General requirements for granting standard approvals
6.—(1) The Department shall not approve a plant protection product under regulation 5 unless the requirements set out in paragraph (2) to (7) are satisfied.
(2) The active substances of the plant protection product shall have been included in Annex I at the time the approval is granted and any conditions laid down in that Annex shall have been fulfilled.
(3) Having regard to current scientific and technical knowledge and upon the appraisal of any dossier submitted for the approval of the product, it shall have been established (pursuant to the uniform principles provided for in Annex VI) that, when used in accordance with regulation 3(2) and having regard to all normal conditions under which it may be used and the consequences of its use, the plant protection product –
(a)is sufficiently effective;
(b)has no unacceptable effects on plants or plant products;
(c)does not cause unnecessary suffering and pain to vertebrates which are to be controlled;
(d)has no harmful effect directly or indirectly on human or animal health (for example, through drinking water, food or feed) or on ground water;
(e)has no unacceptable influence on the environment, having particular regard to –
(i)its fate and distribution in the environment, particularly contamination of water (including drinking water and ground water); and
(ii)its impact on non-target species; and
(f)can be used in such a way that any provisional maximum residue levels determined by the Department under paragraph (7) or by the Commission under Article 4(1)(f) are not exceeded.
(4) The Department, pursuant to the uniform principles provided for in Annex VI, shall have determined the nature and quantity of the active substances of the plant protection product and, where appropriate, any toxicologically or ecotoxicologically significant impurities and co-formulants, applying methods which, until harmonised methods have been adopted under Article 4(1)(c), it has determined are appropriate.
(5) The Department, pursuant to the uniform principles provided for in Annex VI, shall have determined the residues of the plant protection product, resulting from approved uses, which are of toxicological or environmental significance, by applying appropriate methods in general use.
(6) The Department, pursuant to the uniform principles provided for in Annex VI, shall have determined the physical and chemical properties of the plant protection product and shall have adjudged them to be acceptable for the purposes of the appropriate use and storage of the product.
(7) The Department shall have determined provisional maximum residue levels for the agricultural products referred to in the approval and shall have notified them to the Commission.
(8) The Department shall ensure that compliance with the requirements set out in paragraphs (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.