1.The role of participant may be taken over or shared by mutual agreement between an existing participant and a prospective participant, provided that the prospective participant has the right to refer to all the data submitted or referred to by the existing participant.
2.A notification for the purpose of this Article shall be submitted jointly to the [F1competent authority] by the prospective and the existing participant through [F2the system for the exchange of information between the competent authority and applicants] referred to in Article 71 of Regulation (EU) No 528/2012 F3..., and shall include all relevant letters of access.
3.Upon receipt of a notification complying with paragraph 2, the [F1competent authority] shall update [F4its records] with respect to the identity of the participant.
4.A person established in the [F5United Kingdom] having taken over or joined the role of participant pursuant to this Article shall be considered as having submitted a dossier or a letter of access to a dossier for the purpose of Article 95 of Regulation (EU) No 528/2012.
Textual Amendments
F1Words in Art. 10 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. 222(2); 2020 c. 1, Sch. 5 para. 1(1)
F2Words in Art. 10(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. 222(3)(a); 2020 c. 1, Sch. 5 para. 1(1)
F3Words in Art. 10(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. 222(3)(b); 2020 c. 1, Sch. 5 para. 1(1)
1.A participant shall be considered to have withdrawn its support for a substance/product-type combination in the review programme in the following cases:
(a)where it has informed the F6... competent authority F7... of its intention to withdraw;
(b)where it has failed to submit an application within the time limits specified in Article 3(2);
(c)where its application has been rejected pursuant to F8..., Article 4(4) or Article 5(4);
(d)where it has failed to provide the additional information within the time limits provided for by Article 6(5);
(e)where it has otherwise failed to pay the fees payable to the [F9competent authority].
2.A withdrawal shall be considered as timely unless it occurs after the date when the F10... competent authority submits its competent authority report to the applicant pursuant to Article 6(4) of this Regulation.
Textual Amendments
F6Words in Art. 11(1)(a) 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. 223(2)(a)(i); 2020 c. 1, Sch. 5 para. 1(1)
F7Words in Art. 11(1)(a) 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. 223(2)(a)(ii); 2020 c. 1, Sch. 5 para. 1(1)
F8Words in Art. 11(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. 223(2)(b); 2020 c. 1, Sch. 5 para. 1(1)
F111.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.Where a timely withdrawal is known to [F12the competent authority], it shall update [F13its records] with respect to the identity of the participant.
3.Where all participants supporting the same substance/product-type combination have made a timely withdrawal from the review programme, and where the role of participant for that combination has previously been taken over, [F12the competent authority] shall inform the [F14Secretary of State and the Devolved Authorities] F15...
Textual Amendments
F11Art. 12(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. 224(3); 2020 c. 1, Sch. 5 para. 1(1)
F12Words in Art. 12 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. 224(2); 2020 c. 1, Sch. 5 para. 1(1)
F13Words in Art. 12(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. 224(4); 2020 c. 1, Sch. 5 para. 1(1)
1.Where the evaluation of an existing active substance does not allow for conclusions to be drawn relating to the substance as identified in Annex II, the F16... competent authority shall, after consultation with the participant concerned, establish a new substance identity. F17...
2.The [F18competent authority] shall update [F19its records] with respect to the identity of the substance.
Textual Amendments
F16Word in Art. 13(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. 225(2)(a); 2020 c. 1, Sch. 5 para. 1(1)
F17Words in Art. 13(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. 225(2)(b); 2020 c. 1, Sch. 5 para. 1(1)
1.The [F20competent authority] shall publish an open invitation to take over the role of participant for a substance/product-type combination where one of the following cases applies:
(a)where all participants supporting the same substance/product-type combination have made a timely withdrawal pursuant to Article 11, and the role of participant for that combination has not previously been taken over;
(b)following a redefinition pursuant to Article 13, in which case, the invitation shall only concern any substance covered by the existing identity in Annex II, but not by the new substance identity.
2.Within 12 months from the date of the publication referred to in paragraph 1, any person may submit a notification for the combination pursuant to Article 17.
F213.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Textual Amendments
F20Words in Art. 14(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. 226; 2020 c. 1, Sch. 5 para. 1(1)
F21Deleted by Commission Delegated Regulation (EU) 2017/698 of 3 February 2017 amending Delegated Regulation (EU) No 1062/2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament and of the Council concerning the making available on the market and use of biocidal products (Text with EEA relevance).
Where a biocidal product covered by the scope of Regulation (EU) No 528/2012 and being placed on the market consists of, contains or generates an existing active substance which is neither approved, nor included in the review programme, for the product-type, and is not included in [F22the Simplified Active Substance List], that substance shall be eligible for inclusion in the review programme for the relevant product-type on any of the following grounds:
[F23the product was placed on the market before IP completion day and the person placing the product on the market] has relied on guidance published by, or written advice received from, the Commission or a competent authority designated in accordance with Article 26 of Directive 98/8/EC or Article 81 of Regulation (EU) No 528/2012, where that guidance or advice gave objectively justified reasons to believe that the product was excluded from the scope of Directive 98/8/EC or of Regulation (EU) No 528/2012, or that the relevant product-type was one for which the active substance had been notified and where that guidance or advice is subsequently reviewed in a decision adopted pursuant to Article 3(3) of Regulation (EU) No 528/2012 or in new, authoritative guidance published by the Commission [F24before IP completion day or the competent authority after IP completion day];
[F25the product was placed on the market after IP completion day and the person placing the product on the market has relied on guidance published by, or written advice received from, the competent authority after IP completion day, where that guidance or advice gave objectively justified reasons to believe that the product was excluded from the scope of Regulation (EU) No 528/2012, or that the relevant product-type was one for which the active substance had been notified and where that guidance or advice is subsequently reviewed in a decision issued pursuant to Article 3(3) of Regulation (EU) No 528/2012 or in new, authoritative guidance published by the Competent Authority;]
the substance has benefitted from the derogation for food and feed provided for by Article 6 of Regulation (EC) No 1451/2007 [F26and the person placing the product on the market has complied with the time limits provided for by Regulation (EU) No 528/2012];
F27...
Textual Amendments
F22Words in Art. 15 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. 227(2); 2020 c. 1, Sch. 5 para. 1(1)
F23Words in Art. 15(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. 227(3)(a) (as amended by S.I. 2020/1567, reg. 1(2), Sch. 2 para. 70(a)); 2020 c. 1, Sch. 5 para. 1(1)
F24Words in Art. 15(a) 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. 227(3)(b) (as amended by S.I. 2020/1567, reg. 1(2), Sch. 2 para. 70(a)); 2020 c. 1, Sch. 5 para. 1(1)
F25Art. 15(aa) 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. 227(4) (as amended by S.I. 2020/1567, reg. 1(2), Sch. 2 para. 70); 2020 c. 1, Sch. 5 para. 1(1)
[F281.A declaration of interest to notify a substance which is eligible for inclusion in the review programme pursuant to Article 15 shall be submitted through the system for the exchange of information between the competent authority and applicants referred to in Article 71 of Regulation (EU) No 528/2012 by any person with an interest to notify a substance/product-type combination to the competent authority at the latest 12 months after the publication of the decision or guidance referred to in point (a) or (aa) of Article 15.]
2.A declaration shall indicate the relevant substance/product-type combination. In cases referred to in point (a) [F29or (aa)] of Article 15, the declaration shall provide a substantiated justification showing that all the conditions listed therein are fulfilled.
3.Where a declaration has been made in a case referred to in point (a) [F30or (aa)] of Article 15, and the [F31competent authority finds], that paragraph 6 is not applicable, and, where relevant, that the conditions for notification listed in point (a) [F32or (aa)] of Article 15 are fulfilled, [F33it shall update its records accordingly].
4.Where [F34the competent authority determines that a declaration made under paragraph 3 is valid, the competent authority] shall make that information publicly available by electronic means, mentioning the relevant substance/product-type combination. For the purposes of this Regulation, a publication made pursuant to the third subparagraph of Article 3a(3) of Regulation (EC) No 1451/2007 shall be considered as a publication made pursuant to this paragraph.
5.Within 6 months from the date of a publication referred to in paragraph 4, any person with an interest to notify the substance/product-type combination may do so pursuant to Article 17.
6.In cases referred to in [F35points (a) and (aa)] of Article 15, a substance/product-type combination shall be considered as notified by a participant, and shall not be eligible for additional notification where the following conditions apply:
(a)the relevant active substance is already included in the review programme;
(b)one of the dossiers submitted to [F36the competent authority] for the relevant active substance already contains all the data required for the evaluation of the product-type;
(c)the participant which has submitted that dossier indicates an interest to support the substance/product-type combination.
Textual Amendments
F28Art. 16(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. 228(2); 2020 c. 1, Sch. 5 para. 1(1)
F29Words in Art. 16(2) 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. 228(3); 2020 c. 1, Sch. 5 para. 1(1)
F30Words in Art. 16(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. 228(4)(a); 2020 c. 1, Sch. 5 para. 1(1)
F31Words in Art. 16(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. 228(4)(b); 2020 c. 1, Sch. 5 para. 1(1)
F32Words in Art. 16(3) 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. 228(4)(c); 2020 c. 1, Sch. 5 para. 1(1)
F33Words in Art. 16(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. 228(4)(d); 2020 c. 1, Sch. 5 para. 1(1)
F34Words in Art. 16(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. 228(5); 2020 c. 1, Sch. 5 para. 1(1)
[F371.Notifications pursuant to Article 14(2) or Article 16(5) shall be made to the competent authority.]
2.The notification shall be submitted [F38in accordance with the format specified under Article 79 of Regulation 528/2012]. It shall contain the information referred to in Annex I.
F393.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
[F404.Upon receipt of a notification, the competent authority shall inform the notifier of the fee payable. If the notifier fails to pay the appropriate fee within 30 days from the receipt of that information, the competent authority shall reject the notification and inform the notifier.]
5.Upon receipt of payment of the fees, the [F41competent authority] shall verify within 30 days whether the notification complies with the requirements of paragraph 2. If the notification does not comply with those requirements, the [F41competent authority] shall grant the notifier a period of 30 days in which to complete or correct the notification. After the expiry of that 30-day period, the [F41competent authority] shall, within 30 days, either declare that the notification complies with the requirements of paragraph 2 or reject the notificationF42...
6.An appeal may be brought, in accordance with Article 77 of Regulation (EU) No 528/2012 against decisions of the [F41competent authority] taken pursuant to F43... paragraph 5.
7.Where a notification has been found compliant pursuant to paragraph 5, the [F41competent authority] shall without delay:
[F44(a)where the notification has been submitted pursuant to Article 14(2), [F45update its records] with respect to the identity of the participant and, where relevant, of the substance;]
(b)where the notification has been submitted pursuant to Article 16(5), [F46update its records].
Textual Amendments
F37Art. 17(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. 229(3); 2020 c. 1, Sch. 5 para. 1(1)
F38Words in Art. 17(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. 229(4); 2020 c. 1, Sch. 5 para. 1(1)
F39Art. 17(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. 229(5); 2020 c. 1, Sch. 5 para. 1(1)
F40Art. 17(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. 229(6); 2020 c. 1, Sch. 5 para. 1(1)
F41Words in Art. 17 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. 229(2); 2020 c. 1, Sch. 5 para. 1(1)
F42Words in Art. 17(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. 229(7); 2020 c. 1, Sch. 5 para. 1(1)
F43Words in Art. 17(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. 229(8); 2020 c. 1, Sch. 5 para. 1(1)
F44Substituted by Commission Delegated Regulation (EU) 2017/698 of 3 February 2017 amending Delegated Regulation (EU) No 1062/2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament and of the Council concerning the making available on the market and use of biocidal products (Text with EEA relevance).
Where a substance/product-type combination is considered notified in accordance with Article 16(6) or 17(7)(b) the Secretary of State shall include the substance/product-type combination in the review programme.
The paragraph above is subject to the consent requirement.]
Textual Amendments
Where no notification has been received within the time limit referred to in Article 16(5), or where a notification referred to in that Article has been received and subsequently rejected by [F48the competent authority] pursuant to Article 17(4) or (5), [F48the competent authority] shall F49... publish that information electronically.
Textual Amendments
F48Words in Art. 19 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. 231(a); 2020 c. 1, Sch. 5 para. 1(1)
F49Words in Art. 19 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. 231(b); 2020 c. 1, Sch. 5 para. 1(1)
[F51The competent authority shall make a recommendation to the Secretary of State to issue a non-approval decision pursuant to F52... Article 89(5) of Regulation (EU) No 528/2012 in the following cases:]
where the [F53competent authority] informs the [F54Secretary of State and the Devolved Authorities] of all participants' timely withdrawal pursuant to Article 12(3) of this Regulation;
[F44where no person has submitted a notification within the time limits provided for by Article 14(2) of this Regulation, or where such a notification has been submitted and rejected pursuant to Article 17(4) or Article 17(5) thereof;
where a notification has been submitted within the time limits provided for by Article 14(2) of this Regulation and has been found compliant pursuant to Article 17(5) thereof, but the substance identity in the notification only covers part of the existing identity in Annex II to this Regulation.]
In case referred to in point (c) of first paragraph, the draft non-approval decision shall cover any substance covered by the existing identity in Annex II to this Regulation, but not by the notification or any approval decision.
Textual Amendments
F44Substituted by Commission Delegated Regulation (EU) 2017/698 of 3 February 2017 amending Delegated Regulation (EU) No 1062/2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament and of the Council concerning the making available on the market and use of biocidal products (Text with EEA relevance).
F50Word in Art. 20 heading 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. 232(2); 2020 c. 1, Sch. 5 para. 1(1)
F51Words in Art. 20 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. 232(3); 2020 c. 1, Sch. 5 para. 1(1)
F52Words in Art. 20 omitted (1.11.2022) by virtue of The Chemicals (Health and Safety) Trade and Miscellaneous Amendments Regulations 2022 (S.I. 2022/1037), regs. 1(2), 10(5)