CHAPT 2

• Walang Japan and China -> mas matagal ang process when it comes to cosmetic distribution
• Ensures that only cosmetic products that conform to the provisions may be placed in the market
• Responsible for effective functioning of the ACD
• Shall consist of 1 official representative from each member state regulatory authority
• ASEAN Cosmetic Association (ACA) members

  • Organizations from different countries that aim to harmonize and maintain cosmetics regulations, upgrade the standards of technical competence and scientific expertise in the local industries, and expand the cosmetics trade in ASEAN
• ASEAN Cosmetic Committee (ACC)

  1. Established in 2003

  2. Reviews/monitors different guidelines within ACD (ASEAN Cosmetic Directive)

  3. Follow guidelines to distribute, import different cosmetic products
• 1 representative per country + secretary + chairman in ACC
• Aim of ACC is to harmonize cosmetic products
• ACD was created in 2008 to have a unified guideline (January 1, 2008)
• ACD covers drug, food, cosmetic, and devices
• Role of Cosmetic Dealers:
• Fluoride, Triclosan, SLS Sodium Lauryl Sulfate (Cetaphil) have limits
• If a product contains a prohibited ingredient, it will not be approved by FDA
• Role of National Regulatory Authorities (NRA):
• ACD Documents include:
• Definition and examples of cosmetic products are provided in Appendix I and III
• Prohibited, restricted, and permitted ingredients are listed in Annexes of the Asean Cosmetic Directive (Updated Jan 2022)
• Annex II Part 1: List of substances which must not form part of the composition of cosmetic products


  Jan 2022
• Annex III Part 1: List of substances which cosmetic products must not contain except subject to restrictions and conditions laid down


  Jan 2022
• ACD Documents
• ACD -> agreement among ASEAN Countries to harmonize the trade of cosmetics w/n the region
• Annex IV Part I: List of coloring agents allowed for use in cosmetic products


  Jan 2022
• Annex VI: List of preservatives allowed
• Annex VII: List of permitted UV filters which cosmetic products may contain
• Labelling requirements
• Appendix II: ASEAN Cosmetic Labelling Requirement
• ASEAN Sunscreen Labelling Guideline
• Good manufacturing practices
• Appendix VI: ASEAN Guidelines for Cosmetic Good Manufacturing Practices
• Others eh Cosmetics - personnel: knowledge, skills, training - tests, contamination, etc.
• Safety assessment
• Guidelines for the Safety Assessment of a Cosmetic Product
• Adverse event reporting
• A Guide Manual for the Industry: Adverse Event Reporting of Cosmetic Products
• Documentation
• Guidelines for Product Information File (PIF)
• Limits of contaminants
• ASEAN Guidelines on Limits of Contaminants for Cosmetics (Updated Oct 2019)
• Updates and Amendments to the ACD as Adopted During the 37th ACC Meeting and its Related Meetings
• May reporting