Regulation

EU Cosmetic Regulation (1223/2009)

Regulation (EC) No 1223/2009 is the single EU instrument governing the placing on the market of cosmetic products. It defines what a cosmetic is, identifies the responsible person, sets safety-assessment requirements, lists prohibited and restricted substances, and regulates labelling and claims.

The instrument

Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products is a directly applicable EU regulation. It came into application on 11 July 2013 and replaced Directive 76/768/EEC, which had governed cosmetics in the EU since 1976. As a regulation rather than a directive, it applies uniformly across all Member States without national transposition: the same substantive rules apply to a moisturiser sold in France, Italy, Spain, Portugal, Belgium, Germany or any other Member State.

The legal basis is Article 95 of the EC Treaty (now Article 114 TFEU) on the approximation of laws for the establishment and functioning of the internal market, with the dual aim of ensuring a high level of consumer safety and the free movement of cosmetic products within the EU.

Scope and definition of a cosmetic product

Article 2 of the Regulation defines a "cosmetic product" as any substance or mixture intended to be placed in contact with the external parts of the human body — epidermis, hair system, nails, lips, external genital organs — or with the teeth and mucous membranes of the oral cavity, with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition, or correcting body odours.

Three points follow from this definition. First, the application site is restricted: a product intended for ingestion or systemic administration is not a cosmetic. Second, the functions are limited to the list given: cleaning, perfuming, changing appearance, protecting, keeping in good condition, correcting body odours. Third, products that meet the definition of a medicinal product (under Directive 2001/83/EC) cannot also be cosmetics — the medicinal-product classification prevails.

Products typically falling within Regulation 1223/2009 include skin creams, sunscreens, shampoos, toothpastes (in their cosmetic form), deodorants, make-up, fragrances, and many products sold in parapharmacies.

The responsible person

Article 4 requires that every cosmetic product placed on the EU market be associated with a single "responsible person" (RP) established in the EU. The RP is the legal or natural person responsible for ensuring that the product complies with the Regulation. For products manufactured in the EU, the RP is by default the manufacturer; for imported products, the importer is the RP unless another EU-established person is designated in writing.

The RP is the point of contact for national authorities, holds the Product Information File (PIF) at the address indicated on the label, and is responsible for taking corrective action where a product is found to be non-compliant or unsafe. The RP designation must be discoverable from the product label.

Safety assessment and the Product Information File

Article 10 requires that, before a cosmetic product is placed on the market, the responsible person ensures that a cosmetic product safety assessment is performed and a cosmetic product safety report (CPSR) is drawn up. The safety assessment must be carried out by a suitably qualified person — typically a pharmacist, toxicologist or other relevantly qualified scientist — and must consider both the intrinsic toxicology of the ingredients and the conditions of normal and reasonably foreseeable use of the finished product.

The CPSR forms part of the Product Information File (PIF), which the responsible person must hold for ten years after the last batch of the product was placed on the market (Article 11). The PIF must be made available to national competent authorities on request, in an EU official language acceptable to them.

CPNP notification

Article 13 requires the responsible person to notify each cosmetic product to the Commission through the Cosmetic Products Notification Portal (CPNP) before it is placed on the market. The notification covers the category of the product, its name, the name and address of the responsible person, the country of origin in the case of import, the Member State in which it will be made available, contact details, and certain composition information including the presence of substances classified as carcinogenic, mutagenic or toxic to reproduction (CMR) and of nanomaterials.

The CPNP is operated by the European Commission and is accessible to national authorities and to the European poison-control centres. It is not a pre-marketing authorisation: notification does not constitute approval of the product, and the responsible person retains full responsibility for compliance.

Annexes II to VI

The substantive product rules are largely contained in the Annexes to the Regulation, which are updated by Commission regulation as the science evolves:

• Annex II — list of substances prohibited in cosmetic products.
• Annex III — list of substances allowed subject to restrictions on concentration, conditions of use and required warnings (for example, certain alpha-hydroxy acids and salicylic acid).
• Annex IV — list of permitted colorants.
• Annex V — list of permitted preservatives.
• Annex VI — list of permitted UV filters for sunscreens.

A cosmetic product placed on the EU market may not contain substances in Annex II at any concentration, may contain substances in Annex III only within the stated limits and with the stated labelling, and may use only colorants, preservatives and UV filters from Annexes IV, V and VI respectively.

Claims

Article 20 of the Regulation sets the general principle that claims used on cosmetic products must not be misleading. The detail is laid down in Commission Regulation (EU) No 655/2013, which establishes common criteria for the justification of claims used in relation to cosmetic products. The six criteria are legal compliance, truthfulness, evidential support, honesty, fairness, and informed decision-making.

Claims that go beyond cosmetic function — for example, claims to "treat" a disease, or to act pharmacologically on the body — re-classify the product as a medicinal product and remove it from the scope of Regulation 1223/2009. This boundary is policed both by the responsible person at product-design stage and by national authorities post-market.

Enforcement

Enforcement is the role of national authorities: ANSM in France, the Ministero della Salute in Italy, AEMPS in Spain, INFARMED in Portugal, FAMHP in Belgium, the BVL and federal-state authorities in Germany. They carry out market surveillance, investigate undesirable effects reported to them, and may order the withdrawal, recall or modification of non-compliant products. Penalties are set by national law within the framework of Article 37 of the Regulation.

Last reviewed: May 2026.