Use of genetically modified organisms (GMOs)
Pharmakaolin B 860 falls into the "no labelling required" category in accordance with EC Directive No. 1829/2003 and EC Directive No. 1830/200. Pharmakaolin B 860 is an inorganic material derived exclusively from natural mineral deposits. The production process for Pharmakaolin B 860 is entirely free of genetically modified organisms (GMOs), whether animal, vegetable or otherwise.
Aflatoxins occur as metabolites of mould or mildew growing on plant-based foodstuffs. Pharmakaolin B 860 is a mineral material made entirely of inorganic components. During its production, B 860 is subjected to an extensive cleaning process that serves to remove the concomitant materials and to attain the microbiological state required by Pharmacopoea Europaea. Thus, we do not specifically inspect our Pharmakaolin production for aflatoxins. It is safe to say that Pharmakaolin B 860 does not contain any significant level of aflatoxins.
Pharmakaolin B 860 is prepared in a watery slurry, without the use of any organic solvents. Pharmakaolin B 860 is therefore free of such solvents.
Pharmakaolin B 860 is produced exclusively from inorganic materials, none of which contain any animal or animal-derived ingredients. Thus, one can rule out any contamination of Pharmakaolin B 860 with TSEs/BSE. (Transmittable Spongiform Encephalopathies/Bovine Spongiform Encephalopathies or “Mad-Cow Disease”).
We do not use fumigation to sterilize Pharmakaolin B 860, for example with ethylenoxide or formaldehyde. Ionizing radiation is not used in the conservation of Pharmakaolin B 860.
We have our materials inventories tested for dioxin periodically. In the past, these tests have never found dioxin levels that were not well below critical values. Thus, we can confidently certify our kaolins as "dioxin-free".
Pharmakaolin B 860 has practically unlimited durability as a product as well as with regard to its mineral characteristics. Provided the product is stored in a dry place in its original packaging, this durability applies to all of the product features listed in our analysis certificates in accordance with Pharmacopoea Europaea (Ph.Eur). The only exception is "microbial contamination". Due to the various environmental factors involved, we cannot provide any specific data as to the level of microbial contamination likely to occur during storage. However, our experience suggests that when stored in a dry, dark place at a temperature of around 20°C and kept in its original sealed packaging, the product’s microbiological values should remain within the range set forth by Ph.Eur (in its "Kaolin, Heavy" monograph) for at least 3 years.
Kaolin is registered under “EINECS 215-286-4” in the European Inventory of Existing Commercial Chemical Substances (EINECS). It is therefore an “existing substance” as defined by the Chemicals Act, and thus excepted from the reporting requirements imposed on commerce with chemicals. This also means that no animal testing has been necessary since 1979. The Amberg Kaolin Works have not performed any animal testing with regard to Pharmakaolin B860.
Animal or plant sources
Pharmakaolin B 860 is a naturally occurring mineral product which we process without the use of animal or plant materials. Thus, Pharmakaolin B 860 is not derived from any animal or plant sources.