EU Cosmetics Regulation: Requirements and the Substance Restrictions From 2027

The EU Cosmetics Regulation (Regulation (EC) No 1223/2009) is the EU law that sets the safety, ingredient, documentation and labelling rules for every cosmetic product made available on the EU market. It has applied in full since 11 July 2013. Each product needs a responsible person established in the EU, a safety assessment, a product information file and a notification to the European Commission before it is sold.

The annexes that list prohibited and restricted ingredients change regularly. The current change is Commission Regulation (EU) 2026/909. From 1 January 2027, cosmetic products that do not meet its new limits for substances such as Benzyl Salicylate, Citral, aluminium compounds and Triphenyl Phosphate may no longer be placed on the EU market. Products placed on the market before that date can still be sold, but not from 1 July 2028, or from 1 August 2028 for two substances.

This guide explains what the EU Cosmetics Regulation requires, who must comply, what Regulation (EU) 2026/909 changes and how to prepare. It is written for quality and compliance teams at brands, importers and retailers that sell cosmetics in the EU.

What is the EU Cosmetics Regulation?

The EU Cosmetics Regulation is Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products. It sets the rules that every cosmetic product made available on the EU market must meet, to protect human health and keep the internal market working (Article 1). It replaced Directive 76/768/EEC, has applied since 11 July 2013 (Articles 38 and 40) and applies directly in every member state.

It is also referred to as the EU Cosmetic Products Regulation. Its core rule is short. Under Article 3, a cosmetic product made available on the market must be safe for human health when used under normal or reasonably foreseeable conditions of use. The rest of the regulation describes how that safety is demonstrated, documented, communicated and checked.

The regulation does not provide for approval of each product by an authority. It makes one named responsible person accountable for each product, and requires that person to hold the safety evidence and to notify the product to the Commission before it is placed on the market (Articles 4, 10, 11 and 13).

Key terms

A cosmetic product is any substance or mixture intended to be placed in contact with the external parts of the human body (skin, hair, nails, lips and external genital organs) or with the teeth and the mucous membranes of the mouth, exclusively or mainly to clean them, perfume them, change their appearance, protect them, keep them in good condition or correct body odours (Article 2(1)(a)). A product intended to be ingested, inhaled, injected or implanted is not a cosmetic product (Article 2(2)).

Making available on the market is any supply of a cosmetic product for distribution, consumption or use on the EU market in the course of a commercial activity, whether paid for or free of charge (Article 2(1)(g)).

Placing on the market is the first making available of a cosmetic product on the EU market (Article 2(1)(h)). The difference between these two terms decides which of the 2027 and 2028 dates applies to a given product.

Who must comply with the EU Cosmetics Regulation?

Every company that places a cosmetic product on the EU market, or makes one available there, has duties under the EU Cosmetics Regulation. Most of them fall on the responsible person. Under Article 4(1), only cosmetic products for which a responsible person is designated within the EU may be placed on the market. Distributors, including retailers, have their own narrower duties under Article 6.

Which role you hold depends on what you do for each product.

A brand established outside the EU cannot act as its own responsible person. For an imported cosmetic product, each importer is the responsible person for the products it places on the market, unless it designates another person established in the EU by written mandate, and that person accepts in writing (Article 4(5)).

Distributors are not passive. Before making a product available, a distributor must verify that the label carries the responsible person's name and address, the batch number and the list of ingredients, that the language requirements are met and that the date of minimum durability has not passed (Article 6(2)). A distributor that has reason to believe a product does not conform must not make it available until it has been brought into conformity (Article 6(3)).

Article 5(1) lists the provisions the responsible person must ensure compliance with. These are the Cosmetics Regulation requirements that shape day-to-day work.

Safety assessment and product information file

The cosmetic product safety report (CPSR) is the document that demonstrates a product is safe. Annex I sets its content. Part A collects the safety information, including the composition, stability, microbiological quality, impurities, exposure and the toxicological profile of the substances. Part B is the safety assessment, carried out by a person with a formal qualification in pharmacy, toxicology, medicine or a similar discipline (Article 10(2)). The report must be kept up to date after the product is placed on the market (Article 10(1)(c)).

The product information file (PIF) holds the CPSR together with a description of the product, the manufacturing method and a statement of compliance with good manufacturing practice, proof of the effects claimed where justified, and data on any animal testing (Article 11(2)). It must be readily accessible to the competent authority at the responsible person's address shown on the label (Article 11(3)).

Notification through the CPNP

Before placing a product on the market, the responsible person submits a notification to the Commission by electronic means (Article 13(1)). It covers, among other things, the product category and name, the responsible person, the country of origin for imports, the presence of nanomaterials and the frame formulation.

According to the European Commission, this is done through the Cosmetic Products Notification Portal (CPNP), which is free of charge. Once a product is notified there, no further national notification is needed within the EU. The notification must be updated without delay when the information changes (Article 13(7)).

Labelling and claims

Under Article 19(1), the container and packaging must show, in indelible, easily legible and visible lettering:

• the name and address of the responsible person, and the country of origin for imported products
• the nominal content by weight or volume
• the date of minimum durability or, for products that last more than 30 months, the period after opening
• the precautions for use
• the batch number
• the function of the product, unless it is clear from its presentation
• the list of ingredients

The member state where the product is made available to the end user decides the language of most of this information (Article 19(5)). Claims must not imply characteristics or functions the product does not have (Article 20(1)). Commission Regulation (EU) No 655/2013 sets common criteria for claims and requires them to be consistent with the evidence in the product information file.

The EU's cosmetic safety regulation controls ingredients through five annexes. Under Article 14(1), a cosmetic product may not contain:

• substances prohibited in Annex II
• substances restricted in Annex III, unless they are used within the restrictions set there
• colorants, preservatives or UV filters other than those listed in Annexes IV, V and VI, or listed ones used outside their conditions

Article 15 adds a general rule for substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR) under the Classification, Labelling and Packaging Regulation (EC) No 1272/2008 (CLP). Their use in cosmetic products is prohibited, unless the conditions for an exception in Article 15 are met. The most recent CMR update, Commission Regulation (EU) 2026/78, has applied since 1 May 2026.

Traces are treated separately. The unintended presence of a small quantity of a prohibited substance is permitted where it is technically unavoidable in good manufacturing practice and the product remains safe (Article 17).

The annexes are not static. Where the use of a substance poses a potential risk to human health, the Commission may amend Annexes II to VI after consulting the Scientific Committee on Consumer Safety (SCCS) (Article 31(1)). Regulation (EU) 2026/909 is the latest amendment made on that basis.

What does Regulation (EU) 2026/909 change?

Commission Regulation (EU) 2026/909 of 27 April 2026 amends Annexes II, III, V and VI to the EU Cosmetics Regulation. It prohibits Triphenyl Phosphate, sets maximum concentrations by product type for Benzyl Salicylate, Citral, aluminium-containing ingredients, Acetylated Vetiver Oil and water-soluble zinc salts, and caps an impurity in the UV filter DHHB. It entered into force on 18 May 2026.

The entries below carry a transition period. In each case, products that do not comply may not be placed on the EU market from 1 January 2027.

The entry numbers are those that apply after two corrigenda, published on 5 May 2026 and 8 May 2026, renumbered them. The table shows examples. The full list of product types and limits is in the annex to the regulation.

Not everything in the regulation is a tightening. It adds four hair dye substances to Annex III with concentration limits and label warnings (HC Blue No 18, HC Yellow No 16, HC Red No 18 and Hydroxypropyl-p-phenylenediamine), and it allows silver zinc zeolite as a preservative at up to 1% in deodorant spray and powder foundation (Annex V, entry 61). Outside those conditions silver zinc zeolite remains prohibited. These entries carry no transition period.

Can non-compliant cosmetics still be sold after 1 January 2027?

Yes, for a limited time, if they were placed on the EU market before that date. Regulation (EU) 2026/909 sets two dates for each tightened entry. From 1 January 2027, products that do not comply may not be placed on the EU market. From 1 July 2028, they may not be made available at all. For Geranial and Neral the second date is 1 August 2028.

The first date stops new non-compliant product from entering the EU market, whether it is made in the EU or imported. The second date ends the sale of remaining stock by wholesalers and retailers. Under the definitions in Article 2(1) of the Cosmetics Regulation, placing on the market is the first supply on the EU market, and making available is any supply after that.

The responsible person must ensure that each product complies with the substance rules in Article 14 (Article 5(1)). In practice, EU cosmetics compliance with the 2027 limits means knowing the concentration of each affected substance in each product, by product type. The steps below follow from that duty.

The ingredient annexes are not the only part in motion. In July 2025 the European Commission proposed a regulation simplifying requirements for chemical products, COM(2025) 531, which would amend Regulation (EC) No 1223/2009 itself. The European Parliament adopted its first-reading position on 22 October 2026.

As of 11 November 2026, the procedure is still listed as ongoing: the Council has not yet adopted the act and it has not been published in the Official Journal. None of it is law yet. As adopted by Parliament, the text would:

• set a deadline for requesting a derogation when a substance is classified as CMR, and fixed periods for selling existing stock once such a substance is prohibited (Article 15)
• remove the six-month waiting period for notifying products that contain nanomaterials, while keeping the notification itself (Article 16(3))
• require offers made through distance sales, including online, to show key label information such as the responsible person, precautions and ingredients (new Article 19(7))
• replace the Commission's glossary of common ingredient names with internationally recognised nomenclature (Articles 19(6) and 33)

Until a final act is published, the requirements described in this guide apply unchanged.

The Cosmetics Regulation is the specific safety law for cosmetic products, and it connects to three horizontal regimes.

• REACH: under Article 67(2) of the REACH Regulation (EC) No 1907/2006, restrictions that address risks to human health do not apply to the use of substances in cosmetic products, because the Cosmetics Regulation covers those risks. Restrictions adopted on other grounds can still name cosmetic products in Annex XVII of REACH. Our REACH compliance guide explains the wider chemical obligations.
• CLP: a harmonised CMR classification under Regulation (EC) No 1272/2008 triggers the prohibition in Article 15 of the Cosmetics Regulation.
• General product safety: the General Product Safety Regulation (EU) 2023/988 (GPSR) applies only insofar as there are no specific provisions with the same objective in other Union law (Article 2(1) of the GPSR). Measures against cosmetics that pose a serious risk are exchanged through the EU rapid alert system, which the GPSR calls the Safety Gate Rapid Alert System (Articles 25(7) and 27(2) of the Cosmetics Regulation, Articles 25 and 50(2) of the GPSR).

For an example of ingredient screening across a large assortment, see our analysis of 600 cosmetic products sold on Temu.

Does the EU Cosmetics Regulation apply to brands outside the EU?

Yes, for every product sold on the EU market. The regulation covers any cosmetic product made available on the market (Article 1), wherever it is made. A product from a third country needs a responsible person established in the EU, which is the importer unless another EU-established person is designated by written mandate (Article 4(5)).

What are the penalties under the EU Cosmetics Regulation?

The regulation sets no amounts. Member states lay down the penalties for infringements, and those penalties must be effective, proportionate and dissuasive (Article 37). Separately, authorities can require the responsible person to bring a product into conformity, withdraw it or recall it (Article 25).

The framework of the EU Cosmetics Regulation has been in place since 2013. The moving part is the annexes. Each amendment sets limits by substance and by product type, with its own dates, and each one has to be traced back through every formulation, every supplier and every item still in stock.

That is the problem Complir was built around: relating a regulatory change to the products it affects, and collecting supplier evidence through structured requests, with visibility of what is still missing. The team reviews and approves the result.

If the 2027 limits have you checking formulations one product at a time, see how Complir relates a regulatory change to the products it affects.

Sources & References

• Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products: EUR-Lex, Official Journal text
• Regulation (EC) No 1223/2009, consolidated version of 18 May 2026: EUR-Lex
• Commission Regulation (EU) 2026/909 of 27 April 2026 amending Annexes II, III, V and VI: EUR-Lex
• Corrigendum to Regulation (EU) 2026/909, 5 May 2026 (Annex III entry numbers): EUR-Lex
• Corrigendum to Regulation (EU) 2026/909, 8 May 2026 (Annex II entry number): EUR-Lex
• Commission Regulation (EU) 2026/78 of 12 January 2026 on CMR substances in cosmetic products: EUR-Lex
• Commission Regulation (EU) No 655/2013 on common criteria for cosmetic claims: EUR-Lex
• "Keeping pace with science: EU updates cosmetic ingredient rules": European Commission
• Cosmetics legislation overview: European Commission, DG GROW
• Cosmetic Products Notification Portal: European Commission, DG GROW
• Proposal COM(2025) 531 on simplification of requirements for chemical products: EUR-Lex
• Procedure 2025/0531(COD), status and steps: EUR-Lex
• Position of the European Parliament adopted at first reading on 22 October 2026: European Parliament
• Regulation (EC) No 1907/2006 (REACH), consolidated version of 22 June 2026: EUR-Lex
• General Product Safety Regulation (EU) 2023/988: EUR-Lex

This article is for informational purposes only and does not constitute legal advice. Regulatory requirements may vary by product category, market, and specific circumstances. Consult with a qualified legal professional for compliance guidance specific to your situation.