SVHC Candidate List: Substances of Very High Concern and REACH Obligations

What is the SVHC Candidate List?

The Candidate List (formally "List of substances of very high concern proposed for inclusion in Annex XIV") is the official list published by ECHA (European Chemicals Agency) that collects all substances identified as SVHC (Substances of Very High Concern) pursuant to Art. 57 of the REACH Regulation (EC) 1907/2006.

The SVHC identification process follows the procedure set out in Art. 59 REACH: an EU Member State or ECHA itself prepares an identification dossier (Annex XV dossier) documenting the hazardous properties of the substance. The dossier is submitted for a 45-day public consultation, during which third parties (industry, NGOs, other authorities) can submit comments. If no comments contesting the identification are received, ECHA directly includes the substance in the Candidate List. If objections are raised, the decision is referred to the Member State Committee (MSC): if the MSC reaches unanimity, the substance is added; in case of disagreement, the final decision rests with the European Commission.

As of February 2026, the Candidate List contains over 240 substances, with a steady growth trend since its establishment in 2008. ECHA typically updates the list twice a year (January and July), with additions ranging from 2 to 10+ substances per cycle. The latest additions include new endocrine disruptors, bisphenols, and fluorinated substances.

SVHC Identification Criteria: Art. 57 REACH

To be identified as an SVHC, a substance must meet at least one of the criteria defined in Art. 57 of the REACH Regulation:

CMR — Carcinogenic, Mutagenic, or Reprotoxic Substances (Art. 57(a), (b), (c))

Substances classified as carcinogenic (category 1A or 1B according to CLP), germ cell mutagenic (category 1A or 1B) or toxic for reproduction (category 1A or 1B) are automatically eligible for identification as SVHCs. The CMR classification is based on Annex VI of the CLP Regulation (EC) 1272/2008, where substances with harmonized classification in these categories are systematically considered for inclusion in the Candidate List.

Category 1A indicates substances with clear evidence of CMR effects in humans (epidemiological data), while category 1B indicates substances presumed to be CMR in humans (animal data). Both categories meet the SVHC criterion, unlike category 2 (suspected), which does not automatically qualify.

PBT — Persistent, Bioaccumulative, and Toxic Substances (Art. 57(d))

Substances that simultaneously meet the three criteria in Annex XIII of REACH are identifiable as SVHCs:

• Persistence (P) — Degradation half-life greater than 40 days in freshwater, 120 days in soil, 120 days in freshwater sediment, or 60 days in marine water
• Bioaccumulation (B) — Bioconcentration factor (BCF) greater than 2,000 L/kg in aquatic organisms
• Toxicity (T) — NOEC less than 0.01 mg/L for marine or freshwater organisms, or CMR classification cat. 1A/1B or 2, or chronic toxicity tests

vPvB — Very Persistent and Very Bioaccumulative Substances (Art. 57(e))

vPvB substances meet even more stringent criteria: half-life greater than 60 days in freshwater or marine water, or 180 days in sediment or soil (very persistent), and BCF greater than 5,000 L/kg (very bioaccumulative). The toxicity criterion is not required for these substances, because the combination of very high persistence and bioaccumulation is considered sufficient cause for concern in itself.

Substances of Equivalent Concern — Art. 57(f)

Art. 57(f) is an open clause that allows the identification of SVHCs for substances with properties of equivalent concern to the above criteria, assessed on a case-by-case basis. This provision has been used to include the following in the Candidate List:

• Endocrine disruptors — Substances that alter the hormonal system with adverse effects on human health or the environment (e.g., bisphenol A, various phthalates, 4-tert-octylphenol)
• Respiratory sensitisers — Substances that can induce occupational asthma or severe respiratory allergies (e.g. certain diisocyanates)
• Substances with a combination of hazardous properties — Substances that, although not individually meeting the PBT criteria, have overall hazard profiles that are equivalent

Legal obligations arising from inclusion in the Candidate List

The inclusion of a substance in the Candidate List generates a series of immediate legal obligations for all operators in the supply chain. These obligations take effect on the day of publication and do not provide for any transition periods.

REACH Article 33: Communication in the Supply Chain for Articles

The supplier of an article containing a Candidate List substance in a concentration above 0.1% weight/weight (w/w) must provide the recipient with sufficient information to enable the safe use of the article, including at least the name of the substance. This communication must take place automatically (without request) throughout the B2B chain.

In addition, upon request by a consumer, the same information must be provided free of charge within 45 days of receipt of the request (Art. 33, paragraph 2). The 0.1% threshold applies to each sub-article or component of a complex article, not to the article as a whole (CJEU judgment C-106/14 of September 10, 2015, known as the "O2 (Germany)" judgment).

Art. 7(2) REACH: Notification to ECHA for Articles

Producers and importers of articles must notify ECHA if an article contains a substance on the Candidate List in a concentration above 0.1% w/w and if the total quantity of the substance in all articles produced/imported exceeds 1 ton/year per producer or importer. The notification must be made within 6 months of inclusion in the Candidate List.

Art. 31 REACH: Updating Safety Data Sheets

When a substance in a mixture is identified as an SVHC, Section 15 of the Safety Data Sheet (SDS) must be updated to reflect the new status. If the SVHC substance is present above specific thresholds, it may be necessary to provide an SDS even when not previously required (Art. 31(3)(b)).

Art. 34 REACH: Obligation to Communicate New Information

Any actor in the supply chain who becomes aware of new information on the hazardous properties of a substance (including identification as an SVHC) must communicate this information up and down the supply chain.

SCIP Database: Notification of Articles Containing SVHCs

As of January 5, 2021, the Waste Framework Directive (2008/98/EC, Art. 9(1)(i)) requires suppliers of articles containing substances on the Candidate List in concentrations above 0.1% w/w to notify this information to ECHA's SCIP (Substances of Concern In articles as such or in complex objects (Products)) database.

The SCIP database was designed to ensure that information on the presence of SVHCs in articles is available throughout the entire product life cycle, including the waste phase, to support recycling and the circular economy. The SCIP notification requires detailed information:

• Article identification — Name, trade identifiers, product classification
• SVHC substance present — Name, EC/CAS number, concentration range
• Article category — According to the European Article Category System (EuPCS) or TARIC
• Location of the substance — In which component of the complex article is the SVHC present
• Instructions for safe use and disposal

kemXpro facilitates the preparation of SCIP notifications by automatically generating the necessary data from the product composition registered in the system, structuring it in the format required by ECHA.

From the Candidate List to Annex XIV: The Authorization Path

Inclusion in the Candidate List is the first step towards Annex XIV (Authorization List). ECHA periodically publishes recommendations for transferring substances from the Candidate List to Annex XIV, based on prioritization criteria:

• Intrinsic properties — PBT/vPvB and CMR substances have higher priority
• Volumes — High quantities of production/import in the EU
• Widespread dispersive use — Substances used in consumer applications or with high diffuse exposure

Once included in Annex XIV, the use of the substance is prohibited after a specific sunset date, unless the user obtains an authorization from the European Commission. The authorization process requires demonstration that the risks are adequately controlled or that the socioeconomic benefits outweigh the risks, and must include an analysis of alternatives and a substitution plan.

Automatic SVHC Screening with kemXpro

kemXpro offers automated and continuous screening of formulations and articles against the SVHC Candidate List:

Cross-Referencing of Formulations

Each substance present in the formulations registered in kemXpro is automatically cross-referenced with the Candidate List by CAS number, EC number, and chemical name. The system takes into account actual concentrations to determine whether regulatory thresholds are exceeded (0.1% w/w for Art. 33, total quantities for Art. 7(2)). Screening is automatically repeated with each update of the Candidate List.

Tracking the Composition of Articles

For companies that manufacture or import articles, kemXpro allows you to track chemical composition throughout the supply chain, linking supplier declarations to monitored substances. The system automatically calculates whether the concentration of SVHCs in the final article exceeds the 0.1% w/w threshold.

Real-Time Alerts on New Additions

When ECHA publishes an update to the Candidate List, kemXpro immediately performs a complete re-screening of the portfolio. If a new SVHC is present in your formulations or articles, you receive an immediate alert with:

• List of affected products with concentrations and volumes
• Specific obligations triggered (Art. 33, Art. 7(2), SCIP, SDS update)
• Regulatory deadlines and notification deadlines
• Link to the ECHA dossier of the substance for technical details

Substitution planning

kemXpro does not just monitor: it actively supports the planning of SVHC substance substitution. The substitution module allows you to:

• Identify alternatives — Search the database of non-SVHC substances with comparable functional properties
• Assess feasibility — Analyze technical compatibility and impact on end-product performance
• Track progress — Replacement timeline with milestones and responsible parties
• Document the process — Generate reports for authorities demonstrating your commitment to substitution, as required in authorization applications

Reporting and Compliance Documentation

kemXpro automatically generates the documentation needed to demonstrate compliance with Candidate List obligations:

• Art. 33 Report — Pre-filled communications for customers and consumers on the presence of SVHCs in articles, with substance, concentration, and instructions for safe use
• SCIP notification preparation — Export of data in the format required for the ECHA SCIP database
• Art. 7(2) Report — Documentation for notification to ECHA, including aggregate volume calculations
• Complete audit trail — History of all checks, alerts, and actions taken, with timestamp and operator
• Reports for inspections — Documentation exportable to PDF, ready for national inspection authorities