The Anatomy of a Product Information File (PIF)
Regulatory
The PIF must be kept for 10 years after the last batch is placed on the market. It includes the formulation, method of manufacture, proof of effect, and the all-important Cosmetic Product Safety Report (CPSR).
Core Analysis
Formulation and regulation are intrinsically linked. An ingredient that provides excellent yield stress might be restricted to 0.1% in the final formula due to toxicological concerns. Always cross-reference functional desires with regulatory constraints.
| Parameter | Critical Value | Impact |
|---|---|---|
| Temperature | >45°C | Accelerates degradation kinetics |
| pH Range | 4.5 - 5.5 | Optimal for skin microbiome & organic acids |
| Water Activity (aw) | < 0.6 | Microbes cannot proliferate |
Frequently Asked Questions
Who can write the CPSR?
Only a qualified Safety Assessor (typically holding a degree in pharmacy, toxicology, medicine, or a similar discipline recognized by a Member State).
Explore the Institute
Regulations
Reference