Launching a cosmetic product in the European Union

An ordinary cosmetic is ready for an EU launch. Its formula and label need review, its safety information must be maintained, and the product must be notified before it is placed on the market.

This guide focuses on ordinary cosmetics. Different formulas, ingredients and claims raise different questions; a sunscreen or product making medicinal claims needs its own classification and requirements review. This article covers the European Union, not Great Britain. For a broader comparison, read launching a cosmetic product across eight markets. Sources were checked on 3 November 2026.

This article was generated with AI and checked against the sources linked below. It has not been independently reviewed by a local regulatory professional.

Confirm the product and its claims

Identify the formula, intended application, target users, packaging, directions and claims as they will appear in the EU. Cosmetics are governed by Regulation (EC) No 1223/2009. A claim that gives the product a medicinal purpose may lead to a different classification and additional rules. Check the presentation of the complete product, including advertising, rather than relying only on its ingredient list.

Review the current annexes to the Cosmetics Regulation for prohibited and restricted substances and the rules governing colourants, preservatives and UV filters. This consolidated text reflects the rules on 18 May 2026; check the EUR-Lex act record for later amendments and their application dates. Ingredient concentration, product type and required warnings can affect whether a particular use is permitted. CosIng is a useful search tool, but the applicable legislation is the basis for the decision.

The European Commission’s legislation page lists Regulations 2026/78 and 2026/909 among the 2026 amendments to the Cosmetics Regulation. They change entries for specific substances; the latter includes ingredient-specific transition periods. Check the relevant entry and its dates for the actual formula, including any corrigenda, rather than assuming one deadline applies to every ingredient. European Commission: cosmetics legislation.

Identify the responsible person

Only a cosmetic product with a designated responsible person established in the EU can be placed on the EU market. Depending on the supply arrangement, the manufacturer, importer or another designated person can take that role under the regulation’s conditions. Confirm it in writing before ordering market-specific labels.

The responsible person ensures that applicable obligations are met; outsourcing a safety assessment or notification does not remove that responsibility. Agree who receives formula and manufacturing information, keeps the product information file and handles authority enquiries. The responsible person’s name and address must appear on the label under the applicable labelling rules. European Commission: cosmetics legislation.

Prepare the safety report and product file

Before the cosmetic is placed on the market, the responsible person must ensure that it has undergone a safety assessment and that a cosmetic product safety report has been prepared. The assessment is performed by a person with qualifications meeting the regulation’s requirements. Supply the assessor with the actual formula, intended use, ingredient information, product characteristics and available evidence. The assessor determines what further information is needed.

The product information file, or PIF, connects the report to the product. It includes a product description, the safety report, a description of manufacture and a statement on good manufacturing practice, proof of claimed effects where justified, and relevant animal-testing data. Keep it updated and available to the competent authority at the responsible person’s label address. The regulation specifies retention for ten years after the last batch is placed on the market.

Use identifiable formula, packaging and artwork versions. If the fragrance supplier changes its composition, the team needs to know which safety assessment and notification were based on the earlier information.

Notify through CPNP before placement

The responsible person submits required product information through the European Commission’s Cosmetic Products Notification Portal (CPNP) before the product is placed on the market. The information includes product identification, responsible-person contact details and information required for treatment purposes. A CPNP submission is a notification, not a substitute for safety assessment or proof that authorities have approved the product.

The Commission says a product notified through CPNP does not need another national cosmetic notification within the EU. Certain nanomaterials have additional rules and can trigger separate notification requirements; assess the formula rather than assuming that the ordinary product notification covers every situation. European Commission: CPNP.

Review the label and keep the information current

Article 19 of the Cosmetics Regulation sets out label information, subject to its conditions and exceptions. This includes responsible-person details, nominal content, durability information where applicable, precautions, batch identification, product function unless clear from presentation, and ingredients. For imported products, country of origin must be specified. The language of certain information depends on the Member State in which the product is made available.

For a fragranced lotion, verify supplier information and the current applicable fragrance-allergen rules and transition provisions. A list copied from an earlier label or a supplier’s generic statement may not describe the finished concentration. Decide which information needs to change when the formula, contact details or claims change, then update the PIF and notification as required.

After launch, maintain a route for complaints, serious undesirable-effect reporting and corrective action. This guide is a starting point for planning; a qualified assessment of the actual product and current rules is needed before release.

The responsible person’s duties when something goes wrong

Article 5 requires a responsible person who believes, or has reason to believe, that a cosmetic it placed on the market does not comply to take the corrective measures needed to bring it into conformity, withdraw it or recall it, as appropriate. If the product presents a risk to human health, the responsible person must immediately inform the relevant national authorities, including details of the non-compliance and measures taken. It must cooperate with authorities and provide information and documentation following a reasoned request.

Under Article 23, the responsible person and distributors must notify serious undesirable effects known to them or reasonably expected to be known to them to the competent authority of the Member State where the effect occurred without delay, in accordance with that article. This duty is distinct from the Article 5 notification of a product posing a risk. The responsible person should agree in advance who collects complaints, evaluates incidents, contacts authorities and coordinates affected stock.

Where the conditions of Article 25 are met, a competent authority can require appropriate corrective measures, withdrawal or recall within a specified period. The regulation also leaves Member States to establish penalties for infringements; consequences depend on the applicable national rules and facts. Appointment as responsible person does not, by itself, determine who must pay damages in a civil claim. Contracts and product-liability rules require separate review. Cosmetics Regulation, Articles 5, 23, 25 and 37.

For example, EU product-liability rules can make a producer liable without fault for damage caused by a defective product; the relevant producer can include an importer or a company putting its name on a product. Under the earlier Product Liability Directive, the injured person must prove the damage, the defect and the causal relationship between them. This is a separate question from the responsible-person duties under the Cosmetics Regulation. The EU’s newer Product Liability Directive is due for transposition by 9 December 2026; the transition depends on when the product was placed on the market or put into service. Assess the applicable national law and circumstances of the claim, especially around that date. EUR-Lex: Directive 85/374/EEC, Article 4; European Commission: liability for defective products; EUR-Lex: Product Liability Directive.

Sources

• Regulation (EC) No 1223/2009 on cosmetic products, consolidated text of 18 May 2026, especially Articles 4, 8, 10, 11, 13 and 19. Check later amendments, annexes and applicable transition dates for the product.
• European Commission: cosmetics legislation.
• European Commission: Cosmetic Products Notification Portal.
• European Commission: fragrance allergen labelling.