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

• Published date: 15 December 1992
• Official Gazette Publication: Gazzetta ufficiale delle Comunità europee, L 366, 15 dicembre 1992,Journal officiel des Communautés européennes, L 366, 15 décembre 1992,Diario Oficial de las Comunidades Europeas, L 366, 15 de diciembre de 1992

1992R3600 — EN — 10.05.2008 — 005.001

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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 (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 (OJ L 366, 15.12.1992, p.10)

Amended by:

		Official Journal
		No	page	date
►M1	COMMISSION REGULATION (EC) No 491/95 of 3 March 1995	L 49	50	4.3.1995
►M2	COMMISSION REGULATION (EC) No 1199/97 of 27 June 1997	L 170	19	28.6.1997
►M3	COMMISSION REGULATION (EC) No 1972/1999 of 15 September 1999	L 244	41	16.9.1999
►M4	COMMISSION REGULATION (EC) No 2266/2000 of 12 October 2000	L 259	27	13.10.2000
►M5	COMMISSION REGULATION (EC) No 416/2008 of 8 May 2008	L 125	25	9.5.2008

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▼B

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

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Economic Community,

Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market ( 1 ), and in particular Article 8 (2) thereof,

Whereas the Commission is to commence a programme of work for the gradual examination of active substances available on the market two years after the date of notification of Directive 91/414/EEC;

Whereas, given the very high number of active substances on the market on that date, a selection has already been made, taking into account in a balanced manner such aspects as health and/or environmental concern, the possibility of residues in treated products, the importance of the preparations containing these substances for agriculture, any manifest data gaps (or, conversely, the presence of a complete, updated data package), and any similarity of chemical or biological properties;

Whereas the relationship 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;

Whereas a notification procedure has to 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 the Directive and of their undertaking to submit all the requisite 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;

Whereas it is necessary to define the obligations of notifiers with regard to the formats, the periods and the recipient authorities for the information to be submitted; whereas the administrative consequences which shall follow if these obligations are not satisfied have to be defined;

Whereas technical or scientific information about the potentially dangerous effects of an active substance or its residues submitted within the relevant time-limits by any other interested parties should also be taken into consideration for this evaluation;

Whereas the evaluation studies should be distributed among the competent authorities of the Member States; whereas, therefore, for each active substance a rapporteur Member State should be designated to examine and evaluate the information submitted, in close consultation with experts from other Member States, and to present to the Commission the results of the assessment and a recommendation that a decision be taken with regard to the active substance concerned;

Whereas the proceedings established under this Regulation should not prejudice proceedings to be undertaken in the framework of other Community legislations;

Whereas, in order to avoid duplication of work, and in particular experiments involving vertebrate animals, specific provisions have to be provided to stimulate producers to submit collective dossiers;

Whereas the procedures under the Regulation should not prejudice the possibility of investigation and prohibitory action under Council Directive 79/117/EEC ( 2 ), as last amended by Commission Directive 91/188/EEC ( 3 ), where information becomes available to the Commission showing that the requirements for prohibition provided for in Directive 79/117/EEC may be satisfied; whereas at the time of adoption of this Regulation such information regarding Atrazin and Quintozene is under particular examination;

Whereas procedural and administrative measures have to be taken at this time in order to ensure that the evaluation of active substances can effectively start from the date of implementation of Directive 91/414/EEC;

Whereas the measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plant Health,

HAS ADOPTED THIS REGULATION:

Article 1

1. This Regulation lays down detailed rules for the implementation of the first stage of the programme of work referred to in Article 8 (2) of Directive 91/414/EEC (hereinafter referred to as the ‘Directive’). The first stage involves an assessment of the substances listed in Annex I to this Regulation with a view to their possible inclusion in Annex I to Directive 91/414/EEC. The provisions of Article 6 (2) and (3) and the second subparagraph of Article 6 (4) of the Directive shall not apply to a substance listed in Annex I to this Regulation as long as the procedures provided in this Regulation with regard to such a substance have not been finalized.

2. This Regulation shall apply without prejudice to:

(a) reviews conducted by Member States, and in particular reviews with a view to authorization renewals under Article 4 (4) of the Directive;

(b) reviews by the Commission pursuant to Article 5 (5) of the Directive;

(c) assessments carried out under Directive 79/117/EEC.

Article 2

1. For the purpose of this Regulation, ‘plant protection products’, ‘substances’, ‘active substances’, ‘preparations’and ‘authorization of a plant protection product’ shall have the meanings set out in Article 2 of the Directive.

2. The following definitions shall also apply for the purpose of this Regulation:

(a) ‘Producers’ means

— for active substances produced within the Community, the manufacturer or a person established within the Community designated by the manufacturer as his sole representative,

— for active substances produced outside the Community, the person established within the Community and designated by the manufacturer as his sole representative or, whenever such person has not been designated, the importer(s) into the Community of the active substance, either on its own or in a preparation;

(b) ‘Committee’ means the Standing Committee on Plant Health, referred to in Article 19 of the Directive.

Article 3

Member States shall designate an authority to coordinate cooperation with producers, other Member States and the Commission, and generally for the implementation of the programme of work referred to in Article 8 (2) of the Directive. They shall inform the Commission of the name of the designated authority.

Article 4

1. Any producer wishing to secure the inclusion of an active substance referred to in Annex I hereto, or any salts, esters or amines thereof, in Annex I to the Directive, shall so notify the Commission within six months of the date of entry into force of this Regulation.

Without prejudice to the foregoing subparagraph, producers of an active substance listed in Annex I are also bound to inform the Commission within the same period when they no longer seek its inclusion in Annex I to the Directive.

▼M1

1a. Notwithstanding the provisions of paragraph 1, producers having a permanent office in Austria, Finland or Sweden may notify the Commission by 30 April 1995 at the latest.

▼B

2. Notification must be made to the Commission, DG VI, rue de la Loi 200, B-1049 Brussels, in accordance with the notification as shown in Annex II hereto, completed and containing the undertaking referred to in part 5 of the specimen notification.

3. Any producer who has not notified in time any given active substance referred to in paragraph 1 will be permitted to participate in the programme referred to in Article 1 only collectively with other notifiers of that active substance or, in the case referred to in paragraph 4 hereof, in assisting the notifying Member State, with the agreement of the original notifiers.

4. The Commission shall inform the Member States through the Committee when, for any given active substance, no producer has presented a notification in accordance with paragraph 2. Member States shall be able to declare their interest in securing the inclusion of the active substance in Annex I to the Directive, by means of the specimen notification shown in Annex II hereto. Notification must be sent to the Commission as quickly as possible, and no later than six months after the Member States have been informed by the Commission. The Member State having presented the notification shall carry out the duties of a producer as set out in Articles 5 to 8 hereof.

5. When, following the above procedure, no producer or Member State has notified an interest in obtaining the inclusion of a given active substance in Annex I to the Directive, a decision not to include that active substance may be taken in accordance with the final subparagraph of Article 8 (2) of the Directive.

Article 5

1. The Commission shall examine with the Committee the notifications referred to in Article 4 (2) and (4).

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