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 (NIC) presented a technical dossier on Silver Hydrosol to the EFSA in 2005. After 3 years of evaluation, the EFSA found that the totality of evidence submitted was “insufficient to assess the safety” of the product1. In order to keep silver hydrosol available to our clientele in the European Union, NIC decided to market its products for “external use,” while continuing to send additional safety information to the EFSA for consideration in its risk assessment. This is why Sovereign Silver remains on the European market, even though regulatory agencies contend that colloidal silver products are not safe, and therefore cannot be marketed for ingestion.
NIC continues to pursue the rightful approval for our Silver Hydrosol products in Europe through the European Commission and the EFSA.