REACH Regulation: Registration, Evaluation, Authorisation, and Restriction of Chemicals

Introduction

Regulation (EC) No 1907/2006 — REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) — is the most comprehensive chemicals regulation in the world, establishing a single harmonised framework for the manufacture, import, placing on the market, and use of chemical substances in the European Union. REACH reverses the burden of proof: industry, not public authorities, bears the responsibility for demonstrating that chemicals are safe for human health and the environment. The Regulation is administered by the European Chemicals Agency (ECHA) in Helsinki, which coordinates technical evaluations, maintains databases, and supports enforcement.

Scope and Core Principles

REACH applies to all chemical substances manufactured or imported in quantities of one tonne or more per year, whether on their own, in mixtures, or in articles. Exemptions include: (a) radioactive substances; (b) substances under customs supervision; (c) non-isolated intermediates; (d) waste; (e) substances used in medicinal products and food; and (f) polymers (exempted from registration but subject to certain obligations; the 2023 REACH revision proposal signals potential polymer registration requirements).

The core principle is “no data, no market”: substances cannot be manufactured or placed on the EU market unless registered with ECHA, accompanied by a technical dossier containing information on properties, uses, and safe handling. The registration obligation applies to manufacturers and importers — downstream users (formulators, end-users) are generally not required to register but must ensure compliance with REACH obligations for their use of registered substances.

Registration

Title II of REACH establishes the registration framework. Substances are registered in tonnage bands (1–10 tonnes, 10–100 tonnes, 100–1,000 tonnes, and 1,000+ tonnes), with higher tonnages requiring progressively more extensive information, including physicochemical, toxicological, and ecotoxicological data. Registration includes: (a) a technical dossier — substance identity, classification and labelling, guidance on safe use, exposure scenarios, and study summaries; (b) a chemical safety report (CSR) for substances ≥10 tonnes, containing a human health hazard assessment, physicochemical hazard assessment, environmental hazard assessment, and exposure assessment with risk characterisation.

Registration may be individual (one registrant per substance) or joint (multiple registrants sharing data through a Substance Information Exchange Forum (SIEF) ). Joint registration reduces testing costs and avoids unnecessary vertebrate animal testing, a core REACH principle (Article 25). Disputes over data sharing and cost sharing are resolved by ECHA or, failing agreement, by national courts.

Evaluation

Title V establishes two evaluation tracks. Dossier evaluation (Article 40–43) involves ECHA reviewing the compliance of registration dossiers with information requirements, particularly for substances suspected of posing risks. ECHA may request additional information from registrants. Substance evaluation (Article 44–48), managed through the Community Rolling Action Plan (CoRAP) , involves Member State competent authorities evaluating substances prioritised (by hazard or exposure) for in-depth assessment. The CoRAP (updated annually) lists approximately 100–200 substances under evaluation; by 2025, over 1,000 substances had been evaluated, resulting in restrictions, authorisation recommendations, or data improvement requests.

Authorisation

Title VII establishes the authorisation regime for Substances of Very High Concern (SVHCs) . SVHCs are: (a) CMR (carcinogenic, mutagenic, or toxic to reproduction) categories 1A/1B; (b) PBT (persistent, bioaccumulative, and toxic) or vPvB (very persistent, very bioaccumulative); (c) endocrine disruptors; or (d) substances of equivalent concern (e.g., respiratory sensitisers, neurotoxicants). SVHCs are identified by ECHA’s Member State Committee (MSC) and placed on the Candidate List (updated twice yearly; over 240 substances as of 2026).

Substances on the Candidate List are eventually placed on the Authorisation List (Annex XIV) after a prioritisation process. From the “sunset date” (the date after which placing on the market or use is prohibited unless an authorisation is granted), an SVHC may only be used if the European Commission grants an authorisation. Authorisation may be granted where the applicant demonstrates: (a) adequate control of risks (safe use, where a threshold exists); or (b) socioeconomic benefits outweighing the risks, and no suitable alternatives exist (where no threshold exists or adequate control is not demonstrated).

The substitution obligation (Article 55) requires applicants to analyse alternatives and prepare a substitution plan where suitable alternatives are available. Authorisations are time-limited and subject to review periods (typically 4–12 years). The obligation to continually review alternatives ensures a dynamic transition away from SVHCs towards safer substances.

Restriction

Title VIII empowers the Commission to impose restrictions on the manufacture, placing on the market, or use of substances presenting unacceptable risks to human health or the environment. Restrictions are listed in Annex XVII (over 130 restricted substances, including lead in jewellery, cadmium in jewellery and plastics, phthalates in toys, and microplastics intentionally added to products — the broadest restriction in REACH history, adopted 2023). Restrictions follow a scientific and socioeconomic assessment by ECHA’s Risk Assessment Committee (RAC) and Socio-Economic Analysis Committee (SEAC) , with a Commission decision under the comitology procedure.

The 2023 microplastics restriction prohibits the placing on the market of synthetic polymer microparticles intentionally added to products (cosmetics, detergents, fertilisers, paints, and sports surfaces) where they are intended to be washed off, worn off, or otherwise released. Transition periods range from 4 to 12 years depending on the product type.

Enforcement

Enforcement is the responsibility of Member States (Article 125 REACH), which must establish effective, proportionate, and dissuasive penalties, including administrative fines and, for the most serious violations, criminal sanctions. The European Forum for REACH Enforcement (EFOR) , coordinated by ECHA, promotes consistency through best practice exchange, joint enforcement projects, and annual compliance statistics.

The ECHA Enforcement Forum (established 2023, distinct from EFOR) strengthens EU-level coordination, adopting harmonised enforcement criteria and facilitating cross-border information exchange. The 2024 REACH revision proposal introduces EU-level inspection powers and harmonised minimum penalties (up to 4% of annual turnover for non-compliance with registration, authorisation, or restriction obligations).

The REACH Revision (2024–2025)

The European Commission’s 2024 REACH revision proposal (part of the Chemicals Strategy for Sustainability) includes: (a) universal registration obligations for polymers; (b) a generic approach to risk management (essentially banning consumer uses of the most hazardous substances unless essential for society); (c) mandatory data sharing for all substances, including intermediates; (d) establishment of a Mutual Recognition of Data system for animal testing waivers; (e) an essential use concept for critical applications (medicinal products, defence, clean energy) where substitution is not feasible; (f) increased ECHA resources for dossier compliance checks (target of 30% of dossiers checked); and (g) enhanced enforcement through joint EU-level inspections and harmonised sanctions.

Interaction with Other EU Chemical Legislation

REACH operates alongside sector-specific chemical legislation: (a) CLP Regulation (Classification, Labelling and Packaging, Regulation (EC) 1272/2008) — harmonising hazard classification and communication; (b) Biocidal Products Regulation (BPR) , Regulation (EU) 528/2012 — for biocidal active substances; (c) Plant Protection Products Regulation (EC) 1107/2009 — for pesticides; (d) Cosmetics Regulation (EC) 1223/2009; and (e) POPs Regulation (EU) 2019/1021 — for persistent organic pollutants. REACH operates as the default framework, with sector-specific legislation prevailing where overlapping.