The Plant Protection Products Regulations 1995

Provisional approvals

7.—(1) The Ministers 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, approve, for a provisional period not exceeding three years, the placing on the market and use of any plant protection product containing a new active substance which is not included in Annex I, provided that the conditions specified in paragraph (2) below are satisfied.

(2) The conditions mentioned in paragraph (1) are—

(a) a dossier on the active substance has been submitted in accordance with regulation 4(1) and satisfies the requirements of Annexes II and III in relation to the projected uses;

(b) the Ministers have established 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 regulation 6(3) to (7).

(3) When the conditions specified in paragraph (2) above have been satisfied the Ministers shall immediately inform the relevant competent authorities and the Commission of their assessment of the dossier and of the terms of the approval, giving at least the information provided for in Article 12(1).

(4) If, following the examination provided for in Article 6(3) of a dossier submitted under regulation 4(1), it is decided, in accordance with the procedure laid down in Article 19(1), that the active substance does not satisfy the requirements specified in Article 5(1), the Ministers shall withdraw the provisional approval.

(5) If, on expiry of the three year period mentioned in paragraph (1) above, a decision has not been taken concerning the inclusion of the active substance in Annex I, a further period may be provided for in accordance with 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) and the Ministers shall extend the period of the provisional approval accordingly.

(6) The Ministers shall ensure that compliance with the requirements set out in regulation 6(2) to (7) is achieved by official or officially recognised tests and analyses carried out under agricultural, plant health and environmental conditions relevant to the use of the plant protection product and representative of those prevailing where the product is intended to be used in Great Britain.

(7) An approval granted under this regulation shall specify the requirements and conditions relating to the placing on the market and use of the product and such requirements and conditions shall include at least all those necessary to comply with regulation 6(3)(a) to (e).

(8) Any person who contravenes or causes or permits any person to contravene any requirement or condition of an approval granted under this regulation shall be guilty of an offence.

(1)

Article 19 establishes a procedure for the adoption of legislation by the Commission under the Directive.