Title 9

SECTION 424.21

424.21 Use of food ingredients and sources of radiation.

§ 424.21 Use of food ingredients and sources of radiation.

(a)(1) General. No meat or poultry product shall bear or contain any food ingredient that would render it adulterated or misbranded, or which is not approved in this part, part 318 or part 319 of this chapter, or by the Administrator in specific cases.

(2)(i) Poultry products and poultry broth used in the processing of poultry products shall have been processed in the United States only in an official establishment or imported from a foreign country determined to be eligible to export such products to the United States under § 381.196(b), and have been inspected and passed in accordance with the regulations. Detached ova and offal shall not be used in the processing of any poultry products, except that poultry feet may be processed for use as human food in a manner approved by the Administrator in specific cases and detached ova may be used in the processing of poultry products if the processor demonstrates that such ova comply with the requirements of the Federal Food, Drug, and Cosmetic Act.

(ii) Liquid, frozen, and dried egg products used in the processing of any poultry product shall have been prepared under inspection and be so marked in accordance with the Egg Products Inspection Act.

(3) Carcasses, parts thereof, and products of cattle, sheep, swine, goats, or equines may be used in the processing of poultry products only if they were prepared in the United States in an official meat packing establishment or imported from a foreign country determined to be eligible to export such products to the United States under § 327.2(b), were inspected and passed in accordance with the Federal Meat Inspection Act and the regulations under such Act (subchapter A of this chapter), and are so marked.

(b)(1) Food ingredients and sources of radiation. Food ingredients and sources of radiation listed or approved for use in the production of meat or poultry products in 21 CFR chapter I, subchapter A or subchapter B, shall be listed for such use under this chapter, subject to declaration requirements in parts 316 and 317, or subparts M and N, of part 381 of this chapter, unless precluded from such use or further restricted in parts 318 or 319, or subparts O and P, of part 381 of this chapter, or unless such use otherwise results in the adulteration or misbranding of meat or poultry products. Food ingredients and sources of radiation listed or approved for use in the production of meat or poultry products in 21 CFR Chapter I, subchapter A or subchapter B, may be listed or approved for such use under this chapter by the Administrator in § 424.21, subject to declaration requirements in parts 316 and 317, or subparts M and N, of part 381 of this chapter.

(2) No food ingredients or sources of radiation may be used in the preparation of any meat or poultry product, for any purpose, unless the use is listed or approved in 21 CFR chapter I as a direct food additive (21 CFR part 172), a secondary direct food additive (21 CFR part 173), indirect food additive (21 CFR parts 174-178), radiation source (21 CFR part 179), an interim-listed direct food additive (21 CFR part 180), a prior-sanctioned substance (21 CFR part 181), a Generally Recognized As Safe (GRAS) substance (21 CFR parts 182 or 184), or by a regulation in this chapter. Part 319 of this chapter also specifies other food ingredients that are acceptable in preparing specified products.

(3) No food ingredient, the intended use of which is to impart color in any meat or poultry product, shall be used unless such use is approved in 21 CFR chapter I as a color additive (21 CFR Parts 73, 74, 81, and 82) or in a regulation in this chapter.

(4) Petitions to amend 21 CFR chapter I to provide for uses of food additives, or other substances or sources of radiation necessary in the preparation of meat or poultry products, or food ingredients used to impart color to product, should be sent to the Food and Drug Administration, in accordance with the provisions of 21 CFR parts 71 or 171, as appropriate.

(5) Inquiries concerning the regulatory status under the Federal Food, Drug, and Cosmetic Act of any articles intended for use as components of, or in contact with, meat or poultry products, may be addressed to the Food and Drug Administration, Center for Food Safety and Applied Nutrition, 200 C Street, SW, Washington, DC 20204, or the Department of Agriculture, Food Safety and Inspection Service, Office of Policy, Program Development and Evaluation, Washington, DC 20250-3700.

(6) Inquiries concerning the use in specific meat or poultry products of substances that are not affirmed by the Food and Drug Administration as Generally Recognized as Safe (GRAS) or otherwise listed in 21 CFR part 182 or part 184, or of food or color additives listed in 21 CFR regulations for general use in foods or for use in meat, or poultry products, generally, including mixtures of such substances or additives, should be addressed to the Department of Agriculture, Food Safety and Inspection Service, Office of Policy, Program Development and Evaluation, Washington, DC 20250-3700.

(c) The food ingredients specified in the following chart are approved for use in the preparation of meat products, provided they are used for the purposes indicated, within the limit of the amounts stated, and under other conditions specified in this part and Part 317 of this chapter. Part 319 of this chapter specifies other food ingredients that are acceptable in preparing specified meat products. This chart also contains food ingredients that are acceptable for use in poultry products, provided they are used for the purpose indicated, within the limits of the amounts stated and under other conditions specified in this part. No meat or poultry product shall bear or contain any food ingredient that would render it adulterated or misbranded, or which is not approved in this part, or by the Administrator in specific cases.

Class of substance Substance Purpose Products Amount
Acidifiers Acetic acid To adjust acidity Various meat and poultry products 2 Sufficient for purpose. 3
Citric acid ......do ......do Do.
Glucono delta-lactone ......do ......do Do.
Lactic acid ......do ......do Do.
Phosphoric acid ......do ......do Do.
Tartaric acid ......do ......do Do.
Anti-coagulants Citric acid To prevent clotting Fresh blood of livestock 0.2 percent with or without water. When water is used to make a solution of citric acid added to the blood of livestock, not more than 2 parts of water to 1 part of citric acid shall be used.
Sodium citrate ......do ......do Not to exceed 0.5 percent based on the ingoing weight of the product. When water is used to make a solution of sodium citrate added to livestock blood, not more than 2 parts of water to 1 part of sodium citrate shall be used.
Antifoaming agent Methyl polysilicone To retard foaming Soups (meat and poultry) 10 ppm.
......do Rendered fats (meat and poultry) Do.
......do Curing pickle (meat and poultry) 50 ppm.
Antimicrobial Agents Potassium lactate To inhibit microbial growth Various meat and poultry products, except infant formulas and infant food 4.8% by weight of total formulation.
Sodium diacetate ......do ......do 0.25% by weight of total formulation.
Sodium lactate ......do ......do 4.8% by weight of total formulation.
Trisodium phosphate To reduce microbial levels Raw, chilled poultry carcasses 8 to 12 percent; solution to be maintained at 45 °F. to 55 °F. and applied by spraying or dipping carcasses for up to 15 seconds when used in accordance with 21 CFR 182.1778.
Antioxidants and oxygen interceptors Ascorbyl palmitate To retard rancidity Margarine or oleomargarine 0.02 percent (by wt. of finished product) individually or in combination with other antioxidants approved for use in margarine.
Ascorbyl stearate
BHA (butylated hydroxyanisole)
......do Dry sausage 0.003 based on total weight 0.006 percent in combination with other anti-oxidants for use in meat.
......do Rendered animal fat or a combination of such fat and vegetable fat 0.01 percent 0.02 percent in combination with other anti-oxidants for use in meat.
......do Fresh pork, sausage, brown and serve sausages, fresh Italian sausage products, pregrilled beef patties, fresh sausage made from beef or beef and pork, cooked or raw pizza topping and cooked or raw meatballs 0.01 percent based on fat content 0.02 percent in combination with other anti-oxidants for use in meat, based on fat content.
......do Dried meats 0.01 percent based on total weight 0.01 percent in combination with other anti-oxidants for use in meat.
......do Margarine or oleomargarine 0.02 percent (by wt. of the finished product) individually or in combination with other antioxidants approved for use in margarine.
......do Various poultry products 0.01 percent based on fat content (0.02 percent in combination with any other antioxidant for use in poultry) based on fat content.
BHT (butylated hydroxytoluene) ......do Dry sausage 0.003 percent based on total weight 0.006 percent in combination with other anti-oxidants for use in meat.
......do Rendered animal fat or a combination of such fat and vegetable fat 0.01 percent 0.02 percent in combination with other anti-oxidants for use in meat.
......do Fresh pork, sausage, brown and serve sausages, fresh Italian sausage products, pregrilled beef patties, fresh sausage made from beef or beef and pork, cooked or raw pizza topping and cooked or raw meatballs 0.01 percent based on fat content 0.02 percent in combination with other anti-oxidants for use in meat, based on fat content.
......do Dried meats 0.01 percent based on total weight 0.01 percent in combination with other anti-oxidants for use in meat.
......do Margarine or oleomargarine 0.02 percent (by wt. of the finished product) individually or in combination with other antioxidants approved for use in margarine.
......do Various poultry products 0.01 percent based on fat content (0.02 percent in combination with any other antioxidant for use in poultry) based on fat content.
Dodecyl gallate ......do Margarine or oleomargarine 0.02 percent (by wt. of the finished product) individually or in combination with other antioxidants approved for use in margarine.
Glycine ......do Rendered animal fat or a combination of such fat and vegetable fat 0.01 percent 0.02 percent in combination with other anti-oxidants for use in meat.
Octyl gallate ......do Margarine or oleomargarine 0.02 percent (by wt. of the finished product) individually or in combination with other antioxidants approved for use in margarine.
Propyl gallate ......do Dry sausage 0.003 percent based on total weight 0.006 percent in combination with other anti-oxidants for use in meat.
......do Rendered animal fat or a combination of such fat and vegetable fat 0.01 percent 0.02 percent in combination with other anti-oxidants for use in meat.
......do Fresh pork, sausage, brown and serve sausages, fresh Italian sausage products, pregrilled beef patties, fresh sausage made from beef or beef and pork, cooked or raw pizza topping and cooked or raw meatballs 0.01 percent based on fat content 0.02 percent in combination with other anti-oxidants for use in meat, based on fat content.
......do Dried meats 0.01 percent based on total weight 0.01 percent in combination with other anti-oxidants for use in meat.
......do Margarine or oleo-margarine 0.02 percent (by wt. of the finished product) individually or in combination with other antioxidants approved for use in margarine.
......do Various poultry products 0.01 percent based on fat content (0.02 percent in combination with any other antioxidant for use in poultry, except TBHQ, based on fat content).
Resin guaiac ......do Rendered animal fat or a combination of such fat and vegetable fat 0.01 percent 0.02 percent in combination with other antioxidants for use in meat.
TBHQ (tertiary butylhydroquinone) ......do Dry sausage 0.003 percent based on weight 0.006 percent in combina-tion only with BHA and/or BHT.
......do Rendered animal fat or a combination of such fat and vegetable fat 0.01 percent 0.02 percent in combina-tion only with BHA or BHT.
......do Fresh pork, sausage, brown and serve sausages, fresh Italian sausage products, pregrilled beef patties, fresh sausage made from beef or beef and pork, cooked or raw pizza topping and cooked or raw meatballs 0.01 percent based on fat content 0.02 percent in combin-ation only with BHA and/ or BHT, based on fat content.
......do Dried meats 0.01 percent based on total weight 0.01 percent in combina-tion only with BHA and/or BHT.
......do Margarine or oleo-margarine 0.02 percent alone or in combination only with BHA and/or BHT, based on oil or fat content.
......do Various poultry products 0.01 percent based on fat content (0.02 percent in combination only with BHA and/or BHT, based on fat content).
Tocopherols ......do Rendered animal fat or a combination of such fat and vegetable fat 0.03 percent. A 30 percent concentration of tocopherols in vegetable oils shall be used when added as an antioxidant to products designated as “lard” or “rendered pork fat.”
......do Dry sausage, semidry sausage, dried meats, uncooked or cooked fresh sausage made with beef and/or pork, uncooked or cooked Italian sausage products, uncooked or cooked meatballs, uncooked or cooked meat pizza toppings, brown and serve sausages, pregrilled beef patties, and restructured meats Not to exceed 0.03 percent based on fat content. Not used in combination with other antioxidants.
......do Various poultry products 0.03 percent based on fat content (0.02 percent in combination with any other antioxidant for use in poultry, except TBHQ, based on fat content).
Artificial Sweeteners Saccharin To sweeten product Bacon 0.01 percent.
Binders and Extenders Agar-agar To stabilize and thicken Thermally processed canned and jellied meat food products 0.25 percent of finished product.
Algin To extend and stabilize product Breading mix; sauces (meat only) and various poultry products Sufficient for purpose in accordance with 21 CFR 172.5.
A mixture of sodium alginate, calcium carbonate and calcium lactate/lactic acid (or glucono delta lactone) To bind meat pieces Restructured meat food products Sodium alginate not to exceed 1.0 percent; calcium carbonate not to exceed 0.2 percent; and lactic acid/calcium lactate (or glucono delta-lactone) not to exceed 0.3 percent of product formulation. Added mixture may not exceed 1.5 percent of product at formulation. Mixture ingredients must be added dry.
A mixture of sodium alginate, calcium carbonate, lactic acid, and calcium lactate To bind poultry pieces Ground and formed raw or cooked poultry pieces Sodium alginate not more than 0.8 percent, calcium carbonate not more than 0.15 percent; lactic acid and calcium lactate, in combination, not more than 0.6 percent of product formulation. Added mixture may not exceed 1.55 percent of product at formulation. The mixture must be added in dry form.
Bread To bind and extend product Bockwurst 3.5 percent individually or collectively with other binders for use in meat.
......do Chili con carne, chili con carne with beans 8 percent individually or collectively with other binders for use in meat.
......do Spaghetti with meat balls and sauce, spaghetti with meat and sauce and similar products 12 percent individually or collectively with other binders for use in meat.
Carboxymethyl cellulose (cellulose gum) To extend and stabilize product Baked pies (meat only) and various poultry products Sufficient for purpose in accordance with 21 CFR 172.5.
Carrageenan To extend and stabilize product Breading mix; sauces (meat only) and various poultry products Sufficient for purpose in accordance with 21 CFR 172.5.
To prevent purging of brine solution Cured pork products as provided in 9 CFR 319.104(d) Not to exceed 1.5 percent of product formulation; permitted in combination only with soy protein concentrate, combination not to exceed 1.5 percent of product formulation; in accordance with 21 CFR 172.620, 172.623, and 172.626.
Carrageenan, Locust bean gum, and Xanthan gum blend ......do ......do In combination, not to exceed 0.5 percent of formulation; not permitted in combination with other binders approved for use in cured pork products; in accordance with 21 CFR 172.620, 172.623, 172.626, 184.1343, and 172.695.
Cereal To bind and extend product Sausages as provided in 9 CFR Part 319, bockwurst 3.5 percent individually or collectively with other binders for use in meat.
......do Chili con carne, chili con carne with beans 8 percent individually or collectively with other binders for use in meat.
Dried milk ......do Sausages as provided for in 9 CFR Part 319 3.5 percent individually or collectively with other binders for use in meat
Dried skim milk, calcium reduced ......do Sausages as provided in 9 CFR 9 CFR Part 319 Do.
......do Chili con carne, chili con carne with beans 8 percent individually or collectively with other binders for use in meat.
Enzyme (rennet) treated with calcium reduced dried skim milk and calcium lactate ......do Sausages as provided for in 9 CFR Part 319 3.5 percent total finished product (calcium lactate required at rate of 10 percent of binder.)
......do Imitation sausages; nonspecific loaves; soups, stews (meat only) and various poultry products Sufficient for purpose in accordance with 21 CFR 172.5 (calcium lactate required at a rate of 10 percent of binder).
Enzyme (rennet) treated with sodium caseinate and calcium lactate ......do Imitation sausages; nonspecific loaves; soups, stews (meat only) and various poultry products Sufficient for purpose in accordance with 21 CFR 172.5 (calcium lactate required at a rate of 25 percent of binder).
Food starch modified To prevent purging of brine solution Cured pork products as provided for in 9 CFR 319.104(d) Not to exceed 2 percent of product formulation in “Ham Water Added” and “Ham with Natural Juices” products; not to exceed 3.5 percent of product formulation in “Ham and Water Product - X percent of Weight is Added Ingredients” products; permitted in combination only with soy protein concentrate, with combination of modified food starch at 3 percent of product formulation and soy protein concentrate at 0.5 percent of product formulation; in accordance with 21 CFR 172.892.
Gelatin To bind and extend product Various poultry products Sufficient for purpose in accordance with 21 CFR 172.5.
Gums, vegetable ......do Egg roll (meat only) and various poultry products Sufficient for purpose in accordance with 21 CFR 172.5.
Isolated soy protein ......do Sausage as provided for in 9 CFR Part 319, bockwurst 2 percent.
......do Imitation sausages; nonspecific loaves; soups; stews (meat only) and various poultry products Sufficient for purpose in accordance with 21 CFR 172.5.
......do Chili con carne, chili con carne with beans 8 percent individually or collectively with other binders for use in meat.
......do Spaghetti with meatballs and sauce, spaghetti with meat and sauce and similar products 12 percent individually or collectively with other binders and extenders for use in meat.
To prevent purging of brine solution Cured pork products as provided for in 9 CFR 319.104(d) Not to exceed 2 percent of product formulation, not permitted in combination with other binders approved for use in cured pork products.
Methyl cellulose To extend and stabilize product (also carrier) Meat and vegetable patties; various poultry products 0.15 percent.
Sodium caseinate To bind and extend product Imitation sausages, nonspecific loaves, soups, stews (meat only) Sufficient for purpose in accordance with 21 CFR 182.1748 and 21 CFR 172.5.
......do Sausages as provided for in 9 CFR Part 319 2 percent in accordance with 21 CFR 182.1748.
......do Chili con carne, chili con carne with beans 8 percent individually or collectively with other binders and extenders for use in meat in accordance with 21 CFR 182.1748.
......do Spaghetti with meatballs and sauce, spaghetti with meat and sauce and similar products 12 percent individually or collectively with other binders and extenders for use in meat in accordance with 21 CFR 182.1748.
To prevent purging of brine solution Cured pork products as provided for in 9 CFR 319.104(d) Not to exceed 2 percent of product formulation; not permitted in combination with other binders approved for use in cured pork products, in accordance with 21 CFR 182.1748.
To bind and extend product Various poultry products 3 percent in cooked product, 2 percent in raw product, in accordance with 21 CFR 172.5 and 182.1748.
Soy flour ......do Sausages as provided for in 9 CFR Part 319, bockwurst 3.5 percent individually or collectively with other binders and extenders for use in meat.
......do Chili con carne, chili con carne with beans 8 percent individually or collectively with other binders and extenders for use in meat.
......do Spaghetti with meatballs and sauce, spaghetti with meat and sauce and similar products 12 percent individually or collectively with other binders and extenders for use in meat.
Soy protein concentrate ......do Sausage as provided for in 9 CFR Part 319, bockwurst 3.5 percent individually or collectively with other binders and extenders for use in meat.
......do Chili con carne, chili con carne with beans 8 percent individually or collectively with other binders and extenders for use in meat.
......do Spaghetti with meatballs and sauce, spaghetti with meat and sauce and similar products 12 percent individually or collectively with other binders and extenders for use in meat.
To prevent purging of brine solution Cured pork products as provided for in 9 CFR 319.104(d) Not to exceed 3.5 percent of product formulation; permitted in combination only with modified food starch, with combination of modified food starch at 3 percent of product formulation and soy protein concentrate at 0.5 percent of product formulation; in combination only with carrageenan, combination not to exceed 1.5 percent of product formulation.
Starchy vegetable flour To bind and extend product Sausage as provided for in 9 CFR Part 319, bockwurst 3.5 percent individually or collectively with other binders and extenders for use in meat.
......do Chili con carne, chili con carne with beans 8 percent individually or collectively with other binders and extenders for use in meat.
Tapioca dextrin ......do Sausage as provided for in 9 CFR Part 319, bockwurst 3.5 percent individually or collectively with other binders and extenders for use in meat, in accordance with 21 CFR 184.1277.
......do Chili con carne, chili con carne with beans 8 percent individually or collectively with other binders and extenders for use in meat, in accordance with 21 CFR 184.1277.
......do Spaghetti with meatballs and sauce, spaghetti with meat and sauce and similar products 12 individually or collectively with other binders and extenders for use in meat, in accordance with 21 CFR 184.1277.
......do Various poultry products Sufficient for purpose in accordance with 21 CFR 184.1277.
Vegetable starch ......do Sausage as provided for in 9 CFR Part 319, bockwurst 3.5 percent individually or collectively with other binders and extenders for use in meat.
......do Chili con carne, chili con carne with beans 8 percent individually or collectively with other binders and extenders for use in meat.
Wheat gluten To bind and extend product Sausage as provided for in 9 CFR Part 319, bockwurst 3.5 percent individually or collectively with other binders and extenders for use in meat, in accordance with 21 CFR 184.1322.
......do Chili con carne, chili con carne with beans 8 percent individually or collectively with other binders for use in meat, in accordance with 21 CFR 184.1322.
......do Spaghetti with meatballs and sauce, spaghetti with meat and sauce and similar products 12 percent individually or collectively with other binders and extenders for use in meat, in accordance with 21 CFR 184.1322.
......do Various poultry products Sufficient for purpose in accordance with 21 CFR 184.1322.
Whey, Dry or dried To bind or thicken Sausage as provided for in 9 CFR Part 319, bockwurst 3.5 percent individually or collectively with other binders and extenders for use in meat.
......do Imitation sausages, nonspecific loaves, soups, stews (meat only) 8 percent individually or collectively with other binders and extenders for use in meat.
......do Chili con carne, chili con carne with beans, pork or beef with barbecue sauce 8 percent individually or collectively with other binders and extenders for use in meat.
......do Various poultry products Sufficient for purpose in accordance with 21 CFR 184.1322.
Whey, Reduced lactose To bind or thicken Sausage as provided for in 9 CFR Part 319, bockwurst 3.5 percent individually or collectively with other binders and extenders for use in meat.
......do Imitation sausages, nonspecific loaves, soups, stews (meat only) Sufficient for purpose in accordance with 21 CFR 172.5.
......do Chili con carne, chili con carne with beans, pork or beef with barbecue sauce 8 percent individually or collectively with other binders and extenders for use in meat.
Whey, Reduced minerals ......do Sausage as provided for in 9 CFR Part 319, bockwurst 3.5 percent individually or collectively with other binders and extenders for use in meat.
......do Imitation sausages, nonspecific loaves, soups, stews (meat only) Sufficient for purpose in accordance with 21 CFR 172.5.
......do Chili con carne, chili con carne with beans, pork or beef with barbecue sauce 8 percent individually or collectively with other binders and extenders for use in meat.
Whey protein concentrate ......do Sausage as provided in 9 CFR Part 319, bockwurst 3.5 percent individually or collectively with other binders and extenders for use in meat, in accordance with 21 CFR 184.1979c.
......do Imitation sausages, nonspecific loaves, soups, stews Sufficient for purpose in accordance with 21 CFR 184.1979c.
......do Chili con carne, chili con carne with beans, pork or beef with barbecue sauce 8 percent individually or collectively with other binders and extenders for use in meat, in accordance with 21 CFR 184.1979c
To bind meat pieces Restructured meat food products, whole muscle meat cuts 3.5 percent individually or collectively with other binders and extenders for use in meat, in accordance with 21 CFR 184.1979c.
Xanthan gum To maintain: uniform viscosity; suspension of particulate matter, emulsion stability; freeze-thaw stability Meat sauces, gravies or sauces and meats, canned or frozen and/or refrigerated meat salads, canned or frozen meat stews, canned chili or chili with beans, pizza topping mixes and batter or breading mixes Sufficient for purpose in accordance with 21 CFR 172.5.
......do Various poultry products, except uncooked products or sausages or other products with a moisture limitation established by Subpart P of Part 381 Sufficient for purpose
Bleaching Agent Hydrogen peroxide To remove color Tripe (substance must be removed from product by rinsing with clear water) Sufficient for purpose.
Catalysts (substances must be eliminated during process) Nickel To accelerate chemical reaction Rendered animal fats or a combination of such fats and vegetable fats Do.
Sodium amide Rearrangement of fatty acid radicals ......do Do.
Sodium methoxide ......do ......do
Chilling Media Salt (NaCl) To aid in chilling Raw poultry products 700 lbs. to 10,000 gallons of water.
Coloring Agents (artificial) Coal tar dyes (FD&C certified) To color products Various poultry products Sufficient for purpose.
Color additives listed in 21 CFR Part 74, Subpart A of Part 82, Subpart B (operator must furnish evidence to inspector in charge that color additive has been certified for use in connection with foods by the Food and Drug Administration) To color casings or rendered fats; marking and branding product Sausage casings, oleomargarine, shortening, marking or branding ink on product (meat only) Sufficient for purpose (may be mixed with approved natural coloring matters or harmless inert material such as common salt and sugar).
Titanium oxide To whiten Canned ham salad spread and creamed-type canned meat products. Poultry salads and poultry spreads 0.5 percent.
Coloring Agents (natural) Alkanet, annatto, carotene, cochineal, green chlorophyll, saffron and tumeric To color casings or rendered fats; marking and branding product Sausage casings, oleomargarine, shortening, marking or branding ink on product (meat only) Sufficient for purpose (may be mixed with approved artificial dyes or harmless inert material such as common salt and sugar).
Annatto, carotene To color products Various poultry products Sufficient for purpose.
Curing accelerators (must be used only in combination with curing agents) Ascorbic acid To accelerate color fixing or preserve color during storage Cured pork and beef cuts, cured poultry, cured comminuted poultry and meat food products 75 oz to 100 gal pickle at 10 percent pump level; 3/4 oz to 100 lb meat, meat byproduct or poultry product; 10 percent solution to surfaces of cured meat cuts or poultry products prior to packaging. (The use of such solution shall not result in the addition of a significant amount of moisture to the product).
Citric acid or sodium citrate To accelerate color fixing or preserve color during storage Cured pork and beef cuts, cured comminuted meat food product, cured comminuted poultry or poultry products May be used in cured meat products or in 10 percent solution used to spray surfaces of cured meat cuts prior to packaging to replace up to 50 percent of the ascorbic acid, erythorbic acid, sodium ascorbate, or sodium erythorbate that is used. May be used in cured poultry products to replace 50 percent of the ascorbic acid or sodium ascorbate that is used.
Erythorbic acid To accelerate color fixing or preserve color during storage Cured pork and beef cuts, cured poultry, cured comminuted poultry and meat food products 75 oz to 100 gal pickle at 10 percent pump level; 3/4 oz to 100 lb meat, meat byproduct or poultry product; 10 percent solution to surfaces of cured meat cuts or poultry products prior to packaging. (The use of such solution shall not result in the addition of a significant amount of moisture to the product).
Fumaric acid ......do Cured, comminuted meat, poultry or meat and poultry products 0.065 percent (or 1 oz to 100 lb) of the weight of the meat, poultry or the meat or poultry byproducts before processing.
Glucono delta lactone ......do Cured, comminuted meat or meat food product 8 oz to each 100 lb of meat or meat byproduct.
......do Genoa salami 16 oz to 100 lb of meat (1.0 percent).
Sodium acid pyrophosphate ......do Frankfurters, wieners, vienna, bologna, garlic bologna, knockwurst and similar products Not to exceed alone or in combination with other curing accelerators for use in meat the following: 8 oz in 100 lb of meat, or meat and meat byproducts, content of the formula; nor 0.5 percent in the finished product.
Sodium ascorbate To accelerate color fixing or preserve color during storage Cured pork and beef cuts, cured comminuted meat food product, cured comminuted poultry or poultry products 87.5 oz to 100 gal pickle at 10 percent pump level; 7/8 oz to 100 lb meat, meat byproduct or poultry product; 10 percent solution to surfaces of cured meat cuts or poultry products prior to packaging. (The use of such solution shall not result in the addition of a significant amount of moisture to the product).
Sodium erythorbate To accelerate color fixing or preserve color during storage Cured pork and beef cuts, cured comminuted meat food products, cured comminuted poultry or poultry products 87.5 oz to 100 gal pickle at 10 percent pump level; 7/8 oz to 100 lb meat, meat byproduct or poultry product; 10 percent solution to surfaces of cured meat cuts or poultry products prior to packaging. (The use of such solution shall not result in the addition of a significant amount of moisture to the product.)
Curing Agents Sodium or potassium nitrate Source of nitrite Cured meat products other than bacon. Nitrates may not be used in baby, junior, and toddler foods. Cured, comminuted poultry or poultry products 7 lb to 100 gal pickle; 3 1/2 oz to 100 lb meat or poultry product (dry cure); 2 3/4 oz to 100 lb chopped meat or poultry.
Sodium or potassium nitrite (supplies of sodium nitrite and potassium nitrite and mixtures containing them must be kept under the care of a responsible employee of the establishment. The specific nitrite content of such supplies must be known and clearly marked accordingly) To fix color Cured meat and poultry products. Nitrites may not be used in baby, junior, or toddler foods 2 lb to 100 gal pickle at 10 percent pump level; 1 oz to 100 lb meat or poultry product (dry cure); 1/4 oz to 100 lb chopped meat, meat byproduct or poultry product. The use of nitrites, nitrates or combination shall not result in more than 200 ppm of nitrite, calculated as sodium nitrite in finished product, except that nitrites may be used in bacon only in accordance with paragraph (b) of this section.
Denuding Agents (may be used in combination. Must be removed from tripe by rinsing with potable water.) Lime (calcium oxide, calcium hydroxide) To denude mucous membranes Tripe Sufficient for purpose.
Sodium carbonate ......do ......do Do.
Sodium citrate ......do ......do Do.
Sodium gluconate ......do ......do Do.
Sodium hydroxide ......do ......do Do.
Sodium persulfate ......do ......do Do.
Sodium silicates (ortho, meta, and sesqui) ......do ......do Do.
Trisodium phosphate ......do ......do Do.
Emulsifying Agents Actylated monoglycerides To emulsify product Shortening and various poultry products Sufficient for purpose.
Diacetyl tartaric acid esters of mono-and diglycerides ......do ......do Do.
Glycerol-lacto stearate, oleate, or palmitate ......do ......do Do.
Lecithin To emulsify product (also as an antioxidant) Oleomargarine, shortening, various meat and poultry products 0.5 percent in oleomargarine, use in other products - sufficient amount for emulsification.
Mono and diglycerides (glycerol palmitate, etc.) To emulsify product Rendered animal fat or a combination of such fat with vegetable fat; oleomargarine Sufficient for purpose in lard and shortening; 0.5 percent in oleomargarine.
......do Various poultry products Sufficient for purpose.
Mono and diglycerides of fatty acids esterified with any of the following acids: acetic, acetyltartaric, citric, lactic, tartaric, and their sodium and calcium salts; the sodium sulfoacetate derivatives of these mono and diglycerides ......do Margarine or oleomargarine 0.5 percent.
Polyglycerol esters of fatty acids (polyglycerol esters of fatty acids are restricted to those up to and including the decaglycerol esters and otherwise meeting the requirements of § 172.854(a) of the Food Additive Regulations) ......do Rendered animal fat or a combination of such fat with vegetable fat when use is not precluded by standards of identity of composition; oleomargarine Sufficient for purpose for rendered animal fat or combination with vegetable fat; 0.5 percent for oleomargarine.
Polysorbate 60 (polyoxyethylene (20) sorbitan monostearate) ......do Shortening for use in nonstandardized baked goods, baking mixes, icings, fillings, and toppings and in the frying of foods (meat only). Rendered poultry fat or a combination of such fat with vegetable fat 1 percent when used alone. If used with polysorbate 80 the combined total shall not exceed 1 percent.
Polysorbate 80 (polyoxyethylene (20) sorbitan monooleate) ......do Shortening for use in nonstandardized baked goods, baking mixes, icings, fillings, and toppings and in the frying of foods (meat only). Various poultry products 1 percent when used alone. If used with polysorbate 60 the combined total shall not exceed 1 percent.
1,2-propylene glycol esters of fatty acids ......do Margarine or oleomargarine 2.0 percent.
Propylene glycol mono and diesters of fats and fatty acids ......do Rendered animal or poultry fat or a combination of such fat with vegetable fat Sufficient for purpose.
Stearyl-2-lactylic acid ......do Shortening to be used for cake icings and fillings (meat only) 3.0 percent.
Stearyl monoglyceridyl citrate ......do Shortening Sufficient for purpose
Film Forming Agents A mixture consisting of water, sodium alginate, calcium chloride, sodium carboxymethyl-cellulose, and corn syrup solids To reduce cooler shrinkage and help protect surface Freshly dressed meat carcasses. Such carcasses must bear a statement “Protected with a film of water, corn syrup solids, sodium alginate, calcium chloride and sodium carboxymethyl-cellulose.” Formulation may not exceed 1.5 percent of hot carcass weight when applied. Chilled weight may not exceed hot weight.
Flavoring Agents; Protectors and Developers Artificial smoke flavoring To flavor product Various (meat and poultry) 2 Sufficient for purpose.
Autolyzed yeast extract ......do ......do Do.
Benzoic acid (sodium, potassium and calcium salts) To retard flavor reversion Margarine or oleomargarine 0.1 percent individually, or if used in combination with other flavoring agents for use in meat or with sorbic acid and its salts, 0.2 percent (expressed as the acids in the wt. of the finished foods).
Calcium lactate To protect flavor Cooked semi-dry and dry products including sausage, imitation sausage, and nonspecific meat food sticks 0.6 percent in product formulation.
Citric acid ......do Various poultry products Sufficient for purpose.
Flavoring Chili con carne Do.
Corn syrup solids; corn syrup; glucose syrup To flavor product Various poultry products, sausage, hamburger, meat loaf, luncheon meat, chopped or pressed ham Do.
Dextrose ......do Sausage, ham and cured products Do.
Diacetyl ......do Oleomargarine Do.
Disodium guanylate ......do Various meat and poultry products. 2
Disodium inosinate ......do ......do Do.
Harmless bacteria starters of the acidophilus type, lactic acid starter or culture of Pediococcus cerevisiae To develop flavor Dry sausage, pork roll, thuringer, lebanon bologna, cervelat, and salami 0.5 percent.
Harmless lactic acid producing bacteria To prevent the growth of Clostridium botulinum Bacon Sufficient for purpose.
Hydrolyzed plant protein To flavor product Various meat and poultry products. 2 Do.
Isopropyl citrate To protect flavor Oleomargarine 0.02 percent.
Malt syrup To flavor product Cured meat products 2.5 percent.
......do Various poultry products Sufficient for purpose.
Milk protein hydrolysate ......do Various meat and poultry products. 2 Do.
Monoammonium glutamate ......do ......do Do.
Monosodium glutamate ......do ......do Do.
Potassium lactate ......do Various meat and meat food products, poultry and poultry food products, except infant formula and infant food. 2 Not to exceed 2 percent of formulation; in accordance with 21 CFR 184.1639.
Smoke flavoring To flavor product Various meat and poultry products Sufficient for purpose.
Sodium acetate To flavor products Various meat and poultry products Not to exceed 0.25% of formulate in accordance with 21 CFR 184.1721.
Sodium diacetate ......do ......do Not to exceed 0.25% of formulate in accordance with 21 CFR 184.1754.
Sodium lactate ......do Various meat and meat food products, poultry and poultry food products, except infant formula and infant food. 2 Not to exceed 2 percent of formulation in accordance with 21 CFR 184.1768.
Sodium sulfoacetate derivative of mono and diglycerids ......do Various meat and poultry products. 2 0.5 percent.
Sodium tripolyphosphate To help protect flavor “Fresh Beef,” 2 “Beef for further cooking, “Cooked Beef,” Beef Patties, Meat Loaves, Meat Toppings, and similar products derived from pork, lamb, veal, mutton, and goat meat which are cooked or frozen after processing 0.5 percent of total product.
Sodium tripolyphosphate and sodium mixtures, metaphosphate, insoluble; and sodium polyphosphates, glassy ......do ......do Do.
Sorbitol To flavor, to facilitate the removal of casings from product, and to reduce caramelization and charring Cooked sausage labeled frankfurter, frank, furter, wiener, and knockwurst; cured pork and pork products, as provided for in 9 CFR Part 319 Not to exceed 2 percent of the weight of the formula excluding the formula weight of water or ice, when used in accordance with 21 CFR 184.1835.
Starter distillate To help protect flavor Oleomargarine Sufficient for purpose.
Stearyl citrate ......do ......do 0.15 percent.
Sugars (sucrose and dextrose) To flavor product Various meat and poultry products Sufficient for purpose.
Gases Carbon dioxide liquid Contact freezing Various poultry products Do.
Carbon dioxide solid (dry ice) To cool product Chopping of meat, packing of product Sufficient for purpose.
To cool product or facilitate chopping or packaging Various poultry products Do.
Nitrogen To exclude oxygen from sealed containers Various meat and poultry products Do.
Nitrogen, liquid Contact freezant ......do Do.
Hog Scald Agents (must be removed by subsequent cleaning operations) Caustic soda To remove hair Hog carcasses Sufficient for purpose.
Dicotyl sodium sulfosuccinate ......do ......do Do.
Dimethylpolysiloxane ......do ......do Do.
Disodium-calcium ethylenediaminetetra-acetate ......do ......do Do.
Disodium phosphate ......do ......do Do.
Ethylenediaminetetra-acetic acid (sodium salts) ......do ......do Do.
Lime (calcium oxide, calcium hydroxide) ......do ......do Do.
Potassium hydroxide Do.
Propylene glycol ......do ......do Do.
Soap (prepared by the reaction of calcium, potassium, or sodium with rosin or fatty acids of natural fats and oils) ......do ......do Do.
Sodium acid pyrophosphate ......do ......do Do.
Sodium carbonate ......do ......do Do.
Sodium dodecylbenzene sulfonate ......do ......do Do.
Sodium gluconate ......do ......do Do.
Sodium hexametaphosphate ......do ......do Do.
Sodium lauryl sulfate ......do ......do Do.
Sodium mono and dimethylnaphthalene sulfonate (molecular weight 245-260) ......do ......do Do.
Sodium n-alkylbenzene sulfonate (alkyl group predominantly C12 and C13 and not less than 95 percent C10 and C16) ......do ......do Do.
Sodium pyrophosphate ......do ......do Do.
Sodium silicates (ortho, meta, and sesqui) ......do ......do Do.
Sodium sulfate ......do ......do Do.
Sodium tripolyphosphate ......do ......do Do.
Sucrose ......do ......do Do.
Triethanolamine dodecylbenzene sulfonate ......do ......do Do.
Trisodium phosphate ......do ......do Do.
Miscellaneous Adipic acid To acidify Margarine or oleomargarine Sufficient for purpose.
Ascorbic acid, erythorbic acid, citric acid, sodium ascorbate and sodium citrate, singly or in combination To delay discoloration Fresh beef cuts, fresh lamb cuts, and fresh pork cuts Not to exceed, singly or in combination, 500 ppm or 1.8 mg/sq inch of product surface of ascorbic acid (in accordance with 21 CFR 182.3013), erythorbic acid (in accordance with 21 CFR 182.3041), or sodium ascorbate (in accordance with 21 CFR 182.3731); and/or not to exceed, singly or in combination, 250 ppm or 0.9 mg/sq inch of product surface of citric acid (in accordance with 21 CFR 182.6033), or sodium citrate (in accordance with 21 CFR 182.6751).
Calcium disodium, EDTA (calcium disodium ethylene-diaminetetraacetate To preserve product and to protect flavor Margarine or oleomargarine 75 ppm by weight of the finished oleomargarine or margarine.
Calcium propionate To retard mold growth Pizza crust 0.32 percent alone or in combination based on weight of the flour brace used.
......do Fresh pie dough (poultry only) 0.3 percent of calcium propionate or sodium propionate alone, or in combination, based on weight of flour used.
Citric acid To preserve cured color during storage Cured pork cuts Not to exceed 30 percent in water solution used to spray surfaces of cured cuts, prior to packaging, in accordance with 21 CFR 184.1033. (The use of such solution shall not result in the addition of a significant amount of moisture to the product and shall be applied only once to product).
Citric acid (sodium and potassium salts) To acidify Margarine and oleomargarine Sufficient for purpose.
d- and dl-alpha-tocopherol To inhibit nitrosamine formation Pump-cured bacon 500 ppm; by injection or surface application.
Dipotassium phosphate To decrease the amount of cooked out juices Meat food products except where otherwise prohibited by the meat inspection regulations and poultry food products except where otherwise prohibited by the poultry products inspection regulations. For meat food products, 5 percent of phosphate in pickle at 10 percent pump level; 0.5 percent of phosphate in meat food product (only clear solution may be injected into meat food product). For poultry food products, 0.5 percent of total product.
Disodium phosphate ......do ......do Do.
Glycerine Humectant Shelf stable meat snacks Not to exceed 2 percent of the formulation weight of the product in accordance with 21 CFR 182.1320.
Hydrochloric acid To acidify Margarine or oleomargarine Sufficient for purpose.
Lactic acid (sodium and potassium salts) ......do ......do Do.
L-Tartaric acid (sodium and sodium potassium salts) ......do ......do Do.
Monopotassium phosphate To decrease the amount of cooked out juices Meat food products except where otherwise prohibited by the meat inspection regulations and poultry food products except where otherwise prohibited by the poultry products inspection regulations. For meat food products, 5 percent of phosphate in pickle at 10 percent pump level; 0.5 percent of phosphate in meat food product (only clear solution may be injected into meat food product). For poultry products, 0.5 percent of total product.
Monosodium phosphate ......do ......do Do.
Phosphoric acid To acidify Margarine or oleomargarine Sufficient for purpose.
Potassium bicarbonate To alkalize Margarine or oleomargarine Sufficient for purpose.
Potassium carbonate ......do ......do Do.
Potassium pyrophosphate To decrease the amount of cooked out juices Meat food products except where otherwise prohibited by the meat inspection regulations and poultry food products except where otherwise prohibited by the poultry products inspection regulations. 5 percent of phosphate in pickle at 10 percent pump level; 0.5 percent of phosphate in meat food product (only clear solution may be injected into meat food product). For poultry food products, 0.5 percent of total product.
Potassium sorbate To retard mold growth Dry sausage 10 percent in water solution may be applied to casings after stuffing or casings may be dipped in solution prior to stuffing.
Potassium tripolyphosphate To decrease the amount of cooked out juices Meat food products except where otherwise prohibited by the meat inspection regulations and poultry food products except where otherwise prohibited by the poultry products inspection regulations 5 percent of phosphate in pickle at 10 percent pump level; 0.5 percent of phosphate in meat food product (only clear solution may be injected into meat food product). For poultry food products, 0.5 percent of total product.
Propyl paraben (propyl p-hydroxy-benzoate) To retard mold growth Dry sausage 3.5 percent in water solution may be applied to casings after stuffing or casings may be dipped in solution prior to stuffing.
Silicon dioxide Processing aid/dispersant Tocopherol containing bacon curing mixes At level not to exceed 4.0 percent in the dry mix.
Sodium acid pyrophosphate To decrease the amount of cooked out juices Meat food products except where other prohibited by the meat inspection regulations and poultry food products except where otherwise prohibited by the poultry products inspection regulations. For meat food products, 5 percent of phosphate in pickle at 10 percent pump level; 0.5 percent of phosphate in meat food product (only clear solution may be injected into meat food product). For poultry products, 0.5 percent of total product.
Sodium bicarbonate To neutralize excess acidity, cleaning vegetables Rendered fats, soups, curing pickle (meat and poultry) Sufficient for purpose.
To alkalize Margarine or oleomargarine Do.
Sodium carbonate ......do ......do Do.
Sodium citrate buffered with citric acid to a pH of 5.6 To inhibit the growth of micro-organisms and retain product flavor during storage Cured and uncured, processed whole muscle meat and poultry food products, e.g., ham, chicken breasts Not to exceed 1.3 percent of the formulation weight of the product in accordance with 21 CFR 184.1751.
Sodium hydroxide To alkalize Margarine or oleomargarine Sufficient for purpose.
To decrease the amount of cooked out juices Poultry food products containing phosphates May be used only in combination with phosphate in a ratio not to exceed one part sodium hydroxide to four parts phosphate.
......do Meat food products containing phosphates May be used only in combination with phosphates in a ratio not to exceed one part sodium hydroxide to four parts phosphate; the combination shall not exceed 5 percent in pickle at 10 percent pump level; 0.5 percent in product.
Sodium metaphosphate, insoluble ......do Meat food products except where other prohibited by the meat inspection regulations, and poultry food products except where otherwise prohibited by the poultry products inspection regulations For meat food products, 5 percent of phosphate in pickle at 10 percent pump level; 0.5 percent of phosphate in meat food product (only clear solution may be injected into meat food product). For poultry products, 0.5 percent of total product.
Sodium polyphosphate, glassy ......do ......do Do.
Sodium proprionate To retard mold growth Pizza crust 0.32 percent alone or in combination based on weight of the flour brace used.
......do Fresh pie dough (poultry only) 0.3 percent of calcium proprionate or sodium proprionate alone, or in combination, based on weight of flour used.
Sodium pryophosphate To decrease the amount of cooked out juices Meat food products except where otherwise prohibited by the meat inspection regulations and poultry food products except where otherwise prohibited by the poultry products inspection regulations For meat food products, 5 percent of phosphate in pickle at 10 percent pump level; 0.5 percent of phosphate in meat food product (only clear solution may be injected into meat food product). For poultry products, 0.5 percent of total product.
Sodium tripolyphosphate ......do ......do Do.
Sorbic acid (sodium, potassium, and calcium salts) To preserve product and to retard mold growth Margarine or oleomargarine 0.1 percent individually, or if used in combination or with benzoic acid or its salts, 0.2 percent (expressed as the acids in the wt. of the finished foods).
Tricalcium phosphate To preserve product color during dehydration process Mechanically deboned chicken to be dehydrated Not to exceed 2 percent of the weight of the mechanically deboned chicken prior to dehydration, in accordance with 21 CFR 182.1217.
Poultry scald agents (must be removed by subsequent cleaning operations) Alpha-hydro-omega-hydroxy-poly (oxyethylene) poly (oxypropylene) (minimum 15 moles) poly (oxyethylene) block copolymer (poloxamer) To remove feathers Poultry carcasses Not to exceed 0.05 percent by weight in scald water.
Dimethylpolysiloxane ......do ......do Sufficient for purpose.
Dioctyl sodium sulfosuccinate ......do ......do Do.
Dipotassium phosphate ......do ......do Do.
Ethylenediaminetetra-acetic acid (sodium salts) ......do ......do Do.
Lime (calcium oxide, calcium hydroxide) ......do ......do Do.
Polyoxyethylene (20) sorbitan monooleate ......do ......do Not to exceed 0.0175 percent in scald water.
Potassium hydroxide ......do ......do Sufficient for purpose.
Propylene glycol ......do ......do Do.
Sodium acid phosphate ......do ......do Do.
Sodium acid pyrophosphate ......do ......do Do.
Sodium bicarbonate ......do ......do Do.
Sodium carbonate ......do ......do Do.
Sodium dodecylbenzene-sulfonate ......do ......do Do.
Sodium-2-ethylhexyl sulfate ......do ......do Do.
Sodium hexametaphosphate ......do ......do Do.
Sodium hydroxide ......do ......do Do.
Sodium lauryl sulfate ......do ......do Do.
Sodium phosphate (mono-, di-, tribasic) ......do ......do Do.
Sodium pyrophosphate ......do ......do Do.
Sodium sesquicarbonate ......do ......do Do.
Sodium sulfate ......do ......do Do.
Sodium tripolyphosphate ......do ......do Do.
Tetrasodium pyrophosphate ......do ......do Do.
Proteolytic Enzymes Aspergillus flavus oryzae group To soften tissue Raw poultry muscle tissue of hen, cock, mature turkey, mature duck, mature goose, and mature guinea, and raw meat cuts Solutions consisting of water and approved proteolytic enzyme applied or injected into raw meat or poultry tissue shall not result in a gain of more than 3 percent above the weight of the untreated product.
Aspergillus oryzae ......do ......do Do.
Bromelin ......do ......do Do.
Ficin ......do ......do Do.
Papain ......do ......do Do.
Refining Agents (must be eliminated during process of manufacturing) Acetic acid To separate fatty acids and glycerol Rendered fats (meat only) Sufficient for purpose.
Bicarbonate of soda ......do ......do Do.
Carbon (purified charcoal) To aid in refining of animal fats ......do Do.
Caustic soda (sodium hydroxide) To refine fats ......do Do.
Diatomaceous earth; Fuller's earth ......do ......do Do.
Sodium carbonate ......do ......do Do.
Tannic acid ......do ......do Do.
Rendering agents Tricalcium phosphate To aid rendering Animal fats Do.
Trisodium phosphate ......do ......do Do.
Synergists (used in combination with antioxidants) Citric acid To increase effectiveness of antioxidants Any meat product permitted to contain antioxidants as provided for in this part Not to exceed 0.01 percent based on fat content.
......do Poultry fats 0.01 percent alone or in combination with antioxidants in poultry fats.
Malic acid ......do Lard and shortening 0.01 percent based on total weight in combination with antioxidants for use in meat products only.
......do Poultry fats 0.01 percent alone or in combination with antioxidants in poultry fats.
Monoglyceride citrate ......do Lard, shortening, fresh pork sausage, dried meats and poultry fats 0.02 percent.
Monoisopropyl citrate ......do Lard, shortening, oleomargarine, fresh pork sausage, dried meats Do.
......do Poultry fats 0.01 percent poultry fats.
Phosphoric acid ......do Lard, shortening, and poultry fats 0.01 percent.
Tenderizing agents Aspergillus flavus oryzae group To soften tissue Raw poultry muscle tissue of hen, cock, mature turkey, mature duck, mature goose, and mature guinea, and raw meat cuts Solutions consisting of water and approved proteolytic enzyme applied or injected into raw meat or poultry tissue shall not result in a gain of more than 3 percent above the weight of the untreated product.
Aspergillus oryzae ......do ......do Not more than 3 percent of a 0.8 molar solution.
Bromelin ......do ......do Do.
Calcium chloride ......do ......do Do.
Magnesium chloride ......do ......do Do.
Papain To soften tissue Raw poultry muscle tissue of hen, cock, mature turkey, mature duck, mature goose, and mature guinea, and raw meat cuts Solutions consisting of water and approved proteolytic enzyme applied or injected into raw meat or poultry tissue shall not result in a gain of more than 3 percent above the weight of the untreated product.
Potassium chloride ......do ......do Not more than 3 percent of a 2.0 molar solution.
Potassium, magnesium or calcium chloride ......do ......do A solution of approved inorganic chlorides injected into or applied to raw meats or poultry cuts shall not result in a gain of more than 3 percent above the weight of the untreated product.

1 [Reserved]

2 Information as to the specific products for which use of this additive is approved may be obtained upon inquiry addressed to the Labeling and Additives Policy Division, Food Safety and Inspection Service, U.S. Department of Agriculture, Washington, DC 20250.

3 Provided that its use is functional and suitable for the product and it is permitted for use at the lowest level necessary to accomplish the desired technical effect as determined in specific cases prior to label approval under part 412 of this chapter.

4 Special labeling requirements are prescribed in 381.120 for raw poultry chilled in a medium with more than 70 lbs. of salt to 10,000 gals. of water.

[64 FR 72175, Dec. 23, 1999, as amended at 65 FR 3123, Jan. 20, 2000; 65 FR 34391, May 30, 2000; 78 FR 66839, Nov. 7, 2013; 83 FR 25308, May 31, 2018; 84 FR 65268, Nov. 27, 2019]