Cosmetic Compliance in ASEAN
Cosmetic compliance across the ASEAN member states under the ASEAN Cosmetic Directive: a harmonised technical baseline and four-part Product Information File, with country-by-country notification through NPRA, the Thai FDA, HSA, BPOM and the others.
Regulatory framework
- Regulator
- National competent authorities across the member states
- Primary regulation
- ASEAN Harmonised Cosmetic Regulatory Scheme (2003) and the ASEAN Cosmetic Directive
- Notification
- National notification per member state (Quest3+, Notifkos and others)
- Region
- Asia-Pacific
The ASEAN Cosmetic Directive
The Agreement on the ASEAN Harmonised Cosmetic Regulatory Scheme was signed in September 2003, and its core instrument, the ASEAN Cosmetic Directive (ACD), was fully implemented across the member states on 1 January 2008. It now covers eleven states: Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Singapore, Thailand, Vietnam and Timor-Leste. The Directive establishes common lists of prohibited, restricted and permitted ingredients and common rules on classification, claims, labelling and the Product Information File, structured closely on the EU model.
What the Directive does not do is create a single notification. A product must be notified separately in each member state where it is sold, through that state’s own authority and online system, and each notification requires a Responsible Person established in that country. Regulatory oversight is largely post-market: authorities verify the notification, then rely on surveillance and the right to demand the Product Information File.
Notification, country by country
The mechanics and the validity period differ by market. The principal routes are:
- Malaysia: the National Pharmaceutical Regulatory Agency (NPRA), through its Quest3+ system. The notification note is valid for two years.
- Thailand: the Thai Food and Drug Administration, where notification is valid for three years and a local agent is required for an overseas company.
- Singapore: the Health Sciences Authority (HSA), through its Cosmetic Products Notification.
- Indonesia: BPOM (the National Agency of Drug and Food Control), through the Notifkos platform, with a local applicant required.
- Vietnam: the Drug Administration of Vietnam under the Ministry of Health.
The Philippines, Brunei, Cambodia, Laos and Myanmar each operate their own notification on the ACD baseline.
The Product Information File
The ACD requires a Product Information File built to a defined four-part structure (administrative, quality of materials, quality of the finished product, and safety and efficacy). An EU-format safety dossier maps onto it well, but it has to be restructured and cross-referenced against the ASEAN annexes rather than submitted as is.
How Oxford Biosciences helps
Our ASEAN Cosmetic Directive Documentation Package restructures an existing safety dossier into the four-part ASEAN Product Information File format, cross-references the formulation against ASEAN Annexes II to VII, provides an ASEAN-format safety assessment summary, verifies IFRA fragrance compliance, and gives guidance on Good Manufacturing Practice and the Free Sale Certificate. It is £249 in addition to a CPSR engagement. Country-specific notification is a separate engagement and requires a Responsible Person registered in each member state. All fees are exclusive of VAT.
Our services for ASEAN
Global Markets
From £149
Cosmetic regulatory documentation for markets beyond the EU and UK: Canada, Australia, New Zealand, ASEAN, the GCC and Latin America, prepared from the same evidence base by the assessor who signs our CPSRs.
Learn more →CPSR
From £70 · 2 to 3 days
The Cosmetic Product Safety Report is the safety assessment required under Article 10 and Annex I of Regulation (EC) No 1223/2009 before a cosmetic product may be placed on the UK or EU market. Prepared and signed by a qualified safety assessor.
Learn more →Frequently asked questions
Which international markets does Oxford Biosciences cover?
Beyond the EU and UK, Oxford Biosciences prepares the United States MoCRA Toxicological Risk Assessment (£395), the Canadian Health Canada Cosmetic Notification (£395), the Australian AICIS Compliance Statement (£149), the New Zealand EPA Group Standard Compliance Statement (£179), and the ASEAN Cosmetic Directive Documentation Package (£249), with GCC and Latin American markets (Brazil, Mexico, Argentina and Chile) quoted on application. Where markets share an evidence base, a single Product Information File carries the jurisdiction-specific annexes rather than requiring a separate dossier for each.