draft an assessment report and shall send its assessment report and, where relevant, the revised summary of the biocidal product characteristics ... to the applicant.4AWhere an application is validated before 2nd October 2027, the competent authority must, before 31st December 2027—aevaluate the application;bdraft an assessment report;csend the report to the applicant; anddwhere relevant, send the revised summary of the biocidal product characteristics to the applicant.5Subject to paragraph 5A, where it appears that additional information is necessary to carry out the evaluation, the competent authority shall ask the applicant to submit such information within a specified time limit. The period referred to in paragraph 4, shall be suspended from the date of the request until the date the information is received. The time limit given to the applicant shall not exceed 45 days in total unless justified by the nature of the data requested or by exceptional circumstances.The competent authority shall reject the application if the applicant fails to submit the requested information within the deadline and shall inform the applicant ... accordingly.5AWhere paragraph 4A applies and it appears that additional information is necessary to carry out the evaluation, the competent authority must ask the applicant to submit such information within a specified time limit. The deadline of 31st December 2027 referred to in paragraph 4A is to be extended by a period equal to the number of days beginning with the date on which the applicant is asked for additional information and ending with the date on which that information is received by the competent authority. But the deadline may not be extended by more than 45 days in total, unless it is justified by the nature of the data requested or by exceptional circumstances.The competent authority must reject the application if the applicant fails to submit the requested information within the specified time limit and must inform the applicant accordingly.6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7Where authorisation of the change is granted, the competent authority shall, within 30 days, amend the authorisation of the biocidal product in conformity with the change.Procedure for major changes of productsArticle 81The authorisation holder, or its representative, shall submit to the competent authority an application complying with Article 5.2The competent authority shall inform the applicant of the appropriate fee. If the applicant fails to pay the fee within 30 days, the competent authority shall reject the application and inform the applicant ... accordingly. Upon receipt of the fee, the competent authority shall accept the application and inform the applicant accordingly indicating the date of acceptance.2AWhere the application is one that has been resubmitted by virtue of Article 95M of Regulation (EU) No 528/2012, paragraph 2 applies as if for “shall inform the applicant of the appropriate fee” there were substituted “shall inform the applicant before 31st December 2027 of the appropriate fee”.3The competent authority shall validate the application within 30 days of its acceptance if it complies with the requirements laid down in Article 5 and inform the applicant ... accordingly.In the context of the validation referred to in the first subparagraph, the competent authority shall not make an assessment of the quality or the adequacy of the data or justifications submitted.Where the competent authority considers that the application is incomplete, it shall inform the applicant as to what additional information is required for the validation of the application and shall set a reasonable time limit for the submission of that information. That time limit shall not normally exceed 90 days.The competent authority shall, within 30 days of receipt of the additional information, validate the application if it determines that the additional information submitted is sufficient to comply with the requirements laid down in Article 5.The competent authority shall reject the application if the applicant fails to submit the requested information within the deadline and shall inform the applicant ... accordingly.4Subject to paragraph 4A, within 180 days of validating an application, the competent authority shall evaluate the application and draft an assessment report and shall send its assessment report and, where relevant, the revised summary of the biocidal product characteristics ... to the applicant.4AWhere the application is validated but not authorised before 4th July 2027, the competent authority must, before 31st December 2027—aevaluate the application;bdraft an assessment report;csend the report to the applicant; anddwhere relevant, send the revised summary of the biocidal product characteristics to the applicant.5Subject to paragraph 5A where it appears that additional information is necessary to carry out the evaluation, the competent authority shall ask the applicant to submit such information within a specified time limit. The period referred to in paragraph 4 shall be suspended from the date of the request until the date on which the information is received. The time limit given to the applicant shall not exceed 90 days in total unless justified by the nature of the data requested or by exceptional circumstances.The competent authority shall reject the application if the applicant fails to submit the requested information within the deadline and shall inform the applicant ... accordingly.5AWhere paragraph 4A applies and it appears to the competent authority that additional information is necessary to carry out the evaluation, the competent authority must ask the applicant to submit such information within a specified time limit. The deadline of 31st December 2027 referred to in paragraph 4A is to be extended by a period equal to the number of days beginning with the date on which the applicant is asked for additional information and ending with the date on which that information is received by the competent authority. But the deadline may not be extended by more than 90 days in total, unless it is justified by the nature of the data requested or by exceptional circumstances.The competent authority must reject the application if the applicant fails to submit the requested information within the deadline and must inform the applicant accordingly.6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7Where authorisation of the change is granted, the competent authority shall, within 30 days, amend the authorisation of the biocidal product in conformity with the change.Biocidal products authorised in accordance with Article 26 of Regulation (EU) No 528/2012Article 9. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Procedure for changes already agreed by other Member StatesArticle 9a. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Coordination group, arbitration and derogation from mutual recognitionArticle 10. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Arts. 9-13 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. 187; 2020 c. 1, Sch. 5 para. 1(1)Words in Ch. 2 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. 183; 2020 c. 1, Sch. 5 para. 1(1)Words in Art. 6(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. 184(2)(a); 2020 c. 1, Sch. 5 para. 1(1)Words in Art. 6(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. 184(2)(b); 2020 c. 1, Sch. 5 para. 1(1)Words in Art. 6(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. 184(2)(c); 2020 c. 1, Sch. 5 para. 1(1)Words in Art. 6(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. 184(2)(d); 2020 c. 1, Sch. 5 para. 1(1)Words in Art. 6(3) 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. 184(3)(a)(i); 2020 c. 1, Sch. 5 para. 1(1)Words in Art. 6(3) 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. 184(3)(a)(ii); 2020 c. 1, Sch. 5 para. 1(1)Words in Art. 6(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. 184(3)(a)(iii); 2020 c. 1, Sch. 5 para. 1(1)Words in Art. 6(3) 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. 184(3)(b)(i); 2020 c. 1, Sch. 5 para. 1(1)Word in Art. 6(3) 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. 184(3)(b)(ii); 2020 c. 1, Sch. 5 para. 1(1)Words in Art. 6(4) 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. 184(4)(a); 2020 c. 1, Sch. 5 para. 1(1)Word in Art. 6(4) 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. 184(4)(b); 2020 c. 1, Sch. 5 para. 1(1)Words in Art. 7(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. 185(3); 2020 c. 1, Sch. 5 para. 1(1)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. 185(4)(a); 2020 c. 1, Sch. 5 para. 1(1)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. 185(4)(b); 2020 c. 1, Sch. 5 para. 1(1)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. 185(4)(c); 2020 c. 1, Sch. 5 para. 1(1)Words in Art. 7(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. 185(6); 2020 c. 1, Sch. 5 para. 1(1)Words in Art. 7(5) 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. 185(7); 2020 c. 1, Sch. 5 para. 1(1)Art. 7(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. 185(8); 2020 c. 1, Sch. 5 para. 1(1)Art. 7(7) 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. 185(9); 2020 c. 1, Sch. 5 para. 1(1)Words in Art. 7(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. 185(5); 2020 c. 1, Sch. 5 para. 1(1)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. 185(4)(d); 2020 c. 1, Sch. 5 para. 1(1)Words in Art. 7 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. 185(2); 2020 c. 1, Sch. 5 para. 1(1)Words in Art. 8(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. 186(3); 2020 c. 1, Sch. 5 para. 1(1)Words in Art. 8(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. 186(4)(a); 2020 c. 1, Sch. 5 para. 1(1)Words in Art. 8(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. 186(4)(b); 2020 c. 1, Sch. 5 para. 1(1)Words in Art. 8(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. 186(4)(d); 2020 c. 1, Sch. 5 para. 1(1)Words in Art. 8(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. 186(6); 2020 c. 1, Sch. 5 para. 1(1)Words in Art. 8(5) 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. 186(7); 2020 c. 1, Sch. 5 para. 1(1)Art. 8(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. 186(8); 2020 c. 1, Sch. 5 para. 1(1)Art. 8(7) 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. 186(9); 2020 c. 1, Sch. 5 para. 1(1)Words in Art. 8(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. 186(5); 2020 c. 1, Sch. 5 para. 1(1)Words in Art. 8(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. 186(4)(c); 2020 c. 1, Sch. 5 para. 1(1)Words in Art. 8 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. 186(2); 2020 c. 1, Sch. 5 para. 1(1)Art. 7(2A) inserted (31.12.2022) by The Biocidal Products (Health and Safety) (Amendment) Regulations 2022 (S.I. 2022/1291), regs. 1(2), 3(2)(a)Art. 7(4A) inserted (31.12.2022) by The Biocidal Products (Health and Safety) (Amendment) Regulations 2022 (S.I. 2022/1291), regs. 1(2), 3(2)(c)Art. 7(5A) inserted (31.12.2022) by The Biocidal Products (Health and Safety) (Amendment) Regulations 2022 (S.I. 2022/1291), regs. 1(2), 3(2)(e)Words in Art. 7(4) inserted (31.12.2022) by The Biocidal Products (Health and Safety) (Amendment) Regulations 2022 (S.I. 2022/1291), regs. 1(2), 3(2)(b)Words in Art. 7(5) inserted (31.12.2022) by The Biocidal Products (Health and Safety) (Amendment) Regulations 2022 (S.I. 2022/1291), regs. 1(2), 3(2)(d)Art. 8(2A) inserted (31.12.2022) by The Biocidal Products (Health and Safety) (Amendment) Regulations 2022 (S.I. 2022/1291), regs. 1(2), 3(3)(a)Art. 8(4A) inserted (31.12.2022) by The Biocidal Products (Health and Safety) (Amendment) Regulations 2022 (S.I. 2022/1291), regs. 1(2), 3(3)(c)Art. 8(5A) inserted (31.12.2022) by The Biocidal Products (Health and Safety) (Amendment) Regulations 2022 (S.I. 2022/1291), regs. 1(2), 3(3)(e)Words in Art. 8(4) inserted (31.12.2022) by The Biocidal Products (Health and Safety) (Amendment) Regulations 2022 (S.I. 2022/1291), regs. 1(2), 3(3)(b)Words in Art. 8(5) inserted (31.12.2022) by The Biocidal Products (Health and Safety) (Amendment) Regulations 2022 (S.I. 2022/1291), regs. 1(2), 3(3)(d)