Keywords

Summary



Keywords

1. Approximation of laws – Classification, packaging and labelling of dangerous substances – Directive 67/548 – Adaptation to technical progress

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

2. Approximation of laws – Classification, packaging and labelling of dangerous substances – Directive 67/548 – Adaptation to technical progress

(Art. 205(2) EC; Council Directive 67/548, Art. 29; Commission Decision 1999/468, Art. 5)

3. Approximation of laws – Classification, packaging and labelling of substances and mixtures – Regulation No 790/2009 – Adaptation to technical and scientific progress

(European Parliament and Council Regulation No 1272/2008; Commission Regulation No 790/2009; Council Directive 67/548)

Summary

1. 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.

As regards the classification of the borate substances in Annex I to Directive 67/548, the Commission did not commit a manifest error of assessment in basing its assessment of the intrinsic properties of the substances at issue on the results of animal testing in which those substances had been administered orally. 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, as when children ingest certain quantities of substances that are not intended for consumption orally. Furthermore, an assessment of the hazards linked to the substances’ intrinsic properties, which constitutes the first stage of the process of risk assessment, must not be limited in light of specific circumstances of use, as in the case of a risk assessment, and may be properly carried out regardless of the place where the substance is used, the route by which contact with the substance might arise (by ingestion, by inhalation or by dermal penetration) and the possible levels of exposure to the substance.

Nor is it apparent from point 1.1.5 of the explanatory memorandum to the proposal for Directive 2008/58 amending Directive 67/548, for the purpose of its adaptation to technical progress, for the 30th time that the Commission committed a manifest error of assessment in mentioning there elements of risk assessment that are provided for by Regulation No 1488/94 laying down the principles for the assessment of risks to man and the environment of existing substances in accordance with Regulation No 793/93. Having regard to the broad discretion which the system of assessment under Directive 67/548 grants to the Commission, that system does not preclude recourse to risk assessment to confirm the merits of a classification proposal founded on study of the substances’ intrinsic properties.

Next, in relying on the judgment of experts who had recourse in particular to the read-across method in order to assess the intrinsic properties of the borate substances at issue, the Commission did not manifestly exceed the limits of the discretion which it has in this regard. Whilst that method is not mentioned as such in Annex VI to Directive 67/548, the list of sources from which the data required for classification of the borate substances may be extracted, which is set out in section 1.6.1(b) of that annex, is, however, merely illustrative, as is apparent from the words ‘for example’. Application of the read-across method and the assessment which was made of the physicochemical properties of the borate substances at issue were, moreover, the result of a consensus reached at the end of a process that lasted several years by numerous experts sitting on several scientific committees in the presence of representatives of the industry concerned.

Nor is Directive 2008/58 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 in essence is in a state of flux, making it difficult to state detailed and individual reasons for the classifications made, so that the statement of reasons contained in the directive is sufficient in view of the nature of that 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 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.

Finally, the principle of proportionality was not infringed on classification of the borate substances at issue, at the end of a procedure covering the period from 1999 to 2008 and after numerous discussions by several committees of experts, in which the representatives of the industry concerned participated, for the sole reason that studies liable to call into question the classifications adopted were ongoing. Classifications adopted by adaptations to technical progress, such as Directive 2008/58 and Regulation No 790/2009 amending, for the purposes of its adaptation to technical and scientific progress, Regulation No 1272/2008, are based on scientific and technical knowledge as it stands at a given moment, which subsequent matters are liable to affect.

In light of the foregoing, there is no factor of such a kind as to affect the validity of Directive 2008/58 and, consequently, of Regulation No 790/2009, in so far as that directive and that regulation classified certain borate substances as reprotoxic in category 2.

(see paras 59-60, 64-65, 67, 71, 74-76, 80, 82, 96-98, 109-110, 118-121, 126-128, 130-131, operative part)

2. Neither Article 29 of Directive 67/548 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances nor Article 5 of Decision 1999/468 laying down the procedures for the exercise of implementing powers conferred on the Commission provides that the Committee on Adaptation to Technical Progress (the ATP Committee) is obliged to adopt a separate opinion for each classification proposed in the draft measures. Nor is there any such requirement under the ATP Committee’s Rules of Procedure, in particular under Article 5(2), which does not authorise the members of the ATP Committee to demand a separate vote when classifying substances in categories, even though they are able to demand that the discussion be extended. Therefore, there was no breach of the essential procedural requirements referred to in Article 29 of Directive 67/548, read in conjunction with Article 5 of Decision 1999/468, when, despite a disagreement within it, the ATP Committee gave, by a qualified majority within the meaning of Article 205(2) EC, a single opinion on all the classifications proposed within the framework of Directive 2008/58 amending Directive 67/548, for the purpose of its adaptation to technical progress, for the 30th time.

(see paras 63-65, 67)

3. The validity of Regulation No 790/2009 amending, for the purposes of its adaptation to technical and scientific progress, Regulation No 1272/2008 and classifying certain borate substances as reprotoxic in category 2 is not affected by the fact that, in adopting that legislation, the Commission had recourse, as its legal basis, to Article 53, rather than Article 37, of Regulation No 1272/2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548 and 1999/45, and amending Regulation No 1907/2006.

Article 37 of Regulation No 1272/2008 forms part of Chapter 1 of Title V of that regulation, a chapter which is headed ‘Establishing harmonised classification and labelling of substances’. The use of the word ‘establishing’ in this context indicates that the procedure provided for in Article 37 of the regulation should be used only when adopting new classifications. On the other hand, under the procedure provided for in Article 53 of the regulation, the Commission may adjust and adapt Annexes I to VII to the regulation to technical and scientific progress. Regulation No 790/2009 merely incorporates into Regulation No 1272/2008 the classifications at issue, which had already been adopted on the basis of criteria and principles laid down within the framework of Directive 67/548 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances. It follows that Article 53 of Regulation No 1272/2008 can legitimately constitute the legal basis for adopting Regulation No 790/2009.

Nor is the validity of Regulation No 790/2009 affected by the Commission’s decision to incorporate the classifications at issue into Table 3.1 in Part 3 of Annex VI to Regulation No 1272/2008 with the aid of the translation table contained in Annex VII to that regulation. A repetition of the process of assessing the intrinsic properties of the borate substances was not necessary in view of the fact that Regulation No 790/2009 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. As regards the translation table in Annex VII to Regulation No 1272/2008, under Article 61(3) of that regulation all substances must be classified in both the old and the new system until 1 June 2015. It follows that all the classifications established under Directive 67/548 must be translated, with the aid of the translation table set out in Annex VII, into the corresponding classifications under Regulation No 1272/2008.

(see paras 136-139, 142-145, operative part)