Council Directive of 15 July 1991 concerning the placing of plant protection products on the market (91/414/EEC) (repealed)

Article 13 U.K.

1. Without prejudice to Article 10, Member States shall require that applicants for authorization of a plant protection product submit with their application:

(a) a dossier satisfying, in the light of current scientific and technical knowledge, the requirements set out in Annex III; and

(b) for each active substance in the plant protection product, a dossier satisfying, in the light of current scientific and technical knowledge, the requirements set out in Annex II.

2. By way of derogation from paragraph 1, and without prejudice to the provisions of paragraphs 3 and 4, applicants shall be exempted from supplying the information required under paragraph 1 (b) except for that identifying the active substance if the active substance is already listed in Annex I, taking into account the conditions of inclusion in Annex I, and does not differ significantly in degree of purity and nature of impurities, from the composition registered in the dossier accompanying the original application.

3. In granting authorizations, Member States shall not make use of the information referred to in Annex II for the benefit of other applicants:

(a) unless the applicant has agreed with the first applicant that use may be made of such information; or

(b) for a period of 10 years from first inclusion in Annex I of an active substance not on the market two years after the date of notification of this Directive; or

(c) for periods not exceeding 10 years from the date of the decision in each Member State and provided for in existing national rules, concerning an active substance on the market two years after the date of notification of this Directive; and

[X1 (d) for a period of five years from the date of a decision, following receipt of further information necessary for first inclusion in Annex I, or to vary the conditions for, or to maintain the inclusion of an active substance in Annex I, which has been taken either to vary the conditions for, or to maintain, the inclusion of an active substance in Annex I, unless the five-year period expires before the period provided for in paragraphs 3 (b) and (c), in which case the period of five years shall be extended so as to expire on the same date as those periods.]

4. In granting authorizations, Member States shall not make use of the information referred to in Annex III to the benefit of other applicants:

(a) unless the applicant has agreed with the first applicant that use may be made of such information; or

(b) for a period of 10 years from first authorization of the plant protection product in any Member State, where authorization follows the inclusion in Annex I of any active substance contained in the product; or

(c) for periods not exceeding 10 years and provided for in existing national rules after the first authorization of the plant protection product in each Member State, where that authorization precedes inclusion in Annex I of any active substance contained in the product.

5. Member States, on examination of an application for authorization, shall inform the Commission of instances [X1 where they consider an active substance as listed] in Annex I, which has been produced by a person or manufacturing process other than those specified in the dossier on the basis of which the active substance was first included in Annex I. They shall transmit to it all data regarding the identify and impurities of the active substance.

6. By way of derogation from paragraph 1, for active substances already on the market two years after notification of this Directive, Member States may, with due regard for the provisions of the Treaty, continue to apply previous national rules concerning data requirements as long as such substances are not included in Annex I.

7. Notwithstanding paragraph 1, and without prejudice to Article 10, where the active substance is listed in Annex I:

(a) applicants for authorization of plant protection products shall, before carrying out experiments involving vertebrate animals, enquire of the competent authority of the Member State to which they intend making application:

• (a) whether the plant protection product for which an application is to be made is the same as a plant protection product for which authorization has been granted, and

• as to the name and address of the holder or holders of the authorization or authorizations.

The enquiry shall be supported by evidence that the prospective applicant intends to apply for authorization on his own behalf and that the other information specified in paragraph 1 is available;

(b) the competent authority of the Member State, if satisfied that the applicant intends to apply, shall provide the name and address of the holder or holders of previous relevant authorizations and shall at the time inform the holders of the authorizations of the name and address of the applicant.

The holder or holders of previous authorizations and the applicant shall take all reasonable steps to reach agreement on the sharing of information so as to avoid the duplication of testing on vertebrate animals.

Where data is requested with a view to inclusion in Annex I of an active substance already on the market two years after notification of this Directive, the competent authorities of the Member State shall encourage data holders to cooperate in the provision of the requested data, with a view to limiting the duplication of testing on vertebrate animals.

If, nevertheless, the applicant and holders of previous authorizations of the same product can still not reach an agreement on the sharing of data, Member States may introduce national measures obliging the applicant and holders of previous authorizations located within their territory to share the data with a view to avoiding duplicative testing on vertebrate animals and determine both the procedure for utilizing information, and the reasonable balance of the interests of the parties concerned.

Editorial Information

X1 Substituted by Corrigendum to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant products on the market (Official Journal of the European Communities No L 230 of 19 August 1991).