What is a Substance of Very High Concern (SVHC)?

A Substance of Very High Concern (SVHC) is a chemical the EU has formally identified as especially harmful. Under the REACH Regulation, a substance can be an SVHC because it causes cancer, damages DNA or harms fertility, because it persists and builds up in the environment, or because it causes an equivalent level of concern, such as disrupting hormones.

When a substance is identified as an SVHC, the European Chemicals Agency (ECHA) adds it to the Candidate List. From that day, companies that make, import or sell products containing it above 0.1% by weight have legal duties to tell their customers and, in many cases, ECHA.

How a substance becomes an SVHC

1. A proposal. A Member State or ECHA, at the Commission's request, prepares a dossier showing the substance meets one of the criteria in REACH Article 57.
2. Consultation. The proposal is published for public comment.
3. Agreement. ECHA's Member State Committee agrees the identification.
4. Inclusion. ECHA adds the substance to the Candidate List in one of its regular updates, usually about twice a year.

The criteria in Article 57 are:

• carcinogenic, mutagenic or toxic for reproduction (CMR, category 1A or 1B);
• persistent, bioaccumulative and toxic (PBT);
• very persistent and very bioaccumulative (vPvB);
• of equivalent concern, such as endocrine disruptors.

What it means for your products

For articles, meaning physical products such as clothing, electronics, furniture or toys, the key rules are:

• Inform your business customers (REACH Article 33(1)). If an article contains a Candidate List substance above 0.1% by weight, you must give recipients enough information for safe use, at least the substance name.
• Answer consumers (REACH Article 33(2)). A consumer can ask whether a product contains an SVHC. You must answer within 45 days, free of charge.
• Notify the SCIP database. Under the Waste Framework Directive, suppliers of such articles must notify ECHA's SCIP database.
• Notify ECHA (REACH Article 7(2)). Producers and importers must notify when the substance is above 0.1% in their articles and they handle more than one tonne of it per year, within six months of it being listed.

The 0.1% threshold applies to each article in a product, not to the product as a whole. The EU Court of Justice confirmed this in 2015 (Case C-106/14). A small SVHC-containing cable inside a large appliance can trigger the duty on its own.

Being on the Candidate List is not a ban. Later, a substance can move to the Authorisation List (REACH Annex XIV), or be restricted under Annex XVII. Some SVHCs are also restricted in specific products by other laws, such as RoHS for electrical and electronic equipment.

SVHCs and the Digital Product Passport

The Ecodesign for Sustainable Products Regulation (ESPR) treats Candidate List substances as substances of concern. Where a product group's delegated act requires it, the Digital Product Passport will show the substances of concern a product contains, where they are and in what concentration. This is meant to help repairers and recyclers handle products safely and keep harmful substances out of recycled materials.

How to prepare

1. Map your articles down to component level, not only the finished product.
2. Request SVHC declarations from suppliers for every component and material, against the latest Candidate List.
3. Re-check after each Candidate List update. New entries apply immediately, and suppliers need to confirm again.
4. Prepare a consumer response process so requests are answered within 45 days.
5. Keep evidence: dated supplier declarations and test reports for each article.