Regulation (EC) No. 1223/2009 is the main legal framework governing cosmetic products in the European Union (EU). Its primary goal is to ensure a high level of consumer health protection and guarantee that products entering the market are safe. This regulation applies to all cosmetic products placed on the EU market, regardless of whether they are produced within the EU or imported. All manufacturers, importers, and distributors must comply with these requirements to legally market their products.

Key Requirements

1. Responsible Person (RP)

Every cosmetic product must have a Responsible Person (RP) based in the EU. The RP is responsible for ensuring that the product complies with all regulatory requirements, including safety, labeling, documentation, and market surveillance. For imported products, appointing an RP is mandatory.

2. Product Information File (PIF)

Before a product can be marketed, a Product Information File (PIF) must be compiled and kept available for regulatory inspection. The PIF includes:

• Product composition and active ingredients.
• Safety assessment, conducted by a qualified safety assessor.
• Manufacturing process description, ensuring compliance with Good Manufacturing Practices (GMP).

3. CPNP Registration

Before being placed on the market, all cosmetic products must be registered in the Cosmetic Products Notification Portal (CPNP). This electronic system allows regulatory authorities to monitor products and ensure compliance.

4. Safety Assessment and Banned Substances

A mandatory safety assessment must be carried out by a qualified professional to confirm product safety. Additionally, the EU strictly prohibits animal testing for both finished products and ingredients. Certain substances are also banned or restricted under the regulation’s annexes.

5. Labeling and Packaging

Product labels must include essential information:

• Manufacturer’s or Responsible Person’s name and address.
• List of ingredients (INCI nomenclature).
• Expiration date or Period After Opening (PAO).
• Usage instructions and warnings regarding potential side effects.

6. Market Surveillance

Even after a product is placed on the market, the RP must continuously monitor its safety, collect consumer feedback, and report any undesirable effects to the relevant authorities.

Conclusion

Regulation No. 1223/2009 establishes strict requirements for the manufacturing, labeling, safety, and market surveillance of cosmetic products. Manufacturers and importers must ensure full compliance to avoid penalties or product recalls. Adhering to this regulation not only guarantees legal market entry in the EU but also builds consumer trust and strengthens brand reputation.