In Germany, the Ordinance on Food Supplements (Verordnung über Nahrungsergänzungsmittel, NemV), has transposed the provisions of Directive 2002/46/EC into German law.
Germany has a mandatory notification requirement for food supplements, which is outlined in the NemV. Manufacturers or importers who wish to introduce a food supplement to the German market, must provide notification of the product no later than the time of initial marketing by completing the notification paperwork and providing a sample of the label.
Food supplements are foodstuffs. Therefore, they are subject to the relevant food law provisions. Foodstuffs means any substance or product, whether processed, partially processed or unprocessed, intended to be, or reasonably expected to be ingested by humans.
Medicinal products are intended to heal, alleviate, prevent or identify diseases, suffering, physical defects or health disorders, or to influence the condition, state or function of the body or the mental state.
According to § 1 of the Ordinance on Food Supplements (Verordnung über Nahrungsergänzungsmittel, NemV), food supplements are foodstuffs:
- intended to supplement a normal diet,
- which are concentrated sources of nutrients or other substances with a specific nutritional or physiological effect, alone or in combination and,
- which are marketed in a dosage form, such as capsules, pastilles, tablets, pills and other similar forms, sachets of powder, ampoules of liquids, drop dispensing bottles and other similar forms of liquids and powders designated to be taken in measured small unit quantities.
Food supplements must not be labelled as medicinal products or be advertised with claims relating to healing, alleviating or preventing diseases.
NHP Consulting will prepare the required regulatory documentation to achieve market compliance for food supplements in Germany.