3.3 Product Specifications

Transcription

1 analysis of enzyme activity, amino bound nitrogen (by Formol titration), total nitrogen (Kjehldahl method), percent dry matter, total bacteria count, Clostridium sp., and coliform bacteria. 3.3 Product Specifications The product specifications for Amizate are presented in Table The product specifications for Amizate include limits for protein, moisture, and fat, similar to the specifications outlined in the U.S. Code of Federal Regulations (CFR) for fish protein isolate (21 CFR , U.S. FDA, 2013) and also contain limits for degree of hydrolysis (amino nitrogen/total nitrogen), lead, mercury, and microbial limits for aerobic plate count, coliforms, Clostridium perfringens, Clostridium botulinum, and yeast and mold. Table Product Specifications for Amizate Test Parameters/Test Test Method Specification Composition Moisture (%) Vacuum oven 4.0 Total Nitrogen (%) Kjeldahl 10.0 Amino Nitrogen (%) Formol titration 5.0 Amino Nitrogen/Total Nitrogen (%) Calculated 45 Fat (%) Acid hydrolysis (AB 11) 1.5 Ash (%) Crude ash (AB 18) 11 ph 0.25% w/w solution in water 7.5 Contaminant Limits Histamine (mg/kg) HPLC (Nofima A55) < 100 Lead (Pb) (mg/kg) ICP-MS < 0.2 Mercury (Hg) (mg/kg) CV-AFS < 0.5 Microbial Limits Aerobic Plate Count NMKL #86 < 10,000 Coliform (CFU/g) NMKL #44 < 10 Yeast (CFU/g) NMKL #91 < 100 (CFU/g) NMKL #91 < 100 Clostridium perfringens NKLM #95 Not detected CFU = colony forming units; CV-AFS = Cold Vapor Atomic Fluorescence Spectrophotometry; HPLC = high performance liquid chromatography; ICP-MS = Inductively coupled plasma mass spectroscopy; NMKL = Nordic Committee on Food Analysis; Nofima = The Norwegian Institute for Food, Fisheries and Aquaculture Research 3.4 Batch Analysis The results of the analysis of 3 non-consecutive batches (see Table 3.4-1) indicate that the manufacturing process produces a consistent product that conforms to the specifications 11

2 outlined in Table The results also demonstrate that Amizate is free from heavy metal and microbiological contamination. Table Summary of the Product Analysis for 3 Batches of Amizate Test Parameters/Test Specification Batch Number A1A A1A A1A Composition Moisture (%) NM NM Total Protein a Total Nitrogen (%) Amino Nitrogen (%) Amino Nitrogen/Total Nitrogen (%) Fat (%) Ash (%) ph Contaminant Limits Histamine (mg/kg) <100 <100 <100 <100 Lead (Pb) (mg/kg) < <0.05 <0.05 Mercury (Hg) (mg/kg) <0.5 < < < Microbial Limits Aerobic Plate Count <10, Coliform (CFU/g) <10 <10 <10 <10 Mold (CFU/g) <100 <100 <100 <100 Yeast (CU/g) <100 <100 <100 <100 CFU = colony forming units; NM = not measured a Total Nitrogen = Nitrogen x Additional Compositional Characterization Amino Acid Content The results of the analyses for total and free amino acids in 4 manufactured batches of Amizate are presented below in Table The production process does not selectively remove or add protein, peptides or amino acids, and Amizate provides a balanced supply of amino acids (i.e., all of the amino acids present in salmon protein are present in Amizate in their relative amounts). A comparison of the amino acid profile in Amizate with those present in raw Atlantic salmon is presented in Table The concentration factor (i.e., the ratio of amino acids in Amizate compared to raw Atlantic salmon) is approximately 4-fold. 12

3 Table Summary of the Amino Acid Analysis for 4 Batches of Amizate Amino Acid (g/kg) Batch Number Average of A1A A1A A1A A1A Batches Total Amino Acids Cysteine Methionine Asparagine and aspartic acid Threonine Serine Glutamine and glutamic acid Proline Glycine Alanine Valine Isoleucine Leucine Tyrosine Phenylalanine Histidine Lysine Arginine Tryptophan Sum Free Amino Acids Cysteine < Methionine Aspartic acid Threonine Serine Glutamine and glutamic acid Proline Glycine Alanine Valine Isoleucine Leucine Tyrosine Phenylalanine Histidine Lysine Arginine Tryptophan Sum

4 Table Comparison of Amino Acid Content in Amizate with Raw Atlantic Salmon Amino Acid Raw Atlantic Salmon (g/kg) Amizate (g/kg) Ratio of Amino Acids in Amizate vs. Raw Salmon Alanine Arginine Aspartic acid Cysteine Glutamine Glycine Histidine Hydroxyproline Isoleucine Leucine Lysine Methionine Phenylalanine Proline Serine Threonine Tryptophan Tyrosine Valine Average Molecular Size of Peptides in Amizate Zymtech has conducted analyses to determine the molecular weight of the peptides present in Amizate using matrix-assisted laser desorption/ionization (MALDI) mass spectrometry. No fragments larger than 560 Da were detected (Figure ; Appendix A). This molecular weight peptide distribution produced during preparation of extensively hydrolyzed whey protein used in hypo-allergenic infant formula is typically <3,000 and partially hydrolyzed whey protein preparations typically contain peptide distributions of between 3,000 to 10,000 Da (Oldaeus et al., 1992). 14

5 Figure MALDI specturm of Amizate Mass Range of 350 to 20,000 Da Largest peptide in Amizate 560 Da Micronutrients The manufacturing process for Amizate results in the concentration of minerals in the ingredient and mineral concentrations of up to 15% are typically of Amizate preparations. The results of the mineral analysis of 4 batches of Amizate, as well as the average mineral content of the 4 batches are presented in Table below. Table Summary of the Mineral and Elemental Analysis for 4 Batches of Amizate Metal (mg/kg) a Batch Number A1A A1A A1A A1A Average of 4 Batches Sodium (Na) 46,000 43,000 42,744 35,664 41,852.0 Fluoride (F - ion) 34 <30 <30 <30 <31.0 Chloride (Cl - ion) 15,100 19,500 17,700 19,500 18,000 Phosphorus (P) 8,609 7,900 8,151 8,092 8,188.0 Sulfur (S) 12,405 14,575 15,656 16,758 14,

6 Table Summary of the Mineral and Elemental Analysis for 4 Batches of Amizate Metal (mg/kg) a Batch Number A1A A1A A1A A1A Average of 4 Batches Chromium (Cr) Copper (Cu) Magnesium (Mg) Manganese (Mn) Selenium (Se) Silicone (Si) Zinc (Zn) 1,552 1,564 1,466 1,511 1,523.3 Calcium (Ca) Iron (Fe) Mercury (Hg) (µg/kg) <2.5 <2.5 <2.5 <2.5 <2.5 Cadmium (Cd) Arsenic (As) Lead (Pb) 0.03 <0.05 < <0.05 Potassium (K) 15,531 15,300 15,731 13,612 15,043.5 Vanadium (V) Aluminum (Al) < < <0.7 Nickel (Ni) <1.2 2 <0.25 <0.3 <0.9 Molybdenum (Mo) Boron (B) 1.7 <3.5 <3.5 < a Units are mg/kg unless specified otherwise. Amizate also contains B vitamins and vitamin C. The results of the analysis of a sample batch are provided below in Table Table Summary of the Vitamin Analysis for Amizate Vitamin Result (mg/kg) Vitamin B1 (Thiamine) <2.4 Vitamin B2 (Riboflavin) 2.1 Vitamin B3 (Niacin) 42 Vitamin B6 (Pyridoxine) 6.7 Vitamin B9 (Folic acid) 1.9 Vitamin B12 (Cyanocobalamin) 1.6 Vitamin C (Ascorbic acid)

7 3.5.4 Other Potential Contaminants Heavy Metals Concentrations of heavy metals in Amizate are consistently below levels of toxicological concern. Table Heavy Metal Analyses Heavy Metal A1A A1A A1A A1A A1A Mercury (Hg) (ppb) <2.5 <2.5 <2.5 <2.5 <2.5 Cadmium (Cd) (ppm) Arsenic (As) (ppm) Lead (Pb) (ppm) 0.03 <0.05 < < Biogenic Amines Four batches of Amizate were analyzed for the presence of the biogenic amines, including histamine, cadaverine, and putrescine, and the results are presented in Table Histamine levels in Amizate were below the level of detection (i.e., <100 mg/kg). Table Biogenic Amine Analyses Toxin a (mg/kg) Batch A1A A1A A1A A1A Histamine <100 <100 <100 <100 Cadaverine <100 <100 < Putrescine 130 <100 < a Detected by Nofima, the Norwegian Institute of Food, Fisheries and Aquaculture Research, using internal method A55 (HPLC) Environmental Contaminants Amizate is manufactured from farmed Atlantic salmon in Norway, which undergoes regular testing for dioxins and dioxin-like polychlorinated biphenyls (PCBs) by the Norwegian National Institute of Nutrition and Seafood Research (NIFES) and the Norwegian Institute of Food, Fisheries and Aquaculture Research (Nofima). The levels of these compounds are well within acceptable limits. Furthermore, dioxins and dioxin-like compounds are lipid soluble, and the majority of the oils/fats from the Atlantic salmon source material is removed during the manufacture of Amizate (i.e., fat content is <1.5% in the final product). Therefore, these contaminants are not expected to be present in Amizate at amounts of toxicological concern. 17

8 3.6 Stability of Amizate Studies conducted with the final product indicate that Amizate is stable when stored for at least 18 months under specified conditions (i.e., protected from frost, extreme heat, oxygen, humidity, and UV light). Under these storage conditions, there were no notable changes observed with respect to microbial growth, moisture uptake, and composition (e.g., loss of amino acid content) in the Amizate product. 4.0 INTENDED USE OF AMIZATE IN FOOD 4.1 Current Regulatory Status of Protein Hydrolyzates in the United States Regulatory Status as a Food Ingredient United States Currently, hydrolyzed salmon protein is not listed in U.S. Food and Drug Administration (FDA) s GRAS Notice Inventory. However, the ProGo hydrolyzed salmon protein ingredient developed by Hofseth Biocare ASA is self-affirmed GRAS. A GRAS Notice has been submitted for hydrolyzed sardine protein (GRN 360, U.S. FDA, 2011b). The FDA indicated that they had no questions regarding the conclusion that hydrolyzed sardine protein is GRAS when used as a food ingredient in beverages, breakfast cereals, frozen dairy desserts and mixes, milk and milk products, fish products, pastas, hard and soft candy, soups and soup mixes, processed fruits and vegetables, and fruit and vegetable juices, at levels up to 0.6 g/serving. The FDA also did not have questions regarding the GRAS status of acid-extracted protein from the edible tissues of various unspecified seafood species (which includes fish and non-fish sources such as molluscs and Crustacean shellfish), which is used as a protein source in finished seafood products of the same species as the extracted seafood protein, or to secondary processed seafood product of a different species (GRN 147, U.S. FDA, 2004a). Moreover, protein isolates from the edible portion of bony fish species that are generally recognized as safe for human consumption, which are extracted using food-grade hexane and ethanol, are approved as direct food additives in food supplements (21 CFR , U.S. FDA, 2013). Protein hydrolyzates from other sources (i.e., hydrolyzed plant protein, hydrolyzed vegetable protein, hydrolyzed animal protein, and hydrolyzed milk protein) have been in use in the food supply in the U.S. prior to 1958 and thus are presumed to be GRAS substances by the FDA, or have prior sanction or approval for use in foods (USDA, 1958; Proctor, 1977; Subcommittee on Review of the GRAS List, 1972). A number of GRAS Notices have also been filed for hydrolyzed protein isolates from various other sources with no objections from the FDA, including soy protein hydrolyzate with enzyme-modified lecithin (GRN 134, U.S. FDA, 2004b); 18

9 hydrolyzed wheat gluten isolate, pea protein isolate (GRN 182, U.S. FDA, 2006); concentrated hydrolyzed milk protein (GRN 199, U.S. FDA, 2007); canola protein isolate and hydrolyzed canola protein isolate (GRN 386, U.S. FDA, 2011c). For food labeling purposes, protein hydrolyzates from other sources are non-standardized foods and it is stipulated that the common or usual name of a protein hydrolyzate must be specific to the ingredient and include the identity of the food source from which the protein was derived (e.g., hydrolyzed salmon protein ) (21 CFR , U.S. FDA, 2013). Therefore, foods containing Amizate as an ingredient will be subject to these labeling provisions Norway Amizate has received a certificate of Approval from the Norwegian Food Safety Authority and is permitted for use as a food ingredient/supplement product in Norway (see Appendix B) India A food license for the marketing of Amizate in food supplement products has been issued to Elder Pharmaceutical by The Food Safety Standard of India (see Appendix B). Amizate has been marketed in food supplement products in India since 2009 under the marketing name Pepamino tablets distributed by Elder Pharmaceutical and to date 10.5 million servings of Amizate have been safely consumed in India without a single case-report of adverse effects (Appendix B). 4.2 Intended Use of Amizate and Levels of Use in Foods Zymtech proposes to market Amizate as a direct food ingredient for use in conventional foods and beverages. The individual proposed food-uses and use-levels for Amizate employed in the current intake analysis are summarized in Table Food codes representative of each proposed food-use were chosen from the U.S. National Center for Health Statistics (NCHS) National Health and Nutrition Examination Surveys (NHANES) (CDC, 2011; USDA, 2012). Food codes were grouped in food-use categories according to Title 21, Section of the Code of Federal Regulations (U.S. FDA, 2013). Product-specific adjustment factors were developed based on data provided in the standard recipe file for the Continuing Survey of Food Intakes by Individuals (CSFII) , 1998 survey (USDA, 2000). All food codes included in the current intake assessment are listed in the full intakes report in Appendix C. 19

10 Table Summary of the Individual Proposed Food-Uses and Use-Levels for Amizate in the United States (NHANES ) Food Category Proposed Food-Uses Maximum Use-Level (%) Beverages and Beverage Bases Energy, Sport, and Electrolyte Drinks 3.5 Non Milk-Based Meal Replacement Beverages 10 Grain Products and Pastas Cereal and Granola Bars 10 Energy, Meal Replacement, and Fortified Bars 10 Milk and Milk Products Milk-Based Meal Replacements 10 Snack foods Savory Snacks 1 Soups and soup mixes Prepared and Canned Soups Intended Use of Amizate in Medical Foods Zymtech also proposes to use Amizate as an ingredient in medical foods and foods for special dietary use to be consumed by individuals requiring dietary protein supplementation, as deemed necessary by a medical practitioner. These include individuals with physiological/pathological conditions which limit the utilization of dietary protein (e.g., pancreatitis, celiac, and inflammatory bowel disease), or malnourished individuals. The intended use of Amizate is 10 g/day, providing approximately 7.5 g of supplemental amino acids and short peptides per day. 5.0 ESTIMATED DIETARY CONSUMPTION OF AMIZATE BASED UPON INTENDED FOOD USES 5.1 Background Dietary Intake of Protein As part of their derivation of Dietary Reference Intake (DRI) values for protein, the Institute of Medicine (IOM) also conducted an assessment of the background dietary protein intakes for the U.S. population using the CSFII ( , 1998) (IOM, 2005). The mean and 90 th percentile intakes of protein among individual life stage and gender groups based on this assessment are presented in Table Among the total U.S. population, including pregnant and/or lactating individuals, the mean and 90 th percentile intake of proteins was estimated at 75.3 and g/day, respectively (IOM, 2005). 20

11 Table Estimated Daily Intake of Protein Among Population Groups in the United States Based on the CSFII ( , 1998) a Population Group Age Group (Years) No. of Individuals Surveyed Daily Intake of Protein (g/day) Mean 90 th Percentile Infants 0-6 months months Children 1-3 years 3, years 3, Males Females Males Females Males Females Teenagers 9-13 years years Adults years Total Population years 1,806 1, years 1,680 1, >70 years Pregnancy Lactating All age groups combined 21, All age groups combined (+P/L) b a Data taken from IOM, b All age groups including pregnant and/or lactating individuals 5.2 Background Intake of Salmon Protein Background dietary consumption of protein from salmon specifically was calculated using data from the NHANES (CDC, 2011; USDA, 2012). Based on the consumption data of salmon 3, the mean and 90 th percentile intake of salmon in the total U.S. population (on an alluser basis) was estimated at 72.1 and g/day (Table 5.2-1). Since approximately 20% of a serving of salmon consist of protein, the mean and 90 th percentile intakes of salmon protein is estimated at 14.4 and 27.6 g/day, respectively. 3 The intakes assessment included salmon consumed in the following forms: baked or broiled; battered or fried; canned; cooked (not specified as to cooking method); dried; floured or breaded; raw; smoked; and steamed or poached. Salmon that were consumed within specific dishes (e.g., pasta with salmon) were not included in the assessment. 21

12 Table Estimated Daily Intake of Salmon Protein Among Population Groups in the United States ( NHANES Data) Population Group Age Group (Years) Number of Consumers Mean (g/day) Intake of Salmon a 90 th Percentile (g/day) Intake of Salmon Protein b Mean (g/day) 90 th Percentile (g/day) Toddlers 1 to * 70.6* 9.8* 14.1* Children 4 to * 34.0* 5.6* 6.8* Female Teenagers 11 to * 57.4* 7.1* 11.5* Male Teenagers 11 to * 136.5* 18.7* 27.3* Female Adults 19 to Male Adults 19 to Elderly Adults 65 and up Total Population All Ages NHANES = the National Health and Nutrition Examination Survey a Estimates are not provided for an all-person basis as only a small number of consumers were identified. b Calculated assuming that approximately 20% of a serving of salmon consist of protein. * Intake estimate may not be statistically reliable. 5.3 Estimated Intake of Amizate Methodology An assessment of the anticipated dietary exposure to Amizate under the proposed conditions of food-use and use levels was conducted using the food consumption data included in the NHANES (CDC, 2011; USDA, 2012). A full description of the survey and methodology employed in the intake assessment of Amizate is provided in Appendix C. An abbreviated description along with the pertinent results is provided below. The NHANES data are collected and released in 2-year cycles with the most recent cycle containing data collected in (CDC, 2011; USDA, 2012). NHANES survey data were collected from individuals and households via 24-hour dietary recalls administered on 2 non-consecutive days (Day 1 and Day 2). Calculations for the mean and 90 th percentile allperson and all-user intakes were performed for each of the individual proposed food-uses of Amizate and the percentage of consumers were determined. The per person and per kilogram body weight intakes were reported for the following population groups: toddlers, ages 1 to 3; children, ages 4 to 10; female teenagers, ages 11 to 18; male teenagers, ages 11 to 18; 22

13 female adults, ages 19 to 64; male adults, ages 19 to 64; elderly, ages 65; and total population (all age and gender groups combined). It should be noted that this type of intake methodology is generally considered to be worst case as a result of several conservative assumptions made in the consumption estimates. For example, it is often assumed that all food products within a food category contain the ingredient at the maximum specified level of use. In addition, it is well established that the length of a dietary survey affects the estimated consumption of individual users. Short-term surveys, such as the typical 2- or 3-day dietary surveys, overestimate the consumption of food products that are consumed relatively infrequently Estimated Daily Consumption of Amizate from Proposed Food Uses The estimated intakes of Amizate on a mg/person/day and mg/kg body weight/day basis from proposed food-uses in the U.S. by population group are summarized in Tables and , respectively. Approximately 67.0% of the total U.S. population was identified as potential consumers of Amizate from the proposed food uses. Consumption of proposed fooduses by the total U.S. population resulted in an estimated mean and 90 th percentile all-user intakes of Amizate of 5.56 g/person/day (83.41 mg/kg body weight/day) and g/person/ day ( mg/kg body weight/day), respectively. Within the individual population groups, male adults were determined to have the greatest estimated mean and 90 th percentile all-user intakes of Amizate on an absolute basis at 9.78 and g/person/day, respectively. On a body weight basis, male teenagers were identified as the population group having the highest all-user Amizate intakes, with mean and 90 th percentile estimated at and mg/kg body weight/day, respectively. The mean and 90 th percentile all-user intakes among male adults were similar, at and mg/kg body weight/day, respectively. 23

14 Table Summary of the Estimated Daily Intake of Amizate from Proposed Food- Uses in the United States by Population Group ( NHANES Data) Population Group Age Group (Years) All-Person Consumption (g/day) Mean 90 th Percentile % Users All-Users Consumption (g/day) n Mean 90 th Percentile Toddlers 1 to Children 4 to Female Teenagers 11 to Male Teenagers 11 to Female Adults 19 to , Male Adults 19 to , Elderly Adults 65 and up Total Population All Ages , NHANES = the National Health and Nutrition Examination Survey. Table Summary of the Estimated Daily Per Kilogram Body Weight Intake of Amizate from Proposed Food-Uses in the United States by Population Group ( NHANES Data) Population Group Age Group (Years) All-Person Consumption (mg/kg bw/day) Mean 90 th Percentile All-Users Consumption (mg/kg bw/day) % n Mean 90 th Percentile Toddlers 1 to Children 4 to Female Teenagers 11 to Male Teenagers 11 to Female Adults 19 to , Male Adults 19 to , Elderly Adults 65 and up Total Population All Ages , bw = body weight; NHANES = the United States National Health and Nutrition Examination Survey Estimated Consumption of Amino Acids and Peptides from Proposed Food Uses Amizate is composed of 750 g/kg 4 of amino acids and short peptides. Based on the estimated intakes of Amizate among all-users, the exposure to amino acids and short peptides are calculated and summarized below in Table Protein equivalent amount calculated from total nitrogen content. 24

15 Table Summary of the Estimated Intake of Amino Acids and Short Peptides a from the Intended Uses of Amizate Population Group Age Group (Years) Intakes (g/day) Intakes (mg/kg bw/day) Mean 90 th Percentile Mean 90 th Percentile Toddlers 1 to Children 4 to Female Teenagers 11 to Male Teenagers 11 to Female Adults 19 to Male Adults 19 to Elderly Adults 65 and up Total Population All Ages a Calculations were based on a content of 750 g of amino acids and peptides per kg of Amizate A comparison of the intake of amino acids and short peptides from the proposed-food uses of Amizate with the background dietary intake of total protein and protein from salmon specifically in the U.S. is presented in Table As shown in Table , the amino acid profile of Amizate is similar to that of raw Atlantic salmon. Therefore, consumption of Amizate can be considered comparable to the ingestion of salmon-derived proteins from the diet. The proposed food uses of Amizate will result in intakes of amino acids and short peptides that are less than the amount of salmon protein that are typically consumed by the U.S. population through the diet. Furthermore, it should be noted that the intake of amino acids and short peptides from Amizate is less than the amount that would be consumed from a single 200 g serving of Atlantic salmon, which contains approximately 40 g of protein (USDA, 2013). Additionally, the intake of amino acids and peptides from the proposed food uses of Amizate is at least 7-folds less than the background dietary intake of total protein in the total U.S. population. As such, the intake of amino acids and short peptides from the propose food-uses of Amizate would not contribute significantly to the overall protein intake of humans. 25

16 Table Comparison of the All-User Total U.S. Population Intakes of Protein from All Dietary Sources, Salmon Protein, and Intended Uses of Amizate Population Mean Intake (g/day) 90 th Percentile Intake (g/day) Group Total Protein Salmon Protein Amino Acids and Peptides from Amizate Total Protein Salmon Protein Amino Acids and Peptides from Amizate Toddlers * * 2.1 Children * * 3.9 Female Teenagers 65.3 to * to * 4.9 Male Teenagers Female Adults 79.1 to * to * to to Male Adults 86.8 to to Elderly Adults 56.4 to to Total Population a The population groups used by the IOM (2005) in their derivation of the dietary intake of total protein in the U.S. differ slightly from those used in the current intakes assessment. As such, a range of the values reported is presented in this table. Please refer to Table for the complete dataset. *Intake estimate may not be statistically reliable. 5.4 Summary of Intake Estimates Consumption data and information pertaining to the individual proposed food uses of Amizate were employed to estimate the all-person and all-user intakes of Amizate for specific demographic groups and for the total U.S. population. This type of intake methodology is generally considered to be worst case as a result of several conservative assumptions made in the consumption estimates. This is especially the case for toddlers and children, which are not the target market for food products containing Amizate. Additionally, the length of a dietary survey affects the estimated consumption of individual users. In summary, on an all-user basis, the mean and 90 th percentile intakes of Amizate by the total U.S. population from all proposed food-uses were determined to be 5.56 g/person/day (83.41 mg/kg body weight/day) and g/person/day ( mg/kg body weight/day), respectively. Since Amizate is composed of 750 g/kg of amino acids and short peptides, the mean and 90 th percentile intakes of amino acids and peptides from the proposed food-uses among the total U.S. population would be 4.2 g/person/day (62.6 mg/kg body weight/day) and 8.6 g/person/day (136.4 mg/kg body weight/day), respectively. The intake of amino acids and short peptides from the proposed food-uses of Amizate will not contribute significantly to total dietary protein intakes by the U.S. population. 26