This Regulation lays down rules for the carrying out of the work programme for the systematic examination of all existing active substances referred to in Article 89 of Regulation (EU) No 528/2012.
For the purposes of this Regulation, the following definitions shall apply:
[F1‘non-approval decision’ means a decision—
pursuant to Article 9(1)(b) of Regulation (EU) No 528/2012 not to approve a substance/product-type combination;
made before IP completion day, pursuant to the third subparagraph of Article 89(1) of that Regulation as it had effect immediately before IP completion day, not to approve a substance/product-type combination;
made after IP completion day, pursuant to Article 89(5) of that Regulation, not to approve a substance/product-type combination; or
not to include it in Annex I or IA to Directive 98/8/EC.]
‘substance/product-type combination included in the review programme’ means a substance/product-type combination listed in Annex II which complies with the following conditions:
it has not been the subject of either of the following:
a Directive on inclusion in Annex I or IA to Directive 98/8/EC,
a Regulation [F2, made before IP completion day,] providing that it is approved pursuant to the third subparagraph of Article 89(1) of Regulation (EU) No 528/2012;
[F3a decision issued by the Secretary of State pursuant to Article 89(5) of Regulation (EU) No 528/2012 after IP completion day;]
it has not been the subject of any non-approval decision or the latest non-approval decision concerning it has been repealed;
‘participant’ means a person who has submitted an application for a substance/product-type combination included in the review programme, or has submitted a notification found compliant pursuant to Article 17(5) of this Regulation, or on whose behalf such application or notification has been submitted.
[F4“competent authority” means the authority appointed in accordance with regulation 5 of the Biocidal Products and Chemicals (Appointment of Authorities and Enforcement) Regulations 2013;]
[F5“the consent requirement” means the requirement for consent in accordance with Article 83B of Regulation (EU) No 528/2012;
“appropriate fee” means the fee payable for the activity concerned in regulations made under section 43 of the Health and Safety at Work etc. Act 1974 where the competent authority is appointed in accordance with regulation 5 of the Biocidal Products and Chemicals (Appointment of Authorities and Enforcement) Regulations 2013;
“Devolved Authority” means—
the Scottish Ministers, or
the Welsh Ministers.]
Textual Amendments
F1Art. 2(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. 214(2) (as amended by S.I. 2020/1567, reg. 1(2), Sch. 2 para. 68(a)); 2020 c. 1, Sch. 5 para. 1(1)
F2Words in Art. 2(b)(i) 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. 214(3)(a) (as amended by S.I. 2020/1567, reg. 1(2), Sch. 2 para. 68(a)); 2020 c. 1, Sch. 5 para. 1(1)
F3Words in Art. 2(b)(i) 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. 214(3)(b) (as amended by S.I. 2020/1567, reg. 1(2), Sch. 2 para. 68(a)); 2020 c. 1, Sch. 5 para. 1(1)
F4Art. 2(d) 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. 214(4) (as substituted by S.I. 2020/1567, reg. 1(2), Sch. 2 para. 68(b)); 2020 c. 1, Sch. 5 para. 1(1)
F5Arts. 2(e)-(g) inserted 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. 214(5) (as substituted) by S.I. 2020/1567, reg. 1(2), Sch. 2 para. 68(c)); 2020 c. 1, Sch. 5 para. 1(1)