REACH in plain terms
Regulation (EC) No 1907/2006, known as REACH after its four procedures, Registration, Evaluation, Authorisation and Restriction of Chemicals, is the EU’s framework law on chemical substances. Its purpose is a high level of protection of human health and the environment, including the promotion of alternatives to animal testing, together with the free circulation of substances on the internal market and enhanced competitiveness and innovation (Art. 1(1)). It places the responsibility on industry: manufacturers, importers and downstream users must ensure that they manufacture, place on the market or use substances that do not adversely affect human health or the environment (Art. 1(3)).
The regulation reaches far beyond the chemical industry. Every product is a substance, a mixture or an article, and articles carry duties of their own: registration of substances intended to be released, notification and communication of substances of very high concern from the Candidate List, and the restrictions in Annex XVII that name substances in jewellery, toys, textiles, leather, furniture, electronics, packaging and cosmetics. Since the final registration deadline of 1 June 2018 the “no data, no market” principle of Article 5 applies to every substance manufactured or imported at 1 tonne a year or more, and Annex XVII is amended several times a year, most recently by Regulations (EU) 2026/859 and 2026/1168.
Official text Read the regulation on EUR-Lex: Regulation (EC) No 1907/2006 (CELEX 32006R1907), or the consolidated text of 22 June 2026 that includes every amendment to Annex XVII.
Scope
REACH applies to the manufacture, placing on the market and use of substances on their own, in mixtures or in articles, and to the placing on the market of mixtures (Art. 1(2)). A substance is a chemical element and its compounds, a mixture is a solution of two or more substances, and an article is an object which during production is given a special shape, surface or design that determines its function to a greater degree than its chemical composition does (Art. 3(1) to Art. 3(3)). The actors are the manufacturer (Art. 3(9)), the importer (Art. 3(11)), the producer of an article (Art. 3(4)), the downstream user (Art. 3(13)), the distributor (Art. 3(14)) and, for non-EU manufacturers, the only representative of Article 8.
Article 2 draws the outer limits. Radioactive substances, substances under customs supervision in transit, non-isolated intermediates, the carriage of dangerous goods and waste are outside the regulation, and Member States may exempt substances for defence (Art. 2(1) to Art. 2(3)). Medicinal products, food and feed are exempt from registration, downstream-user duties, evaluation and authorisation, and cosmetics from the safety data sheet rules and from authorisation of CMR substances (Art. 2(5), Art. 2(6) and Art. 56(5)); polymers are exempt from registration, though their monomers are not (Art. 2(9) and Art. 6(3)). The restrictions in Annex XVII reach every sector, with one carve-out: they do not apply to cosmetics as regards risks to human health, which the Cosmetics Regulation covers (Art. 67(2)).
Tonnage is counted per legal entity and per calendar year, so each importing company in a group needs its own registration or must be covered by an only representative. For articles, the Court of Justice settled in Case C-106/14 (10 September 2015) that the 0,1 % threshold for Candidate List substances is calculated per article as produced or imported, including every article assembled into a complex product, never against the weight of the finished product.
Registration: no data, no market
A substance may not be manufactured in or placed on the market in the EU unless it has been registered where registration is required (Art. 5). The duty falls on each manufacturer and importer at 1 tonne a year or more (Art. 6(1)); the registration contains the technical dossier of Article 10 with the Annex VI to XI information for the tonnage band (Art. 12), and from 10 tonnes a chemical safety assessment documented in a chemical safety report (Art. 14). Registrants of the same substance share data and submit jointly through a lead registrant (Art. 11 and Art. 27 to Art. 30). The phase-in deadlines of Article 23 (1 December 2010, 1 June 2013 and 1 June 2018) have passed, so a new substance or a new importer needs a registration before the first tonne.
Registrations must be kept up to date without undue delay when the tonnage band, composition, uses, classification or hazard knowledge changes (Art. 22), within the deadlines set by Implementing Regulation (EU) 2020/1435. ECHA checks dossiers for compliance, with a target of 20 % of the registrations in every tonnage band by 31 December 2027 (Art. 41(5)), and the Member States evaluate substances of concern under the Community rolling action plan (Art. 44 to Art. 48). A registration can be lost: an incomplete dossier is rejected (Art. 20) and manufacture or import must stop.
Articles: intended release, Candidate List notification and Article 33
Producers and importers of articles have three duties. A substance intended to be released from articles under normal or reasonably foreseeable conditions of use, a fragrance in an eraser or the ink in a cartridge, must be registered when the total exceeds 1 tonne a year, unless it is already registered for that use (Art. 7(1) and Art. 7(6)). A Candidate List substance present above 0,1 % weight by weight in the articles and totalling more than 1 tonne a year must be notified to ECHA within six months of its inclusion in the list, unless the producer or importer can exclude exposure during use and disposal (Art. 7(2), Art. 7(3) and Art. 7(7)).
The third duty reaches every supplier of an article, including distributors and retailers (Art. 3(33)). Where a Candidate List substance is present above 0,1 %, the supplier must give the business recipient enough information for safe use, at least the name of the substance, with every delivery, and must answer a consumer’s request within 45 days free of charge (Art. 33). The same articles must be notified to ECHA’s SCIP database under Article 9(1)(i) of the Waste Framework Directive since 5 January 2021. ECHA updates the Candidate List twice a year, so screening bills of materials is a recurring task, not a one-off exercise.
Authorisation and the Candidate List
Substances of very high concern are those meeting the criteria of Article 57: carcinogens, mutagens and reproductive toxicants of category 1A or 1B, PBT and vPvB substances under Annex XIII, and substances of equivalent concern such as endocrine disruptors and respiratory sensitisers. ECHA identifies them through the Article 59 procedure and places them on the Candidate List, which triggers the Article 7(2) and Article 33 duties immediately and the safety data sheet duty of Article 31(1)(c) for the substance itself.
From the Candidate List the Commission moves priority substances into Annex XIV (Art. 58). After the sunset date an Annex XIV substance may only be placed on the market or used for a purpose covered by an authorisation the Commission has granted to an applicant on adequate-control or socio-economic grounds (Art. 56, Art. 60 and Art. 62). The authorisation number goes on the label (Art. 65), and a downstream user who relies on an authorisation granted up the supply chain must notify ECHA within three months of the first supply (Art. 66). Exemptions apply to uses that other Union legislation already regulates, such as cosmetics for human-health risks, medicinal products and food (Art. 56(4) and Art. 56(5)).
Restrictions in Annex XVII
A substance listed in Annex XVII may not be manufactured, placed on the market or used unless it complies with the conditions of its entry (Art. 67(1)). Restrictions are adopted by the Commission on a dossier prepared by ECHA or a Member State, after opinions of the Committees for Risk Assessment and Socio-economic Analysis and a public consultation (Art. 68 to Art. 73). The entries that matter most to product companies are the ones on substances in articles: nickel in jewellery and items in prolonged skin contact (entry 27), the CMR entries 28 to 30 banning supply to the general public, cadmium in plastics, jewellery and brazing (entry 23), lead in jewellery and consumer articles (entry 63), phthalates in toys, childcare articles and consumer articles (entries 51 and 52), azo dyes in textiles and leather (entry 43), chromium VI in leather (entry 47), PAHs in rubber and plastic parts (entry 50), PFOA and related substances (entry 68), D4, D5 and D6 (entry 70) and the newest entries on formaldehyde (77), microplastics (78), PFHxA (79), DMAC and NEP (80 and 81), PFAS in firefighting foams (82) and 2,4-dinitrotoluene (83).
The current calendar is dense: entry 70 applies to D4, D5 and D6 as substances and in mixtures from 6 June 2026, entry 77 to formaldehyde emissions from articles from 6 August 2026 and from road vehicles from 6 August 2027, entry 79 to PFHxA in consumer clothing, footwear, textiles, food-contact paper and board, cosmetics and consumer mixtures from 10 October 2026, and entry 83 to 2,4-dinitrotoluene in articles from 10 May 2027. Entry 78 on microplastics keeps its product-specific transition periods to 2035, with the derogations for medicinal products in clinical trials and for research and development corrected retroactively by Regulation (EU) 2026/1168 and its solid-matrix derogation narrowed from 22 June 2028.
Information in the supply chain
Title IV keeps the information flowing in both directions. Suppliers of substances and mixtures provide a safety data sheet in the Annex II format, in an official language of the Member State of supply and free of charge, for hazardous substances and mixtures, PBT and vPvB substances and Candidate List substances, on request for certain mixtures below the classification limits, and with exposure scenarios annexed when a chemical safety report was required (Art. 31). For other substances the registration number, authorisation, restriction and risk-management information of Article 32 travels instead. Updated sheets go to every recipient of the last 12 months when new hazard information, an authorisation or a restriction arrives (Art. 31(9)).
Downstream users, from formulators to industrial and professional users, use substances within the conditions of the exposure scenarios they receive or prepare their own chemical safety report and report the use to ECHA (Art. 37 to Art. 39), and every actor passes new hazard information and doubts about the risk-management measures up the chain (Art. 34). Workers get access to the information for the substances they handle (Art. 35), and every manufacturer, importer, downstream user and distributor keeps the information needed for its REACH duties for at least 10 years after the last manufacture, import, supply or use (Art. 36).
How REACH relates to CLP, RoHS, POPs and the SCIP database
The CLP Regulation (EC) No 1272/2008 decides how a substance or mixture is classified, labelled and packaged, and those classifications trigger REACH duties: the safety data sheet, the CMR entries 28 to 30 of Annex XVII (updated for newly classified substances by Regulation (EU) 2025/1731) and the Article 57 criteria for substances of very high concern. The RoHS Directive restricts ten substances in electrical and electronic equipment in parallel, with its own exemptions and CE-marking route, and the POPs Regulation bans the persistent organic pollutants of the Stockholm Convention independently of Annex XVII. The Waste Framework Directive’s SCIP database receives the Candidate List information that Article 33 requires suppliers of articles to pass on, so the same bill-of-materials screening serves both duties.
Enforcement and consequences
Member States designate the competent authorities and enforcement bodies, maintain a system of official controls and lay down effective, proportionate and dissuasive penalties (Art. 121, Art. 125 and Art. 126). ECHA’s Forum for Exchange of Information on Enforcement coordinates Union-wide inspection projects on registration, safety data sheets, Candidate List communication and restricted substances in consumer products (Art. 76(1)(f) and Art. 77(4)). For products, the market-surveillance powers of Regulation (EU) 2019/1020, which lists REACH in its Annex I, allow authorities to order withdrawal, recall and destruction and to stop non-compliant articles at the border. In Denmark, Miljøstyrelsen’s chemical inspection enforces REACH, and the Chemicals Act provides for fines and, for intentional or grossly negligent breaches that harm or endanger health or the environment, imprisonment of up to two years.
How Conphora helps
Conphora monitors the REACH Regulation, every amendment to Annex XVII and each Candidate List update, maps your products and their bills of materials against the entries and the 0,1 % threshold, and flags the application dates that fall in your calendar, from D4, D5 and D6 in June 2026 to 2,4-dinitrotoluene in May 2027. The platform helps you keep supplier declarations, test reports, safety data sheets and Article 33 communications in order, prepares the SCIP notification alongside, and alerts you when a new restriction, authorisation or Candidate List entry changes what you must do.
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Sources
- Regulation (EC) No 1907/2006 (REACH), consolidated text of 22 June 2026 (EUR-Lex)
- Regulation (EC) No 1907/2006 as published in OJ L 396, 30 December 2006 (EUR-Lex)
- Document information, dates and relationships for CELEX 32006R1907 (EUR-Lex)
- Regulation (EC) No 1272/2008 on classification, labelling and packaging (CLP) (EUR-Lex)
- Commission Regulation (EU) 2020/878 amending Annex II on safety data sheets (EUR-Lex)
- Commission Implementing Regulation (EU) 2020/1435 on the deadlines for updating registrations (EUR-Lex)
- Commission Regulation (EU) 2023/1464 on formaldehyde and formaldehyde releasers (EUR-Lex)
- Commission Regulation (EU) 2023/2055 on synthetic polymer microparticles (EUR-Lex)
- Commission Regulation (EU) 2024/1328 on D4, D5 and D6 (EUR-Lex)
- Commission Regulation (EU) 2024/2462 on PFHxA, its salts and PFHxA-related substances (EUR-Lex)
- Commission Regulation (EU) 2025/660 on PAHs in clay targets (EUR-Lex)
- Commission Regulation (EU) 2025/1090 on DMAC and NEP (EUR-Lex)
- Commission Regulation (EU) 2025/1731 on CMR substances subject to restrictions (EUR-Lex)
- Commission Regulation (EU) 2025/1988 on PFAS in firefighting foams (EUR-Lex)
- Commission Regulation (EU) 2026/859 on 2,4-dinitrotoluene in articles (EUR-Lex)
- Commission Regulation (EU) 2026/1168 amending the microplastics entry (EUR-Lex)
- Regulation (EU) 2019/1020 on market surveillance and compliance of products (EUR-Lex)
- Directive 2008/98/EC on waste, consolidated text, Article 9 on the SCIP database (EUR-Lex)
- Judgment of the Court of 10 September 2015, Case C-106/14, FCD and FMB (EUR-Lex)
- Understanding REACH (European Chemicals Agency)
- Candidate List of substances of very high concern for authorisation (European Chemicals Agency)
- Substances restricted under REACH, Annex XVII (European Chemicals Agency)
- REACH Regulation (European Commission, DG Internal Market, Industry, Entrepreneurship and SMEs)
This guide is for general information and is not legal advice.