SVHC — Substances of Very High Concern — is a regulatory category under the EU REACH Regulation covering chemical substances that pose the most serious risks to human health or the environment. The European Chemicals Agency (ECHA) maintains a public Candidate List which, as of 4 February 2026, contains 253 substances. Inclusion on the list does not by itself ban a substance, but it triggers an immediate set of legal obligations: suppliers must inform recipients of articles containing the SVHC above 0.1% w/w, respond to consumer requests within 45 days, notify ECHA where tonnage thresholds are exceeded, update safety data sheets, and submit notifications to the SCIP database under the Waste Framework Directive.
This guide explains SVHC end-to-end for compliance specialists, EHS managers, regulatory affairs professionals, and product portfolio managers. It covers the Article 57 criteria that define what makes a substance an SVHC, the identification process from Annex XV dossier to Candidate List entry, the four obligations triggered by listing, the route from the Candidate List to the Annex XIV Authorisation List, and the recent regulatory developments — including the 4 February 2026 list update that added n-Hexane on a precedent-setting neurotoxicity-based criterion and the European Commission’s December 2025 proposal to abolish the SCIP database. For the broader framework context, see our REACH Compliance Guide.
At a glance
- Framework: Substances of Very High Concern (SVHC) — defined under Article 57 of REACH (Regulation EC 1907/2006), administered by ECHA in Helsinki.
- Identification criteria: CMR Category 1A/1B (Article 57 a-c) · PBT (d) · vPvB (e) · Equivalent level of concern (f), including endocrine disruption and now neurotoxicity.
- Candidate List size: 253 entries as of 4 February 2026.
- Latest additions: n-Hexane (CAS 110-54-3) — first SVHC ever identified on neurotoxicity grounds — and BPAF (CAS 1478-61-1).
- Annex XIV (Authorisation List): ~59 substances after the 7th amendment; 12th recommendation pending Commission adoption.
- SCIP database: 17.5+ million notifications; pending abolition proposal under the December 2025 EU Commission Simplification Package.
- Related tools: ATE Calculator · H-Statements · Storage Segregation · Label Constructor.
What is an SVHC?
Substances of Very High Concern (SVHC) are a regulatory category established by Title VII (Authorisation) of the EU REACH Regulation. The category captures substances whose hazardous properties make them candidates for the most stringent control mechanism under REACH — authorisation of every specific use, with the underlying assumption that the use should ultimately be phased out unless companies can justify continued production or use to ECHA’s risk assessment committees and the European Commission.
The Candidate List is not a list of banned chemicals. A more accurate framing is “early warning”: a substance listed on the Candidate List remains lawful to manufacture, import, and use in the EU, but suppliers face an immediate set of supply chain obligations, and downstream regulatory action — either restriction under Annex XVII or authorisation under Annex XIV — becomes substantially more likely. For companies in the supply chain, Candidate List inclusion is the signal to begin substitution planning, supplier audits, and customer communication strategy.
SVHC identification is one of three regulatory mechanisms under REACH for managing chemical risk. Restriction under Annex XVII imposes immediate conditions on placing on the market or use (content limits, use bans, emissions caps). Authorisation under Annex XIV requires explicit Commission permission for each specific use after a sunset date. SVHC identification is the gateway to authorisation and a complementary trigger for supply chain transparency. For the broader context of how SVHCs fit into the REACH framework and how authorisation differs from restriction, see the parent REACH pillar.
Article 57 criteria — the four routes to SVHC
The four criteria in Article 57 of REACH define what makes a substance an SVHC. A substance qualifies if it meets any one of these criteria — the criteria are independent, not cumulative.
CMR — Article 57 (a), (b), (c)
A substance is an SVHC if it is classified under the CLP Regulation as Carcinogenic Category 1A or 1B (Article 57 a), Mutagenic Category 1A or 1B (b), or Reproductive Toxicant Category 1A or 1B (c). These are substances assigned the hazard codes H340 (germ-cell mutagenicity), H350 (carcinogenicity), or H360 (reproductive toxicity) at category 1A or 1B level — either through harmonised classification in Annex VI of CLP or through self-classification supported by available data.
The CMR criteria capture the majority of SVHCs. Historical analyses of the Candidate List have shown that roughly 80–90% of substances meet at least one CMR criterion. Examples include lead chromate molybdate sulfate (carcinogenic Category 1B), various phthalates (reproductive toxicants Category 1B), and many aromatic amines. The CMR route is the most procedurally straightforward path to SVHC identification: the underlying classification has already been agreed at EU level (in the case of harmonised classifications) or by the registrant, and the SVHC dossier essentially confirms the existing categorisation.
PBT — Article 57 (d)
PBT — Persistent, Bioaccumulative and Toxic — substances meet all three criteria simultaneously under Annex XIII of REACH:
- Persistence: environmental half-life above defined thresholds in marine water (>60 days), freshwater (>40 days), marine sediment (>180 days), freshwater sediment (>120 days), or soil (>120 days), measured under simulation conditions.
- Bioaccumulation: measured Bioconcentration Factor (BCF) ≥ 2,000 L/kg in aquatic species, or supporting evidence from field studies of biomagnification.
- Toxicity: long-term NOEC (No Observed Effect Concentration) < 0.01 mg/L for marine or freshwater organisms, CMR Category 1A/1B classification, or chronic toxicity Categories 1, 2, or 3 under CLP.
A substance must satisfy all three properties to qualify as PBT. Examples include certain UV stabilisers (UV-328, UV-327), short-chain chlorinated paraffins, and various brominated flame retardants. PBT identification often requires extensive non-standard testing programmes and is one of the most data-intensive routes to SVHC status.
vPvB — Article 57 (e)
vPvB — very Persistent and very Bioaccumulative — applies to substances meeting more stringent persistence and bioaccumulation thresholds than PBT, but without the toxicity criterion. The vPvB thresholds are:
- Persistence: half-life >60 days in marine or freshwater, or >180 days in sediment or soil
- Bioaccumulation: BCF > 5,000 L/kg
The regulatory reasoning is that substances which persist indefinitely and accumulate to very high concentrations pose serious long-term risks even when no acute toxicity has been measured at current environmental exposures. The vPvB criterion reflects the precautionary principle: by the time toxicity is observed in the environment, the persistence and bioaccumulation will already have produced widespread distribution that is effectively irreversible.
Equivalent level of concern (ELOC) — Article 57 (f)
The most flexible — and historically the most contested — criterion. Article 57(f) covers substances “for which there is scientific evidence of probable serious effects to human health or the environment which give rise to an equivalent level of concern to those of other substances listed in points (a) to (e)”. Substances under Article 57(f) are identified case-by-case, with the Member State Committee playing a particularly important role.
Historically, ELOC has been used primarily to bring endocrine-disrupting substances (EDs) onto the Candidate List in the years before the EU formalised endocrine disruption hazard classes under CLP. Substances such as 4-nonylphenol, 4-tert-octylphenol, and various phthalates were initially identified under Article 57(f) for endocrine-disrupting properties before CLP’s endocrine disruption classes were finalised.
In February 2026, ELOC was used for the first time to identify a substance based on neurotoxicity: n-Hexane (CAS 110-54-3) became the first SVHC ever identified on the grounds of equivalent concern for neurotoxic effects. The Member State Committee unanimously agreed that the established neurotoxicity of n-Hexane on the peripheral nervous system — well-documented in occupational health literature — gives rise to a level of concern equivalent to CMR and PBT substances. The precedent is expected to open the door for further neurotoxicity-based listings in coming years, and broadens the practical scope of Article 57(f) beyond endocrine disruption for the first time.
The SVHC identification process
The process from substance dossier to Candidate List entry follows a defined sequence under Article 59 of REACH. The full process typically takes 9–18 months, though contested substances can take significantly longer.
Step 1 — Annex XV dossier
A Member State Competent Authority, or ECHA at the request of the European Commission, prepares an Annex XV dossier documenting why the substance meets one or more Article 57 criteria. The dossier sets out the available hazard data, the proposed classification basis, exposure considerations, and the regulatory rationale for SVHC identification rather than alternative regulatory routes. Annex XV dossiers are substantial documents — typically 50–200 pages — and represent the largest single workstream in the SVHC process.
Step 2 — Public consultation (45 days)
ECHA publishes the dossier on its website and opens a 45-day public consultation. Industry, NGOs, individual citizens, Member States, and any interested party may submit comments and additional information. Comments are typically focused on the strength of the scientific evidence, the appropriateness of the regulatory route, the adequacy of available alternatives, and the practical implications for the supply chain. The consultation is publicly visible on the ECHA Registry of Intentions until Outcome (ROI).
Step 3 — Member State Committee (MSC) decision
If no substantive comments challenge the basis for SVHC identification, the substance is added to the Candidate List automatically. If substantive comments are received, the dossier is referred to ECHA’s Member State Committee (MSC) for unanimous decision. The MSC consists of one representative per Member State plus Iceland, Liechtenstein, and Norway, and meets four times per year.
Where unanimous agreement is not reached, the European Commission decides under the regulatory committee procedure (comitology). MSC disagreements can stretch the SVHC process by months. At the 16 September 2025 MSC meeting, for example, Austria, the Czech Republic, and Slovakia abstained on the inclusion of melamine in the 12th Annex XIV recommendation, citing concerns about whether authorisation was the most appropriate regulatory tool for managing melamine’s risks.
Step 4 — Addition to Candidate List
Once approved, the substance is published on the Candidate List on the ECHA website. The publication date is the date from which the supply chain obligations apply — there is no further grace period. Companies must have their Article 33, Article 7(2), SDS, and SCIP processes ready to operate from the publication date forward.
The Candidate List — historical and current
Historical evolution
The Candidate List was first published on 28 October 2008 with 15 substances. Updates have followed roughly twice a year — typically in June and January — though the exact cadence has varied with the volume of substance dossiers in the pipeline. The list has grown substantially since 2008:
| Year-end | Approximate Candidate List size |
|---|---|
| 2008 | 15 substances |
| 2013 | 144 substances |
| 2018 | 197 substances |
| 2022 | 224 substances |
| Mid-2025 | 250 substances |
| Feb 2026 | 253 substances |
In 2025 alone, the list grew through three updates: January 2025 added a small set of substances; June 2025 raised the total to 250; November 2025 reached 251. February 2026 added two more, bringing the list to 253.
The 4 February 2026 update
The most recent update added two substances to the Candidate List:
| Substance | CAS No. | Basis |
|---|---|---|
| n-Hexane | 110-54-3 | Article 57(f) — equivalent level of concern (neurotoxicity) |
| 4,4’-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphenol (BPAF) and its salts | 1478-61-1 | Article 57(c) — toxic for reproduction |
The n-Hexane addition is regulatory-precedent-setting: it is the first substance ever added to the Candidate List on neurotoxicity grounds under the equivalent-concern criterion, expanding the practical scope of Article 57(f) beyond endocrine disruption. The MSC unanimously agreed to the identification at its December 2025 meeting.
BPAF was identified as a reproductive toxicant without committee involvement under the standard CMR-based route, since it already met Article 57(c) criteria from its CLP classification. The MSC also withdrew an SVHC proposal for 4,4’-methylenediphenol (Bisphenol F, BPF) before the December 2025 meeting, following industry comments on the strength of the evidence base.
How to check substances against the Candidate List
The authoritative Candidate List is published at echa.europa.eu/candidate-list-table and is progressively being transitioned to the ECHA CHEM platform (transition planned through July 2026). Both interfaces allow search by substance name, CAS number, EC number, or hazard category. For practical compliance work, companies maintain their own substance inventories and cross-reference them against the Candidate List at each update. The 0.1% w/w threshold for article-level obligations applies to the entire article, not to component parts: a screw containing 0.5% of an SVHC is itself an article above threshold even if the screw is a small component of a larger product.
Obligations triggered by Candidate List inclusion
Listing on the Candidate List triggers four distinct obligations under REACH and the EU Waste Framework Directive. All are simultaneous and cumulative — a single SVHC presence in your supply chain typically activates all four. The supply chain consequences are immediate, not deferred until a substance moves to Annex XIV.
Article 33 — supply chain communication
Suppliers of articles containing an SVHC at >0.1% w/w must provide recipients with sufficient information to allow safe use of the article — at minimum, the SVHC name. The information must be passed on automatically when the article is placed on the market, not only on request. The obligation applies to suppliers of articles to professional or industrial users.
On request from a consumer, the same information must be provided free of charge within 45 days. The 45-day timer starts on receipt of the consumer’s request. Article 33 obligations apply across the entire EU/EEA supply chain regardless of where the article was manufactured — an article imported from outside the EU and placed on the EU market generates the same disclosure obligations as one manufactured in the EU.
Article 7(2) — notification to ECHA
Producers and importers of articles containing an SVHC must notify ECHA if both conditions are met:
- The SVHC is present at >0.1% w/w in the article, and
- The total tonnage of the SVHC in the relevant articles exceeds 1 tonne per year per producer or importer
The notification must be submitted within six months of the substance being added to the Candidate List. The notification covers identification of the producer or importer, the substance and its tonnage, and the use category. Article 7(2) is separate from REACH registration (which applies to substances on their own or in mixtures) — it specifically covers SVHCs in articles where the substance is not intended to be released under normal or reasonably foreseeable conditions of use.
Exemptions from Article 7(2) apply where the SVHC has already been registered for the same use, or where exposure can be excluded under normal and reasonably foreseeable conditions including disposal.
Safety Data Sheet — Section 15 update
If the SVHC is supplied on its own or in a mixture, suppliers must provide a Safety Data Sheet under Article 31 of REACH. Section 15 must be updated to reflect the SVHC identification. For mixtures not classified as hazardous under CLP but containing an SVHC at ≥0.1% w/w (non-gaseous mixtures), recipients must be supplied with an SDS on request, even where one would not otherwise be required.
The SDS should also include the hazard statements (H-codes) and precautionary statements (P-codes) reflecting the substance’s full classification. Where the substance triggers Annex XIV-style controls, the SDS exposure scenarios should anticipate the eventual authorisation requirements.
SCIP database notification
Since 5 January 2021, suppliers placing articles containing SVHCs at >0.1% w/w on the EU market must notify the SCIP database (Substances of Concern In articles as such or in complex objects/Products) under the EU Waste Framework Directive 2008/98/EC. The SCIP database is maintained by ECHA and is publicly searchable.
The SCIP notification includes:
- Article identification (name, primary article identifier, EC/CAS where applicable)
- Identification of the SVHC and its concentration range
- The material category in which the substance is incorporated
- Safe-use instructions covering the article’s full lifecycle including waste handling
Notifications are submitted through ECHA’s IUCLID interface or through system-to-system integrations (e.g. from automotive IMDS systems via the SCIP interface). Enforcement is at national level — fines for non-compliance vary by Member State but can reach €1 million in some jurisdictions, including potential criminal liability.
The SCIP database — operational state and pending abolition
Operational scale
The SCIP database went online on 28 October 2020 and notification became mandatory on 5 January 2021. As of April 2026, the database contains over 17.5 million article notifications from approximately 6,000+ companies across the EU/EEA. The most-notified product categories typically include automotive components, electrical and electronic equipment, construction materials, and consumer goods such as furniture and textiles.
Many notifications duplicate the same article across multiple supply chain actors — the same component supplied by a sub-supplier and incorporated into a complex object generates separate notifications at each level. ECHA has acknowledged that the duplicated notifications inflate the published number relative to the underlying universe of distinct articles, but a significant share of the dataset reflects genuine supply chain depth.
Pending abolition — December 2025 proposal
On 10 December 2025, the European Commission presented a comprehensive Simplification Package in environmental law (documents COM(2025) 980 through 986). The package includes a formal legislative proposal to amend the Waste Framework Directive which explicitly provides for the abolition of the SCIP database and the associated reporting obligation.
The Commission’s stated reasoning: disproportionately high compliance costs relative to demonstrated benefits, and low effective usage of the database by the intended target groups — waste-management and recycling companies. The proposal frames the SCIP requirement as a candidate for streamlining under the broader “simplifying for sustainable competitiveness” agenda.
As of May 2026, the proposal is not yet adopted. SCIP reporting obligations remain fully in force. The amendment will only take effect after adoption by the European Parliament and Council and publication in the Official Journal. Companies should continue submitting SCIP notifications and monitor the legislative process. If adopted, the abolition would mark a significant simplification of SVHC compliance for article-level obligations — but the Article 33 (supply chain), Article 7(2) (ECHA tonnage notification), and SDS Section 15 update obligations would remain in place under REACH, unaffected by the WFD amendment.
From Candidate List to Annex XIV (Authorisation)
Inclusion on the Candidate List is a necessary but not sufficient step toward authorisation. Substances move from the Candidate List to Annex XIV — the Authorisation List — through a prioritisation process run by ECHA every two to three years.
Prioritisation (Article 58)
ECHA periodically reviews Candidate List substances and proposes those most appropriate for inclusion in Annex XIV, based on:
- Hazard characteristics: PBT/vPvB substances and non-threshold CMRs are prioritised
- Wide-dispersive use: substances used in many products by many sectors face stronger prioritisation
- High volume: registered tonnage in the EU market
- Substitutability: whether suitable alternatives exist on the market
ECHA prepares draft recommendations, opens stakeholder consultations on the draft, secures Member State Committee opinion, and forwards the final recommendation to the European Commission. The Commission then decides on Annex XIV inclusion and the associated dates through implementing regulation.
Current Annex XIV state
Annex XIV contained 59 substances after the 7th amendment in April 2022. The list has been updated several times since, with the most recent ECHA recommendations:
- 12th recommendation: adopted by MSC on 16 September 2025, submitted to the European Commission by end-November 2025. Under Commission review for adoption.
- 13th recommendation: prioritisation exercise launched in 2025, including assessment of 15 newly added SVHCs. Stakeholder consultation expected from February 2026 onwards.
Authorisation application
Once a substance is included in Annex XIV, each entry specifies:
- Latest Application Date (LAD): the deadline by which an authorisation application must be received by ECHA to allow continued use beyond the sunset date pending decision
- Sunset Date: after which the substance may not be placed on the EU market or used unless an authorisation has been granted or the use is exempt
An authorisation application requires:
- A Chemical Safety Report (CSR) covering each applied-for use
- An Analysis of Alternatives (AoA) demonstrating that suitable alternative substances or technologies do not exist or are not yet ready for substitution
- Usually a Socio-Economic Analysis (SEA) demonstrating that the benefits of continued use outweigh the residual risks
Applications are reviewed by ECHA’s Risk Assessment Committee (RAC) and Socio-Economic Analysis Committee (SEAC). Their joint opinions support the European Commission’s authorisation decision. Authorisations are use-specific, time-limited, and typically include a review period of seven or twelve years after which the holder must re-apply. The “adequate control route” — demonstrating that the use is adequately controlled — does not apply to PBT, vPvB, or non-threshold CMR substances; for those, the applicant must rely on the socio-economic balance.
Strategic implications for industry
For companies whose products or processes use Candidate List substances, SVHC listing is the starting signal for several parallel strategic decisions that cannot wait for the eventual Annex XIV move.
Substitution planning. The earliest, lowest-cost response to SVHC listing is substitution. Companies that wait until a substance reaches Annex XIV typically face rushed alternatives assessments, customer requalifications, accelerated timelines, and weakened bargaining position with downstream customers. Substitution is also subject to the “regrettable substitution” risk — replacing one SVHC with another substance that turns out to share similar hazard properties or to be itself a Candidate List substance in waiting. Robust alternatives assessments use the GreenScreen, Column Model, or similar structured comparative-hazard frameworks.
Supply chain visibility. Effective SVHC compliance requires up-to-date knowledge of substance content across the entire supply chain, including substances present in articles purchased from non-EU suppliers. Robust supplier declarations, periodic content audits, and Material Safety Data Sheet review at supplier qualification are baseline practices. Companies with deep supply chains often invest in dedicated supply chain data platforms — the cost of compliance scales with supplier count.
Authorisation versus exemption. Some uses of Annex XIV substances are exempt from authorisation — including uses already controlled by other EU legislation (such as biocidal products, plant protection products, and certain pharmaceutical applications), uses in scientific research and development, and certain transported intermediates. Identifying applicable exemptions before applying for authorisation can save significant cost and time. Where authorisation is the only viable path, application well before the LAD is critical.
Cross-jurisdictional alignment. Companies supplying both EU and other markets must track SVHC-equivalent regimes in those jurisdictions. UK REACH operates a parallel Candidate List that has begun to diverge from EU REACH. The United States has no direct SVHC equivalent under OSHA HCS but does maintain related lists under the Toxic Substances Control Act (TSCA), notably the TSCA Inventory and various risk evaluation rosters. China’s MEP and Korea’s K-REACH operate further parallel regimes.
UK REACH SVHC framework
After Brexit, Great Britain operates a separate UK REACH regime, while Northern Ireland continues to apply EU REACH under the Windsor Framework. The UK Candidate List operates under nearly identical Article 57 criteria as EU REACH, but the lists have begun to diverge in both timing and substance selection:
- The UK Health and Safety Executive (HSE), supported by the Environment Agency, prepares UK SVHC dossiers
- UK SVHC dossiers go through a 6-week consultation (slightly shorter than EU’s 45 days)
- The UK Candidate List is maintained separately at hse.gov.uk/reach
- UK Annex 14 follows a distinct prioritisation and timetable from EU Annex XIV
In early 2026, the HSE proposed adding DOTE (Dimethyltin compounds), MOTE (Monomethyltin compounds), and TEL (Tetraethyl lead) to the UK Annex 14 Authorisation List. The public consultation closed on 4 February 2026. UK Annex 14 inclusion timetables continue to lag EU Annex XIV by several months to years for most substances.
For companies supplying both markets, dual-jurisdiction SVHC tracking has become a meaningful additional compliance overhead. The differences are primarily in timing rather than substance — the underlying chemistry and hazard profiles are the same, but the regulatory windows and obligation start dates differ. A dedicated cluster article on EU and UK SVHC divergence is planned under the REACH pillar.
Recent updates (2025-2026)
Candidate List growth and the neurotoxicity precedent
The Candidate List grew from 247 substances in early 2025 to 253 entries in February 2026. The most consequential development was the n-Hexane identification on neurotoxicity grounds — the first time Article 57(f) ELOC was applied for a non-endocrine-disruption endpoint. The precedent broadens the practical scope of ELOC and signals that future SVHC identifications may rely on a wider range of hazard endpoints, potentially including immunotoxicity, developmental neurotoxicity, and behavioural endpoints.
SCIP database abolition proposal (December 2025)
The European Commission’s 10 December 2025 Simplification Package proposes abolishing the SCIP database. Until adoption, SCIP obligations remain in force. The proposal is widely discussed in industry as the most significant simplification of SVHC compliance to date — but companies should plan on continued SCIP submissions through at least 2026 and likely well into 2027.
REACH revision shelved (April 2026)
The European Commission’s planned comprehensive revision of REACH was officially shelved on 27 April 2026 by Environment Commissioner Roswall. The shelving has indirect but important implications for SVHC strategy: previously discussed reforms — mandatory SVHC dossier re-submission every 10 years, broader prioritisation criteria, polymer-level SVHC consideration — are no longer on the legislative table. SVHC identification will continue under the existing Article 57 framework for the foreseeable future. For more context on the wider regulatory environment, see our REACH Compliance Guide.
PFAS universal restriction (expected end of 2026)
The Commission’s expected PFAS universal restriction proposal — anticipated by end of 2026 — operates under Annex XVII (restriction) rather than the SVHC/authorisation route. The restriction proposal has been prepared by five Member States (Germany, Netherlands, Norway, Sweden, Denmark) and would cover the entire PFAS chemical group rather than individual substances. Many individual PFAS substances are nonetheless candidates for SVHC identification, and the relationship between the universal PFAS restriction and individual SVHC-by-SVHC listings remains a strategic question for chemical manufacturers and downstream users — particularly in sectors such as semiconductors, medical devices, and high-performance coatings where PFAS alternatives are limited.
Frequently asked questions
What is an SVHC?
An SVHC — Substance of Very High Concern — is a chemical substance identified under Article 57 of the REACH Regulation as posing serious risks to human health or the environment. SVHCs include CMR Category 1A/1B substances, PBT and vPvB substances, and substances of equivalent concern such as endocrine disruptors and (since February 2026) certain neurotoxicants. SVHC status itself is not a ban — it is a regulatory marker that triggers supply chain disclosure and notification obligations.
How many SVHC are on the Candidate List?
As of 4 February 2026, the Candidate List contains 253 substances. The list is updated approximately twice a year by ECHA, typically in June and January. Recent additions include n-Hexane (the first SVHC identified on neurotoxicity grounds under the equivalent-concern criterion) and BPAF, a reproductive toxicant identified through the standard CMR route.
What’s the difference between an SVHC and a CMR substance?
CMR — Carcinogenic, Mutagenic, or Reproductive toxicant — is one of four pathways to SVHC identification under Article 57. All CMR Category 1A and 1B substances qualify as SVHCs (Article 57 a-c), but not all SVHCs are CMRs: SVHCs also include PBT substances (d), vPvB substances (e), and equivalent-concern substances (f). Of the 253 substances currently on the Candidate List, the majority are CMRs, but a growing minority — particularly endocrine disruptors and the newly precedent-setting neurotoxicants — are listed under Article 57(f).
What is the 0.1% threshold for SVHC?
The 0.1% w/w (weight-by-weight) threshold is the concentration at which an SVHC in an article triggers supply chain obligations under REACH. Above this threshold, Article 33 (supply chain disclosure, including 45-day response to consumer requests), Article 7(2) (ECHA notification if total tonnage exceeds 1 t/y), and SCIP database notification all apply. The threshold is calculated per article, not per article component — a screw containing 0.5% of an SVHC is itself an article above threshold even if the screw is a small component of a larger product such as a vehicle or appliance.
Is an SVHC banned in the EU?
No. SVHC identification by itself does not ban a substance. Inclusion on the Candidate List triggers supply chain obligations but the substance remains lawful to manufacture, import, and use. A ban-equivalent effect only applies if the substance is subsequently included in Annex XIV (Authorisation List) and its sunset date passes without authorisation being granted, or if the substance is restricted under Annex XVII. Of the 253 substances on the Candidate List, only a subset (currently around 60-70) have been moved to Annex XIV.
What is Article 33 of REACH?
Article 33 is the REACH provision requiring suppliers of articles containing an SVHC above 0.1% w/w to communicate that fact down the supply chain. Information sufficient for safe use — at minimum the SVHC name — must be provided automatically to recipients and, on request from a consumer, within 45 days free of charge. Article 33 applies regardless of whether the article was manufactured in the EU or imported, and regardless of whether the SVHC has been subsequently moved to Annex XIV.
What is the SCIP database?
SCIP — Substances of Concern In articles as such or in complex objects (Products) — is the ECHA database receiving notifications about articles placed on the EU market that contain SVHCs above 0.1% w/w. SCIP notifications have been mandatory since 5 January 2021 under the EU Waste Framework Directive, and the database contains over 17.5 million article notifications. In December 2025, the European Commission proposed abolishing SCIP as part of its Simplification Package; the proposal is not yet adopted, and SCIP obligations remain in force until further notice.
What’s the latest SVHC list update?
The most recent Candidate List update was on 4 February 2026, adding n-Hexane (CAS 110-54-3) and BPAF (CAS 1478-61-1) to bring the total to 253 substances. n-Hexane is regulatory-precedent-setting: it is the first SVHC identified on neurotoxicity grounds under Article 57(f) (equivalent level of concern), broadening the practical scope of the ELOC criterion beyond endocrine disruption for the first time since the Candidate List was established in 2008.
Key takeaways
- SVHC is the most stringent category under REACH for managing chemical risks. Substances identified under Article 57 face immediate supply chain disclosure obligations and can be moved to authorisation under Annex XIV.
- The Candidate List stood at 253 entries on 4 February 2026. The n-Hexane addition is the first SVHC identified on neurotoxicity grounds under the equivalent-concern criterion, a regulatory precedent broadening Article 57(f).
- Listing triggers four parallel obligations: Article 33 (supply chain disclosure with 45-day consumer response), Article 7(2) (ECHA tonnage notification for >1 t/y), SDS Section 15 update, and SCIP database notification.
- The SCIP database may be abolished. The December 2025 EU Commission proposal under the Simplification Package would remove the WFD notification obligation. The proposal is not yet adopted; SCIP submissions remain mandatory until then.
- From Candidate List to Annex XIV is a separate process. The 12th ECHA recommendation is pending Commission adoption; the 13th is under preparation. Authorisation is the regulatory endpoint of the SVHC route — but most Candidate List substances never reach Annex XIV.
- Substitution planning starts at listing, not at sunset date. Companies that wait for Annex XIV inclusion face compressed timelines, weakened bargaining position, and elevated regrettable-substitution risk.
Articles in this pillar
For the broader REACH framework that governs SVHC identification, see the REACH Compliance Guide and the REACH Registration Step-by-Step cluster article, which covers the registration mechanism that feeds substance hazard data into the SVHC identification process.
Further cluster articles diving into specific SVHC topics — including detailed Article 57 criteria breakdowns, the practical mechanics of authorisation applications, EU versus UK SVHC divergence, and case studies of high-impact recent additions — will follow under this pillar.
Sources
- Regulation (EC) No 1907/2006 (REACH) Article 57
- ECHA — Candidate List of Substances of Very High Concern for Authorisation
- ECHA — Authorisation List (Annex XIV)
- ECHA — Candidate List update of 4 February 2026 (n-Hexane and BPAF additions)
- Annex XIII REACH — Criteria for PBT and vPvB identification
- EU Waste Framework Directive 2008/98/EC (consolidated)
- ECHA — SCIP database
- European Commission — Simplification Package COM(2025) 980-986, 10 December 2025
- ECHA — Annex XIV 12th recommendation (Member State Committee adoption, 16 September 2025)
- UK Health and Safety Executive — UK REACH SVHCs
- ECHA — Member State Committee
- Regulation (EC) No 1272/2008 on Classification, Labelling and Packaging (CLP)
- European Commission DG ENVI — Commissioner Roswall statement on REACH revision, 27 April 2026