CHAPTER IIACTIVE SUBSTANCES, SAFENERS, SYNERGISTS AND CO-FORMULANTS
SECTION 1Active substances
Subsection 3Renewal and review
F1Article 21Review of approval
1
A competent authority may review the approval of an active substance in relation to its constituent territory at any time.
2
The competent authority must review the approval of an active substance in relation to its constituent territory where—
a
the competent authority has assessed confirmatory information as reviewing authority in accordance with Article 20A(1),
b
the competent authority receives the assessment of the reviewing competent authority in accordance with Article 20A(2)(b), or
c
further information required in accordance with a condition under Article 6(1)(f) has not been provided within the period specified in the condition.
3
Where the competent authority considers that—
a
in light of new scientific and technical knowledge or the assessment of the reviewing authority in accordance with Article 20A, there are indications that the active substance no longer satisfies the approval criteria provided for in Article 4, or
b
further information required in accordance with a condition under Article 6(1)(f) has not been provided
the competent authority must inform each of the other competent authorities and the producer of the active substance accordingly, setting a period for the submission of comments.
4
The competent authority may obtain independent scientific advice, where the competent authority considers it appropriate to do so.
5
Where the competent authority concludes, having considered comments received during the period set in accordance with paragraph 3 and any other information or matters that the competent authority considers relevant to the review, that paragraph 3(a) or (b) apply, the competent authority must decide to either—
a
amend the conditions or restrictions of the approval, or
b
withdraw the approval.
6
Where the reasons for withdrawing the approval of an active substance—
a
relate to immediate concerns for the protection of human or animal health or the environment, plant protection products containing that active substance must be withdrawn from the market immediately;
b
do not fall within point (a), the competent authority must set a grace period in respect of existing stocks of the plant protection products containing that active substance.
7
The grace period—
a
for the sale and distribution of the plant protection products must take into account the normal period of use of those plant protection products but must not exceed six months;
b
for the disposal, storage, and use of the plant protection products must be consecutive to the period described in point (a) and must not exceed one year.
8
As soon as reasonably practicable after making a decision under paragraph 5, the competent authority must—
a
notify the producer of the active substance and the other competent authorities in writing of the decision, the reasons for that decision, and the details of any grace period set in accordance with paragraphs 6 and 7, and
b
update the approvals register accordingly.
9
The Secretary of State may review an active substance under paragraph 1 or 2 instead of a competent authority—
a
in relation to Wales, with the consent of the Welsh Ministers;
b
in relation to Scotland, with the consent of the Scottish Ministers.
10
Where the Secretary of State reviews an active substance in accordance with paragraph 9, a reference in paragraphs 3 to 6 and 8 to the competent authority is to be read as a reference to the Secretary of State.