Compliance Process (Cosmetics)
Basic Cosmetic Requirements
01.
Administrative- & General Product Info
- Admin Info: Product Owner, RP, Manufacturer (& GMP compliance), Target Market, Distributor, Importer (as applicable)
- Product: Target Population, Intended use, General purpose, Main action, Formulation type, Type of exposure (Leave-on, rinse-off), Application area
02.
Raw Material
- Ingredients/Raw materials used
- Supplier information
- Physico-chemical properties
- Safety Data Sheets, Certificates of analysis
- Toxicity data
- Other information such as impurities, nano-materials, CMR properties
03.
Product Composition
- Quantitative FINAL formulation – compliant COA, applicable certificate
- Manufacturing & analysis method
04.
Product Stability
- Packaging compatibility
- Physico-chemical properties
- Microbial quantity
- Long-term, accelerated and freeze-thaw stability testing
- Best before use/Expiry date information
05.
Packaging
- Technical specifications
- Type (pump, spray, jar)
- Pack size
- Impurities
- Formulation compatibility
06.
Labelling
- Minimum info
- Name or registered name and the address of the RP
- Nominal content – weight or volume
- Date of minimum durability/ Best before
- Batch number
- Precautions
- Cosmetic function
- Ingredients
- Country of Origin
07.
Claims
- Content claims
- Non-content claims
- Product claims
- Substantiation
08.
CPSR
- Composition
- Stability
- Microbiological quality
- Impurities – packaging material
- Normal or foreseeable use of the cosmetic
- Exposure to the cosmetic
- Exposure to the substances
- Toxicological profile of the substances
- Undesirable and serious undesirable effects
- Assessment conclusion
- Labelled warnings and instructions for use
- Safety Assessor
Cosmetic Compliance
and the process followed
01.
Project Set Up
Administrative set-up
Product Info Audit to determine compliance status
Review testing results if available
Set-up project plan
02.
Information collection & Product testing phase
Review ingredient compliance
Commence required laboratory testing
Collection of raw material, packaging and other required information
Preliminary product label review
03.
CPSR & PIF
Safety assessment
Final product label review
Compilation of Product Information File (PIF)
04.
Product Notification
CPNP Notification (EU & UK)
Compliance Process Timeline
01.
Info Audit
(5 days)
02.
Formulation Ingredient Compliance Review
(3 days)
03.
Product Testing
Stability Testing
(12 weeks)
Micro Testing
(4 weeks)
04.
Safety Assessment (SA) & CPSR
(10 days)
05.
Final Label Review
(3 days)
06.
PIF
Please note: the Safety Assessment and compilation of the Cosmetic Product Safety Report can only commence once all the required information and data has been received and when all the required testing has been completed