The EU cosmetics regulation (1223/2009) explained for 2026

The EU cosmetics regulation explained

The EU cosmetics regulation is Regulation (EC) No 1223/2009, directly applicable in every Member State since 11 July 2013. Before launch, a product needs an EU-established responsible person, a cosmetic product safety report (CPSR), a product information file, a CPNP notification, and it must meet the ingredient annexes, the animal-testing ban and the labelling rules.

This European cosmetics regulation replaced Directive 76/768/EEC. CMR rules in Article 15 applied earlier, from 1 December 2010. Member States do not transpose it. Article references follow the consolidated version of 18 May 2026.

What counts as a cosmetic product

Article 2(1)(a) defines a cosmetic as any substance or mixture meant to touch the external parts of the body (skin, hair, nails, lips, external genital organs) or the teeth and the mucous membranes of the mouth. The purpose must be, only or mainly, to clean, perfume, change appearance, protect, keep in good condition or correct body odours. Products that are swallowed, inhaled, injected or implanted are not cosmetics (Art. 2(2)).

Article 3 requires the product to be safe under normal or reasonably foreseeable use. A warning on the pack doesn't excuse the other requirements.

The responsible person

Under Article 4, only a product with a responsible person (RP) may be placed on the EU market. The RP is a legal or natural person established in the EU. A non-EU brand cannot be its own RP.

Article 4(3) to (6) splits the role:

• A product made in the EU: the EU manufacturer. It may appoint another EU-established person by written mandate, accepted in writing.
• A product made in the EU by a non-EU manufacturer: an EU-established RP appointed by written mandate.
• An imported product: each importer, for the product it places on the market, unless it appoints an EU-established RP by mandate.
• A distributor becomes the RP if it sells under its own name or trademark, or changes the product in a way that may affect compliance. Translating the label alone doesn't count.

The RP must correct, withdraw or recall a non-compliant product, and tell the competent authorities at once about a risk to health (Article 5). Before supply, a distributor checks the RP address, batch number, ingredient list, language and durability date, and must not supply a product it believes does not comply (Art. 6). Manufacture must follow good manufacturing practice (Art. 8).

Safety assessment and the CPSR

Before launch, the RP ensures a safety assessment and a CPSR under Article 10 and Annex I. The assessment covers intended use and systemic exposure, and it is kept up to date.

Part A of the CPSR holds the safety information: composition, stability, microbiological quality (including the challenge test), impurities and packaging, exposure, toxicological profiles, and undesirable effects. Part B is the assessment: the conclusion, labelled warnings and instructions, and the reasoning. Products for children under three, and external intimate hygiene products, need a specific assessment.

The assessor needs a diploma or other formal qualification from a university course in pharmacy, toxicology, medicine or a similar discipline, or a course a Member State recognises as equivalent (Art. 10(2)). Non-clinical safety studies used in that assessment and done after 30 June 1988 must follow good laboratory practice or a recognised equivalent (Art. 10(3)). Annex I guidelines: Implementing Decision 2013/674/EU.

The product information file

Article 11 requires the RP to keep a product information file (PIF) for 10 years after the last batch was placed on the market. It holds a product description, the CPSR, the manufacturing method and a GMP statement, proof of a claimed effect where justified, and animal-testing data, including tests done for non-EU requirements. It must be readily accessible at the RP address on the label, in a language the authority easily understands.

CPNP notification

Before launch, the RP notifies the product under Article 13: category and name, RP and PIF address, origin for imports, Member State of placing, a contact person, nanomaterials, any CMR 1A or 1B substances, and the frame formulation. The original label and a packaging photo go in when the product is placed on the market. A distributor that translates the labelling also notifies (Art. 13(3)).

Notification uses the free Cosmetic Products Notification Portal, also used by authorities and poison centres.

Article 16 adds a nanomaterial notification six months before placing on the market. That step doesn't apply to nano colorants, preservatives or UV filters already regulated in Annexes IV to VI, or to nanomaterials that meet an Annex III entry.

The RP and distributors must report serious undesirable effects without delay to the authority of the Member State where they happened, with any corrective measures (Article 23).

Ingredient annexes and banned substances

EU cosmetics legislation sets ingredient rules in Article 14 and the annexes:

Colorants, preservatives and UV filters must be on the matching positive list and used under the listed conditions. Annex II's highest reference is 1767, Triphenyl Phosphate, fixed by a May 2026 corrigendum. That is a reference number, not a headcount: some entries are groups, and some are deleted. It was added by Regulation (EU) 2026/909, whose changes mostly apply to placing on the market from 1 January 2027.

Article 15 bans CMR substances with a harmonised classification in CLP Annex VI, Part 3. Category 1A and 1B substances stay banned unless four conditions are all met: food-safety compliance, no suitable alternatives, an application for a particular use with known exposure, and an SCCS opinion that the use is safe, including for vulnerable groups. Category 2 substances are banned unless the SCCS has found the use safe. After a 1A or 1B listing, the Commission must amend the annexes within 15 months, through its CMR omnibus acts. A technically unavoidable trace of a prohibited substance is tolerated if the product remains safe under Article 3.

The animal testing ban

Article 18 has banned finished-product animal testing in the EU since 11 September 2004. Ingredient testing in the EU, and sale of a product whose final formulation or ingredients were animal-tested to meet this Regulation, have been banned since 11 March 2009 for most endpoints. Repeated-dose toxicity, reproductive toxicity and toxicokinetics have been covered since 11 March 2013, whether or not an alternative exists (Commission page).

The ban covers testing done to meet cosmetics requirements. It doesn't stop every animal test that other chemicals law, such as REACH, may still require (2023 Commission communication).

Labelling requirements

Article 19 requires indelible, easily legible and visible lettering on the container and packaging:

• the RP's name or registered name and address (highlight the address where the PIF is kept, if several appear), plus country of origin for imports
• nominal content by weight or volume, except under 5 g or 5 ml, free samples and single-use packs
• the date of minimum durability, as "best used before the end of" or the Annex VII symbol. If durability exceeds 30 months, that date isn't required. Show the period after opening instead, unless durability after opening is irrelevant
• particular precautions, at least those in Annexes III to VI
• the batch number or product reference, on the packaging alone if the container is too small
• the function, unless clear from the presentation
• an ingredient list headed "ingredients", which may sit on the outer packaging alone

Ingredients go in descending order of weight when added. Those under 1% may follow, in any order. Fragrance is "parfum" or "aroma", plus allergens Annex III says must be named. Nanomaterials are followed by "(nano)". Names come from the Art. 33 glossary, which takes INCI into account. The current glossary is Implementing Decision (EU) 2025/1175, applying from 30 July 2026.

The Member State where the product reaches the end user sets the language for nominal content, durability, precautions and function (Art. 19(5)). That rule doesn't cover the ingredient list.

Claims

Article 20 says labels, marketing and advertising must not imply characteristics or functions the product doesn't have. A "not tested on animals" claim is allowed only if the manufacturer and its suppliers neither performed nor commissioned animal testing on the finished product, a prototype or any ingredient, and didn't use an ingredient others tested on animals to develop a new cosmetic. Regulation (EU) No 655/2013 sets six criteria: legal compliance, truthfulness, evidential support, honesty, fairness and informed decision-making.

Recent changes to watch

• Fragrance allergens: Regulation (EU) 2023/1545 added 56 allergens to the 24 already labelled individually, above 0.001% in leave-on products and 0.01% in rinse-off products. Placing non-compliant products was allowed until 31 July 2026. That date has passed. They may be made available until 31 July 2028.
• Regulation (EU) 2025/877 applied from 1 September 2025. It added Annex II entries 1731 to 1751, including TPO (Trimethylbenzoyl Diphenylphosphine Oxide), used in gel nails, and removed the old Annex III entry for professional nail use.
• Regulation (EU) 2026/78 applied from 1 May 2026. It amended Annexes II to V, added Annex II entries 1752 to 1766, revised the silver entries and changed the Annex V entry for o-Phenylphenol.
• Regulation (EU) 2026/909 amends Annexes II, III, V and VI, including Benzyl Salicylate, Triphenyl Phosphate, aluminium, zinc salts, citral, a DHHB impurity limit and hair dyes. For most changes, non-compliant products cannot be placed on the market from 1 January 2027, or made available from 1 July 2028.

The Chemicals Omnibus, proposed on 8 July 2025, would simplify rules and reduce paperwork under CLP, this Regulation and the Fertilising Products Regulation. Parliament and Council reached a provisional agreement in June 2026. As of 21 October 2026 that text was not law. Check the adopted act before you change a process.

UK cosmetics regulations

Great Britain kept Regulation 1223/2009 as amended by Schedule 34 of SI 2019/696, enforced under the Cosmetic Products Enforcement Regulations 2013. The GB responsible person must be established in the UK. Notify on SCPN before GB launch. Nanomaterials need at least six months' notice where that extra step applies. Keep the PIF for 10 years (GOV.UK, updated 29 June 2026).

Northern Ireland is different. Under the Windsor Framework the EU Regulation still applies, the RP must be in Northern Ireland or the EU, and notification goes through CPNP (GOV.UK, Northern Ireland). GB lists can diverge from the EU annexes, so check the GB lists separately.

RegAffairs AI answers questions about EU cosmetics requirements with source links.