Southeast Asia Market Entry: Ingredients & Restrictions
ASEAN ingredient rules follow the same architecture as the EU: prohibited substances, restricted substances with conditions, and positive lists for preservatives, colourants and UV filters. The lists track the EU model without being identical.
At a glance
- Prohibited
- A directive annex naming substances that may not be used
- Restricted
- Conditions on concentration, product type and warnings
- Positive lists
- Separate lists for preservatives, colourants and UV filters
- Practical point
- EU alignment is close, and the differences are checked at notification
What the market requires
Prohibited and restricted annexes
The directive carries its own annexes. Because the lists track the EU model with local differences, a formula assessed for Europe still needs a specific check against the ASEAN annexes rather than an assumption of equivalence.
Positive lists
Preservatives, colourants and UV filters are permitted only from the corresponding lists, each with its own conditions. Where a market applies a particular position on a substance, the notification review is where it surfaces.
Sunscreen and other categories
Sunscreen is treated as a cosmetic across most of the region, with permitted filters drawn from the positive list. That differs from the United States, so the same brand can need different actives by market.
What this means for your brief
Add an ASEAN screening to the same review you run for Europe, and treat the two as separate checks even though the structure is similar. Divergences are few but consequential, and they are cheapest to resolve on a draft.
What we provide
- Formula documentation identifying restricted substances with concentrations for the annexes screening
- Raw material specifications that support the notifier's review
- Reformulation support where a substance needs changing for the region
Capabilities above are limited to what is verifiable: GMPC and ISO 22716 certification audited by third parties, cosmetics production licence 粤妆20250206, and FDA MoCRA facility registration. See certifications.
Market questions
Is an EU-compliant formula fine for ASEAN?
Usually close, but not automatic. The annexes are harmonised rather than identical, so a specific check is part of preparing the notification.
Are UV filters treated the same as in the US?
No. Most of the region treats sunscreen as a cosmetic with a permitted list of filters, whereas the US applies an OTC drug monograph with a different permitted set.
More on Southeast Asia market entry
Regulatory requirements change. Confirm the current position for your product with your local adviser or appointed representative before you place artwork or place an order. See also certifications and compliance and the sourcing glossary.
Sourcing for Southeast Asia?
Send your product brief with the destination market — quotation and formula recommendations within 24 hours.
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