Article 15U.K.Review of approval of an active substance
1.The Commission 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 Commission may also review the approval of an active substance for one or more product-types at the request of a Member State 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 Commission shall make publicly available the information that it is carrying out a review and shall provide an opportunity for applicant to submit comments. The Commission shall take due account of those comments in its review.
Where those indications are confirmed, the Commission shall adopt an implementing Regulation amending the conditions of approval of an active substance or cancelling its approval. That implementing Regulation shall be adopted in accordance with the examination procedure referred to in Article 82(3). Article 9(2) shall apply. The Commission shall inform the initial applicants for the approval accordingly.
On duly justified imperative grounds of urgency the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 82(4).
2.The Commission may consult the Agency on any questions of a scientific or technical nature related to the review of approval of an active substance. The Agency shall, within 270 days of the request, prepare an opinion and submit it to the Commission.
3.Where the Commission decides to cancel or amend the approval of an active substance for one or more product-types, the Member States or, in the case of a Union authorisation, the Commission 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.