The authorisation procedure is one of the regulatory tools of the European regulation (EC) REACH n°1907/2006 aiming to ban the use of substances of very high concern (SVHC) included in the Annex XIV of REACH, so as to replace them with technically and economically feasible alternatives.
This process concerns manufacturers, importers and downstream users of substances. Only representatives of foreign manufacturers can also apply for an authorisation.
Authorisation today impacts many industries, including the aerospace, electronics, automotive, energy, and paint industries. Moreover, defence applications are not de facto exempted from the authorisation process. Member states must decide on a case by case basis whether a company can benefit or not from this procedure (outlined in article 2.3 of REACH).
General principles
The REACh regulation relies on four main procedures: registration, evaluation, restriction and authorisation of chemical substances.
From the Candidate List to the Annex XIV of REACH
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: Carcinogenic, mutagenic or toxic for reproduction meeting the criteria for classification as CMR category 1A or 1B, in accordance with Regulation n°1272/2008 (CLP), Persistents bioaccumulative and toxic (PBT), Very persistent and very bioaccumulative (vPvB), Or substances of equivalent concern.
This work is supported by Expert Groups of ECHA and the EU Member States and is based on various criteria and screening methodologies in order to identify the most relevant SVHCs.
Annex XIV is the last step of this prioritisation process. 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 to include SVHCs in the Annex XIV are made by ECHA and are debated by all relevant stakeholders (Member States, companies, NGOs, etc.). The final decision of inclusion of the substance into Annex XIV is taken by the European Commission.
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.
As of today (2022/03/02), 223 substances are listed on the Candidate List and 54 substances (date 2022/03/02) are listed in the Annex XIV. The candidate list is usually updated every 6 months and the Annex XIV is updated every 12 to 18 months.
Scope of authorisation
The authorisation procedure is complex and concerns manufacturers, importers, downstream users and Only Representatives of substances for which: No alternative to the Annex XIV substance is deemed technically and/or economically feasible or for which Alternatives may exist but still need time to be fully qualified and deployed.
The banning of the use takes effect at the "Sunset date". As of this date, the use of the substance is only possible for companies which have been granted an authorisation or for those that have submitted their dossier before the Latest Application Date. The latter indeed benefit from a transitional period, pending the EU Commission final decision.
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. From this point of view, it is the supply chain of the substance that matters. For instance, subcontractors of authorised importers will not be covered if the Annex XIV substance they use is supplied via a supply chain for which no authorisation application has been made or granted.
Finally, downstream users that do not need to apply for an authorisation nevertheless have the obligation to notify their use(s) to ECHA (art. 66 of REACH) and check the compliance of their risk management measures.
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.
The use applied for
"Use" under the authorisation process
Authorisation applications are made for one or several specific uses. Article 3 of REACH thus defines a “use” as: “any processing, formulation, consumption, storage, keeping, treatment, filling into containers, transfer from one container to another, mixing, production of an article or any other use”.
