Identify the substances concerned
Manufacture of a candidate substance : obligations

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FIC0159 V1 Practical sheet

Identify the substances concerned


Manufacture of a candidate substance : obligations

Author : Gautier VINCENT

Publication date: June 10, 2017 | Lire en français

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1. Identify the substances concerned

The substances covered by the authorization are identified as SVHC (substances of very high concern – ) due to their hazardous properties. A distinction is made between:

  • substances classified as carcinogenic and/or mutagenic and/or toxic for reproduction (CMR) in category 1A or 1B in accordance with CLP regulations (corresponding to the former categories 1 and 2 of the DSD Directive);

  • persistent, bioaccumulative, and toxic (PBT) substances or very persistent and very bioaccumulative (vPvB) substances in accordance with the criteria set out in Annex XIII;

  • substances that disrupt the endocrine system or, based on scientific evidence, have serious effects on human health or the environment and require a level of concern equivalent to the previous properties.

  • ...
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