Provisional approvals
7.—(1) The Department 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) 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 Department has 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) have been satisfied the Department shall immediately inform the relevant competent authorities and the Commission of its 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, that the active substance does not satisfy the requirements specified in Article 5(1), the Department shall withdraw the provisional approval.
(5) Before the expiry of an approval under paragraph (1) and at the request of the approval holder, the Department may, subject to Article 8, extend that approval.
(6) The Department 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 Northern Ireland.
(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.