Day 1 – Exploring the cosmetic regulations

1. Opening and introduction

2. General principles of regulating cosmetics

• Global standards
• EU Regulation and the EU approach
• .SA Regulation, SA approach to and the current SA legislation status
• The definition and role of Responsible Person and Qualified Safety Assessor

3. How to deal with Annexes of the regulations

• Banned substances – traces
• Restricted substances
• Positive lists - allowed substances for specific purposes

4. GMP and related manufacturing standards

5. Cosmetic claims

• What can you say about cosmetic products and their efficacy
• How can you substantiate claims

Day 2 – How do you demonstrate the Safety and Compliance of your Cosmetic Products?

1 . Cosmetic product dossier (PIF)

• Dossier structure and minimum contents
• What are the essential documents and data
• Which test reports are required and what information should they provide

2. Cosmetic Products Safety Assessment

• General principles of safety assessment
• The assessment in practice, step-wise approach
• Important practicalities you won’t find in guidelines
• The role, responsibilities and qualifications of the Safety Assessor

3. Analytical and clinical testing

• Which testing makes sense
• Testing strategies – how to implement appropriate testing in your NPD

4. Product stability and stability testing approaches

• What defines the expiry date or Period After Opening (PAO)
• How to test product stability – physico-chemical and microbiological