Case C-77/09
Gowan Comércio Internacional e Serviços Lda
v
Ministero della Salute
(Reference for a preliminary ruling from the
Tribunale amministrativo regionale del Lazio)
(Plant protection products – Directive 2006/134/EC – Validity – Restrictions on the use of fenarimol as an active substance)
Summary of the Judgment
1. Preliminary rulings – Assessment of validity – Admissibility – Need to provide the Court with sufficient information on the factual and legislative context
(Art. 234 EC)
2. Agriculture – Approximation of laws – Placing of plant protection products on the market – Directive 91/414
(Council Directive 91/414, Art. 19 and Annex I; Commission Directive 2006/134)
3. Agriculture – Approximation of laws – Placing of plant protection products on the market – Directive 91/414
(Council Directive 91/414, Art. 19 and Annex I; Commission Directive 2006/134)
4. Agriculture – Approximation of laws – Placing of plant protection products on the market – Directive 91/414
(Arts 168 TFEU and 191(1) and (2), TFEU; Council Directive 91/414, Annex I; Commission Directive 2006/134)
5. Agriculture – Approximation of laws – Placing of plant protection products on the market – Directive 91/414
(Council Directive 91/414, Art. 5(5), and Annex I; Commission Directive 2006/134)
1. The Court may refuse to rule on a question referred by a national court only when it is manifest that the interpretation or the assessment of the validity of Community law sought by that court bears no relation to the true nature of the main action or its purpose, or when the problem is hypothetical and the Court does not have before it the factual or legal material necessary for it to give a useful answer to the questions submitted to it.
That is not the case when, first, it is not disputed before the Court that the question raised regarding the validity of a directive is relevant to the resolution of the dispute in the main proceedings and, second, the national court has explained that it had doubts regarding the validity of the directive, essentially because of the inconsistency between the restrictions of the use of a substance laid down by that directive and the technical and scientific assessments of the substance which were, overall, positive, so that the Court has sufficient information to enable it to examine the validity of the directive in relation to the situation which is the subject of the main proceedings.
(see paras 25-27)
2. As is clear from recitals 5, 6 and 9 in the preamble thereto, Directive 91/414 concerning the placing of plant protection products on the market aims to remove barriers to intra-Community trade in plant protection products, while maintaining a high level of protection of the environment and of human and animal health. To enable it to accomplish effectively the task entrusted to it and having regard to the complex scientific assessments which it must make when, in the course of examining requests for the inclusion of active substances in Annex I to Directive 91/414, it assesses the risks posed by the use of those substances, the Commission must be allowed a broad discretion.
The exercise of that discretion is not, however, excluded from review by the Court. In the context of such a review the courts of the Union must verify that the relevant procedural rules have been complied with, that the facts admitted by the Commission have been accurately stated and that there has been no manifest error of appraisal or misuse of powers. In particular, in order to establish whether the competent institution has committed a manifest error of appraisal, the courts of the Union must determine whether that institution examined, carefully and impartially, all the relevant facts of the individual case, facts which support the conclusions reached.
(see paras 54-57)
3. Under Directive 91/414 concerning the placing of plant protection products on the market, although the Commission is required to take account of the scientific assessment prepared by the rapporteur Member State, that assessment is not binding on the Commission, or the Council, as the case may be, which remain entitled, in the procedure provided for by Article 19 of that directive, to adopt risk management measures different from those proposed by the rapporteur Member State.
As regards Directive 2006/134 amending Council Directive 91/414/EEC to include fenarimol as active substance, since, first, the information provided by the notifier confirmed the initial assessment of the rapporteur Member State as regards the absence of any unacceptable risk and was accepted by the ‘evaluation’ working group and, second, Directive 2006/134 does not undermine the results of the scientific assessment of risks posed by that active substance because the latter directive serves to authorise its use in plant protection products, there is nothing to suggest that Directive 2006/134 is vitiated by a manifest error of assessment on the part of the Commission.
In those circumstances it cannot be claimed that the Commission failed to take into account with care and impartiality the scientific evidence produced by the rapporteur Member State at the stage of assessment of the risks posed by the use of fenarimol.
(see paras 60, 62-63, 65, 67)
4. When it proves to be impossible to determine with certainty the existence or extent of the alleged risk because of the insufficiency, inconclusiveness or imprecision of the results of studies conducted, but the likelihood of real harm to public health persists should the risk materialise, the precautionary principle justifies the adoption of restrictive measures, provided they are non-discriminatory and objective.
As regards the procedure for the inclusion of fenarimol in Annex I to Directive 91/414 concerning the placing of plant protection products on the market, it emerged, when the draft decision seeking to include fenarimol in Annex I to Directive 91/414 was drawn up, that there were still certain concerns regarding the intrinsic toxic effects of fenarimol including potential endocrine disrupting properties, justifying the view that its use should not be unrestricted. Such concerns cannot be considered to be based on purely hypothetical considerations.
In the light of this evidence, which tends to demonstrate that there was still some scientific uncertainty regarding the assessment of the effects on the endocrine system of substances such as fenarimol, the Commission cannot be considered to have applied the precautionary principle in a manifestly erroneous manner in attaching restrictions of use to the authorisation of that substance.
(see paras 76-79)
5. It must be acknowledged that the Commission has a broad discretion when it adopts risk management measures under the procedure for the inclusion of a substance in Annex I to Directive 91/414 concerning the placing of plant protection products on the market.
As regards the question whether the measures restricting the use of fenarimol are suitable for achieving the objectives pursued by Directive 91/414, it appears from the procedure leading to the adoption of Directive 2006/134 amending Directive 91/414 to include fenarimol as active substance and the recitals in the preamble to that directive, that the Commission endeavoured to strike a balance between the objectives of Directive 91/414 relating to the improvement of plant production, the protection of human and animal health, groundwater and the environment and the interest of the notifier in obtaining the inclusion of fenarimol in Annex I to Directive 91/414 on conclusion of the scientific assessment of the risks posed by that substance. Given the concerns on the subject of the potential endocrine disrupting effects of fenarimol and the scientific uncertainty in that regard which justified the Commission’s application of the precautionary principle, the restrictions which Directive 2006/134 imposes on the use of that substance do not appear unsuitable for the achievement of those objectives.
As regards the question whether the measure at issue was necessary, it must be observed that, although the inclusion of fenarimol in Annex I to Directive 91/414 was reduced to a period of 18 months, it appears from recital 11 in the preamble to Directive 2006/134 that that time-limit does not preclude the possible renewal of that inclusion pursuant to the provisions of Article 5(5) of Directive 91/414. Similarly, it is clear from recital 6 in the preamble to Directive 2006/134 that the fact that the authorisation of fenarimol is limited to only those uses which have actually been assessed and judged compliant with the conditions of Directive 91/414 does not prevent other uses being included in Annex I to that directive after a full assessment of them.
In those circumstances, the measures restricting the use of fenarimol cannot be considered to exceed what is necessary to achieve the objectives pursued. Directive 2006/134 is, therefore, not invalid by reason of the breach of the principle of proportionality.
(see paras 82-87)