REACH — Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals — is the EU’s primary chemicals regulation. It applies to cosmetic manufacturers, but in a way that many brands misunderstand. REACH and EU Cosmetics Regulation (EC) No 1223/2009 overlap, interact, and sometimes conflict. Getting the relationship right is essential for EU market compliance.

How Does REACH Apply to Cosmetic Products?

REACH applies to chemical substances manufactured in or imported into the EU in quantities of 1 tonne or more per year. For cosmetic manufacturers, the most relevant aspects of REACH are:

Annex XVII restrictions: Substances that are restricted or prohibited in consumer products, including cosmetics. These restrictions apply in addition to the restrictions in EU Cosmetics Regulation.

Substances of Very High Concern (SVHCs): Substances on the SVHC candidate list that may be subject to authorisation requirements or communication obligations.

Registration requirements: Manufacturers and importers of chemical substances above 1 tonne/year must register those substances with ECHA (European Chemicals Agency). For cosmetic manufacturers, this typically applies to bulk raw material manufacturers, not finished product manufacturers — but importers of raw materials into the EU may have registration obligations.

Safety Data Sheets (SDS): Suppliers of chemical substances must provide SDS to downstream users. Cosmetic manufacturers receive SDS from their raw material suppliers and must use the information in their safety assessments.

What Is REACH Annex XVII?

REACH Annex XVII is the list of substances subject to restrictions on manufacture, placing on the market, or use. It contains over 70 entries, each specifying a substance or group of substances and the conditions under which they are restricted.

For cosmetic manufacturers, the most relevant Annex XVII restrictions include:

Entry 3 — Liquid substances or mixtures: Restrictions on liquid products in certain packaging formats to prevent child poisoning. Relevant for liquid cosmetics in packaging that could be mistaken for beverages.

Entry 28-30 — CMR substances: Substances classified as carcinogenic, mutagenic, or reprotoxic (CMR) categories 1A and 1B are generally prohibited in consumer products including cosmetics. This overlaps with EU Cosmetics Regulation Annex II (prohibited substances) but REACH Annex XVII may cover substances not yet listed in Cosmetics Regulation annexes.

Entry 40 — Azodyes: Certain azo colorants that can release carcinogenic aromatic amines are restricted in consumer products. Relevant for cosmetics containing azo colorants.

Entry 46 — Mercury compounds: Mercury and its compounds are restricted in cosmetics. This overlaps with EU Cosmetics Regulation but REACH Annex XVII may have different concentration limits.

Entry 72 — Nonylphenol ethoxylates (NPEs): Restricted in cleaning products and textiles but the restriction has implications for cosmetic formulations using certain surfactants.

The full Annex XVII list is updated regularly by ECHA. Cosmetic manufacturers must monitor updates and assess their formulations against current restrictions.

What Are SVHCs and Do They Affect Cosmetics?

Substances of Very High Concern (SVHCs) are substances that meet one or more of the following criteria:

CMR category 1A or 1B (carcinogenic, mutagenic, or reprotoxic)
Persistent, bioaccumulative, and toxic (PBT)
Very persistent and very bioaccumulative (vPvB)
Substances of equivalent concern (e.g., endocrine disruptors)

ECHA maintains the SVHC Candidate List, which currently contains over 240 substances. Substances on the Candidate List are subject to communication obligations: suppliers of articles (including cosmetic products) containing SVHCs above 0.1% w/w must inform recipients and, upon request, consumers.

For cosmetic manufacturers, the SVHC communication obligation means:

Screening formulations: Check all ingredients against the SVHC Candidate List. If any ingredient is on the list, calculate its concentration in the finished product.
Communication to retailers: If an SVHC is present above 0.1% w/w, inform B2B customers (retailers, distributors) automatically. Inform consumers upon request within 45 days.
Monitoring list updates: ECHA updates the Candidate List twice per year. Formulations must be re-screened after each update.

Note that SVHCs on the Candidate List are not automatically prohibited in cosmetics — they are subject to communication obligations. However, SVHCs that progress to the Authorisation List (REACH Annex XIV) require specific authorisation for continued use, and SVHCs that are added to REACH Annex XVII are restricted.

REACH vs. EU Cosmetics Regulation: How Do They Interact?

The relationship between REACH and EU Cosmetics Regulation is governed by Article 2(6) of REACH, which states that substances used in cosmetic products are exempt from REACH authorisation requirements (but not from REACH registration or restriction requirements) where EU Cosmetics Regulation provides specific controls.

In practice, this means:

Requirement	REACH	EU Cosmetics Regulation
Substance registration	Yes (for manufacturers/importers >1 tonne/year)	No
Substance restrictions	Annex XVII	Annex II (prohibited), Annex III (restricted)
Authorisation for SVHCs	Exempt for cosmetics where Cosmetics Regulation applies	Annex II/III controls apply instead
CMR substances	Annex XVII restrictions	Article 15 — CMR substances generally prohibited
Communication obligations	SVHC >0.1% w/w	Labelling requirements

The practical consequence: cosmetic manufacturers must comply with both REACH Annex XVII restrictions and EU Cosmetics Regulation annexes. Where both apply to the same substance, the stricter requirement prevails.

Practical REACH Compliance Steps for Cosmetic Manufacturers

Step 1: Obtain SDS from All Raw Material Suppliers

Request current Safety Data Sheets from all raw material suppliers. SDS contain REACH registration numbers, SVHC information, and Annex XVII restriction status. A supplier who cannot provide a current SDS is a compliance risk.

Step 2: Screen Formulations Against REACH Annex XVII

For each ingredient in your formulation, check whether it appears in REACH Annex XVII. ECHA’s website provides a searchable Annex XVII database. Pay particular attention to:

Colorants (azo colorants, Entry 40)
Preservatives (some preservatives have Annex XVII restrictions)
Surfactants (NPE restrictions, Entry 72)
Heavy metal compounds (mercury, lead, cadmium restrictions)

Step 3: Screen Formulations Against the SVHC Candidate List

Download the current SVHC Candidate List from ECHA and screen all ingredients. Calculate the concentration of any SVHC present in the finished product. Implement communication procedures for SVHCs above 0.1% w/w.

Step 4: Verify REACH Registration Status of Raw Materials

For substances manufactured in or imported into the EU above 1 tonne/year, REACH registration is required. As a cosmetic manufacturer (downstream user), you are not responsible for registering substances — that’s your supplier’s obligation. But you should verify that your suppliers have registered the substances they supply. Unregistered substances cannot legally be placed on the EU market.

Step 5: Implement a Monitoring Programme

REACH Annex XVII is updated by the European Parliament and Council. The SVHC Candidate List is updated by ECHA twice per year. Establish a monitoring programme to track updates and assess their impact on your formulations.

The French Regulatory Context

In France, ECHA’s REACH enforcement is implemented by ANSES (Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail) and DGPR (Direction générale de la prévention des risques). French market surveillance authorities conduct inspections of cosmetic manufacturers and importers for REACH compliance.

France has also been active in proposing SVHC candidates and Annex XVII restrictions at the EU level — particularly for endocrine disruptors and CMR substances in consumer products. Brands selling in France should monitor French regulatory activity at ANSES for early warning of upcoming restrictions.

REACH compliance for cosmetic manufacturers is not a one-time exercise — it’s an ongoing programme of formulation screening, supplier management, and regulatory monitoring. The brands that manage it well integrate REACH screening into their product development process, so compliance is built in from the start rather than retrofitted before market launch.

At Care Europe, we conduct REACH compliance assessments for cosmetic manufacturers entering the EU market, including Annex XVII screening, SVHC candidate list review, and supplier SDS audits. Contact us at [email protected].

REACH Compliance for Cosmetic Manufacturers: The Annex XVII Checklist