How are Supplements Regulated in Europe & why is Sovereign Silver labeled differently there for External Use?
In Europe, just like in Canada, the regulatory framework for Food Supplements is quite different from the USA, in that no product may be placed on the market prior to undergoing a thorough assessment, where the efficacy and safety, correlated to its intended purpose(s), is reviewed by a Risk Assessment division composed of knowledgeable scientists. The division in charge is referred to the ANS panel (Panel on Food Additives and Nutrient Sources).
Label claims are reviewed, and approved or rejected according to the findings from said evaluation. These may not, however, be therapeutic claims.
Unless a Food Supplement product was marketed in Europe prior to May 15, 1997, with evidence of substantial sales, application for product approval must first be submitted to the European Commission who, in turn, and in light of their prior assessment, will forward it to the European Food Safety Authority (EFSA) for scientific evaluation, or reject the dossier. Evaluation by EFSA is performed on a risk assessment basis. A review of the safety of use of the supplement and its bioavailability is performed, in light of which the final opinion is issued.
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. This answer was expected, considering the fact that no guidance was available for NIC to provide EFSA with the information they required. After all, how can one defend the parameters of a product when the safety parameters have not been defined by those seeking to regulate them?
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.
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