Keywords
Summary

Keywords

1. Acts of the institutions – Temporal application – Procedural rules – Rules amending the evaluation procedure of active substances in plant-protection products – Immediate application to ongoing evaluation procedures

(Commission Regulations Nos 451/2000, Art. 8, and 1490/2002)

2. Community law – Principles – Protection of legitimate expectations – Limits

3. Agriculture – Approximation of laws – Placing of plant-protection products on the market – Directive 91/414

(Commission Regulation No 451/2000, Art. 8(7); Council Directive 91/414, Art. 8(2))

4. Agriculture – Approximation of laws – Placing of plant-protection products on the market –Directive 91/414

(European Parliament and Council Regulation No 178/2002, Art. 28(1); Commission Regulation No 451/2000, Art. 8(7); Council Directive 91/414)

5. Agriculture – Approximation of laws – Placing of plant-protection products on the market –Directive 91/414

(Council Directive 91/414, Art. 5(1))

6. Community law – Principles – Rights of the defence – Scope

(Commission Regulation No 451/2000, Arts 8(2) and 5; Council Directive 91/414)

7. Community law – Principles – Protection of legitimate expectations – Conditions

(Commission Regulation No 451/2000, Art. 8)

8. Agriculture – Approximation of laws – Placing of plant-protection products on the market –Directive 91/414

(Council Directive 91/414, Art. 5(1))

Summary

1. Unlike substantive rules of Community law, which must be interpreted as not applying, in principle, to situations existing before their entry into force, procedural rules are of immediate application. The provisions of Regulation No 1490/2002 laying down further detailed rules for the implementation of the third stage of the programme of work referred to in Article 8(2) of Directive 91/414 and amending Regulation No 451/2000, which provide for the European Food Safety Authority’s involvement in the evaluation procedure for active substances, constitute procedural rules which are of immediate application.

Consequently, the immediate application of the new provisions of Article 8 of Regulation No 451/2000 laying down the detailed rules for the implementation of the second and third stages of the work programme referred to in Article 8(2) of Directive 91/414 to ongoing evaluation procedures for active substances cannot be illegal. Furthermore, in the light of the immediate application of procedural rules, there is no requirement for any specific statement of reasons on that point in Regulation No 1490/2002.

(see paras 45-47)

2. The scope of the principle of the protection of legitimate expectations cannot be extended to the point of generally preventing new rules from applying to the future effects of situations which arose under the earlier rules.

(see para. 48)

3. Even if the time-limit of one year laid down by Article 8(7) of Regulation No 451/2000 laying down the detailed rules for the implementation of the second and third stages of the work programme referred to in Article 8(2) of Directive 91/414, for the evaluation by the European Food Safety Authority of the draft assessment report of the rapporteur Member State and for the delivery of an opinion on whether the active substance can be expected to meet the safety requirements of Directive 91/414 concerning the placing of plant protection products on the market were mandatory, failure to comply with that time-limit could affect the legality of a decision not to include an active substance in Annex I to Directive 91/414 only if it were established that the content of that decision could have differed if that irregularity had not occurred.

(see paras 55-56)

4. In evaluation procedures for dossiers notified by producers who wish to secure the inclusion of an active substance in Annex I to Directive 91/414 concerning the placing of plant protection products on the market, as provided for in Article 8 of Regulation No 451/2000 laying down the detailed rules for the implementation of the second and third stages of the work programme referred to in Article 8(2) of Directive 91/414, the opinion of the Scientific Panel on Plant health, Plant protection products and their Residues (‘the PPR Panel’) is binding on the European Food Safety Authority (EFSA) as regards the issues on which it has been consulted, but that is subject always to the general assessment of the risk posed by the active substance at issue.

The wording of Article 28(1) of Regulation No 178/2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety implies that the EFSA must, if it decides to request a scientific opinion from such a panel, comply with that opinion. That interpretation is borne out by the rules which the EFSA has established for itself: if the PPR Panel is consulted, it is laid down that the report of the meetings of national experts must take account of its opinion. An exception to that rule is conceivable only where the EFSA has available to it scientific information justifying the setting aside of that opinion.

Nevertheless, the opinion of the PPR Panel, which may be consulted on certain specific difficulties in the dossiers to be evaluated, cannot be confused with the opinion of the EFSA, drawn up pursuant to Article 8(7) of Regulation No 451/2000, on whether the active substance can be expected to meet the safety requirements of Directive 91/414. The PPR Panel carries out a risk assessment of a theoretical nature, whereas it is the task of the EFSA, when it carries out the same assessment, to take into account the practical contingencies connected with the management of those risks. The PPR Panel may not therefore under any circumstances assume the role assigned to the EFSA in the preparation of the opinion referred to in Article 8(7).

(see paras 68-70, 75)

5. The criteria set out in Article 5(1) of Directive 91/414 concerning the placing of plant protection products on the market for a substance to be capable of being included in Annex I are framed in broad terms and based on an analysis of the risk of harmful effects on human or animal health or on groundwater or any unacceptable influence on the environment. Furthermore, that provision must be interpreted in conjunction with the precautionary principle. In accordance with that principle, where there is scientific uncertainty as to the existence or extent of risks to human health, the Community institutions may take protective measures without having to wait until the reality and seriousness of those risks become fully apparent. Moreover, in a situation in which the precautionary principle is applied, which by definition coincides with a situation in which there is scientific uncertainty, a risk assessment cannot be required to provide the Community institutions with conclusive scientific evidence of the reality of the risk and the seriousness of the potential adverse effects were that risk to become a reality.

(see paras 115-116)

6. Respect for the rights of the defence is, in all proceedings initiated against a person which are liable to culminate in a measure adversely affecting that person, a fundamental principle of Community law which must be guaranteed even in the absence of any rules governing the proceedings in question. That principle requires that the addressees of decisions which significantly affect their interests be placed in a position in which they may effectively make known their views. A decision not to include an active substance in Annex I to Directive 91/414 concerning the placing of plant protection products on the market adversely affects the person making the request for inclusion of that substance since it refuses to grant that request.

However, the legislative provisions applicable to the evaluation procedure of a substance the inclusion of which in Annex I has been requested, do not impose any requirement that a notifier be given the opportunity to submit studies during that procedure. Article 8(2) and (5) of Regulation No 451/2000 laying down the detailed rules for the implementation of the second and third stages of the work programme referred to in Article 8(2) of Directive 91/414 provides that new studies are not, in principle, to be accepted, once the rapporteur Member State and the European Food Safety Authority (EFSA) respectively have commenced the evaluation of the active substance. Even though, under those provisions the rapporteur Member State, if necessary with the agreement of the EFSA, where the draft assessment report has already been sent to the latter, may request the notifier to submit within specified periods further data considered by that Member State or the EFSA necessary to clarify the dossier, those provisions do not provide for such an exception in respect of the submission of new studies. A fortiori, there is no possibility of providing further data or studies after the EFSA has finalised its report.

(see paras 127-130)

7. The right to rely on the principle of the protection of legitimate expectations extends to any individual who is in a situation in which it is clear that the Community authorities have, by giving him precise assurances, led him to entertain legitimate expectations. Regardless of the form in which it is communicated, precise, unconditional and consistent information which comes from an authorised and reliable source constitutes such assurance. However, a person may not plead infringement of the principle unless he has been given precise assurances by the authorities. Furthermore, only assurances which comply with the applicable rules may give rise to such legitimate expectations.

In that regard, as part of the procedure for evaluating an active substance for the purposes of its inclusion in Annex I to Directive 91/414 concerning the placing of plant protection products on the market, which is provided for in Article 8 of Regulation No 451/2000 laying down the detailed rules for the implementation of the second and third stages of the work programme referred to in Article 8(2) of Directive 91/414, the European Food Safety Authority (EFSA) is to evaluate the harmful effects of the substance concerned and deliver a scientific opinion on that point to the Commission. A meeting between the notifier or notifiers of the active substance in question and the EFSA generally takes place before the peer review commences. In the light of the role thus conferred on the EFSA in that procedure, it must be held that both precise assurances made by the Commission and those made by EFSA in the course of that procedure are capable of giving rise to a legitimate expectation on the part of the notifier.

(see paras 132, 148-149)

8. Article 5(1)(b) of Directive 91/414 concerning the placing of plant protection products on the market, interpreted in combination with the precautionary principle, that, in the domain of human health, the existence of solid evidence which, while not resolving scientific uncertainty, may reasonably raise doubts as to the safety of a substance, justifies, in principle, the refusal to include that substance in Annex I to that directive.

The reference in Article 5(1) of Directive 91/414 to current scientific and technical knowledge cannot support the inference that undertakings which have notified an active substance and which are faced with the likelihood of a decision not to include that substance in Annex I should have the possibility of submitting new data for as long as doubts persist regarding the safety of that active substance. Such an interpretation would run counter to the objective of a high level of protection of the environment and of human and animal health which underlies Article 5(1), in that it would be tantamount to granting to the notifier – on whom the burden of proof lies as regards the safety of the active substance and who has a better knowledge of that substance – a right of veto over a decision not to include the substance in Annex I. Such an interpretation of that provision is particularly inconceivable having regard to the fact that it is possible to (re)notify the active substance on the basis of Article 6(2) of Directive 91/414, with a view to its inclusion in Annex I to that directive.

(see paras 180-182)