EU E-Numbers vs U.S. GRAS: A Cross-Market Guide for Supplement Brands
If you sell supplements in both the United States and the European Union, here is the critical fact: GRAS status does not transfer to EU markets. The EU has its own framework for food additives (E-numbers), its own Novel Food regulation, and its own safety assessment process. An ingredient that is perfectly legal in the U.S. may be unauthorized, restricted, or subject to a completely different concentration limit in the EU.
The U.S. GRAS System
In the United States, a food ingredient is permitted if it is:
- GRAS — Generally Recognized As Safe for its intended use (self-determined or via FDA GRAS notification)
- Approved as a food additive — Listed in 21 CFR 172 after a Food Additive Petition
- Prior-sanctioned — Authorized before the 1958 Food Additives Amendment
Browse all GRAS-listed substances to verify your U.S. ingredient status. Remember: GRAS is use-specific and self-determined — the FDA can challenge any determination.
The EU E-Number System
In the European Union, food additives are regulated under Regulation (EC) No 1333/2008. Each authorized food additive receives an E-number (e.g., E300 = ascorbic acid). E-numbers are grouped by function:
- E100–E199 — Colors
- E200–E299 — Preservatives
- E300–E399 — Antioxidants
- E400–E499 — Thickeners, stabilizers, emulsifiers
- E500–E599 — Acidity regulators
- E600–E699 — Flavor enhancers
- E700–E999 — Sweeteners, glazing agents, others
Each E-number has specific permitted food categories and maximum use levels — it is not a blanket approval. An additive authorized in breakfast cereals at 100 mg/kg may not be authorized in dietary supplements at all.
Key Differences at a Glance
| Aspect | U.S. (GRAS) | EU (E-Number) |
|---|---|---|
| Legal Basis | FD&C Act §201(s) | Regulation (EC) 1333/2008 |
| Who Approves | Manufacturer (self-determined) or FDA (voluntary notification) | European Food Safety Authority (EFSA) → European Commission |
| Scope | Use-specific conditions | Food-category-specific with maximum levels |
| Novel Foods | No separate "novel food" category; covered by GRAS or food additive petition | Regulation (EU) 2015/2283 requires pre-market authorization for novel foods |
| Cross-market Transfer | Does NOT transfer to EU | Does NOT transfer to U.S. |
The EU Novel Food Framework
Under Regulation (EU) 2015/2283, any food that was not consumed to a significant degree in the EU before May 15, 1997, is considered a "novel food" and requires pre-market authorization. This is a major trap for Asian brands:
- Many Asian botanicals used for centuries in Korea, Japan, and China are "novel" in the EU — they have no significant consumption history in Europe before 1997.
- Novel Food applications can take 17–24 months and require detailed toxicological data.
- GRAS status is irrelevant in the EU. The EFSA conducts its own risk assessment independently.
If your supplement contains any ingredient that is not already authorized in the EU (as a food additive with an E-number, a novel food with an authorization, or a traditional food from a third country), you cannot legally market it in the EU without an application.
How to Check Both Markets
Selling in both the U.S. and EU? Here is the practical checklist:
- U.S. compliance — Verify each ingredient's GRAS status and Prop 65 status for its intended use.
- EU compliance — Check whether each additive has an E-number authorization in the relevant food category. If no E-number exists, check the EU Novel Food catalogue.
- Concentration limits — Compare U.S. and EU maximum use levels. They are almost always different.
- Labeling — EU requires E-numbers on ingredient lists (e.g., "ascorbic acid (E300)"), not just INCI or common names.
- Health claims — EU health claims are regulated under Regulation (EC) 1924/2006. Only authorized claims may be used. Approved claims differ from U.S. structure/function claims.
This guide is for informational purposes only and does not constitute legal or regulatory advice. EU and U.S. food additive regulations are complex and subject to change. Always review current EU regulations and consult a qualified regulatory professional for your product. Not affiliated with the European Commission or the U.S. FDA. IngredientCompliance is an independent tool operated by Gerim-Sterling LLC.