“Probiotic” on a food supplement as a health claim
Article 2(2)(5) and Article 10 of Regulation 1924/2006 — what can be said about bacterial cultures?

Under the European Commission’s interpretation, the statement “contains probiotics” on a food supplement is a health claim within Article 2(2)(5) of Regulation (EC) No 1924/2006, not a nutrition claim of the “contains …” type. The Standing Committee on the Food Chain and Animal Health endorsed this reading on 14 December 2007. On 20 December 2024 the European Ombudsman found it reasonable (case 2273/2023/MIK). The Union list contains no permitted claim that would allow the word “probiotic” on a supplement, so Article 10(1) excludes it from labelling and advertising. The same applies to “prebiotic” and “prebiotic fibre”. What remains on the label is mandatory information, which by definition is not a claim: a neutral category name required by § 5(2)(2) of the Polish Minister of Health regulation (consolidated text, Dz.U. 2026 item 1364), the name of the microorganism with its strain in the list of ingredients, and the numerical content per daily portion.

1. The definition: why “probiotic” falls within Article 2(2)(5)

A health claim is any claim that states, suggests or implies that a relationship exists between a food category, a food or one of its constituents and health (Art. 2(2)(5)). The definition does not require an organ, function or effect to be named. An implied relationship with health is enough. In C-544/10 Deutsches Weintor (paras 34–35), the CJEU stressed that “relationship” must be understood broadly. The definition says nothing about whether the relationship must be direct or indirect, or about its intensity or duration. The Court held that describing a wine as “easily digestible” (“bekömmlich”), together with a reference to reduced acidity, is a health claim.

The Commission guidance of 14 December 2007 (point III.1, pp. 10–11) applies this logic to “contains …” statements. Such a statement is a nutrition claim if the name of the substance gives only factual information, e.g. “contains lycopene” or “contains lutein”. It becomes a health claim when the name of the substance or category describes a function or implies an effect on health. The guidance gives “contains antioxidants” and “contains probiotics/prebiotics” as examples, because the reference to probiotic or prebiotic implies a health benefit. It also classifies a functional adjective attached to an ingredient as a health claim: “with prebiotic fibres”, “contains prebiotic fibres”.

The Commission bases this classification on the WHO definition, quoted in the Ombudsman’s decision (para 13). Probiotics are “live microorganisms which when administered in adequate amounts confer a health benefit on the host”. The health benefit is part of the definition itself. That is what separates “probiotic” from the name of a bacterial species, which in the list of ingredients describes what the ingredient is, not what it does.

2. Status of the 2007 guidance and the Ombudsman decision of 20 December 2024

The guidance itself states that it has no formal legal status and that, in the event of a dispute, ultimate responsibility for interpreting the law lies with the Court of Justice. No CJEU judgment rules directly on the word “probiotic”. The guidance is nevertheless the only document agreed with the Member States in the Standing Committee, and the Commission applies it consistently.

In November 2023 an organisation representing the European probiotic industry complained about this interpretation to the European Ombudsman. It asked for “contains probiotics” to be treated as a nutrition claim or as a neutral descriptor of composition. The decision of 20 December 2024 in case 2273/2023/MIK found no maladministration. Key findings:

• Para 25: the inquiry revealed no manifest error in the Commission’s assessment that the term “probiotics” suggests health benefits to consumers and may influence their choice of food and readiness to pay a higher price.
• Para 27: it is reasonable to treat statements such as “contains probiotics” as health claims, and nothing suggests the 2007 guidance is out of date.
• Para 29: the Commission’s position does not create legal uncertainty. It clarifies the legal framework.
• Para 30: the Ombudsman does not assess whether some Member States allow the term contrary to the Regulation. If they did, that would mean those Member States do not comply with EU law, not that the Commission is wrong.

The decision also records the Commission’s reasoning. No application for a health claim concerning live microorganisms, “probiotics” or similar terms has so far received a favourable EFSA opinion. The Commission gave four reasons: no evidence of effects in a healthy population, insufficient characterisation of strains, poor-quality studies and undefined claimed effects. An Ombudsman decision is not a judgment and does not bind courts. It does confirm that the Commission has no intention of changing its interpretation, and it gives control authorities an EU-level document to rely on.

3. Why no claim is permitted, and why Article 10(3) does not fix it

Article 10(1) prohibits health claims that do not meet the requirements of Chapters II and IV and are not on the lists in Articles 13 and 14. The list in Regulation (EU) No 432/2012 contains one claim on live cultures: “Live cultures in yoghurt or fermented milk improve lactose digestion of the product in individuals who have difficulty digesting lactose”. It may be used only for yoghurt or fermented milk containing at least 10⁸ CFU of live starter microorganisms (Lactobacillus delbrueckii subsp. bulgaricus and Streptococcus thermophilus) per gram. A capsule or sachet of freeze-dried bacteria is neither yoghurt nor fermented milk, so this claim does not carry over to a supplement.

EFSA assessed claims for microorganisms that were not sufficiently characterised in batch opinions (EFSA Journal 2009;7(9):1247 and 2010;8(2):1470). It set out the requirements for claims on the gastrointestinal tract, the immune system and defence against pathogens in its 2016 guidance (EFSA Journal 2016;14(1):4369). Any future claim would have to concern a characterised strain and a defined physiological effect. The word “probiotic” covers a whole class of organisms, so it cannot itself be the subject of such an authorisation.

Article 10(3) allows references to general, non-specific health benefits if accompanied by a claim from the lists. The Commission, however, treats “probiotic” as a health claim requiring authorisation, not as a general reference. Even an attempt to classify it as a general reference runs into the relevance requirement. Implementing Decision 2013/63/EU (Annex, point 3) requires the specific claim to bear some relevance to the general reference, and places the burden of demonstrating the link on the operator. In C-524/18 Schwabe, the CJEU confirmed that “accompanying” has both a substantive and a visual dimension. A vitamin D immune claim does not explain what the bacteria do for health, so it does not “cover” a word that refers to the bacteria. More on this mechanism: CJEU C-524/18 Schwabe — accompanying general claims.

4. Mandatory information: what can be said about bacterial cultures

Article 2(2)(1) defines a claim as a message that is not mandatory under EU or national legislation. The 2007 guidance (Part I) stresses that mandatory labelling indications must be distinguished from claims. For a food supplement, the following are mandatory:

• Category name or nature of the substances. Article 6(3)(a) of Directive 2002/46/EC and § 5(2)(2) of the Polish regulation require “the names of the categories of nutrients or substances that characterise the product or an indication of the nature of those nutrients or substances”. Neither text prescribes the word “probiotic”. Neutral terms meet the requirement, e.g. “bacterial cultures”, “live bacterial cultures”, “lactic acid bacteria” or “lactic acid bacteria and inulin”.
• List of ingredients with the name of the microorganism. Genus, species and strain designation describe the ingredient, not its effect. After the 2020 reclassification of the genus Lactobacillus, many species names changed. Details: what the Lactobacillus renaming means for labels.
• Numerical content per daily portion. § 5(3)–(4) of the Polish regulation requires the content of substances with a nutritional or other physiological effect to be declared in numerical form, per recommended daily portion. The regulation sets no unit for microorganisms. Market practice is colony-forming units (CFU) per portion. The declaration should remain true until the best-before date, because the number of live cells falls over time (see best-before date on a food supplement).

An argument heard in practice runs as follows: the category name is mandatory, so “probiotic” used as the category name is not a claim either. The argument is weak. What is mandatory is a category name, not a particular word. If a neutral term fulfils the obligation, choosing a word that, according to the Commission and the Ombudsman, implies a health benefit is a voluntary choice. The Polish regulation neither defines “probiotic” nor sets conditions for it. And the same word repeated on the front of the pack, in the trade name or in advertising goes beyond mandatory information.

5. Brand names, fancy names and generic descriptors

• Brand or fancy name (Art. 1(3)). A trade mark, brand name or fancy name that may be construed as a claim may be used without authorisation only if accompanied by a related claim that complies with the Regulation. A “Probio-” element in a product name points to “probiotic”. Without a permitted claim about the bacteria, there is nothing to accompany it with.
• The transitional period has ended. Products bearing trade marks or brand names existing before 1 January 2005 could remain on the market until 19 January 2022 (Art. 28(2)). Since then, an older mark no longer protects the name.
• Generic descriptor (Art. 1(4)). A derogation for traditional names of classes of foods requires an application under Regulation (EU) No 907/2013 and a Commission act. Regulation (EU) 2019/343 granted such derogations for, among others, “Hustenbonbon” (Germany, Austria), “keelpastille” (Netherlands) and “cough drops” (United Kingdom): cough and throat sweets in specific Member States. It also covers “tonic” in the name of quinine beverages. None of them covers “probiotic” or “prebiotic”.

6. “Prebiotic”: same mechanism, but permitted claims exist for specific fibres

The 2007 guidance puts “prebiotic” and “prebiotic fibre” alongside “probiotic”. The practical difference is that permitted health claims exist for some fibres. Regulation (EU) 2015/2314 added the claim “Chicory inulin contributes to normal bowel function by increasing stool frequency”. The conditions are demanding. The food must provide at least 12 g of native chicory inulin per day, and consumers must be told that the beneficial effect is obtained with that daily intake. Native chicory inulin is a non-fractionated mixture with a mean degree of polymerisation of ≥ 9. From 1 January 2016 the authorisation was restricted for five years to the applicant (BENEO-Orafti). A capsule supplement rarely provides 12 g, so in practice this concerns powders.

A permitted chicory inulin claim does not legalise the word “prebiotic”. The claim must be used in the wording on the list or in wording with the same meaning for consumers. “Prebiotic” implies an effect on the gut microbiota, whereas the listed effect concerns stool frequency. The nutrition claim “source of fibre” requires at least 3 g of fibre per 100 g or 1.5 g per 100 kcal (Annex to Regulation 1924/2006). It is calculated per 100 g, not per portion. How such thresholds work on a supplement is shown using sugars as an example: “sugar-free” on a food supplement.

7. Other Member States: the Italian example and the risk of an “export” label

Some Member States have adopted their own guidelines, as the complainant pointed out to the Ombudsman. One example is the Italian Linee guida su probiotici e prebiotici (Ministero della Salute, March 2018 revision). In it, the ministry acknowledges that indicating a probiotic for the balance of the intestinal flora is not a health claim that can be authorised under Article 13(5) of Regulation 1924/2006. It nevertheless allows products that meet the guidelines to state this physiological effect and to use the terms “probiotico” and “prebiotico”. One condition is at least 10⁹ live cells per day of at least one strain in the recommended daily portion.

For a Polish manufacturer or importer this has two consequences. First, Regulation 1924/2006 applies directly in every Member State, and national guidelines do not bind the authorities of other Member States. A label that follows Italian practice is therefore not safe on the Polish or German market. Second, in para 30 the Ombudsman expressly suggested that divergent national practice may amount to a breach of EU law, which is for the Commission to address. The durability of such national positions is not guaranteed.

8. Advertising, online shops and communication to professionals

The Regulation applies to claims in commercial communications: in the labelling, presentation or advertising of foods delivered to the final consumer (Art. 1(2)). An online shop description, a marketplace listing, a sponsored post and materials for pharmacies are subject to the same rules as the label. In C-19/15 Innova Vital (ECLI:EU:C:2016:563), the CJEU held that the Regulation also covers communications addressed exclusively to health professionals, if they concern food intended for the final consumer. A leaflet “for doctors” or pharmacist training with the slogan “probiotic supporting the microbiota” is therefore not exempt. How advertising and labelling are assessed together is covered in our analysis of CJEU C-657/24 Kyberg. Notifying a product to the Polish Chief Sanitary Inspectorate (GIS) is not an assessment of claims and does not legalise “probiotic”: health claims versus supplement notification.

9. What the law does not decide

• EU law does not define “probiotic” or “prebiotic”. Their classification as health claims follows from the definition in Art. 2(2)(5) as interpreted by the Commission, not from a specific provision.
• The 2007 guidance and the Ombudsman’s decision do not bind courts. The CJEU has not yet ruled directly on the word “probiotic”. Only a preliminary ruling could settle the question definitively.
• The Polish regulation sets neither a unit for declaring microorganisms nor a minimum cell count per portion. Colony-forming units (CFU) are market practice, not a requirement of that act.
• There is no EU list of strains permitted in supplements. Strain safety, novel-food status and any notification are separate questions, independent of claims.
• The status of related terms (“synbiotic”, “postbiotic”, “probiotic bacterial cultures”) has not been separately decided. The test is the same: does the name imply a function or health benefit? On postbiotics: postbiotics in EU law.

10. Checklist: a supplement with bacterial cultures or inulin

1. Category name: meet § 5(2)(2) of the Polish regulation (Art. 6(3)(a) of Directive 2002/46/EC) with a neutral term (“bacterial cultures”, “lactic acid bacteria”), without “probiotic” or “prebiotic”.
2. List of ingredients: give the current genus and species name and the strain designation, in line with current taxonomy.
3. Content: declare the cell count (CFU) per recommended daily portion and make sure it remains true until the best-before date.
4. Front and name: remove “probiotic”, “contains probiotics”, “Probio-” in the name and symbols suggesting an effect on the gut; Art. 1(3) requires a permitted claim for such a name, and none exists for bacteria in supplements.
5. Inulin and fibre: use the ingredient name instead of “prebiotic fibre”; the chicory inulin claim only with at least 12 g of native inulin per day and information on that amount.
6. General references: do not assume a vitamin claim “covers” a slogan about the microbiota; Art. 10(3) requires relevance (Decision 2013/63/EU, C-524/18).
7. Advertising and e-commerce: apply the same rules to product pages, ads, influencers and materials for doctors and pharmacists (Art. 1(2), C-19/15).
8. Multi-market labels: do not carry wording allowed under another Member State’s national guidelines (e.g. Italy’s) onto the Polish or German market; Regulation 1924/2006 applies directly.

Frequently asked questions

Can a food supplement label say “probiotic”?

Under the Commission’s 2007 interpretation, which the European Ombudsman found reasonable in case 2273/2023/MIK, the word “probiotic” is a health claim. No permitted claim on the Union list covers it on a supplement, so Article 10(1) of Regulation 1924/2006 excludes it from labelling and advertising.

Is “contains probiotics” a “contains …” nutrition claim?

No. The Commission guidance (point III.1) treats “contains …” as a nutrition claim only where the name is purely factual, e.g. “contains lycopene”. “Contains probiotics/prebiotics” implies a health benefit, so it is a health claim.

What category name can be used instead of “probiotic”?

§ 5(2)(2) of the Polish regulation and Art. 6(3)(a) of Directive 2002/46/EC require a category name or an indication of the nature of the substances, but no particular word. Neutral terms such as “bacterial cultures”, “live bacterial cultures” or “lactic acid bacteria” meet the requirement, supplemented by the strain name in the list of ingredients and the CFU per daily portion.

Can the live yoghurt cultures claim be used on a supplement?

No. The Regulation 432/2012 claim on improved lactose digestion applies to yoghurt or fermented milk containing at least 10⁸ CFU of live starter microorganisms per gram. A capsule or sachet supplement is not such a food.

Do the Italian guidelines allow “probiotico” in Poland too?

No. The 2018 Italian guidelines govern national practice only. Regulation 1924/2006 applies directly in every Member State, and in para 30 of the decision the Ombudsman indicated that divergent national practice may amount to a breach of EU law.

Glossary

Health claim

A claim that states, suggests or implies a relationship between a food or one of its constituents and health (Art. 2(2)(5) Reg. 1924/2006).

Mandatory information

Information required by EU or national law. It is not a claim (Art. 2(2)(1)), e.g. the category name of substances on a supplement (§ 5(2)(2) of the Polish regulation).

Reference to general benefits

A non-specific statement about health benefits, permitted only with an accompanying relevant claim from the lists (Art. 10(3), Decision 2013/63/EU point 3).

Generic descriptor

A traditional name of a class of foods implying a health effect, exempted from the Regulation by a Commission act following an application (Art. 1(4), Reg. 907/2013 and 2019/343).

CFU

Colony-forming units: a measure of the number of live microbial cells capable of growing in culture.

Conclusion

The word “probiotic” on a food supplement is not neutral information about composition. Under the Commission’s 2007 interpretation, which the European Ombudsman found reasonable in December 2024, it is a health claim, because the definition of a probiotic contains a health benefit. No permitted claim exists for it on a supplement, and the only claim on live cultures concerns yoghurt. Article 10(1) therefore excludes the term, and neither Article 10(3) nor Article 1(3) offers a way around it. The same applies to “prebiotic” and “prebiotic fibre”, although chicory inulin has a bowel-function claim at 12 g per day. A safe label relies on mandatory information: a neutral category name under § 5(2)(2) of the Polish regulation, the full strain name and the CFU per daily portion. The same rules cover advertising, online shops and communication to professionals.

Primary sources

1. Regulation (EC) No 1924/2006 on nutrition and health claims made on foods: Art. 1(2)–(4), Art. 2(2)(1) and (5), Art. 10, Art. 28(2), Annex (“source of fibre”); consolidated text.
2. European Commission, Guidance on the implementation of Regulation No 1924/2006 … Conclusions of the Standing Committee on the Food Chain and Animal Health, 14.12.2007: introduction, Part I, point III.1.
3. European Ombudsman, Decision on how the European Commission deals with the labelling of foodstuff that contain probiotics as ‘health claims’ (case 2273/2023/MIK), 20.12.2024: paras 13, 25, 27, 29, 30.
4. CJEU, judgment of 6.9.2012, C-544/10 Deutsches Weintor, ECLI:EU:C:2012:526, paras 34–35.
5. CJEU, judgment of 14.7.2016, C-19/15 Innova Vital, ECLI:EU:C:2016:563.
6. CJEU, judgment of 30.1.2020, C-524/18 Dr. Willmar Schwabe, ECLI:EU:C:2020:60.
7. Commission Regulation (EU) No 432/2012: entry “Live yoghurt cultures” (EFSA Journal 2010;8(10):1763).
8. Commission Regulation (EU) 2015/2314: native chicory inulin claim (EFSA Journal 2015;13(1):3951).
9. Commission Regulation (EU) No 907/2013 (applications on generic descriptors) and Commission Regulation (EU) 2019/343 (derogations for generic descriptors).
10. Commission Implementing Decision 2013/63/EU: guidelines on Art. 10 of Reg. 1924/2006, Annex point 3.
11. Directive 2002/46/EC on food supplements: Art. 6(3)(a).
12. Notice of the Polish Minister of Health of 2.10.2026 on the consolidated text of the regulation on the composition and labelling of food supplements, Dz.U. 2026 item 1364: § 5(2)–(4) (in Polish).
13. EFSA NDA Panel: EFSA Journal 2009;7(9):1247 and 2010;8(2):1470 (non-characterised microorganisms); EFSA Journal 2016;14(1):4369 (guidance on claims related to the immune system and the gastrointestinal tract).
14. Ministero della Salute, Linee guida su probiotici e prebiotici, March 2018 revision.