The REACh[1] regulation relies on four main procedures:[2] registration, evaluation, restriction and authorisation of chemical substances.
EU Member States or the European Chemicals Agency, on request of the European Commission, can submit propositions to identify Substances of Very High Concern, based on the criteria laid down in article 57 of REACH: This work is supported by Expert Groups of ECHA and the EU Member States[3] and is based on various criteria and screening methodologies in order to identify the most relevant SVHCs.
It lists SVHCs which exhibit a particularly high risk for human health or the environment (based on their inherent properties, quantities and uses) in order to forbid their use in the EU market.
Recommendations[5] to include SVHCs in the Annex XIV are made by ECHA and are debated by all relevant stakeholders (Member States, companies, NGOs, etc.).
When listed in Annex XIV of the REACh regulation, a substance is therefore assigned a “sunset date” after which its use will be banned, unless an Authorisation is granted for a definite period of time.
The authorisation procedure is complex and concerns manufacturers, importers, downstream users and Only Representatives of substances[8] for which: The banning of the use takes effect at the "Sunset date".
An exception is made for downstream users in the case where an upstream stakeholder, within the supply chain, has been granted an authorisation for this very substance and this very use.
Concerned companies are thus invited to take measures as soon as a substance they use enters the Candidate list by enquiring on the impacted actors and their strategies.
In the framework of an authorisation dossier, the description of the use applied for has to specify the market, the supply chain, processes or the type of articles concerned.
In that particular case, future restrictions procedure could however limit the placing on the market of such articles if a risk remains (art.
An AfA can be made for one or several substances (in that case, grouping will need to be demonstrated on the basis of annex XI of REACH[12][13]), one or several uses applied for and by one or several companies.
The Chemical Safety Report contains: The AoA aims to demonstrate that no alternative is appropriate, i.e. technically and / or economically feasible, less risky and available.
[14] ECHA strongly advise to follow these windows as plenary sessions of the two committees (RAC and SEAC) are organised in March, June, September and December of each year.
Applications are deemed received after business rules check is successfully passed and provided ECHA fees[15] are paid on time.
Each dossier requires implementing a specific strategy, being it to define the uses, the analysis of the industrial processes and associated risks, the alternatives, or the socio-economic impacts of the banning of the substance.