Recital 31 of the Regulation states as following:
The Commission, in close cooperation with industry, Member States and other relevant stakeholders, should develop guidance to fulfil the requirements under this Regulation related to preparations (in particular with regard to safety data sheets incorporating exposure scenarios) including assessment of substances incorporated into special preparations — such as metals incorporated in alloys. In doing so, the Commission should take full account of the work that will have been carried out within the framework of the RIPs and should include the necessary guidance on this matter in the overall REACH guidance package. This guidance should be available before the application of this Regulation.
EIMAG – the European Industry Metallic Alloys Group of which EUROALLIAGES is a founding member – developed in 2008 a Technical Guidance Document on the Assessment of Substances in Preparations and Special Preparations. This guidance consists of a series of flowcharts illustrating the assessment methodology, supported by an explanatory text.
More detailed guidances on Metals, followed by special sections on Alloys are being developed and updated within the framework of the Human Health and Environment Metal Assessment Fact Sheets (HERAG and MERAG), under the aegis of EUROMETAUX, EUROFER and ICMM The "bio-elution" approach is explained as in vitro alternative testing.
HERAG is intended to address the specific properties of metals, metal compounds, alloys and other naturally occurring inorganic substances that sometimes warrant the application of a risk assessment methodology, which is different from that developed for and applicable to organic industrial chemicals. HERAG is not intended to replace current risk assessment concepts but rather to amend current methodology by addressing metal-specific aspects: http://www.herag.net
The guidance document for the environmental risk assessment of metals and inorganic metal compounds MERAG can be consulted here: