1. Understanding Regulatory Requirements
• Identify the specific regulatory framework in your target market (e.g., FDA in the U.S., EU Cosmetics Regulation in Europe, etc.).
• Learn about ingredient restrictions, labeling requirements, and safety testing mandates.
2. Product Formulation Compliance
• Ensure the formulation adheres to approved ingredient lists and concentration limits.
• Check for banned or restricted substances.
3. Safety Assessment
• Conduct a Cosmetic Product Safety Report (CPSR) or equivalent, which evaluates:
• Toxicological profiles of ingredients.
• Potential skin irritation or sensitization risks.
• Microbial stability and preservative effectiveness.
4. Stability and Compatibility Testing
• Test product stability over time under various conditions (temperature, humidity, light exposure).
• Evaluate packaging compatibility with the product.
5. Microbial and Efficacy Testing
• Perform microbial contamination testing to ensure the product is free from harmful pathogens.
• Conduct efficacy tests (e.g., SPF testing for sunscreen) if applicable.
6. Documentation and Labeling
• Create compliant labels, including:
• Ingredient lists (INCI names).
• Usage instructions and warnings.
• Manufacturer’s details and batch number.
• Prepare a Product Information File (PIF) or similar document for regulatory inspection.
7. Registration or Notification
• Submit the product to relevant regulatory authorities:
• EU: Notify through the Cosmetic Products Notification Portal (CPNP).
• US: Voluntary registration with the FDA.
• Other Markets: Comply with local requirements (e.g., ASEAN Cosmetics Directive).
8. Certification (if applicable)
• Obtain certifications based on your product’s focus (optional but beneficial):
• Organic or Natural Certifications (e.g., COSMOS, USDA Organic).
• Cruelty-Free (e.g., Leaping Bunny, PETA).
• Vegan Certification (e.g., Vegan Society).