4.

Those uniform principles, which are necessary to guarantee that, in their decisions on plant protection products, the Member States apply the requirements of Article 4(1) of the basic directive uniformly, were laid down by Directive 94/43/EC, namely the directive which the Parliament wishes to be annulled. For the present purposes, it is appropriate first of all to consider the wording of the last four recitals in the preamble to that directive: ‘Whereas the provisions of this directive on the protection of water are without prejudice to Member States' obligations under the directives concerning the protection of water, and in particular Directives 75/440/EEC, 80/68/EEC and 80/778/EEC; Whereas a review of the abovementioned directives is necessary and this should be carried out as soon as possible; Whereas, pending such review, the provisions of this directive concerning the protection of water are transitional in nature; Whereas it is important to evaluate the impact of the use of plant protection products on groundwater, but whereas the models currently available do not enable a precise estimate to be made of the foreseeable concentration in such water; whereas it is therefore necessary to re-examine the provisions of Part C, point 2.5.1.2(b) of Annex VI to Directive 91/414/EEC as soon as models validated at Community level enable such concentration to be estimated precisely.’ Then there are the provisions at issue in these proceedings, which are concerned, from the point of view of environmental impact, with groundwater. Those provisions are set out in Annex VI, both in part B, concerning evaluation of the information notified in support of applications for authorization (point Β 2.5.1.2.), and in part C, which is concerned with decision-making (point C 2.5.1.2.). Point Β 2.5.1.2. states: ‘Member States shall evaluate the possibility of the plant protection product reaching surface water under the proposed conditions of use; if this possibility exists they shall estimate, using a suitable calculation model validated at Community level, the short-term and long-term predicted concentration of the active substance and of metabolites, degradation and reaction products that could be expected in the surface water in the area of envisaged use after use of the plant protection product according to the proposed conditions of use. If there is no validated Community calculation model, Member States shall base their evaluation especially on the results of mobility and persistence-in-soil studies and the information on run-off and drift as provided for in Annexes II and III.’ Point C 2.5.1.2. comprises four paragraphs, dealing respectively with: (a) the conditions to be met for an authorization to be granted; (b) the possibility of granting a conditional authorization for a limited period not exceeding five years; (c) the possibility of granting a further conditional authorization; and (d) the possibility of introducing at any time, having regard to the local situation, appropriate conditions or restrictions. In view of the importance of those paragraphs for the purposes of this case, I consider it necessary to reproduce them in full: ‘(a) An authorization shall be granted only in the following cases: (1) Where adequate monitoring data relevant to the proposed conditions of use of the plant protection product are not available and on the basis of the evaluation it appears that, after use of the plant protection product under the conditions proposed, the foreseeable concentration of the active substance or of relevant metabolites or breakdown or reaction products in groundwater intended for the production of drinking water does not exceed the lower of the following concentrations: (i) the maximum admissible concentration laid down by Council Directive 80/778/EEC of 15 July 1980 relating to the quality of water intended for human consumption; or (ii) the maximum concentration laid down by the Commission when including the active substance in Annex I, on the basis of appropriate data, in particular toxicological data, or, where that concentration has not been laid down, the concentration corresponding to one-tenth of the ADI laid down when the active substance was included in Annex I; (2) where adequate monitoring data relevant to the proposed conditions of use of the plant protection product are available and support the conclusion that in practice, after use of the plant protection product under the conditions proposed, the concentration of the active substance or of relevant metabolites or breakdown or reaction products in groundwater intended for the production of drinking water has not exceeded or no longer exceeds and is not in danger of exceeding the appropriate maximum concentration as referred to in (1) above. (b) Irrespective of the provisions in (a) above, where the concentration referred to in (a)(l)(ii) is greater than that referred to in (a)(l)(i), a conditional authorization, which is not an authorization within the meaning of Article 10(1) of this directive and which is for a limited period of not more than five years, may be issued only in those cases in which the conditions specified in (1) or (2) below are fulfilled: (1) where adequate monitoring data relevant to the proposed conditions of use of the plant protection product are not available, every conditional authorization issued shall be subject to the following requirements: (i) it appearing on the basis of the evaluation that, after use of the plant protection product under the conditions proposed, the foreseeable concentration of the activé substance of relevant metabolites or breakdown or reaction products in groundwater intended for the production of drinking water does not exceed the maximum concentration referred to in (a)(l)(ii) above; and (ii) it being ensured that an adequate monitoring programme covering areas liable to be contaminated is introduced or continued in the Member State, using suitable methods of sampling and analysis, so that it can be estimated whether the maximum concentration referred to in (a)(l)(i) above will be exceeded; it is for the Member States to decide who is to bear the cost of that monitoring programme; (iii) where appropriate, attaching to the authorization of the conditions for or restrictions on the use of the product concerned, to appear on the label, having regard to agricultural plant health, and environmental (including climatic) conditions in the envisaged area of use; (iv) if necessary, amendment or withdrawal of the conditional authorization, in accordance with Article 4(5) and (6), where monitoring results show that, despite the imposing of the conditions or restrictions referred to in (iii) above, after use of the plant protection product under the conditions proposed, the concentration of the active substance or of relevant metabolites or breakdown or reaction products in groundwater intended for the production of drinking water will exceed the concentration referred to in (a)(l)(i) above; (2) where adequate monitoring data relevant to the conditions of use of the plant protection product are available and support the conclusion that in practice, after use of the plant protection product under the conditions proposed, there is no risk that the concentration of the active substance or of relevant metabolites or breakdown or reaction products in groundwater intended for the production of drinking water will exceed the maximum concentration referred to in (a)(l)(ii) above, every conditional authorization issued shall be subject to the following requirements: (i) prior investigation of the significance of the risk of the maximum concentration referred to in (a)(l)(i) being exceeded and of the factors involved; (ii) it being ensured that an adequate programme, consisting of measures referred to in (b)(l)(ii), (iii) and (iv) above, is introduced or continued in the Member State so as to make sure that in practice the concentration does not exceed the maximum admissible concentration referred to in (a)(1)(i) above. (c) If, upon expiry of the conditional authorization, monitoring results show that in practice the concentration of the active substance or of relevant metabolites or breakdown or reaction products, as a result of the use of the plant protection product under the proposed conditions of use, in groundwater intended for the production of drinking water has been reduced to a level approaching the maximum admissible concentration referred to in (a)(1)(i) above and if other amendments to the proposed conditions of use could be expected to ensure that the foreseeable concentration will be reduced below that maximum concentration, a further conditional authorization including those new amendments may be issued for a single period of not more than five years. (d) A Member State may at any time introduce appropriate conditions for or restrictions on the product's use, having regard to local agricultural, plant-health and environmental (including climatic) conditions, in order to comply with the concentration referred to in (a)(l)(i) above in water intended for human consumption, in accordance with Directive 80/778/EEC.’