SVHC

# SVHC A Substance of Very High Concern (SVHC) is a chemical identified under the EU [REACHy/reach) Regulation as particularly hazardous to human health or the environment. SVHCs are listed on the Candidate List, which triggers communication duties for articles containing them above 0.1 percent by weight, and they are the pool from which substances are selected for authorisation. ## Key facts - SVHC criteria are set in REACH Article 57: CMR substances, PBT and vPvB substances, and substances of equivalent concern such as endocrine disruptors. - Identified SVHCs are placed on the Candidate List, published by ECHA and typically updated twice a year. - Suppliers of articles containing a Candidate List substance above 0.1 percent weight by weight must communicate its presence down the supply chain. - Consumers have a right to ask about SVHCs in articles and must receive an answer within 45 days. - Suppliers must notify the SCIP database of articles containing Candidate List substances above 0.1 percent. - Some SVHCs are moved to the Authorisation List (Annex XIV) with sunset dates after which use requires an authorisation. - Importers of articles have the same SVHC duties as EU manufacturers; the obligations follow the product, not the company type. ## The Article 57 criteria REACH Article 57 defines what makes a substance of very high concern. The first group is substances classified as carcinogenic, mutagenic or toxic for reproduction in category 1A or 1B, the CMR substances, where the hazard to human health is established. The second group is substances that are persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB), identified according to the criteria in REACH Annex XIII, where the concern is long-term environmental accumulation. The third group is substances of equivalent concern identified on a case-by-case basis, where scientific evidence shows probable serious effects giving rise to an equivalent level of concern. This route has been used for endocrine disrupting chemicals, for substances with neurotoxic or immunotoxic properties and for respiratory sensitisers, among others. The equivalent-concern route keeps the system responsive to evolving science rather than frozen around the original hazard classes. Identification follows a formal process: a member state or ECHA prepares an Annex XV dossier, there is public consultation, the Member State Committee seeks unanimous agreement, and the Commission decides where agreement is not reached. Publication on the Candidate List is the legal moment from which the communication and notification duties apply. ## Candidate List duties for articles The duties that matter most to product companies attach to articles. Under REACH Article 33, any supplier of an article containing a Candidate List substance above 0.1 percent weight by weight must provide the recipient with sufficient information for safe use, including at minimum the name of the substance. This applies at every supply step, from component supplier to retailer, and the information must be provided automatically to professional recipients. Consumers have a direct right: on request, suppliers must inform consumers whether their articles contain Candidate List substances above 0.1 percent, within 45 days, free of charge. Companies need a process for handling these requests, because the clock runs from receipt and the answer must be accurate. Many businesses publish SVHC information proactively to reduce request handling. The 0.1 percent threshold applies to the article as supplied, and for complex products made of multiple articles, the long-standing interpretation applies the threshold to each component article. This means a finished product must be assessed at the component level: a single small part containing an SVHC above 0.1 percent triggers duties for the whole supplied product. Bills of materials must therefore carry substance data down to component level. ## Notification duties: ECHA and SCIP Beyond communication, REACH Article 7 requires producers and importers of articles to notify ECHA if their articles contain a Candidate List substance above 0.1 percent and the total quantity in all their articles exceeds one tonne per year. Exemptions apply where the substance is already registered for that use or where exposure can be excluded, but the notification duty catches larger-volume article suppliers and should be assessed annually. Separately, the Waste Framework Directive requires suppliers to notify the SCIP database of articles containing Candidate List substances above 0.1 percent. SCIP notifications include the article's identity, the SVHC, concentration range and safe use information, and are intended to help waste operators identify and manage SVHCs at end of life. Unlike the Article 7 notification, SCIP has no tonnage threshold: any in-scope article placed on the EU market must be notified, which makes it the broader operational duty for most product companies. Both notifications are submitted through ECHA's systems and require structured data on articles and substances. Companies typically integrate SVHC data collection into their product lifecycle management so that notifications can be generated from the bill of materials rather than assembled manually. ## Authorisation: from Candidate List to Annex XIV The Candidate List is also the pipeline for authorisation. ECHA periodically recommends priority SVHCs for inclusion in Annex XIV, the Authorisation List, and the Commission decides. Each Annex XIV entry sets a sunset date after which the substance may not be placed on the market or used unless an authorisation has been granted for that use, plus an application deadline typically 18 months before the sunset date. Authorisation applications must demonstrate either that risks are adequately controlled or that the socio-economic benefits of continued use outweigh the risks and no suitable alternatives exist. Authorisations are use-specific and time-limited, with review periods, and holders must continue seeking substitutes. The policy goal is progressive substitution: authorisation is a bridge, not a permanent permission. For article suppliers, Annex XIV matters mainly through the supply chain: if a substance used in components becomes subject to authorisation, suppliers may face reformulation, and the article producer must verify that upstream uses remain authorised or have been substituted. Monitoring the Authorisation List and ECHA's recommendations is part of substance stewardship. | Stage | Legal basis | Trigger and effect | |---|---|---| | SVHC identification | REACH Article 57 | Substance meets hazard criteria | | Candidate List | Article 59 | Communication duties apply from listing | | Article 33 communication | 0.1% w/w in articles | Inform recipients and consumers | | Article 7 notification | 0.1% w/w and 1 tonne/year | Notify ECHA | | SCIP notification | Waste Framework Directive | Notify database, no tonnage threshold | | Authorisation List | Annex XIV | Sunset dates, use requires authorisation | ## Managing SVHCs in practice Effective SVHC management starts with substance data. Companies should maintain a restricted substances list incorporating the Candidate List, require full material declarations or certified compliance statements from suppliers, and test high-risk materials and components on a risk basis. Each Candidate List update, typically in January and June, should trigger a review of bills of materials and supplier declarations. Contracts should oblige suppliers to disclose Candidate List substances above 0.1 percent, notify the buyer of formulation changes and provide the data needed for SCIP notifications. Verification testing focuses on known SVHC applications: phthalates in plastics, flame retardants in electronics, chromium VI in leather and metal coatings, and borates in various applications, among others. Substitution is the strategic response. Where an SVHC is identified in the product, assess alternatives early, because Candidate List substances frequently progress toward restriction or authorisation. Designing out SVHCs before they are regulated avoids the cost and disruption of forced reformulation under a sunset deadline. ## Frequently asked questions How do I know if my product contains an SVHC? Map the bill of materials against the current Candidate List, obtain substance declarations from suppliers for components and materials, and verify high-risk items by testing. Repeat the exercise after each Candidate List update. Does the 0.1 percent threshold apply to the whole product or each part? The threshold applies to each article as supplied, which for complex products means each component article. Assess components individually against the 0.1 percent limit. What must I tell a consumer who asks about SVHCs? Whether the article contains any Candidate List substance above 0.1 percent, with the substance name and safe use information, within 45 days and free of charge. Have a documented process for these requests. What is the difference between the Candidate List and the Authorisation List? The Candidate List identifies SVHCs and triggers communication and notification duties. The Authorisation List (Annex XIV) contains a subset with sunset dates after which use requires an authorisation. All Annex XIV substances were Candidate List substances first. Do SVHC duties apply to imported articles? Yes. Importers of articles have the same Article 33, Article 7 and SCIP duties as EU manufacturers. The obligations follow the product placed on the EU market. Can an SVHC be removed from the Candidate List? Listings are reviewed as science evolves, and substances can be removed where the basis no longer holds, though this is uncommon. More often, substances progress from the Candidate List to restriction or authorisation. ## Sources - EU chemicals policy overview - EU Safety Gate rapid alert system - EU market surveillance framework