CosmeticsEUEU: Cosmetic Products Regulation review announced for 2025

EU: Cosmetic Products Regulation review announced for 2025

 

The EU Commission has announced its intention to review the Cosmetic Products Regulation.  The initiative will assess whether the rules are working as intended.  The call for evidence from the market and various stakeholders will be opened soon.

The EU Cosmetic Products Regulation (Regulation (EC) No 1223/2009) is a key piece of legislation governing the production, sale, and safety of cosmetic products across the European Union. It was adopted in 2009 and fully implemented in July 2013, replacing the previous Cosmetics Directive to create a harmonized and rigorous regulatory framework across all EU member states. Its primary objective is to ensure a high level of safety for human health by setting strict requirements for cosmetics placed on the EU market.

Key Features and Requirements

  1. Safety and Responsibility: The regulation mandates that only safe cosmetic products can be marketed. Every cosmetic product must undergo a comprehensive safety assessment, and each product must have a designated “responsible person” (usually the manufacturer or importer) within the EU who is accountable for its compliance with the regulation.
  2. Good Manufacturing Practices (GMP): The regulation stipulates that cosmetic products must be manufactured according to Good Manufacturing Practices (GMP), which ensure quality and safety in production.
  3. Ingredient Restrictions: Certain ingredients, particularly those that may pose risks to human health, are either restricted or banned. The regulation includes annexes listing prohibited substances, substances with restricted use, and allowed colorants, preservatives, and UV filters. These lists are continually updated as scientific data evolve.
  4. Animal Testing Ban: The regulation enforces a ban on animal testing for cosmetic products and ingredients. Since 2013, it has been illegal in the EU to sell cosmetic products that have been tested on animals, regardless of where the testing took place, reflecting the EU’s commitment to alternative testing methods.
  5. Product Labeling and Claims: Labels on cosmetics must include essential information, such as the list of ingredients, usage instructions, expiration dates (if applicable), and the contact details of the responsible person. Claims about product efficacy, safety, or benefits must be substantiated, and misleading claims are prohibited.
  6. Cosmetic Product Safety Report (CPSR): The regulation requires that every cosmetic product has a detailed safety report, the CPSR, which includes information about product composition, microbiological quality, packaging, and the potential impact on human health.
  7. Notification and Transparency: Before a product can be marketed in the EU, it must be notified on the Cosmetic Products Notification Portal (CPNP), a centralized EU system for cosmetic product notifications. This portal improves transparency and traceability, allowing market surveillance authorities across the EU to access product information easily.
  8. Market Surveillance and Compliance: National authorities in each EU member state are responsible for monitoring and enforcing compliance. They have the power to inspect facilities, request documentation, and withdraw non-compliant products from the market.

To find out more about regulatory compliance for cosmetics, please contact the Product Compliance Institute directly.

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