It is an authorization which is only a temporary derogation to continue using substance of very high concern because the final goal of this process is to progressively replace the use of risky substance by feasible alternatives (technically and financially).
All the users in terms of REACH definition (formulators, importers, downstream users) of one of the Annex XIV substances in Europe must carry out an Authorisation dossier to continue to be able to use the substance in question.
CEHTRA's team is experienced and the entire dossier is done in-house, from the exposure estimation to the assessment of socio-economic impacts.
Chemical substances that are considered the most dangerous by the European Union are classified under Annex XIV of REACH (See authorisation list).
In order to be able to continue to use the substances, the companies are under the obligation to complete a complex and strategic dossier comprising a detailed risk evaluation, an analysis of alternatives and a complete socio-economic analysis. CEHTRA has the know-how and experience to cover all three of these dossiers using seasoned experts in the area with a long history of SEA experience.
You can feel more comfortable knowing that your dossier is safe in our hands.
How we can help you out:
1- Anticipate the inclusion in the candidate or authorization list or your substances’ portfolio
Secure the substances’ portfolio from future inclusion in the different constraining lists (Authorisation list, Candidate list, Restriction list…) based on:
- Tox/Ecotox hazard assessment based on SVHC properties
- Regulatory scoring based on the supporting information
2- Accompany clients in all the steps of the REACH authorisation process:
From the diagnostic of their requirements, to defending the dossier in front of the authority right through to the final committees’ opinions. CEHTRA has all the resources internally to:
- Manage and generate the chemical Safety report (CSR)
- Define the best strategy for the whole dossier
- Draft the Analysis of Alternatives based on client’s data
- Build the socio-economic analysis based on the scope discussed with the client
- Support the client during all the process steps (public consultation, or demand from ECHA’s committees)
Possibility also to perform defense exemption dossier if the dossier perimeter requires this option.
3- Ensure your conformity with an up-stream dossier
In some case, you are already covered by a formulator dossier as for CTAC or CCST consortium for use of chromates compounds. Even, if you are potentially covered, you must do a conformity assessment in case of control by the local authority.