Both the US and the EU cap "gluten-free" at 20 parts per million — the FDA under 21 CFR 101.91, the EU under Regulation (EU) No 828/2014. The differences sit around the edges: the EU adds a "very low gluten" tier at 100 mg/kg and specific oats rules; the US adds a records-based regime for fermented foods. Compliance is self-declared in both — certification is the independent layer on top.
The US rule: FDA 21 CFR 101.91
The FDA's gluten-free final rule, published in 2013 with compliance from August 2014, defines when a food sold in the US may voluntarily carry "gluten-free", "free of gluten", "no gluten" or "without gluten". A compliant food either inherently contains no gluten, or contains no ingredient that is a gluten-containing grain or derived from one without processing that removes gluten — and in every case, any unavoidable gluten present must be less than 20 ppm. The rule covers FDA-regulated foods including dietary supplements; meat, poultry and most egg products (USDA jurisdiction) and most alcoholic beverages (TTB, which follows a parallel policy under Ruling 2020-2) sit outside it. Two things the rule notably does not do: it does not require testing — compliance is the manufacturer's responsibility, verified by FDA enforcement rather than pre-approval — and it does not require any symbol. Any gluten-free logo you see on a US shelf is voluntary, and if it carries authority, that authority comes from the certifier behind it.
In 2020 the FDA added a companion rule for fermented and hydrolyzed foods — yogurt, sauerkraut, soy sauce, hydrolyzed proteins — where current test methods cannot reliably quantify gluten in the finished product. For these, the manufacturer must hold records showing the food met the gluten-free definition before fermentation or hydrolysis, must have evaluated cross-contact risk during processing, and must keep those records for at least two years. In other words: for a whole category of foods, the gluten-free claim is only as good as the paper trail behind it — which is precisely what a desk review reads.
The EU rule: Regulation (EU) No 828/2014
The EU harmonized gluten-absence claims in Commission Implementing Regulation (EU) No 828/2014, applicable since 20 July 2016. It permits exactly two statements. "Gluten-free" requires no more than 20 mg/kg (the same 20 ppm figure) in the food as sold to the final consumer. "Very low gluten" — a tier with no US equivalent — is allowed up to 100 mg/kg, and only for foods containing wheat, rye, barley or oat ingredients specially processed to reduce gluten. The regulation also handles oats explicitly: oats in a food carrying either claim must be specially produced and processed to avoid contamination, and must themselves not exceed 20 mg/kg. No other wordings are permitted — inventive phrasings that suggest gluten absence outside these two defined claims are non-compliant. As in the US, there is no mandatory symbol and no pre-approval; the claim is the operator's responsibility under general food-information law.
US vs EU gluten-free rules at a glance
| United States (FDA) | European Union | |
|---|---|---|
| Legal basis | 21 CFR 101.91 (final rule 2013); fermented/hydrolyzed foods rule (2020) | Commission Implementing Regulation (EU) No 828/2014, applicable since July 2016 |
| "Gluten-free" threshold | Less than 20 ppm | No more than 20 mg/kg (equivalent to 20 ppm) |
| Second tier | None | "Very low gluten" at no more than 100 mg/kg, for specially processed cereal ingredients |
| Oats | Allowed if the finished food is under 20 ppm; no special oats clause | Oats must be specially produced/processed to avoid contamination and be under 20 mg/kg themselves |
| Fermented / hydrolyzed foods | Records-based compliance: gluten-free status evidenced before fermentation/hydrolysis; records kept 2+ years | No dedicated regime; the 20 mg/kg limit applies to the food as sold |
| Testing required by law | No — manufacturer responsibility, FDA enforcement | No — operator responsibility, member-state enforcement |
| Mandatory symbol | None; logos are voluntary certification marks | None; the crossed-grain symbol is a private licensing scheme, not law |
Allergen labeling is a different law — and the trap inside it
Gluten-free rules are often confused with allergen declaration, and the overlap bites in both directions. In the US, FALCPA requires wheat to be declared as a major allergen — but barley and rye are not on the major-allergen list, so a product can be free of declared allergens and still contain gluten from barley malt. Conversely, under both the FDA rule and EU law, a food can lawfully be labeled gluten-free while containing wheat-derived ingredients processed to remove gluten (EU law pairs this with a wheat allergen declaration; specially processed wheat starch is the classic case). The practical takeaway for manufacturers: your allergen program and your gluten-free claim need each other's data, but neither substitutes for the other — and a reviewer will read both.
Regulation says what the label may claim. Certification says who checked.
Neither the FDA nor the European Commission certifies gluten-free products. Both regimes are self-declared: you put the words on the pack, you carry the liability, and enforcement arrives after the fact — via FDA sampling, import refusals, or a member-state authority responding to a complaint. Third-party certification adds the layer the law leaves out: an independent review of your ingredient specs, cross-contact controls and test data against a published standard, repeated annually, with a certificate a buyer can check by its number in seconds. Every V-Cert gluten-free certificate states the exact threshold standard it was reviewed against (≤20 ppm under the FDA definition), because a quantified claim should stay quantified all the way to the certificate. What the review involves for smaller producers and supplement brands is covered in the gluten-free certification guide, and the application is online, with the quote scoped to the products you list, while the review stays human.
Frequently asked questions
What is the legal gluten-free limit in the US?
Less than 20 parts per million of gluten, under FDA rule 21 CFR 101.91. A compliant food must also not contain a gluten-containing grain, or an ingredient derived from one unless processed to remove gluten below that level. The rule applies to FDA-regulated foods including dietary supplements.
What does "very low gluten" mean, and can I use it in the US?
It is an EU-only claim under Regulation 828/2014 for foods with wheat, rye, barley or oat ingredients specially processed to reduce gluten, capped at 100 mg/kg. US law has no such tier, so the phrase has no defined status on a US label and using it there invites regulatory questions rather than answering them.
Does the FDA test or approve gluten-free products?
No. The claim is voluntary and self-declared; the manufacturer is responsible for compliance and the FDA enforces through sampling and post-market action. There is no pre-approval and no official government gluten-free logo. Independent certification is a voluntary layer that verifies a manufacturer's evidence against a published standard.
Can a product with wheat-derived ingredients be labeled gluten-free?
Yes, in both jurisdictions, if the ingredient was processed to remove gluten and the finished food stays under the 20 ppm threshold — specially processed wheat starch is the standard example. In the EU the wheat allergen must still be declared, so a gluten-free label and a wheat allergen statement can lawfully appear on the same pack.
How are fermented foods like soy sauce handled?
In the US, a dedicated 2020 FDA rule applies: because finished-product tests cannot reliably quantify gluten after fermentation or hydrolysis, manufacturers must hold records proving ingredients met the gluten-free definition before processing, evaluate cross-contact, and keep those records at least two years. The EU applies its standard 20 mg/kg limit to the food as sold.