REACH Restrictions on Cosmetic Fragrances and Preservatives: Your EU Compliance Checklist for 2026

Of the more than 70 restriction entries currently listed in REACH Annex XVII, a meaningful subset applies directly to substances still commonly found in cosmetic formulations. Yet in our experience reviewing EU market entry dossiers, REACH compliance is the regulatory layer most frequently handled with a single supplier declaration — checked once, filed away, and rarely revisited.

That approach works until it doesn’t. And when it fails, it typically fails during a DGCCRF inspection or a cosmetic product notification review, not at customs.

This post covers the practical overlap between REACH restrictions and EU cosmetics regulation for two ingredient categories where that overlap is most consequential: fragrances and preservatives. If you’re preparing a product for the French or broader European market in 2026, this is the checklist your formulation team needs before the Responsible Person signs anything.

Why Fragrances and Preservatives Are REACH’s Highest-Risk Categories for Cosmetics

Fragrance ingredients and preservatives share a regulatory characteristic that sets them apart from most other cosmetic raw materials: they are chemically active by design. Fragrances are volatile organic compounds that interact directly with skin and mucous membranes. Preservatives are, by definition, biocidally active. That activity is exactly what makes them effective — and exactly what draws regulatory scrutiny.

Under REACH Regulation (EC) No 1907/2006, chemical substances are restricted when the risk to human health or the environment cannot be adequately controlled. Annex XVII codifies those restrictions by substance or substance group, and the relevant entries for cosmetics cover nitromusks, polycyclic musks, certain acrylates, and several preservative actives that intersect with REACH obligations in ways that don’t always surface in a supplier’s Safety Data Sheet.

Separately, the EU Cosmetics Regulation (EC) No 1223/2009 restricts these categories through its own annexes. Annex II lists prohibited substances. Annex III lists those restricted to specific maximum concentrations and conditions of use. Annex V is dedicated to permitted preservatives with their concentration limits. The two frameworks run in parallel. Compliance with one does not guarantee compliance with the other — and many non-conformities arise precisely in that gap.

The Key REACH Restrictions That Affect Cosmetic Formulations

Fragrance allergens and musks. Several fragrance compounds in REACH Annex XVII are prohibited or concentration-restricted in consumer products. Nitromusks including musk ambrette, musk tibetene, and musk moscow appear explicitly. Polycyclic musks such as AHTN (Tonalide) and HHCB (Galaxolide) are subject to restriction due to persistent, bioaccumulative, and toxic (PBT) concerns — even if low concentrations remain permissible in some rinse-off formulations under 1223/2009.

The ECHA Candidate List of Substances of Very High Concern (SVHCs) currently contains over 240 entries. Any ingredient present in your finished formulation above 0.1% by weight that appears on this list triggers mandatory communication obligations. Your Responsible Person must document the SVHC assessment, and downstream users — distributors and retailers — must be informed under REACH Article 33. That 0.1% threshold catches more fragrance blend components than most formulation teams expect, particularly in leave-on products where typical fragrance loadings run between 0.5% and 2.0%.

Preservative crossover. Methylchloroisothiazolinone (CMIT) and methylisothiazolinone (MIT) — commonly supplied as the 3:1 MCI/MIT combination — are dual-regulated. Under 1223/2009, the MCI/MIT mixture is restricted to a maximum of 0.0015% in rinse-off products and prohibited entirely in leave-on products, following SCCS opinions identifying sensitisation risk at previously permitted levels. REACH adds a further layer: both substances have been flagged under restriction review processes linked to serious skin sensitisation.

Formaldehyde and formaldehyde-releasing preservatives (DMDM hydantoin, imidazolidinyl urea, quaternium-15, and others) carry a combined restriction under 1223/2009: a maximum of 0.2% free formaldehyde in cosmetics other than oral hygiene products, with a mandatory warning statement required on the label above 0.05%. Under CLP Regulation (EC) No 1272/2008, formaldehyde is classified as a category 1B carcinogen — a classification that affects how mixtures containing it must be classified and labelled for supply purposes.

Phenoxyethanol, widely adopted as a paraben alternative, has a maximum permitted concentration of 1.0% under Annex V of 1223/2009. Recent SCCS opinions have raised concerns specifically for products intended for children under three years of age. It’s not currently a REACH restriction matter, but the SCCS opinion trajectory is a reliable indicator of where restrictions may travel next.

Your Six-Step REACH Compliance Checklist for Fragrance and Preservative Ingredients

This sequence reflects the review order we use at Care Europe when preparing market entry dossiers for EU-bound cosmetic products. Work through it before finalising any formulation — and repeat it every time a raw material is changed or re-sourced.

1. Map every fragrance component and preservative at the CAS level. Fragrance blends are commonly purchased as finished mixtures under trade names. REACH obligations apply to individual substances, not blends. Request a full CAS-level ingredient disclosure from your fragrance supplier, covering every component present above 0.01% in the blend. Many suppliers provide this under a confidentiality agreement. Without this disclosure, the remaining steps cannot be completed accurately.

2. Screen each CAS number against REACH Annex XVII. Cross-reference every substance against the current REACH Annex XVII restriction list using ECHA’s chemical database. Pay particular attention to entries covering CMR substances in consumer mixtures and those specific to fragrance compounds and preservative actives.

3. Check each substance against the ECHA Candidate List. Run each CAS number through ECHA’s SVHC Candidate List, freely accessible at echa.europa.eu. Flag any substance present above 0.1% in the finished formulation, document the assessment in your product information file (PIF), and prepare supplier communication as required under REACH Article 33.

4. Verify concentration limits against 1223/2009 Annex III and Annex V. A substance that passes REACH screening must still comply with 1223/2009 concentration limits in the finished product. Note that these limits apply to the finished formulation, not the raw material. A 10% fragrance blend containing 5% limonene contributes 0.5% limonene to your formulation — that figure must be checked against the applicable Annex III conditions of use.

5. Confirm fragrance allergen labelling obligations. Under 1223/2009, fragrance allergens present above 0.001% in leave-on products, or above 0.01% in rinse-off products, must be declared by individual name on the product label. The allergen list was originally 26 substances and has been progressively expanded through subsequent annexe amendments. Confirm you are working from the current version of Annex III — not a version predating the most recent update.

6. Update Safety Data Sheets and PIF documentation. SDS documents under REACH must reflect current hazard classifications under CLP. A SDS issued in 2021 may not incorporate 2023 or 2024 CLP amendments. If your Responsible Person is based in France, retain French-language PIF documentation throughout — DGCCRF inspectors are not required to accept English-language files, and mixed-language dossiers invite closer scrutiny.

What French DGCCRF Inspections Actually Look For

France’s Direction Générale de la Concurrence, de la Consommation et de la Répression des Fraudes is among the more active national market surveillance authorities in the EU. Its annual cosmetics enforcement surveys consistently document non-conformity rates above 25% in sampled products, and fragrance-related labelling issues account for a disproportionate share of those findings.

The specific failures that recur year after year: fragrance allergens above the labelling threshold not declared on the product label, quantitative ingredient declarations that don’t match the current formulation, and fragrance compounds present in the formula that weren’t fully disclosed in the CPNP notification at the time the product was first placed on the French market.

REACH documentation gaps tend to surface during these same inspections. An inspector reviewing a PIF who finds a 2020 SDS, an SVHC assessment predating the current Candidate List, or a CPNP notification that doesn’t reflect a formulation change will look further. The inspection rarely stops at the first anomaly.

Before Your Next CPNP Notification

The CPNP notification process requires the Responsible Person to confirm that a safety assessment has been completed by a qualified cosmetic safety assessor. That assessment must account for the product’s intended use, known or expected systemic absorption, and the toxicological profile of each ingredient. REACH documentation — SDS files, Candidate List status, Annex XVII screening results — feeds directly into that toxicological profile.

Treating REACH compliance as a separate administrative step from the safety assessment wastes time and creates gaps in the PIF. They share the same source data: CAS-level ingredient disclosures, concentration data, SDS files, and supplier confirmations. Running them in parallel closes those gaps and reduces the back-and-forth with your safety assessor.

The six-step checklist above won’t pre-empt every regulatory risk, but it will close the most common ones we see in EU market entry reviews. Work through it in order, document each step in the PIF, and revisit it every time your formulation or your suppliers change.

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

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Related from our network

• ISO 17025 Cosmetic Ingredient Testing and Safety Documentation — Qalitex Laboratories provides analytical testing and CAS-level substance verification to support REACH compliance documentation for EU-bound products.
• Raw Material Certificate of Analysis Verification — Androxa supports supplier qualification and ingredient impurity profiling for brands building EU market entry dossiers.