A food supplement may bear the statement “gluten-free” only if, as sold to the final consumer, it contains no more than 20 mg of gluten per kilogram of product. That is the rule in the Annex to Commission Implementing Regulation (EU) No 828/2014. The threshold applies per kilogram of the finished product, capsule shell included, not per daily portion. Information on the absence of gluten may be given only through the statements in the Annex: “gluten-free” or “very low gluten” (up to 100 mg/kg, and only with cereal ingredients specially processed to reduce gluten). Oats in a “gluten-free” product must come from a controlled supply chain and contain no more than 20 mg/kg of gluten, yet they must still be emphasised as an allergen in the ingredients list. The “gluten-free” statement does not lift allergen labelling under Annex II to Regulation (EU) No 1169/2011, and the allergen exemption for wheat-based maltodextrin does not by itself make a product gluten-free.
1. What Regulation 828/2014 actually lays down
Implementing Regulation (EU) No 828/2014 was adopted under Article 36(3)(d) of Regulation No 1169/2011 (FIC). That point was added by Delegated Regulation (EU) No 1155/2013. Gluten information is therefore voluntary food information. It must meet Article 36(2) FIC: it must not mislead, must not be ambiguous or confusing, and must be based on relevant scientific data. The same thresholds were previously laid down in Regulation (EC) No 41/2009 for foods for particular nutritional uses. Regulation No 609/2013 repealed it with effect from 20 July 2016. From that date Regulation 828/2014 applies to all food, food supplements included.
| Provision | Content | What it means for a supplement |
|---|---|---|
| Art. 2(a) | Gluten is a protein fraction from wheat, rye, barley, oats or their crossbred varieties and derivatives, insoluble in water and 0.5 M sodium chloride solution. | The definition includes oats. Wheat means any Triticum species (Art. 2(b)), spelt and khorasan included. |
| Art. 3(1) | Information on the absence or reduced presence of gluten is given only through the statements in the Annex and under its conditions. | The list of statements is closed (section 3). |
| Annex, Part A | “Gluten-free”: no more than 20 mg/kg in the food as sold to the final consumer. “Very low gluten”: no more than 100 mg/kg, only for food with ingredients from these cereals specially processed to reduce gluten. | For a typical supplement only “gluten-free” is realistic. |
| Annex, Part B | Oats in a “gluten-free” or “very low gluten” food must be specially produced, prepared and/or processed to avoid contamination by wheat, rye or barley. Gluten in those oats: no more than 20 mg/kg. | Relevant to oat beta-glucan and oat bran, for example. |
| Art. 3(2) | May be accompanied by “suitable for people intolerant to gluten” or “suitable for coeliacs”. | Only alongside an Annex statement, never instead of it. |
| Art. 3(3) | “Specifically formulated for people intolerant to gluten” or “…for coeliacs” only if the food is specially produced to reduce gluten in ingredients or to replace them with naturally gluten-free ingredients. | A product made only from naturally gluten-free ingredients does not meet this condition (section 6). |
| Art. 4 | Gluten information is prohibited on infant formulae and follow-on formulae. | Not relevant to supplements, but it shows that gluten information is not available for every category. |
2. 20 mg/kg “as sold”: how to read it for capsules and powders
The threshold refers to the food “as sold to the final consumer”. For a supplement the sample that is tested and assessed is therefore the finished form: the capsule with its shell, the tablet with its coating, the powder with its carrier. A result for the fill blend alone does not settle compliance if the shell or excipients come from a different source. The threshold does not change with the portion. The law has no “gluten-free per daily portion” variant.
It helps to see the scale. At the limit of 20 mg/kg, a 1.5 g daily portion (for instance three 0.5 g capsules) supplies at most 0.03 mg of gluten. A 10 g portion of powder supplies at most 0.2 mg. For comparison, in the randomised trial by Catassi et al. (2007), patients with coeliac disease took 0, 10 or 50 mg of gluten a day in a capsule for 90 days. The authors concluded that intake of contaminating gluten should be kept below 50 mg a day. These figures explain why the threshold is set per kilogram: it protects the whole diet, not a single product. They give no basis, however, for a “gluten-free” statement on a product at 30 mg/kg simply because the portion is small.
3. Only the Annex statements: “contains no gluten”, “0% gluten”, “free from gluten”
Article 3(1) states that where statements are used to inform consumers about the absence of gluten, such information “shall be given only through the statements and in accordance with the conditions set out in the Annex”. The English language version has two: “gluten-free” and “very low gluten”. The Regulation has no clause such as “or any claim likely to have the same meaning for the consumer”, which is familiar from the Annex to Regulation No 1924/2006. Variants such as “contains no gluten”, “0% gluten” or “free from gluten” are therefore not on the closed list. On a literal reading of Article 3(1) they are not permitted. The safest course is to use the Annex wording and, on a multilingual pack, the equivalent from each language version of the Regulation (“bezglutenowy”, “glutenfrei”).
The same applies to the accompanying statements. “For coeliacs”, “coeliac-safe” or “suitable for a gluten-free diet” are not the wording of Article 3(2). That provision allows two specific phrases, and only next to the main statement.
4. A naturally gluten-free supplement and Article 7(1)(c) FIC
Most vitamin and mineral supplements contain no cereal ingredients. Recital 10 of Regulation 828/2014 allows food made from naturally gluten-free ingredients to bear a statement on the absence of gluten. The condition is compliance with the general fair information practices of FIC. Article 7(1)(c) prohibits suggesting that a food possesses special characteristics when in fact all similar foods possess them, “in particular by specifically emphasising the presence or absence of certain ingredients and/or nutrients”.
For supplements this objection is hard to raise against the bare “gluten-free” statement. The category of “similar foods” is not uniformly gluten-free. Carriers, fillers and shells are sometimes made from wheat starch, and botanical extracts may carry traces of cereal contamination. The risk arises with differentiating messages: “the only gluten-free magnesium”, “unlike others, no gluten” on a product from a category where gluten is practically absent. A neutral Annex statement backed by a test result is safer than a marketing slogan.
5. Gluten and allergens are two separate regimes
A “gluten-free” statement has no effect on the obligation under Articles 9(1)(c) and 21 FIC. Commission Notice 2017/C 428/01 says so expressly in point 12: when a product containing one of the cereals in Annex II (e.g. oats) meets the requirements of Regulation 828/2014, it may bear the statement “gluten-free”. The cereal must still be indicated and emphasised in the list of ingredients. The relationship also works the other way. An allergen exemption for an ingredient is not evidence that the finished product contains no more than 20 mg/kg.
| Ingredient in the supplement | Emphasis as an allergen (FIC Annex II) | Can the product be “gluten-free”? |
|---|---|---|
| Wheat-based maltodextrin, wheat-based glucose syrup (including dextrose) | No, exemption in Annex II point 1(a)–(b). | Yes, if the finished product is ≤ 20 mg/kg. The exemption alone does not prove it. |
| Barley-based glucose syrup | No, exemption in point 1(c). | As above: the product result decides. |
| Wheat starch | Yes, “wheat starch” emphasised (no exemption). | Yes, at ≤ 20 mg/kg. Specially processed (gluten-reduced) starch also allows “very low gluten” at ≤ 100 mg/kg. |
| Oat beta-glucan, oat bran | Yes, “oats” emphasised (point 12 of the Notice). | Only with oats from a controlled chain (≤ 20 mg/kg in the oats) and a product at ≤ 20 mg/kg (Annex Part B). |
| Young barley or wheat grass powder | Derived from barley or wheat; Annex II provides no exemption for it. | Only on the basis of the product result. Risk of grain contamination at harvest. |
| Wheat germ | Yes, a wheat product without exemption. | Only on the basis of the finished product result. |
Allergen exemptions and emphasis are covered in our article on FIC Annex II exemptions in food supplements. The Notice also allows the word “gluten” to be added voluntarily after the cereal name, e.g. “wheat flour (gluten)” (point 10). That is part of the ingredients list, not information on the absence of gluten.
6. “Suitable for coeliacs” versus “specifically formulated for coeliacs”
Both phrases may accompany “gluten-free”, but their conditions differ. The Article 3(2) phrase (“suitable for people intolerant to gluten” or “suitable for coeliacs”) requires only compliance with the Annex. The Article 3(3) phrase (“specifically formulated…”) additionally requires that the food was specially produced, prepared and/or processed to reduce the gluten content of ingredients or to replace gluten-containing ingredients with naturally gluten-free ones.
A vitamin D capsule in sunflower oil was not “specifically formulated”. No gluten-containing ingredient was replaced. The position differs where the manufacturer redesigned the recipe: it swapped a wheat-starch filler for rice flour and segregated the production line. That fact is worth documenting in the product file, because it is what justifies the stronger phrase.
Neither phrase is a health claim within the meaning of Regulation No 1924/2006. The scope of permitted information is set by Regulation 828/2014, adopted under FIC. Wording that goes beyond that scope, e.g. “supports the gut of people with coeliac disease”, refers to health. It then falls under Regulation No 1924/2006, and no such claim is authorised.
7. Proof of compliance: specifications, batch testing and “may contain gluten”
Regulation 828/2014 does not prescribe an analytical method. Recital 12 says that Codex STAN 118-1979 for foods for persons intolerant to gluten should be taken into consideration. In official controls, methods are chosen under Article 34 of Regulation (EU) 2017/625: in line with Union rules or, where there are none, with internationally recognised rules or protocols. In practice laboratories use ELISA immunoassays. For hydrolysed and fermented ingredients, where gluten is broken into fragments, the sandwich format may underestimate the result. Laboratories then use a competitive format. When ordering a test, tell the laboratory whether the product contains such ingredients.
- Raw-material specifications: a supplier declaration on the cereal origin of every ingredient, including the shell, carriers and anti-caking agents.
- Finished-product testing: a result for the product as sold, not for the fill alone. Frequency follows the risk assessment: less often for a mineral blend, more often for botanical extracts and products with oats.
- Safety margin: a result just under 20 mg/kg offers little comfort given the measurement uncertainty typical of immunoassays. An internal specification limit below the threshold reduces the risk of a dispute with an official result.
- Precautionary statements: “gluten-free” next to “may contain gluten” is internally contradictory and ambiguous within the meaning of Article 36(2)(b) FIC. If the contamination risk is real, drop the statement rather than add a caveat.
Notifying a food supplement to the Polish Chief Sanitary Inspector (GIS) does not confirm its gluten content. The authority receives the label template but does not test the product. Compliance of the statement is checked only in official controls, e.g. when a sample is taken from the market. The procedure is described in our article on GIS notification.
8. The crossed grain symbol
The crossed grain symbol does not derive from Regulation 828/2014. It is a private certification mark of coeliac societies, granted under licence with its own audit requirements. Using it requires the consent of the mark owner. It neither replaces nor waives the Annex conditions. A graphic suggesting the absence of gluten is information on the absence of gluten even without the word “gluten-free” next to it. A home-made, unlicensed ear-of-grain symbol on an untested product is a risk under Articles 7 and 36(2) FIC.
9. What the rules leave open
- Synonyms in enforcement practice. The literal wording of Article 3(1) excludes variants outside the Annex. There is, however, no published Commission or GIS position assessing specific variants such as “contains no gluten”.
- Testing frequency. Neither Regulation 828/2014 nor FIC says how many batches must be tested. That is a decision for the operator’s HACCP system.
- Cereal grass powders. There is no EU guidance on how to treat young barley and wheat leaves under FIC Annex II. A cautious reading emphasises them as barley or wheat products.
- Oats and coeliac disease. Recital 7 notes that oat tolerance in people with coeliac disease is still being studied. Part B of the Annex addresses contamination only, not sensitivity to avenin.
10. Checklist: a “gluten-free” statement on a food supplement
- Wording: use only “gluten-free” or, with specially processed cereal ingredients, “very low gluten”. Remove “0% gluten”, “contains no gluten” and similar variants.
- Threshold: confirm by a test that the finished product as sold, shell included, contains no more than 20 mg/kg of gluten.
- Oats: for oat beta-glucan or oat bran, obtain supplier confirmation of a controlled chain and gluten in the oats of no more than 20 mg/kg.
- Allergens: regardless of the statement, emphasise FIC Annex II cereals in the ingredients list unless the ingredient benefits from an exemption in point 1(a)–(d).
- Accompanying phrases: add “suitable for coeliacs” only next to an Annex statement. Use “specifically formulated” only with a documented change of recipe or process.
- Consistency: do not combine “gluten-free” with “may contain gluten”. Do not present the absence of gluten as a feature that sets the product apart from its category.
- Graphics: use the crossed grain symbol only under licence. Treat any other grain symbol as information on the absence of gluten.
- Documentation: keep raw-material specifications, batch test results with the method, and the rationale for testing frequency ready for an official control.
Frequently asked questions
How much gluten may a food supplement labelled gluten-free contain?
No more than 20 mg of gluten per kilogram of product as sold to the final consumer, under the Annex to Implementing Regulation (EU) No 828/2014. The threshold applies to the whole product, capsule shell included, not to the daily portion.
Can a supplement say “contains no gluten” instead of “gluten-free”?
Article 3(1) of Regulation 828/2014 allows information on the absence of gluten only through the statements in the Annex. The Regulation has no clause covering statements with the same meaning. It is therefore safer to use “gluten-free”.
Can a supplement with oat beta-glucan be gluten-free?
Yes, if the oats were produced to avoid contamination by wheat, rye or barley, the gluten in the oats does not exceed 20 mg/kg, and the finished product contains no more than 20 mg/kg. The oats must still be emphasised as an allergen in the ingredients list.
Does wheat-based maltodextrin rule out a gluten-free statement?
No. Wheat-based maltodextrin is exempt from allergen emphasis (FIC Annex II point 1(b)). The gluten-free statement still depends on the result for the whole product: no more than 20 mg/kg of gluten. The allergen exemption alone does not prove that.
Does a GIS notification confirm that a supplement is gluten-free?
No. GIS receives the label template but does not test gluten content. The operator is responsible for compliance with Regulation 828/2014, and official controls verify it, for example by sampling products on the market.
Glossary
- Gluten (Reg. 828/2014)
- A protein fraction from wheat, rye, barley, oats, their crossbred varieties and derivatives, insoluble in water and 0.5 M sodium chloride solution.
- Gluten-free
- Annex statement under Reg. 828/2014 for food containing no more than 20 mg/kg of gluten as sold.
- Very low gluten
- Statement for food with specially processed ingredients from wheat, rye, barley or oats, containing no more than 100 mg/kg of gluten.
- Controlled oats
- Oats specially produced, prepared and/or processed to avoid contamination by other cereals, with no more than 20 mg/kg of gluten (Annex Part B).
- Voluntary information
- Food information provided on the operator’s own initiative. Subject to Article 36 FIC: it must not mislead or be ambiguous.
Conclusion
A “gluten-free” statement on a supplement requires three things: the right wording from a closed list, a result of no more than 20 mg/kg for the product as sold and, with oats, a controlled supply chain. Allergen labelling applies regardless of the statement, so oats and wheat starch stay emphasised in the ingredients list. The most common errors are variants outside the Annex, a statement without a test of the finished capsule, combining “gluten-free” with “may contain gluten”, and “specifically formulated” on a product nobody redesigned. Related topics: allergen labelling in the EU, US and Canada and “sugar-free” on a food supplement.
Primary sources
- Commission Implementing Regulation (EU) No 828/2014 of 30.7.2014 on the requirements for the provision of information to consumers on the absence or reduced presence of gluten in food (OJ L 228, 31.7.2014, p. 5).
- Regulation (EU) No 1169/2011 (consolidated): Articles 7, 9, 21, 36, Annex II.
- Commission Delegated Regulation (EU) No 1155/2013 adding Article 36(3)(d) FIC.
- Commission Notice of 13.7.2017 (2017/C 428/01) relating to the provision of information on substances or products causing allergies or intolerances, points 8–12.
- Regulation (EU) No 609/2013, repealing Regulation (EC) No 41/2009 from 20.7.2016.
- Regulation (EU) 2017/625 on official controls, Article 34.
- Codex Alimentarius, CXS 118-1979, Standard for foods for special dietary use for persons intolerant to gluten.
- Catassi C. et al., A prospective, double-blind, placebo-controlled trial to establish a safe gluten threshold for patients with celiac disease, Am J Clin Nutr 2007;85(1):160–166.