Cosmetic Dossiers
Contents of Product Information File (PIF)
PRODUCT SAFETY INFORMATION
Quantitative and Qualitative Composition
Physical-chemical Characteristics and stability of the Product
Microbiological Quality
Impurities, Traces and Packaging Materials
Results of Stability Tests
List of Ingredients INCI-names
Normal and Reasonable Foreseeable Use
Product & Substances Exposure
Undesirable and Serious Undesirable Effects
Warnings on the Packing
GMP Compliance Statement
Toxicological Risk Assessment
- LD50 Toxicity
- Local Toxicity (Skin Sensitization)
- Repeated Dose Toxicity (OECD 407)
- IFRA Evaluation
- Qualitative Risk Assessment (QRA)
- Photo-toxicity
- Mutagenicity
- Toxicological Profile of the Ingredients
- acute toxicity via relevant routes of exposure
- skin irritation and skin corrosivity
- mucous membrane irritation (eye irritation)
- skin sensitisation
- dermal/percutaneous absorption
- repeated dose toxicity (normally 28- or 90-day studies)
- mutagenicity/genotoxicity
- carcinogenicity
- reproduction toxicity
- toxicokinetics (ADME studies)
- photo-induced toxicity
- Quantitative Risk Assessment (QRA) Parfum Ingredients
- MoS Calculation (Margin of Safety)
- SAF Calculation (Safety Assessment Factor)
- Undesirable & Serious Undesirable Effects
PRODUCT SAFETY ASSESSMENT
Conclusion
Warnings and Instructions for Use