EU Cosmetic Compliance

The European Union regulates cosmetics under a single instrument, Regulation (EC) No 1223/2009, directly applicable across all member states and, through the EEA Agreement, in Norway, Iceland and Liechtenstein. A product cannot be placed on the market until four elements are in place, and they all sit under a Responsible Person who carries the legal duty for each of them.

The Responsible Person

Every cosmetic placed on the EU market must have a Responsible Person established within the Union (Articles 4 and 5). The role can sit with the manufacturer or importer, or be delegated to a third party by written mandate, but the establishment must be inside the EU; a UK or other third-country address will not satisfy it. The Responsible Person ensures the safety assessment is in place, holds the Product Information File, makes the CPNP notification, ensures labelling and claims comply, runs cosmetovigilance, and takes corrective action and informs the competent authorities where a product is non-compliant or unsafe. Oxford Biosciences acts as EU Responsible Person through our company registered in the Republic of Ireland.

The Cosmetic Product Safety Report

Safety is substantiated through a Cosmetic Product Safety Report under Article 10 and Annex I. Part A assembles the safety information: the quantitative and qualitative composition, physico-chemical characteristics and stability, microbiological quality, impurities and traces, packaging information, normal and reasonably foreseeable use, exposure to the product and to each substance, the toxicological profile of the ingredients, and any undesirable effects. Part B is the assessor’s reasoned conclusion, including the margin of safety derived from the no-observed-adverse-effect level and the systemic exposure dose, the labelled warnings, and the reasoning. Annex I requires the assessor to hold a qualification in pharmacy, toxicology, medicine or a similar discipline; ours are prepared and signed by a Clinical Pharmacologist.

The Product Information File

The Responsible Person keeps a Product Information File under Article 11, containing the product description, the safety report, a description of the manufacturing method with a statement of good manufacturing practice compliance, proof of the claimed effect where justified, and data on any animal testing. It is kept readily accessible to the competent authority of the member state where the file is held, in a language that authority can understand, and retained for ten years after the last batch was placed on the market.

Notification through CPNP

Before a product is placed on the market the Responsible Person notifies it through the Cosmetic Products Notification Portal (CPNP) under Article 13. The notification covers the product category and name, the Responsible Person, the frame formulation, the presence of CMR substances and nanomaterials, and the original labelling and, where reasonably legible, a photograph of the packaging, so that competent authorities and poison centres hold the information they need. Importers notify per product they place on the market; distributors who make a product available in another member state and translate the labelling notify the relevant elements.

Labelling and claims

Labelling follows Article 19, requiring the Responsible Person’s name and EU address, the nominal content, the date of minimum durability or period-after-opening, precautions, the batch number, the function, and the ingredient list by INCI name. Claims follow Article 20 and Commission Regulation (EU) No 655/2013, which sets six Common Criteria, legal compliance, truthfulness, evidential support, honesty, fairness and informed decision-making, given operational detail by the Commission’s Technical Document on cosmetic claims and its guidance on “free-from” and hypoallergenic claims.

The annexes and the 2026 Omnibus acts

The substance controls sit in Annexes II to VI, prohibited substances, restricted substances, and permitted colorants, preservatives and UV filters. They are revised regularly, principally to fold in new CMR classifications from the CLP Regulation, through Omnibus acts. Two took effect in 2026. Omnibus VIII, Commission Regulation (EU) 2026/78, applies from 1 May 2026 and prohibits or restricts substances newly classified as CMR under the 22nd Adaptation to Technical Progress, including perboric acid and certain nanomaterials, with silver and hexyl salicylate restricted by condition; it draws no distinction between placing and making available, so affected stock had to be off the market by that date. The second ingredient Omnibus, Commission Regulation (EU) 2026/909, was published on 28 April 2026 and entered into force on 18 May 2026, revising the restrictions on Citral (including geranial and neral), Benzyl Salicylate, water-soluble zinc salts and the UV filter DHHB, and adding new hair dyes and a preservative to Annex V, with transitional periods running into 2027. Keeping a formulation compliant means tracking both tracks, and checking it separately against the diverging Great Britain annexes for any product also sold there.

Cosmetics are not CE-marked

Cosmetics do not carry CE marking. The CE mark applies to product categories such as toys, electronics and medical devices, not cosmetics. A cosmetic demonstrates compliance through its safety report, its CPNP notification and its Responsible Person, never a CE mark, so any supplier suggesting a cosmetic “needs a CE mark” has misunderstood the regime.

How we help

We act as your EU Responsible Person through our Irish-registered entity, prepare and sign the CPSR, compile and hold the Product Information File, make the CPNP notification, and review labelling and claims against Article 19, Article 20 and the Common Criteria. We track the Omnibus annex updates and flag where a product needs reformulation or relabelling against the 2026 dates.