Etimine SA v Secretary of State for Work and Pensions.
Date: 2011-07-21
59. First of all, it should be pointed out that in this complex technical and legal context, which in essence is in a state of flux, Directive 67/548 gives the Commission, in respect of the substance of the assessment, a broad discretion as to the scope of the measures to be taken to adapt the annexes to that directive to technical progress (Case C-425/08 Enviro Tech (Europe)  [2009] ECR I-10035, paragraph 46).
60. In accordance with settled case-law, where the European Union authorities have a broad discretion, in particular as to the assessment of highly complex scientific and technical facts in order to determine the nature and scope of the measures which they adopt, review by the European Union judicature is limited to verifying whether there has been a manifest error of assessment or a misuse of powers, or whether those authorities have manifestly exceeded the limits of their discretion. In such a context, the European Union judicature cannot substitute its assessment of scientific and technical facts for that of the institutions on which alone the EC Treaty has placed that task ( Enviro Tech (Europe) , paragraph 47).
Infringement of essential procedural requirements
108. Moreover, the REACH Regulation recognises, in Article 13, the importance of the use of alternative methods, such as the read-across method, in order to evaluate the human toxicity of chemicals by means other than vertebrate animal tests.
113. Whilst it is true that the Court has held, first, that the statement of reasons for a European Union measure must appear in that measure and, second, that it must be adopted by the author of the measure (see Case C-378/00 Commission  v Parliament and Council  [2003] ECR I-937, paragraph 66 and the case-law cited), the fact remains that the degree of reasoning required varies.
114. Thus, the Court has previously held that the requirements to be satisfied by the statement of reasons depend on the circumstances of each case, in particular the content of the measure, the nature of the reasons given and the interest which the addressees of the measure, or other parties to whom it is of direct and individual concern, may have in obtaining explanations (Case C-333/07 Régie Networks  [2008] ECR I-10807, paragraph 63 and the case-law cited).
115. It is also clear from settled case-law that the scope of the obligation to state reasons depends on the nature of the measure in question and that, in the case of measures of general application, the statement of reasons may be confined to indicating the general situation which led to the adoption of the measure and the general objectives which it is intended to achieve. In that context, the Court has repeatedly ruled that if the contested measure clearly discloses the essential objective pursued by the institution, it would be excessive to require a specific statement of reasons for the various technical choices made (see, to this effect, Case C-221/09 AJD Tuna  [2011] ECR I-0000, paragraph 59 and the case-law cited).
124. It is to be recalled first of all that, according to settled case-law, the principle of proportionality, which is one of the general principles of Community law, requires that measures adopted by Community institutions do not exceed the limits of what is appropriate and necessary in order to attain the objectives legitimately pursued by the legislation in question; when there is a choice between several appropriate measures recourse must be had to the least onerous, and the disadvantages caused must not be disproportionate to the aims pursued (see Case C-343/09 Afton Chemical  [2010] ECR I-0000, paragraph 45 and the case-law cited).
125. With regard to judicial review of the conditions referred to in the previous paragraph, in so far as adoption by the Commission of a directive or a regulation entails political, economic and social choices on its part, in which it is called upon to undertake complex assessments, it must be stated that the Commission has a broad discretion in that respect, so that judicial review of the legality of those acts is necessarily limited. The legality of a measure adopted in that sphere can be affected only if the measure is manifestly inappropriate having regard to the objective which the Commission is seeking to pursue (see, to this effect, Afton Chemical , paragraph 46 and the case-law cited).
126. In that regard, it is to be noted at the outset that, as the Court has already stated in Enviro Tech (Europe) , paragraph 46, classification measures under Directive 67/548 are adopted within a complex technical and legal framework and in essence are liable to evolve. In this context, classifications adopted by adaptations to technical progress, such as the 30th ATP Directive and the 1st ATP Regulation, are based on scientific and technical knowledge as it stands at a given moment, which subsequent matters are liable to affect.