SVHC & Restricted Substances List: How It Affects Your Cosmetic Formula

A raw material sitting quietly in your formulation cupboard today can, without a single change on your part, become a compliance problem tomorrow. Not because you did anything wrong but because a scientific committee, somewhere in Brussels or London, decided it deserved a second look.

That's the uncomfortable reality behind two of the least-discussed but most consequential lists in cosmetic regulation: the SVHC Candidate List and the various restricted substance annexes that govern what can and can't go into a finished cosmetic product. Neither is exotic. Both can quietly reshape a formula you thought was finished.

Start With a Question: What Makes a Substance "Of Very High Concern"?

Not every hazardous chemical earns this label. A Substance of Very High Concern (SVHC), as defined by the European Chemicals Agency, is one that meets at least one of a short but serious set of criteria: it's carcinogenic, mutagenic, or toxic to reproduction (the "CMR" category); it's persistent, bioaccumulative, and toxic (PBT) or very persistent and very bioaccumulative (vPvB); or it causes an equivalent level of concern through other means, such as endocrine disruption.

In other words, the SVHC list isn't a general hazard warning. It's a shortlist of substances the EU has decided warrant active tracking and, eventually, tighter controls — sometimes leading to outright restriction or authorisation requirements.

Two Different Lists, Two Different Jobs

It helps to think of SVHCs and restricted substances as two stages of the same conversation. The SVHC Candidate List is the "we're watching this" stage inclusion triggers disclosure obligations but doesn't necessarily ban the substance outright. Restricted substance annexes under both REACH Annex XVII and, more specifically for cosmetics, Annexes II to VI of the Cosmetics Regulation — are the "action has been taken" stage, where a substance is banned outright, capped at a maximum concentration, or permitted only in specific product types with specific warnings.

A substance can move from one stage to the other. Some never do. Others sit on the Candidate List for years while further evaluation continues.

Why This Matters Even If You Didn't Choose the Ingredient Yourself

Here's the part that catches brand owners off guard. You don't need to have deliberately selected a concerning substance for it to affect you. Fragrance blends, in particular, are compound mixtures a single "natural fragrance" ingredient on your label can contain dozens of individual aromatic chemicals, some of which may appear on the SVHC list or be subject to concentration limits under the Cosmetics Regulation's fragrance allergen rules.

A formulator choosing a beautiful, complex fragrance oil is, in effect, choosing everything inside it known and disclosed, or otherwise.

A Short Case in Point

Picture a small skincare brand that has been using the same anti-ageing serum formula, unchanged, for three years. Sales are healthy. No customer complaints. Then, during a routine CPSR update ahead of a product refresh, the safety assessor flags that one of the formula's UV filters was added to the SVHC Candidate List the previous year, based on newly reviewed endocrine-disruption data.

Nothing about the finished product changed. The science behind that one ingredient did and because the brand kept its CPSR under periodic review rather than treating it as a one-time document, the issue surfaced during a routine check rather than during a market surveillance audit or, worse, a retailer's own compliance sweep.

What SVHC Listing Actually Requires of You

Listing on the Candidate List triggers specific, concrete duties:

• Suppliers must inform you if a substance or mixture they supply contains an SVHC above 0.1% by weight
• You, in turn, may have downstream communication duties if you supply that substance further, particularly for exported "articles"
• Your safety assessor needs this information to properly re-evaluate your CPSR's risk assessment for the ingredient in question
• Depending on the substance and its eventual regulatory trajectory, it may later move toward outright restriction under the Cosmetics Regulation, at which point reformulation becomes unavoidable

Where Cosmetic-Specific Rules Take the Lead

It's worth being precise here, because the two systems don't always move in lockstep. The Cosmetics Regulation's own Annexes II through VI are usually the more immediately relevant reference point for formulators, because they're written specifically with cosmetic use, exposure routes, and concentration limits in mind. Annex II lists substances prohibited outright in cosmetic products. Annex III lists substances subject to restrictions, such as maximum concentration or specific warning requirements. Annexes IV, V, and VI cover permitted colourants, preservatives, and UV filters respectively each with its own approved list and conditions of use.

REACH restrictions and the SVHC list matter most where a substance isn't already specifically addressed by these cosmetic-specific annexes, or where new science is still working its way through the evaluation pipeline before a cosmetics-specific rule catches up.

Practical Habits Worth Building

None of this requires a legal team on retainer. It requires a habit.

• Check new raw materials against the current SVHC Candidate List before formulating not after your product has launched.
• Revisit long-standing formulas periodically, not just when you're actively reformulating, since the underlying substance data can shift beneath an unchanged product.
• Ask fragrance and colour suppliers directly whether their blends contain any SVHC or restricted-substance components above threshold, rather than assuming a "trade secret" formula is automatically clean.
• Keep your CPSR as a living document, reviewed on a set schedule, rather than a certificate filed away and forgotten.

Frequently Asked Questions

How is the SVHC Candidate List different from a full ban?

Candidate List inclusion triggers disclosure and monitoring obligations, but doesn't itself ban a substance. A ban or concentration limit only follows if the substance is later moved into a restriction or authorisation process, or separately prohibited under the Cosmetics Regulation's own annexes.

Do I need to check every single raw material against the SVHC list myself?

Your suppliers carry a disclosure duty above the 0.1% threshold, but proactively checking key or long-standing raw materials yourself, especially fragrance and colour components, is good practice rather than a strict legal requirement in every case.

Can a naturally derived ingredient still be restricted?

Yes. Restriction and SVHC status are based on a substance's chemical identity and hazard profile, not its origin. A number of naturally occurring fragrance and plant-derived compounds appear on restricted-substance and allergen lists.

What should I do if I discover my product contains a newly listed SVHC?

Flag it to your safety assessor immediately for a CPSR review, confirm the exact concentration used in your formula, and monitor whether the substance moves toward formal restriction, which would require reformulation ahead of any compliance deadline.

How often should I re-check my existing formulas against these lists?

There's no single mandated frequency, but reviewing key long-standing formulas annually, or whenever your CPSR is due for its periodic update, is a practical rhythm that catches most changes before they become urgent.

The Underlying Point

Regulatory science doesn't stand still, and a formula that was compliant on day one doesn't stay compliant by default forever. The SVHC list and the various restricted substance annexes exist precisely because chemical safety understanding evolves and a cosmetic brand that treats compliance as an ongoing habit, rather than a box ticked once at launch, is the one that catches these shifts early, quietly, and on its own terms.

Want your formula checked against current restricted substance and SVHC data? NestQual prepares CPSRs, PIFs, and full compliance packs for cosmetic brands entering the UK, EU, and global markets including reviewing your ingredients against current regulatory lists as part of your safety assessment.

Get a CPSR for your product See the Complete Compliance Pack

Sources

1. European Chemicals Agency, Candidate List of Substances of Very High Concern (SVHC) — echa.europa.eu
2. European Parliament and Council, Regulation (EC) No 1223/2009 on cosmetic products, Annexes II–VI — eur-lex.europa.eu
3. European Parliament and Council, Regulation (EC) No 1907/2006 (REACH), Annex XVII — eur-lex.europa.eu
4. Health and Safety Executive (HSE), UK REACH — hse.gov.uk
5. Cosmetic, Toiletry and Perfumery Association (CTPA), Safety of Cosmetics — ctpa.org.uk

This article is for general information and does not constitute legal advice. Always confirm current requirements for your specific product and market with a qualified safety assessor or Responsible Person.