CHAPTER II

APPROVAL OF ACTIVE SUBSTANCES

Evaluation of applications
Article 8
1
The ... competent authority shall, within 365 days of the validation of an application, evaluate it in accordance with Articles 4 and 5, including, where relevant, any proposal to adapt data requirements submitted in accordance with Article 6(3), and produce an assessment report and evaluation conclusions.
The competent authority shall give the applicant the opportunity to provide written comments on the assessment report and on the conclusions of the evaluation within 30 days. The competent authority shall take due account of those comments.
2
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 .... As specified in the second subparagraph of Article 6(2), the ... competent authority may, as appropriate, require the applicant to provide sufficient data to permit a determination of whether an active substance meets the criteria referred to in Article 5(1) or Article 10(1). The 365-day period referred to in paragraph 1 of this Article shall be suspended from the date of issue of the request until the date the information is received. The suspension shall not exceed 180 days in total unless it is justified by the nature of the data requested or by exceptional circumstances.
2A
The competent authority may request from the applicant available information on, and take into account, evaluations undertaken by third countries in order to complete its evaluation. The weight given to those third country evaluations shall take into account the equivalence of the evaluation process.
3
Where the ... competent authority considers that there are concerns for human health, animal health or the environment as a result of the cumulative effects from the use of biocidal products containing the same or different active substances, it shall document its concerns in accordance with the requirements of the relevant parts of Section II.3 of Annex XV to Regulation (EC) No 1907/2006 and include this as part of its conclusions.
4
Within 270 days of producing its assessment reports and evaluation conclusions the competent authority shall prepare and submit an opinion on the approval of the active substance to the Secretary of State and the Devolved Authorities.
Art. 8(2A) 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. 68(5); 2020 c. 1, Sch. 5 para. 1(1)
Word in Art. 8(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. 68(2)(a); 2020 c. 1, Sch. 5 para. 1(1)
Word 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. 68(2)(b); 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. 68(2)(c); 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. 68(3); 2020 c. 1, Sch. 5 para. 1(1)
Word 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. 68(4)(a); 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. 68(4)(b); 2020 c. 1, Sch. 5 para. 1(1)
Word 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. 68(6); 2020 c. 1, Sch. 5 para. 1(1)
Art. 8(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. 68(7); 2020 c. 1, Sch. 5 para. 1(1)