Product Information File or PIF

1. Product Information File or PIF

2. Requirements for Industry The Company or Person placing a cosmetic product in the market shall: • Notify the regulatory authorities before the product is put in the market (article 1-3) • Ensure that they will not cause damage to human health under normal or reasonably foreseeable conditions of use (article 3) • Keep the product information file readily accessible to the regulatory authorities (article 8) • Must have adequate knowledge or experience (article 8-d)

3. PIF • Must be at the address of the Company responsible for placing the product in the market (as specified on the label): manufacturer, importer or distributor • PIF must be in the local language or English • Must be “readily accessible”. What does that mean? 1 day, 1 week? Depends if the audit is unannounced or not • Must be kept updated of all modifications

4. PIF • Qualitative and quantitative composition of the product: name and percentage of ingredients (for perfumes name of supplier, code of perfume and percentage) • Specifications of the raw materials and finished product (physico-chemical and microbiological) • Manufacturing method complying with ASEAN GMP Guidelines • Assessment of the safety for human health of the finished product, its ingredients, its chemical structure and its level of exposure

5. PIF • Existing data on undesirable effects on human health resulting form the use of the product • Supporting data for claimed benefits (efficacy assessment) • Available methods used to check the ingredients corresponding with the certificate of analysis (Article 9) • Criteria used for microbiological control; chemical purity of ingredients and/or methods for checking compliance with those criteria

6. PIF • Qualitative and quantitative composition of the product: name and percentage of ingredients (for perfumes name of supplier, code of perfume and percentage) • Specifications of the raw materials and finished product (physico-chemical and microbiological) • Manufacturing method complying with ASEAN GMP Guidelines • Assessment of the safety for human health of the finished product, its ingredients, its chemical structure and its level of exposure

7. Example

8. PIF • Qualitative and quantitative composition of the product: name and percentage of ingredients (for perfumes name of supplier, code of perfume and percentage) • Specifications of the raw materials and finished product (physico-chemical and microbiological) • Manufacturing method complying with ASEAN GMP Guidelines • Assessment of the safety for human health of the finished product, its ingredients, its chemical structure and its level of exposure

9. Raw Material Specification • Physico Chemical: • Colour • Odour • Appearance • IR Spectrum • Refractive index • Saponification index • Heavy Metals content • Microbiological: • Bacteria • Fungi and Yeast Obtained from supplier Methods must be available Manufacturer must check compliance

10. Raw Material Specification Special attention should be taken to: • Water • Impurities • Interactions between impurities • RM manufacturing process • GMP of supplier • Ingredients of natural origin: • Which plant-animal • Which part is used • Consistency of supply

11. Finished Product Specification Developed by manufacturer Must be relevant Must have the test methods Must check compliance • Physico Chemical: • Colour • Odour • Appearance • pH • Water content • Viscosity • Microbiological: • Bacteria • Fungus & Yeast • Stability

12. PIF • Qualitative and quantitative composition of the product: name and percentage of ingredients (for perfumes name of supplier, code of perfume and percentage) • Specifications of the raw materials and finished product (physico-chemical and microbiological) • Manufacturing method complying with ASEAN GMP Guidelines • Assessment of the safety for human health of the finished product, its ingredients, its chemical structure and its level of exposure

13. Manufacturing Method • Pre-mix ingredients 1 to 5 in a SS tank and bring to 70°C while mixing • In a secondary SS tank mix ingredients 6 to 8 and bring to 70°C • Mix contents of tank 2 into tank 1 while stirring at high speed for 30 min. • Cool to 40°C stirring gently and add perfume. Mix for 15 min.

14. PIF • Qualitative and quantitative composition of the product: name and percentage of ingredients (for perfumes name of supplier, code of perfume and percentage) • Specifications of the raw materials and finished product (physico-chemical and microbiological) • Manufacturing method complying with ASEAN GMP Guidelines • Assessment of the safety for human health of the finished product, its ingredients, its chemical structure and its level of exposure

15. Article 3 ASEAN Cosmetic Directive A cosmetic product placed on the market must not cause damage to human health when applied under normal or reasonably foreseeable conditions of use, taking account, in particular, of the product’s presentation, its labeling, instructions for its use and disposal, warning statements as well as any other indication or information provided by the manufacturer or his authorised agent or by any other person responsible for placing the product on the market

16. Safety Assessment of Ingredients Inherent toxicity of ingredient Safety assessment Exposure, concentration of the ingredient Chemical Structure Implications for the finished product

17. Raw Material SCCP opinion ACSB opinion CIR opinion Public Scientific Literature Supplier’s data file Finished Product RM concentrations Use quantity and frequency Safety tests done In-market data (complaint level) Safety Assessment

18. PIF • Existing data on undesirable effects on human health resulting form the use of the product • Supporting data for claimed benefits (efficacy assessment) • Available methods used to check the ingredients corresponding with the certificate of analysis (Article 9) • Criteria used for microbiological control; chemical purity of ingredients and/or methods for checking compliance with those criteria

19. Undesirable Effects on Human Health • Need to have a complaint management system • Personnel must be trained in data collection, data analysis and reporting • Results of investigations must be documented • Analysis of trends

20. PIF • Existing data on undesirable effects on human health resulting form the use of the product • Supporting data for claimed benefits (efficacy assessment) • Available methods used to check the ingredients corresponding with the certificate of analysis (Article 9) • Criteria used for microbiological control; chemical purity of ingredients and/or methods for checking compliance with those criteria

21. Claimed Benefits • Based on ingredient properties (from literature, from supplier’s files, etc.) • Based on test performed on the finished product All claims must be substantiated If not, claims should be changed

22. PIF • Existing data on undesirable effects on human health resulting form the use of the product • Supporting data for claimed benefits (efficacy assessment) • Available methods used to check the ingredients corresponding with the certificate of analysis (Article 9) • Criteria used for microbiological control; chemical purity of ingredients and/or methods for checking compliance with those criteria

23. Article 9: test methods As these are common to many ingredients/products they can form part of a separate file

24. PIF: suggestions • Specific part: • Product name and function • Formulation • Method of Manufacturing • Product specification • Safety Assessment • Efficacy Assessment • Packaging and labeling • Complaint analysis

25. PIF: Suggestions 2. Ingredient File: • RM specification • Supplier data • Toxicity data – Safety assessment • First Aid measures (MSDS)

26. PIF A dynamic set of data influenced by: • New ingredients • New RM suppliers • New production process • New information available • New manufacturer • Etc. Must be readily available

27. Thank You