REACH SVHC — Hazardous Substance Declarations in Product Passports

What Is REACH?

REACH — Registration, Evaluation, Authorisation and Restriction of Chemicals — is the EU’s foundational chemicals regulation. Adopted as Regulation (EC) 1907/2006, it governs the manufacture, import, and use of chemical substances in the European Union. REACH places the burden of proof on industry: companies must demonstrate that the substances they use are safe, rather than regulators proving they are dangerous.

REACH applies to all chemical substances — not just those used in industrial processes, but those present in finished articles placed on the EU market. If your product contains chemical substances, REACH applies to you. There are no sector exemptions for consumer electronics, textiles, furniture, construction products, or any other manufactured good.

The European Chemicals Agency (ECHA) administers REACH from Helsinki. ECHA maintains the substance databases, manages registrations, conducts evaluations, and publishes the Candidate List of Substances of Very High Concern that is central to DPP compliance.

Substances of Very High Concern (SVHCs)

Article 57 of REACH defines SVHCs. These are substances that pose serious risks to human health or the environment. A substance qualifies as an SVHC if it meets one or more of the following criteria:

• Carcinogenic, mutagenic, or toxic to reproduction (CMR) — classified as Category 1A or 1B under Regulation (EC) 1272/2008 (CLP Regulation).
• Persistent, bioaccumulative, and toxic (PBT) — meets the criteria in Annex XIII of REACH.
• Very persistent and very bioaccumulative (vPvB) — also defined in Annex XIII of REACH.
• Equivalent concern — substances such as endocrine disruptors for which there is scientific evidence of probable serious effects to human health or the environment, identified on a case-by-case basis under Article 57(f).

SVHCs are not banned. Inclusion on the Candidate List triggers communication obligations. Inclusion on the Authorisation List (Annex XIV of REACH) triggers the requirement to obtain authorisation before use. These are distinct steps with different legal consequences.

The SVHC Candidate List

The Candidate List is ECHA’s register of substances identified as SVHCs. As of early 2026, it contains over 240 substances. ECHA updates the list twice per year — typically in January and June — adding new substances following a formal identification process under Article 59 of REACH.

Each addition to the Candidate List triggers immediate legal obligations for manufacturers and importers. There is no transition period. The moment a substance appears on the Candidate List, the Article 33 communication duty applies to every article on the EU market containing that substance above the 0.1% threshold.

This makes the Candidate List one of the most dynamic compliance obligations in EU product regulation. A product that was fully compliant yesterday can become non-compliant overnight if a substance it contains is added to the list. Manufacturers must monitor every update and re-evaluate their products against each new addition.

Article 33: The Duty to Communicate

Article 33(1) of REACH imposes a communication obligation on any supplier of an article containing an SVHC above 0.1% weight by weight (w/w). The supplier must provide the recipient with sufficient information to allow safe use of the article. At a minimum, the supplier must disclose the name of the SVHC present.

This obligation flows down the supply chain. If you are a manufacturer selling to a distributor, you must inform the distributor. If you are a distributor selling to a retailer, you must inform the retailer. The duty applies at every transaction where the article changes hands within the professional supply chain.

Article 33(2) extends this right to consumers. Any consumer may request SVHC information for any article. The supplier must respond within 45 days, free of charge. This consumer right to know has been in force since REACH entered into application in 2008 and is now being reinforced through Digital Product Passport requirements.

The 0.1% threshold applies at the article level, not the product level. For complex products made up of multiple articles (such as an electronic device with a circuit board, housing, cables, and battery), the threshold must be assessed for each individual article within the product. A product can contain an SVHC at less than 0.1% of total product weight but still trigger Article 33 if any individual component exceeds the threshold.

How SVHC Declarations Connect to the Digital Product Passport

The Ecodesign for Sustainable Products Regulation (ESPR) — Regulation (EU) 2024/1781 — requires Digital Product Passports to include information on substances of concern. Article 7(5)(b) of the ESPR specifies that the DPP must contain data on “substances of concern” present in the product, referencing both REACH and the CLP Regulation (Regulation (EC) 1272/2008).

This is a significant expansion of existing obligations. Under REACH alone, SVHC information flows only through the supply chain and to consumers upon request. Under the ESPR, this information must be embedded in a machine-readable Digital Product Passport that is permanently linked to the product and accessible via a data carrier such as a QR code.

The ESPR goes further than REACH in two ways. First, it may require disclosure of substances of concern beyond SVHCs — the term “substances of concern” in the ESPR is broader and may include substances restricted under other regulations. Second, the DPP must provide this information in a structured, standardised format that enables automated processing, not just the free-text disclosures that Article 33 of REACH currently permits.

Delegated acts under the ESPR will specify exactly which substance data must appear in the DPP for each product category, including whether detailed concentration data is public or restricted to persons of legitimate interest under Article 10.

The Battery Regulation Connection

The Battery Regulation (Regulation (EU) 2023/1542) provides the first live example of SVHC data in a Digital Product Passport. Annex XIII, Category D, requires the battery passport to declare:

• Mercury content (Article 6 compliance).
• Cadmium content (Article 6 compliance).
• Lead content (Article 6 compliance).
• Any SVHC present in the battery above 0.1% w/w, identified by name and CAS number.

This is not future legislation. The battery passport obligation applies from 18 February 2027 for all industrial and electric vehicle batteries with a capacity above 2 kWh. Manufacturers placing these batteries on the EU market must include SVHC declarations in the battery passport from that date.

The Battery Regulation demonstrates how DPP substance declarations will work in practice: specific substances are called out by name, concentrations are declared against defined thresholds, and the data is structured for machine readability. Other product categories under the ESPR will follow the same pattern.

The SCIP Database

ECHA’s SCIP database — Substances of Concern In articles as such or in complex objects (Products) — has been mandatory since 5 January 2021. It was established under Article 9(1)(i) of the Waste Framework Directive (Directive 2008/98/EC, as amended by Directive (EU) 2018/851).

SCIP requires any supplier placing an article on the EU market that contains an SVHC above 0.1% w/w to notify ECHA. The notification must include the article identity, the SVHC name and concentration range, the article category, and instructions for safe use. The SCIP database is publicly accessible and currently contains millions of notifications.

The relationship between SCIP and the Digital Product Passport is a key question. The Commission has indicated that the DPP should, where possible, reduce or replace overlapping reporting obligations. If a product’s DPP already contains structured SVHC data in a format accessible to waste treatment operators, the separate SCIP notification may become redundant.

However, until the Commission formally addresses this overlap, both obligations remain in force. Manufacturers must continue to submit SCIP notifications AND prepare to include substance of concern data in their Digital Product Passports. Maintaining a single source of truth for SVHC data — as Traceable’s platform enables — is essential for managing this dual obligation efficiently.

What Manufacturers Must Do

SVHC compliance for Digital Product Passports requires a systematic approach across four domains: identification, tracking, declaration, and maintenance.

Identification

You must know what is in your products at the substance level. This requires full material declarations from every supplier in your chain. For each component, you need to know the substances present and their concentrations. Relying on assumptions or generic material data is insufficient — the 0.1% threshold requires precise knowledge.

Analytical testing (XRF screening, ICP-MS, GC-MS) may be necessary where supplier declarations are unavailable or unreliable. Testing is particularly important for components sourced from regions with less mature chemical management systems.

Tracking

Each product must be assessed against the current Candidate List at the time it is placed on the market. Because the Candidate List is updated twice per year, a product assessed in January must be re-assessed if it is still being placed on the market after the June update. Any new SVHC additions that are relevant to your product’s material composition trigger an immediate obligation to update your declarations.

Declaration

For the Digital Product Passport, SVHC data must be structured in the format specified by the applicable delegated act. This typically means: substance name, CAS number (Chemical Abstracts Service registry number), EC number, concentration range, location within the product (which component or article contains the substance), and a reference to safe use information.

Maintenance

DPP substance data must remain accurate throughout the product’s lifecycle. If a new SVHC is added to the Candidate List that is present in products already on the market, the DPP must be updated. The ESPR requires that DPP data be kept current for the entire period the product is on the market and, potentially, for a defined period after end-of-life.

Supply Chain Data Collection

SVHC compliance depends entirely on supply chain transparency. You cannot declare what you do not know. Collecting substance data from suppliers is the single most challenging aspect of SVHC compliance for most manufacturers.

Industry-standard formats for material declarations include:

• IPC-1752A — the standard material declaration format widely used in the electronics industry.
• Full Material Declaration (FMD) — a complete disclosure of all substances in a component, including those not currently on any restricted or candidate list.
• IMDS (International Material Data System) — the automotive industry’s standard for material data exchange.
• SCIP notification data — if your supplier has already submitted SCIP notifications, that data can serve as a starting point for your DPP substance declarations.

The critical requirement is to obtain data at the article level, not just the product level. For a complex product with 50 components, you need substance data for each individual component. The 0.1% threshold is assessed per article, so aggregating at the product level masks the true SVHC profile.

Contractual requirements are essential. Your supplier agreements should mandate timely disclosure of substance information, including updates when formulations change or new SVHCs are identified. Without contractual teeth, supplier data requests often go unanswered.

Thresholds and Calculations

The 0.1% w/w threshold is deceptively simple to state and complex to apply. Several clarifications are essential.

The threshold applies to each SVHC individually. If a product contains three different SVHCs each at 0.08%, none triggers the threshold individually, and no declaration is required for any of them — even though the combined SVHC content is 0.24%.

The threshold is assessed at the article level. The European Court of Justice confirmed this in Case C-106/14 (FCD and FMB v. Ministre de l’Ecologie), ruling that the 0.1% threshold applies to each article within a complex product, not to the complex product as a whole. A laptop may weigh 2 kg, but if a 5-gram capacitor within it contains an SVHC at 0.15% of the capacitor’s weight, the threshold is triggered for that capacitor.

Weight by weight means mass fraction. It is the mass of the SVHC divided by the total mass of the article in which it is present. It is not based on volume, surface area, or molar concentration.

For the Digital Product Passport, the delegated act may specify additional granularity — for example, requiring concentration ranges (e.g., 0.1%-0.5%, 0.5%-1%, >1%) rather than exact concentrations, to balance transparency with the protection of proprietary formulation data.

Penalties for Non-Declaration

Enforcement of SVHC obligations under REACH is a Member State responsibility. Each EU Member State designates national competent authorities and defines penalties in its own legislation. This means penalties vary across the EU, but they are uniformly serious.

Common enforcement actions include:

• Fines — ranging from tens of thousands to millions of euros depending on the Member State and the severity of the violation. Germany, France, and the Netherlands have imposed significant fines for REACH non-compliance.
• Product withdrawal — market surveillance authorities can order the withdrawal of non-compliant products from the market under Regulation (EU) 2019/1020.
• Import refusal — customs authorities can refuse entry to products that do not meet REACH requirements, including SVHC communication obligations.
• Criminal liability — some Member States classify serious REACH violations as criminal offences, carrying potential imprisonment for responsible individuals.

Under the ESPR, additional penalties apply for DPP non-compliance. Article 68 of Regulation (EU) 2024/1781 requires Member States to establish “effective, proportionate and dissuasive” penalties for infringements. Failing to include required substance of concern data in a Digital Product Passport constitutes an ESPR infringement independent of REACH enforcement.

The practical risk extends beyond fines. A product passport that omits required SVHC declarations is a non-compliant DPP. A non-compliant DPP means a non-compliant product. A non-compliant product cannot legally be placed on the EU market. The commercial consequence — loss of market access — is often more significant than the fine itself.

How Traceable Helps with SVHC Compliance

Traceable’s platform integrates SVHC management directly into the Digital Product Passport workflow. The platform maintains a synchronised copy of the ECHA Candidate List and automatically cross-references it against the material composition data in each product passport.

When ECHA updates the Candidate List, Traceable alerts manufacturers whose products contain newly listed substances. The platform identifies affected products, calculates whether the 0.1% threshold is exceeded at the article level, and flags the DPPs that require updates. This eliminates the manual monitoring burden that makes Candidate List compliance so error-prone.

For supply chain data collection, Traceable provides standardised templates that suppliers can complete directly, with validation rules that ensure data completeness and accuracy. The platform supports IPC-1752A imports and can ingest existing SCIP notification data to pre-populate substance declarations.

The result is a single source of truth for substance of concern data that feeds both your DPP declarations and your SCIP notification obligations — maintained continuously against the live Candidate List.

This guide reflects the regulatory position as of March 2026. The ECHA Candidate List is updated twice per year, and ESPR delegated acts specifying substance of concern requirements for specific product categories are being adopted on a rolling basis. Subscribe to Traceable’s Regulatory Radar for alerts when new SVHCs are added to the Candidate List and when new delegated acts define substance disclosure requirements for your product categories.