Opinion of the Advocate General — ECLI:EU:C:2011:178
Date: 2011-03-24
Language of the case: English
Subject matter: Environment;Consumer protection;Approximation of laws;Public health
Procedure: Reference for a preliminary ruling
Origin: United Kingdom

Summary of Discussions on the Use of QSARs, Read-Across and Grouping in the Technical Committee for Classification and Labelling (TC C&L)’, 28 February 2007, at p. 67 of the Commission document. 28 – See ‘Report on the regulatory uses and applications in OECD member countries of (quantitative) structure-activity relationship [(Q)SAR] models in the assessment of new and existing chemicals’, available at: http://www.oecd.org/dataoecd/55/22/38131728.pdf. 29 – See, for example, Hart, J., ‘Nickel compounds – a category approach for metals in EU legislation’, a report to the Danish Environmental Protection Agency, January 2008, available at: http://cms.mim.dk/NR/rdonlyres/07DB028E-134E-4796-BF6D-97B9AD5F9E82/0/Nikkel.pdf; Hart, J., and Veith, G.D., ‘Applying Chemical Categories to Classification & Labelling: A Case Study of Volatile Aliphatic Ethers’, a report to the Danish Environmental Protection Agency, January 2007, available at: http://www.qsari.org/documents/aliphaticethers.pdf, and Comber, M., and Simpson, B., ‘Grouping of Petroleum Substances’, September 2006, at p. 113 of the Commission document cited in footnote 27. 30 – Application of the group concept requires it to be possible for physicochemical properties, the effects on human health and environmental effects or environmental fate to be predicted from data for a reference substance or substances within the group by interpolation from other substances in the group. Ideally, a category should include all potential elements of similar substances. 31 – See paragraph 2.1 of ‘Practical guide 6: How to report read-across and categories’ and paragraph 3.1.2.4 of the ‘Evaluation under REACH – Progress Report 2009’, available on the ECHA website. 32 – See paragraph 3.1.2.2 of the ‘Evaluation under REACH – Progress Report 2009’. 33 – See also Article 10(5) of Regulation No 793/93. 34 – My emphasis. See also section 1.5 of that annex. 35 – OJ 1986 L 358, p. 1. 36 – See points 27 to 32 of this Opinion. 37 – See the document of the World Health Organisation, International Agency for Research on Cancer, ‘Chromium, Nickel and Welding, Summary of Data Reported and Evaluation’, IARC Monographs on the Evaluation of Carcinogenic Risks to Humans, vol. 49, 5 November 1997, included in Annex I to the Commission’s observations. 38 – Available in English on the website of the European Commission, Directorate-General for Health and Consumers (see, in particular, p. 4 et seq.). 39 – My emphasis. 40 – OJ 1993 L 227, p. 9, that directive having been repealed. 41 – See, inter alia, Article 9 of that regulation. 42 – Case C‑425/08 [2009] ECR I-10035. 43 – Paragraphs 46 and 47 of that judgment and the case-law cited. 44 – See Case C-380/03 Germany v Parliament and Council [2006] ECR I-11573, paragraph 107 and case-law cited. 45 – Ibid., paragraph 108 and case-law cited. 46 – Case 250/84 Eridania zuccherifici nazionali and Others [1986] ECR 117, paragraph 38. See also Case 167/88 AGPB [1989] ECR 1653, paragraph 34. 47 – Case C‑303/88 Italy v Commission [1991] ECR I-1433, paragraph 52 and case-law cited. 48 – Case 819/79 Germany v Commission [1981] ECR 21. 49 – Case T‑504/93 Tiercé Ladbroke v Commission [1997] ECR II-923, paragraphs 52 to 55. 50 – See PowerPoint presentation given by the applicant in the main proceedings in Brussels on 29 September 2008, contained in Annex 3 to the Commission’s observations. 51 – See, for example, final risk assessment report on nickel carbonates, published by the DEPA, available on the website of the Danish Environment Ministry (the Kingdom of Denmark was designated as rapporteur under Regulation No 793/93) at the following address: http://www.mst.dk/NR/rdonlyres/2929A8CB-8A5B-43C9-BB67-506D847E960E/0/Ni_carbonate_EU_RAR_HH_March_2008_finaldraft.pdf. 52 – See ‘Background documentation to nickel-entries in ATP 30’ and ‘Background documentation to nickel-entries in ATP 31’, available on the Commission website at the following address: http://tcsweb3.jrc.it/home.php?CONTENU=/DOCUMENTS/Classification-Labelling/. 53 – See Commission document cited in footnote 27, and Hart, J., op. cit. 54 – See recital 1 in the preamble to the 1st ATP Regulation. 55 – My emphasis. 56 – That measure is adopted in accordance with the regulatory procedure with scrutiny laid down in Article 5a(1) to (4) of Decision 1999/468. 57 – Ibid.