A side-by-side comparison of the two largest food labeling regulatory frameworks. Understand the differences before you export.
The core difference: FDA regulations (21 CFR) require 9 major allergens and use a Nutrition Facts panel, while EU FIC Regulation 1169/2011 mandates 14 allergens with bold emphasis in ingredients and a different nutrition declaration format. Health claims are more restricted in the EU (only authorized claims allowed), while the US permits more flexible structure/function claims with disclaimers.
| Requirement | FDA (US) | EU (FIC 1169/2011) |
|---|---|---|
| Regulation | 21 CFR Part 101 | Regulation (EU) 1169/2011 |
| Major Allergens | 9 (milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, soybeans, sesame) | 14 (plus celery, mustard, sesame, sulphites, lupin, molluscs) |
| Allergen Format | "Contains" statement OR in ingredients list | Must be emphasized in ingredients list (bold, caps, underline) |
| Nutrition Panel | Nutrition Facts (serving-based, voluntary nutrients allowed) | Nutrition Declaration (per 100g/100ml mandatory, servings optional) |
| Required Nutrients | Calories, total fat, sat fat, sodium, total carb, fiber, sugars, protein, vit D, calcium, iron, potassium | Energy, fat, saturates, carbs, sugars, protein, salt |
| Health Claims | Structure/function claims allowed with disclaimer; FDA-approved health claims; qualified health claims | Only EU-authorized claims from the EU Register (Article 13, 14) |
| Ingredient Order | Descending order by weight | Descending order by weight at manufacturing |
| Date Marking | "Best if used by" recommended; "Use by" for safety | "Best before" for quality; "Use by" for safety (more strictly enforced) |
| Country of Origin | Required for specific products (meat, seafood, produce) | Required when omission would mislead; mandatory for honey, fruit, etc. |
| Font Size | Minimum 1/16 inch; specific x-height rules | Minimum x-height 1.2mm (0.8mm for small packages) |
| Language | English required; other languages permitted | Language of market where sold (mandatory) |
If you export from the US to the EU, you must add bold emphasis to allergens in the ingredients list and check for the 5 additional EU allergens (celery, mustard, sulphites, lupin, molluscs). Simply using a US "Contains" statement is not sufficient for EU compliance.
Allowed without pre-approval. Must include disclaimer: "This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease."
12 authorized claims based on significant scientific agreement (e.g., calcium and osteoporosis, sodium and hypertension).
Emerging evidence claims with qualifying language (e.g., "Some scientific evidence suggests...").
Must be on the EU Register of nutrition and health claims. Over 200 authorized claims (e.g., "Vitamin C contributes to the normal function of the immune system").
Strictly regulated; only a handful authorized (e.g., calcium and bone health, MUFA/PUFA and cholesterol).
Any claim not on the EU Register is prohibited. Terms like "detox," "superfood," and unapproved probiotic claims are commonly rejected.
The EU requires allergens to be emphasized within the ingredients list itself, not just in a separate 'Contains' statement.
US Nutrition Facts panels use serving sizes and list 12+ nutrients. EU panels use per 100g and only 7 mandatory nutrients.
A claim allowed in the US (like 'supports heart health') may be unauthorized in the EU without the specific approved wording.
Celery, mustard, lupin, molluscs, and sulphites are EU allergens but not US allergens. Exporters often miss these.
EU minimum x-height is 1.2mm (stricter than FDA). Small packages have different rules in both jurisdictions.
'Best before' vs 'Best if used by' — the EU is stricter about which date format implies safety vs quality.
Check your label against FDA and EU regulations simultaneously. Catch cross-market compliance issues before they cost you.
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