Keywords

Summary



Keywords

Approximation of laws – Classification, packaging and labelling of dangerous substances –Directive 67/548 – Adaptation to technical progress – Classification of certain nickel substances as dangerous substances

(Art. 253 EC; European Parliament and Council Regulations No 1907/2006 and No 1272/2008; Commission Regulation No 790/2009; Council Directive 67/548; Commission Directives 2008/58 and 2009/2)

Summary

In a complex technical and legal context, which in essence is in a state of flux, Directive 67/548 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances 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. 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.

Having regard to the scope of that review and in the light of the conclusions, formulated after a long consultation process over the period from 2000 to 2008, of numerous experts’ reports and studies completed in order to arrive at the final adaptations of Directive 67/548, which were made on adoption of Directives 2008/58 and 2009/2 amending Council Directive 67/548, for the purpose of its adaptation to technical progress, for the 30th and 31st time respectively, the Commission did not manifestly exceed the limits of its discretion in relying, when adopting the decisions classifying certain nickel substances at a high hazard level, on the judgment of experts who had recourse in particular to the read-across method in order to assess the intrinsic properties of the nickel substances at issue. It is also not apparent that the Commission manifestly exceeded the limits of its discretion in taking the view, in those circumstances, that, given the state of scientific knowledge as it stood, there was sufficient technical progress to justify adapting Directive 67/548. Accordingly, Article 28 of Directive 67/548 could validly constitute the legal basis for adoption of Directives 2008/58 and 2009/2.

Nor is the validity of the classification of those substances on the basis of an assessment of the hazards linked to their intrinsic properties called into question by the fact that certain nickel carbonates were handled or used only in laboratory conditions. Although neither Directive 67/548 nor Regulation No 1272/2008 on classification, labelling and packaging of substances and mixtures or the REACH Regulation defines ‘normal handling or use’, this concept includes all handling and uses occurring in normal circumstances, which encompasses, in particular, the need to take account of realistic and foreseeable accidents.

Furthermore, Directive 2008/58 is not vitiated by a failure to state reasons in breach of Article 253 EC, having regard to the fact, first, that it is a measure of general application which falls within a complex technical and legal context that makes it difficult to state detailed and individual reasons for the classifications made, so that the statement of reasons is sufficient in view of the nature of the measure, and second, that the representatives of the industry concerned were involved in the process for drawing up the directive and that the scientific reasoning and the data which substantiated the classifications at issue appeared in a number of documents and of sets of minutes of meetings of experts which were disclosed to the public before the directive was adopted.

So far as concerns the adoption of the classifications at issue in Table 3.1 in Part 3 of Annex VI to Regulation No 1272/2008, the Commission did not err by using the translation table in Annex VII to that regulation rather than considering the criteria in Annex I thereto. A repetition of the assessment process was not necessary in view of the fact that Regulation No 790/2009 amending, for the purposes of its adaptation to technical and scientific progress, Regulation No 1272/2008 merely incorporates into Regulation No 1272/2008 the same classifications as those which had undergone the complex assessment procedure applicable within the framework of Directive 67/548.

Consequently, there is no factor of such a kind as to affect the validity, first, of Directives 2008/58 and 2009/2 and, second, of Regulation No 790/2009, in so far as those directives and that regulation classified as carcinogenic to man in category 1, mutagenic in category 3 and reprotoxic in category 2 substances such as certain nickel carbonates, nickel hydroxides and other grouped nickel substances.

(see paras 59-60, 77, 79, 82-83, 92-95, 102-105, 115, 117, 120, operative part)