Commission Regulation (EC) No 1112/2002 of 20 June 2002 laying down the detailed rules for the implementation of the fourth stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC (Text with EEA relevance)

• Published date: 27 June 2002
• Official Gazette Publication: Gazzetta ufficiale delle Comunità europee, L 168, 27 giugno 2002,Diario Oficial de las Comunidades Europeas, L 168, 27 de junio de 2002,Journal officiel des Communautés européennes, L 168, 27 juin 2002

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Commission Regulation (EC) No 1112/2002 of 20 June 2002 laying down the detailed rules for the implementation of the fourth stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC (Text with EEA relevance)

Official Journal L 168 , 27/06/2002 P. 0014 - 0030

Commission Regulation (EC) No 1112/2002

of 20 June 2002

laying down the detailed rules for the implementation of the fourth stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market(1), as last amended by Commission Directive 2002/48/EC(2), and in particular Article 8(2) second subparagraph thereof,

Whereas:

(1) The Commission is to undertake a programme of work for the gradual examination of active substances that were on the market two years after the date of notification of Directive 91/414/EEC. The first stage of this programme was laid down by Commission Regulation (EEC) No 3600/92 of 11 December 1992 laying down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC concerning the placing of plant protection products on the market(3), as last amended by Commission Regulation (EC) No 2266/2000(4). This first stage is ongoing. The second and third stages of work were laid down by Commission Regulation (EC) No 451/2000 of 28 February 2000 laying down the detailed rules for the implementation of the second and third stages of the work programme referred to in Article 8(2) of Council Directive 91/414/EEC(5), and are also ongoing.

(2) A fourth stage of work should be provided for all the existing active substances not covered by the first, second and third stages of the programme. For certain categories of active substances, it is desirable to indicate which particular active substances or under which conditions of use they should be included in the fourth stage of the programme.

(3) A notification procedure should be provided by which interested producers can inform the Commission of their interest in securing the inclusion of an active substance in Annex I of Directive 91/414/EEC and of their undertaking to submit all the required information for a proper evaluation of, and decision on, that active substance in the light of the criteria for inclusion set out in Article 5 of the Directive. Such information would permit further prioritisation of the work programme and enable decisions to be taken on whether these substances should stay on the market after 25 July 2003 pending the outcome of the evaluation on whether their use may be expected to satisfy the requirements of Article 5 of Directive 91/414/EEC.

(4) It is necessary to define the obligations of notifiers with regard to the formats, periods and recipient authorities for the information to be submitted. Different levels of notification are appropriate for different categories of active substances. For certain categories of active substances, data requirements and evaluation criteria are developed. Therefore, it should be required that the interested producers provide detailed information relating to the current stage of completeness of their dossiers and on the endpoints and undertake to provide a full data package within a set deadline. For the remaining active substances the interested producers should provide basic information in order to identify adequately the active substance and its uses and also undertake to provide a data package within a set deadline.

(5) Notification should not be a prerequisite for the possibility after inclusion of the active substance in Annex I to Directive 91/414/EEC to place plant protection products on the market subject to the provisions of Article 13 of the Directive.

(6) The procedures established in this Regulation should not prejudice procedures and actions to be undertaken in the framework of other Community legislation, in particular, under Council Directive 79/117/EEC of 21 December 1978 prohibiting the placing on the market and use of plant protection products containing certain active substances(6), as last amended by Commission Directive 91/188/EEC(7), where information becomes available to the Commission showing that its requirements may be satisfied.

(7) The Commission will, subject to the conclusions of the progress report on the programme of work to the European Parliament and the Council, referred to in the third subparagraph of Article 8(2) of Directive 91/414/EEC, adopt further detailed regulatory provisions permitting the finalisation as soon as possible of the evaluation and decision making of active substances for which the provisions of the present Regulation concerning notification are satisfied.

(8) The fourth subparagraph of Article 8(2) of Directive 91/414/EEC provides for a Commission Decision not to include in Annex I active substances in cases where the requirements of Article 5 of the Directive are not satisfied or the requisite information and data have not been submitted within the prescribed time period and for Member States to withdraw authorisations of plant protection products containing such active substances. However, it may in particular cases and in the light of detailed reasons provided by Member States, be appropriate to delay such withdrawal for certain uses which are essential and for which there is no alternative to protect efficiently plants or plant products, so as to allow the development of alternatives replacing the use of withdrawn products. The necessity to re-examine these provisions will have to be demonstrated on a case-by-case basis.

(9) Where, for a particular active substance, the requirements of the present Regulation concerning notification are not satisfied, interested parties are not prevented from seeking inclusion of such active substances in Annex I of Directive 91/414/EEC, through the procedures of Article 6(2) of Directive 91/414/EEC, at a later date.

(10) It is appropriate for manufacturers to bear the costs of the evaluation needed to demonstrate that their products are safe to market and therefore a fee has to be paid to the authority designated by the Commission to examine the notifications for the active substances.

(11) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

HAS ADOPTED THIS REGULATION:

CHAPTER 1

GENERAL PROVISIONS AND DEFINITIONS

Article 1

Scope

1. This Regulation lays down detailed rules for the initial implementation of the fourth stage of the programme of work referred to in Article 8(2) of Directive 91/414/EEC concerning the...