REACH

# REACH REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) is the European Union's framework regulation for chemicals, in force since 2007. Administered by the European Chemicals Agency (ECHA) in Helsinki, it requires companies to register chemical substances, and it restricts hazardous substances in products through authorisation and restriction processes that directly affect consumer goods. ## Key facts - REACH is Regulation (EC) No 1907/2006, in force from 1 June 2007, and one of the strictest chemicals laws in the world. - It is administered by the European Chemicals Agency (ECHA), based in Helsinki, Finland. - Companies manufacturing or importing substances at one tonne or more per year must register them with ECHA. - Annex XVII lists restrictions on the manufacture, placing on the market and use of hazardous substances, including in consumer articles. - Substances of Very High Concern (SVHCs) are listed on the Candidate List, triggering communication duties in the supply chain. - Some SVHCs move to the Authorisation List (Annex XIV), after which they cannot be used without an authorisation. - The principle is "no data, no market": unregistered substances at or above one tonne per year cannot be manufactured or imported in the EU. ## Registration: no data, no market Registration is REACH's foundation. Any company that manufactures a substance in the EU or imports it, whether on its own, in mixtures or intentionally released from articles, at one tonne or more per year must submit a registration dossier to ECHA. The dossier includes the substance's identity, its hazards, its uses and exposure scenarios, and guidance on safe use. Data requirements scale with tonnage: higher volumes require more extensive toxicological and ecotoxicological testing, with the most demanding data set applying at one thousand tonnes per year and above. Lower tonnage bands have reduced but still meaningful requirements, so even small-volume manufacturers must characterise hazards properly. A central principle is data sharing. Companies registering the same substance must share vertebrate test data to avoid duplicate animal testing, submitting jointly through a lead registrant. This reduces costs and testing, though it requires cooperation between competitors within Substance Information Exchange Fora. Registration is not a one-time event: dossiers must be updated when new information on hazards, uses or volumes emerges. The last major registration deadline passed in 2018, covering substances at one to one hundred tonnes per year, which means the system now covers the large majority of substances on the EU market above the one-tonne threshold. New substances and new market entrants must still register before manufacturing or importing. ## Evaluation: checking dossiers and substances ECHA and the member states evaluate registrations in two ways. Dossier evaluation checks a proportion of registration dossiers for compliance with the data requirements and examines testing proposals, particularly those involving vertebrate animals, to ensure testing is justified. Where dossiers are incomplete, ECHA issues decisions requiring the registrant to provide the missing data by a deadline. Substance evaluation looks at substances of potential concern across all their registrations. A member state evaluates the substance and may conclude that EU-wide risk management is needed, leading to proposals for harmonised classification, identification as an SVHC, or restriction. Evaluation is the pipeline that converts registration data into regulatory action. ## Authorisation: SVHCs and the Candidate List Authorisation targets substances of very high concern: carcinogenic, mutagenic or reprotoxic substances, persistent bioaccumulative and toxic substances, and substances of equivalent concern such as endocrine disruptors. When a substance meets the criteria, it is placed on the Candidate List, which ECHA updates typically twice a year. Candidate listing triggers immediate duties for articles. Under Article 33, suppliers of articles containing a Candidate List substance above 0.1 percent by weight must communicate its presence to professional recipients, providing enough information for safe use, and must answer consumer requests within 45 days. Under the Waste Framework Directive, companies must also notify the SCIP database of SVHCs in articles, so waste operators can identify them. Substances can progress from the Candidate List to the Authorisation List in Annex XIV, which sets sunset dates after which the substance cannot be placed on the market or used without an authorisation granted for specific uses. Authorisation applications must show that risks are adequately controlled or that the socio-economic benefits outweigh the risks with no suitable alternatives. The aim is progressive substitution of the most hazardous substances. ## Restriction: Annex XVII and consumer products Restriction is the most directly relevant REACH process for consumer product companies. Annex XVII lists substances whose manufacture, placing on the market or use is limited or banned, with each entry defining the scope, the concentration limit and any exemptions. Restrictions apply to articles, meaning finished consumer products, not only to bulk chemicals. Well-known entries limit polycyclic aromatic hydrocarbons in rubber and plastic parts that contact skin, restrict certain phthalates in toys and childcare articles, control azo dyes that release aromatic amines in textiles and leather, limit nickel release from articles in prolonged skin contact, and restrict lead in jewellery and other consumer articles. New restrictions are added through a defined process involving ECHA opinions and Commission decisions, and companies must track proposals that affect their product categories. Because restrictions apply at the article level, importers of finished goods must verify compliance through their supply chains. Testing of finished products or components by accredited laboratories against the relevant Annex XVII entries is standard practice for products with plausible exposure, such as children's products, textiles, jewellery and electronics accessories. | REACH process | What it does | Business trigger | |---|---|---| | Registration | Dossiers on substances at 1+ tonnes/year | Manufacturing or importing substances | | Evaluation | Checks dossiers, assesses substances | Data requests from ECHA | | Authorisation | Candidate List and Annex XIV controls | SVHC above 0.1% in articles | | Restriction | Annex XVII bans and limits | Selling articles containing listed substances | | SCIP notification | SVHC data for waste operators | Articles with Candidate List substances | ## REACH and articles: what importers must do Most consumer product companies encounter REACH as importers of articles rather than as chemical manufacturers. The duties are: check products against Annex XVII restrictions, communicate SVHCs above 0.1 percent under Article 33, notify the SCIP database where required, and respond to enforcement. None of these require the importer to register substances, but all require supply chain transparency. Practical compliance starts with a restricted substances list that translates Annex XVII entries and the Candidate List into clear requirements for suppliers, written into purchasing contracts and quality agreements. Suppliers provide declarations and test reports, and the importer runs risk-based verification testing, focusing on high-risk materials and product types such as children's goods, textiles and jewellery. Documentation should be kept so that market surveillance authorities can be shown the basis for compliance claims. REACH enforcement is carried out by member state authorities, often in coordinated enforcement projects that target specific restrictions across the EU. Penalties are set nationally and can include fines, product withdrawals and criminal sanctions. Because the Candidate List grows regularly, the restricted substances list and supplier declarations must be refreshed on a schedule, not treated as one-time paperwork. Many companies tie the refresh to each Candidate List update and to every bill-of-materials change, so compliance stays aligned with both regulation and product reality. ## Frequently asked questions Does REACH apply to finished products or only to chemicals? Both. Registration applies to substances, but restrictions in Annex XVII and the SVHC communication duties apply to articles, meaning finished products. Importers of consumer goods must comply with the article-level duties. What is the 0.1 percent SVHC threshold? Under Article 33, suppliers of articles containing a Candidate List substance above 0.1 percent weight by weight must communicate its presence down the supply chain and to consumers on request. The threshold applies to each article as supplied. How often is the Candidate List updated? ECHA typically updates the Candidate List twice a year, in January and June. Companies should check each update against their bills of materials and refresh supplier declarations accordingly. What is the difference between restriction and authorisation? Restriction bans or limits specific uses of a substance for everyone through Annex XVII. Authorisation requires individual companies to obtain permission to continue using an Annex XIV substance after its sunset date. A substance can be subject to both. Do I need to register substances in imported articles? Registration applies to substances manufactured or imported at one tonne or more per year, including substances intended to be released from articles. Most importers of finished articles do not trigger registration, but they must still meet restriction, communication and notification duties. What is the SCIP database? The database for Substances of Concern In articles as such or in complex objects (Products), established under the Waste Framework Directive. Suppliers must notify ECHA of articles containing Candidate List substances above 0.1 percent, so waste operators can manage them safely. ## Sources - EU chemicals policy overview - EU Safety Gate rapid alert system - EU market surveillance framework