The requirements for undertaking chemical safety assessments by manufacturers and
importers should be defined in detail in a technical annex to allow them to meet their
obligations. To achieve fair burden sharing with their customers, manufacturers and
importers should in their chemical safety assessment address not only their own uses and
the uses for which they place their substances on the market, but also all uses which their
customers ask them to address.
(31) 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.
(32) A chemical safety assessment should not need to be performed for substances in
preparations in certain very small concentrations which are considered as not giving rise to
concern. Substances in preparations in such low concentrations should also be exempt
from authorisation. These provisions should apply equally to preparations that are solid
mixtures of substances until a specific shape is given to such a preparation that transforms
it into an article.
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