General provisions
Article 8
1
By way of derogation from Article 4, a Member State may, to enable a gradual assessment to be made of the properties of new active substances and to make it easier for new preparations to be made available for use in agriculture, authorize, for a provisional period not exceeding three years, the placing on the market of plant protection products containing an active substance not listed in Annex I and not yet available on the market two years after notification of this Directive, provided that:
a
following application of Article 6 (2) and (3) it is found that the dossier on the active substance satisfies the requirements of Annexes II and III in relation to the projected uses;
b
the Member State establishes that the active substance can satisfy the requirements of Article 5 (1) and that the plant protection product may be expected to satisfy the requirements of Article 4 (1) (b) to (f).
In such cases the Member State shall immediately inform the other Member States and the Commission of its assessment of the dossier and of the terms of the authorization, giving at least the information provided for in Article 12 (1).
Following the evaluation of the dossier as provided for in Article 6 (3), it may be decided, in accordance with the procedure laid down in Article 19, that the active substance does not satisfy the requirements specified in Article 5 (1). In such cases the Member States shall ensure that the authorizations must be withdrawn.
By way of derogation from Article 6, if, on expiry of the three-year period, a decision has not been taken concerning the inclusion of an active substance in Annex I, a further period may be ordered by the procedure referred to in Article 19 to enable a full examination to be made of the dossier and, where appropriate, of any additional information requested in accordance with Article 6 (3) and (4).
The provisions of Article 4 (2), (3), (5) and (6) shall apply to authorizations granted under the terms of this paragraph without prejudice to the foregoing subparagraphs.
2
By way of derogation from Article 4 and without prejudice to paragraph 3 or to Directive 79/117/EEC, a Member State may, during a period of 12 years following the notification of this Directive, authorize the placing on the market in its territory of plant protection products containing active substances not listed in Annex I that are already on the market two years after the date of notification of this Directive.
After the adoption of this Directive, the Commission shall commence a programme of work for the gradual examination of these active substances within the 12-year period referred to in the foregoing subparagraph. This programme may require interested parties to submit all requisite data to the Commission and the Member States within a period provided for in the programme. A Regulation, adopted according to the procedure laid down in Article 19, will set out all the provisions necessary for the implementation of the programme.
Ten years following notification of this Directive the Commission shall present to the European Parliament and the Council a progress report on the programme. Depending upon the conclusions of the report, it may be decided, according to the procedure laid down in Article 19, whether, for certain substances, the 12-year period referred to in the first subparagraph is to be extended for a period to be determined.
During the 12-year period referred to in the first subparagraph it may, following examination by the Committee referred to in Article 19 of such active substance, be decided by the procedure laid down in that Article that the substance can be included in Annex I and under which conditions, or, in cases where the requirements of Article 5 are not satisfied or the requisite information and data have not been submitted within the prescribed period, that such active substance will not be included in Annex I. The Member States shall ensure that the relevant authorizations are granted, withdrawn or varied, as appropriate, within a prescribed period.
3
Where they review plant protection products containing an active substance in accordance with paragraph 2, and before such review has taken place, Member States shall apply the requirements laid down in Article 4 (1) (b) (i) to (v), and (c) to (f) in accordance with national provisions concerning the data to be provided.
4
By way of further derogation from Article 4, in special circumstances a Member State may authorize for a period not exceeding 120 days the placing on the market of plant protection products not complying with Article 4 for a limited and controlled use if such a measure appears necessary because of an unforeseeable danger which cannot be contained by other means. In this case, the Member State concerned shall immediately inform the other Member States and the Commission of its action. It shall be decided without delay, in accordance with the procedure laid down in Article 19, whether and under which conditions the action taken by the Member State may be extended for a given period, repeated, or revoked.