The key conclusion: “found in a database” does not mean “authorised”. For communication about constipation, normal bowel function or intestinal transit, the ingredient name is not enough. You must check the record’s source, exact wording, product category, dose and required consumer information.
1. What does the C.L.A.I.M.S. report contain?
The supplied report raport_claims_Zatwardzenie.pdf was generated on 12 August 2026 for the query “Constipation”. It reports 27 reverse-search results by health effect. Its database reference is SANCO/11074/2013, dated 12 June 2013, and the report expressly states that the tool is auxiliary and is not legal advice.
The results fall into two fundamentally different groups:
- 11 records marked “Reg 432/2012” — these are claims connected with the EU list of permitted health claims. Their use still depends on the exact wording and all conditions in the legal act.
- 16 records marked “SANCO/11074/2013” — these are mainly plant-substance claims in a pending or transitional context. SANCO/11074/2013 is not the number of a Commission Regulation.
2. The register, the permitted list and the transitional period are different things
The EU Register is a reference tool
The EU Register of Health Claims displays permitted claims as well as non-authorised claims and their status information. It is a practical control point, but a search result does not replace reading the legal act. In particular, a record arising from Regulation 432/2012 must be distinguished from an “on hold” or historical pending record.
Regulation 432/2012 provides the basis for the permitted list
Commission Regulation (EU) No 432/2012 establishes the list of permitted health claims made on foods, apart from claims referring to disease-risk reduction and children’s development and health. In practice, the entry tied to this act — together with its conditions of use — is the appropriate starting point for assessing a marketing statement.
A transitional period is not an authorisation
Article 28 of Regulation (EC) No 1924/2006 may be relevant to certain claims used previously and awaiting assessment, particularly in the area of plant substances. It is a conditional mechanism, not a new permission. It does not turn a SANCO/11074/2013 record into a claim from the 432/2012 list, does not permit free rewriting and does not remove the requirements of Article 10 on clarity and the prohibition of non-authorised claims.
In 2025, the Court of Justice in Case C-386/23, Novel Nutriology examined the relationship between pending botanical claims and Articles 28(5) and (6). This is another reason not to use the shortcut “it is in the database, therefore it is allowed”. The assessment must be made for the particular claim, product, market and advertising context.
| What the report shows | What it means | What it does not mean |
|---|---|---|
| Reg 432/2012 | The claim has a basis in the act establishing the permitted list. | It does not mean that dose, product category, wording or consumer information can be ignored. |
| SANCO/11074/2013 | A database record for a pending claim, including a botanical claim. | It is not an authorising act or a Commission Regulation number. |
| Article 28 transitional treatment | A possible conditional mechanism for continuing certain previously used claims. | It is not a blanket licence and does not create a right to paraphrase freely. |
3. The main permitted gut-related claims
The following examples come from the 11 records marked Reg 432/2012 in the report. Listing them here is not permission to use them for any product. The conditions are part of the claim.
- Wheat bran fibre: the report identifies a claim relating to an acceleration of intestinal transit, with a condition of at least 10 g of wheat bran fibre per day; it also points to the requirement that the food be high in fibre.
- Lactulose: the claim concerns an acceleration of intestinal transit and requires 10 g of lactulose in a quantified single portion; consumers must be informed of the amount associated with the beneficial effect.
- Lactitol: the claim concerns normal bowel function through increased bowel frequency; the report identifies 10 g in a single quantified daily portion and a restriction concerning foods for children.
- Chicory inulin: the claim concerns normal bowel function through increased bowel frequency; the condition includes 12 g of natural chicory inulin per day and additional compositional criteria.
- Green kiwifruit: the claim concerns normal bowel function through increased bowel frequency, but applies to fresh green kiwifruit sold as such or only peeled or cut.
- Prunes: the claim concerns normal bowel function when 100 g of prunes are consumed per day.
- Rye fibre: it may be linked to helping normal bowel function where the condition concerning a food high in fibre is met.
- Barley, oat, wheat-bran and sugar-beet fibre: the report includes these in connection with claims about increased faecal bulk, subject to the condition that the food is high in the relevant fibre.
4. Why do the 16 SANCO records require extra care?
The SANCO/11074/2013 group includes, among others, flax, psyllium, rhubarb, aloe, blackthorn, bilberry, senna and botanical mixtures. Their descriptions refer to regularity, peristalsis, slowing or maintaining intestinal transit. These are search results from botanical-claim documentation, not the equivalent of a “Reg 432/2012” entry.
The presence of such a record does not answer the essential questions: whether the claim still meets the conditions for use in a particular Member State, whether the product was covered by lawful prior use, whether the communication is advertising for a food, whether it enters the medicinal-product area, or whether the proposed paraphrase preserves the same meaning. Aloe, senna and hydroxyanthracene derivatives also raise separate safety and restriction issues.
A SANCO record may therefore be a starting point for further analysis, but it should not be copied automatically onto a label, product page or advertisement. If a business relies on Article 28, it should document the basis of that position; a screenshot from a search tool is not enough.
5. Checklist for a food business or marketer
- Identify the status: record the legal act, entry number and whether the record is on the permitted list or in the pending group.
- Read the conditions of use: dose, ingredient form, food category, minimum fibre content and mandatory consumer information are part of the claim.
- Compare the product with the condition: containing an ingredient does not necessarily mean that the declared portion provides the required amount.
- Assess the whole communication: images, product name, “for constipation” wording and advertising copy can together give a message broader than the authorised sentence.
- Check Article 28 separately for plants: document prior use, the relevant market, wording and legal basis. Do not call a SANCO record an authorisation.
- Verify currency: check the current Commission register and legal text before publication, because the C.L.A.I.M.S. report is a dated snapshot.
Frequently asked questions
Is “constipation” an official health claim?
No. It describes a problem or symptom. Official claims concern the relationship between a specified ingredient and a body function, such as normal bowel function, faecal bulk or intestinal transit. They should not be converted into a promise to treat a disease.
Can I use the wheat-bran-fibre claim if my product contains bran?
Not automatically. The conditions concerning the fibre type, product content, daily amount and consumer information must be met. A general “with bran” description is not a substitute for analytical verification.
Can a SANCO/11074/2013 record be treated like a 432/2012 entry?
No. They have different statuses. A SANCO record may relate to a pending claim and a possible transitional mechanism, but it is not itself an authorising act.
Sources
- C.L.A.I.M.S. report “raport_claims_Zatwardzenie.pdf”, report ID CLAIMS-2026-9414, generated 12 August 2026 — source of the search data; the report is auxiliary and not legal advice.
- European Commission: EU Register of Health Claims — reference register for permitted and non-authorised claims.
- Commission Regulation (EU) No 432/2012 — permitted health claims and their conditions of use.
- Regulation (EC) No 1924/2006 — legal framework for nutrition and health claims, including Articles 10 and 28.
- Court of Justice of the EU, C-386/23, Novel Nutriology — pending botanical claims, Article 10 and transitional measures.