SVHC candidate list: the 0.1% rule and the duties each addition triggers

A Substance of Very High Concern is one that meets the criteria in Article 57 of REACH: carcinogenic, mutagenic or toxic for reproduction (CMR), persistent, bioaccumulative and toxic (PBT), very persistent and very bioaccumulative (vPvB), or of equivalent concern (e.g. endocrine disruptors). Once identified, it is added to the candidate list, which currently contains more than 240 entries and grows at every update cycle.

ECHA publishes updates in January and June. A substance moves onto the candidate list through an Annex XV dossier prepared by a Member State or ECHA, followed by a 45-day public consultation and a decision by the Member State Committee. Once on the list, it is a candidate for inclusion in Annex XIV (the authorisation list), which is the next escalation.

Checking one substance is easy. Checking a portfolio is where teams come unstuck, because the candidate list is published by substance identity and your risk sits in articles and mixtures several tiers down the supply chain.

1. Search by identifier, not name. Use the EC number or CAS number against ECHA's candidate list. Trade names and supplier synonyms will miss entries, and several SVHCs are group entries covering many CAS numbers.
2. Check group entries carefully. Entries such as the four-phthalate group or the lead compounds group cover substances that never appear under their own name in the list.
3. Calculate at the article level. The 0.1% w/w threshold applies to each article as produced or imported, not to the finished assembly. A component above 0.1% triggers duties even if it is a fraction of the whole product.
4. Ask suppliers in writing. Article 33 obliges your suppliers to tell you. A declaration that names the candidate list version it was checked against is worth far more than one that does not.
5. Re-run at every update. A clean portfolio in January can be non-compliant in June. The check is a standing job, not a one-off.

Automating that last step is the point of a REACH compliance platform: the list is monitored, your substance master is re-screened on publication day, and only the affected SKUs surface for action.

These three lists get used interchangeably and mean very different things commercially.

• Candidate list (SVHC). Identification only. You may still use and sell the substance, but communication, SCIP and notification duties apply.
• Annex XIV (authorisation list). Use is prohibited after the sunset date unless a specific authorisation has been granted. This is the one that removes a substance from your formulation.
• Annex XVII (restriction list). Conditions or bans on specific uses, applying to everyone, with no authorisation route.

A candidate list addition is therefore an early warning rather than a ban. The commercial value of tracking it is the lead time it buys you to reformulate before an Annex XIV sunset date makes the decision for you.

Nothing appears on the candidate list without a long, visible run-up. If you are monitoring the right stages you get roughly twelve to eighteen months of warning, which is the difference between planning a reformulation and scrambling through one.

1. Registry of Intentions. A Member State or ECHA declares an intention to prepare an Annex XV dossier. This is the earliest public signal, and the one most businesses ignore.
2. Annex XV dossier submitted. The dossier sets out the evidence that the substance meets one or more Article 57 criteria.
3. 45-day public consultation. Anyone can comment, including on uses and tonnages. This is your window to submit use and exposure information.
4. Member State Committee. If comments are received, the MSC seeks unanimous agreement. Where it cannot agree, the decision passes to the European Commission.
5. Inclusion decision and publication. ECHA publishes the updated candidate list, normally in January and in June.
6. Duties apply immediately. Article 33 communication applies from the date of inclusion, as does the SCIP notification duty for articles placed on the EU market.

An addition is not a filing exercise, it is a chain of dependent tasks with one hard deadline in it: the 45-day consumer response window under Article 33(2). This is the timeline that works.

Take a specialty formulator with 340 raw materials and 1,200 finished SKUs. A plasticiser used in a packaging component is added to the candidate list in the June update.

• Screening. The CAS number matches two raw materials directly and appears as a declared component in one supplier specification for a closure. Three hits, not one.
• Threshold test. The 0.1% w/w test applies per article, so the closure is assessed on its own weight, not on the weight of the filled unit. Across the filled unit the substance is well under 0.1%. On the closure it is 0.4%. The duty applies.
• Scope. That closure is used on 61 SKUs across four brands, supplied to 23 business customers in the EU.
• Article 33(1). All 23 customers must receive the substance name and sufficient safe-use information. Not on request: automatically, as a supplier of the article.
• SCIP. Each of the 61 SKUs placed on the EU market needs a SCIP notification identifying the complex object, the article containing the SVHC and its concentration range.
• SDS. The closure is an article, not a mixture, so no SDS follows from it. The two raw material matches do require Section 15 revisions and reissue to everyone supplied in the last twelve months.
• What determines effort. None of this is intellectually hard. The cost sits entirely in whether the bill of materials down to component level, the customer shipment history and the SDS distribution log can be queried together. If they can, this is an afternoon. If they cannot, it is six weeks.

These get used interchangeably and they carry very different consequences. Being clear about which one you are looking at determines whether you are communicating, applying for authorisation, or stopping supply.

• Candidate list (Article 59). Identification only. The substance stays legal to use. It triggers communication, notification and SCIP duties. Over 240 entries.
• Authorisation list (Annex XIV). A subset promoted from the candidate list. After the sunset date the substance cannot be used or placed on the market for a listed use without a granted authorisation. Applications are expensive and take years, so the practical answer is usually substitution.
• Restriction list (Annex XVII). A separate route entirely. It bans or limits specific uses of a substance whether or not it is an SVHC. A substance can be restricted without ever appearing on the candidate list.

The escalation path matters commercially. A candidate list addition is an early warning that a substance may reach Annex XIV within a few years. Treating each addition as a substitution planning trigger, not only a paperwork trigger, is what separates businesses that reformulate calmly from those that reformulate under a sunset date.

• Article 33: if an article contains an SVHC above 0.1% weight by weight, you must communicate that to recipients (B2B always, consumers on request within 45 days).
• Article 7(2): notify ECHA if you produce or import articles containing an SVHC above 0.1% w/w and the total tonnage exceeds one tonne per year.
• SDS update: Safety Data Sheets must be re-issued to reflect the new classification.
• SCIP database: articles containing SVHCs above 0.1% w/w placed on the EU market must be notified to the ECHA SCIP database.

The UK SVHC list started identical to the EU list at the point of Brexit and is slowly diverging. UK additions go through the HSE and the Environment Agency on a separate timeline. Substances can be added to one list and not the other; running both regimes in parallel is the practical reality for any business selling into GB and the EU.

Every January and June update forces the same scramble: cross-check the new substances against thousands of raw materials and SKUs, identify which customers hold articles above 0.1% w/w, redraft Article 33 statements, refile SCIP entries and re-issue SDSs. Done in spreadsheets and shared inboxes, the work is slow, easy to miss and impossible to audit.

REACH compliance software replaces that scramble with one substance master tagged against the live EU and UK SVHC lists. The day ECHA publishes an update, the affected raw materials, SKUs, customers and open declarations surface in one view, and Willow drafts the Article 33 communications, SCIP submissions and SDS revisions for the regulatory team to review.

• Live SVHC candidate list monitoring across EU and UK REACH
• Article 33 disclosure generation tied to the article bill of materials
• SCIP database submission with audit trail
• Automatic SDS re-issue when a classification changes
• Customer-level declaration tracking with read receipts