SAFETY WHICH CONFORMS TO EU REGULATIONS
Chemicals that are present in the environment as pollutants may be present in the raw materials used for the production of nutraceutical ingredients. The detection of harmful- or questionable-chemicals in ingredients for human consumption has to be considered a matter of public health. The EU Contaminants Regulation is based on the prevention and the management of such risks. The limit set by the regulatory authority for PAH, Heavy Metals, Aflatoxins, Pesticides Residue and Residual solvent is very stringent.
Pure’nsafe Extracts range of Products which keep away these contaminants meet the specification set by the EU Contaminants Regulation. Accurate determination of the presence of contaminants is carried out with modern instruments like GCMS, LCMS-MS, HPLTLC and HPLC.
1.POLYCYCLIC-AROMATIC HYDROCARBONS(PAHs)
Polycyclic-aromatic hydrocarbons (PAHs) are organic environmental contaminants which occur in many vegetables based ingredients at extremely low concentrations
PAH develop especially during incomplete combustion of organic materials. These are fat soluble, non-volatile, extremely persistent and occur in exhaust gases from motor vehicles, coal furnaces and mineral oils burning.
Additionally, PAH can generate during food processing and preparing through smoking, drying, frying, grilling, roasting and baking. The contamination of vegetable oils with PAH may result from the contact of oil seeds with combustion fumes during the process of drying.
Long-term health effects of exposure to PAHs may include cataracts, kidney and liver damage, and jaundice. Long-term exposure to low levels of some PAHs has caused cancer. Benzo(a)pyrene is the most common PAH to cause cancer in animals. Workers exposed to mixtures of PAHs and other compounds have an increased risk of skin, lung, bladder, and gastrointestinal cancers.We follow highly sensitive tests capable of detecting these toxic materials using GCMS
2.HEAVY METALS
It has been shown that heavy metals toxicity to humans is as a result of long term or high level exposure to pollutants common in the environment including the air, water, food and numerous consumer products.
Lead, arsenic, and cadmium are each present in the environment, including water, air, soil, and foods, either as naturally occurring substances or as a result of contamination from human activity. Each has been associated with negative health effects when consumed at high levels, such as cancer and/or developmental effects.
EU restrictions apply to these levels of trace elements (Heavy metals) in nutraceutical ingredients and we specialize in detecting these in both ingredients and raw materials. Here again we use advanced instruments like ICP-MS (Inductively Coupled Plasma-Mass Spectrometry) to detect the presence of heavy metals.
3.AFLATOXINS
Humans are exposed to aflatoxins by consuming foods contaminated with products of fungal growth. Such exposure is difficult to avoid because fungal growth in foods is not easy to prevent. Even though heavily contaminated food supplies are not permitted in the market place in developed countries, concern still remains for the possible adverse effects resulting from long-term exposure to low levels of aflatoxins in the food supply.
Evidence of acute aflatoxicosis in humans has been reported from many parts of the world.
Conditions increasing the likelihood of acute aflatoxicosis in humans include limited availability of food, environmental conditions that favor fungal development in crops and commodities, and lack of regulatory systems for aflatoxin monitoring and control.
Aflatoxins are genotoxic carcinogens. For this type of carcinogen, it is generally felt that there is no threshold dose below which no tumor formation would occur. In other words, only a zero level of exposure will result in no risk.
Aflatoxin B1 is on the list of human carcinogens. This is supported by a number of epidemiological studies done in Asia and Africa that have demonstrated a positive association between dietary aflatoxins and Liver Cell Cancer.Level of aflatoxin is accurately determined using LCMS-MS
4.PESTICIDE RESIDUES
Pesticide residue is any substance or mixture of substances in food for man or animals resulting from the use of a pesticide and includes any specified derivatives, such as degradation and conversion products, metabolites, reaction products, and impurities that are considered to be of toxicological significance. Pesticides are chemicals used in agriculture to protect crops against insects, fungi, weeds and other pests. Pesticide residues on the food we eat are to be highly regulated. Do Pesticide Residues Add to the Risk of Developing Cancer? It is one of the many reasons for the incidence rate increase of cancer.
We have been carrying out residue testing for many years, providing pesticide-free ingredients across the nutraceutical supply chain. Our experience is such that we know what to look for in any given item and choose an appropriate testing regimen for it. Presence of Trace elements are accurately determined with GCMS
5.RESIDUAL SOLVENTS
Residual solvents are defined here as organic volatile chemicals that are used or produced in the manufacture of a substance or excipients, or in the preparation of drug products. The solvents are not completely removed by practical manufacturing techniques. Since there is no therapeutic benefit from residual solvents, all residual solvents should be removed to the extent possible to meet product specifications, good manufacturing practices, or other quality-based requirements. Drug products should contain no higher levels of residual solvents than can be supported by safety data. Some solvents that are known to cause unacceptable toxicities. We use head- space GC to accurately determine the presence of Residual Solvents.
PRODUCTS YOU CAN TRUST
Products are analysed in modern laboratories by highly trained scientific staff, using powerful analytical equipments. We are accredited to the internationally recognized HACCP, ISO22000, ISO9001, KOSHER, HALAL and GMP quality standard and Food Safety Management System (FSMSS) and Varion is an internationally certified manufacturer following Good Manufacturing Practices as per Food Codex standard set by the Codex Alimentarius Commission.