ASEAN Cosmetic Directive (ACD)

1. Certification Overview

The ASEAN Cosmetic Directive (ACD) is an agreement designed to reduce trade barriers within the region by harmonizing cosmetic product requirements among ASEAN countries.

The member countries of the ACD are Vietnam, Thailand, Singapore, the Philippines, Malaysia, Myanmar, Indonesia, Laos, Cambodia, and Brunei, totaling 10 countries.

2. Key Elements

1. Ingredient Guidelines (Annexes)

• Annex II (Prohibited): Ingredients not permitted for use

• Annex III (Restriction): Ingredients with specified usage amounts or uses
• Annex IV, VI, VIII (Permitted): Only permitted dyes, preservatives, and UV filters may be used.

2. Labeling Requirements

• ASEAN Common Mandatory Labeling Requirements
• Product name, country of manufacture, full ingredients, volume, batch number, expiration date, etc. must be included
• Mandatory local language notation

3. Product Information File (PIF)

• Corresponds to the technical file of a medical device
• All cosmetics must have a PIF consisting of four parts, which the local importer must retain so that it can be submitted within 24 to 48 hours upon request by local authorities
• PART 4
  • PART 1: Administrative documents (registration certificate, label draft, power of attorney)
  • PART 2: Manufacturing and Quality Control (Raw Material List, Manufacturing Process Summary, GMP Certificate)
  • PART 3: Product safety (microbiological/heavy metal test results, safety assessment report)
  • PART 4: Proof of efficacy (clinical data, supporting materials for advertising claims)

4. Manufacturing Quality Control (ASEAN GMP)

• All cosmetic manufacturing facilities must comply with the ASEAN Cosmetic GMP Guidelines.
• For Korean companies, having a CGMP certificate issued by the Ministry of Food and Drug Safety is recognized as compliance with ASEAN GMP.

5. Post-Market Surveillance

• Instead of strict prior inspections, products circulating in the market are collected and tested; if side effects are reported or prohibited ingredients are found, the information is immediately shared with all ASEAN countries for product recall/withdrawal.

3. Certification Procedure

1. Ingredient Review: Comparison of Full Ingredient List with ACD Annex List
2. RP Selection: Designation of local representatives (importers) for each country
3. Online Reporting: Product Registration in Each Country’s System
4. Establishing PIF: Preparing technical documents in ACD standard formats

4. ACD Document

1. Definition and Examples of Cosmetics
   • Appendix I: List of Cosmetic Products by Category (Example)
   • Appendix III: ASEAN Cosmetics Labeling Guidelines
2. Prohibited, restricted, and permitted ingredients specified in the Annex to the ASEAN Cosmetic Guidelines
   • Appendix II Part 1: List of Substances Not to be Included in Cosmetic Compositions
   • Appendix III Part 1: List of Substances Not to be Included in Cosmetics (Except Where Subject to Specified Restrictions and Conditions)
   • Appendix IV Part 1: List of Colorants Permitted for Use in Cosmetics
   • Appendix VI: List of Permitted Preservatives
   • Appendix VII: List of Permitted Sunscreens to be Included in Cosmetics
3. Labeling requirements
   • Appendix II: ASEAN Cosmetic Labeling Requirements
   • ASEAN Sunscreen Labeling Guidelines
4. Good manufacturing standards
   • Appendix VI: ASEAN Good Manufacturing Practice Guidelines for Cosmetics
5. Safety assessment
   • Cosmetic Safety Evaluation Guidelines
6. Reporting adverse reactions
   • Industry Guidelines: Reporting Cosmetic Adverse Effects
7. Documentation
   • Product Information File (PIF) Instructions
8. Pollutant limit
   • ASEAN Guidelines on Permissible Standards for Hazardous Substances in Cosmetics

Source
ASEAN Consumer Information Handbook on Cosmetic Product