ASEAN Cosmetic Directive
The ASEAN Economic Ministers signed the Agreement on the ASEAN Harmonized Cosmetic Regulatory Scheme at the 35th ASEAN Economic Ministers Meeting in Cambodia in September 2003.
The Scheme is the culmination of 4 years of work by the ASEAN Consultative Committee on Standards and Quality (ACCSQ) Cosmetic Product Working Group (CPWG), formed in 1998 in response to a request from the ASEAN Cosmetic Association (ACA) to harmonise regulations across the region to reduce technical barriers to trade.
The Scheme, which has been co-developed with the cosmetic industry, comprises the signed Agreement and its 2 Schedules as follows:
- Schedule A (Phase 1): ASEAN Mutual Recognition Arrangement (MRA) of Product
Registration Approvals for Cosmetics; and
- Schedule B (Phase 2): The ASEAN Cosmetic Directive
Phase 1 is an interim voluntary phase whilst Phase 2 (ASEAN Cosmetic Directive) must be implemented by all member countries by January 2008. Member countries can choose to proceed directly to Phase 2 without going through Phase 1.
The common technical requirements under the ASEAN Harmonized Cosmetic Regulatory Scheme provide for a common definition for cosmetics, and detail the ingredients that cannot be used in cosmetics as well as listings of permitted preservatives, UV absorbers and colourants.
The links to these documents are given below:
- Agreement on the ASEAN Harmonised Cosmetic Regulatory Scheme
- Appendix I (Illustrative List by Categories of Cosmetic Products)
- Appendix II (ASEAN Cosmetic Labeling Requirements)
- Appendix III (ASEAN Cosmetic Claims Guidelines)
- Appendix IV (ASEAN Cosmetic Product Registration Requirements) Document is no longer in use
- Appendix V (Asean Cosmetic Import Export Requirements) Document is no longer in use
- Appendix VI (ASEAN Guidelines for Cosmetic Good Manufacturing Practices)
- Annexes of the ASEAN Cosmetic Directive Updated Jan 2016
- Annex II Part 1: List of substances which must not form part of the composition of cosmetic products
- Annex III Part 1: List of substances which cosmetic products must not contain except subject to restrictions and conditions laid down (Draft version)
- Annex IV Part 1: List of colouring agents allowed for use in cosmetic products
- Annex VI: List of preservatives allowed
- Annex VII: List of permitted UV filters which cosmetic products may contain
- A Guide Manual for the Industry - Adverse Event Reporting of Cosmetic Products
- Guidelines for the Safety Assessment of a Cosmetic Product
- Guidelines for Product Information File (PIF)
- ASEAN Guidelines on Microbiological Limit in Cosmetic Products
- ASEAN Sunscreen Guidelines