Article 23A Review of basic substance approvalF1
A competent authority may review the approval of a basic substance at any time.
A competent authority must review the approval of a basic substance where—
the competent authority has received and assessed confirmatory information in accordance with Article 20A (as applied by Article 23(5E));
further information required in accordance with a condition under Article 6(1)(f) has not been provided within the period specified in that condition.
Where the competent authority considers that there are indications that the substance no longer satisfies the criteria provided for in Article 23(1) to (3), the competent authority must inform the other competent authorities and the interested party referred to in Article 23(3) accordingly, setting a period for the submission of comments.
The competent authority may obtain independent scientific advice, where the competent authority considers it appropriate to do so.
Where the competent authority concludes that, having considered comments received during the period set in accordance with paragraph 3 and any other information or matters that the competent authority considers important and relevant to the review, the substance no longer satisfies the criteria provided for in Article 23(1), the competent authority must decide to either—
amend the conditions of the approval, or
withdraw the approval.
As soon as reasonably practicable after making a decision under paragraph 5, the competent authority must—
notify the other competent authorities and the interested party referred to in Article 23(3) in writing of the decision and the reasons for it, and
update the approvals register accordingly.
The Secretary of State may review an active substance under paragraph 1 or 2 instead of a competent authority—
in relation to Wales, with the consent of the Welsh Ministers;
in relation to Scotland, with the consent of the Scottish Ministers.
Where the Secretary of State reviews an active substance in accordance with paragraph 7, a reference in paragraphs 3 to 6 to the competent authority is to be read as a reference to the Secretary of State.
Annotations
Textual amendments
- F1
Art. 23A inserted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 4(30) (with Sch. 1) (as amended by S.I. 2020/1376, regs. 1(4), 3(4)(f)); 2020 c. 1, Sch. 5 para. 1(1)