Commission Regulation (EC) No 1490/2002 of 14 August 2002 laying down further detailed rules for the implementation of the third stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC and amending Regulation (EC) No 451/2000 (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 the second subparagraph of Article 8(2) thereof,

Whereas:

1. The Commission is to undertake a programme of work for the gradual examination of active substances on the market two years after the date of notification of Directive 91/414/EEC within a period of 12 years. 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 Regulation (EC) No 2266/2000⁽⁴⁾. This first stage is ongoing.

2. The second stage of work was 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 is also ongoing.

3. A third stage of work was provided for in Regulation (EC) No 451/2000 for an additional number of active substances not covered by the first and second stages of the programme. Producers wishing to secure the inclusion of these active substances in Annex I to Directive 91/414/EEC have provided detailed information relating to the current stage of completeness of their dossiers and on the endpoints and have undertaken to provide a full data package.

4. For the third stage of the work programme, Article 10(3) of Regulation (EC) No 451/2000 specifies that detailed provisions concerning the submission of complete dossiers, the time limit(s) for their submission and the fee regime for the active substances concerned have to be established by the Commission in a Regulation to be adopted in accordance with the second subparagraph of Article 8(2) of Directive 91/414/EEC.

5. Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002⁽⁶⁾ created the European Food Safety Authority (EFSA) to ensure that the Community has access to high-quality, independent and efficient scientific and technical support in order to achieve a high level of health protection in relation to legislation concerning safety of food and feed. It is therefore appropriate to provide that the EFSA should have a role in the programme of work on active substances, and the scope of this involvement should be defined as soon as possible.

6. In order to ensure that dossiers are received by the Member States in a manageable way, the active substances to be evaluated should be divided into two groups with separate time limits for the submission of dossiers.

7. Further, at an initial stage it should be sufficient that notifiers provide only a list of the available tests and studies to the rapporteur Member States, in order to permit the Member States to establish whether a full data package is available to be submitted by the specified time limit. Where such data will not be available by the time limit, it will not be possible to complete re-evaluation of the active substance within the timetable provided for in Directive 91/414/EEC and a decision should therefore be taken immediately not to include the substance concerned in Annex I to the Directive. Authorisation of products containing such active substance should be withdrawn by Member States.

8. The relationships between producers, Member States, the Commission and the EFSA and the obligations on each of them for the implementation of the programme should be laid down, taking into account experience gained during the first and second stages of the programme. Close cooperation between all parties involved and a scrupulous respect of time limits laid down is necessary to ensure the efficiency of the programme. Strict time limits for all elements of the third stage of the work programme should be set in order to ensure its finalisation within an acceptable time period. Where cooperation with notifiers ceases it is impossible to continue further evaluation efficiently and therefore the evaluation should be terminated.

9. In order to ensure that all relevant information on the potentially dangerous effects of an active substance or its residues are considered, technical or scientific information submitted within the relevant time limits by any person should also be taken into consideration in the evaluations.

10. It is necessary to define the obligations of notifiers with regard to the formats, time periods and recipient authorities for the information to be submitted.

11. The task of evaluation should be distributed among the competent authorities of the Member States. Therefore, for each active substance a rapporteur Member State should be designated. The rapporteur Member State should assess the completeness check provided by the notifier, and examine and evaluate the information submitted. It should present to the EFSA the results of the evaluation and make a recommendation to the Commission concerning the decision to be taken with regard to the active substance concerned.

12. Member States should send draft reports of their evaluations to the EFSA. The draft reports prepared by the rapporteur Member States should be peer reviewed by the EFSA before they are submitted to the Standing Committee on the Food Chain and Animal Health.

13. In order to avoid duplication of work, and in particular experiments involving vertebrate animals, producers should be encouraged to submit collective dossiers.

14. The notification and submission of a dossier 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 that Directive. Therefore, operators which have not submitted notifications should be able to be informed at all stages of the evaluation process of the possible further requirements for continued marketing of plant-protection products containing an active substance under evaluation.

15. 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 prohibiting the placing on the market and use of plant-protection products containing certain active substances⁽⁷⁾, as last amended by the Act of Accession of Austria, Finland and Sweden, where information becomes available to the Commission showing that its requirements may be satisfied.

16. The use of anti-microbials from classes, which are or may be used in human or veterinary medicine for the purpose of plant protection should be discouraged. Two of the substances concerned by this Regulation — kasugamycin and streptomycine — fall into this category⁽⁸⁾. Pending eventual decisions on their inclusion in Annex I, their uses should continue to be restricted and only be permitted where essential. For the purpose of their evaluation, information on anti-microbial resistance will be required.

17. This Regulation shall be without prejudice to Community obligations regarding methyl bromide under the Montreal Protocol.

18. In the case of an apparent imbalance in the responsibilities borne by the Member States as rapporteur in the assessment and evaluation, it should be possible to replace the Member State originally designated as rapporteur for a particular active substance by another Member State.

19. To ensure the proper resourcing of this stage of the programme of work, a fee should be paid to the Member States for the handling and evaluation of dossiers in addition to the fee already paid for the evaluation of the notifications pursuant to Article 13 of Regulation (EC) No 451/2000.

20. Regulation (EC) No 451/2000 provided that for the active substances covered by the third stage of the work programme, the time limit for the submission of a full data package was 25 May 2003 at the latest. That Regulation also provided that detailed provisions concerning the submission of complete dossiers would be established at a later stage. In order to organise the work programme efficiently, it is not necessary to submit full data packages shortly before full dossiers have to be submitted. However, to ensure that active substances without full data packages do not remain on the market, a list of available data should be submitted, while the full data packages should be submitted only in exceptional cases and on request.

21. Regulation (EC) No 451/2000 should be amended accordingly.

22. 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: