Chemistry: analytical and immunological testing – Metal or metal containing
Reexamination Certificate
2001-03-16
2003-07-08
Soderquist, Arlen (Department: 1743)
Chemistry: analytical and immunological testing
Metal or metal containing
C436S020000, C436S076000, C436S080000, C436S081000, C436S083000, C436S084000
Reexamination Certificate
active
06589794
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to an assay to determine whether metal chelates of amino acids meet the European Union definition necessary for approved sale in member countries.
BACKGROUND OF THE INVENTION
Maintaining the health and well being of domestic animals and poultry requires that essential nutrients be present in the diet in sufficient amounts and in a biologically available form. Because certain nutrients are often deficient in common feed ingredients, supplemental amounts of these nutrients are often added to the feed of domesticated animals and poultry. These feed additives span a wide range of nutrients including vitamins and trace elements. Several feed additives are developed to provide the nutrients in forms that are readily biologically utilizable. The degree of biological availability of nutrients is often referred to as “bioavailability”. Bioavailability often depends on the physical and/or chemical properties of the form in which the nutrient is present in the diet. Increased bioavailability of supplemental nutrients (feed additive) is beneficial because it allows the use of lower concentration of the additive in the diet to meet the nutritional needs of animals, while also lowering the potential harmful effects of high levels of incorporation of the additive both on animals and on the environment.
The important role of the trace elements copper, iron, manganese and zinc in animal nutrition has long been recognized. The beneficial effect of iron on blood formation was recognized as early as the 17th century. In 1928, Hart et al. provided the first conclusive evidence that copper was required for recovery from anemia in rats. Zinc was shown to be required for normal growth and health in rats in 1934 and is now considered to be essential for the health of plants, animals and humans. The essential role of manganese for the health of animals and humans has been recognized since 1936.
Many commercial feed additives have been developed to enhance the bioavailability of the trace elements. The beneficial effects of these products are attributed to the association of the metal with an organic molecule, usually called a ligand. This association or bonding results in the increased availability of the metal for utilization by animals, i.e. increased bioavailability. The increased bioavailability of the trace elements in these products is a result of increased solubility, greater stability in the gut, enhanced absorption into circulation and/or improved metabolic utilization.
Most countries regulate the production, labeling, distribution and sale of animal feeds to protect consumers, producers and environment. Different countries have different regulations to govern additives containing trace elements. Most countries require manufacturers to register feed additives containing trace elements before they can be marketed and added to feed. Some countries have strict specifications for feed additives and may require manufacturers to submit detailed analytical methods for the quality assurance of their products. These analytical methods are confidential information and are used by the regulatory agencies only for inspecting the manufacturer's products. Consumers interested in determining the quality of an additive containing trace elements must develop their own methods to examine these products to see if they in fact meet regulatory definitions.
In 1998, the European Union approved the use of a specific group of trace element chelates of amino acids as feed additives. This action is contained as Commission Directive 98/19/EC that amends Directive 70/524/EEC issued on Nov. 23, 1970. The approved additives include copper, iron, manganese and zinc chelates of amino acids hydrate.
The chemical formulas assigned to these additives are:
1) Cupric Chelate of amino acid hydrate, Cu (X)
1-3.
n H
2
O. X is the anion of any amino acid derived from hydrolyzed Soya Protein. The number of amino acid molecules per metal ion is from 1 to 3. The molecular weight of the hydrated chelate must not exceed 1500.
2) Iron Chelate of amino acid hydrate, Fe (X)
1-3.
n H
2
O. X is the anion of any amino acid derived from hydrolyzed Soya Protein. The number of amino acid molecules per metal ion is from 1 to 3. The molecular weight of the hydrated chelate must not exceed 1500.
3) Manganese Chelate of amino acid hydrate, Mn (X)
1-3.
n H
2
O. X is the anion of any amino acid derived from hydrolyzed Soya Protein. The number of amino acid molecules per metal ion is from 1 to 3. The molecular weight of the hydrated chelate must not exceed 1500.
4) Zinc Chelate of amino acid hydrate, Zn (X)
1-3.
H
2
O. X is the anion of any amino acid derived from hydrolyzed Soya Protein. The number of amino acid molecules per metal ion is from 1 to 3. The molecular weight of the hydrated chelate must not exceed 1500.
The approval of these additives and the above definitions was in response to an application of one manufacturer of these products. However, other manufacturers are allowed to market their products in the European Union countries as long as they assert that their products meet these specifications. In the absence of published methods to assess these products, consumers are unable to make an informed decision regarding their quality and compliance to specifications approved by the EU Commission Directive.
Accordingly, it is a primary objective of this invention to provide a simple method for the analysis of trace metal chelate of amino acids to determine if these products in fact meet the specifications of the EU Commission Directive 70/524/EEC of Nov. 23, 1970 as amended by Commission Directive 98/19/EC.
It is another objective to provide a simple yet reliable test method which can be run using widely available test materials.
It is a yet further objective to provide a test which allows consumers to make their own decisions about whether available products in fact meet the European Union definition.
It is a further objective to provide a test which is also predictive of bioavailability of soluble trace mineral proteinates.
The method and manner of accomplishing these and other objectives of the present invention will be apparent from the detailed description of the invention which follows.
SUMMARY OF THE INVENTION
A simple method for the systematic and comprehensive analysis of trace element chelates of amino acids is described. The metal content of a sample of the trace element chelate of an amino acid is initially determined by using a known appropriate quantitative procedure. An aliquot of the sample is extracted in water or mild acid to simulate the gut and the metal content of the extract is determined to insure the complete extraction of the metal. The extract is then filtered through an ultrafiltration membrane with a nominal molecular weight limit (NMWL) of 500,000 Daltons (500K Daltons) to remove large molecules and insoluble substances including inert carrier. If the product contains carriers/diluents that form gelatinous materials on mixing with water that may clog the ultrafiltration membrane it is removed by centrifugation or vacuum filtration prior to ultrafiltration through the 500,000 Dalton membrane. An aliquot of the 500K ultrafiltrate is filtered through an ultrafiltration membrane with a nominal molecular weight limit of 1500-3000 Daltons. The metal content is determined in an aliquot of the ultrafiltrate. Free and Total amino acids in other aliquots of the ultrafiltrate are determined by using a known and appropriate automated amino acid analyzer. The amino acid profile is then compared to that of soy protein, the only legal source for the EU. Since EU specifications require the product to be made from soy protein, the resulting amino acid profile should be similar to that of soy protein. If wide variations are found, it is indicative that non-soy protein source was used to produce the chelate and it is therefore non-compliant.
Next the concentration of free amino acids in the ultrafiltrate is determined. It must be sufficient to form a 1:1 chelate of the metal but
Abdel-Monem Mahmoud M.
Anderson Michael D.
McKee, Voorhees & Sease, P.L.C
Soderquist Arlen
Zinpro Corporation
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