Commission Delegated Regulation (EU) No 1062/2014Show full title

CHAPTER 2 U.K. PROCESS FOR EVALUATION OF DOSSIERS

Article 3 U.K. Application for approval or inclusion in [F1 the Simplified Active Substance List]

1. An application for approval or inclusion in [F2 the Simplified Active Substance List] may be submitted only by a participant whose notification has been found compliant by the [F3 competent authority] pursuant to Article 17(5) of this Regulation.

Where the application concerns inclusion in [F2 the Simplified Active Substance List], it may only concern [F4 categories A or B] of that [F5 list].

2. Applications referred to in paragraph 1 shall be submitted to the [F3 competent authority] within two years of the declaration of compliance pursuant to Article 17(5).

Textual Amendments

F1 Words in Art. 3 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. 215(2); 2020 c. 1, Sch. 5 para. 1(1)

F2 Words in Art. 3(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. 215(4)(a); 2020 c. 1, Sch. 5 para. 1(1)

F3 Words in Art. 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. 215(3); 2020 c. 1, Sch. 5 para. 1(1)

F4 Words in Art. 3(1) 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)(a) (as inserted by S.I. 2020/1567, reg. 1(2), Sch. 4); 2020 c. 1, Sch. 5 para. 1(1)

F5 Word in Art. 3(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. 215(4)(b); 2020 c. 1, Sch. 5 para. 1(1)

[F6 Article 4 U.K. Acceptance of applications

The competent authority shall inform the participant of the appropriate fee within 30 days after the competent authority has accepted the application. If the participant fails to pay the fee within 30 days of notification of the fee, the competent authority shall reject the application and inform the participant accordingly.]

Textual Amendments

F6 Art. 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. 216; 2020 c. 1, Sch. 5 para. 1(1)

Article 5 U.K. Validation of applications for approval or inclusion in [F7 category B] of [F8 the Simplified Active Substance List]

[F9 1. Where an application for approval or inclusion in [F10 category B] of the Simplified Active Substance List containing the data required in accordance with Article 6(1) and (2) of Regulation (EU) No 528/2012 has been accepted by the competent authority and the appropriate fee has been paid pursuant to Article 4 the competent authority shall validate the application within 30 days of that payment.]

F11 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3. In the cases referred to in [F12 paragraph 1], the F13 ... competent authority shall not make an assessment of the quality or the adequacy of the data or justifications submitted.

4. Where the F14 ... competent authority considers that the application is incomplete, it shall inform the participant 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 F14 ... 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 requirement laid down in paragraph [F15 1].

The F14 ... competent authority shall reject the application if the participant fails to submit the requested information within the deadline and shall inform the participant F16 ... accordingly. In such cases, part of the [F17 appropriate fees paid] shall be reimbursed.

On validating an application, the F14 ... competent authority shall without delay inform the participant, F18 ... indicating the date of the validation.

Textual Amendments

F7 Words in Art. 5 heading substituted (1.11.2022) by The Chemicals (Health and Safety) Trade and Miscellaneous Amendments Regulations 2022 (S.I. 2022/1037), regs. 1(2), 10(2)

F8 Words in Art. 5 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. 217(2); 2020 c. 1, Sch. 5 para. 1(1)

F9 Art. 5(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. 217(3); 2020 c. 1, Sch. 5 para. 1(1)

F10 Words in Art. 5(1) substituted (1.11.2022) by The Chemicals (Health and Safety) Trade and Miscellaneous Amendments Regulations 2022 (S.I. 2022/1037), regs. 1(2), 10(3)

F11 Art. 5(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. 217(4); 2020 c. 1, Sch. 5 para. 1(1)

F12 Words in Art. 5(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. 217(5)(i); 2020 c. 1, Sch. 5 para. 1(1)

F13 Word in Art. 5(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. 217(5)(ii); 2020 c. 1, Sch. 5 para. 1(1)

F14 Word in Art. 5(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. 217(6)(a); 2020 c. 1, Sch. 5 para. 1(1)

F15 Word in Art. 5(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. 217(6)(b); 2020 c. 1, Sch. 5 para. 1(1)

F16 Words in Art. 5(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. 217(6)(c)(i); 2020 c. 1, Sch. 5 para. 1(1)

F17 Words in Art. 5(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. 217(6)(c)(ii); 2020 c. 1, Sch. 5 para. 1(1)

F18 Words in Art. 5(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. 217(6)(d); 2020 c. 1, Sch. 5 para. 1(1)

Article 6 U.K. Evaluation of applications

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

(a) where an application has been validated pursuant to Article 5;

[F19 (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 [F20 category A] of [F21 the Simplified Active Substance List] has been accepted F22 ... and the [F23 appropriate fee] has been paid pursuant to Article 4(4).

2. The F24 ... 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 [F25 produce an assessment report and conclusions of its evaluation].

3. Where several participants support the same substance/product-type combination, the F26 ... competent authority shall draft only one assessment report. The assessment report and the conclusions shall be [F27 produced] 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 [F28 specified by the Secretary of State and Devolved Authorities].

4. Prior to [F29 producing] its conclusions F30 ... the F31 ... 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 F31 ... competent authority shall take due account of those comments when finalising its evaluation.

5. Where it appears that additional information is necessary to carry out the evaluation, the F32 ... competent authority shall ask the participant to submit such information within a specified time limitF33 ....

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.

6. Where the F34 ... 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(1) and include this as part of its conclusions.

7. Upon finalisation of its hazard evaluation, the F35 ... competent authority shall without undue delay and no later than at the time [F36 the assessment report is produced] pursuant to paragraph 3, as appropriate:

(a) submit a proposal to the [F37 relevant authority] pursuant to [F38 Article 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 [F39 the [F40 GB mandatory classification] and labelling list defined in Article 2 of that Regulation];

(b) consult the [F41 relevant 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.

Textual Amendments

F19 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)

F20 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)

F21 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)

F22 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)

F23 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)

F24 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)

F25 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)

F26 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)

F27 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)

F28 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)

F29 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)

F30 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)

F31 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)

F32 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)

F33 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)

F34 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)

F35 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)

F36 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)

F37 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)

F38 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)

F39 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)

F40 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)

F41 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)

[F42 Article 6a U.K. Applications for which the competent authority of the United Kingdom was the evaluating competent authority before 30 March 2019

1. This Article is applicable to applications for which the competent authority of the United Kingdom was the evaluating competent authority before 30 March 2019 for the entries 79, 85, 113, 171, 187, 188, 321, 345, 346, 458, 531, 554, 571, 599, 609, 1045, 1046 and 1047 of Annex II.

2. The evaluating competent authority of a Member State having replaced the competent authority of the United Kingdom in relation to an application that has been submitted before 30 March 2019 , shall inform the participant of the fees payable under Article 80(2) of Regulation (EU) No 528/2012 at the latest by 30 April 2019 , and shall reject the application if the participant fails to pay the fees within a period of time fixed by the evaluating competent authority. It shall inform the participant and the Agency accordingly.

3. By derogation from the time limits laid down in Article 6(3), the assessment report and the conclusions shall be sent by the evaluating competent authority within either of the following time limits, whichever is the later:

(a) 31 December 2020 ;

(b) the time limit for submitting the assessment report pursuant to Article 6(3)(b) set out in Annex III.]

Textual Amendments

F42 Inserted by Commission Delegated Regulation (EU) 2019/227 of 28 November 2018 amending Delegated Regulation (EU) No 1062/2014 as regards certain active substances/product-type combinations for which the competent authority of the United Kingdom has been designated as the evaluating competent authority (Text with EEA relevance).

[F44 Article 7 U.K. Opinion of [F43 the competent authority]

1. This Article shall apply where the competent authority has produced an assessment report pursuant to Article 6(2) and, where relevant, a proposal or a consultation pursuant to Article 6(7).

2. The competent authority shall within 270 days of completion of the assessment report, prepare and submit an opinion to the Secretary of State and the Devolved Authorities on the approval of the substance/product-type combination or its inclusion in [F45 categories A or B] of the Simplified Active Substance list or both.

The competent authority shall start the preparation of the opinion within 90 days of the completion of the assessment report and evaluation conclusions.]

Textual Amendments

F43 Words in Art. 7 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. 219(2); 2020 c. 1, Sch. 5 para. 1(1)

F44 Art. 7(1)(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. 219(3); 2020 c. 1, Sch. 5 para. 1(1)

F45 Words in Art. 7(2) 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)(c) (as inserted by S.I. 2020/1567, reg. 1(2), Sch. 4); 2020 c. 1, Sch. 5 para. 1(1)

Article 8 U.K. Active substances which are candidates for substitution

1. When preparing its opinion pursuant to Article 7(2), [F46 the competent authority] shall examine whether the active substance fulfils any of the criteria listed in Article 10(1) of Regulation (EU) No 528/2012 and address the matter in its opinion.

2. Prior to submitting its opinion to [F47 the Secretary of State], [F46 the competent authority] shall make publicly available, without prejudice to Articles 66 and 67 of Regulation (EU) No 528/2012, information on potential candidates for substitution during a period of no more than 60 days, during which time interested third parties may submit relevant information, including information on available substitutes. [F46 The competent authority] shall take due account of the information received when finalising its opinion.

3. Where the active substance is approved and fulfils one of the criteria laid down in Article 10(1) of Regulation (EU) No 528/2012, it shall be identified as a candidate for substitution in the [F48 decision made pursuant to Article 89(5) of that Regulation].

Textual Amendments

F46 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. 220(a); 2020 c. 1, Sch. 5 para. 1(1)

F47 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. 220(b); 2020 c. 1, Sch. 5 para. 1(1)

F48 Words in Art. 8(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. 220(c); 2020 c. 1, Sch. 5 para. 1(1)

Article 9 U.K. [F49 Decision]

Upon receipt of the opinion of [F50 the competent authority] pursuant to Article 7(2), [F51 the Secretary of State] shall without undue delay [F52 issue a decision pursuant to Article 89(5)] or, as appropriate, Article 28(1) of Regulation (EU) No 528/2012.

[F53 The Secretary of State's decision is subject to the consent requirement.]

Textual Amendments

F49 Art. 9 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. 221(2); 2020 c. 1, Sch. 5 para. 1(1)

F50 Words in Art. 9 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. 221(3)(a); 2020 c. 1, Sch. 5 para. 1(1)

F51 Words in Art. 9 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. 221(3)(b); 2020 c. 1, Sch. 5 para. 1(1)

F52 Words in Art. 9 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. 221(3)(c); 2020 c. 1, Sch. 5 para. 1(1)

F53 Words in Art. 9 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. 221(4); 2020 c. 1, Sch. 5 para. 1(1)

(1)

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).