How Dietary Supplements are Regulated in Europe

In Europe, food supplements are “foodstuffs the purpose of which is to supplement the normal diet and which are concentrated sources of nutrients or other substances with a nutritional or physiological function, alone or in combination, marketed in dose form, namely forms such as capsules, pastilles, tablets, pills and other similar forms, sachets of powder, ampules of liquids, drop dispensing bottles, and other similar forms of liquids and powders designed to be taken in measured small unit quantities.”

The Food Supplements Directive (FSD) Directive 2002/46/EC, establishes a definition for food supplements, establishes a list of allowable vitamins and minerals, and sets labeling requirements. The Directive calls for the establishment of harmonized minimum and maximum dosage amounts; however, this has yet to be done and remains a competence of EU member states. Also, substances other than vitamins and minerals are not directly covered by the directive, and rules regulating these substances are still governed by individual EU member states.

Safety and Efficacy of Food Supplements are evaluated by the European Food Safety Authority (EFSA), an entity set up in January 2002 as an independent source of scientific advice that produces opinions which then are used by the European Commission to adopt legislation.

Most relevant for companies in the food supplements sector, EFSA has also been tasked by the European Commission to evaluate proposals for the addition of vitamins and minerals to the Food Supplements Directive and to evaluate nutrition and health claims. EFSA has worked with the European Commission on assessing how to establish maximum limits for vitamins and minerals in food supplements and fortified foods, and provided opinions on substances other than vitamins and minerals. EFSA works in close collaboration with national authorities and in open consultation with its stakeholders.

Natural Immunogenics is actively working on the data compilation requested by the EFSA, to assess the toxicological profile of Silver Hydrosol. Guidance documents from EFSA were released in July 2018, and NIC has targeted early 2020 to present the irrefutable evidence of silver hydrosol safety. It is important to note that some of the assays require months of evaluations and several hundreds of thousands of dollars. In the meanwhile, silver hydrosol remains available in the EU as a product for external use.

Since 2009, Natural Immunogenics has accumulated additional data on silver hydrosol characterization, and evidence of product safety and efficacy in the form of Human Case Studies. This additional information resulted in other international Federal Health Agencies approving the product for ingestion, based on unequivocal evidence of safety, and efficacy in several health applications.