Article 6 Evaluation of applications

United Kingdom

This Article shall apply where any of the following conditions applies:

(a)

where an application has been validated pursuant to Article 5;

F1(b)

where, before IP completion day, the evaluating competent authority in a Member State has accepted the dossier as complete pursuant to Article 13 of Regulation (EC) No 1451/2007 but not yet submitted the competent authority report to the Commission pursuant to Article 14(4) of that Regulation;

(c)

where an application for inclusion in F2category A of F3the Simplified Active Substance List has been accepted F4... and the F5appropriate fee has been paid pursuant to Article 4(4).

The F6... competent authority shall evaluate the application in accordance with Articles 4 and 5 of Regulation (EU) No 528/2012, including, where relevant, any proposal to adapt data requirements submitted in accordance with Article 6(3) of that Regulation, and F7produce an assessment report and conclusions of its evaluation.

Where several participants support the same substance/product-type combination, the F8... competent authority shall draft only one assessment report. The assessment report and the conclusions shall be F9produced within either of the following time-limits, whichever is the later:

(a)

365 days of the last validation referred to in paragraph 1(a), acceptance of completeness referred to in paragraph 1(b) or payment of the fee referred to in paragraph 1(c), for the substance/product-type combination in question;

(b)

the time limits F10specified by the Secretary of State and Devolved Authorities.

Prior to F11producing its conclusions F12... the F13... competent authority shall give the participant 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 when finalising its evaluation.

Where it appears that additional information is necessary to carry out the evaluation, the F14... competent authority shall ask the participant to submit such information within a specified time limitF15....

The 365-day period referred to in paragraph 3 shall be suspended from the date of issue of the request until the date the information is received. Unless it is justified by the nature of the data requested or by exceptional circumstances, the suspension shall not exceed the following time-limits:

(a)

365 days in cases where the additional information relates to concerns which were not addressed under Directive 98/8/EC or under the practice established for application of that Directive;

(b)

180 days in other cases.

Where the F16... 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 of the European Parliament and of the Council^f1 and include this as part of its conclusions.

Upon finalisation of its hazard evaluation, the F17... competent authority shall without undue delay and no later than at the time F18the assessment report is produced pursuant to paragraph 3, as appropriate:

(a)

submit a proposal to the F19relevant authority pursuant to F20Article 37A(2) of Regulation (EC) No 1272/2008, where it considers that one of the criteria referred to in Article 36(1) thereof is fulfilled and not properly addressed in F21the F22GB mandatory classification and labelling list defined in Article 2 of that Regulation;

(b)

consult the F23relevant authority appointed under Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC where it considers that one of the criteria of Article 5(1)(d) or (e) of Regulation (EU) No 528/2012, or the condition of Article 10(1)(d) of that Regulation, is fulfilled and not properly addressed in Annex XIV to Regulation (EC) No 1907/2006 or in the candidate list referred to in Article 59(1) of that Regulation.

Annotations

Textual amendments

F1: Art. 6(1)(b) 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. 218(2)(a) (as amended by S.I. 2020/1567, reg. 1(2), Sch. 2 para. 69); 2020 c. 1, Sch. 5 para. 1(1)
F2: Words in Art. 6(1)(c) substituted (31.12.2020 immediately before IP completion day) 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. 4 para. 4(3)(b) (as inserted by S.I. 2020/1567, reg. 1(2), Sch. 4); 2020 c. 1, Sch. 5 para. 1(1)
F3: Words in Art. 6(1)(c) 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. 218(2)(b)(i); 2020 c. 1, Sch. 5 para. 1(1)
F4: Words in Art. 6(1)(c) 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. 218(2)(b)(ii); 2020 c. 1, Sch. 5 para. 1(1)
F5: Words in Art. 6(1)(c) 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. 218(2)(b)(iii); 2020 c. 1, Sch. 5 para. 1(1)
F6: Word in Art. 6(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. 218(3)(a); 2020 c. 1, Sch. 5 para. 1(1)
F7: Words in Art. 6(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. 218(3)(b); 2020 c. 1, Sch. 5 para. 1(1)
F8: Word 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. 218(4)(a); 2020 c. 1, Sch. 5 para. 1(1)
F9: 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. 218(4)(b); 2020 c. 1, Sch. 5 para. 1(1)
F10: Words in Art. 6(3)(b) 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. 218(4)(c); 2020 c. 1, Sch. 5 para. 1(1)
F11: Word 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. 218(5)(a); 2020 c. 1, Sch. 5 para. 1(1)
F12: Words in Art. 6(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. 218(5)(b); 2020 c. 1, Sch. 5 para. 1(1)
F13: Word in Art. 6(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. 218(5)(c); 2020 c. 1, Sch. 5 para. 1(1)
F14: Word in Art. 6(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. 218(6)(a); 2020 c. 1, Sch. 5 para. 1(1)
F15: Words in Art. 6(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. 218(6)(b); 2020 c. 1, Sch. 5 para. 1(1)
F16: Word in Art. 6(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. 218(7); 2020 c. 1, Sch. 5 para. 1(1)
F17: Word in Art. 6(7) 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. 218(8)(a); 2020 c. 1, Sch. 5 para. 1(1)
F18: Words in Art. 6(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. 218(8)(b); 2020 c. 1, Sch. 5 para. 1(1)
F19: Words in Art. 6(7)(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. 218(8)(c)(i); 2020 c. 1, Sch. 5 para. 1(1)
F20: Words in Art. 6(7)(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. 218(8)(c)(ii); 2020 c. 1, Sch. 5 para. 1(1)
F21: Words in Art. 6(7)(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. 218(8)(c)(iii); 2020 c. 1, Sch. 5 para. 1(1)
F22: Words in Art. 6(7)(a) substituted (1.11.2022) by The Chemicals (Health and Safety) Trade and Miscellaneous Amendments Regulations 2022 (S.I. 2022/1037), regs. 1(2), 10(4)
F23: Words in Art. 6(7)(b) 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. 218(8)(d); 2020 c. 1, Sch. 5 para. 1(1)

Footnotes

f1: Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1).