请查看这份文件2014/84/EU
(1) Directive 2009/48/EC establishes general requirements for substances which are classified as carcinogenic, mutagenic or toxic for reproduction (CMR) under Regulation (EC) No 1272/2008 of the European Parliament and of the Council (2). CMR substances category 2 may not be used in toys, incomponents of toys or in micro-structurally distinct parts of toys, except if those substances are contained in individual concentrations equal to or smaller than therelevant concentrations established for the classification of mixtures containing them as CMRs, they are inaccessible to children or their use has been permitted. The Commission may permit the use of CMR substances category 2 in toys if the use of the substance has been evaluated by the Scientific Committee and found to be safe, in particular in view of exposure, and the substance is not prohibited for use in consumer articles under Regulation (EC) No 1907/2006 of the European Parliament and of the Council (3). Appendix A of Annex II to Directive 2009/48/EC contains the list of CMR substances and their permitted uses.
(2) Nickel (CAS No 7440-02-0) is a typical metal. Its main primary uses are in the production of nickel-containing alloys (including stainless steel), in nickel plating, in the production of nickel-containing products such as batteries and welding electrodes, and in the production of chemicals containing nickel. Nickel is also used in toys for its resistance to corrosion and its high electrical conductivity, for example in model railway tracks and for battery
contacts.
(3) Nickel is classified under Regulation (EC) No 1272/2008 as carcinogenic category 2. In the absence of any specific requirements, nickel can be contained in toys in concentrations equal to or smaller than the relevant concentration established for the classification of mixtures containing it as CMRs, namely 1 %.
(4) Nickel was comprehensively evaluated under Council Regulation (EEC) No 793/93 (4). The 2008 European Union Risk Assessment Report (EU RAR) (5
) concluded that, with regard to the occupational assessment regarding carcinogenicity, there was a need for further studies to evaluate the inhalation carcinogenicity of nickel. The 2009 Addendum (6) to the EU RAR, prepared for the purpose of the transitional measures under Regulation (EC)
No 1907/2006, concluded that no further measures at Union level were required, as the results from the twoyear carcinogenicity study with inhalation exposure of rats to metallic nickel did not point towards a revision of the existing carcinogenicity classification.