Asia Personal Care & Cosmetics Market Guide 2016

Notes
Signed into force in 2007, the ASEAN Cosmetics Directive provides for mutual recognition of market authorization; therefore, once a product is registered in one country, it applies across all member states. However,
there are still some differing national level requirements; therefore, the information provided here may not always reflect the compliance requirements in each ASEAN member state. The overview provided here,
cites many, but not all of the requirements where there may be differences. In addition, companies must still then notify their product across each new ASEAN country into which they enter.
Local Business Partner Requirements
Registration requirements for overseas manufacturers and their local distributors are prescribed by the local Authorities e.g. Licence to Operate, Certificate of Incorporation of the Company, etc.
Responsible Agent: a legal or natural person based within the ASEAN country where the product is registered. ASEAN requires that the safety assessor, who also contributes to the preparation of the PIF, be
independent.
Additional Resources
1. ASEAN Cosmetics Directive: http://www.hsa.gov.sg/content/hsa/en/Health_Products_Regulation/Cosmetic_Products/Overview/ASEAN_Cosmetic_Directive.html Included in the Directive are the following
annexes:
Annex I: Products considered cosmetics
Annex II : Prohibited ingredients list
Annex III : Restricted ingredients list
Annex IV : Colorants positive list
Annex VI : Preservatives positive list
Annex VII : UV Filters positive list
2. List of ASEAN Ingredients Annexes: http://aseancosmetics.org/default/asean-cosmetics-directive/technical-documents
3. ASEAN Guidelines for Microbiological Limits in Cosmetics Products: http://www.hsa.gov.sg/content/dam/HSA/HPRG/Cosmetic_Products/Microbiological%20limit%20in%20cosmetic%20products_2012.pdf
3. ASEAN Product Information File (PIF) Guidelines: http://www.hsa.gov.sg/content/dam/HSA/HPRG/Cosmetic_Products/Guidelines%20for%20Product%20Information%20File%20(PIF).pdf
4. ASEAN Guidelines for Safety Assessment: http://bpfk.moh.gov.my/images/Guidelines_Central/Guidelines_on_Cosmetic/Annex_I_Part_6_.pdf
5. ASEAN Cosmetics Labeling Requirements: http://www.hsa.gov.sg/content/dam/HSA/HPRG/Cosmetic_Products/Appendix%20II%2004%20September%202007A.pdf
6. ASEAN Cosmetics Claims Labeling: http://www.hsa.gov.sg/content/dam/HSA/HPRG/Cosmetic_Products/Appendix%20III%2010%20September%202007A.pdf
7. ASEAN Guidance on Cosmetics Good Manufacturing Practices: http://www.hsa.gov.sg/content/dam/HSA/HPRG/Cosmetic_Products/Appendix%20VI%20(ASEAN%20Guidelines%20for%20Cosmetic%20Good%20Manu
8. ASEAN Guidance on Adverse Event Reporting: http://bpfk.moh.gov.my/images/Guidelines_Central/Guidelines_on_Cosmetic/Annex_1_Part_11_.pdf
9. ASEAN Guidance on Evaluating the Safety of Botanical Raw Materials Used in Cosmetics:
10. ASEAN Guidance on Sunscreen/Sunscreen Protection Factor Labeling: http://www.fda.gov.ph/attachments/article/15927/ASEAN%20Sunscreen%20Guidelines%20rev01%20May%202015.pdf
11. Relevant trade associations for the industry that provide support and documentation on exporting cosmetics and personal care products:
ASEAN Cosmetics Association: http://aseancosmetics.org