Eye nutrients: which claims are approved
Futures Nutrition Editorial Team · 13 August 2026
Eye nutrients: which claims are approved
13 August 2026
The short answer: in the EU exactly four nutrients may be connected with the maintenance of vision — vitamin A, riboflavin (vitamin B2), zinc and the omega-3 fatty acid DHA. Lutein and zeaxanthin, which usually take the front of the pack on eye supplements, are not among them. The applications for them were assessed and refused. That does not mean the substances are harmful; it means the evidence submitted was not enough for the authority — and that nobody may print a statement about their effect on the pack.
Anyone standing in front of a shelf of eye supplements therefore sees a curious inversion: the substances with the biggest appearance on the display side are the ones without an approved claim, and the substances that carry an approved claim sit in small print on the back, in the nutrition table. Anyone who knows which four those are reads any pack in half a minute.
The four approved claims in their exact wording
The governing text is Regulation (EU) No 432/2012 of 16 May 2012. It lists the permitted health claims with their official wording — which may not be departed from, not even in a more favourable direction. Under the health relationship "maintenance of normal vision" there are four entries:
| Nutrient | Approved claim | Condition of use | EFSA opinion |
|---|---|---|---|
| Vitamin A | "Vitamin A contributes to the maintenance of normal vision." | at least a source of vitamin A | 2009;7(9):1221 · 2010;8(10):1754 |
| Riboflavin (vitamin B2) | "Riboflavin contributes to the maintenance of normal vision." | at least a source of riboflavin | 2010;8(10):1814 |
| Zinc | "Zinc contributes to the maintenance of normal vision." | at least a source of zinc | 2009;7(9):1229 |
| DHA | "DHA contributes to the maintenance of normal vision." | at least 40 mg DHA per 100 g and per 100 kcal, information on 250 mg a day | 2010;8(10):1734 · 2011;9(4):2078 |
In the EU register of nutrition and health claims these entries carry the numbers 16, 4239 and 4701 (vitamin A), 39 (riboflavin), 361 (zinc) as well as 508 and others (DHA). Four nutrients, a single sentence pattern — the law gives no more than that on the subject of vision.
What is missing is striking. Vitamin C has no vision claim, vitamin E has none, selenium has none, beta-carotene as such has none. Vitamin E carries a different approved claim, often implied in eye supplements: "Vitamin E contributes to the protection of cells from oxidative stress." That is a statement about cells in general, not about the eye.
What "maintenance of normal vision" means — and what it does not
In the register the health relationship reads literally "maintenance of normal vision" — the upkeep of a normal function. Three things follow from that, and all three are regularly read past:
Maintenance is not improvement. The claim says the nutrient helps maintain normal vision — not that an existing visual weakness becomes smaller. A product advertising "sharper sight" is using a claim that does not exist.
Normal is the reference point. Short-sightedness or long-sightedness is a refractive error of the eye and is corrected with glasses or a lens; it is not a nutrient matter. Wearing glasses changes nothing about what the claim covers.
Diseases are excluded. Claims that refer to preventing, treating or curing a disease are generally not permitted for foods (Regulation (EC) No 1924/2006, Article 12). Eye diseases expressly belong there, and food supplements are not medicines. Anyone with symptoms belongs at the ophthalmologist, not at the shelf.
The condition: 15 per cent of the reference value
All three vitamin and mineral claims hang on the same condition: the food must be at least a "source of" the nutrient in question. What that means numerically is set out in Annex XIII of Regulation (EU) No 1169/2011: as a rule, 15 per cent of the nutrient reference value (NRV) counts as a significant amount.
| Nutrient | NRV per day | 15 % = significant amount | DGE recommendation for adults |
|---|---|---|---|
| Vitamin A | 800 µg | 120 µg | 850 µg RAE (m) · 700 µg RAE (f) |
| Riboflavin | 1.4 mg | 0.21 mg | 1.4 mg (m) · 1.1 mg (f) |
| Zinc | 10 mg | 1.5 mg | 11–16 mg (m) · 7–10 mg (f), depending on phytate intake |
| Vitamin E (cell protection claim) | 12 mg | 1.8 mg | no D-A-CH reference value in this table |
For food supplements the amount does not refer to 100 grams but to the daily portion stated on the label — that is what § 4(3) of the German food supplements regulation (Nahrungsergänzungsmittelverordnung, NemV) prescribes, together with the duty to state the percentage of the reference value. In practice that means: the percentage on the back of the pack is the figure from which the condition can be read off. Anything above 15 per cent carries the claim, anything below does not.
An example from our own range: our Vitamin A + E + lutein provides 400 µg of vitamin A per tablet (50 % NRV), 20 mg of vitamin E (167 % NRV) and 10 mg of lutein from Tagetes erecta extract.
The vitamin A amount is thus a good three times above the threshold of 120 µg — the condition is met. The same principle applies to zinc: Zinc + vitamin B3 contains 25 mg of zinc per tablet (250 % NRV) and is therefore far above the 1.5 mg from which the zinc claim may be used at all.
A numerical trap sits, in the case of vitamin A, in the comparison of the two right-hand columns of the table. The reference value on the label is a pure calculation figure; the DGE recommendation, by contrast, counts in retinol activity equivalents (RAE), and there 1 µg of retinol corresponds to as much as 12 µg of beta-carotene. Older tables use 6 µg. The same amount of beta-carotene therefore yields different microgram figures depending on the conversion key — one reason why percentages on packs and the recommendations of scientific societies do not line up.
Lutein and zeaxanthin: assessed and refused
Lutein is the carotenoid people associate with the eyes — which is exactly why the register is worth a look. The applications for a vision claim are recorded there, with the original wording and the ground for refusal:
| Claim applied for (extract) | Health relationship | Status | Entry |
|---|---|---|---|
| "Lutein promotes healthy eye function … Lutein contributes to the protection of vision" | maintenance of vision | not authorised | 1931 |
| "Lutein helps maintain a healthy vision" (example from Tagetes or Calendula officinalis) | maintenance of normal vision | not authorised | 2080 |
| "Eye protection factor(s)" (lutein/zeaxanthin) | maintenance of normal vision | not authorised | 1606 |
| "Due to the antioxidant properties lutein/zeaxanthin contributes to the hindrance of harmful oxidative processes" | protection of DNA, proteins and lipids | not authorised | 1914 |
In the first two cases the reasoning reads, word for word, that the evidence provided is insufficient to substantiate this claimed effect for this food; the corresponding EFSA opinions are 2010;8(2):1492 and 2011;9(4):2030. Entry 2080 is notable: it expressly names Tagetes as an example source — that is, precisely the plant from which the lutein in supplements is usually obtained.
Two practical consequences follow. First, lutein may be declared as an ingredient with an amount — a statement about its effect may not. Second, there is no percentage behind the milligram figure, because no reference value is laid down for lutein in Annex XIII of Regulation (EU) No 1169/2011. A missing percentage is therefore not a labelling defect in the case of lutein, but the rule.
The case of anthocyanins from bilberry and blackcurrant is similar. The claim applied for — that they are "good for the eyes" and improve dark adaptation as well as eye fatigue during screen work — was likewise refused (entry 2796, EFSA 2011;9(6):2244) — here on a different ground: the food was not sufficiently characterised for a scientific assessment. That is a difference worth knowing: in one case the evidence was lacking, in the other the object under assessment was not defined clearly enough.
DHA: the claim with an amount condition
DHA is the odd one out, because its condition does not run through the 15 per cent key. The claim is permitted only for foods with at least 40 mg of DHA per 100 g and per 100 kcal — and in addition the consumer must be informed that the beneficial effect is obtained with a daily intake of 250 mg of DHA. Those 250 mg are the figure an omega-3 product has to be measured against; they do not stand there as a recommendation but as part of the authorisation.
DHA comes from oily sea fish or from microalgae oil and is not part of our range. Anyone wanting to use the claim will therefore look for it outside the classic combined eye products.
What this means at the shelf
From all this follows a short order of checks that works on any pack:
The detailed version, with amounts and combinations, is in the eye supplement buying guide.
- Look at the back, not the front. The image and the product name say nothing about the amount.
- Look for the four nutrients. If none of them appears in the table, there is nothing permissible to say about vision — regardless of how much lutein is in there.
- Read the percentage. Below 15 per cent of the reference value the nutrient is not even formally "contained" in the sense of being highlighted.
- Add several products together. Zinc sits in many combinations; the day's total counts, not the single tablet. What else the range holds is shown by the category Eyes, and the single-nutrient zinc products are under Zinc.
Food supplements are not a substitute for a balanced and varied diet and a healthy lifestyle.
Frequently asked questions
Is lutein worthless if there is no approved claim for it? No — the two questions are separate. A refusal in the register means that the documents submitted do not support the specific effect claimed. It is not a finding that the substance does nothing, and certainly not a safety verdict. Lutein remains a permitted ingredient and occurs naturally in kale, spinach and egg yolk. It is only that nothing may be advertised with it.
Why is there no percentage for lutein on the pack? Because Annex XIII of Regulation (EU) No 1169/2011 lays down reference values only for vitamins and minerals. Lutein is neither, so there is no value a percentage could refer to. The statement "10 mg" is complete as it stands.
Is a normal diet enough for the four nutrients? For vitamin A and riboflavin the DGE recommendations, at 700 to 850 µg RAE and 1.1 to 1.4 mg per day respectively, lie in an order of magnitude that a mixed diet usually covers. With zinc it depends heavily on the menu: the recommendation ranges from 7 mg at low to 16 mg at high phytate intake, because phytate from wholegrains and pulses slows absorption. With DHA the gap is largest when no sea fish comes to the table.
Is a product even allowed to be called "for the eyes"? The product name is one thing, the health claim another. A statement about an effect is permitted only in the wording Regulation (EU) No 432/2012 sets out, and only for the nutrient it is authorised for. What a buyer can go by is therefore not the name on the display side, but the nutrition table underneath.
