The Blog

REACH manages chemical risks through three closely linked mechanisms: the Candidate List, the Authorisation List and the Restriction List. Each sends a different regulatory signal and requires a different business response. This article focuses on one of these mechanisms and explains what it means in practice for companies operating in the EU market.

Why Annex XIV is a turning point

If the Candidate List represents a warning, inclusion in the Authorisation List (REACH Annex XIV) represents a decisive shift. From this point onwards, the default position under EU law is prohibition. After the sunset date, a substance listed in Annex XIV may no longer be used or placed on the EU market unless an authorisation has been granted for a specific use or the use benefits from an exemption.

At this stage, companies are no longer planning for a hypothetical future. They are facing a concrete decision between authorisation, substitution, or discontinuation of use.

How substances are prioritised for authorisation

ECHA regularly screens substances on the Candidate List to determine which should be prioritised for inclusion in Annex XIV. This prioritisation is based on intrinsic hazard properties, volumes placed on the EU market and the extent to which uses are wide dispersive.

As part of this process, ECHA launches a three-month public consultation. While this consultation does not reopen the SVHC identification, it is a critical opportunity to provide robust information on uses, socio-economic impacts and substitution challenges. In practice, the quality of information submitted at this stage can significantly influence how uses are framed, whether exemptions are proposed and how realistic authorisation timelines become.

The draft recommendation for Annex XIV specifies key parameters, including the sunset date, the latest application date, possible review periods and any proposed exemptions. The Member State Committee then adopts an opinion, after which ECHA submits its final recommendation to the European Commission for decision.

Timing, cost and complexity of authorisation

Authorisation is often perceived as a purely legal exercise. In reality, it is a complex strategic project. Applications require detailed chemical safety assessments, analysis of alternatives and, usually, socio-economic analysis demonstrating that the benefits of continued use outweigh the risks.

Authorisation applications are resource-intensive and costly, and their outcome is never guaranteed. At the same time, substitution may involve long development cycles, requalification of products, customer approvals and potential loss of performance. As the sunset date approaches, the ability to switch strategies diminishes rapidly.

This is why companies that begin their assessment only after a substance is recommended for Annex XIV often find themselves locked into suboptimal choices.

Exemptions: opportunity and risk

REACH provides for generic exemptions from authorisation, and ECHA may also propose substance- or use-specific exemptions where other EU legislation already ensures adequate risk control. While exemptions can provide relief, they are often narrowly defined and subject to interpretation.

Misunderstanding the scope or conditions of an exemption is a common compliance pitfall. Companies relying on exemptions should ensure that their interpretation is robust, documented and defensible in the event of enforcement.

Making the authorisation or substitution decision

When a substance is moving towards Annex XIV, companies should systematically assess whether their uses are exempt, whether authorisation is realistically achievable, and whether substitution is feasible within the available timeframe. This assessment should not only consider regulatory criteria, but also commercial impacts, customer expectations and long-term competitiveness.

Building on our core expertise in preparing authorisation applications, at REACHLaw we support companies addressing these decisions through authorisation readiness assessments, substitution feasibility studies and Comply+Right stress tests that quantify regulatory, economic and supply chain risks. The aim is to enable informed, defensible decisions under regulatory pressure – not last-minute compliance.

Final reflection

REACH authorisation is not simply the end of a regulatory process. It is the point where regulatory policy directly shapes business strategy. Companies that engage early, with structured analysis and clear priorities, retain control. Those that wait are forced to react.

That distinction increasingly defines who remains compliant – and competitive – in a tightening regulatory environment.

Before a substance reaches the Authorisation List, earlier signals typically appear through inclusion on the Candidate List, where companies still have more time and flexibility to act.