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FLUKE
Kimball Electronics
Tolomatic
Industrial Scientific
AHEAD
roboception
By Abhishek Shetty | Fri Dec 29 2023 | 2 min read

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

  1. Special Authorization Requirement Every use of an Annex XIV substance requires explicit approval from ECHA, unless it falls under an exemption.
  2. Approved Uses & Conditions The list specifies which sectors or applications are permitted and outlines risk management conditions.
  3. Sunset Date This is the cutoff after which the substance cannot be used without authorization.
  4. Latest Application Date (LAD) Applications must be submitted well before the sunset date. Usage may continue during assessment if submitted on time.
  5. Dynamic Updates Annex XIV is updated every 1–2 years. New substances are proposed based on scientific and socio-economic criteria.

> Click here for the latest EU REACH Authorisation List

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

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> Don’t wait until a substance hits its sunset date. > Reach out to our compliance experts and future-proof your supply chain now.

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Understanding the EU REACH Annex XIV Authorisation List

Annex XIV, also called the REACH Authorisation List, is maintained by ECHA and includes Substances of Very High Concern (SVHCs) that require explicit authorisation before they can be used or placed on the EU market. Once the Sunset Date passes, companies must either hold an authorisation for their use or stop using the substance.
Sunset Date: The final cutoff after which a substance cannot be used without authorisation. Latest Application Date (LAD): The deadline to apply for authorisation. If an application is submitted before the LAD, the company can continue using the substance until a decision is made.
Applications can be made by EU manufacturers, importers, downstream users, or an Only Representative for non-EU producers. Each application must cover the specific use and include a Chemical Safety Report, Socio-Economic Analysis, and Analysis of Alternatives.
Annex XIV is updated every 1–2 years . ECHA proposes new substances from the Candidate List based on their risk profile, with final inclusion decided by the European Commission.
PFAS (per- and polyfluoroalkyl substances) : Currently under active review for authorisation. Phthalates and chromium compounds: Scope of authorisation is expanding. These additions reflect increased EU focus on substances with endocrine-disrupting and high persistence properties.
Non-compliance can result in: Fines and enforcement actions Bans on product placement in the EU market Severe supply chain disruptions and reputational risks
Map SVHCs in your supply chain against the Candidate and Annex XIV lists. Engage suppliers early to confirm coverage by upstream authorisations. Plan substitution strategies for high-risk substances like PFAS. Submit applications before the LAD if continued use is unavoidable.