Regulation (EU) No 528/2012 of the European Parliament and of the CouncilShow full title

Article 54 U.K. Assessment of technical equivalence

[F1 1. Where it is necessary to establish the technical equivalence of active substances, the person seeking to establish that equivalence (‘the applicant’) shall submit an application to the [F2 competent authority].]

2. The applicant shall submit all data that the [F2 competent authority] requires to assess technical equivalence.

[F1 3. The [F2 competent authority] shall inform the applicant of the [F3 appropriate fees] and shall reject the application if the applicant fails to pay the fees within 30 days. It shall inform the applicant accordingly.]

4. After giving the applicant the opportunity to submit comments, the [F2 competent authority] shall take a decision within 90 days of receipt of the application referred to in paragraph 1 and shall communicate it F4 ... to the applicant.

5. Where, in the opinion of the [F2 competent authority], additional information is necessary to carry out the assessment of technical equivalence, the [F2 competent authority] shall ask the applicant to submit such information within a time limit specified by the [F2 competent authority]. The [F2 competent authority] shall reject the application if the applicant fails to submit the additional information within the specified time limit. The 90-day period referred to in paragraph 4 shall be suspended from the date of issue of the request until the information is received. The suspension shall not exceed 180 days except where justified by the nature of the data requested or in exceptional circumstances.

F5 6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

7. An appeal may be brought, in accordance with Article 77, against decisions of the [F2 competent authority] under paragraphs 3, 4 and 5 of this Article.

F6 8. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F1 Substituted by Regulation (EU) No 334/2014 of the European Parliament and of the Council of 11 March 2014 amending Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products, with regard to certain conditions for access to the market (Text with EEA relevance).

F2 Words in Art. 54 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. 101(a); 2020 c. 1, Sch. 5 para. 1(1)

F3 Words in Art. 54(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. 101(b); 2020 c. 1, Sch. 5 para. 1(1)

F4 Words in Art. 54(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. 101(c); 2020 c. 1, Sch. 5 para. 1(1)

F5 Art. 54(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. 101(d); 2020 c. 1, Sch. 5 para. 1(1)

F6 Art. 54(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. 101(e); 2020 c. 1, Sch. 5 para. 1(1)