Around 80% of the population regularly take food supplements and most consumers are convinced that the products are safe and effective. Despite the popularity of FS, some concerns have been raised about its quality and safety, particularly regarding the presence of contaminants such as microbial and heavy metal contamination, mycotoxins, pesticides, PAHs, synthetic drug adulteration, substituting herbs, and fraudulent labelling of ingredients. Various amounts of contaminants were reported in a considerable number of commercially available food supplements. The assessment of the risk associated with the consumption of food supplements, especially in the sensitive populations such as elderly and children, is particularly challenging due to frequent exposure to multiple contaminants and different sources of exposure, as well as possible pre-existing conditions and corresponding therapies. Considering the wide availability of the products and the retrospective control by regulatory authorities, there is a lack of adequate attention until reports of patient harm occur.
COMMISSION REGULATION (EU) 2023/915
For effective protection of public health, food supplements that exceed the maximum levels of contaminants should not be marketed or used. For this reason, EU Regulation on food contaminants has set maximum permitted levels for various contaminants that could potentially be present in food. Since food supplements are regulated as food, this regulation applies. To ensure product safety, these levels are set “as low as reasonably achievable” in compliance with the industry guidelines and good manufacturing practice.
Recently, Regulation (EC) 1881/2006 setting maximum levels for certain contaminants in food was replaced by Regulation (EU) 2023/915, as more than 50 additions and revisions to the list of contaminants, maximum levels and food categories have been amended, added or are pending approval since its first publication.
The regulation covers:
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mycotoxins (aflatoxins, ochratoxin A, patulin, deoxynivalenol, zearalenone, fumonisins, citrinin, ergot sclerotia and ergot alkaloids);
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metals (lead, cadmium, mercury, inorganic tin and arsenic);
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plant toxins (erucic acid, tropane alkaloids, hydrocyanic acid, pyrrolizidine alkaloids, opium alkaloids and Δ9-THC);
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processing contaminants (polycyclic aromatic hydrocarbons (PAHs), benzo(a)pyrene, sum of 4 PAHs; 3-monochloropropane-1,2-diol (3-MCPD)and glycidyl fatty acid esters);
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halogenated persistent organic pollutants (dioxins, dioxin-like polychlorinated biphenyls (PCBs), non-dioxin-like PCBs; the perfluoroalkyl substances: perfluorooctane sulfonic acid (PFOS), perfluorooctanoic acid (PFOA), perfluorononanoic acid (PFNA) and perfluorohexane sulfonic acid (PFHxS));
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other contaminants:
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melamine,
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nitrates,
As food supplements have become an integral part of modern society, the same principle of food safety naturally applies to food supplements. Products that are susceptible to certain contaminants must be tested to ensure that the maximum levels are not exceeded. In the context of the new regulation, some of the most important contaminants for the wide range of food supplements in various forms and formulations are listed below.
Contaminant |
Maximum level |
|
Mycotoxin |
Citrinin |
Rice supplements fermented with red yeast Monascus purpureus are currently the only product category for which a maximum limit has been set in EU legislation. The citrinin content in such supplements must not exceed 100 μg/kg. |
Heavy metals |
Lead |
For lead the maximum levels ranges from 0.01 mg/kg in some baby foods to 3 mg/kg in food supplements. |
Cadmium |
The maximum allowed cadmium content range from 0.005 mg/kg in milk protein-based baby foods to 1 mg/kg in food supplements (except food supplements consisting at least of 80 % from dried seaweed, from products derived from seaweed or from dried bivalve molluscs 3 mg/kg). |
|
Mercury |
Food supplements must not contain more than 0.1 mg/kg of mercury. |
|
Arsenic |
Rice-based products, baby foods, fruit juices, and salt require testing. The maximum allowed arsenic content in regulated products ranges from 0.01 to 0.5 mg/kg. |
|
Pyrrolizidine alkaloids |
Pyrrolizidine content is measured as a sum of over 30 individual pyrrolizidine alkaloids |
Maximum pyrrolizidine content for food supplements containing botanical preparation including extracts is 400 µg/kg, while maximum level for pollen-based food supplements, pollen and pollen products is 500 μg/kg.Herbal infusions composed exclusively of rooibos, anise, lemon balm, chamomile,thyme, peppermint, lemon verbena, and their mixtures, dried herbs and cumin seeds is 400 μg/kg, while other herbal infusions 200 µg/kg.The maximum level for herbs such as dried borage, lovage, marjoram, and oregano is 1000 μg/kg. |
Polycyclic aromatic hydrocarbons (PAHs) |
Benzo(a)pyreneSum of PAHs:benzo(a)pyrene, benz(a)anthracene, benzo(b) fluoranthene and chrysene |
For the food supplements containing botanicals and their preparations and food supplements containing propolis, royal jelly, spirulina or their preparations, the maximum level of benzo(a)pyrene must not exceed 10,0 mg/kg while the sum of PAHs is at 50,0 mg/kg. For food supplements containing vegetable oils the maximum level of benzo(a)pyrene must not exceed 2,0 mg/kg while the sum of PAHs is at 10,0 mg/kg |