The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019

Commission Regulation (EU) No 1141/2010 laying down the procedure for the renewal of the inclusion of a second group of active substances in Annex I to Council Directive 91/414/EEC and establishing the list of those substances

15.—(1) Commission Regulation (EU) No 1141/2010 laying down the procedure for the renewal of the inclusion of a second group of active substances in Annex I to Council Directive 91/414/EEC and establishing the list of those substances is amended as follows.

(2) For Article 1, substitute—

“Article 1 Scope

1.   This Regulation lays down the procedure for the determination of the existing renewal application by the relevant competent authority as assessing competent authority.

2.   The “existing renewal application” is the application for the renewal of the approval of the active substance famoxadone which—

(a) was made to the United Kingdom as rapporteur Member State in accordance with Article 4 as it had effect immediately before exit day, and

(b) is taken as being made under this Regulation and Article 15(1) of Regulation (EC) No 1107/2009 on the date on which it was made.

3.   Anything done under this Regulation as it had effect immediately before exit day in relation to the existing renewal application—

(a) by the United Kingdom as rapporteur Member State;

(b) by the European Food Safety Authority;

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

4.   In this Article—

(a) “rapporteur Member State” has the meaning given in Article 2(c) as it had effect immediately before exit day;

(b) the “relevant competent authority” is the Secretary of State.”.

(3) In Article 2—

(a) for point (b) substitute—

“(b) ‘applicant’ means the producer who made the existing renewal application;”;

(b) omit points (c) to (f);

(c) after point (f) insert—

“(g) ‘Regulation (EC) No 1107/2009’ means Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market;

(h) ‘assessing competent authority’ has the meaning given by Article 15(1) of Regulation (EC) No 1107/2009;

(i) ‘existing renewal application’ has the meaning given by Article 1(2).”.

(4) After Article 2 insert—

“Article 2A Determination of existing renewal application

1.   Where the assessing competent authority considers that additional data from the applicant is necessary to finalise the relevant conclusion, the assessing competent authority may set a period of up to one month for the applicant to supply that data.

2.   The assessing competent authority must notify the other competent authorities—

(a) as to the data received in accordance with paragraph 1, or

(b) where no data is received during the period described in paragraph 1.

3.   On request from a competent authority, the assessing competent authority must provide a copy of data received in accordance with paragraph 1.

4.   The assessing competent authority must send the other competent authorities a finalised conclusion as soon as reasonably practicable after the conclusion is finalised.

5.   Article 20 of Regulation (EC) No 1107/2009 applies to the determination of an existing renewal application, and for the purpose of that Article the existing renewal application is taken to relate to each constituent territory.

6.   In paragraph 1, “relevant conclusion” means the conclusion of the European Food Safety Authority in respect of the existing renewal application, delivered in accordance with the second subparagraph of Article 16(2) as it had effect immediately before exit day.

7.   In this Article, “competent authority” and “constituent territory” have the meanings given in Article 3A of Regulation (EC) No 1107/2009.”.

(5) Omit Articles 3 to 21.

(6) After Article 21, omit the words from “This Regulation” to “Member States”.

(7) Omit Annexes 1 and 2.