REACH SVHC Compliance for Cosmetic Brands: What the Growing Candidate List Means for Your EU Formulations

In January 2025, ECHA added eight new entries to the SVHC candidate list, quietly pushing the total past 240 substances. For most cosmetic brands absorbed in reformulation timelines and CPNP filings, that update barely registered. For the brands that were paying attention, it created immediate raw material review obligations — and, in several cases, exposed gaps in supplier documentation that had been sitting undetected for years.

That’s the nature of REACH SVHC compliance. It doesn’t announce itself loudly. It accumulates.

Europe’s cosmetics and personal care sector generates more than €80 billion in annual revenue and supports roughly 1.8 million jobs across the value chain. Regulatory risk is distributed across that entire structure, and the SVHC candidate list is one of its most dynamic moving parts. Understanding precisely how it works — and exactly where it intersects with cosmetic product compliance — still trips up experienced regulatory teams. And the intersection is more nuanced than most brands assume.

How the SVHC Candidate List Works — and Why It Moves Faster Than You Think

The candidate list is maintained under REACH Regulation (EC) No 1907/2006. “SVHC” covers substances with specific hazard profiles: carcinogens, mutagens, and reproductive toxicants (CMRs); persistent, bioaccumulative, and toxic substances (PBTs); very persistent and very bioaccumulative substances (vPvBs); and an expanding category of substances identified as endocrine disruptors or substances of equivalent concern.

The addition process is set out in Article 59 of REACH. An EU member state authority — or ECHA itself, at the Commission’s request — submits a substance dossier. A 45-day public consultation period follows, during which industry, NGOs, and other stakeholders can submit scientific evidence or objections. ECHA’s Member State Committee then reaches a unanimous decision; if consensus fails, the European Commission decides.

ECHA has historically updated the list twice a year, broadly in January and July, though the schedule has shifted slightly in recent years. The practical implication: your compliance baseline can change on a six-month cycle. Brands that do a single annual SVHC review are already behind before the year ends.

Once a substance appears on the candidate list, it may be prioritised for Annex XIV — the authorisation list — which means that continued use requires an explicit Commission authorisation after a specified sunset date. For cosmetics, authorisation is almost never commercially viable. The process costs upwards of €150,000, typically takes several years, and rarely succeeds for consumer-facing product categories. Candidate list inclusion is therefore often a precursor to reformulation, not just a documentation exercise.

Why Cosmetic Brands Have a Specific — and Frequently Misunderstood — SVHC Problem

This is where the regulatory picture gets genuinely complicated. And it’s where we see the most consistent compliance gaps.

Cosmetic products are classified as mixtures under REACH, not as articles. This distinction matters enormously, because the well-known 0.1% w/w SVHC threshold for disclosure obligations under Articles 7 and 33 applies specifically to articles — solid manufactured objects where a chemical substance is present in the matrix. Your moisturiser, shampoo, or serum formula is not an article. Your bottle, pump dispenser, cap, and closure assembly are.

This creates two distinct compliance tracks running simultaneously.

Track 1 — Your formulation: For cosmetic mixtures, the primary mechanism by which SVHC status translates into a formulation obligation runs through CLP classification. When a substance on the SVHC candidate list receives a harmonised CMR classification under CLP Regulation (EC) No 1272/2008, Article 15 of Regulation 1223/2009 is triggered automatically. CMR Category 1A and 1B substances are prohibited outright in cosmetics. CMR Category 2 substances are prohibited unless the SCCS has specifically evaluated them and determined use is safe.

Titanium dioxide is the clearest recent illustration. After its classification as a suspected carcinogen by inhalation (Category 2) under CLP, the Commission introduced restrictions on TiO₂ in aerosolised cosmetic products — spray sunscreens, setting sprays, dry shampoos — via Commission Regulation (EU) 2021/1902. Brands that hadn’t tracked the CLP trajectory missed an 18-month reformulation clock that was effectively hidden inside a REACH SVHC designation.

Track 2 — Your packaging and article components: Pump mechanisms, closures, jars, applicator caps, and squeeze tube components are articles under REACH. If your packaging supplier uses a substance on the SVHC candidate list above 0.1% by weight in any of those components, Article 33 requires them to communicate that information to you — and you must pass it on to any customer or consumer who requests it, within 45 days. France’s DGCCRF has cited brands during market surveillance inspections for failing to maintain this documentation chain.

Track 3 — Your raw material extended SDS. Under Article 31 of REACH and the Annex II SDS requirements, suppliers must provide an extended Safety Data Sheet (eSDS) when they supply a mixture containing more than 0.1% of an SVHC. If you are sourcing a botanical extract, emulsifier, fragrance compound, or preservative system that contains an SVHC above threshold, you should be receiving an eSDS from your supplier. Auditing whether those documents are actually on file — and current — is often the most revealing exercise brands can do. Many discover they are not receiving them.

SVHC Substances Cosmetic Formulators Need to Monitor Right Now

Not every entry on the 240-substance candidate list touches cosmetics, but several clusters demand specific attention in 2026.

Phthalates in packaging components: DEHP, DBP, and BBP are already on the authorisation list (Annex XIV) and restricted under Annex XVII of REACH. The primary cosmetics concern is packaging — plasticised PVC in closures, caps, and flexible squeeze tubes. DINP restrictions for articles have also been in force since 2020. If your packaging supply chain audit hasn’t explicitly addressed phthalate content in article components, it’s incomplete.

Boric acid and borates: Boric acid carries SVHC status and is restricted under Annex III of Regulation 1223/2009, with maximum concentrations that vary by product type and user group. The 2021 SCCS opinion tightened permissible levels further, particularly for products intended for children under 3 and applications near mucous membranes. France’s ANSM has conducted targeted post-market surveillance on boron levels in baby toiletries specifically.

Fragrance components: Several fragrance substances are under active SVHC evaluation due to skin sensitisation profiles and endocrine disruption concerns. Complex fragrance blends sourced at supplier level carry significant opacity — a compound cleared during supplier onboarding may now contain an SVHC-listed ingredient following a subsequent candidate list update. Requesting annual updated component declarations from fragrance suppliers is no longer optional for brands that want to stay ahead.

Formaldehyde releasers: DMDM hydantoin, imidazolidinyl urea, and quaternium-15 remain under regulatory scrutiny under both REACH and Regulation 1223/2009. The CMR 1B classification of formaldehyde under CLP has cascading implications for preservation systems that rely on formaldehyde release. SCCS has issued incremental opinion updates, and member states — particularly Germany and France — have been proactive in enforcement actions for products with elevated formaldehyde levels from releaser chemistry.

Resorcinol: Used primarily in oxidative hair colourants, resorcinol has been designated an endocrine disruptor and is restricted under Annex III of Regulation 1223/2009. Its SVHC status remains an active discussion, and the Commission has flagged it as a priority substance under the Chemicals Strategy for Sustainability.

Building an SVHC Monitoring Process That Actually Works

The brands that handle REACH SVHC compliance effectively share one operational characteristic: they don’t treat it as a one-time audit. They build monitoring into their standard procedures, distributed across procurement, regulatory affairs, and their Responsible Person function.

Here is what a functional process looks like in practice.

1. Maintain a live raw material inventory mapped to the current candidate list. ECHA’s INESIS database and the official candidate list page are publicly accessible. Assign a responsible party — internal or contracted — to run a comparison after every biannual update. Document the review date and findings.

2. Request extended Safety Data Sheets proactively. Your supplier qualification process should include an explicit contractual requirement for eSDS delivery whenever any ingredient contains an SVHC above 0.1%. Don’t rely on suppliers to volunteer this — most won’t unless asked.

3. Audit packaging suppliers against Article 33 obligations. Request written confirmation from each primary packaging supplier identifying which, if any, components contain SVHC substances above 0.1% w/w. File this in the product technical file alongside your Safety Assessment and CPNP notification records.

4. Set a CLP watch trigger for CMR classification changes. ATP amendments to the CLP regulation update CMR classifications on a rolling basis. When a cosmetically relevant substance receives a CMR 1A, 1B, or 2 classification, your Responsible Person needs to assess the impact on Annex II and III compliance under Regulation 1223/2009 — and that review needs to happen before the next batch of affected product ships.

5. Brief your safety assessor on candidate list developments. Your Cosmetic Product Safety Report should reflect the current regulatory status of every substance in the formulation. An SVHC listing or CLP reclassification mid-product lifecycle may require a safety report update, not just a formulation note.

6. Document your consumer response procedure for Article 33(2) requests. If a consumer asks whether a product contains SVHC substances, you have 45 days to respond accurately. That requires a traceable, documented process — not an ad hoc search of your supplier files.

The brands that encounter problems under REACH SVHC compliance are rarely those ignoring it entirely. They’re the ones who did a thorough review two or three years ago and haven’t revisited it since. With the candidate list now exceeding 240 substances and ECHA’s SVHC identification activity accelerating under the EU Chemicals Strategy for Sustainability, the useful life of a “completed” compliance review is shorter than it’s ever been.

If your last SVHC gap analysis predates 2024, it’s already overdue. The next candidate list update won’t wait for your reformulation schedule.

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Written by Sam Sammane, Founder, Care Europe | Founder, Qalitex Group. Learn more about our team

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