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

CHAPTER XI TRANSITIONAL AND FINAL PROVISIONS

Article 80 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.

Article 81 Derogation for safeners and synergists, co-formulants and adjuvants

1. By way of derogation from Article 28(1), a Member State may, for a period of 5 years following the adoption of the programme referred to in Article 26, authorise the placing on the market in its territory of plant protection products containing safeners and synergists, which have not been approved, where they are included in that programme.

2. By way of derogation from Article 27 and without prejudice to Community law, Member States may apply national provisions for co-formulants not included in Annex III until 14 June 2016.

Where, after 14 June 2016, a Member State has serious grounds for considering that a co-formulant not included in Annex III is likely to constitute a serious risk to human or animal health or the environment, it may temporarily prohibit or restrict the application of a co-formulant in question within its territory. It shall immediately inform the other Member States and the Commission thereof and give reasons for its decision. Article 71 shall apply.

3. By way of derogation from Article 58(1) Member States may apply national provisions for authorisation of adjuvants until the adoption of detailed rules referred to in Article 58(2).

Article 82 Review clause

By 14 December 2014, the Commission shall present a report to the European Parliament and the Council on the functioning of mutual recognition of authorisations and in particular on the application by the Member States of the provisions referred to in Article 36(3) and Article 50(2), the division of the Community into three zones and on the application of the criteria for the approval of active substances, safeners and synergists as set out in Annex II and the impact thereof on the diversification and competitiveness of agriculture as well as on human health and on the environment. The report may be accompanied, if necessary, by the appropriate legislative proposals to amend those provisions.

Article 83 Repeal

Without prejudice to Article 80, Directives 79/117/EEC and 91/414/EEC, as amended by the acts listed in Annex V, are repealed with effect from 14 June 2011, without prejudice to the obligations of the Member States relating to the time limits for transposition into national law and application of the Directives set out in that Annex.

References to the repealed Directives shall be construed as references to this Regulation. In particular, references in other Community legislation, such as Regulation (EC) No 1782/2003, to Article 3 of Directive 91/414/EEC shall be construed as references to Article 55 of this Regulation.

Article 84 Entry into force and application

This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.

By 14 June 2011, the Commission shall adopt the following:

(a)

a Regulation containing the list of the active substances already approved at the moment of adoption of that Regulation;

(b)

a Regulation on data requirements for active substances, as referred to in Article 8(1)(b);

(c)

a Regulation on data requirements for plant protection products, as referred to in Article 8(1)(c);

(d)

a Regulation on uniform principles for risk assessment for plant protection products, as referred to in Article 36;

(e)

a Regulation containing the requirements of the labelling of plant protection products, as referred to in Article 65(1).

This Regulation shall apply from 14 June 2011.

(1)

OJ L 169, 29.6.2007, p. 10.

(2)

OJ L 15, 18.1.2008, p. 5.