L 11/6 Official Journal of the European Union 16.1.2009 DIRECTIVES COMMISSION DIRECTIVE 2009/2[EC of 15 January 2009 amending, for the purpose of its adaptation to technical progress, for the 31st time, Council Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (Text with EEA relevance) THE COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Community, Having regard to Council Directive 67/548/EEC of 27 June 1967 on the approximation of the laws, regulations and admin- istrative provisions relating to the classification, packaging and labelling of dangerous substances (), and in particular Article 28 thereof, Whereas: (1)  Article 4(3) of Directive 67/548/EEC sets out the criteria and the procedure to be followed to harmonise the clas- sification and labelling of substances. Paragraphs 4.1.3, 4.1.4 and 4.1.5 of Annex VI to Directive 67/548/EEC oblige industry to provide information to Member States and Member States to make proposals for harmonised classification and labelling as a matter of urgency, when information becomes available justifying that a substance fulfils the criteria as a mutagenic, carcinogenic or repro- ductive toxic chemical. (2)  Annex I to Directive 67/548/EEC contains a list of dangerous substances, together with particulars of the classification and labelling of each substance. That list needs to be updated to include further notified new substances and further existing substances, as well as to adapt certain entries to technical progress. In addition, it is necessary, in that Annex, to delete entries for certain substances. (3) Annex I to Directive 67/548/EEC already contains numerous group entries in particular for metal compounds evaluated using a grouping and read across approach based on analogy between substances. () O] 196, 16.8.1967, p. 1. (4) Annex [ to Directive 67/548EEC also contains certain groups where members of the group are identified and where the classification was derived by applying grouping and read across approaches, notably the petroleum streams and gasses. Annex VI to Directive 67/548EEC states that the data required for classification and labelling may be obtained from a number of different sources, including the results of validated structure-activity relationships and expert judgement. The classifications of the nickel compounds listed in this Directive are based on the effects originating from the Ni(2+) ion and on the available data for nickel compounds. The classifications were derived by grouping nickel compounds into categories on the basis of water solubility (e.g. groups insoluble, slightly soluble and soluble nickel compounds respectively). Water solubility was used as an initial criterion to define these categories, based on the argument that nickel substances having similar water solubility will indicate similar bioavailability of the Ni(2+) ion and similar systemic toxicity. This justifies a read across within groups from the substances for which the available adequate test data demonstrate a specific systemic effect to those lacking such test data. For some effects, read across between groups is justified, as similar effects have been observed across the range of water solubility. For example, epidemiological studies show that both soluble and insoluble nickel compounds (at opposite ends of the range of solubility) have local carcinogenic effects in the respiratory tract. There is, therefore, good reason to conclude that slightly soluble compounds (at the middle of this range) have similar carcinogenic properties. As part of an evaluation of all the available information for the nickel compounds, water solubility can be used as an approximation of systemic bioavailability of the Ni(2+) ion for many effects and substances.