REGAFFAIRS AI
Guide · 2026-10-24 · 8 min

What is the REACH regulation? The EU chemicals law explained

REACH is the EU's main chemicals law. It requires substance registration from 1 tonne a year, with exemptions, plus evaluation and controls on use.

What is the REACH regulation?

The REACH regulation is the European Union's main chemicals law, Regulation (EC) No 1907/2006 on the Registration, Evaluation, Authorisation and Restriction of Chemicals (European Commission). Since 1 June 2007 (Article 141(1)) it has applied in the EU and the EEA (Norway, Iceland and Liechtenstein) (Commission), and EU manufacturers and importers must register a substance at 1 tonne or more a year with the European Chemicals Agency (ECHA) unless an exemption applies.

REACH stands for Registration, Evaluation, Authorisation and Restriction of Chemicals. The regulation was adopted on 18 December 2006 and published in the Official Journal (OJ L 396) on 30 December 2006. The current consolidated text on EUR-Lex is dated 22 June 2026. Check EUR-Lex for later amendments before making a compliance decision.

What EU REACH legislation covers

Article 1 aims to protect human health and the environment while allowing substances to circulate freely within the internal market. It also promotes competitiveness, innovation and alternative methods for assessing hazards. Manufacturers, importers and downstream users must ensure that the substances they handle "do not adversely affect human health or the environment". The precautionary principle sits behind the text (consolidated REACH).

REACH covers substances on their own, in mixtures and in articles. Article 2 excludes radioactive substances, certain substances under customs supervision and non-isolated intermediates. Waste is not a substance, mixture or article for REACH purposes under Article 2(2). Substances used in human or veterinary medicines, and in food or feed, are exempt from registration for those uses. Annex IV substances, and substances covered by Annex V, are also exempt from registration. Polymers are not registered. Monomers and other substances in a polymer are registered only if they are 2% or more by weight, total 1 tonne a year or more, and have not already been registered further up the supply chain (Articles 2 and 6).

Who runs REACH

Article 75 set up ECHA, based in Helsinki, to manage and in some cases carry out the technical, scientific and administrative work. The Commission calls the agency "the central point in the REACH system", since it runs the databases the system depends on (DG Environment).

Enforcement is different. "Enforcement of REACH is a responsibility of national authorities," says the Commission. Each Member State sets its own penalties, which must be "effective, proportionate and dissuasive" under Article 126, and ECHA hosts a Forum where national inspectors coordinate (REACH enforcement). That Forum's REF-12 project ran 2,603 controls. One in three substances in imported mixtures had no registration, and 16% of the restricted substances checked broke the rules (Council note ST 10294/26).

The four processes

Registration

The core rule is Article 5, known as "no data, no market". A substance can't be manufactured in the EU or placed on the market unless it's registered where REACH requires it (Commission). Under Article 6(1), manufacturers and importers register substances, on their own or in mixtures, at 1 tonne or more a year. Exemptions apply, and registration carries a fee. The threshold counts per substance, per company (Commission).

The data you submit grows with tonnage. Annexes VII to X set the standard information for 1, 10, 100 and 1,000 tonnes a year, and each band adds to the one below. From 10 tonnes a year, a chemical safety report is generally required (ECHA).

Many guides still talk about registration deadlines. Those were phase-in dates for existing substances: 30 November 2010, 31 May 2013 and 31 May 2018 (ECHA). All three have passed. Today, where registration is required, it must be completed before manufacture or import at 1 tonne a year or more.

Articles have their own rules under Article 7. Unless exempt, a producer or importer registers a substance in articles when it totals over 1 tonne a year and is intended to be released during normal or reasonably foreseeable use. They must also notify ECHA of a Candidate List substance above 0.1% by weight and over 1 tonne a year in total, unless exposure can be excluded. Product and process orientated R&D (PPORD) has a five-year registration exemption following notification, which can be extended (Article 9).

Evaluation

ECHA "may check that registration dossiers comply", and authorities can pick substances for "a broader substance evaluation" (Commission). Dossier evaluation covers compliance checks and the review of testing proposals (ECHA). Substance evaluation is done by Member States, working from the Community Rolling Action Plan (CoRAP), a list that runs three years ahead (ECHA).

Authorisation

Authorisation targets substances of very high concern (SVHCs), which can have "serious and often irreversible effects on human health and the environment" (Commission). Article 57 includes carcinogenic, mutagenic or reproductive-toxic substances in category 1A or 1B. It also covers persistent, bioaccumulative and toxic (PBT) substances, very persistent and very bioaccumulative (vPvB) substances, and substances of equivalent concern, such as certain endocrine disruptors (ECHA authorisation handbook).

The Candidate List and the Authorisation List have different effects. An identified SVHC first goes on the Candidate List. The Candidate List had 253 entries after ECHA added two substances, including n-hexane, on 4 February 2026. Check ECHA's live table before you rely on the number. Some Candidate List substances later move to Annex XIV, the Authorisation List. After the sunset date, a listed substance cannot be placed on the market for a use, or used, unless that use is authorised (Commission). Other exemptions and transitional rules in REACH can also apply (consolidated REACH).

Article 55 says the risks must be "properly controlled" and SVHCs "progressively replaced by suitable alternative substances or technologies where these are economically and technically viable". Applicants for authorisation have to analyse alternatives (consolidated REACH).

Restriction

"Restrictions are enacted via amendments to Annex XVII of REACH" (Commission). A Member State, or ECHA at the Commission's request, proposes a restriction under Articles 69 to 73. Article 68(2) is a simplified procedure for CMR substances in consumer products. Under Article 67, manufacture, marketing and use must meet the conditions in the relevant Annex XVII entry. Scientific research and development is exempt.

The Commission reported on 2 July 2026 that 11 REACH restrictions had been adopted since 2022, with six more close to completion. Current work includes PFAS, hexavalent chromium substances and octocrylene (Commission news).

The universal PFAS restriction remains a proposal. ECHA's risk committee (RAC) adopted its final opinion on 2 March 2026, and the socio-economic committee (SEAC) agreed its draft opinion on 10 March 2026 (ECHA). SEAC's final opinion is expected by the end of 2026. Then both opinions go to the Commission, which drafts a proposal for the REACH Committee (ECHA).

Information down the supply chain

REACH also sets out what suppliers tell their customers. Where Article 31 requires a safety data sheet, it must follow Annex II. That annex has 16 headings. It was last replaced by Regulation (EU) 2020/878.

For articles, Article 33(1) applies once a Candidate List substance is above 0.1% w/w. The supplier must give recipients enough information for safe use, at minimum the substance name. Consumers can ask for the same information and must get it free within 45 days (ECHA).

The actors and their roles

REACH assigns duties by role, defined in Article 3. The registration duties below are subject to exemptions.

RoleWho it isRegisters?
ManufacturerEstablished in the EU, makes a substance thereYes, at 1 t/y or more
ImporterEstablished in the EU, responsible for importYes, at 1 t/y or more
Only representativeEstablished in the EU, appointed by a non-EU manufacturer, formulator or article producer (Article 8)Takes on the importer's registration duties for covered imports
Downstream userUses a substance in industrial or professional activitiesNo
DistributorOnly stores and places on the market, including retailersNo

A non-EU company can't register directly. The manufacturer, the importer or the only representative has to be established in the EU. The company sells through those importers, who register, or it appoints an only representative. Importers covered by that appointment count as downstream users. Distributors, retailers and consumers don't register, and "a distributor or a consumer is not a downstream user" under Article 3.

Is the REACH regulation being revised?

The Commission is not opening REACH in the current mandate. The Chemicals Industry Action Plan of 8 July 2025 promised "a proposal for a targeted revision of REACH to simplify the rules and speed up the procedures for industry" by the end of 2025 (COM(2025) 530). It never came.

On 27 April 2026, Commissioner Jessica Roswall told Parliament's ENVI Committee: "We have come to the conclusion to not open REACH at this point." The Legislative Train lists the file as "Blocked" by the Commission, rather than an active legislative proposal (European Parliament). A Council note of 12 June 2026 says the revision "would not be pursued in the current mandate". The note describes a focus on adapting REACH through implementing and delegated acts, alongside stronger enforcement on non-compliant products and third-country substances (ST 10294/26). Possible items on that route include registration data for the new CLP hazard classes, harmonised or digital SDSs, and a simpler application.

Earlier ideas included a 10-year registration validity and a Mixture Assessment Factor. These are not enacted requirements (European Parliament). The Commission said on 19 August 2026 that "no major changes" to REACH are expected in the near future.

The chemicals omnibus is a different file. It amends CLP, cosmetics and fertilising products. Parliament adopted its first reading on 22 October 2026, and it is awaiting Council (2025/0531(COD)). Its fertiliser part replaces extended REACH registration with standard rules. A proposed ECHA Basic Regulation, not yet adopted, would move ECHA's governance provisions out of REACH (2025/0207(COD)). Neither file amends REACH's core registration, authorisation or restriction obligations.

RegAffairs AI's answer on the REACH regulation links its claims to the official sources.