Opinion of the Advocate General — ECLI:EU:C:2011:179
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 record of which is available in English in Annex I to the observations of the French Government. 26 – Rules of Procedure of the Committee for Adaptation to Technical Progress of Directive 67/548, available in English in Annex 2 to the observations of the French Government. 27 – That provision applies to existing substances, listed in the European Inventory of Existing Commercial Chemical Substances (EINECS), while section 1.6.1(a) of Annex VI to Directive 67/548 applies to new substances. 28 – Case C‑448/06 cp-Pharma [2008] ECR I‑5685, paragraph 27 and cited case-law. 29 – Case C‑343/09 Afton Chemical [2010] ECR I‑0000, paragraph 28 and the case-law cited. 30 – The applicant in the main proceedings mentions soap, glass, insulation, adhesives, paper, detergents, fibreglass, ceramics, cosmetics and biocide products. 31 – My emphasis. 32 – OJ 1993 L 227, p. 9, the directive having since been repealed. 33 – My emphasis. 34 – Summary of the minutes of the meeting of the TCCL and the working group bringing together specialised experts in reproductive toxicity, on classification of boric acid and the borates, set out in English in Annex 1 to the Commission’s observations. 35 – Commission Regulation of 28 June 1994 laying down the principles for the assessment of risks to man and the environment of existing substances in accordance with Council Regulation (EEC) No 793/93 (OJ 1994 L 161, p. 3). 36 – Draft, in English, at Annex 2 to the Commission’s observations. 37 – My emphasis. 38 – Ibid. 39 – Ibid. 40 – The fourth to seventh subparagraphs of point 1.1.4 of that statement read as follows: ‘… Annex VI, section 4.2.3.3, lists three reasons why animal data on reproductive toxic effects may not be relevant for humans: the level of the doses administered, for example where effects have been demonstrated only at high doses, or where marked toxico-kinetic differences exist, or the route of administration is inappropriate. In section 1.1.3 it is demonstrated that NOAEL [No Observed Adverse Effect Level] observed in the animal studies is well below the maximum dose administered in an Annex V method for investigating reproductive toxicity. The available data on toxico-kinetics do not indicate major differences between laboratory animals and humans. It is not known whether there are significant differences in the toxico-dynamics between humans and laboratory animal models and in the absence of such knowledge it must be assumed that the effects seen in animals could occur in humans. The available studies on animals were conducted using the oral route of administration. This route is an appropriate route of administration in accordance with Article 2(2)(n) of Directive 67/548.’ The English acronym ‘NOAEL’ is a unit of measurement for designating the dose which has no toxic effect, that is to say, the maximum dose for a substance for which no toxic (adverse) effect is observed. 41 – See, in particular, Method B.31, referred to under Section B.IV ‘Reproductive Toxicity. 42 – See sections 3.1.1 and 4.2.3 of Annex VI to Directive 67/548. 43 – The sixth subparagraph in section 4.2.3.3 of Annex VI to Directive 67/548 concerns, in these circumstances, supporting evidence on mechanism of action or site of action, or chemical relationship to other known anti-fertility agents or other information from humans. 44 – See recital 2 in the preamble to the 30th ATP Directive. 45 – It should be recalled that this provision states that the data required for classification of the substances in question may, where appropriate, be obtained from a number of different sources including not only the results of previous tests, information taken from reference works and the literature, and information derived from practical experience but also the results of validated structure-activity relationships and expert judgment. 46 – See the document of the Commission’s Joint Research Centre, ‘A Compendium of Case Studies that helped to shape the REACH Guidance on Chemical Categories and Read Across’, 2007, available at: http://ecb.jrc.ec.europa.eu/documents/QSAR/EUR_22481_EN.pdf. See, in particular, Gallegos, A., Langezaal, I., and Worth, A., ‘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. 47 – 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. 48 – 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, GD., ‘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 46. 49 – 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. 50 – 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. 51 – See paragraph 3.1.2.2 of the ‘Evaluation under REACH – Progress Report 2009’. 52 – See also Article 10(5) of Regulation No 793/93. 53 – My emphasis. See also section 1.5 of that annex. 54 – OJ 1986 L 358, p. 1. 55 – See, for example, Gallegos, A., Langezaal, I., and Worth, A., op. cit. (p. 72 and the many references cited). 56 – See Case C‑380/03 Germany v Parliament and Council [2006] ECR I‑11573, paragraph 107 and case-law cited. 57 – Ibid., paragraph 108 and case-law cited. 58 – Case 250/84 Eridania zuccherifici nazionali and Others [1986] ECR 117, paragraph 38. See also Case 167/88 AGPB [1989] ECR 1653, paragraph 34. 59 – Case C‑303/88 Italy v Commission [1991] ECR I‑1433, paragraph 52 and case-law cited. 60 – Case 819/79 Germany v Commission [1981] ECR 21. 61 – Case T‑504/93 Tiercé Ladbroke v Commission [1997] ECR II‑923, paragraphs 52 to 55. 62 – See ‘Background Documentation to Boron’ available at the following address: http://tcsweb3.jrc.it/home.php?CONTENU=/DOCUMENTS/Classification-Labelling/. 63 – Afton Chemical, paragraph 45 and case-law cited. 64 – Ibid., paragraph 46 and case-law cited. 65 – See also recitals 1 and 3 in the preamble to Regulation No 1272/2008. 66 – See minutes of the meeting of 16 February 2007, cited in footnote 25. 67 – See, in this regard, minutes of the TCCL meeting of 20 February 2006, referred to at point 110 of this Opinion. 68 – Ibid. 69 – My emphasis. 70 – That measure is adopted in accordance with the regulatory procedure with scrutiny laid down in Article 5a of Decision 1999/468. 71 – Ibid.