5

Article 4 of that directive provides: ‘1. Member States shall ensure that a plant protection product is not authorised unless: (a) its active substances are listed in Annex I and any conditions laid down therein are fulfilled, and, with regard to the following points (b), (c), (d) and (e), pursuant to the uniform principles provided for in Annex VI, unless (b) it is established, in the light of current scientific and technical knowledge and shown from appraisal of the dossier provided for in Annex III, that when used in accordance with Article 3 (3), and having regard to all normal conditions under which it may be used, and to the consequences of its use: (i) it is sufficiently effective; (ii) it shall not have any unacceptable effects on plants or plant products; (iii) it does not cause unnecessary suffering and pain to vertebrates to be controlled; (iv) it has no harmful effect on human or animal health, directly or indirectly (e.g. through drinking water, food or feed) or on groundwater; (v) it has no unacceptable influence on the environment, having particular regard to the following considerations: — its fate and distribution in the environment, particularly contamination of water including drinking water and groundwater, — its impact on non-target species; (c) the nature and quantity of its active substances and, where appropriate, any toxicologically or ecotoxicologically significant impurities and co-formulants can be determined by appropriate methods, harmonised according to the procedure provided in Article 21, or, if not, agreed by the authorities responsible for the authorisation; (d) its residues, resulting from authorised uses, and which are of toxicological or environmental significance, can be determined by appropriate methods in general use; (e) its physical and chemical properties have been determined and deemed acceptable for the purposes of the appropriate use and storage of the product; (f) where appropriate, the MRLs [maximum residue levels] for the agricultural products affected by the use referred to in the authorisation have been set or modified in accordance with Regulation (EC) No 396/2005 ... 2. The authorisation must stipulate the requirements relating to the placing on the market and use of the product or at least those aimed at ensuring compliance with the provisions of paragraph 1(b). 3. Member States shall ensure that compliance with the requirements set out in paragraph 1 (b) to (f) is established by official or officially recognised tests and analyses carried out under agricultural, plant health and environmental conditions relevant to use of the plant protection product in question and representative of these prevailing where the product is intended to be used, within the territory of the Member State concerned. 4. Without prejudice to paragraphs 5 and 6, authorisations shall be granted for a fixed period of up to 10 years only, determined by the Member States; they may be renewed after verification that the conditions imposed in paragraph 1 are still satisfied. Renewal may be granted for the period necessary to the competent authorities of the Member States, for such verification, where an application for renewal has been made. 5. Authorisations may be reviewed at any time if there are indications that any of the requirements referred to in paragraph 1 are no longer satisfied. In such instances the Member States may require the applicant for authorisation or party to whom an extension of the field of application was granted in accordance with Article 9 to submit further information necessary for the review. The authorisation may, where necessary, be extended for the period necessary to complete a review and provide such further information. 6. Without prejudice to decisions already taken pursuant to Article 10, an authorisation shall be cancelled if it is established that: (a) the requirements for obtaining the authorisation are not or are no longer satisfied; (b) false or misleading particulars were supplied concerning the facts on the basis of which the authorisation was granted; or modified if it is established that: (c) on the basis of developments in scientific and technical knowledge the manner of use and amounts used can be modified. It may also be cancelled or modified at the request of the holder of the authorisation, who shall state the reasons therefor; amendments can be granted only if it is established that the requirements of Article 4(1) continue to be satisfied. Where a Member State withdraws an authorisation, it shall immediately inform the holder of the authorisation; moreover, it may grant a period of grace for the disposal, storage, placing on the market and use of existing stocks, of a length in accordance with the reason for the withdrawal, without prejudice to any period provided for by decision taken under Council Directive 79/117/EEC of 21 December 1978 prohibiting the placing on the market and use of plant protection products containing certain active substances, as last amended by Directive 90/335/EEC, or Article 6(1) or Article 8(1) or (2) of this directive.’