REACH Authorisation: Process, Requirements and Key Insights
- Rim Kaidi
- Nov 26
- 4 min read
Updated: Nov 27
Understanding REACH Authorisation: A Control Mechanism for the Most Hazardous Substances
Introduction
The REACH Regulation (EC No 1907/2006) aims to ensure a high level of protection for human health and the environment from the risks posed by chemical substances. Among its four main pillars, Registration, Evaluation, Authorisation and Restriction, the Authorisation process is often the most complex for non-specialists to understand. Yet it plays a critical role in managing the most hazardous substances on the European market.
This article explains what REACH Authorisation is, why it exists, who is affected, how an Authorisation dossier is built, and how we support our clients throughout the process.ation est d’expliquer ce qu’est l’autorisation REACH, pourquoi elle existe, qui est concerné, et comment se constitue un dossier d’autorisation et enfin comment nous accompagnons nos clients.
Why is Authorisation required?
Certain chemical substances present severe hazards: carcinogenic, mutagenic, or toxic to reproduction (CMR); persistent, bioaccumulative and toxic (PBT); or endocrine disruptors. These substances are identified as Substances of Very High Concern (SVHCs).
Once an SVHC is added to Annex XIV of REACH (the “Authorisation List”), its use is prohibited after a specified sunset date, unless a specific Authorisation is granted for defined uses.
The REACH Authorisation process therefore aims to:
Control risks associated with the use of these substances.
Encourage substitution with safer alternatives.
Allow continued use when no technically or economically feasible alternative is available.
Who is concerned?
The following companies may require an Authorisation:
Users of a substance listed in Annex XIV.
Importers or suppliers placing the substance on the market for a specific use.
It is essential to note that Authorisation is use-specific, not substance-specific: a company may apply for Authorisation for one defined use, even if other uses of the same substance are banned.
When should an Authorisation be submitted?
It is strongly recommended to submit the application before the Latest Application Date (LAD) for each substance. If the authorities take longer to assess the dossier, the applicant may continue using the substance beyond the sunset date while awaiting the decision.
Once granted, the Authorisation allows continued use of the substance beyond the sunset date under the conditions specified.
Steps of the Authorisation Process:
The Authorisation workflow includes:
Identification of the substance as an SVHC.
Inclusion in Annex XIV.
Preparation and submission of the Authorisation dossier.
Evaluation by ECHA (Risk Assessment Committee – RAC, and Socio-economic Analysis Committee – SEAC).
Final decision by the European Commission.
Building a REACH Authorisation Dossier
A REACH Authorisation dossier is a highly technical and regulatory submission. It must demonstrate that risks are adequately controlled (for threshold substances) or minimised as far as possible (for non-threshold substances such as CMRs), and that no suitable alternatives exist.
The dossier includes:
Justification for the Application
The applicant must explain why Authorisation is needed by defining:
The precise uses of the substance, including technical context, operational constraints, and sector-specific details.
The quantities involved.
Chemical Safety Report (CSR)
This report assesses human health and/or environmental risks associated with the use of the substance. It includes:
Exposure scenarios describing risk management measures and operational conditions.
Risk characterisation comparing exposure levels with “safe” limits (usually derived by RAC experts).
Analysis of Alternatives
The applicant must demonstrate:
That alternatives have been investigated.
Why they are not technically or economically viable.
That alternatives would reduce risks to humans and/or the environment.
It is now strongly recommended to include a Substitution Plan, describing timelines, milestones, organisational structure, and reporting mechanisms related to the future switch to alternatives.
Socio-economic Analysis (SEA)
This analysis generally compares:
The societal benefits (not only company benefits) of continuing to use the substance,vs.
The human health/environmental costs of discontinuing its use.
Submission and Follow-up
The dossier is submitted via ECHA’s portal. Fees apply depending on company size. The evaluation period is not legally fixed and may range from 18 months to 3 years based on our experience.
Once Authorisation is granted, companies must:
Comply with the conditions described in their dossier, plus any additional conditions set by EU authorities.
Prepare a review report when the Authorisation expires (typically after 4, 7, or 12 years), justifying why substitution could not be completed within the initial timeframe.
Key Points for Non-Experts
REACH Authorisation is not automatic and must be justified.
It concerns the most hazardous substances.
The dossier is highly technical and often requires collaboration across the supply chain.
How CEHTRA Supports You
At CEHTRA, our experts assist clients with all stages of the Authorisation process:
Definition of the use(s)
Project management
Preparation of all dossier components: CSR, Analysis of Alternatives, Substitution Plan, SEA
Dossier submission
Defence and responses to ECHA committees
Our clients have consistently obtained the full durations requested, even for complex cases.
Our experts are also active members of NeRSAP (Network of Experts in Socio-economic Analysis and Analysis of Alternatives under REACH), ensuring they remain aligned with regulatory expectations and can engage informally with authorities when needed.
Finally, these dossiers are complex and time-consuming. From experience, drafting all components typically requires 6 to 15 months, depending on team availability.
For any additional questions, feel free to contact our experts.