A food supplement may say “source of vitamin D” only if it contains at least a significant amount of that vitamin. As a rule, that means 15% of the nutrient reference value (NRV), or 0.75 µg for vitamin D. The same threshold also controls health claims. Regulation (EU) No 432/2012 allows claims on vitamins and minerals only for food that is “at least a source of” the nutrient. What the rules do not say expressly is the quantity of supplement that the 15% refers to. Annex XIII to Regulation 1169/2011 names 100 g, 100 ml or a package containing a single portion, and is silent on the daily portion. Article 5(1)(d) of Regulation 1924/2006 and Article 8 of Directive 2002/46/EC still give a consistent answer: for a supplement, the recommended daily portion is the basis. In Poland the same threshold also applies as the minimum vitamin and mineral content of every food supplement, under § 4(2) of the Polish Minister of Health regulation on the composition and labelling of food supplements.
1. What the Annex to Regulation 1924/2006 actually says
Nutrition claims are permitted only if they are listed in the Annex to Regulation 1924/2006 and meet its conditions (Article 8(1)). For vitamins and minerals the Annex has three entries:
- “SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S]”. This claim, and any claim likely to have the same meaning for the consumer, “may only be made where the product contains at least a significant amount as defined in the Annex to Directive 90/496/EEC or an amount provided for by derogations granted according to Article 6 of Regulation (EC) No 1925/2006”.
- “HIGH [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S]”. Requires “at least twice the value of ‘source of’”. With a 15% threshold this means 30% NRV on the same basis.
- “CONTAINS [NAME OF THE NUTRIENT OR OTHER SUBSTANCE]”. “For vitamins and minerals the conditions of the claim ‘source of’ shall apply.” The Polish language version mentions only vitamins at this point, but the English and German texts cover vitamins and minerals. “Contains zinc” therefore needs the same threshold.
Recital 20 adds that claims on added vitamins and minerals such as “with …”, “added …” or “enriched …” are subject to the conditions for “source of”. The boundary is the definition in Article 2(2)(1): a claim is a message that is not mandatory. The mandatory parts of a supplement label are therefore not claims. These include the name of the nutrient categories (Article 6(3)(a) of Directive 2002/46/EC) and the numerical declaration with the percentage of reference values (Article 8). A front-of-pack “with vitamin D”, a “rich in zinc” icon or “high dose” goes beyond mandatory information. Such wording has to be assessed as a claim likely to have the same meaning as “source of” or “high”.
Fixed terms in three language versions
| Concept | EN (authentic) | PL | DE |
|---|---|---|---|
| “Source” claim | ‘source of [name of vitamin]’ | „źródło [nazwa witaminy]” | „[Name des Vitamins]-Quelle” (in the “enthält” entry: „Quelle von“) |
| “High” claim | ‘high [name of vitamin]’ | „wysoka zawartość [nazwa witaminy]” | „hoher [Name des Vitamins]-Gehalt” |
| Threshold | significant amount | znacząca ilość | signifikante Menge |
| Reference value (Annex XIII Part A point 1) | nutrient reference values (NRVs) | referencyjne wartości spożycia (RWS) | Nährstoffbezugswerte (NRV); Annex heading: „Referenzmengen“ |
| Basis of supplement declaration (Article 8(2) Directive 2002/46/EC) | portion recommended for daily consumption | porcja zalecana do dziennego spożycia | empfohlene Tagesdosis |
2. Three bases in Annex XIII, none expressly for supplements
The reference to the Annex to Directive 90/496/EEC is now read as a reference to Regulation 1169/2011, because Article 53(2) of that Regulation provides that references to the repealed acts are construed as references to it. Point 2 of Part A of Annex XIII reads:
“As a rule, the following values should be taken into consideration in deciding what constitutes a significant amount: — 15% of the nutrient reference values specified in point 1 supplied by 100 g or 100 ml in the case of products other than beverages, — 7,5% of the nutrient reference values specified in point 1 supplied by 100 ml in the case of beverages, or, — 15% of the nutrient reference values specified in point 1 per portion if the package contains only a single portion.”
The text leads to four conclusions for supplements:
- No “daily portion” basis. Annex XIII knows 100 g, 100 ml and a package containing only one portion. A bottle of 60 capsules is not a single-portion package. A one-day sachet or vial is, and the third indent applies to it directly.
- “As a rule”. The threshold is not drafted as a rigid definition. The values are to be “taken into consideration”. That leaves room for an interpretation that matches the basis to the product form.
- Article 29(1)(a) of Regulation 1169/2011 excludes supplements from Section 3 of Chapter IV, i.e. from the mandatory nutrition declaration per 100 g/100 ml. The exclusion concerns that Section. It does not remove the significant-amount threshold to which the Annex to Regulation 1924/2006 refers. The threshold binds supplements, but without an express basis.
- The derogation route under Regulation 1925/2006 is closed for supplements. Article 6(6) of that Regulation lets the Commission set minimum amounts for fortified foods, including amounts below the significant amount. Under Article 1(2), however, its provisions on vitamins and minerals “shall not apply to food supplements covered by Directive 2002/46/EC”. That leaves supplements with the Annex XIII significant amount only.
3. Why the recommended daily portion and not 100 g
Five provisions point to the daily portion, although none says so expressly:
- Article 5(1)(d) of Regulation 1924/2006. A claim is permitted only if “the quantity of the product that can reasonably be expected to be consumed provides a significant quantity of the nutrient […] as defined in Community legislation”. For a supplement, a product in dose form, that quantity is the recommended daily portion. Nobody consumes 100 g of tablets.
- Article 5(3). Claims refer to the food ready for consumption in accordance with the manufacturer’s instructions. For a supplement, the instruction is the recommended daily portion (Article 6(3)(b) of Directive 2002/46/EC).
- Article 7, last sentence. “In the case of food supplements, the nutrition information shall be provided in accordance with Article 8 of Directive 2002/46/EC.” Article 8(2) of the Directive requires amounts per portion recommended for daily consumption, and Article 8(3) requires the percentage of reference values. The label on which the consumer checks the claim therefore works only with the daily portion.
- Article 5(3) of Directive 2002/46/EC and recital 15. The legislature announced minimum amounts “per daily portion of consumption as recommended by the manufacturer” to ensure that significant amounts of vitamins and minerals are present in supplements. The Commission has not adopted them. Its food supplements page states that, despite consultations, no proposal has yet been presented. The direction is still clear: a significant amount in a supplement is conceived per daily portion.
- Arithmetic. For any daily portion below 100 g, the %NRV per 100 g is always higher than the %NRV per portion. For a 500 mg tablet the factor is 200. A “per 100 g” basis would make almost any trace amount a “source”. That would defeat the aim stated in recital 14 and in Article 5(1)(d).
4. Worked examples (hypothetical products)
The formulations below are hypothetical examples, not descriptions of products on the market. NRVs under Annex XIII Part A point 1: vitamin D 5 µg, vitamin C 80 mg, zinc 10 mg, magnesium 375 mg, selenium 55 µg, vitamin B12 2.5 µg.
| Product (hypothetical) | Content per recommended daily portion | % NRV per daily portion | % NRV “per 100 g” | “Source of” / 432/2012 | “High” |
|---|---|---|---|---|---|
| A. 500 mg tablet, 1 daily, vitamin D | 0.5 µg | 10% | 2,000% | no | no |
| B. 400 mg capsule, 2 daily, zinc 1 mg/capsule | 2 mg | 20% | 2,500% | yes | no (3 mg needed) |
| C. 20 g powder sachet, 1 daily, vitamin C | 10 mg | 12.5% | 62.5% | no | no |
| D. 1.2 g tablet, 1 daily, magnesium | 112.5 mg | 30.0% | 2,500% | yes | yes, but exactly at the threshold (see section 7) |
| E. 250 mg tablet, 2 daily, selenium 4 µg/tablet | 8 µg | 14.5% | 2,909% | no | no |
| F. 25 ml vial (single-portion package), 1 daily, vitamin B12 | 0.5 µg | 20% | (not relevant: the portion in the package is the basis) | yes (Annex XIII point 2, third indent) | no |
Sachet C shows that the problem is not limited to tablets. With a 20 g portion it passes the “per 100 g” threshold, and even the “high” threshold, although the daily portion supplies only 12.5% NRV. Product E is a typical formulation error. It is 0.25 µg of selenium short per daily portion, so no selenium claim may be used. In Poland it also fails the composition minimum (section 6).
5. The same threshold opens Regulation 432/2012 health claims
The conditions of use for almost all vitamin and mineral claims in the Annex to Regulation 432/2012 read the same way: “The claim may be used only for food which is at least a source of vitamin D as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.” Entries with different conditions are few; the third point below covers them. The consequences:
- A supplement below 15% NRV per daily portion may not bear a health claim on that vitamin or mineral. The same applies to the “general” references under Article 10(3), which must be accompanied by a specific listed claim. Below the threshold, no such accompanying claim is available. For product A in the table, “Vitamin D contributes to the maintenance of normal bones” is not allowed, not even in small print on the back panel.
- Being a “source” is enough. Health claims do not require “high”. Product B (20% NRV zinc) may use authorised zinc claims but may not call itself “rich in zinc”.
- Some entries have their own conditions. The vitamin C claim on immune function during and after intense physical exercise may be used only for food “which provides a daily intake of 200 mg vitamin C”, with information that this is in addition to the recommended daily intake. The chloride claim cannot be used on chloride from sodium chloride, and the chromium claims concern trivalent chromium. For choline, which has no NRV in Annex XIII, the Commission set its own threshold: 82.5 mg per 100 g, 100 ml or single portion. The condition of the specific entry prevails over the general pattern.
- Ingredient status unlocks nothing. A permitted chemical form under Annex II to Directive 2002/46/EC, a novel-food listing or a “natural” origin does not replace the quantitative threshold or the requirement for an authorised claim. Article 10(2) of Regulation 1924/2006 also applies, including information on the quantity of food and pattern of consumption required to obtain the claimed effect.
The wider picture of health claims on supplements, including the relationship with national notification, is covered in the guide to health claims on food supplements. For vitamin D, see also the analysis of authorised claims and scientific evidence.
6. Poland: 15% NRV per daily portion as a composition minimum
Poland has filled the gap left by the EU minimums that were never adopted. § 4(2) of the Minister of Health regulation of 9 October 2007 on the composition and labelling of food supplements provides that the minimum amount of vitamins and minerals present in food supplements in the portion recommended for daily consumption is not less than 15% of the reference intakes in point 1 of Part A of Annex XIII to Regulation 1169/2011. § 5(4) and (5) require the content to be declared per recommended daily portion and as a percentage of the reference intakes. The amendments of 2025 (Dz.U. item 1182) and 2026 (Dz.U. item 1115) changed Annex 2 on chemical forms and left § 4 untouched.
Consequences for the Polish market:
- In Poland the question of the reference basis largely loses practical weight. Every vitamin and mineral with an NRV present in a supplement must reach 15% NRV per daily portion. Otherwise the product fails the composition requirement, whether or not it bears any claim.
- Meeting the composition minimum is not the same as having a right to a claim. It only satisfies the quantitative threshold. A health claim must still come from the Union list and follow the authorised wording.
- Notification of first placing on the market to the Chief Sanitary Inspectorate (GIS) confirms neither composition nor claims. The procedure is described in the guide to GIS notification of food supplements.
7. Declaring at the threshold: tolerances in the Commission guidance
The Commission’s December 2012 guidance for competent authorities on tolerances for nutrient values sets the ordinary tolerances for vitamins and minerals in supplements at +50%/−20% (vitamins) and +45%/−20% (minerals), measurement uncertainty included. It is different when the declared value equals the level in the conditions of use of a claim. Then only the measurement uncertainty is applied below that level, and +50% for vitamins or +45% for minerals above it (section 5.1 and Table 3). The measured value should stay within the tolerances throughout the shelf life (section 2.2). The guidance has no formal legal status, but control authorities work with it.
For product D in the table (magnesium at exactly 30% NRV with a “high” claim), a control result below 112.5 mg that measurement uncertainty does not explain undermines the claim. A formulation with an overage and stability data is safer than a declaration that sits exactly on the threshold. The overage must also fit within national maximum levels.
8. What the rules do not expressly decide
- The reference basis for supplements. Neither Regulation 1924/2006 nor Annex XIII says “daily portion”. The answer in section 3 is a systematic interpretation, not an express rule.
- EU guidance. The conclusions of the Standing Committee on the Food Chain and Animal Health of 14 December 2007 on the implementation of Regulation 1924/2006 deal with interaction with other legislation, comparative claims and claim classification. They do not discuss the reference basis for supplements. The 2018 Commission Notice (Q&A on Regulation 1169/2011, point 3.7) only clarifies terminology for the %NRV on supplements. It also confirms that the nutrition information of a supplement bearing a claim follows Article 8 of Directive 2002/46/EC.
- Case law. C-137/13 Herbaria (5.11.2014) concerned the organic production rules (Article 27(1)(f) of Regulation 889/2008). In it the Court noted that marketing a food as a supplement with a nutrition or health claim implies that it must contain a determined quantity of the substance. It did not rule on how that quantity is calculated.
- Dosage ranges and liquid supplements. The rules do not say whether “1–2 capsules” should be calculated at the lower end. Nor do they say whether a liquid supplement is a “beverage” for the 7.5% per 100 ml threshold. On a daily-portion basis the second question loses practical relevance.
- EU minimums. Article 5(3)–(4) of Directive 2002/46/EC provides for minimum amounts per daily portion, but the Commission has not adopted them. The Polish minimum in § 4(2) is a national rule.
9. Checklist before placing a vitamin or mineral claim
- Basis. Take the recommended daily portion from the label. For a range, use the smallest portion; for a single-portion package, use that portion.
- “Source of” threshold. Calculate the %NRV under Annex XIII Part A point 1 and check that it is at least 15%.
- “High” threshold. “Rich in”, “high”, “high dose” and wording with the same meaning need at least 30% NRV on the same basis.
- Hidden claims. Check the front of pack, icons and e-commerce copy for “with…”, “added…”, “enriched…” and “contains…”. All of them need the “source of” threshold.
- Health claim. Pick the entry from the Union list (432/2012 and later acts) and read its conditions. “At least a source of” usually suffices, but some entries have their own thresholds, e.g. 200 mg vitamin C daily, or restrictions on the form of the nutrient.
- Margin and stability. Declare a value with an overage above the threshold and confirm it with end-of-shelf-life stability testing. At a claim threshold the authority allows only measurement uncertainty downwards.
- Polish market. Every vitamin and mineral with an NRV must reach at least 15% NRV per daily portion (§ 4(2)), even if the product bears no claims.
Glossary
- Significant amount
- Threshold in point 2 of Part A of Annex XIII to Regulation 1169/2011: as a rule 15% NRV per 100 g, 7.5% per 100 ml of a beverage, or 15% per portion in a single-portion package.
- Nutrient reference values (NRVs)
- Values for 27 vitamins and minerals in point 1 of Part A of Annex XIII (adults), e.g. vitamin D 5 µg, vitamin C 80 mg, magnesium 375 mg.
- Recommended daily portion
- The portion of the product recommended for daily consumption, mandatory on a supplement label (Article 6(3)(b) of Directive 2002/46/EC). Nutrient content is declared per this portion (Article 8(2)).
- Nutrition claim
- A non-mandatory message suggesting particular beneficial nutritional properties due to a nutrient content, permitted only in the wording and under the conditions of the Annex to Regulation 1924/2006.
- “At least a source of” condition
- The standard condition of use for vitamin and mineral health claims in Regulation 432/2012, referring to the threshold of the “source of” claim.
Conclusion
A food supplement may bear “source of [vitamin or mineral]” when it supplies at least 15% NRV, and “high” when it supplies at least 30% NRV. Annex XIII has no “daily portion” basis, and the derogations under Regulation 1925/2006 do not apply to supplements. Even so, Articles 5(1)(d) and 7 of Regulation 1924/2006 and Article 8 of Directive 2002/46/EC point to the recommended daily portion as the only basis consistent with the purpose of the rules. The same threshold decides health claims, because Regulation 432/2012 requires the food to be “at least a source of” the nutrient. A supplement with less than 15% NRV per daily portion therefore may not bear a health claim on that nutrient. In Poland such a product also fails the composition minimum in § 4(2) of the Minister of Health regulation. When the declaration sits exactly on the threshold, the control authority tolerates only measurement uncertainty downwards.
Primary sources
- Regulation (EC) No 1924/2006, consolidated 13.12.2014: Article 2(2)(1), Articles 5, 7, 8, 10(2)–(3); Annex: “source of”, “high”, “contains”.
- Regulation (EC) No 1924/2006, original text: recitals 14 and 20.
- Regulation (EU) No 1169/2011, consolidated 1.4.2025: Article 29(1)(a), Article 30(2)(f), Article 53(2); Annex XIII Part A points 1–2.
- Directive 2002/46/EC, consolidated 26.11.2025: Article 5(3)–(4), Article 6(3), Article 8(1)–(3); recital 15 (original text).
- Regulation (EC) No 1925/2006, consolidated 26.11.2025: Articles 1(2) and 6(6).
- Commission Regulation (EU) No 432/2012, consolidated 20.8.2025: Annex, conditions of use for vitamin and mineral claims.
- Polish Minister of Health regulation of 9.10.2007 on the composition and labelling of food supplements (consolidated Dz.U. 2023 item 79): § 4(2), § 5(3)–(5); amendments: Dz.U. 2025 item 1182, Dz.U. 2026 item 1115.
- Commission Notice 2018/C 196/01: Q&A on Regulation 1169/2011, points 3.7.1–3.7.2.
- European Commission, guidance for competent authorities on tolerances (December 2012): sections 2.2, 4, 5.1, Tables 2–3.
- Conclusions of the Standing Committee on the Food Chain and Animal Health of 14.12.2007: guidance on Regulation 1924/2006.
- European Commission, “Food supplements” page: status of work on minimum and maximum amounts of vitamins and minerals.
- CJEU judgment of 5.11.2014, C-137/13 Herbaria Kräuterparadies, ECLI:EU:C:2014:2335: operative part.