REACH Regulation SVHC: A Practical Guide for Cosmetic Brands Entering the EU Market

ECHA’s Candidate List crossed 240 substances in early 2025, and it grows twice a year. For cosmetic brands supplying the EU market, every update cycle is a potential compliance event — a substance that wasn’t an issue when you launched could become one six months later without any change to your formulation.

And yet, in our work advising brands on EU market entry, the SVHC framework under REACH (Regulation (EC) No 1907/2006) remains one of the most consistently misunderstood obligations. Not because it’s impossibly complex, but because the confusion between what REACH requires of cosmetic formulators versus what it requires of ingredient suppliers — and packaging suppliers — leads brands to either over-engineer their compliance documentation or, more dangerously, miss obligations entirely.

This guide is an attempt to make that distinction clear and give you a practical path through it.

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What SVHC Actually Means Under REACH

REACH introduced the category of Substances of Very High Concern (SVHC) under Article 57 of the regulation. SVHC is not a voluntary hazard label or a third-party certification. It’s a formal legal classification maintained by ECHA that triggers specific obligations — and it applies when a substance meets at least one of the following criteria:

• CMR category 1A or 1B — carcinogenic, mutagenic, or reprotoxic
• PBT or vPvB — persistent, bioaccumulative, and toxic, or very persistent and very bioaccumulative
• Endocrine-disrupting properties with potential serious effects to human health or the environment
• Equivalent level of concern — a catch-all for substances with serious but less categorisable hazard profiles

Once a substance is formally identified and placed on the SVHC Candidate List under Article 59, obligations attach. The list currently holds over 240 entries, with ECHA adding new substances in rounds each year. It has been growing consistently since the first entries appeared in 2008, and there is no credible regulatory signal that the pace will slow — if anything, the expansion of endocrine disruptor criteria under the 2023 REACH revision proposals suggests more additions ahead.

The critical thing to understand: inclusion on the Candidate List is not the same as restriction. A substance on the Candidate List remains legally usable. What changes are your communication and notification obligations. Substances that progress further in the regulatory process get placed on the Authorisation List (Annex XIV), where they become prohibited without a specific ECHA-granted authorisation. Annex XIV currently contains 59 substances, and several UV filters and industrial solvents that appear in cosmetic-adjacent chemistry sit on it.

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Why the 0.1% Threshold Is More Complicated Than It Looks

The figure everyone quotes is 0.1% w/w. That’s the concentration threshold in an “article” above which SVHC disclosure obligations activate under Article 33. But the word article is doing significant regulatory work here, and it’s often misapplied to finished cosmetic products.

Under REACH, an “article” is defined as an object that has been given a special shape, surface, or design during production which determines its function to a greater degree than does its chemical composition. A finished cosmetic product — a face cream, a body lotion, a perfume — is generally treated as a mixture, not an article. Mixtures fall under a different compliance pathway: the Safety Data Sheet requirements under Regulation (EU) 2020/878, and the hazard communication obligations that flow from it.

Where Article 33 actually bites cosmetic brands is upstream: in packaging components and certain delivery mechanisms — pumps, aluminium tubes, wax-coated applicators, glass bottles with specific functional coatings. These frequently qualify as articles under REACH. If they contain an SVHC above the 0.1% threshold by mass of the article, the supplier has a duty to communicate that information to professional recipients. And critically, under Article 33(2), if a consumer requests information about SVHCs in an article you’ve sold them, you must respond within 45 days.

This asymmetry is important. Many brands build a REACH compliance file entirely around their formulation and assume the job is done. It isn’t. Your packaging supply chain represents a separate, parallel obligation — and in our experience, around 30% of packaging suppliers sourcing from outside the EU will not have Article 33 SVHC declarations ready when you ask for them. When you’re acting as the EU responsible person or importer, that obligation falls to you.

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REACH SVHC Obligations: A Step-by-Step Compliance Process

Here’s how we typically structure a REACH SVHC review for a brand preparing for EU market entry.

Step 1 — Screen your ingredient portfolio against the current Candidate List

Pull the live ECHA Candidate List from echa.europa.eu — it’s publicly available and updated in real time. Cross-reference every raw material in your formulation against it. Pay particular attention to preservatives, UV filters, fragrances, and azo colorants; these categories have seen sustained SVHC additions over the past several update cycles. If any ingredient is present on the list, assess the concentration in the finished mixture. Even if you’re below 0.1%, document the finding and your rationale.

Step 2 — Request formal SVHC declarations from all ingredient suppliers

For each raw material, request a written SVHC declaration confirming whether the substance or mixture contains an SVHC above 0.1% w/w. Keep these on file. And be precise about what you’re asking for: an SVHC declaration is not the same as a REACH registration number. Suppliers sometimes conflate the two. REACH registration covers substances manufactured or imported into the EU above 1 tonne per year — it’s primarily a manufacturer/importer obligation and is upstream of your downstream user status. The registration number tells you the substance is known to ECHA; it does not tell you what the SVHC concentration is.

Step 3 — Audit your packaging supply chain

For every non-formulation component, determine whether it qualifies as an article under REACH. Request Article 33 SVHC communications from each packaging supplier. Set a deadline — 4 to 6 weeks is realistic for suppliers that have the information ready. Build additional buffer for non-EU suppliers who are less familiar with the framework.

Step 4 — Check Annex XIV and Annex XVII

Before finalising your compliance file, cross-reference your formulation and packaging against both REACH annexes. Annex XIV contains substances requiring authorisation — using them without a valid ECHA authorisation decision is a prohibited act. Annex XVII lists over 70 substance groups under restriction, including lead compounds, specific nickel compounds in metal components, and polycyclic aromatic hydrocarbons (PAHs) in rubber and plastic articles. For cosmetic brands, metal packaging, rubber seals, and decorative plastic elements are the most common Annex XVII exposure points.

Step 5 — Compile your REACH CoC file

A REACH Certificate of Compliance (CoC) is not an official ECHA document — there’s no form you submit or stamp you receive. It’s an internal compliance record that you maintain as the EU importer or responsible entity, demonstrating that your supply chain has been assessed. A well-constructed REACH CoC file should include: your SVHC Candidate List screening records with dates, supplier SVHC declarations for each raw material and packaging component, any Annex XIV and Annex XVII assessments, and a dated review log showing when each element was last verified. EU retailers, particularly in the French and German markets, are increasingly requesting this file as part of their supplier qualification process.

Step 6 — Build a structured review cycle

With ECHA issuing Candidate List updates twice a year, your REACH file is only as accurate as its last review. A substance that didn’t appear on the Candidate List when you first screened your formulation can become an active obligation in the next cycle. Set calendar reminders following ECHA update rounds. A review doesn’t require starting from scratch — it requires checking your current ingredient and packaging list against the delta of new additions.

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The Mistakes That Create Exposure in EU Market Entry Projects

Most of the REACH compliance failures we encounter in market entry work aren’t egregious omissions — they’re structural gaps that accumulate quietly.

The most common: treating “REACH registered” as synonymous with “REACH compliant.” Registration tells you the substance has been registered with ECHA by its manufacturer or importer; it says nothing about your Article 33 or Annex XIV obligations as a downstream user. An SDS from a REACH-registered supplier is a necessary input to your compliance work, not a conclusion.

A close second: launching on a snapshot. Brands screen against the Candidate List during their market entry project and consider it done. No review trigger is built in. Eighteen months later, a fragrance component or preservative that was clean at launch appears on the Candidate List — and because no one noticed, the obligation is technically active but unaddressed.

And third: ignoring the restriction landscape in Annex XVII when assessing packaging. We’ve seen brands invest heavily in formulation compliance documentation while sourcing pumps and closures from suppliers whose materials contain restricted nickel concentrations. The finished product passes cosmetics safety assessment under Regulation 1223/2009 — but the packaging article fails REACH Annex XVII. Both need to be clear.

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What to Do Before Your Next EU Launch

If you’re preparing a cosmetic product for EU market entry, the REACH SVHC framework should be active on your compliance timeline at least 90 days before launch. Getting packaging declarations in order from non-EU suppliers alone can take 4 to 6 weeks, and any Annex XIV finding will require a more substantive assessment.

Start with the Candidate List screen. It takes under an hour if your formulation is complete and your supplier SDSs are current. That single exercise will tell you where you’re exposed — and in the majority of cases, the issues are manageable. But you can only manage what you’ve mapped. Waiting until a retailer requests your REACH CoC file or until a DGCCRF inspection surfaces the gap is a far more expensive way to learn this.

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Written by Nour Abochama, Quality & Regulatory Advisor, Care Europe. Learn more about our team

Talk to our team about EU market entry. Contact us

Related from our network

• REACH and International Ingredient Testing: What a Compliant COA Looks Like — Understanding certificate of analysis standards when sourcing raw materials for EU-bound cosmetic products
• Health Canada vs. REACH: How Compliance Requirements Diverge for Cosmetic Brands Operating in Both Markets — A practical comparison for brands navigating North American and European regulatory frameworks simultaneously