The dossier and substance evaluation are processes under REACH that only become relevant after the initial registration of a substance.
The registration dossier will be checked by the European Chemicals Agency (ECHA) for completeness, quality and up-to-datedness if seen as necessary and without the need for prior notice. Furthermore, ECHA may review the submitted data to ensure the data is both conclusive and sufficient for determining the hazard potential of a substance. ECHA will often ask for additional or better data than provided, which can lead to significant additional testing and subsequently working costs.
Contrary to the dossier evaluation, the substance evaluation aims to determine if use of the substance poses a risk to human health or the environment. Currently this evaluation is primarily used for substances that are known or are suspected to have a severe hazard potential for humans or the environment. This includes in particular substances with known or suspected CMR (Carcinogenic, Mutagenic or Reproduction toxicity), PBT/vPvB or endocrine-disruptive (ED) properties. This process often leads to the identification of the substance as so called SVHC (substance of very high concern) and through that an inclusion of the substance into Annex XIV (authorisation) or XVII (restriction) of REACH.
For a substance undergoing a substance evaluation process by ECHA, significant planning and strategy is essential to defend the substance and to potentially identify alternatives early in the process to mitigate impact on the business. CSB has significant experience with the ECHA evaluation processes, chemical market knowledge and contacts in industry and authorities, that can be used to support you during the evaluation process.
- We check the situation and develop together with you the optimal strategy
- We identify key players and organise the process
- We make sure that the work is done in time
- We support you in handling authorities and can lead the discussion
- We use our partners to support you in all aspects