Regulation (EC) No 1107/2009 of the European Parliament and of the CouncilShow full title

Article 80 U.K. Transitional measures

1. Directive 91/414/EEC shall continue to apply, with respect to the procedure and the conditions for approval:

(a) to active substances for which a decision has been adopted in accordance with Article 6(3) of Directive 91/414/EEC before 14 June 2011;

(b) to active substances listed in Annex I to Regulation (EC) No 737/2007(1);

(c) to active substances for which completeness has been established in accordance with Article 16 of Regulation (EC) No 33/2008(2);

(d) to active substances for which completeness has been established in accordance with Article 6 of Regulation (EC) No 33/2008 before 14 June 2011.

On the basis of the examination carried out under Directive 91/414/EEC, a Regulation on the approval of such a substance shall be adopted in accordance with Article 13(2) of this Regulation. For active substances referred to in point (b) of this paragraph that approval shall not be considered as the renewal of approval referred to in Article 14 of this Regulation.

2. Article 13(1) to (4) and Annexes II and III to Directive 91/414/EEC shall continue to apply with respect to active substances included in Annex I to that Directive and to active substances approved in accordance with paragraph 1 of this Article:

(a) for a period of five years from the date of their inclusion or approval, for active substances covered by Article 8(2) of Directive 91/414/EEC;

(b) for a period of 10 years from the date of their inclusion or approval, for active substances which were not on the market on 26 July 1993;

(c) for a period of five years from the date of the renewal of the inclusion or renewal of the approval, for active substances whose inclusion in Annex I to Directive 91/414/EEC expires by 24 November 2011. This provision shall only apply to data necessary for the renewal of the approval and which were certified as compliant with the principles of good laboratory practice by that date.

3. Where Article 13 of Directive 91/414/EEC applies by virtue of paragraph 1 or paragraph 2 of this Article, it shall be subject to any special rules concerning Directive 91/414/EEC laid down in the Act of Accession by which a Member State joined the Community.

4. For active substances for which the first approval expires by 14 December 2012, the application provided for in Article 14 shall be submitted by a producer of the active substance to a Member State, with a copy to the other Member States, the Commission and the Authority, no later than two years before the expiry of the first approval.

5. Applications for authorisations of plant protection products:

(a) under Article 4 of Directive 91/414/EEC which are pending in the Member States; or

(b) which are due to be amended or withdrawn following an inclusion in Annex I to Directive 91/414/EEC or following an approval in accordance with paragraph 1 of this Article;

on 14 June 2011 shall be decided on the basis of national law in force before that date.

After that decision, this Regulation shall apply.

6. Products labelled in accordance with Article 16 of Directive 91/414/EEC may continue to be placed on the market until 14 June 2015.

7. By 14 December 2013, the Commission shall establish a list of substances included in Annex I to Directive 91/414/EEC which satisfy the criteria set out in point 4 of Annex II to this Regulation and to which the provisions of Article 50 of this Regulation shall apply.

[F1 8. To a product which was granted an authorisation under Article 32(1) based on an application submitted before  15 July 2019 , and which after that date falls under the definition in point 34 of Article 3, this Regulation shall continue to apply for the duration provided in the authorisation.]

Textual Amendments

F1 Inserted by Regulation (EU) 2019/1009 of the European Parliament and of the Council of 5 June 2019 laying down rules on the making available on the market of EU fertilising products and amending Regulations (EC) No 1069/2009 and (EC) No 1107/2009 and repealing Regulation (EC) No 2003/2003 (Text with EEA relevance).

(1)

OJ L 169, 29.6.2007, p. 10.

(2)

OJ L 15, 18.1.2008, p. 5.