August 02, 2025

Cosmetic product safety is vital to public health and consumer trust in the EU. Regulation (EC) No. 1223/2009 sets a legal framework ensuring that cosmetics placed on the EU market are safe under normal or foreseeable use.

1. Overview of Regulation (EC) No. 1223/2009

This regulation applies to all cosmetics sold in the EU, aiming to protect health, harmonize safety standards, ensure transparency, and promote alternatives to animal testing. Key requirements include a safety assessment before market release, maintaining a Product Information File (PIF), and notification through the Cosmetic Product Notification Portal (CPNP).

2. What Is Cosmetic Safety Assessment?

It is a scientific evaluation of product composition, intended use, exposure, and toxicological risks, documented in the Cosmetic Product Safety Report (CPSR). The CPSR must be ready before marketing and accessible to regulators.

3. CPSR Structure (Annex I)

  • Part A: Objective data on composition, stability, microbiological quality, toxicology, impurities, and exposure.
  • Part B: Expert assessor’s opinion, safety conclusion, usage warnings, and justification.

4. Key Compliance Principles

  • Qualified Assessor: Only a professional with expertise in toxicology or related fields may perform the safety assessment.
  • Ingredient Compliance: Ingredients must comply with annexes covering prohibited, restricted substances, colorants, preservatives, and UV filters.
  • Alternatives to Animal Testing: Use validated in vitro, in silico, or human data methods since animal testing is banned.
  • Exposure & Margin of Safety (MoS): Compute MoS based on absorption, exposure, and vulnerable groups.
  • Labeling: Must comply with Article 19 — ingredient list, content, expiry, function, batch details, and Responsible Person info; no misleading claims allowed.

5. Product Information File (PIF)

Must be maintained for 10 years, including product details, CPSR, GMP statement, proof for claims, and animal testing history (pre-ban).

6. Role of the Responsible Person (RP)

The RP, established in the EU, ensures product compliance, submits notifications, holds the PIF, and manages post-market surveillance.

7. Common Pitfalls

Avoid missing toxicological data, unqualified assessors, lack of exposure justification, ignoring impurities, and labeling errors.

8. Special Considerations

  • Natural/Organic Products: Still require rigorous safety evaluation due to allergens or contaminants.
  • Imported Cosmetics: Must meet full EU standards and have complete CPSRs and traceability.

9. CPSR Impact on Labeling

Safety assessments guide mandatory warnings and restrictions, especially for vulnerable populations and ingredient disclosures.

10. Emerging Trends

Focus on sustainable cosmetics, personalized safety assessments, greater transparency, and advanced non-animal testing methods.

How Maven Supports You

Maven offers expert support for CPSR preparation, ingredient toxicology, label compliance, PIF and CPNP management, risk assessments, and clean beauty regulatory strategy, ensuring safe, compliant, market-ready products in the EU.

Conclusion

Cosmetic safety assessment per EU Regulation (EC) No. 1223/2009 is a critical scientific and regulatory process. Adequate evaluation and documentation foster consumer safety and enable successful market access. Partner with Maven for precise navigation of cosmetic regulations.