Food supplements are defined in EU legislation as concentrated sources of nutrients or other substances with a nutritional or physiological effect, intended to supplement the normal diet. They are marketed in dose form, such as capsules, pills, and powders, and may contain substances including vitamins, minerals, amino acids, essential fatty acids, fibers, and extracts from plants and herbs.1
Supplements are regulated as foods, which means that they must comply with the same EU regulations on contaminants, pesticide residues, food additives, and nutrition and health claims as any other food product. In addition, they must only contain authorized ingredients and additives and respect the applicable labeling rules.
Which ingredients may be used to manufacture food supplements?
Directive 2002/46/EC on food supplements lists the vitamins and minerals that are authorized for manufacturing supplements in Europe, as well as the forms in which they may be used and the units in which their concentrations must be displayed. Nutrient amounts must be declared per portion, both numerically and as a percentage of the daily reference intake value. The declared values should be based on average results obtained from laboratory tests.2
Table 1: Daily reference intake values for vitamins and minerals3
Vitamin or mineral | Daily reference intake |
Vitamin A | 800 μg |
Vitamin D | 5 μg |
Vitamin E | 12 mg |
Vitamin K | 75 μg |
Vitamin C | 80 mg |
Thiamin | 1.1 mg |
Riboflavin | 1.4 mg |
Niacin | 16 mg |
Vitamin B6 | 1.4 mg |
Folic acid | 200 μg |
Vitamin B12 | 2.5 μg |
Biotin | 50 μg |
Pantothenic acid | 6 mg |
Potassium | 2,000 mg |
Chloride | 800 mg |
Calcium | 800 mg |
Phosphorus | 700 mg |
Magnesium | 375 mg |
Iron | 14 mg |
Zinc | 10 mg |
Copper | 1 mg |
Manganese | 2 mg |
Fluoride | 3.5 mg |
Selenium | 55 μg |
Chromium | 40 μg |
Molybdenum | 50 μg |
Iodine | 150 μg |
Ingredients other than vitamins and minerals may also be used to produce supplements, as long as they have been approved under the novel foods regulation or other relevant legislation on the EU or national level. Examples of supplement ingredients authorized as novel foods include various plant extracts and iron hydroxide adipate tartrate, which is the first engineered nanomaterial approved in any food category.4
In addition to the main ingredients, food additives, such as sweeteners, colors, preservatives, coatings, anti-caking agents, bulking agents, and flavor enhancers, must be approved to be used in supplements. Approved additives and the food categories they are authorized for are listed in Regulation (EC) 1333/2008.5
What are the rules for health and nutrition claims?
Food supplement labels can include health and nutrition claims, as long as the benefits are scientifically proven and labeling rules are followed. In essence, companies must prove the supplement contains an appropriate amount of a given ingredient to achieve the claimed benefit. Examples include several vitamins and minerals contributing to normal physiological functions and melatonin contributing to the reduction of time to fall asleep.6
Rules on food supplement contaminants
Food supplement manufacturers must ensure that their products do not contain certain contaminants, such as mycotoxins, heavy metals, or PAH compounds, in concentrations exceeding the maximum permitted levels set in Regulation (EU) 2023/915 on food contaminants.
Table 2: Maximum contaminant levels in food supplements7
Contaminant | Type of food supplement | Maximum level |
Citrinin | Supplements based on rice fermented with red yeast Monascus purpureus | 100 μg/kg |
Pyrrolizidine alkaloids | Supplements containing botanical preparations and extracts | 400 μg/kg |
Pyrrolizidine alkaloids | Pollen-based supplements | 500 μg/kg |
Lead | All supplements | 3.0 mg/kg |
Cadmium | Supplements consisting of at least 80% dried seaweed or derived from seaweed or dried bivalve mollusks | 3.0 mg/kg |
Cadmium | All other supplements | 1.0 mg/kg |
Mercury | All supplements | 0.10 mg/kg |
Polycyclic aromatic hydrocarbons (PAH) | Supplements containing botanicals, propolis, royal jelly, spirulina, or their preparations | Benzo(a)pyrene: 10.0 μg/kg; Sum of benzo(a)pyrene, benz(a)anthracene, benzo(b) fluoranthene, and chrysene: 50.0 μg/kg |
In addition to the contaminants specified above, supplements must not contain excessive concentrations of pesticide residues or unauthorized ingredients, such as pharmaceuticals. If these are found, products may be recalled from the market or be denied entry into the EU. In 2023, reasons for food supplement recalls included ethylene oxide residues and the unauthorized presence of sildenafil, sibutramine, cannabinoids, yohimbine, and tadalafil.8
Supplement testing by EU regulations
Measurlabs provides a wide variety of food testing and analysis services to help companies maintain high product quality and ensure compliance with EU regulations. Some of the popular testing options for food supplements include the following:
Standard and extended dietary supplement contaminant analyses, covering both chemical and microbiological parameters
PAH 4 screening, covering the polycyclic aromatic hydrocarbons specified in Regulation (EU) 2023/915
We also offer vitamin and mineral content determination for most nutrients listed in Directive 2002/46/EC. If you want to learn more about supplement testing or request a quote for your product, please contact us via the form below or at info@measurlabs.com.
References
1 The definition of food supplements can be found in Article 2 of Directive 2002/46/EC. See also EFSA’s Food supplements page.
2 Approved vitamins and minerals are listed in Annex I of Directive 2002/46/EC, and the forms they should take in Annex II. See Article 8 and Article 9 of the directive for labeling requirements.
3 The daily reference intake values for vitamins and minerals are listed in Annex XIII of Regulation (EU) No 1169/2011.
4 See Regulation (EU) 2017/2470 for a list of approved novel foods.
5 Regulation (EC) No 1333/2008 on food additives.
6 See the EU Register on Health Claims for claims that are currently authorized and the conditions for their use.
7 The maximum levels are specified in the consolidated version of Regulation (EU) 2023/915.
8 See the RASFF portal (Rapid Alert System for Food and Feed), serious risk alerts in the “dietetic foods, food supplement and fortified food” category, reported between 01.01.2023 and 31.12.2023.