Paragraph 6 Ongoing active substance approval applications

(1)

This paragraph applies in relation to an application for approval of an active substance, or for amendment of the conditions of such an approval, where—

(a)

before exit day, that application was submitted to the United Kingdom as rapporteur Member State under Article 7 of Regulation (EC) No 1107/2009 as it had effect immediately before exit day, and

(b)

immediately before exit day, a Regulation adopted under Article 13(2) of Regulation (EC) No 1107/2009 as it had effect immediately before exit day in relation to that application has not entered into force.

(2)

An application in relation to which this paragraph applies is taken as being made on the day on which it was made—

(a)

where the application is for approval of an active substance, under Article 7(1) of Regulation (EC) No 1107/2009;

(b)

where the application is for amendment of the conditions of approval of an active substance, under Article 7(1A) of Regulation (EC) No 1107/2009.

(3)

The relevant competent authority is the assessing competent authority for an application to which this paragraph applies.

(4)

Anything done before exit day in relation to an application to which this paragraph applies—

(a)

by the rapporteur Member State;

(b)

by the European Food Safety Authority under Article 10 or 12 of Regulation (EC) No 1107/2009 as it had effect immediately before exit day;

is taken to have been done by the relevant competent authority as the assessing competent authority.

(5)

In sub-paragraphs (3) and (4), the “relevant competent authority” is the Secretary of State, subject to sub-paragraphs (6) to (8).

(6)

The Secretary of State may appoint another competent authority as the relevant competent authority for an application to which this paragraph applies with the agreement of that competent authority.

(7)

The relevant competent authority must notify the applicant following an appointment under sub-paragraph (6).

(8)

An appointment in accordance with sub-paragraph (6) does not affect anything done by the Secretary of State as assessing competent authority prior to appointment.

(9)

In this paragraph—

“assessing competent authority” has the same meaning as in Subsection 2 of Section 1 of Chapter 2 of Regulation (EC) No 1107/2009;
“rapporteur Member State” has the meaning given by Article 3(22) of Regulation (EC) No 1107/2009 as it had effect immediately before exit day.