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EXPERTISE · SVHCs

Substances of Very High Concern

What an SVHC is, what it means for a substance or an article, and what it means for you as a manufacturer, importer or downstream user.

The REACH category that drives most substance-in-article obligations.

A Substance of Very High Concern (SVHC) is a substance identified under REACH as meeting one of the criteria set out in Article 57: it is carcinogenic, mutagenic or toxic to reproduction (CMR); persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB); or gives rise to an equivalent level of concern, such as an endocrine disruptor.
Being identified as an SVHC is the trigger point for a wide range of obligations — some attaching to the substance itself, others attaching to any article that contains it above a set concentration. Getting a clear position depends on knowing which of those obligations actually apply to your role.
SVHC screening across substances, mixtures and articles
Candidate List and Authorisation List status tracking
Article 7, 33 and 66 obligation assessment
Evidence-building for defensible SVHC positions
WHY SVHCs ARE REGULATED

Why SVHCs exist as a category, and why the direction of travel is phase-out.

SVHCs are identified because they carry a risk to human health or the environment that is serious, and often hard to reverse once it has occurred — cancer, genetic damage and reproductive harm sit alongside substances that persist in the environment or build up in living tissue over time, sometimes well beyond the point where the original use has stopped. That combination of severity and irreversibility is why REACH treats them as a distinct category, rather than folding them into general hazard classification alone.

Being added to the SVHC Candidate List is rarely the end point. UK and EU regulators use it as the first step toward a managed phase-out: substances can progress to the Authorisation List, where use requires an authorisation that is deliberately time-limited and hard to obtain, granted only where no suitable alternative exists and a case has been made for continued use. The intent is not to license indefinite use, but to create pressure — and a deadline — for substitution.

That reflects the precautionary principle behind UK and EU chemicals policy: where the potential harm is serious and hard to undo, regulators act to reduce exposure before the evidence of harm becomes conclusive, rather than waiting for proof after the fact. For an SVHC, that usually means a steady tightening of use rather than a single cut-off point — which is exactly why treating a Candidate List listing as an early warning, rather than a formality, matters.

TURNING PHASE-OUT INTO ADVANTAGE

Why getting ahead of an SVHC phase-out pays off.

Treating a listing as a prompt to act — rather than a deadline to manage — tends to pay off in ways that go beyond compliance.

Competitive and innovation edge
Searching for a safer alternative early, rather than under deadline pressure, is often what drives genuinely better-performing materials, formulations or processes — and being first to market with a validated substitute is a real commercial advantage, not just a cost of doing business.
A more appealing supplier
Large customers, retailers and public sector buyers increasingly hold their own restricted substance lists that go beyond the legal minimum, and expect suppliers to demonstrate SVHC-free or SVHC-reduced products as standard. Substituting ahead of the regulatory deadline makes your organisation a lower-risk, more attractive choice.
Progress toward sustainability targets
Substitution work does double duty — it satisfies a regulatory obligation while also contributing directly to your organisation’s own sustainability and ESG commitments, and to the ones your customers are increasingly asking their supply chain to help meet.

Waiting until an authorisation or restriction deadline forces the issue means reacting under time pressure, often with fewer alternative suppliers and less room to negotiate. Getting ahead keeps that choice — and the advantage — in your hands.

WHAT QUALIFIES AS AN SVHC

Four routes to the same designation.

A substance only needs to meet one of these Article 57 criteria to be proposed as an SVHC. In practice, many substances meet more than one.

CMR
Substances classified as carcinogenic, mutagenic or toxic to reproduction, category 1A or 1B under CLP.
PBT
Substances that are persistent, bioaccumulative and toxic, meeting the criteria set out in REACH Annex XIII.
vPvB
Substances that are very persistent and very bioaccumulative, even where standard toxicity thresholds are not met.
Equivalent level of concern
Substances such as endocrine disruptors, where scientific evidence points to probable serious effects on health or the environment, even though the substance does not meet the CMR, PBT or vPvB criteria directly.
CANDIDATE LIST vs AUTHORISATION LIST

Two different lists, two very different consequences.

Confusing the two is one of the most common SVHC mistakes we see. Being on the Candidate List does not mean a substance is banned; being on the Authorisation List can mean exactly that, after its sunset date.

Candidate List
The list of substances formally identified as SVHCs under Article 57. Being added to the Candidate List is what triggers the Article 33 communication duty and SCIP notification for articles containing the substance above 0.1% by weight — the obligation applies immediately on listing, with no separate authorisation step needed.
Authorisation List (Annex XIV)
A smaller, prioritised subset of the Candidate List. Once a substance is added to Annex XIV, it is given a latest application date and a sunset date. After the sunset date, that substance cannot be manufactured, placed on the market or used in the EU without a specific authorisation from ECHA, regardless of concentration.
Every Authorisation List substance started life on the Candidate List, but most Candidate List substances never move onto Annex XIV
Candidate List obligations (Article 33, SCIP) are about communication and disclosure; Authorisation List obligations are about whether continued use is permitted at all
A Candidate List substance can be used freely subject to communication duties; an Annex XIV substance cannot be used past its sunset date without authorisation
Both lists are maintained separately for UK REACH and EU REACH, and the two can diverge
THE SUBSTANCE OR MIXTURE ITSELF

What SVHC status means if you handle the substance directly.

When a substance you manufacture, import or use is identified as an SVHC, the immediate consequence is heightened information and communication duties. Safety data sheets need to reflect the SVHC status, and anyone you supply the substance or a mixture containing it to needs to be told.

If the substance is later added to the Authorisation List, the position changes materially: continued use after the sunset date requires an authorisation from ECHA, granted only where the applicant can demonstrate adequate control of the risk or that the socio-economic benefits outweigh it, and that no suitable alternative exists.

That case rests on a specific set of technical documents: a Chemical Safety Report covering the risks of the use applied for, an Analysis of Alternatives setting out whether a safer substitute is available, and, where adequate control cannot be demonstrated, a Socio-Economic Analysis weighing the costs and benefits of continued use. Defence and other exempted uses often need a comparable case built and evidenced to the same standard.

SDS updates to reflect SVHC status and any Candidate List entry
Communication of SVHC content to customers and downstream users
Monitoring for Authorisation List (Annex XIV) prioritisation
Chemical Safety Reports covering the specific use applied for
Analysis of Alternatives to evidence whether a substitute is viable
Socio-Economic Analysis where the adequate control route does not apply
Defence and other exemption case documentation, built to the same standard
SVHCs IN ARTICLES

What SVHC status means when it is inside a finished article.

Articles are treated differently to substances and mixtures under REACH, but an SVHC present in an article above 0.1% weight by weight still triggers obligations. The main duty, under Article 33, is to communicate the substance’s presence to professional and commercial customers automatically, and to consumers on request.

If the total quantity of that SVHC across all the producer or importer’s articles exceeds one tonne per year, Article 7 can also require notification or registration with ECHA. Suppliers of articles placed on the EU market above the same 0.1% threshold have a further, separate duty to notify the SCIP database.

Screening bills of materials for SVHCs above the 0.1% w/w threshold
Article 33 supply chain and consumer communication support
Article 7 tonnage calculation and notification assessment
SCIP database notification for articles placed on the EU market
MANUFACTURING, IMPORTING & USING SVHCs

Your role decides which article ties your obligations together.

Articles 7, 33 and 66 sit at the centre of SVHC compliance for articles and downstream use. We cover each in detail on its own page, linked below.

Manufacturing
If you manufacture a substance or an article containing an SVHC, you carry the primary duty to know its SVHC status, communicate it correctly, and assess whether Article 7 notification or registration applies based on the total tonnage across your articles.
See Article 7 ↗
Importing
Importing carries the same duties as manufacturing for the articles or substances you bring into the UK or EU. You take on the Article 33 communication duty, the Article 7 tonnage assessment, and the SCIP notification obligation as if you had made the article yourself.
See Article 7 ↗
Downstream use
As a downstream user, your duties depend on what you receive and what you do with it. You need to pass on SVHC information you are given under Article 33, and where you are relying on an authorisation granted to someone else in your supply chain, Article 66 can require you to notify ECHA of that use.
See Article 66 ↗
HOW WE HELP

Turning SVHC status into a clear, workable position.

SVHC obligations sit at the intersection of several REACH articles at once, and the Candidate List grows twice a year, so a position that was complete last year may not be complete today. Missing a change here is one of the more common routes into non-compliance — see our page on the risks of non-compliance for the wider picture.
We help organisations screen for SVHCs across their products and supply chains, work out exactly which of Articles 7, 33 and 66 apply to their role, and build the evidence and communication trail those obligations depend on.
SVHC screening across substances, mixtures, articles and bills of materials
Candidate List and Authorisation List monitoring, in GB and the EU
Article 7, 33 and 66 obligation assessment and evidence
SCIP database notification and dossier support
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