Before a cosmetic product can be legally placed on the EU market, it must undergo a comprehensive safety assessment conducted by a qualified safety assessor. This evaluation ensures that the product is safe for consumers and fully complies with Regulation (EC) No. 1223/2009. The results of this assessment must be documented in the Product Information File (PIF), which must be available for regulatory inspections.

Key Steps in the Safety Assessment Process

1. Toxicological Assessment of Ingredients
   • Each ingredient is evaluated for its potential health risks, including:
     • Irritation and sensitization (e.g., does the product cause skin reactions?).
     • Carcinogenic, mutagenic, or reproductive toxicity risks (CMR substances).
   • The Margin of Safety (MoS) is calculated to ensure that the product’s ingredients remain at safe concentration levels.
2. Microbiological Safety
   • Products with high water content (e.g., creams, lotions) must be tested for microbial contamination.
   • The Preservative Efficacy Test (PET) assesses whether the preservatives effectively prevent bacterial growth over time.
3. Exposure Assessment
   • The frequency and amount of product use are analyzed based on:
     • Whether it is a leave-on (e.g., moisturizers, serums) or rinse-off (e.g., shampoos, cleansers) product.
     • The target consumer group (e.g., general use vs. children, sensitive skin users).
4. Final Safety Report
   • After all safety evaluations are completed, a Cosmetic Product Safety Report (CPSR) is compiled.
   • This report must be kept available for inspection by EU regulatory authorities and serves as proof that the product has passed the necessary safety checks.

Why Cosmetic Safety Assessments Are Essential

Ensuring the safety of cosmetic products is not only a legal requirement but also a key factor in consumer trust and brand reputation. A properly conducted safety assessment reduces risks, prevents allergic reactions, and ensures that all ingredients meet EU regulatory standards.