CHAPTER XVII

FINAL PROVISIONS

Transitional measures concerning access to the active substance dossier
Article 95
1
The competent authority
shall make publicly available and shall regularly update a list of all active substances, and all substances generating an active substance, for which a dossier complying with Annex II to this Regulation or with Annex IIA or IVA to Directive 98/8/EC and, where relevant, Annex IIIA to that Directive (‘the complete substance dossier’)
is
submitted and accepted or validated by
the competent authority
in a procedure provided for by this Regulation or that Directive (‘the relevant substances’). For each relevant substance, the list shall also include all persons having made such a submission or a submission to the
competent authority
in accordance with the second subparagraph of this paragraph, and indicate their role as specified in that subparagraph, and the product-type(s) for which they have made a submission, as well as the date of inclusion of the substance in the list.
A person established within the
United Kingdom
who manufactures or imports a relevant substance, on its own or in biocidal products (‘the substance supplier’) or who manufactures or makes available on the market a biocidal product consisting of, containing or generating that relevant substance (‘the product supplier’), may at any time submit to the
competent authority
either a complete substance dossier for that relevant substance, a
letter of access which provides the competent authority with access to a complete substance dossier
, or a reference to a complete substance dossier for which all data protection periods have expired. Following the renewal of the approval of an active substance, any substance supplier or product supplier may submit to the
competent authority
a letter of access to all the data which was considered by the
... competent authority as relevant for the purpose of the renewal, and for which the protection period has not yet expired (‘the relevant data’).
The
competent authority
shall inform the submitting supplier of the
appropriate fees
. It shall reject the application if the submitting supplier fails to pay those fees within 30 days and shall inform the submitting supplier accordingly.
Upon receipt of the
appropriate fees
, the
competent authority
shall verify whether the submission complies with the second subparagraph of this paragraph and shall inform the submitting supplier accordingly.
2
As of 1 September 2015, a biocidal product consisting of, containing or generating a relevant substance, included in the list referred to in paragraph 1, shall not be made available on the market unless either the substance supplier or the product supplier is included in the list referred to in paragraph 1 for the product-type(s) to which the product belongs.
3
For the purposes of making a submission in accordance with the second subparagraph of paragraph 1 of this article, Article 63(3) of this Regulation shall apply to all toxicological, ecotoxicological and environmental fate and behaviour studies relating to substances listed in Annex II to Regulation (EC) No 1451/2007, including any such studies not involving tests on vertebrates.
4
A substance supplier or a product supplier included in the list referred to in paragraph 1 to whom a letter of access has been issued for the purpose of this Article or a right to refer to a study has been granted in accordance with paragraph 3 shall be entitled to allow applicants for the authorisation of a biocidal product to make reference to that letter of access or that study for the purposes of Article 20(1)
, where that letter of access gives the competent authority direct access to the information, and where the competent authority holds the relevant data
.
5
By way of derogation from Article 60, all data protection periods for active substance/product-type combinations listed in Annex II to Regulation (EC) No 1451/2007, but for which a decision on inclusion in Annex I to Directive 98/8/EC was not taken before 1 September 2013, shall end on 31 December 2025.
6
Paragraphs 1 to 5 shall not apply to substances listed in
the Simplified Active Substance List
in
categories A and C
or to biocidal products containing only such substances.
7
The
competent authority
shall regularly update the list referred to in paragraph 1 of this Article. Following the renewal of the approval of an active substance, the
competent authority
shall remove from the list any substance supplier or product supplier who has not, within 12 months of the renewal, submitted all the relevant data or a letter of access to all the relevant data, either in accordance with the second subparagraph of paragraph 1 of this Article or in an application in accordance with Article 13.
8
The competent authority may refuse to accept a letter of access for the purposes of this Article if they do not hold the relevant data.
Substituted by Regulation (EU) No 334/2014 of the European Parliament and of the Council of 11 March 2014 amending Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products, with regard to certain conditions for access to the market (Text with EEA relevance).
Art. 95(8) 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. 136(6); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 95(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. 136(2)(a)(i); 2020 c. 1, Sch. 5 para. 1(1)
Word in Art. 95(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. 136(2)(a)(ii); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 95(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. 136(2)(a)(iii); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 95(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. 136(2)(a)(iv); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 95(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. 136(2)(b)(i); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 95(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. 136(2)(b)(ii); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 95(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. 136(2)(b)(iii); 2020 c. 1, Sch. 5 para. 1(1)
Word in Art. 95(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. 136(2)(b)(iv); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 95(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. 136(2)(c)(i); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 95(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. 136(2)(c)(ii); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 95(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. 136(2)(d)(i); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 95(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. 136(2)(d)(ii); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 95(4) 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. 136(3); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 95(6) 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. 136(4); 2020 c. 1, Sch. 5 para. 1(1)
Words in Art. 95(6) substituted (31.12.2020 immediately before IP completion day) by S.I. 2019/720, Sch. 4 para. 4(2) (as inserted by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1567), reg. 1(2), Sch. 4)
Words in Art. 95(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. 136(5); 2020 c. 1, Sch. 5 para. 1(1)