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 listed in § 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)
(i)
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 listed in § 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.
(ii)
Pork from carcasses or carcass parts used as an ingredient in poultry products that has been found free of trichinae, as described under § 318.10 (a)(2), (e) and (f) of the Federal meat inspection regulations ( 9 CFR 318.10 (a)(2), (e) and (f) ), is not required to be treated for the destruction of trichinae.
(iii)
Poultry products containing pork muscle tissue which the Administrator determines at the time the labeling for the product is submitted for approval in accordance with part 381 of the regulations in subchapter A or upon subsequent reevaluation of the product would be prepared in such a manner that the product might be eaten rare or without thorough cooking because of the appearance of the finished product or otherwise, shall be effectively heated, refrigerated, or cured to destroy any possible live trichinae, as prescribed in § 318.10(c) of this chapter, at the official establishment where such products are prepared. In lieu of such treatment of poultry products containing pork, the pork ingredient may be so treated.
(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 . | |
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| 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. | |
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| ......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. | ||
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| ......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). | ||
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| 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 . | |
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| 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 . | ||
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| ......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. | ||
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| 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. | |
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| ......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
| ||