The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019

Regulation (EU) No 528/2012

76.  For Article 15, substitute—

“Article 15 Review of approval of an active substance

1.   The Secretary of State may review the approval of an active substance for one or more product-types at any time where there are significant indications that the conditions laid down in Article 4(1) or, where applicable, the conditions set out in Article 5(2) are no longer met. The Secretary of State may also review the approval of an active substance for one or more product-types at the request of the competent authority if there are indications that the use of the active substance in biocidal products or treated articles raises significant concerns about the safety of such biocidal products or treated articles. The Secretary of State shall make publically available the information that it is carrying out a review and shall provide an opportunity for the applicant to submit comments. The Secretary of State shall take due account of those comments in the review.

2.   Where any of the Devolved Authorities proposes that an active substance should be reviewed the Secretary of State shall have regard to such proposals in deciding whether to review the approval of an active substance.

3.   Where those indications are confirmed, the Secretary of State shall issue a decision amending the conditions of approval of an active substance or cancelling its approval. Article 9(2) shall apply. The competent authority shall inform the initial applicants for the approval accordingly.

4.   On duly justified imperative grounds of urgency the Secretary of State may issue immediately applicable decisions.

5.   Paragraphs 1, 3 and 4 are subject to the consent requirement.

6.   Where the Secretary of State decides to cancel or amend the approval of an active substance for one or more product-types the competent authority shall cancel or, where appropriate, amend the authorisations of biocidal products of the product-type(s) concerned containing that active substance. Articles 48 and 52 shall apply accordingly.”