Gluten-Free Labelling and Certification Readiness
Meet the FDA definition first, use the wheat statement where needed and treat certification as an extra, private layer.
In Short
- Below 20 ppm under FDA rule.
- Wheat needs the asterisk note.
- Fermented: keep records 2 years.
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In the US, 21 CFR 101.91 sets what 'gluten-free' and similar claims mean, including the below 20 ppm limit and records for fermented or hydrolysed foods. Private certification such as GFCO adds its own requirements. This guide covers the FDA rule in detail and what GFCO states publicly. Orientation, not legal advice. Sources checked 4 Oct 2026.
What the claim means
Under 101.91(a), the gluten-containing grains are wheat, rye and barley, including their species and crossbred hybrids. A food labelled gluten-free must either inherently contain no gluten or contain no ingredient that is a gluten-containing grain, no ingredient derived from one that has not been processed to remove gluten, and no processed ingredient whose use results in 20 ppm or more gluten in the food.
Ingredient check (101.91(a)(3))
| Ingredient | Can the food claim gluten-free? |
|---|---|
| Wheat flour | No |
| Wheat-derived, not processed to remove gluten | No |
| Wheat starch processed to remove gluten | Only if the food stays below 20 ppm, with wheat statement |
| Rice flour | Yes, if unavoidable gluten stays below 20 ppm |
- Wheat flour
- Can the food claim gluten-free?
- No
- Wheat-derived, not processed to remove gluten
- Can the food claim gluten-free?
- No
- Wheat starch processed to remove gluten
- Can the food claim gluten-free?
- Only if the food stays below 20 ppm, with wheat statement
- Rice flour
- Can the food claim gluten-free?
- Yes, if unavoidable gluten stays below 20 ppm
More on what the claim means
In every case, any unavoidable presence of gluten must be below 20 ppm, that is below 20 mg per kg of food.
Equivalent wording and the wheat statement
Section 101.91(b) applies the same rules to 'no gluten', 'free of gluten' and 'without gluten'. A food that declares wheat in its ingredient list or a 'Contains wheat' statement and also carries one of these claims is misbranded unless the word wheat is followed by an asterisk or other symbol pointing to this statement close to the ingredient list: 'The wheat has been processed to allow this food to meet the Food and Drug Administration (FDA) requirements for gluten-free foods.'
Testing, Fermented and Hydrolysed Foods
Under 101.91(c)(1), FDA uses a scientifically valid method able to detect 20 ppm gluten when it checks compliance by analysis. Where no such method works because the food or an ingredient is fermented or hydrolysed, the manufacturer must make and keep records giving adequate assurance that the food was gluten-free before fermentation or hydrolysis, that cross-contact was evaluated and that measures are in place where it was identified.
More on testing, Fermented and Hydrolysed Foods
Those records are kept for at least two years after the food enters interstate commerce. Distilled components are assessed by checking for absence of protein.
Where certification fits
Certification is a private scheme layered on top of the rule. GFCO's public homepage states that its programme requires all starting ingredients and finished products to test below the gluten-free threshold of the country of sale or 10 ppm, whichever is lower, and prohibits oats where a country requires that.
More on where certification fits
The GFCO standard document itself, including audit, testing frequency and mark-use rules, was not reviewed. Section 101.91(d) stops US states setting different definitions for these claims; it does not limit what a private certifier requires.
Controls that support the claim
A defensible claim rests on everyday control: approved suppliers with gluten specifications, receiving checks, segregated storage, cleaning between products, a sampling and testing plan and label approval. Keep the claim file per product: formula version, ingredient specifications, test results with the method used, cleaning and changeover records and the approved label.
Worked Example: Product GF-31 Claim File
More on controls that support the claim
A named person approves the claim and reopens it when a recipe, supplier or line changes. Results support the decision; they do not make it.
Questions
Are oats a gluten-containing grain under the FDA rule?
The definition in 101.91(a)(1) lists wheat, rye and barley and their hybrids. Any unavoidable gluten in a food claiming gluten-free must still be below 20 ppm.
Can a product with wheat starch be labelled gluten-free?
Only if the processed ingredient leaves less than 20 ppm gluten in the food and the wheat declaration carries the asterisk statement in 101.91(b)(3).
What records do fermented foods need?
Records giving adequate assurance under 101.91(c)(2)-(3), kept for at least two years after introduction into interstate commerce (101.91(c)(4)).
Is GFCO certification required by law?
No. It is a voluntary private scheme with its own threshold and rules; the FDA rule applies to the claim either way.
Practical orientation, not legal advice. Rules differ by jurisdiction; your quality and compliance team decides what applies.
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