REACH GLOSSARY

Annex XIV of REACH is the Authorisation List: the list of Substances of Very High Concern (SVHCs) whose placing on the market or use is prohibited after a specified Sunset Date unless an authorisation covering that specific use has been granted by the European Commission, or the use is exempt. Each Annex XIV entry specifies a Latest Application Date (LAD) and a Sunset Date. The LAD is typically 18 months before the Sunset Date; submitting an application by the LAD allows continued use pending the Commission decision.

An Annex XV dossier is the scientific and technical documentation submitted to ECHA to support: (1) identification of a substance as an SVHC for inclusion in the Candidate List; (2) proposals for new or amended restrictions under Annex XVII; or (3) proposals for inclusion in the Authorisation List (Annex XIV). Dossiers may be submitted by ECHA itself or by a Member State. The dossier must demonstrate that the substance meets the relevant hazard criteria and that regulatory action is warranted.

Annex XVII of REACH is the legally binding Restriction List, setting conditions on the manufacture, placing on the market, or use of specific substances, either as such, in mixtures, or in articles. As of 19 June 2025, Annex XVII contains 77 entries. Key recent additions include: Entry 77 (formaldehyde and releasers: emissions limits for furniture, wood-based articles, and vehicle interiors, applicable from 6 August 2026 for furniture and 6 August 2027 for road vehicles); expanded Entry 63 (lead in PVC: ≤0.1% from 29 November 2024); and new CMR substance additions under Commission Regulation (EU) 2025/1731 (effective 1 September 2025, adding TBBPA, N,N-dimethyl-p-toluidine, TPO photoinitiator, BPAF, dibutyltin maleate, and dibutyltin oxide to Appendices). Commission Regulation (EU) 2025/1090 (effective 2 June 2025) added restrictions on DMAC (N,N-dimethylacetamide) and NEP (1-ethylpyrrolidin-2-one).

Under REACH Article 3(3), an ‘article’ is an object which during production is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition. Articles include manufactured products such as electronic components, furniture, textiles, vehicles, and toys. Substances or mixtures intentionally released from articles during use (e.g., printer ink cartridges) are subject to article notification obligations if they meet SVHC thresholds.

Article 33 of REACH requires suppliers of articles containing Candidate List SVHCs above 0.1% weight by weight (w/w) to provide sufficient information to allow the safe use of the article to professional recipients automatically, and to consumers within 45 days of request, free of charge. At minimum, the SVHC name must be communicated. This obligation arises immediately upon a substance’s inclusion in the Candidate List, regardless of tonnage. As of February 4, 2026, the Candidate List contains 253 entries.

Article 7(2) of REACH requires producers and importers of articles to notify ECHA when: (a) the article contains a Candidate List SVHC above 0.1% w/w, and (b) the total quantity of that SVHC present in all articles placed on the EU market by that producer/importer exceeds one tonne per year. Notification must be submitted within six months of the substance’s inclusion in the Candidate List. As of February 4, 2026, the Candidate List contains 253 entries; notifications for substances added on that date are due by August 4, 2026.

An Authorisation Application (AfA) under REACH is the formal submission made by a manufacturer, importer, or downstream user to ECHA requesting permission to continue using an Annex XIV substance after its Sunset Date. The application must include: a Chemical Safety Report for the applied-for uses; an Analysis of Alternatives; a Substitution Plan if technically and economically feasible alternatives exist; and a Socio-Economic Analysis (SEA) where adequate control cannot be demonstrated. Applications are evaluated by ECHA’s RAC and SEAC committees; the final decision is taken by the European Commission.

The Candidate List is ECHA’s list of Substances of Very High Concern (SVHCs) identified under Article 59 of REACH. Substances are added following a formal process including Annex XV dossier submission, public consultation, and Member State Committee agreement. As of February 4, 2026, the Candidate List contains 253 entries. ECHA updates the list periodically — typically in January and June each year, with occasional interim updates. Candidate List inclusion triggers immediate obligations under Articles 7, 31, and 33 of REACH.

A Chemical Safety Assessment (CSA) is a hazard and risk assessment conducted by a REACH registrant for a substance manufactured or imported above 10 tonnes per year that is classified as hazardous or is PBT/vPvB. The CSA follows the methodology in Annex I and includes: hazard assessment (physico-chemical, human health, environmental); PBT/vPvB assessment; exposure assessment; and risk characterisation. The results are documented in the Chemical Safety Report (CSR).

A Chemical Safety Report (CSR) is the formal document recording the results of a Chemical Safety Assessment. It is a mandatory part of a REACH registration dossier for substances above 10 t/year that are classified as hazardous or PBT/vPvB. The CSR documents hazard data, DNELs, PNECs, exposure scenarios, risk characterisation ratios, and risk management measures. Exposure scenarios from the CSR are appended to Safety Data Sheets (eSDS).

The Classification, Labelling and Packaging (CLP) Regulation (EC) No 1272/2008 is the EU regulation governing the hazard classification, labelling, and packaging of chemical substances and mixtures. CLP implements the UN Globally Harmonised System (GHS) in the EU. Harmonised classifications under CLP (Annex VI) determine REACH obligations: substances classified as CMR Cat 1A/1B, PBT, or vPvB qualify as SVHCs under REACH Article 57 and may be added to the Candidate List.

A CMR substance is a chemical classified as Carcinogenic, Mutagenic, or Toxic for Reproduction under CLP Regulation (EC) No 1272/2008. Categories: 1A (known CMR effect on humans), 1B (presumed CMR effect, primarily based on animal evidence), and 2 (suspected CMR). Under REACH Article 57(a)(b)(c), substances classified as CMR Cat 1A/1B qualify as SVHCs and can be added to the Candidate List and subsequently to the Authorisation List (Annex XIV). Commission Regulation (EU) 2025/1731 (effective 1 September 2025) added newly classified CMR 1B substances including TBBPA, N,N-dimethyl-p-toluidine, and others to Annex XVII Appendices.

A Compliance Check is a formal ECHA evaluation process under REACH Article 41 to verify whether the information in a registration dossier complies with the information requirements of Annexes VII–X. ECHA selects dossiers for compliance checks based on risk-based criteria. If the dossier is found to be incomplete or inaccurate, ECHA issues a Decision requiring the registrant to submit additional information within a defined timeline. ECHA has progressively increased the rate of compliance checking since 2013.

A Derived No-Effect Level (DNEL) is the level of exposure to a substance above which humans should not be exposed. DNELs are derived by registrants as part of the Chemical Safety Assessment (Annex I) and are reported in the Chemical Safety Report. DNELs are substance-specific and route-specific (inhalation, dermal, oral) and distinguish between workers and the general population. They appear in Safety Data Sheet Section 8 and serve as reference values for risk characterisation.

Under REACH Article 3(13), a downstream user (DU) is any natural or legal person established in the EU, other than the manufacturer or importer, who uses a substance, either on its own or in a mixture, in the course of their industrial or professional activities. Downstream users include formulators, processors, and industrial users. They are distinct from distributors. Downstream users have specific REACH obligations including: checking eSDS coverage, preparing downstream user CSRs where required, notifying ECHA of uncovered uses under Article 38, and applying appropriate risk management measures.

The European Chemicals Agency (ECHA) is the EU regulatory body established by REACH Regulation (EC) No 1907/2006 to manage the technical, scientific, and administrative aspects of REACH. ECHA maintains the registration database, operates the REACH-IT system, coordinates substance evaluation and restriction processes, manages the Candidate List, Authorisation List (Annex XIV), and the SCIP database, and provides scientific opinions through its Risk Assessment Committee (RAC) and Socio-Economic Analysis Committee (SEAC). Since 16 September 2025, ECHA hosts the new ECHA CHEM database as the primary substance information portal.

Endocrine disruptors (EDs) are substances that interfere with the hormonal systems of living organisms. Under REACH Article 57(f), substances identified as having endocrine-disrupting properties with probable serious effects on human health or the environment — and for which there is scientific evidence of probable serious effects — may be identified as SVHCs on the basis of ‘equivalent concern.’ ECHA’s Integrated Regulatory Strategy identifies EDs as a priority substance group for restriction and SVHC identification under the REACH Recast.

An Exposure Scenario (ES) is the set of conditions, including operational conditions and risk management measures, that describe how a substance can be used safely. Exposure scenarios are developed by registrants as part of the Chemical Safety Assessment for substances manufactured or imported above 10 t/year that require a CSR. They are communicated to downstream users as annexes to the extended Safety Data Sheet (eSDS). If a downstream user’s use is not covered by any ES in the supplier’s eSDS, the DU must take action.

An extended Safety Data Sheet (eSDS) is a Safety Data Sheet that includes one or more Exposure Scenarios appended to Section 16. The eSDS is required when a Chemical Safety Report has been prepared for the substance (i.e., hazardous substances or PBT/vPvB substances above 10 t/year). It communicates the specific conditions of safe use (operational conditions, risk management measures) for each identified use to downstream users in the supply chain. The eSDS is the primary REACH communication tool for chemical supply chains.

Under REACH Article 3(11), an importer is any natural or legal person established within the EU who is responsible for the import of substances, mixtures, or articles into the EU customs territory. EU importers bear the same registration obligations as EU manufacturers: substances imported above 1 tonne per year must be registered by the importer unless they are registered by a non-EU manufacturer’s Only Representative. Importers of articles must comply with Article 33 and Article 7(2) notification obligations for SVHC-containing articles.

IUCLID is the software application developed by ECHA and OECD for recording, storing, maintaining, and exchanging data on intrinsic and hazard properties of chemical substances. REACH registrants use IUCLID to prepare and submit registration dossiers to ECHA via REACH-IT. IUCLID dossiers contain physico-chemical data, toxicological and ecotoxicological data, classification and labelling, and Chemical Safety Reports. ECHA regularly updates IUCLID to align with regulatory and format changes.

The Latest Application Date (LAD) is the deadline by which an application for authorisation of an Annex XIV substance must be submitted to ECHA to allow continued use of that substance beyond its Sunset Date while the application is being evaluated. The LAD is specified in each Annex XIV entry, typically set 18 months before the Sunset Date. If a complete application is submitted before the LAD, the applicant may continue use legally until the European Commission makes a decision, even if the Sunset Date has passed.

Under REACH Article 3(9), a manufacturer is any natural or legal person established within the EU who manufactures a substance within the EU. EU manufacturers of substances above 1 tonne per year must register those substances with ECHA before placing them on the EU market. Manufacturers are primary duty holders for registration, Chemical Safety Assessment, Safety Data Sheet preparation, and supply chain communication obligations.

Under REACH Article 3(2), a mixture is a mixture or solution composed of two or more substances. Mixtures as such are not registered under REACH, but the substances they contain must be registered. Suppliers of mixtures must provide Safety Data Sheets to professional recipients for classified mixtures, and must communicate SVHC content above 0.1% w/w to recipients and consumers. The REACH SDS obligations (Articles 31–32) apply throughout the mixture supply chain.

'No data, no market' is the foundational REACH principle under Article 5: no substance may be manufactured in or imported into the EU, either on its own, in a mixture, or in an article, above 1 tonne per year without prior registration with ECHA, unless it is exempt. This principle reverses the pre-REACH approach, placing the burden of demonstrating safety on industry rather than on regulators.

An Only Representative (OR) is a legal person established in the EU who is appointed by a non-EU manufacturer to fulfil registration obligations under REACH on behalf of EU importers of the manufacturer’s substances. Under Article 8, when an OR is appointed, EU importers of the represented substances become downstream users and are relieved of registration obligations for those substances. The OR registers with ECHA, maintains the registration, and reports EU importers to ECHA.

A PBT (Persistent, Bioaccumulative, and Toxic) substance is a substance meeting the criteria set out in Annex XIII of REACH for all three properties simultaneously: persistence (degradation half-lives in water, sediment, or soil exceeding specified thresholds), bioaccumulation (bioconcentration factor (BCF) or bioaccumulation factor (BAF) exceeding specified thresholds), and toxicity (showing chronic toxicity effects in freshwater or marine organisms, or classified as CMR 1A/1B, or showing endocrine-disrupting effects). PBT substances qualify as SVHCs under REACH Article 57(d).

PMT (Persistent, Mobile, and Toxic) and vPvM (very Persistent and very Mobile) are substance hazard categories proposed under the REACH Recast as additional SVHC criteria in Article 57. PMT/vPvM substances are particularly concerning because their mobility means they can contaminate drinking water sources at concentrations that cannot be removed by conventional water treatment. ECHA has already begun identifying PMT/vPvM substances under Article 57(f) (equivalent concern) pending the formal Article 57 amendment expected under the REACH Recast.

A Predicted No-Effect Concentration (PNEC) is the environmental concentration of a substance below which adverse effects on the environment are not expected to occur. PNECs are derived for relevant environmental compartments (freshwater, marine water, sediment, soil, and secondary poisoning) as part of the Chemical Safety Assessment (Annex I). They are used in the environmental risk characterisation: the risk characterisation ratio (RCR) = measured/predicted environmental concentration (PEC) divided by the PNEC.

RAC is ECHA’s Risk Assessment Committee, responsible for preparing scientific opinions on: restriction proposals under Annex XVII; authorisation applications and review reports; and substance evaluation conclusions. RAC assesses the risks to human health and the environment and evaluates whether proposed restrictions or conditions are appropriate to adequately control identified risks. RAC opinions feed into the European Commission’s final decisions on restrictions and authorisations.

The REACH Recast refers to the comprehensive revision of REACH Regulation (EC) No 1907/2006, announced under the EU Chemicals Strategy for Sustainability (CSS) and the European Green Deal. The recast is expected to introduce: formal PMT/vPvM substance criteria; a generic risk approach enabling faster restriction of high-hazard substance groups; polymer registration requirements; revised registration information requirements for low-tonnage substances; stronger enforcement provisions; and integration with the Digital Product Passport framework. A first proposal from the European Commission was anticipated by the end of 2025.

REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) is Regulation (EC) No 1907/2006 of the European Parliament and of the Council, dated 18 December 2006, establishing a comprehensive European Union system for managing chemical substances. REACH came into force on 1 June 2007 and has been amended multiple times. It applies to all chemical substances manufactured in or imported into the EU above 1 tonne per year, with obligations across the supply chain for manufacturers, importers, downstream users, and distributors. REACH established ECHA as its central regulatory body.

The REACH Restriction Roadmap is ECHA’s multi-annual planning tool that lists substances or substance groups for which restriction actions are planned or under preparation, including the proposed timeline. Published under ECHA’s Integrated Regulatory Strategy, the Roadmap gives industry advance warning of upcoming Annex XVII restrictions, typically 3–5 years before restrictions take effect. Groups currently on the roadmap include PFAS (per- and polyfluoroalkyl substances), microplastics, bisphenol A and analogues, and other substance families.

REACH-IT is ECHA’s secure web-based system for submitting formal REACH dossiers, notifications, and inquiries electronically. Through REACH-IT, registrants submit registration dossiers (prepared in IUCLID), applications for authorisation, PPORDs (product and process oriented research and development notifications), Article 7(2) notifications, SCIP dossiers, and C&L notifications. REACH-IT requires legal entity accounts and has role-based access for manufacturers, importers, Only Representatives, and third parties.

Registration is the core REACH obligation under Articles 6–10: any EU manufacturer or importer of a substance (on its own, in a mixture, or for certain uses in articles) above 1 tonne per year must register the substance with ECHA before placing it on the EU market. Registration requires submission of a technical dossier (and a Chemical Safety Report for hazardous or PBT/vPvB substances above 10 t/year) via IUCLID and REACH-IT. Substances are registered on a per-substance, per-registrant basis within a joint submission framework (SIEF).

A registration dossier is the technical package submitted by a manufacturer or importer to ECHA as the basis for REACH substance registration. The dossier contains: a technical dossier with administrative data, physico-chemical properties, toxicological and ecotoxicological data, classification and labelling, guidance on safe use, and study summaries or robust study summaries; and (for substances above 10 t/year that are hazardous or PBT/vPvB) a Chemical Safety Report. Registration dossiers are prepared in IUCLID format.

A restriction under REACH Title VIII (Articles 67–73) is a legally binding condition or prohibition on the manufacture, placing on the market, or use of a substance — on its own, in a mixture, or in an article — where an unacceptable risk to human health or the environment has been identified that requires EU-wide action. Restrictions are listed in Annex XVII. As of 19 June 2025, Annex XVII contains 77 entries. Restrictions may impose concentration limits, use prohibitions, labelling requirements, or emission standards.

A Safety Data Sheet (SDS) is a standardised document providing information about a substance or mixture’s properties, hazards, safe handling, and emergency measures. Under REACH Article 31, SDS must be provided to professional recipients of classified substances and mixtures, substances that are PBT/vPvB, or Candidate List SVHCs. SDS must conform to the format in Regulation (EU) 2015/830 (replacing Regulation (EC) No 453/2010), covering 16 mandatory sections. SDS must be updated when new hazard information becomes available or when a substance is added to the Candidate List.

The SCIP database (Substances of Concern In articles as such or in complex objects/Products) is maintained by ECHA under Article 9 of the EU Waste Framework Directive (2008/98/EC, as amended). EU-based suppliers of articles containing Candidate List SVHCs above 0.1% w/w must notify ECHA via the SCIP database before placing those articles on the EU market, effective from 5 January 2021. The SCIP notification must include: article identification, SVHC identity and concentration, and safe use information. SCIP data is publicly available to enable waste operators to identify SVHC-containing waste streams.

SEAC is ECHA’s Socio-Economic Analysis Committee, which prepares opinions on the socio-economic aspects of proposed restrictions and authorisations under REACH. SEAC evaluates the costs and benefits of proposed regulatory actions, including impacts on industry, consumers, and society. SEAC opinions are based on the socio-economic analysis submitted in authorisation applications or restriction dossiers, supplemented by third-party comments during public consultations. SEAC and RAC opinions together feed into the European Commission’s final decision.

A Substance Information Exchange Forum (SIEF) is the mandatory collaboration platform under REACH Article 29 for registrants of the same substance to share data and costs for joint registration. SIEFs are formed after pre-registration and bring together all manufacturers and importers of the same substance to: share existing data; agree on classification and labelling; prepare a joint technical dossier submitted by the lead registrant; and negotiate data compensation agreements. Joint submissions are mandatory under REACH except in limited circumstances.

A Socio-Economic Analysis (SEA) is a cost-benefit assessment required in REACH authorisation applications where the applicant argues that socio-economic benefits outweigh risks, or where adequate control cannot be demonstrated. The SEA must quantify the benefits of continued authorised use (economic and social value to applicants and downstream users) against the health and environmental costs of the risks. SEA methodology follows ECHA guidance and must include a scenario analysis of what would happen if authorisation is refused.

Under REACH Article 3(1), a substance is a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition. Substances must be identified precisely for REACH purposes using agreed identifiers (molecular formula, SMILES, CAS number, EC number) and classified using Annex VI to the CLP Regulation.

Substance evaluation under REACH Article 44–48 is an in-depth assessment by a Member State Competent Authority (MSCA) to clarify whether a substance poses a risk to human health or the environment. Substances are selected for evaluation based on ECHA’s Community Rolling Action Plan (CoRAP). Following substance evaluation, the MSCA may request additional information from registrants or recommend follow-up regulatory action (restriction, authorisation, or harmonised classification).

A Substance of Very High Concern (SVHC) is a substance meeting one or more criteria under REACH Article 57: CMR Category 1A or 1B; PBT or vPvB per Annex XIII; or other equivalent concern (e.g., endocrine disruptors, PMT/vPvM). SVHCs are identified by ECHA through the Annex XV dossier process and added to the Candidate List. As of February 4, 2026, the Candidate List contains 253 entries. Candidate List inclusion triggers Article 33, Article 7(2), and SCIP database obligations.

The Toxic Chemical Substances Control Act (TCSCA), amended as the Toxic and Concerned Chemical Substances Control Act, is Taiwan’s national chemical management regulation, often referred to as Taiwan REACH. It governs the registration, evaluation, authorisation, and restriction of toxic and concerned chemical substances in Taiwan. Managed by the Taiwan Environmental Protection Administration (TEPA/EPA), TCSCA requires substance registration, SVHC-equivalent notifications, and imposes restrictions on listed substances. Taiwan maintains four classes of controlled substances, with Class 1 subject to prohibition and Class 4 requiring declaration.

In REACH, the tonnage band is the annual manufacture or import volume of a substance, expressed in tonnes, that determines the level of information required in the registration dossier. The four tonnage bands are: 1–10 t/year (basic data requirements, Annexes VI–VII); 10–100 t/year (extended data, Annex VIII); 100–1,000 t/year (further extended data, Annex IX); and >1,000 t/year (comprehensive data, Annex X). Higher tonnage bands require more toxicological and ecotoxicological testing and a Chemical Safety Report.

UK REACH is the retained version of EU REACH Regulation (EC) No 1907/2006, as it applied in Great Britain after Brexit under the European Union (Withdrawal) Act 2018. UK REACH is administered by HSE (Health and Safety Executive) as the UK’s REACH agency. UK REACH contains the same fundamental obligations as EU REACH (registration, SVHC communication, restrictions, authorisations), but operates independently of EU REACH. UK REACH has its own registration deadlines (extended transitional periods until 2026–2027), its own Candidate List and Annex XIV, and its own restriction processes.

A vPvB (very Persistent, very Bioaccumulative) substance meets the more stringent persistence and bioaccumulation criteria in REACH Annex XIII: persistence (degradation half-life >60 days in marine water or >180 days in marine sediment) and bioaccumulation (BCF >5,000). vPvB substances qualify as SVHCs under REACH Article 57(e) and are prioritised for Candidate List inclusion and potential Annex XIV listing. Like PBT substances, no safe level (DNEL/PNEC) can be derived for vPvB substances.

The EU Waste Framework Directive (Directive 2008/98/EC, as amended by Directive (EU) 2018/851) intersects with REACH through the SCIP database obligation. Article 9 of the WFD requires EU-based suppliers of articles containing Candidate List SVHCs above 0.1% w/w to notify ECHA’s SCIP database before placing those articles on the EU market. SCIP data is made publicly available by ECHA to support safe waste management and material recovery of SVHC-containing waste streams.