Regulation (EU) No 528/2012 of the European Parliament and of the CouncilShow full title

[F1 Article 95I U.K. Transitional measures for Article 95 List

1. This Article applies to the list prepared pursuant to Article 95 of Regulation (EU) No 528/2012 (“the Article 95 pre-IP completion day List”) of active substances and persons having made submissions in relation to those active substances.

2. Subject to paragraph 3, from IP completion day the entries included in the Article 95 pre-IP completion day List are to be included in the list prepared pursuant to Article 95 of this Regulation (“the Article 95 List”).

3. An entry on the Article 95 List must be removed if either of the following conditions are not met within 2 years from IP completion day—

(a) the person must be established in the United Kingdom;

(b) the person must provide to the competent authority any of the following—

(i) a complete dossier for the relevant active substance;

(ii) a reference to a complete active substance dossier for which all data protection periods have expired and the competent authority is able to obtain all the data;

(iii) a letter of access to a complete active substance dossier, where that dossier has been submitted to the competent authority within 2 years of IP completion day.

4. Where an entry is removed from the Article 95 List for reasons beyond the control of the supplier of a biocidal product containing the relevant active substance, the competent authority may grant a period of grace for the making available on the market of that biocidal product, except in cases where the continued making available on the market of the biocidal product would constitute an unacceptable risk to human health, animal health or the environment.

5. A period of grace in excess of 180 days may only be granted under paragraph 4 in exceptional circumstances.

6. Where a period of grace is granted in accordance with paragraph 4, and the supplier of a biocidal product does not comply with the second subparagraph of Article 95(1) during that period, the prohibition in Article 95(2) applies.]

Textual Amendments

F1 Arts. 95A-95N inserted (31.12.2020) by S.I. 2019/720, Sch. 4 para. 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)