You've formulated a great cosmetic product. Now the compliance question: can you sell that same formula in the US, EU, and ASEAN—or do you need three different versions?
Here's the cross-reference guide that answers that question in one table.
| Ingredient | US FDA | EU (1223/2009) | ASEAN (ACD) | Verdict |
|---|---|---|---|---|
| Hydroquinone | OTC drug (≤2%), banned in cosmetics in some states | Banned in cosmetics | Banned | **No-go for all cosmetic use** |
| Formaldehyde | Not banned in cosmetics; restricted in some states | Banned (CMR substance) | Banned | **EU/ASEAN: banned. US: legal but risky.** |
| Parabens (isopropyl/isobutyl) | Legal | Banned | Banned | **Must exclude for multi-market products** |
| Triclosan | Banned in OTC antiseptics (2016); legal in cosmetics | Banned (2024) | Restricted | **Phasing out globally** |
| Cyclotetrasiloxane (D4) | Under review | Restricted (2020) | Under review | **EU: restricted. US/ASEAN: monitor.** |
| Microplastics (microbeads) | Banned (2015) | Banned (2023) | Not yet regulated | **Avoid regardless** |
The rule of thumb: Formulate for EU compliance. EU is the most restrictive, and an EU-compliant formula passes in the US and ASEAN 95%+ of the time.
Preservatives are the #1 reason formulas fail multi-market compliance. Here's the current landscape:
| Preservative | US | EU | ASEAN | Max Concentration |
|---|---|---|---|---|
| Phenoxyethanol | ✅ | ✅ (≤1.0%) | ✅ (≤1.0%) | 1.0% |
| Sodium benzoate | ✅ | ✅ | ✅ | 2.5% (acid form) |
| Potassium sorbate | ✅ | ✅ | ✅ | 0.6% (acid form) |
| Benzyl alcohol | ✅ | ✅ (≤1.0%) | ✅ (≤1.0%) | 1.0% |
| Methylisothiazolinone (MIT) | ✅ (rinse-off only) | ❌ (leave-on banned) | ❌ (leave-on) | 0.01% (rinse-off) |
| Parabens (methyl/ethyl) | ✅ | ✅ (restricted) | ✅ (restricted) | 0.4% single, 0.8% mix |
Multi-market preservative strategy: Phenoxyethanol (0.8%) + Sodium Benzoate (0.3%) + Potassium Sorbate (0.2%) + EDTA (0.1%). This broad-spectrum system passes US, EU, and ASEAN.
Sunscreens are regulated as drugs in the US (FDA OTC monograph), cosmetics in the EU, and therapeutic goods in some ASEAN countries. You cannot use one sunscreen formula across all three markets.
| Aspect | US | EU | ASEAN |
|---|---|---|---|
| Classification | OTC drug | Cosmetic | Cosmetic (varies by country) |
| Approved UV filters | 16 filters | 30+ filters | Generally follows EU |
| SPF labeling cap | No official cap (de facto 50+) | SPF 50+ maximum | SPF 50+ (following EU) |
| UVA protection required | Broad Spectrum label | UVA ≥ 1/3 SPF | No specific requirement |
Q: Can I use one INCI list for all three markets?
A: Yes—INCI is the universal nomenclature. But the formulation behind the INCI list may need adjustment. The same ingredient list doesn't guarantee the same formula is compliant.
Q: What's the fastest path to check if my formula is multi-market compliant?
A: Cross-reference your full ingredient list against the EU CosIng database (ec.europa.eu/growth/tools-databases/cosing). EU restrictions are the most comprehensive. If it clears EU, run a secondary check for any ASEAN-specific restrictions.
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