REACH for cosmetic products

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REACH for cosmetic products

REACH for Cosmetics

REACH: Regulation (EC) No 1907/2006 on the Registration, Evaluation, Authorisation and Restriction of Chemicals, is the EU’s overarching framework for the management of chemical substances. It applies across virtually every industrial sector, including cosmetics.

Biorius supports cosmetic brands, ingredient suppliers, and exporters in navigating REACH requirements with precision, helping ensure compliance, maintain market access, and anticipate regulatory risks across the EU supply chain.

REACH and your cosmetic business

Being a cosmetic company does not exempt you from REACH. If your business manufactures, imports, uses, or distributes chemical substances in the EU, REACH almost certainly applies to some aspects of your operations. And if you are located outside the EU, including in countries such as Canada, the United States, the United Kingdom, Switzerland, Australia, or South Korea, exporting to the EU may create REACH related obligations in your supply chain that directly affect your market access.

If you operate within the EU

REACH obligations arise at the substance level across your entire supply chain, from ingredient sourcing through finished product distribution. Registration, restrictions, and authorisation requirements apply to you directly.

If you export to the EU from outside it

You are not directly subject to REACH, but your EU importer is, and their compliance burden flows back to you commercially. Understanding your exposure is a direct business concern.

Two distinct but interacting frameworks

REACH and the EU Cosmetics Regulation, Regulation (EC) No 1223/2009, are two separate legal frameworks with different objects and different obligations. Understanding the distinction and the interaction is essential.

EU Cosmetics Regulation

(EC) No 1223/2009

The EU Cosmetics Regulation governs the placing on the market of finished cosmetic products. It sets requirements for product safety assessment, labelling, ingredient restrictions, CPNP notification, and the appointment of an EU Responsible Person. This is the framework your finished products must comply with to be sold in the EU.

REACH

(EC) No 1907/2006

REACH governs chemical substances themselves, their manufacture, import, use, supply chain communication, and risk management. It applies to substances as such, in mixtures, and in certain circumstances in articles. A cosmetic product is legally a mixture under REACH. REACH obligations operate at the substance level: whether substances are registered with ECHA, whether they appear on regulated lists, and whether adequate safety information flows through the supply chain.

The two frameworks are complementary and must be managed in parallel. Their interaction is significant in practice. REACH restrictions and the authorisation list operate independently of the EU Cosmetics Regulation’s own prohibited and restricted substance lists.

Animal testing interaction: For substances used exclusively in cosmetics, the interaction between REACH and the cosmetic animal testing ban is also relevant. The European Commission and ECHA have clarified that registrants of substances used exclusively in cosmetics may not perform animal testing to meet REACH human health endpoint requirements, except for tests assessing risks to industrial workers.

Active restrictions affecting cosmetic formulations

REACH restrictions (Annex XVII) can directly prohibit or limit the use of specific substances in cosmetic formulations. Recent examples include:

Jun

2026

SILOXANES D4, D5, D6

Commission Regulation (EU) 2024/1328

The restriction on cyclic siloxanes D4, D5, and D6 prohibits their use above 0.1 percent by weight in cosmetic products from 6 June 2026. This affects a wide range of rinse-off and leave-on formulations that rely on siloxanes as emollients, carriers, or sensory modifiers.

2027

→ 2031

MICROPLASTICS

Commission Regulation (EU) 2023/2055

The phased microplastics restriction requires rinse off cosmetics to comply by 2027 and introduces labelling obligations for make up and nail products from 2031. Companies should begin reviewing formulations containing synthetic polymer particles now.

SVHCs

ongoing

AUTHORISATION

REACH Authorisation (Annex XIV)

REACH authorisation procedures can make cosmetic ingredients unavailable in the supply chain entirely if no authorisation is granted before a substance’s sunset date. This operates independently of the Cosmetics Regulation’s own ingredient lists and must be managed separately.

How Biorius can help

Biorius is a specialist cosmetic and chemicals regulatory consultancy with more than 15 years of experience helping cosmetic brands, ingredient suppliers, and non EU exporters, navigate EU compliance. Our REACH services for the cosmetics sector include:

Why Manage REACH with Biorius?

Biorius is an independent third-party expert in cosmetic and chemicals regulation, with more than 15 years of experience and a global reputation for trust and precision in EU compliance.

What sets Biorius apart:

Deep expertise across both REACH and the EU Cosmetics Regulation, managed together, not in silos
No guesswork: we communicate directly with your upstream supply chain to verify registration coverage before gaps become problems
Personalised service with a dedicated account manager and regulatory expert
Streamlined Only Representative setup if Biorius already handles your EU cosmetic compliance

When does REACH apply? The registration obligation

At the core of REACH is the registration obligation. Any substance manufactured in the EU or imported into the EU in quantities of one tonne or more per year, per legal entity, must be registered with ECHA before it is placed on the market.

For cosmetics, this means each ingredient substance in all imported formulations must be assessed individually to determine whether it meets the threshold. Registration is not required at the product level, it is required substance by substance.

1 t

per substance / per legal entity / per year

The “no data, no market” threshold. Any substance manufactured in the EU or imported into the EU at or above one tonne per year must be registered with ECHA before it can be placed on the market.

Aggregation is required: all quantities of the same substance across different formulations must be summed when calculating whether the threshold is met.

Even where registration is not required or is already covered by an upstream registrant, REACH restrictions (Annex XVII) and the authorisation requirement for Substances of Very High Concern, Annex XIV, apply independently to all actors in the supply chain. These obligations cannot be delegated and do not disappear because registration is handled elsewhere.

Discuss your REACH position

Whether you are a cosmetic brand formulating in Europe, an international exporter entering the EU market, including companies based in Canada, the United States, the United Kingdom, Switzerland, Australia, or China, an ingredient supplier assessing registration status, or an importer reviewing your compliance position, Biorius has the expertise to guide you precisely.

REACH for non-EU companies: international exporters

Companies established outside the EU are not directly subject to REACH registration obligations, even if they export products into EU customs territory. The obligation to register falls on EU established manufacturers and importers, or on a duly appointed Only Representative.

However, this does not mean non EU exporters are unaffected by REACH.

Non-EU

Manufacturer / Exporter

outside EU customs territory

EU-based

Importer

REACH obligations fall here

EU

Market

End customer

EU importers facing significant REACH obligations linked to your products will pass compliance costs to you, request substance documentation, or — if the burden cannot be managed — source from alternative already registered suppliers. Understanding your EU importer’s REACH position is therefore a direct commercial concern for any non EU exporter.

The EU importer's position

When a non EU manufacturer exports substances, formulations, or cosmetic products to the EU, the EU based importer legally becomes the responsible actor under REACH. The EU importer must assess whether the substance volumes it is importing meet the registration threshold, manage any Substances of Very High Concern communication obligations, and ensure that regulated substances are not present in impermissible concentrations.

The Only Representative mechanism

Non EU manufacturers have the option and often the commercial incentive to appoint an Only Representative in the EU. The Only Representative is an EU established legal entity that takes on the registration and compliance obligations of importers under REACH.

The Only Representative manages registration submissions to ECHA, maintains records of imported quantities, keeps Safety Data Sheets updated, and manages ongoing communication with importers and authorities.

It is important to note that the Only Representative mechanism is available exclusively to non EU manufacturers. Non EU distributors cannot appoint an Only Representative under REACH.

Appointing an Only Representative gives a non EU manufacturer direct control over its REACH registration, reduces dependency on individual EU importers for compliance, and provides flexibility to supply any EU customer, not only those who already have registration coverage.