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

• Published date: 29 February 2000
• Subject Matter: Legislazione fitosanitaria,Legislación fitosanitaria,Législation phytosanitaire
• Official Gazette Publication: Gazzetta ufficiale delle Comunità europee, L 55, 29 febbraio 2000,Diario Oficial de las Comunidades Europeas, L 55, 29 de febrero de 2000,Journal officiel des Communautés européennes, L 55, 29 février 2000

2000R0451 — EN — 26.06.2003 — 002.001

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This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents

►B 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 (OJ L 055, 29.2.2000, p.25)

Amended by:

		Official Journal
		No	page	date
►M1	Commission Regulation (EC) No 1490/2002 of 14 August 2002	L 224	23	21.8.2002
►M2	Commission Regulation (EC) No 1044/2003 of 18 June 2003	L 151	32	19.6.2003

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▼B

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

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 1999/80/EC ( 2 ), and in particular Article 8(2), second subparagraph, thereof,

Whereas:

(1) The Commission is to undertake a work programme 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 the 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 work programme 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 1972/1999 ( 4 ). The first stage is ongoing. It is necessary to continue and speed up the examination of the remaining active substances, taking into account experience from the first stage.

(2) Given the very high number of existing active substances on the market still to be evaluated, a programme in several phases must be established. Experience has shown that the evaluation and decision-making on an active substance is a time-consuming process. It is therefore not yet possible to provide for a detailed evaluation of all the existing active substances.

(3) Therefore the second stage will provide for the detailed evaluation of a number of active substances comparable to the number covered in the first stage whilst the third stage will prepare for the subsequent evaluation of active substances. For certain categories of active substances further harmonisation is required concerning the dossier to be provided and the evaluation to be carried out. Those categories should therefore not be included in the current proposed work programme but should be covered by further stages for their evaluation with a view to their possible inclusion in Annex I to Directive 91/414/EEC.

(4) For the second stage a selection should be made taking into account, in a balanced manner, such aspects as health and/or environmental concern, possibility of leaving residues in treated products, importance of the preparations containing these substances for agriculture, any manifest data gaps and any similarity of chemical or biological properties.

(5) The relationships between producers, Member States and the Commission and the obligations on each of the parties for the implementation of the programme should be laid down, taking into account experience gained during the first stage of the programme. Close cooperation between all parties involved is necessary to increase the efficiency of the programme.

(6) Technical or scientific information about an active substance, in particular with regard to its potentially dangerous effects or its residues, submitted within the relevant time limits by any other interested parties should also be taken into consideration in the evaluations.

(7) A notification procedure should be provided by which interested producers have the right to inform the Commission of their interest in securing the inclusion of an active substance in Annex I to 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 Directive 91/414/EEC. Therefore the information submitted should include information on a limited range of representative uses for which the notifier must demonstrate, on the basis of the data submitted, that for one or more preparations the requirements of Directive 91/414/EEC in relation to the criteria referred to in its Article 5 can be met.

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

(9) 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 to examine and evaluate the information submitted and to present to the Commission the results of the evaluation and a recommendation for a decision to be taken with regard to the active substance concerned.

(10) Rapporteur Member States should first examine dossiers received, assess the completeness check provided by the notifiers and report to the Commission. It should be established that Member States should send draft reports of their evaluations to the Commission generally within 12 months after the dossiers submitted by notifiers have been considered complete.

(11) The draft reports prepared by the rapporteur Member States should, where necessary, be the subject of preliminary examination by experts of other Member States within a programme coordinated by the Commission before they are submitted to the Standing Committee on Plant Health.

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

(13) 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 Directive 91/414/EEC. Therefore, it should be possible for operators which have not presented notifications to be informed at all stages of the possible further requirements for continued marketing of plant protection products containing an active substance under evaluation.

(14) The procedures provided for 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 ( 5 ), as last amended by Commission Directive 91/188/EEC ( 6 ), where information becomes available to the Commission showing that its requirements may be satisfied.

(15) Directive 91/414/EEC provides in Article 8(2), second subparagraph, a 12-year period for the work programme concerning the evaluation of existing active substances. The 12-year period may be extended by the Commission subject to the conclusions of a progress report, referred to in Article 8(2), third subparagraph, on the programme to the European Parliament and the Council. On the expiry of the time limit, whether or not it was extended, Member States will have to withdraw authorisations of plant protection products containing the active substances which were not included in Annex I to Directive 91/414/EEC. The Commission, subject to the conclusions of that report, will adopt further detailed regulatory provisions serving to finalise as soon as possible the evaluation and decision making of active substances for which the provisions of the present Regulation concerning notification and submission of complete dossiers axe satisfied. Article 8(2), fourth subparagraph, 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 Directive 91/414/EEC are not satisfied or the requisite information and data have not been submitted within the prescribed time period and for the withdrawal by Member States of authorisations of plant protection products containing such active substances. However, subject to the conclusions of the said report and if necessary, it may be appropriate to re-examine these provisions for certain uses which are essential and for which there is no alternative to protect efficiently plants or plant products such as to allow the development of alternatives replacing the use of withdrawn products. The necessity of re-examining those provisions will have to be demonstrated on a case-by-case basis.

(16) If, for a particular active substance, the requirements of the present Regulation concerning notification and submission of complete dossiers are not satisfied, interested parties are not prevented from seeking inclusion of such active substances in Annex I to Directive 91/414/EEC, in accordance with the procedures under Article 6(2) of Directive 91/414/EEC, at a later date.

(17) A third stage of work is envisaged for all the active substances not covered by the first and second stage of the programme. Producers wishing to secure the inclusion of such active substances in Annex I to Directive 91/414/EEC should provide detailed information relating to the

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