SVHC and the 0.1% threshold: how to calculate the concentration per article

In brief

• An SVHC (substance of very high concern) on the ECHA Candidate List is not banned: it triggers information obligations as soon as its concentration exceeds 0.1% weight by weight in an article.
• This threshold is assessed article by article, never on the total mass of the product delivered. A 200 g seal containing 0.25% SVHC is above the threshold, even if the complete assembly shows 0.003%.
• The Candidate List has had 253 entries since 4 February 2026 and is revised twice a year: an undated supplier declaration offers no protection.
• Three obligations apply cumulatively above the threshold: Article 33 information (response within 45 days to a consumer), notification to ECHA under Article 7(2) if the total quantity exceeds 1 t/year, and SCIP notification, with no tonnage condition.
• This guide sets out the 4-step calculation method, a full worked example on an industrial assembly, the 8-criterion checklist for a valid supplier SVHC declaration , and a 10-point control grid.

1. SVHC, Candidate List, Article 33: three notions not to be confused

An SVHC, or substance of very high concern, is a substance identified by ECHA as potentially having serious and lasting effects on health or the environment, and included on the Candidate List for that reason. Inclusion does not amount to a ban: it creates an information obligation in the supply chain and, eventually, a possible move to authorisation.

Three terms underpin the whole subject:

• Candidate List: the reference list published by ECHA, which identifies the substances of very high concern that are candidates for authorisation. It is an evolving list, not a fixed text.
• Article: an object which, during production, is given a special shape, surface or design which determines its function to a greater degree than its chemical composition (Article 3(3) of the REACH Regulation). A seal, a cable, a housing and a screw are all articles.
• Article 33: the article of Regulation (EC) No 1907/2006 that organises the communication of information on SVHCs contained in articles (consolidated text on EUR-Lex).

The operational consequence is simple to state and difficult to maintain: no conclusion can be reached on a product without having reached a conclusion on each of its articles. This is where most dossiers become fragile, because supplier data arrive at the level of the product purchased, whereas the obligation is triggered at component level.

2. What the Candidate List contains and how it evolves

The Candidate List groups substances meeting at least one of the following criteria:

• carcinogenic, mutagenic or toxic for reproduction, category 1A or 1B;
• persistent, bioaccumulative and toxic (PBT);
• very persistent and very bioaccumulative (vPvB);
• equivalent level of concern (endocrine disruptor, respiratory sensitiser, persistent, mobile and toxic substance).

253 entries since 4 February 2026

The list has had 253 entries since 4 February 2026, the date on which ECHA added, among others, n-hexane and bisphenol AF and its salts (official Candidate List, information note from the French national REACH regulatory helpdesk).

A count in entries cannot be compared with a number of substances: an entry may group several salts, isomers or forms. In practice, you therefore work not with names but with identifiers: CAS number, EC number, and the exact name of the entry.

A twice-yearly revision that shifts the scope

ECHA updates the list twice a year, generally at the beginning and in the middle of the year. Each revision can bring in a substance already present in your articles, without any of your suppliers having changed their formulation. In other words, a dossier that is compliant in January can become incomplete in February, without any change in production.

Three dates must therefore be tracked in your document management system:

Without this third date, you can prove that you collected documents, but not that you were up to date.

3. The three obligations triggered by the 0.1% w/w threshold

As soon as an SVHC exceeds 0.1% weight by weight in an article, three distinct obligations are triggered. They do not replace one another. Each relies on distinct evidence, presented in the table of evidence and its limitations in our supplier REACH guide.

Article 33: inform, proactively and then on request

For a professional recipient, the information is proactive: it accompanies the article, states at least the name of the substance and provides the available information allowing safe use. For a consumer, it is reactive: the supplier must respond free of charge within 45 days of receipt of the request, without requiring proof of purchase (communication in the supply chain – ECHA).

Article 7(2): the only obligation subject to tonnage

Notification to ECHA only applies above 1 tonne per year of the substance, cumulated across all articles produced or imported. This tonnage threshold does not exempt from Article 33 or from SCIP: a company that remains below one tonne still owes the information.

SCIP and the French AGEC statement

SCIP notification is made per article concerned, with no quantity condition, and does not exempt from any other obligation. In France,Article L. 541-9-1 of the Environmental Code (AGEC law) adds consumer information on the presence of hazardous substances, with its own scope criteria and a six-month deadline after identification. Three different deliverables may therefore be required for the same article (official FAQ on Article 13-I of the AGEC law). The SCIP notification per article concerned follows its own dossier preparation method.

4. Calculating the threshold per article: the 4-step method

The threshold is a ratio of mass of substance to mass of the article, expressed as a percentage by weight (% w/w). It is calculated in four steps, in this order.

Step 1 – Break the product down into articles

Identify each object whose shape, surface or design determines its function. An industrial assembly is itself an article, but it contains other articles: the calculation is carried out at each relevant level, and the breakdown must be written down, diagrammed and justified.

A point of method that is often overlooked: the " once an article, always an article " interpretation – a component that is already an article before assembly remains one – was confirmed by the Court of Justice of the EU (judgment of 10 September 2015, Case C-106/14, FCD and FMB), which set aside the interpretation previously adopted by the Commission and in ECHA's guidance; ECHA has since updated its guidance accordingly. The breakdown adopted must therefore cite the reference and version of the guidance on which it is based (guide for suppliers of articles – INERIS).

Step 2 – Weigh each article

The reference mass is that of thearticle, not that of the product delivered. A 200 g seal, a 12 g screw, a 1,500 g belt. Where the mass is not known, it is estimated from the material and volume, and the estimate is documented.

Step 3 – Calculate the mass of substance

Mass of substance (g) = mass of the article (g) × concentration of the substance in the article (%)

Two pitfalls: the concentration to use is that in the finished article, not in the raw material purchased; and units must be consistent (g, mg, kg) before any comparison.

Step 4 – Compare with the threshold

Threshold (g) = mass of the article (g) × 0.1%

If the mass of substance exceeds this value, the article is above the threshold for that substance.

Worked example: PD-25 gravimetric dosing station

Illustrative example, constructed for the exercise: an assembly of 18,600 g, produced at 1,200 units per year, made up of seven articles.

Three lessons.

1. The finished product appears compliant. Total DEHP in the unit is 2.10 g, i.e. 0.011% of the 18,600 g; D4 represents 0.003%; lead 0.015%. Calculated on the product delivered, no exceedance appears. Yet three articles exceed the threshold.
2. The threshold is decided on light articles. The 200 g seal accounts for 1% of the assembly, but its 0.50 g of D4 is enough: 0.25% against a threshold of 0.1%. The lighter the article, the smaller the quantity of substance needed to tip the conclusion.
3. An SVHC can be present without exceeding the threshold. The bisphenol A in the window is indeed a listed substance, but at 0.02%: no obligation is triggered by this component. Declaring "SVHC present" without distinguishing this case produces unnecessary declarations, which end up being ignored.

What this calculation triggers, obligation by obligation:

• Article 33(1): inform professional recipients of the presence of DEHP in the belt, D4 in the seal and lead in the fasteners, with the information for safe use.
• Article 33(2): respond to any consumer request within 45 days, free of charge.
• Article 7(2): DEHP 2.10 g × 1,200 = 2.52 kg/year; D4 0.60 kg/year; lead 3.40 kg/year. All well below 1 t/year: no notification is required. It would take around 476,000 units per year to reach one tonne of DEHP.
• SCIP: notification is mandatory for the three articles concerned, with no tonnage condition.
• AGEC: if the station falls within the scope of waste-generating products, specific consumer information must be provided.

5. Why calculating on the finished product is such a common mistake

Four mechanisms explain this mistake, and none of them is a lack of individual rigour:

1. Reassuring dilution. The heavier the assembly, the lower the average concentration appears. Calculating on the finished product mechanically produces a "compliant" result, so nobody questions it.
2. The spreadsheet by commercial reference. Purchasing information systems reason in terms of references sold, not technical bills of materials. Yet it is the bill of materials that contains the articles.
3. Supplier data arrive at the wrong level. A sub-assembly supplier often declares on its product without detailing its components. The information exists, but not at the useful level of granularity. The same flaw affects mixtures, whose exposure scenarios and operational conditions are rarely compared with actual use.
4. The definition of the article is assumed, never written down. Without a documented breakdown, everyone implicitly applies their own: the calculation cannot be reproduced from one campaign to the next.

What this costs. Missing Article 33 information is an enforceable non-compliance, which generally comes to light through the customer, not through an internal check. A SCIP notification not submitted for an article that is concerned weakens the entire dossier, as it suggests that the breakdown has not been done. And industrially, the late discovery of an SVHC in a critical component triggers a costly sequence: requalification, search for an alternative, customer validation, sometimes a review of approved-supplier status. The cost is not the calculation: it is the reaction time.

6. What a valid supplier SVHC declaration must contain: 8 criteria

A supplier SVHC declaration only has evidential value if it is structured. Eight criteria are enough to distinguish a usable document from a comfort certificate.

1. The article identified at the right level: reference, description and breakdown level (component or sub-assembly), with the corresponding mass.
2. The mass of the article in grams or kilograms, stated explicitly.
3. The substances named with CAS number and EC number, without ambiguous wording such as "listed substances". They must match section 3 of the safety data sheet where the supplier holds one.
4. The concentration in% w/w in the article, not in the raw material or mixture purchased.
5. The calculated mass of substance and the explicit comparison with the 0.1% threshold for the article.
6. The version of the Candidate List used (for example: 253 entries, version of 4 February 2026).
7. The date, name and position of the signatory, and the commitment to notify any change in formulation or any new inclusion.
8. The nature of the data: declarative, calculated or analytical (with method and limit of detection), and the recipient's language.

A declaration that meets these eight points can be challenged on its content, but not on its form. An undated "SVHC-free" declaration, with no mass or list version, proves nothing and creates a false sense of security.

7. Collecting and updating: the twice-yearly method

1. Map the articles placed on the market: reference, mass, supplier, import status, destination market. The objective: centralise supplier and product data in a single article database.
2. Freeze the reference version of the list for the campaign (date and number of entries).
3. Send a structured questionnaire, built on the 8 criteria above, rather than a free-form email.
4. Follow up according to a written rule: two reminders at fixed intervals, a technical contact as a second channel, a documented contractual consequence.
5. Cross-check sources for critical articles: declaration, SCIP dossier, available SDS, test report.
6. Rerun the calculation at each revision of the list, and at each change of formulation, site or subcontractor.

A reference database not reviewed for more than a year is behind by at least two revisions. This is the most frequent finding in compliance reviews, and the easiest to correct with a schedule.

8. 10-point control checklist

1. Up-to-date inventory of articles with mass and destination market.
2. Breakdown into articles documented with a diagram and a justification, reference guidance cited.
3. Dated version of the Candidate List for the last campaign (253 entries as of 4 February 2026).
4. 0.1% w/w calculation sheet per article: mass, concentration, mass of substance, threshold.
5. Supplier declarations dated, signed, with CAS, EC, concentration and list version.
6. Article 33 information available for each article above the threshold.
7. Consumer response procedure within 45 days, with a register of requests.
8. Assessment of annual tonnage per SVHC and comparison with 1 t/year for Article 7(2).
9. SCIP dossiers submitted, consistent with internal calculations.
10. Review scheduled at each twice-yearly revision and at each supplier change.

Further reading: the REACH topic cluster

This guide explores a specific point of the pillar guide on supplier REACH compliance, which covers the allocation of responsibilities in the supply chain, Annexes XIV and XVII and the table of evidence.

• Service page: REACH compliance support: scoping the article portfolio, supplier data collection, control and ongoing management.

Tracklab's role in this process

Calculating the threshold, interpreting the regulation and deciding on compliance remain the responsibility of the Quality, Regulatory, Purchasing, R&D and HSE teams. What is difficult to sustain over time is the documentary mechanics: hundreds of references, masses, concentrations, list versions and deadlines that shift twice a year.

Tracklab is a platform for the centralised management of supplier and product data, specialised for the manufacturing and food industries. It centralises supplier and product data, automates document collection, uses AI to extract the critical data contained in documents, links evidence to the articles concerned and tracks renewal deadlines. Calculating the threshold and making the final decision remain your decisions; traceability and follow-up are no longer an annual project.

Official sources

• Regulation (EC) No 1907/2006 (REACH), consolidated text – EUR-Lex
• Candidate List of substances of very high concern – ECHA
• Obligations arising from inclusion on the Candidate List – ECHA
• Communication in the supply chain (Article 33) – ECHA
• SCIP database – ECHA
• SVHCs and articles – French national REACH regulatory helpdesk (INERIS)
• Guide for suppliers of articles – INERIS
• FAQ on Article 13-I of the AGEC law – French Ministry for the Ecological Transition