Why we should not be regulated as nanotechnology
Dispelling fears: our products are not "nanotechnology"
Particles in our hydrosols are not engineered at the nanoscale - a defining characteristic of nanotechnology - but rather occur naturally as part of an electrolytic process. They have known interactions within the body and the environment, and therefore pose no threat of toxicity to either, a primary concern of the otherwise unknown effects of nanotechnology.
Two documents support this position:
A. "Risks Arising from Nanoscience and Nanotechnologies on Food and Feed Safety and the Environment" - European Food Safety Agency Journal 2009
This paper addresses whether or not a given nanomaterial is subject to specific risk assessment intended for "engineered nanomaterials", under the terms described in the EFSA opinion "Risks Arising from Nanoscience and Nanotechnologies on Food and Feed Safety and the Environment" [EFSA Journal 2009 (958) 1-39]. This opinion emphasizes that the risk assessment guidelines given are applicable only to engineered nanomaterials, given that a wide variety of naturally-occurring nanomaterials, to which humans are exposed, especially in foodstuffs, would otherwise become subject to these risk assessments. This is deemed unnecessary because these naturally-occurring nanomaterials which include vitamins, minerals (as in bio-active silver hydrosol), amino acids, proteins, carbohydrates and fats, are all in the nanoscale and so conform to the definition of nanomaterial.
B. A scientific review entitled "120 years of Nanosilver history: Implication for policy makers"
"120 years of Nanosilver History: Implications for Policy Makers" (Nowack et al, 2011), published in the peer reviewed journal Environmental Science and Technology, states the reasons why silver at the Nano size, as in Sovereign Silver, should not be classified as a product of nanotechnology, simply based on its Particle size:
"Regardless of what nomenclature is used, any concept of risk must ultimately derive from chemical and physical characteristics of a specific material. Applying the general prefix "nano" does not in itself automatically render a material harmful. Although today's nanosilver has many alternative nomenclatures and historical aliases, including "colloidal silver", the underlying material is the same; extremely small particles of silver. Contrary to many common assumptions, nanosilver materials have a deep historical record of demonstrated safe use together with a long period of formal and successful regulatory oversight. The use of very high doses of colloidal nanosilver at the beginning of the 20th century has sparked a vast amount of research on the toxicology of nanosilver, resulting in the first exposure limits for silver and subsequent Regulations on its use. Clearly nanosilver is a material that does not fit the paradigm of a "new" chemical with new and unknown risks. To consider otherwise is to confuse nomenclature (nano) instead of considering the material itself."
Bio-Active Silver Hydrosol cannot be regarded as an engineered nanoparticle because:
- Nanomaterials have always existed in the food supply; in fact…… water is a nanomaterial!
- Silver is a naturally-occurring element that is widely distributed, albeit at low concentrations, in drinking water and in food, and in the nanoscale
- Silver Hydrosol cannot be regarded as an 'engineered nanomaterial' because the hydrocolloids ('hydrosols') that characterize its physical state within the purified water that makes up 99.999% of the product, is a natural characteristic that reflects its behavior and state in natural mineral waters and foods containing silt or clay residues
- Silver hydrosols, and products similar to it (e.g. colloidal silver), have been consumed for over 120 years in different parts of the world, with a remarkable safety record. The few incidents of argyria have been associated with use of homemade silver based products; abuse of such products with consumption many times the recommended dosage; the over-use of silver salts, silver proteins or compounds; or exposure via inhalation of silver dust
- There is ample evidence of the historical safe use of Natural Immunogenics' silver hydrosol, with not a single known adverse event reported over more than a decade of sale at the domestic and international levels
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