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HomeGuide → The four pillars

Registration, Evaluation, Authorisation, Restriction

The four processes named in the acronym are not stages of one procedure. They are four separate mechanisms, run on different triggers, and only the first is one you start yourself.

How they interlock

Registration puts information in front of the regulator. Evaluation is the regulator interrogating it. Authorisation and restriction are what the regulator does with the conclusions — and both can reach substances you registered years earlier, or never registered at all.

ProcessWho starts itWhat it can do to you
RegistrationYouWithout it, you cannot lawfully place the substance on the GB market at ≥1 t/y.
EvaluationHSEDemand further data, reject a dossier, or refer a substance onward for regulatory action.
AuthorisationHSE / Secretary of StateMake a specific use unlawful without named permission, on a sunset date.
RestrictionHSE / Secretary of StateLimit or ban manufacture, placing on the market or use — regardless of registration.

Registration

The duty to submit a dossier for each substance manufactured or imported at one tonne a year or more. The dossier scales with tonnage, and above ten tonnes a year it must include a chemical safety report.

Registration is a condition of market access, not an approval. It confirms you supplied the required information and paid the fee. What goes in the dossier →

Evaluation

Two distinct activities sit under this heading, and they are frequently confused.

Dossier evaluation

HSE examines a registration for compliance with the information requirements, and separately examines any testing proposal for higher-tier vertebrate studies before that testing may proceed. A compliance check can arrive at any time and typically requires a response within months, not years.

Substance evaluation

Where there is a suspicion of risk, HSE examines a substance across all its registrations, and can require any registrant to generate further information. The outcome may be that no action is needed, or a referral into authorisation or restriction.

A compliance check failure is not a fine in the first instance — it is a decision with a deadline. Miss the deadline and the registration can be revoked, at which point your market access stops. Build the capacity to respond into your compliance plan.

Authorisation

The mechanism for substances of very high concern — carcinogens, mutagens, reproductive toxicants, PBT and vPvB substances, endocrine disruptors and others of equivalent concern.

  1. Candidate list. A substance is identified as an SVHC and added to the GB candidate list. Duties attach immediately: notification for articles above 0.1% w/w, supply chain communication, and information to consumers on request.
  2. Authorisation list. Selected candidate list substances are prioritised onto the GB authorisation list with a sunset date.
  3. Sunset date. After it, the substance may only be used for a use covered by a granted authorisation, or an exempted use.
  4. Application. Applicants must demonstrate risk is adequately controlled, or that socio-economic benefit outweighs the risk and no suitable alternative exists.

Authorisation is use-specific and time-limited. It is granted to named applicants for named uses, with review periods — it is not a permanent permission attached to the substance.

Restriction

The broadest instrument. A restriction can limit or prohibit the manufacture, placing on the market or use of a substance on its own, in a mixture or in an article, and it applies to everyone — including companies with no registration duty at all.

Because restriction reaches articles, it catches importers who have never thought of themselves as chemical businesses: a company importing finished goods can find a component substance restricted and the product unsellable.

Registration protects market access. It does not protect against the other three.

A valid registration gives no immunity from a later compliance check, candidate listing or restriction. Monitoring the GB lists is a separate, ongoing obligation of doing business in chemicals — and one where GB and EU positions increasingly differ. The divergence →