Compliance with the EU Cosmetic Regulation

Background

On July 11, 2013, the EU Cosmetics Regulation (EC) No 1223/2009 entered into force in the countries of the European Economic Area (EEA), which includes all the countries of the European Union and Norway, Iceland, and Liechtenstein. It set out rules and requirements for cosmetic products to be sold within those countries, repealing the local Directives. Thus,  ensuring the smooth functioning of the internal market for cosmetic products within the European Union.

The regulation aims to ensure the safety of cosmetic products, protecting consumers’ health while providing clear information.

Key steps for compliance

Make sure the product falls under this regulation – does it meet the definition of a cosmetic product, according to the regulation:

"any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, 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."

Nominate a Responsible Person: a legal or natural person based within the EU designated by a cosmetic product manufacturer or importer, who is responsible for ensuring compliance with the regulatory requirements.

Ensure the safety of the product:

• Prohibiting or restricting the use of certain substances in cosmetic products that are known to be harmful.
• Requiring manufacturers to carry out safety assessments on their products before placing them on the market – Cosmetic Product Safety Report (CPSR).

Labeling of the cosmetic products: The regulation requires cosmetic products to be labeled with specific information, such as the name and address of the responsible person, a list of ingredients, and instructions for use. It is mandatory to list the ingredients in order of weight, and include warnings and precautions when necessary.

Ensuring that cosmetic claims are truthful and not misleading: Any claims made about cosmetic products, such as claims of efficacy or performance, must be supported by appropriate evidence.

Prohibiting animal testing of cosmetic products and their ingredients within the EU, as well as the import of products that have been tested on animals outside the EU.

Provide a complete file – Product Information File (PIF) – must be kept by the Responsible Person and be at the disposal of the Authorities in case of Inspection. One PIF is needed per product, it must contain accurate data, and serve as a central repository of information on the cosmetic product.

Companies are required to notify cosmetic products to a central database before placing them on the market.

Keep the product compliant with regulatory evolution – companies must monitor the regulatory and safety news and update the PIF accordingly. They must also report any adverse effects that occur once the product is on the market.

Overall, the EU Cosmetics Regulation aims to ensure that cosmetic products sold in the EU are safe for consumers to use and that manufacturers/or responsible persons are held responsible for the safety of their products.

Our services

• EU-based Domestic Responsible Person;
• Cosmetic Safety Assessment Report (CPSR);
• Product Information File (PIF);
• Labeling; and
• Notification on the Cosmetic Product Notification Portal.

Further Information

EU Bans 4-MBC and Supplements Alpha-arbutin and Arbutin into the Restricted Ingredients List from 2025