In Europe, cosmetic regulation is governed by the European Union (EU) and its regulatory framework known as the EU Cosmetics Regulation (EC) No 1223/2009. This regulation ensures the safety and proper labelling of cosmetic products sold within the EU market. Here are some key points about cosmetic regulation in Europe:

  1. Safety Assessment: The EU Cosmetics Regulation requires that all cosmetic products undergo a safety assessment before they can be placed on the market. This assessment includes evaluating the ingredients used, potential risks associated with their use, and ensuring that the product is safe for consumers under normal or reasonably foreseeable conditions of use.
  2. Prohibited and restricted substances: The regulation prohibits the use of certain substances in cosmetics that are considered harmful or unsafe. For example, substances classified as carcinogens, mutagens, reproductive toxins, or substances that have specific restrictions due to their potential adverse effects are generally not allowed in cosmetic products.
  3. Product Information File (PIF) and Cosmetic Product Safety Report (CPSR): Cosmetic manufacturers or importers must create and maintain a Product Information File (PIF) for each cosmetic product they place on the market. The PIF contains detailed information about the product, including its formulation, safety data, and evidence of compliance with the regulation. The PIF also contains a Cosmetic Product Safety Report (CPSR) which provides a comprehensive safety assessment and supporting data for the product.
  4. Notification: Prior to introducing a cosmetic product to the EU market, manufacturers or importers must notify the competent authorities via the electronic portal CPNP (Cosmetic Product Notification Portal).
  5. Claims: All claims regarding to cosmetics must adhere to and be backed by common criteria outlined in the Annex of Commission Regulation (EU) No 655/2013. These criteria encompass legal compliance, truthfulness, evidential support, honesty, fairness and informed decision-making.
  6. Labelling Requirements: The EU Cosmetics Regulation establishes specific labelling requirements to ensure that consumers have accurate and clear information about the cosmetic products they purchase. These requirements include listing the ingredients (INCI list), providing proper product identification, ensuring the durability of label information, and stating precautions and warnings where necessary.
  7. Animal Testing Ban: As of March 2013, animal testing for cosmetic products and their ingredients has been prohibited in the EU. This ban extends to both finished products and ingredients intended for cosmetic use.
  8. Market Surveillance: EU Member States bear the responsibility of executing market surveillance activities to ensure adherence to cosmetic regulations. They can conduct checks on products currently on the market, verify product safety and labelling, and initiate appropriate enforcement actions in cases of non-compliance. For more details, please refer to the Cosmetovigilance section.

Any Questions?

Do you have any questions? We are here to help you!
Let us know how we can lighten your way to your regulatory success!

Contact us