• Regulatory Guide

REACH SVHC — Hazardous Substance Declarations in Product Passports

Last reviewed: August 2026 · PassoNext Team

Direct answer

REACH (Regulation 1907/2006) serves as the primary chemical control framework across the EU. When ECHA designates a chemical as a Substance of Very High Concern (SVHC), and it makes up over 0.1% of an article’s total weight, companies face mandatory REACH reporting duties to downstream buyers and consumers. Digital Product Passport frameworks approach chemical metrics from a distinct angle, rather than simply copying the REACH framework: Battery passports require full material sets to be reported under Annex XIII point 1(b) instead of simple SVHC forms, and ESPR sector regulations define unique chemical tracking requirements for each product category. The SCIP portal is the central channel for SVHC filings, and passport profiles are taken straight from those same supplier records.

Key Takeaways
  • REACH compliance and battery passport disclosures run on distinct legal tracks rather than overlapping as a single requirement.
  • ​Under REACH, any vendor distributing an article containing a Substance of Very High Concern above 0.1% by weight incurs mandatory disclosure and reporting duties.
  • ​The battery passport requires complete material composition disclosures, capturing trace hazardous compounds beyond just mercury, cadmium, or lead (Annex XIII point 1(b)).
  • Because ECHA updates the SVHC Candidate List twice every year, all registered product disclosures must be continuously revised.
  • ​Obtaining precise chemical data from upstream suppliers is essential to maintaining compliant declarations.
  • PassoNext maintains isolated input modules for REACH chemical entries alongside battery passport composition records to prevent confusion.

What Is REACH?

Adopted under Regulation (EC) 1907/2006, REACH, which stands for Registration, Evaluation, Authorisation of Chemicals, is the EU directive concerning the management and control of chemicals in the European region. REACH is the main regulation governing the production, import, and use of chemical substances in the European Union. This act requires that a company prove that the hazardous use of a particular chemical is not safe for business, not the state.

​REACH covers every chemical application across the market—including substances bound inside finished manufactured goods brought into the EU. Chemical compounds trigger immediate REACH obligations, regardless of your sector. No broad exemptions exist for consumer electronics, apparel, furniture, building materials, or other finished goods.

​The European Chemicals Agency (ECHA) oversees operations from Helsinki. ECHA operates central substance registries, processes corporate filings, executes technical evaluations, and publishes the official Candidate List of Substances of Very High Concern that underpins passport compliance.

​Substances of Very High Concern (SVHCs)

Article 57 of REACH specifies criteria for substances that should be included in the SVHC candidate list. These substances are dangerous chemical compounds that pose a significant risk to human beings or the environment. There are several criteria for substances to be included in the list of SVHC:

  • ​Carcinogenic, mutagenic, or toxic to reproduction (CMR) — designated as Category 1A or 1B hazards under Regulation (EC) 1272/2008 (the CLP Regulation).
  • Persistent, bioaccumulative, and toxic (PBT) — meets environmental hazard criteria defined in Annex XIII of REACH.
  • ​Very persistent and very bioaccumulative (vPvB) — meets extreme persistence criteria established in Annex XIII of REACH.
  • ​Equivalent concern — compounds like endocrine disruptors backed by scientific consensus showing probable, severe impacts on human health or wildlife, assigned on a case-by-case basis under Article 57(f).

Classifying a compound as an SVHC does not necessarily ban it. It is added to the Candidate List, and companies must communicate it through mandatory information exchanges. To move it to the Authorization List (Annex XIV of REACH), companies must apply for its authorization before using the substance on the market. These steps have different implications.

​The SVHC Candidate List

The Candidate List serves as ECHA’s master registry of confirmed SVHCs. Heading into 2026, the list contains more than 240 monitored compounds. ECHA expands this roster twice annually—typically in January and June—following formal evaluation procedures outlined in Article 59 of REACH.

Every newly listed substance triggers immediate compliance duties for importers and domestic manufacturers alike. The regulation provides no grace period. The moment ECHA adds a compound, Article 33 disclosure duties take effect for every article on the EU market containing that substance above the 0.1% threshold.

​Consequently, the Candidate List represents one of the most volatile compliance tracks in European product law. A product line that met every standard yesterday can turn non-compliant overnight following a single list update. Manufacturers must continuously monitor ECHA additions and re-verify their material inventories after every update.

​Article 33: The Duty to Communicate

Article 33(1) of REACH establishes a strict communication mandate for suppliers distributing articles containing an SVHC above 0.1% weight by weight (w/w). Vendors must provide downstream recipients with sufficient technical data to guarantee safe product handling, specifying the name of the SVHC at a minimum.

​This requirement cascades down every link of the commercial chain. Manufacturers selling to wholesale distributors must provide this data; distributors passing goods to retail stores must pass it along. The obligation triggers at every transaction point where an article changes hands in the professional market.

​Article 33(2) extends this transparency directly to end consumers. Any buyer can request SVHC disclosures for any retail item. Vendors must issue a comprehensive reply within 45 days without charging a fee. This consumer right-to-know has been enforced since REACH went live in 2008 and is now gaining additional enforcement momentum through Digital Product Passport systems.

The 0.1% threshold applies to individual articles, not to the overall composition of a product. If a complex product comprises various parts (e.g., a computer case, a circuit board, cables, and a battery in a laptop), the manufacturer has to calculate the mass percentage of SVHCs for each separate part. Therefore, an assembled product may contain a particular part in which the mass percentage of SVHCs is higher than 0.1%, thus subject to Article 33 requirements.

How SVHC Declarations Connect to the Digital Product Passport

The Ecodesign for Sustainable Products Regulation (ESPR) — Regulation (EU) 2024/1781 — mandates that Digital Product Passports incorporate disclosures on substances of concern. Article 7(5)(b) of the ESPR specifies that passports must record “substances of concern” embedded in the product, citing both REACH and the CLP Regulation (Regulation (EC) 1272/2008).

This represents a major shift from traditional requirements. Under standard REACH rules, SVHC disclosures move through internal supply channels and reach consumers only upon explicit request. The ESPR transforms this by embedding structured data directly inside a machine-readable passport, linked to the item via a physical data carrier like a QR code.

The ESPR extends beyond the requirements of REACH in two critical areas. Firstly, the reportable scope of restricted substances goes beyond the list of SVHCs. The ESPR defines substances of concern more broadly than those included in the candidate list. Secondly, passport systems require the data to be structured in standardized computer-read formats and accessible for database interrogation, which goes beyond the requirements of Article 33 regarding documentation and provision of information. The forthcoming delegated acts on the ESPR will provide detailed requirements for the type of information to be provided for each product category, ranging from disclosure of specific concentration metrics to confidentiality under Article 10.

The Battery Regulation Connection

​The Battery Regulation (Regulation (EU) 2023/1542) offers the first operational framework for integrating SVHC data into Digital Product Passports. Annex XIII point 1(b), combined with Annex VI Part A, mandates that battery passports explicitly report:

  • Mercury levels (Article 6 compliance).
  • ​Cadmium levels (Article 6 compliance).
  • ​Lead levels (Article 6 compliance).
  • ​Additional hazardous substances contained within the casing beyond mercury, cadmium, or lead (Annex VI Part A point 8), along with critical raw materials present above a 0.1% weight-by-weight concentration (Annex VI Part A point 10).

This framework takes effect as soon as a law is passed. Battery passport requirements apply to industrial and electric vehicle batteries with an energy content above 2 kilowatt-hours (kWh) from 18 February 2027. Producers and importers of large batteries entering the EU market must put comprehensive material composition information in the passport starting from the specified date per Annex XIII, point (b). The Battery Regulation does not include any language from REACH, so the phrase substance of very high concern is not present in Regulation (EU) 2023/1542.

The Battery Regulation shows how passport chemical logging works in practice: designated compounds are named explicitly, concentrations are measured against defined thresholds, and values are structured for automated digital processing. Future product categories regulated under the ESPR will adopt this exact operational structure.

​The SCIP Database

​ECHA’s SCIP platform—Substances of Concern In articles as such or in complex objects (Products)—became a legal requirement on 5 January 2021. The registry was established under Article 9(1)(i) of the Waste Framework Directive (Directive 2008/98/EC, as amended by Directive (EU) 2018/851).

​SCIP mandates that any vendor distributing an article in the EU containing an SVHC above 0.1% w/w must submit a formal filing to ECHA. Notifications must detail the article’s commercial identity, exact SVHC names, concentration ranges, primary product categories, and safe handling guidelines. The public SCIP portal currently hosts millions of active records.

Integrating SCIP notifications with Digital Product Passports remains an ongoing project. The European Commission has stated that passport systems should eliminate duplicate reporting requirements wherever possible. Once a product passport provides structured SVHC profiles accessible to waste handling operators, separate SCIP filings may become obsolete.

However, until the Commission issues a formal exemption, both requirements remain active law. Companies must submit required SCIP filings WHILE building out substance data for their product passports. Maintaining a unified chemical master file—such as the setup provided by PassoNext—is the most effective way to handle this dual requirement.

​What Manufacturers Must Do

Managing SVHC requirements for Digital Product Passports requires a clear process across four core areas: identification, tracking, declaration, and maintenance.

​Identification

​You must maintain exact material breakdowns down to the chemical level. Achieving this requires full material declarations (FMDs) from every tier of your supply network. For every component, you must document all embedded substances and their concentration levels. Relying on estimates or generic specs is a compliance risk—verifying the 0.1% threshold demands precise metrics.

​Where supplier records are missing or unverified, laboratory testing (using XRF screening, ICP-MS, or GC-MS) becomes necessary. Analytical testing is vital when working with suppliers operating in regions with looser chemical controls.

​Tracking

​Products must be evaluated against the current Candidate List at the exact time they are placed on the market. Because ECHA updates the list every six months, a product line validated in January must be re-screened if distribution continues past the June update. Any newly listed SVHC found in your product triggers an immediate obligation to update your public declarations.

​Declaration

​For passport compliance, SVHC entries must be formatted to match the standards established in the applicable delegated act. Standard fields include: chemical name, CAS registry number, EC number, concentration range, component location within the assembly, and handling guidelines for safe use.

​Maintenance

​Substance metrics inside product passports must remain accurate across the product’s entire market lifecycle. When ECHA adds a new chemical to the Candidate List that exists in items currently on store shelves, the corresponding passport records must be updated. The ESPR requires passport entries to remain live for as long as the product line is sold, plus a designated window after end-of-life.

​Supply Chain Data Collection

Accurate SVHC reporting depends on complete supply chain transparency. You cannot report details you have not verified. Gathering granular chemical disclosures from vendors remains the most challenging part of SVHC compliance for most manufacturers.
​Common industry reporting formats include:

  • ​IPC-1752A — the standard material declaration format widely used across the electronics sector.
  • ​Full Material Declaration (FMD) — complete reporting of every chemical present in a part, including unlisted or non-regulated compounds.
  • ​IMDS (International Material Data System) — the automotive industry’s shared platform for material tracking.
  • ​SCIP notification records — existing SCIP entries submitted by upstream suppliers can serve as an initial baseline for passport database records.

​The critical requirement is obtaining data per individual article rather than the overall product assembly. For a complex item containing 50 individual components, you must secure chemical profiles for every single component. Because the 0.1% limit is calculated at the component level, averaging mass across the entire product masks internal SVHC violations.

​Enforceable supply chain contracts are essential. Purchase agreements should require suppliers to disclose substance changes promptly and provide updates whenever ECHA adds new SVHCs. Without clear contractual mandates, suppliers often delay or ignore data requests.

Thresholds and Calculations

The 0.1% weight-by-weight (w/w) limit sounds simple on the surface, but applying it requires careful calculation.

​The 0.1% limit applies to each SVHC individually. If a component contains three separate SVHCs at 0.08% each, no individual substance triggers the reporting threshold, and no formal declaration is required for any of them—even though their combined weight reaches 0.24%.

​Calculations must be made at the individual article level. The European Court of Justice confirmed this standard in Case C-106/14 (FCD and FMB v. Ministre de l’Ecologie), ruling that the 0.1% threshold applies to every distinct article inside a complex assembly, not the assembly as a whole. For instance, in a 2 kg electronic device, if a single 5-gram internal capacitor contains an SVHC at 0.15% of that capacitor’s mass, the reporting duty triggers for that capacitor.

​Weight by weight measures mass fraction. It represents the mass of the specific SVHC divided by the total mass of the individual article containing it. It is not calculated using volume, surface area, or chemical concentration ratios.

For Digital Product Passports, specific delegated acts may dictate data resolution—such as requiring standardized concentration bands (e.g., 0.1%–0.5%, 0.5%–1%, >1%) instead of exact percentages, balancing market transparency with trade secret protection.

​Penalties for Non-Declaration

Enforcing REACH SVHC requirements is the responsibility of individual EU Member States. Each country designates national enforcement agencies and establishes its own penalty structures. While fines vary across borders, regulatory enforcement remains strict.

​Standard administrative and legal actions include:

  • ​Financial penalties — fines range from tens of thousands to millions of euros depending on the jurisdiction and severity of the violation. Regulatory bodies in Germany, France, and the Netherlands routinely impose heavy fines for REACH non-compliance.
  • ​Product recalls and sales bans — market surveillance authorities can mandate the immediate removal and recall of non-compliant goods under Regulation (EU) 2019/1020.
  • ​Customs rejections — border officials can deny entry to incoming shipments that fail to satisfy REACH documentation rules, including missing SVHC disclosures.
  • ​Criminal prosecution — several Member States treat severe REACH violations as criminal offences, exposing executive officers to potential prison sentences.

​The ESPR introduces additional penalties for passport non-compliance. Article 74 of Regulation (EU) 2024/1781 obligates Member States to establish “effective, proportionate and dissuasive” penalties for statutory violations. Publishing a Digital Product Passport that lacks mandatory substance declarations constitutes an ESPR violation independent of REACH enforcement.

The commercial risk extends well beyond government fines. A product passport missing required SVHC entries is legally invalid. An invalid passport renders the underlying product non-compliant, making it illegal to distribute or sell within the European Union. Losing market access presents a far greater financial threat than administrative fines.

​How PassoNext Helps with SVHC Compliance

​PassoNext embeds SVHC tracking directly into the Digital Product Passport creation process. The system maintains a synchronized copy of the official ECHA Candidate List and automatically evaluates listed compounds against the raw material records attached to each passport.

​Whenever ECHA updates the Candidate List, PassoNext automatically notifies manufacturers whose inventory contains newly flagged substances. The platform flags impacted items, calculates whether the 0.1% threshold is crossed at the component level, and highlights passports needing updates. This removes the manual oversight burden that leads to compliance errors.

​To simplify vendor management, PassoNext provides standardized intake forms that suppliers can complete directly, built with validation checks to catch incomplete entries. The platform processes IPC-1752A uploads and imports existing SCIP filings to populate passport records efficiently.

​This establishes a central, validated source of truth for chemical disclosures that powers both your passport declarations and your SCIP filings—kept synchronized against live ECHA updates.

​This guide reflects regulatory standards active as of March 2026. The ECHA Candidate List expands twice a year, and ESPR delegated acts specifying chemical tracking rules for individual product groups continue to roll out. Subscribe to PassoNext’s Regulatory Radar for instant alerts when ECHA adds new SVHCs or when new delegated acts introduce chemical rules for your product lines.

What This Means For Your Business

Hazardous substance logging represents one of the most data-intensive steps in passport compliance. You must identify every SVHC across your product line and track exact concentration levels down to individual components. Gathering this information from upstream suppliers often has the longest lead time in a compliance launch.

​Because the ECHA Candidate List updates every January and July, discovering a newly listed substance in your products requires updating your active passport records immediately.

Action Steps

  1. ​Request full chemical disclosures from every supplier across your supply chain.
  2. ​Audit all supplier records against the current ECHA Candidate List.
  3. ​Establish an internal process to review Candidate List updates every January and July.
  4. ​Populate required SVHC fields inside your master product passport template.
  5. ​Create a workflow to update live product passports whenever the Candidate List expands.
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Frequently asked questions

What is REACH and what are Substances of Very High Concern?

REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) is Regulation (EC) 1907/2006; Substances of Very High Concern (SVHCs) are described in Article 57 as substances which meet criteria such as carcinogenic, mutagenic or toxic to reproduction (Category 1A or 1B under CLP Regulation), persistent, bioaccumulative and toxic (PBT), very persistent and very bioaccumulative (vPvB) or of equivalent concern such as endocrine disruptors, identified on a case-by-case basis under Article 57(f).

Article 33(1) contains a communication obligation upon any supplier of an article containing an SVHC above 0.1% by weight; this means the supplier must provide enough information that allows the recipient to use the article safely, and at minimum must provide the name of the SVHC present. Article 33(2) grants consumers a corresponding right to request SVHC information for any article, and suppliers must respond within 45 days, free of charge.

The threshold is assessed against each SVHC individually, and at the article level (not the product level). In the case C-106/14 (FCD and FMB v. Ministre de l’Ecologie), the European Court of Justice ruled that for a complex product comprising multiple articles, the threshold must be assessed against each article in the product. A product may contain an SVHC at below 0.1% of total product weight, but Article 33 could still apply if any one of its components exceeds the threshold.

Article 7(5)(b) of the ESPR (Regulation (EU) 2024/1781) states that the Digital Product Passports shall contain information on substances of concern contained in the product, with reference to both REACH and the CLP Regulation. The Battery Regulation takes this one step further, as Annex XIII 1(b) stipulates that the battery passport shall declare the material composition, including any hazardous substances present apart from mercury, cadmium and lead, and the critical raw materials present. This shall apply from 18 February 2027 for in-scope batteries; mercury, cadmium and lead are covered by the marking requirements referenced at Annex XIII 1(q).

Not yet: the SCIP database, mandatory under Article 9(1)(i) of the Waste Framework Directive as of 5 January 2021, requires that any supplier that places on the EU market an article containing an SVHC (above 0.1% w/w) shall notify ECHA. The Commission indicated that the DPP should reduce or replace overlapping reporting obligations where possible, but until the Commission acts on this issue, both obligations remain due. Manufacturers shall continue to submit SCIP notifications and include information on substances of concern in their DPPs.

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