EU REACH Regulation: Registration, Authorisation, and Restriction

The EU REACH regulation requires any company that manufactures a chemical substance in the European Economic Area, or imports one into it, at a volume of one tonne or more per year to register that substance with the European Chemicals Agency (ECHA) before it can be placed on the market. REACH stands for Registration, Evaluation, Authorisation and Restriction of Chemicals. It is formally Regulation (EC) No 1907/2006, in force since 1 June 2007, and it puts the burden of proving chemical safety on the companies producing and selling those chemicals rather than on public authorities. The European Commission calls the underlying principle “no data, no market”: without a valid registration, a substance cannot legally be manufactured in or imported into the EU.¹

Who Has to Register

Your obligations depend entirely on where you sit in the supply chain. REACH divides companies into four roles, and only two of them carry the registration duty directly.

Manufacturers and Importers

A manufacturer is any company physically producing a chemical substance within the EU. An importer is any EU-based company bringing a substance in from outside the bloc. Both carry the primary duty to register substances at or above the one-tonne threshold and to demonstrate they can be used safely. Both must keep all compliance records for at least ten years after they last manufactured, imported, or supplied the substance, and both must provide safety data sheets to their customers for hazardous substances.²

The one-tonne threshold applies per registrant, not per substance in the market. Two companies each importing 800 kilograms of the same chemical each sit below the threshold individually.

Only Representatives for Non-EU Companies

A company based outside the EU cannot register a substance directly. It must appoint an Only Representative, a person or legal entity established in the EU who takes on the importer’s registration obligations. The Only Representative must have practical experience with substances and their data, and must keep current records of quantities imported and customers supplied.³ Once an Only Representative is in place, the EU companies that physically import the goods become downstream users rather than importers, which lightens their compliance load. The non-EU manufacturer must notify its importers of the appointment.

Downstream Users

Downstream users are companies that use chemicals in their industrial or professional activities without manufacturing or importing them: a paint-mixing shop, an electronics assembler, a cleaning products formulator. They do not normally register substances themselves, but they must follow the risk management measures set out in the safety data sheets they receive. If a downstream user puts a substance to a use their supplier’s registration does not cover, they may need to prepare their own chemical safety report or notify ECHA of that use.⁴

What REACH Covers and What It Exempts

The regulation applies to substances on their own, in mixtures, and in finished articles. That scope reaches from industrial solvents and cleaning agents to chemicals embedded in clothing, electronics, and furniture.²

Several categories fall outside the standard registration obligation:

Radioactive substances, which sit under the Euratom framework.⁵
Substances under customs supervision that are merely passing through the EU to a non-EU destination.
Waste, which is not treated as a substance, mixture, or article under REACH. Recovering usable chemicals from waste may still trigger registration.
Non-isolated intermediates, meaning chemicals consumed in a reaction without leaving the equipment.
Certain naturally occurring substances such as water and noble gases, provided they have not been chemically modified.
Synthetic polymers, currently exempt under Article 2(9). The monomers and other substances that make up a polymer must still be registered if the polymer contains 2% or more by weight of that monomer and the total quantity reaches one tonne or more per year. A proposed REACH revision may eventually require polymer registration; as of early 2026 this remains under debate.⁶

How Registration Actually Works

Compiling the registration dossier is the most expensive and time-consuming part of REACH compliance. Every registrant must submit a technical dossier covering the substance’s identity, its physical and chemical properties, and toxicological and ecotoxicological data. The depth of data scales with volume: higher tonnage bands demand progressively more testing.

The Chemical Safety Report

For substances at ten tonnes or more per year, the registrant must also prepare a Chemical Safety Report. This document sets out the chemical safety assessment, identifies how the substance is used across its lifecycle, and specifies acceptable exposure levels for workers, consumers, and the environment, along with the operational conditions and protective measures needed to keep risk within safe boundaries.⁷

One Substance, One Registration

Companies registering the same substance cannot file independently. They must coordinate through a joint submission, joining a Substance Information Exchange Forum (SIEF) where they share existing test data, agree on classification, and split costs. The lead registrant submits shared data on behalf of the group; each co-registrant submits its own company-specific information. Joining a SIEF usually involves buying a letter of access to the existing dataset, and the price varies with the substance’s tonnage band and the amount of testing already done.

Animal Testing as a Last Resort

Testing on vertebrate animals is permitted only when no alternative can produce reliable results. Before proposing a vertebrate study, registrants must exhaust other options: published literature, computer models predicting properties from similar substances, in vitro tests on isolated cells or tissues, and read-across from existing data on related chemicals.⁸ Adapting standard testing requirements this way requires a documented scientific justification inside the dossier. If the alternative cannot deliver information comparable to the standard test, the test still has to be done.

IUCLID, REACH-IT, and the Fee

Dossiers must be prepared in the International Uniform Chemical Information Database (IUCLID), the standardized software that structures data for ECHA and flags gaps before filing. The completed dossier is uploaded through REACH-IT, the secure portal linking companies, member state authorities, and ECHA.⁹ ECHA then runs an automated technical completeness check. That check does not evaluate whether the science is sound; it confirms that all required fields are filled and data-sharing agreements are in place. Missing items come back with a deadline to fix.

Passing the completeness check triggers an invoice. Fees are set by Commission Regulation (EC) No 340/2008 and depend on the tonnage band and the company’s size. A joint submission is substantially cheaper than filing individually. A large company submitting alone for a substance above 1,000 tonnes per year pays over €40,000; the same company in a joint submission pays roughly €30,000. Small and medium-sized enterprises get significant reductions, and micro-enterprises in joint submissions at the lowest tonnage band can pay under €100.

ECHA audits SME claims. A company that incorrectly declared itself an SME to obtain the discount must pay the difference to the correct fee plus an administrative charge of up to €19,900.¹⁰ A company that spots its own error and tells ECHA before the audit avoids the surcharge and pays only the fee difference.

Once payment clears, ECHA issues a registration number. That number is the company’s proof of compliance and must be referenced in supply chain communications. Without it, products can be held at customs or pulled from shelves.

If Your Products Are Articles, Not Bulk Chemicals

REACH does not stop at drums and tankers. Companies that produce or import finished articles, meaning consumer products, components, and manufactured goods, have their own obligations when those articles contain substances of very high concern (SVHCs).

Notifying ECHA Under Article 7

If an article contains an SVHC from the Candidate List at a concentration above 0.1% by weight, and the total quantity of that substance across all articles the company produces or imports exceeds one tonne per year, the producer or importer must notify ECHA.¹¹ The notification covers the substance’s identity, its classification, a description of how it is used in the article, and the tonnage range. This duty can be waived only if the company can show that no exposure to humans or the environment will occur during normal use, including disposal.

Informing Customers and Consumers

Any supplier of an article containing an SVHC above 0.1% must inform the recipient, providing at least the name of the substance. That information duty reaches the end consumer: when a consumer asks whether a product contains a Candidate List substance, the supplier has 45 days to respond.¹²

The Court of Justice of the EU has clarified how the 0.1% threshold works for complex products. It applies to each individual component article, not the mass of the finished product as a whole.¹³ A laptop containing one small part with an SVHC above 0.1% of that part’s weight triggers the duty, even if the substance is a negligible fraction of the laptop’s total mass.

The SCIP Database

Since January 2021, suppliers placing articles on the EU market that contain Candidate List SVHCs above 0.1% by weight must also submit a notification to ECHA’s SCIP database (Substances of Concern In articles as such or in complex objects/Products).¹⁴ The database exists so information about hazardous substances follows products through their lifecycle and into the waste stream. Retailers selling exclusively to consumers are exempt from SCIP notification. Producers, importers, and distributors are not. When a new substance is added to the Candidate List, affected suppliers must submit or update their SCIP notification at the time of the next supply.

Safety Data Sheets

Safety data sheets are the main vehicle for communicating chemical hazard information down the supply chain. Manufacturers and importers must provide an SDS for every hazardous substance or mixture they supply, and downstream users who supply hazardous products to their own customers must pass this information along.⁴ The SDS must be supplied free of charge in the official language of the member state where the product is placed on the market.

Updates go to customers without delay whenever new information about hazards or risk management becomes available, whenever an authorisation is granted or refused, and whenever a restriction is imposed. An outdated SDS can expose a downstream user to risks they cannot anticipate, and enforcement authorities treat failures to update and distribute SDS information as a serious breach.

Keeping Your Registration Current

A registration dossier is not a one-time filing. REACH requires updates “without undue delay” whenever certain things change:

Moving to a higher tonnage band, which brings additional data requirements.
New identified uses for the substance beyond those already covered.
New hazard information about risks to human health or the environment.
Changes to the harmonized or self-classification.
Changes to the registrant’s name, address, or status as manufacturer or importer.
Ceasing or restarting manufacture or import of the substance.

Registrants who let their dossiers grow stale face enforcement action during compliance checks. ECHA increasingly cross-references registration data with market surveillance information, so a dossier claiming a 1–10 tonne band while customs records show 50-tonne shipments draws attention quickly.

Authorisation and Restriction

The most hazardous substances, meaning carcinogens, mutagens, reproductive toxins, persistent bioaccumulative and toxic chemicals, endocrine disruptors, and similar categories, can be placed on the Candidate List of Substances of Very High Concern. As of early 2026 the Candidate List contains 253 entries. Listing immediately triggers the notification, communication, and SCIP obligations described above.

From the Candidate List, substances may move to Annex XIV, the Authorisation List. Once on Annex XIV, a substance cannot be used or placed on the market after a specified sunset date unless the European Commission grants an authorisation.¹⁵ Each listed substance carries two key dates: a latest application date, by which authorisation applications must be submitted, and a later sunset date, after which use without authorisation is illegal. For 1-bromopropane, a reproductive toxin, the latest application date was 4 January 2019 and the sunset date was 4 July 2020.

An authorisation application requires the applicant to show either that risks from the substance’s use are adequately controlled or that the socioeconomic benefits outweigh the risks and no suitable alternatives exist. It is a document-heavy process, and authorisations are granted for limited periods. Companies with substances heading toward Annex XIV generally start looking for substitutes early.

Restrictions work differently. Rather than requiring individual applications for permission, a restriction imposes conditions or outright bans on the manufacture, sale, or use of a substance across the entire EU. Member states or ECHA (at the Commission’s request) can propose a restriction. The proposal goes through public consultation and review by ECHA’s scientific committees before the Commission makes a final decision. Restrictions are collected in Annex XVII and apply to everyone. No individual exemptions, no application process.

What Noncompliance Costs

National enforcement authorities in each member state carry out inspections and impose penalties, and those penalties vary sharply across the bloc. Some countries cap fines for a first offence at under €5,000. Others allow penalties reaching tens of millions of euros or unlimited fines, and criminal sanctions including imprisonment are possible in certain member states for the most serious violations.¹⁶

The UK Is Now a Separate System

An EU REACH registration does not cover the United Kingdom, and a UK REACH registration does not cover the EU. Since the end of the Brexit transition period, the UK operates its own REACH system. The UK initially adopted the EU’s Candidate List and framework, but the two systems are now diverging: substances added to the EU Candidate List after Brexit must go through a separate UK assessment before appearing on the UK list, and vice versa. Companies selling chemicals into both markets need to maintain compliance with both regimes independently, which for non-EU exporters means appointing representatives and filing separate dossiers in each jurisdiction.

1
European Commission. REACH Explained
2
EUR-Lex. Regulation (EC) No 1907/2006 – Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)
3
ReachOnline. REACH Article 8 – Only Representative of a Non-Community Manufacturer
4
European Chemicals Agency. Downstream User Roles and Obligations
5
DGUV. Substances Exempted From the Obligation to Register
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Reach.lu. Polymers Under REACH
7
ReachOnline. REACH Article 14 – Chemical Safety Report and Duty to Apply and Recommend Risk Reduction Measures
8
European Chemicals Agency. How to Avoid Unnecessary Testing on Animals
9
European Chemicals Agency. REACH-IT
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European Chemicals Agency. SME Registrants – Check Your Company Size and Documents
11
ReachOnline. REACH Article 7 – Registration and Notification of Substances in Articles
12
European Commission. REACH Regulation
13
Court of Justice of the European Union. Judgment in Case C-106/14
14
European Chemicals Agency. Information Requirements for SCIP Notifications
15
ReachOnline. Annex XIV – List of Substances Subject to Authorisation
16
Italian Ministry of the Environment. Draft Final Report REACH Penalties