Polyols in food supplements
When the label must warn of laxative effects (FIC Annex III point 2.4)

A food supplement containing more than 10% added polyols authorised under Regulation (EC) No 1333/2008 must carry the statement “excessive consumption may produce laxative effects”. The duty follows from point 2.4 of Annex III to Regulation (EU) No 1169/2011 (FIC), read with Article 10(1). The threshold is calculated on the mass of the whole product as sold, not per portion. The technological function of the polyol is irrelevant: sorbitol used as a filler in an effervescent tablet triggers the warning just as xylitol used to sweeten a sachet does. Function does matter for a separate duty under point 2.1: the statement “with sweetener(s)” next to the name of the food. The FIC consolidated version of 1 April 2025 contains no exemption for erythritol. In its 2023 opinion the EFSA FAF Panel found that the data do not support such an exemption.

1. Which substances are “polyols” for point 2.4

Point 2.4 of Annex III does not list substances. It refers to “added polyols authorised pursuant to Regulation (EC) No 1333/2008”. In Regulation 1333/2008 polyols form Group IV in Part C of Annex II. The background to the EFSA mandate on erythritol, reproduced in the 2023 opinion, lists the group expressly: E 420 sorbitols, E 421 mannitol, E 953 isomalt, E 965 maltitols, E 966 lactitol, E 967 xylitol and E 968 erythritol. All seven belong to the functional class of sweeteners, but they may also be used for other purposes: as bulking agents, humectants or carriers.

According to the table of authorisations EFSA reproduced from Part E of Annex II, Group IV is authorised at quantum satis in category 17.1 (food supplements in solid form including capsules and tablets, excluding chewable forms) and in category 17.2 (food supplements in liquid form). Chewable forms (category 17.3) have separate entries not covered by that table. The absence of a numerical limit is not a free hand: good manufacturing practice caps the amount, and on the label the amount has Annex III consequences.

2. How to calculate the 10% threshold

The provision covers foods “containing more than 10% added polyols”. Three calculation rules follow.

• The denominator is the whole product as sold. For a tablet, the tablet mass including coating; for a capsule, the fill plus the shell; for a powder, the powder in the sachet. Point 2.4 does not refer to the daily portion or to 100 g of “actives”. The percentage is the same whether calculated per tablet or per 100 g of tablets.
• The numerator is the sum of all added Group IV polyols. 6% sorbitol plus 5% isomalt is 11%, so the warning is required although neither polyol exceeds the threshold alone.
• “Added” includes polyols brought in with premixes and carriers. Erythritol is authorised as a carrier in food additives (Annex III Part 1) and in nutrients (Annex III Part 5 Section A). A polyol in a vitamin premix was added to the food, just at an earlier stage. Polyols naturally present in a raw material, such as sorbitol in a fruit powder, do not count.

Because food supplements are exempt from the mandatory nutrition declaration (Article 29(1)(a) FIC), polyol content is not visible on the label. An official control authority will establish it from the recipe, supplier specifications or laboratory analysis. The threshold calculation therefore belongs in the product file, not just in the artwork decision.

3. The warning versus “with sweetener(s)”

Points 2.1–2.4 of Annex III contain four separate statements. Their conditions must be assessed separately:

Annex I point 1 of Regulation 1333/2008 defines sweeteners functionally: substances “used to impart a sweet taste to foods”. FIC Annex VII Part C requires an additive in the ingredients list to be designated by the name of the category corresponding to its principal function. If sorbitol in a tablet functions as a bulking agent (“bulking agent: sorbitol”) and the product contains no other sweetener, point 2.1 does not apply. Point 2.4 still does, because content counts, not function. If the same sorbitol sweetens an effervescent tablet, both statements apply. In an inspection it is hard to defend the view that a polyol in a clearly sweet-tasting product “only bulks”. The functional classification must reflect the recipe.

For a food supplement, the name of the food is “food supplement” (Article 6(1) of Directive 2002/46/EC). The point 2.1 statement should therefore stand next to that name, not in the ingredients list or on the back panel.

4. Erythritol: the 2023 EFSA opinion granted no exemption

An erythritol producer applied to the Commission under Article 10(2) FIC to exempt erythritol from the warning, arguing high absorption in the small intestine. The EFSA FAF Panel assessed the application together with the re-evaluation of E 968 (EFSA Journal 2023;21(12):8430, published 20.12.2023). Findings that matter for the label:

• Erythritol is absorbed at 60–90%, dose-dependently, and is excreted mainly unchanged in urine.
• The Panel considered diarrhoea adverse and the most sensitive endpoint. From human interventional studies it took a reference point of 0.5 g/kg bw (lower bound of the NOAEL range) and set an ADI of 0.5 g/kg bw per day. It is the first ADI for a food additive based on an immediate adverse effect such as diarrhoea.
• In the Panel’s view the current warning “remains appropriate”, and the available data do not support exempting erythritol from point 2.4 for foods containing more than 10% erythritol.

An EFSA opinion does not change the law. Amending Annex III requires a Commission delegated act (Articles 10(2) and 51 FIC). In the FIC consolidated version of 1 April 2025, point 2.4 reads as it did in 2011. Energy value is a separate matter: Annex XIV assigns erythritol 0 kJ/g and other polyols 10 kJ/g. That is relevant for energy claims, not for the warning.

5. Supplement formats where the threshold is often exceeded

6. Label, online shop and national notification

• Legibility. Annex III statements are mandatory food information, so Article 13(1) FIC applies: conspicuous place, clear legibility, nothing obscuring them. The minimum x-height of 1.2 mm (0.9 mm where the largest surface is below 80 cm²) in Article 13(2)–(3) refers expressly to the Article 9(1) particulars, while Annex III statements are Article 10 particulars. Going below that standard is still unwise.
• Wording. Use the formula of the language version of Annex III for the market, not a paraphrase. “May have a laxative effect” or “too much may loosen stools” does not reproduce the provision.
• Distance selling. Article 14(1)(a) FIC requires mandatory food information, except the date of minimum durability, to be available before the purchase is concluded. The warning and the sweetener statement must therefore appear on the product page, not only in an illegible pack photo.
• Notification in Poland. The label template filed with the notification to the Chief Sanitary Inspector (GIS) on first placing on the market (Article 29 of the Act on food and nutrition safety) should include both statements. A recipe change that crosses the 10% threshold is a label change. The notification does not confirm label compliance. The food business operator is responsible for it (Article 17(1) of Regulation 178/2002). The procedure is described in the GIS notification guide.

7. What point 2.4 does not decide

• “Sugar-free” claims. The warning does not replace the conditions of Regulation 1924/2006: “sugars-free” requires no more than 0.5 g sugars per 100 g, and “with no added sugars” requires no added mono- or disaccharides or any other food used for its sweetening properties. Health claims on sugar replacers in Regulation 432/2012 have their own conditions of use.
• Whether a polyol may be used in the category. The warning does not legalise an additive use. That is governed by Annex II to Regulation 1333/2008 for categories 17.1–17.3, and specifications by Regulation (EU) No 231/2012.
• Daily dose. The provision does not link the warning to the polyol amount per recommended portion. A 5 g sachet with 2 g erythritol needs the warning, although 2 g is small compared with the ADI. Only the percentage counts.
• Additional consumer wording. The point 2.4 statement is fixed. Extra sentences about polyol tolerance must not weaken or obscure the warning (Articles 7 and 13(1) FIC).

8. Checklist: polyols in a food supplement

1. Inventory. List all Group IV additives (E 420, E 421, E 953, E 965, E 966, E 967, E 968), including those in premixes, carriers, shells and coatings.
2. Threshold. Add up the added polyols and divide by the mass of the product as sold. Above 10% means the point 2.4 warning is mandatory.
3. Function. Determine the principal function of each polyol and designate it in the ingredients list by category name (Annex VII Part C).
4. Sweeteners. If any additive sweetens, add the point 2.1 or 2.2 statement next to “food supplement”. With aspartame, add the point 2.3 statement.
5. Glycerol. Document whether and why E 422 is excluded from the threshold.
6. Wording and legibility. Use the Annex III formula of the market language in a legible place on the pack.
7. E-commerce and notification. Repeat the statements on the product page. Update the label template after any recipe change that moves the polyol share across the threshold.

Glossary

Group IV

Polyols in Part C of Annex II to Regulation 1333/2008: E 420, E 421, E 953, E 965, E 966, E 967, E 968.

Added polyols

Polyols used as food additives, directly or via a premix or carrier; excludes polyols naturally present in a raw material.

FIC Annex III

List of foods whose labelling must include additional mandatory particulars (Article 10(1) of Regulation 1169/2011).

ADI

Acceptable daily intake; for erythritol EFSA set 0.5 g/kg body weight per day in 2023.

Conclusion

One number decides the warning “excessive consumption may produce laxative effects”: the share of added Group IV polyols in the mass of the supplement as sold. Above 10% the statement is mandatory regardless of the polyol’s function, the portion size, or whether the polyol is erythritol. In 2023 EFSA found no basis to exempt erythritol, and Annex III has not changed. The “with sweetener(s)” statement next to “food supplement” is a separate duty that depends on a sweetening function, not on a threshold. Both statements must also appear on the online product page.

Primary sources

1. Regulation (EU) No 1169/2011 (consolidated 1.4.2025): Articles 7, 10, 13, 14, 29; Annexes I point 9, III points 2.1–2.4, VII Part C, XIV.
2. Regulation (EC) No 1333/2008 on food additives: Annex I point 1, Annex II (Group IV, categories 17.1–17.3), Annex III Parts 1 and 5.
3. Commission Regulation (EU) No 1129/2011 establishing the Union list of food additives (Annex II).
4. EFSA FAF Panel, Re-evaluation of erythritol (E 968) as a food additive, EFSA Journal 2023;21(12):8430.
5. Directive 2002/46/EC on food supplements: Article 6(1).
6. Regulation (EC) No 1924/2006: Annex (“sugars-free”, “with no added sugars”).
7. Commission Regulation (EU) No 231/2012: specifications for food additives.
8. Regulation (EC) No 178/2002: Article 17(1).