You can click the link below to access the EU Cosmetics Regulation:

EU Cosmetics Regulation (EC) No 1223/2009

What Is the EU Cosmetics Regulation? What Is Its Purpose?

The EU Cosmetics Regulation is the legal framework applicable to cosmetic products placed on the European Union market. The main objectives of the Regulation are to ensure the free movement of cosmetic products within the market and to protect human health.

Scope of the EU Cosmetics Regulation

According to the Regulation, a “cosmetic product” is any substance or mixture intended to be placed in contact with the external parts of the human body (such as the skin, hair, nails, lips and external genital organs) or with the teeth and the 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. Products that do not fall within the definition of a cosmetic product, such as medicinal products, medical devices or biocidal products, are not covered by the Regulation.

Examples of products falling within the scope of the Regulation include skin care creams and masks, make-up removal products and shampoos.

Key Obligations Under the EU Cosmetics Regulation

  • A Responsible Person established within the European Union must be designated for each cosmetic product placed on the EU market. The Responsible Person is responsible for ensuring that the cosmetic product complies with the applicable requirements of the Regulation. For imported cosmetic products, the importer is the Responsible Person by default, unless the importer designates, by written mandate, another person established within the European Union to act as the Responsible Person.
  • A Product Information File (PIF) must be maintained by the Responsible Person for each cosmetic product placed on the EU market. The PIF must contain the information and documentation required under Article 11 of the Regulation, including a description of the cosmetic product, the Cosmetic Product Safety Report (CPSR), a description of the manufacturing method and a statement of compliance with Good Manufacturing Practice (GMP), as well as proof of the effect claimed where justified by the nature or effect of the product. The PIF must be kept for a period of 10 years following the date on which the last batch of the cosmetic product was placed on the market.
  • Before a cosmetic product is placed on the EU market, the Responsible Person must ensure that the product has undergone a cosmetic product safety assessment and that a Cosmetic Product Safety Report (CPSR) is established in accordance with Annex I of the Regulation. The safety assessment must be carried out by a suitably qualified safety assessor holding a diploma or other evidence of formal qualifications in pharmacy, toxicology, medicine or a similar discipline, or a qualification recognised as equivalent by a Member State.
  • Products must be notified through the European Commission’s central electronic portal, the Cosmetic Products Notification Portal (CPNP), before being placed on the market.
  • All cosmetic products must be manufactured in accordance with Good Manufacturing Practice (GMP).
  • Companies must also comply with the restrictions laid down under the Cosmetics Regulation.
  • Product claims must comply with the requirements of Article 20 of the Regulation and must be supported by adequate and verifiable evidence where required. Claims must not imply characteristics or functions that the cosmetic product does not have.

Comply with the EU Cosmetics Regulation with Chemleg

Chemleg helps you place your cosmetic products on the European Union market in compliance with the applicable requirements. Our services within this scope include:

You can arrange a meeting with our experts to obtain detailed information about the compliance of your products.