Only vitamins and minerals listed in Annex I to Directive 2002/46/EC may be used in the manufacture of food supplements in the forms listed in Annex II (please note the most recent consolidated version).
Vitamin and mineral compounds used in food supplements must meet the relevant purity criteria. Read more about purity requirements here. If a vitamin or mineral compound is an authorised novel food, the purity criteria for it are set out in the Union list of novel foods approved under Regulation (EU) 2017/2470 (note the most recent consolidated version).
You can apply for new vitamin or mineral compounds to be added to the annex to the Food Supplement Directive by two different procedures, depending on whether the compound is a novel food or not:
- Compounds that have a significant history of use in food before 15 May 1997, and are therefore not considered novel foods, are applied by an application submitted to the European Commission.
- European Commission's guide to submitting an application (in English, pdf)
- For compounds that do not have a significant history of use in food before 15 May 1997, and are therefore considered novel foods, a novel food authorisation is applied for in the European Commission's electronic system.
Amounts of vitamins and minerals in food supplements
Minimum levels
In order for a food supplement to be sold as a source of a vitamin or mineral, the daily intake of that vitamin or mineral must be at least 15 percent of the daily reference intake when consumed according to the instructions of use.
If a food supplement is sold as an excellent or good source of a vitamin or mineral, or marketed in such a way that the food supplement is rich in vitamins or minerals (e.g. in the name of the product), the daily intake of the food supplement must be at least 30 percent of the daily reference intake when consumed according to the instructions of use.
Read more on the Food Authority's website.
Maximum levels
So far, no maximum levels have been set in legislation for vitamins and minerals contained in food supplements. However, a food supplement must be safe and the amount of vitamin or mineral it provides per day must not pose a health hazard to consumers. The European Food Safety Authority (EFSA) has assessed the safety of nutrients and assigned Tolerable Upper Intake Limits (ULs) for certain vitamins and minerals. The UL value indicates how much vitamin or mineral can be consumed as a whole in continuous long-term use without any safety risk. The UL values for the different nutrients are listed in the table below.
The Finnish Food Authority considers that if the amount of a vitamin or mineral in the recommended daily dose of a food supplement exceeds the UL value, the food supplement can be considered to pose a health hazard to consumers. In these cases, food business operators must take measures to manage the health hazard. The measures must be considered on a case-by-case basis, appropriate to the situation in question. Possible health hazard management measures include:
- lowering the concentration of the nutrient in the daily dose of the food supplement,
- reduction of the recommended daily dose,
- a warning label, or
- some other way to ensure the safety of the food supplement.
Food supplements containing other than permitted vitamins and/or minerals, or their sources, or for which safety is not ensured, shall not be placed on the market. Instructions for the recall of food supplements can be found here.
Table: Reference and minimum daily intakes of nutrients1 and Tolerable Upper Intake Levels2,3,4,5,6,7,11 (UL)
|
Nutrient (unit) |
RDI | Minimum level (15 % of RDI) |
UL (1-3) |
UL (4-6) |
UL (7-10) |
UL (11-14) |
UL (15-17) |
UL (18-) |
| Vitamins | ||||||||
| Vitamin A (µg) | 800 | 120 | 800 | 1100 | 1500 | 2000 | 2600 | 3000 |
| Vitamin D (µg) | 5 | 0,75 | 508 | 50 | 50 | 100 | 100 | 100 |
| Vitamin E (mg) | 12 | 1,8 | 100 | 120 | 160 | 220 | 260 | 300 |
| Vitamin K (µg) | 75 | 11,25 | - | - | - | - | - | - |
| Vitamin C (mg) | 80 | 12 | - | - | - | - | - | - |
| Thiamin (B1) (mg) | 1,1 | 0,165 | - | - | - | - | - | - |
| Riboflavin (B2) (mg) | 1,4 | 0,21 | - | - | - | - | - | - |
| Niacin (B3) (mg) | 16 | 2,4 | ||||||
| Nicotinic acid | 2 | 3 | 4 | 6 | 8 | 10 | ||
| Niacinamide | 150 | 220 | 350 | 500 | 700 | 900 | ||
| Vitamin B6 (mg) | 1,4 | 0,21 | 3,29 | 4,5 | 6,1 | 8,6 | 10,7 | 12 |
| Folic acid (B9) (µg) | 200 | 30 | 200 | 300 | 400 | 600 | 800 | 1000 |
| Vitamin B12 (µg) | 2,5 | 0,375 | - | - | - | - | - | - |
| Biotin (B7) (µg) | 50 | 7,5 | - | - | - | - | - | - |
| Pantothenic acid (B5) (mg) | 6 | 0.9 | - | - | - | - | - | - |
| Minerals | ||||||||
| Potassium (mg) | 2000 | 300 | - | - | - | - | - | - |
| Chloride (mg) | 800 | 120 | - | - | - | - | - | - |
| Calcium (mg) | 800 | 120 | - | - | - | - | - | 2500 |
| Phosphorus (mg) | 700 | 105 | - | - | - | - | - | - |
| Magnesium (mg) | 375 | 56,25 | - | - | - | - | - | 25010 |
| Iron (mg) | 14 | 2,1 | - | - | - | - | - | - |
| Zinc (mg) | 10 | 1,5 | 7 | 10 | 13 | 18 | 22 | 25 |
| Copper (mg) | 1 | 0,15 | 1 | 2 | 3 | 4 | 4 | 5 |
| Manganese (mg) | 2 | 0,3 | - | - | - | - | - | - |
| Fluoride (mg) | 3,5 | 0,525 | 1,611 | 2 | 2 | - | - | - |
| Selenium (µg) | 55 | 8,25 | 7012 | 95 | 130 | 180 | 230 | 255 |
| Chromium (µg) | 40 | 6 | - | - | - | - | - | - |
| Molybdene (µg) | 50 | 7,5 | 100 | 200 | 250 | 400 | 500 | 600 |
| Iodine (µg) | 150 | 22,5 | 200 | 250 | 300 | 450 | 500 | 600 |
1 Food Information Regulation (EU) No 1169/2011 Annex XIII
2 Tolerable Upper Intake Levels for Vitamins and Minerals, Scientific Committee on Food, Scientific Panel on Dietetic Products, Nutrition and Allergies, EFSA, February 2006.
3 Scientific Opinion on the Tolerable Upper Intake Level of vitamin D, EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA), EFSA Journal 2012; 10 (7):2813.
4 Scientific Opinion on the update of Tolerable Upper Intake Level for vitamin D for infants, EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA), EFSA Journal 2018; 16 (8): 5365.
5 Scientific opinion on the tolerable upper intake level for selenium, EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA), EFSA Journal 2023;21(1):7704.
6 Scientific opinion on the tolerable upper intake level for vitamin B6, EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA), EFSA Journal 2023;21(5):8006.
7 Scientific opinion on the tolerable upper intake level for vitamin D, including the derivation of a conversion factor for calcidiol monohydrate, EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA), EFSA Journal 2023;21(8):8145
8 Tolerable upper intake level for vitamin D is 25 µg for infants of 0-6 months of age and 35 µg for infants of 6-12 months of age.
9 Tolerable upper intake level for vitamin B6 is 2,2 mg for infants of 4-6 months of age and 2,5 mg for infants of 7-11 months of age.
10 Concerns only readily dissociable Mg salts (e.g. chloride, sulphate, aspartate, lactate) and compounds like MgO in food supplements, water or added to foods; does not include Mg naturally present in foods and beverages.
11 Updated consumer risk assessment of fluoride in food and drinking water including the contribution from other sources of oral exposure, EFSA Scientific Committee, EFSA Journal. 2025;23:e9478. Tolerable upper intake level for fluoride is 1 mg for children under 1 year of age, 1,6 mg for children of 1-3 years of age, and 2 mg for children of 4-8 years of age.
12 Tolerable upper intake level for selenium is 45 µg for infants of 4-6 months of age and 55 µg for infants of 7-11 months of age.