What are dietary supplements?
At European level, these requirements are primarily contained in Directive 2002/46/EC on food supplements.
(1) For the purposes of this Directive, the following definitions shall apply
- (a) ‘food supplement’ means a food intended to supplement the normal diet and consisting of single or multiple concentrates of nutrients or other substances having a nutritional or physiological action, placed on the market in a dosaged form, such as capsules, pastilles, tablets, pills and other similar forms of administration, powder sachets, liquid ampoules, dropper bottles and similar forms of administration of liquids and powders for ingestion in measured small quantities;
- (b) “nutrients” means the following substances: (i) vitamins, (ii) minerals.
Accordingly, a food supplement is intended to supplement the general diet. Whether and in what form this is necessary for the individual consumer is determined by diet, living conditions and needs.
Which substances may dietary supplements contain?
Food supplements may contain one nutrient or a combination of several nutrients. The nutrients (vitamins and minerals) that may be used are laid down uniformly and in detail by law throughout Europe. These have been tested for safety and bioavailability.
There is also a banned list of other substances for which there are safety concerns.
Who controls food supplements and how is safety ensured?
Unlike medicinal products, food supplements may be placed on the market without prior authorisation. However, in Germany, for example, the obligation to notify (§ 5 NemV) applies according to which the manufacturer or importer must notify the Federal Office of Consumer Protection and Food Safety (BVL) of the food supplement before it is placed on the market.
However, the main responsibility for a safe product lies with the manufacturer. Self-checks and an in-house quality management system should ensure conformity with legal regulations, quality and safety of the food supplement. Independent contract laboratories can assist manufacturers in testing their products.
The laboratories of the Tentamus Group routinely and reliably carry out laboratory analyses, labelling tests and hygiene audits and can assist you in securing your food supplement.
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