REACH Compliance for Cosmetic Ingredients — The Annex XVII Restrictions Explained

When a formulation team in North America selects a fragrance ingredient or a preservative, their primary reference is typically the FDA’s list of prohibited substances and their internal safety database. What they often do not check — until a European distributor raises the question — is whether that same ingredient is subject to restrictions under Regulation (EC) No 1907/2006, better known as REACH. That gap has delayed more than a few EU launches and, in some cases, required reformulation after significant investment in packaging and marketing.

This article is for regulatory affairs managers, quality directors, and formulation leads at brands preparing for EU market entry. It explains how REACH interacts with cosmetics compliance, what Annex XVII restrictions mean in practice, and where the most common compliance gaps appear.

What Is REACH and Does It Apply to Cosmetics?

REACH — Registration, Evaluation, Authorisation and Restriction of Chemicals — is the EU’s primary chemicals regulation. It entered into force on 1 June 2007 and is administered by the European Chemicals Agency (ECHA). REACH applies to chemical substances manufactured in or imported into the EU in quantities of one tonne or more per year per manufacturer or importer.

Cosmetic products are not exempt from REACH. While Regulation (EC) No 1223/2009 on cosmetics governs the finished product, REACH governs the chemical substances used as ingredients. The two regulations operate in parallel. A cosmetic ingredient can be fully compliant with the cosmetics regulation’s Annexes and still be subject to REACH restrictions that limit its concentration, use conditions, or require specific labeling.

The relationship is explicitly acknowledged in both regulations. Article 15 of the Cosmetics Regulation states that substances classified as CMR (carcinogenic, mutagenic, or toxic for reproduction) under Regulation (EC) No 1272/2008 (CLP) are prohibited in cosmetic products, with limited exceptions — a provision that aligns with REACH’s broader chemical safety framework.

Understanding Annex XVII

Annex XVII of REACH contains the restrictions on the manufacture, placing on the market, and use of certain dangerous substances, mixtures, and articles. It is a living document — entries are added or amended through Commission Regulations as new scientific evidence emerges or as ECHA’s Risk Assessment Committee and Socioeconomic Analysis Committee complete their evaluations.

Each entry in Annex XVII specifies:

The substance or group of substances covered (by name, CAS number, or EC number)
The conditions or concentration limits under which the restriction applies
Whether the restriction covers manufacture, use, supply to the general public, or professional use
Any labeling requirements triggered by the restriction

For cosmetic formulators, the most practically relevant entries include restrictions on certain aromatic amines, polycyclic aromatic hydrocarbons (PAHs) in certain mixtures, formaldehyde-releasing preservatives at concentrations above specified thresholds, and certain phthalates. The specific entries and their current thresholds should always be verified against the current version of Annex XVII, as amendments are published periodically in the Official Journal of the European Union.

Substances of Very High Concern (SVHCs) and the Candidate List

Separate from Annex XVII, REACH maintains a Candidate List of Substances of Very High Concern (SVHCs). SVHCs are substances that meet one or more of the following criteria: CMR category 1A or 1B; persistent, bioaccumulative, and toxic (PBT); very persistent and very bioaccumulative (vPvB); or substances of equivalent concern (including endocrine disruptors).

Inclusion on the Candidate List triggers communication obligations: suppliers of articles containing SVHCs above 0.1% by weight must provide information to recipients and, upon request, to consumers within 45 days. For cosmetic products, this is particularly relevant for packaging components — certain plasticisers and stabilisers used in packaging materials may be SVHCs.

ECHA updates the Candidate List periodically. Regulatory teams should monitor ECHA’s website and subscribe to update notifications, as a substance can move from the Candidate List to the Authorisation List (Annex XIV) or to a restriction under Annex XVII.

Where Cosmetic Brands Most Often Encounter REACH Issues

Fragrance ingredients: The fragrance industry uses a large number of chemical substances, some of which appear on the Candidate List or are subject to Annex XVII restrictions. Fragrance suppliers operating in the EU are generally well-versed in REACH compliance, but brands sourcing fragrance compounds from outside the EU should request explicit REACH compliance declarations from their suppliers.

Preservatives: Certain preservatives that are permitted under the Cosmetics Regulation’s Annex V (the list of permitted preservatives) may nonetheless be subject to concentration limits or labeling requirements under REACH. The two sets of limits are not always identical.

Colorants and UV filters: Similar dual-compliance considerations apply. A colorant listed in Annex IV of the Cosmetics Regulation may still be subject to REACH restrictions depending on its chemical classification.

Packaging materials: As noted above, packaging components — particularly flexible plastics — may contain SVHCs. This is an area that cosmetic compliance teams sometimes overlook because their focus is on the formulation rather than the container.

Post-Brexit Considerations

Following the United Kingdom’s departure from the EU, Great Britain operates its own version of REACH (UK REACH), administered by the Health and Safety Executive (HSE). While UK REACH is broadly similar to EU REACH in structure, the two regimes are diverging over time as each makes independent amendments. Brands selling in both the EU and Great Britain need to track both Annex XVII equivalents separately.

Northern Ireland remains subject to EU REACH under the Windsor Framework arrangements, which adds a further layer of complexity for brands with UK supply chains.

Practical Action Step

Use this checklist when reviewing a formulation for EU REACH compliance:

Obtain Safety Data Sheets (SDS) for all raw materials from EU-compliant suppliers
Check each ingredient against the current Annex XVII of REACH for applicable restrictions
Check each ingredient against the current ECHA Candidate List for SVHC status
Verify that fragrance compounds are accompanied by a REACH compliance declaration
Review packaging components for SVHC content above 0.1% by weight
Confirm that any SVHC communication obligations to downstream users are met
Monitor ECHA’s website for Candidate List updates and Annex XVII amendments
If selling in both EU and Great Britain, maintain separate compliance tracking for UK REACH

REACH compliance for cosmetic ingredients is a specialist area where requirements vary depending on the specific substance, its concentration, and its intended use. Consult a qualified EU regulatory expert before finalising your formulation and supply chain strategy.

Care Europe provides REACH compliance support for cosmetic brands entering the EU market, including ingredient screening, supplier documentation review, and ongoing regulatory monitoring. Contact us to discuss your compliance needs.

REACH Compliance for Cosmetic Ingredients — The Annex XVII Restrictions Explained