Table of Contents
What Is the REACH Annex XIV Authorisation List?
Annex XIV, also known as the REACH Authorisation List, is a dynamic regulatory list maintained by the European Chemicals Agency (ECHA). It includes Substances of Very High Concern (SVHCs) that require specific authorization before they can be used or placed on the EU market. These substances are selected from the Candidate List and cannot be used beyond a specified sunset date unless:
- A company has applied for and received authorization, or
- The use is explicitly exempted.
Why REACH Annex XIV Matters
Substances are prioritized for inclusion based on:
- Carcinogenic, Mutagenic, or Reprotoxic (CMR) properties
- Persistent, Bioaccumulative, and Toxic (PBT) traits
- Very Persistent and Very Bioaccumulative (vPvB) nature
- Endocrine-disrupting properties
- Or equivalent concern to human health/environment
The inclusion of substances in Annex XIV reflects their significant risk and enforces strict regulatory oversight.
Key Components of the REACH Annex XIV Authorisation Framework
-
Special Authorization Requirement Every use of an Annex XIV substance requires explicit approval from ECHA, unless it falls under an exemption.
-
Approved Uses & Conditions The list specifies which sectors or applications are permitted and outlines risk management conditions.
-
Sunset Date This is the cutoff after which the substance cannot be used without authorization.
-
Latest Application Date (LAD) Applications must be submitted well before the sunset date. Usage may continue during assessment if submitted on time.
-
Dynamic Updates Annex XIV is updated every 1–2 years. New substances are proposed based on scientific and socio-economic criteria.
How Substances Are Selected for Annex XIV
From the REACH Candidate List, substances are prioritized for Annex XIV using the following criteria (Article 57):
- (a) CMR: Carcinogenicity (1A/1B)
- (b) M: Germ cell mutagenicity (1A/1B)
- (c) R: Reproductive toxicity (1A/1B)
- (d) PBT: Persistent, Bioaccumulative, Toxic (per Annex XIII)
- (e) vPvB: Very Persistent and Very Bioaccumulative (Annex XIII)
- (f) Equivalent Concern: e.g., endocrine disruptors not meeting d/e criteria but still posing serious risk
Each substance is evaluated case-by-case by ECHA committees with input from industry and public stakeholders.
Applying for REACH Annex XIV Authorization: What Companies Must Do
Who applies?
- EU-based manufacturers
- Importers
- Downstream users
- Or Only Representatives acting on behalf of non-EU entities
When to apply?
- Well before the Latest Application Date (LAD)
What the application includes:
- Chemical Safety Report
- Socio-economic analysis (SEA)
- Analysis of Alternatives (AoA)
- Substitution plan (if feasible)
The application is evaluated by ECHA's Risk Assessment Committee (RAC) and Socio-Economic Analysis Committee (SEAC). The final decision is made by the European Commission.
Risk of Inaction
Failing to apply for authorization before the LAD or continuing to use a substance past its sunset date can lead to:
- Fines
- Product bans
- Market access denial in the EU
- Severe disruption to supply chains
2025 Update: New Prioritized Substances for Annex XIV
ECHA continues to prioritize additional SVHCs for authorization. As of 2025:
- Discussions around listing per- and polyfluoroalkyl substances (PFAS) have intensified
- Authorisation scope for certain phthalates and chromium compounds is expanding
Acquis simplifies your compliance
Don’t wait until a substance hits its sunset date. Reach out to our compliance experts and future-proof your supply chain now.
