What Are SVHCs? A Plain-Language Guide to REACH’s Candidate List

If you’ve ever filled out a customer compliance questionnaire or received compliance information from a material supplier, you’ve probably come across the acronyms REACH, RoHS, and SVHC. REACH and RoHS get reasonable coverage elsewhere, but SVHCs rarely get a clear explanation. This article covers what you need to know about SVHCs and how they relate to REACH and product materials.

SVHCs Are a Subset of REACH, Not the Whole Story

SVHC stands for Substance of Very High Concern for Authorization. It is an element of the REACH directive (which stands for “Registration, Evaluation, Authorisation and Restriction of Chemicals”; its formal name is “Regulation (EC) No 1907/2006”). REACH aims to identify and manage chemicals that raise safety, waste management, or environmental concerns. More specifically, when people refer to “the SVHC list,” they mean the Candidate List of Substances of Very High Concern for Authorization, maintained by the European Chemicals Agency (ECHA) and publicly available on their website.

Three Lists, Three Levels of Regulatory Consequence

Chemicals are evaluated, and either no action is taken or they are assigned to one of three lists:

1. The SVHC List (or Candidate List). Substances land here because they have properties that raise serious red flags: they may be (or have some limited evidence to show they might be) carcinogenic, mutagenic, or toxic to reproduction (CMRs); they may persist in the environment and accumulate in living organisms (PBTs or vPvBs); or they may have other serious effects such as endocrine disruption.
2. The Authorization List (Annex XIV of REACH). Substances here cannot be used after a specific sunset date unless a company applies for and receives explicit authorization from the European Commission. Approval is only granted if the company can demonstrate that risks are adequately controlled, or that the socioeconomic benefits outweigh the risks and no suitable alternatives exist.
3. The Restriction List (Annex XVII) works somewhat like the opposite of authorization: it bans the use of chemicals under specific conditions or entirely. Restrictions can apply to any substance, not just SVHCs. They might prohibit a substance in consumer products while still allowing it in industrial settings, for example.

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The 0.1% Rule Is Where SVHC Compliance Gets Practical

A capacitor is a great example of this. Capacitors store energy whether or not they are mounted on a PCBA, but separate the casing from its internal pathways and the capacitor no longer works. What you’re left with are two separate articles: the casing and the internal assembly.

See the ECHA-published ‘Guidance on requirements for substances in articles’ for many examples.

If a substance is present below 0.1% w/w in an article within your product, it falls below the threshold and can be ignored. If a substance exceeds 0.1% in any single article, you need to take action.

Having an SVHC Above 0.1% Triggers Disclosure, Not Automatic Non-Compliance

Having SVHCs in your product above the 0.1% threshold does not automatically make you non-compliant. What it does is trigger the following specific obligation:

“Directly after a substance is included in the Candidate List, suppliers…have to provide enough information to allow the safe use of the article to the recipients of the article. In this case, recipients are industrial or professional users and distributors, but not consumers. As a minimum the name of the substance in question has to be communicated. Consumers can request similar information. The supplier of the article has to provide this information within 45 days, free of charge.” [Article 33 (REACH Regulation)]

In practical terms, your obligations depend on which situation applies to you:

• If your product contains no SVHCs above 0.1% w/w, you can consider your product “REACH Compliant” by way of being clear of SVHC-related obligations (assuming you meet REACH’s other requirements).
• If your product does contain SVHCs above 0.1% w/w, you can still consider your product “REACH compliant” but only if you’re meeting the SVHC communication requirements described above (and all of REACH’s other requirements).

That said, SVHCs can increase supply chain risk, since a substance could be reassigned to the Authorization or Restriction List. Some have remained on the Candidate List for years or decades, and others have been removed entirely, so escalation is not a certainty.

Some customers might also be put off by SVHCs if they have other SVHC-free options.

SVHC Compliance Is One Part of a Broader REACH Obligation

SVHCs are one piece of the REACH puzzle. Registration obligations, restrictions, and reporting thresholds each carry their own rules and timelines, and we’ll cover those another time.

SVHC and REACH requirements evolve as ECHA updates its lists. If you are managing materials documentation for a regulated medical device, building a regular review cycle into your compliance process is the most reliable way to stay ahead of changes.

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