EU REACH Regulation: Authorization Regime for Substances of Very High Concern (Annex XIV)
ENFORCEMENT TIMELINE
Ongoing (the Authorization List is updated periodically)
Overview
Under the "Authorization" regime of the REACH Regulation (Regulation (EC) No 1907/2006), a substance of very high concern (SVHC) posing an especially serious risk to human health or the environment, once added to ECHA's Authorization List (Annex XIV), is in principle banned from manufacture, import, or use within the EU unless a company obtains European Commission authorization for that specific use.
To obtain authorization, applicants must rigorously demonstrate either that no suitable alternative exists, or that the socio-economic benefits of continued use substantially outweigh the risks. After the sunset date, any use without authorization is banned entirely.
Enforcement Timeline
SVHC identification: A substance is added to the Candidate List.
Addition to Annex XIV: Based on ECHA's prioritization recommendation, the European Commission adopts an amending regulation to Annex XIV.
Latest Application Date: Companies must submit an Application for Authorization to ECHA at least 18 months before the sunset date.
Sunset Date: The final deadline after which manufacture, import, or use of a substance without authorization is prohibited.
Business Impact
Companies importing or using chemicals, and electronics and automotive suppliers, face a choice — switching to alternative substances or preparing a costly authorization application — whenever a chemical they or their supply chain uses (such as chromates, lead compounds, or phthalates) is added to Annex XIV, ahead of the sunset date.