Keywords

Summary



Keywords

1. Actions for annulment – Interest in bringing proceedings – Action directed against a measure which has been repealed

(Arts 231 EC and 233 EC)

2. Agriculture – Approximation of laws – Placing of plant protection products on the market – Directive 91/414 – Procedure for inclusion of the active substances of those products in Annex I to that directive – Discretion of the Commission

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

3. Agriculture – Approximation of laws – Placing of plant protection products on the market –Directive 91/414 – Procedure for inclusion of the active substances of those products in Annex I to that directive – Existence of scientific uncertainty regarding the safety of a substance

(Commission Regulation No 451/2000, Arts 6(1), (2), (3) and 8(5))

4. Protection of public health – Risk assessment – Application of the precautionary principle – Scope – Concepts of ‘risk’ and ‘hazard’

(Arts 3 EC, 6 EC, 152(1) EC, 153(1) and (2) EC and 174(1) and (2) EC)

5. Agriculture – Approximation of laws – Placing of plant protection products on the market – Directive 91/414 – Procedure for inclusion of the active substances of those products in Annex I to that directive

(Commission Regulation No 451/2000, Art. 8(8) and (9))

6. Agriculture – Approximation of laws – Placing of plant protection products on the market – Directive 91/414 – Procedure for inclusion of the active substances of those products in Annex I to that directive – Procedures for the exercise of implementing powers conferred on the Commission

(Council Decision 1999/468, Art. 5(4))

7. Actions for annulment – Pleas in law – Absence or inadequacy of the statement of reasons – Error of assessment – Distinction

(Arts 230 EC and 253 EC)

Summary

1. An applicant may continue to have an interest in securing the annulment of a measure which has been repealed, in so far as a repeal does not give rise to the same legal effects as annulment by the General Court. The repeal of a measure of an institution does not amount to recognition of its illegality and takes effect ex nunc , whereas its annulment would take effect ex tunc .

Moreover, an institution whose act has been declared void is required to take the necessary measures to comply with the judgment. Those measures involve, inter alia, the removal of the effects of the illegal conduct found in the judgment annulling the act. The institution concerned may thus be required to take adequate steps to restore the applicant to his original position or to avoid the adoption of an identical measure.

(see paras 68-69)

2. As is clear from the fifth, sixth and ninth recitals in the preamble thereto, Directive 91/414 concerning the placing of plant protection products on the market seeks to remove barriers to intra-Community trade in those products, while maintaining a high level of protection of the environment and of human and animal health. In that context, if the Commission is to be able to pursue effectively the objective assigned to it, account being taken of the complex technical assessments which it must undertake, it must be recognised as enjoying a broad discretion.

Under the 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, the Commission is not bound by the opinion of the European Food Safety Authority (EFSA). Although, admittedly, the Commission adopts its decision not to include, or to include, the substance in question in Annex I to Directive 91/414 after obtaining the opinion of EFSA, that there is nothing in Regulation No 451/2000 to suggest that the Commission is obliged to comply with EFSA opinions in substantive terms and therefore has no discretion. Likewise, it is clear from the legislative framework that the view of the rapporteur Member State in the evaluation process is not decisive.

(see paras 86-87, 95)

3. Article 8(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 concerning the placing of plant protection products on the market provides that, without prejudice to Article 7 of that directive, submission of new studies will not be accepted. However, the rapporteur Member State, with the agreement of the European Food Safety Authority (EFSA), may request the notifiers to submit within specified periods further data considered by the rapporteur Member State or EFSA to be necessary to clarify the dossier.

The communication of further data can therefore have the purpose only of clarifying information already submitted in the complete dossier which must be presented by the notifiers.

The submission of an additional study will be possible only in so far as the study was ongoing at the time of submission of the complete dossier, the communication of that study was announced when the dossier was submitted, and the study was submitted no later than one year after the submission of that dossier.

(see paras 110-111, 113)

4. Article 152(1) EC provides that a high level of human health protection is to be ensured in the definition and implementation of all Community policies and activities. The precautionary principle constitutes a general principle of Community law requiring the authorities in question, in the particular context of the exercise of the powers conferred on them by the relevant rules, to take appropriate measures to prevent specific potential risks to public health, safety and the environment, by giving precedence to the requirements related to the protection of those interests over economic interests.

The risk assessment consists, for the Community institution faced with potentially negative effects stemming from a phenomenon, in assessing, on the basis of a scientific assessment of the risks, whether they exceed the level of risk deemed unacceptable for society. Thus, in order for the Community institutions to be able to carry out a risk assessment, it is important for them, first, to have a scientific assessment of the risks and, secondly, to determine what level of risk is deemed unacceptable for society.

A scientific risk assessment is a scientific process which is commonly accepted as consisting, in so far as possible, in the identification and characterisation of a hazard, the assessment of exposure to the hazard and the characterisation of the risk.

In such a situation, ‘risk’ thus constitutes the degree of probability that the acceptance of certain measures or practices will adversely affect the interests safeguarded by the legal order. ‘Hazard’ is commonly used in a broader sense and describes any product or procedure capable of having an adverse effect on human health.

The responsibility for determining the level of risk which is deemed unacceptable lies, provided that the applicable rules are observed, with the Community institutions responsible for the political choice of determining an appropriate level of protection for society. It is for those institutions to determine the critical probability threshold for adverse effects on human health and for the seriousness of those possible effects which, in their judgment, is no longer acceptable for society and above which it is necessary, in the interests of protecting human health, to take preventive measures in spite of any existing scientific uncertainty.

In determining that level of risk, the Community institutions are bound by their obligation, under the first subparagraph of Article 152(1) EC, to ensure a high level of human health protection. That high level does not necessarily, in order to be compatible with that provision, have to be the highest that is technically possible.

(see paras 143-149)

5. In the absence of a provision setting out either expressly or implicitly the consequences of failure to comply with a procedural time-limit such as that established by 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, such failure can entail the annulment, in whole or in part, of the act to be adopted within the period in question only if it is shown that, had it not been for such an irregularity, that act might have been substantively different.

(see para. 203)

6. It is apparent from Article 5(4) of Decision 1999/468 laying down the procedures for the exercise of implementing powers conferred on the Commission, that, if the measures envisaged are not in accordance with the opinion of the competent Committee, or if no opinion is delivered, the Commission must, without delay, submit to the Council a proposal relating to the measures to be taken and must inform the European Parliament. In using the expression ‘without delay’, the Community legislature, whilst requiring it to act swiftly, does allow the Commission a certain degree of latitude. In that connection, the amount of time which the Commission has to consider the various courses of action open to it has to be appraised in the light of the complexity of the matter concerned.

In order to assess whether the Commission acted without delay, it is necessary to ascertain whether it acted within a reasonable period of time, having regard to the circumstances of the case, and the Commission must be afforded a broad degree of latitude to reach a compromise.

Consequently, and a fortiori in the case of a regulatory committee, the Commission must have available to it a broad degree of temporal latitude, depending on the difficulty, complexity and sensitive nature of the matter, to seek a compromise within the committee before putting a draft measure to the vote.

(see paras 211, 218-219, 222-223)

7. A plea based on infringement of Article 253 EC is a separate plea from one based on a manifest error of assessment. While the former, which alleges absence of reasons or inadequacy of the reasons stated, goes to an issue of infringement of essential procedural requirements within the meaning of Article 230 EC and, involving a matter of public policy, must be raised by the Community judicature of its own motion, the latter, which goes to the substantive legality of a decision, is concerned with the infringement of a rule of law relating to the application of the Treaty, again within the meaning of Article 230 EC, and can be examined by the Community judicature only if raised by the applicant. The obligation to state reasons is thus a separate question from that of the merits of those reasons.

(see para. 245)