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No. 36/2008 In the Official Journal of the European Union published on 15 September 2008, the Commission announced Directive 2008/58/EC done at Brussels, 21 August 2008. This is the 30th amendment of Directive 67/548/EEC, entering into force on 5 October 2008.
2008/58/EC Amendments
2008/58/EC mainly amends the Annex I of 67/548/EEC, which 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 this amendment, there are:
800 chemical substances (nearly 290 are carcinogenic and mutagenic) Add 380 substances Amend classification and labeling of 516 substances Delete 3 substances The main amendments are: Certain notes in the foreword of Annex I should be amended or added to clarify the obligations on manufacturers, distributors and importers of certain substances, to reflect that benzene has, in addition to other effects, been classified as mutagenic, and to reflect that the classification and labeling in Annex I relating to physico-chemical properties need not be applied when testing shows that the specific form of a substance marketed has different physicochemical properties.
Note 6 in the foreword of Annex I should be deleted as the provisions of this note no longer apply from the date on which Commission Directive 2001/60/EC (2) enters into force.
A new Note 7 should be added to the foreword of Annex I to reflect that alloys containing nickel are to be classified for sensitization on the basis of their release rate rather than on the concentration of nickel. For the complete information on each substance, please refer to the Directive.
Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 June 2009 at the latest.
Information Source Directive 2008/58/EC SGS Taiwan LTD. Taipei Multi Chemical Laboratory t: +886 2 2299 3279
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