In written comments sent to members of CARACAL (Competent Authorities for REACH and CLP), the [German] Federal Institute for Occupational Safety and Health (Bundesanstalt für Arbeitsschutz und Arbeitsmedizin: BAuA) noted disparities in the regulations that apply to substances of very high concern (SVHCs).
When they are added to a mixture, they require communication in the supply chain and, if already included in REACH annex XIV, an authorization. But they do not when they are present in a substance as impurities that result from production of a substance. Both cases involve a product that has identical ingredients, but that is regulated differently.
The BAuA thus finds it impossible to arrive at a conclusive assessment of the risks posed by SVHCs.
The crux of the matter is that REACH has not required any information on the exact composition of substances that result from production. The ECHA guidelines for substance identity according to REACH and CLP consider constituents with a concentration up to 20% as impurities that do not require authorization.
As a solution the Institute recommends that every constituent of a substance that is present in a concentration of more than 0.1% by mass is to be specified. To create legal security, the BAuA suggests, the planned revision of REACH should legally define the requirements for information on a substance’s composition and record them in Annex VI of the Regulation. That would mean that companies dealing with chemicals requiring authorization would face additional information requirements.
To enable even more clarity, the BAuA also recommends that the definition of a “substance” in Article III of REACH be specified. Up to now, a substance has been understood as “a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used….”
Clarification would therefore specify what kind of substance is covered by the Regulation:
- For a substance with primary constituents and impurities that result from production
- For a pure substance
A response from the EU Commission regarding the suggestions made by the BAuA is expected soon.
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