Judgment — ECLI:EU:C:2009:635
Date: 2009-10-15
Language of the case: French
Court formation: Second Chamber
Based on: Treaty establishing the European Economic Community (1957)
Subject matter: Approximation of laws
Concepts: Dangerous substances
Procedure: Reference for a preliminary ruling
Origin: Belgium

summary reports of the CMR – Carcinogens, Mutagens, Reproductive Toxicants working group of 14 to 16 May 2003 and of 15 to 17 January 2003 (documents No ECBI/56/03 Rev.2 and No ECBI/30/03 Rev.3; ‘CMR working group reports’), the grounds for the classification of n-propyl bromide as category 2 toxic are based on the harmful effects on fertility, found during standard studies on a species of rat, and on the structural similarity between that substance and its isomer, 2-bromopropane, also called iso-bromopropane, classified as category 1 toxic due to both known impairment of human fertility and developmental toxicity to humans. 69 Thus, the fact that n-propyl bromide causes marked harm to the reproductive organs in rats of both sexes on administration of doses which have not given rise to other systematic effects constitutes the most obvious effect resulting from the studies referred to in the CMR working group reports. Furthermore, those studies conclude that the toxic effects are not produced solely on administration of high doses. 70 It is therefore apparent that the experts’ opinion was based on the criteria set out in point 4.2.3 of Annex VI to Directive 67/548 and, in particular, in point 4.2.3.3 of that annex and that the Commission, on the basis of that opinion, was thus able validly to classify n-propyl bromide as a substance ‘toxic for reproduction in category 2’. 71 Accordingly, it must be held that the Commission’s exercise of its discretion in classifying n-propyl bromide as a substance ‘toxic for reproduction in category 2’ is not vitiated by manifest error or by an abuse of power and that the Commission has not manifestly exceeded the limits of its discretion. – The questions concerning the precautionary principle and the principle of proportionality 72 Before the Conseil d’État, Enviro Tech submitted that the Commission had applied only the precautionary principle when classifying n-propyl bromide as a highly flammable substance toxic for reproduction, in order to circumvent the criteria laid down in Annexes V and VI to Directive 67/548. 73 In addition, it alleged that the principle of proportionality was not applied in that classification of n-propyl bromide. 74 In that regard, it is sufficient to note that, contrary to the allegations of the applicant in the main proceedings, the Commission did not base its decision classifying n-propyl bromide on the precautionary principle, but based its decision on analyses carried out in accordance with the methods and the criteria laid down in Annexes V and VI to Directive 67/548. 75 As to the alleged breach of the principle of proportionality, the applicant in the main proceedings submits that the Commission based its decision on tests other than those carried out on competing products, in particular chlorine halogens. 76 However, that argument cannot be accepted. As follows from the observations of the Swedish Government, the structure of chlorine halogens is very different from that of bromine halogens. 77 In addition, the applicant in the main proceedings has failed to show that the classification of n-propyl bromide as a ‘highly flammable’ substance and a substance ‘toxic for reproduction in category 2’, within the meaning of Directive 67/548, is manifestly unsuited to achieve the objective pursued and that the inconveniences caused by that classification are disproportionate to that objective. 78 It follows from the foregoing considerations that the answer to the national court must be that examination of the first question has shown no factor capable of affecting the validity of Directive 2004/73, in that it classifies n-propyl bromide as a highly flammable substance (R11) and toxic for reproduction in category 2 (R60). The second question 79 Since the second question was referred only in the event that the Court found that Directive 2004/73 did not comply with Directive 67/548, there is no need to answer that question. Costs 80 Since these proceedings are, for the parties to the main proceedings, a step in the action pending before the national court, the decision on costs is a matter for that court. Costs incurred in submitting observations to the Court, other than the costs of those parties, are not recoverable. On those grounds, the Court (Second Chamber) hereby rules: Examination of the questions referred has shown no factor capable of affecting the validity of Directive 2004/73/EC of 29 April 2004 adapting to technical progress for the 29th time Council Directive 67/548/EEC of 27 June 1967 on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances, in that it classifies n-propyl bromide as a highly flammable substance (R11) and toxic for reproduction in category 2 (R60). [Signatures] * Language of the case: French.