§ 318.7 - Approval of substances for use in the preparation of products.

Latest version.

(a)(1) No substance may be used in the preparation of any product unless it is approved in paragraph (c)(4) of this section or elsewhere in part 318 or in part 319 of this subchapter, or by the Administrator in specific cases.

(2) Approval of new substances or new uses or new levels of use of approved substances may be granted by the Administrator if:

(i) The substance has been previously approved by the Food and Drug Administration (FDA) for use in meat or meat food products as a food additive, color additive, or as a substance generally recognized as safe and is listed in title 21 of the Code of Federal Regulations, parts 73, 74, 81, 172, 173, 179, 182 or 184.

(ii) Its use is in compliance with applicable FDA requirements; and

(iii) The Administrator has determined that:

(A) The use of the substance will not render the product in which it is used adulterated or misbranded or otherwise not in compliance with the requirements of the Act; and

(B) Its use is functional and suitable for the product and it is permitted for use at the lowest level necessary to accomplish the stated technical effect as determined in specific cases.

(3) Whenever the Administrator determines that approval of a new substance or new use or new level of use of an approved substance should be granted in accordance with paragraph (a)(2) of this section, the Administrator shall issue a final rule amending the chart of substances in paragraph (c)(4) of this section to include the additional substance or new use of the substance, and any technical effect or change in level of use of the substance.

(4) No product shall bear or contain any substance which would render it adulterated or misbranded, or which is not approved in part 318 or part 319 of this subchapter, or by the Administrator in specific cases.

(b) Requirements for the use of nitrite and sodium ascorbate or sodium erythorbate (isoascorbate) in bacon. Nitrates shall not be used in curing bacon.

(1) Pumped bacon. With respect to bacon injected with curing ingredients and massaged bacon: sodium nitrite shall be used at 120 parts per million (PPM) ingoing or an equivalent amount of potassium nitrite shall be used (148 PPM ingoing); and 550 PPM of sodium ascorbate or sodium erythorbate (isoascorbate) shall be used. Sodium ascorbate or sodium erythorbate have a molecular weight of approximately 198. Hydrated forms of these substances shall be adjusted to attain the equivalent of 550 PPM of sodium ascorbate or sodium erythorbate.

(2) The Department shall collect samples of pumped bacon from producing plants and analyze them for the level of nitrosamines by the Thermal Energy Analyzer (TEA). In the event that a TEA analysis indicates that a confirmable level of nitrosamines might be present, additional samples shall be collected and analyzed by gas chromatography. Presumptive positive results must be confirmed by mass spectrometry before being considered positive. If, during the interval required for the Department to analyze the confirmatory samples by gas chromotography and mass spectrometry, changes are made in processing procedures which are expected to result in no confirmable levels of nitrosamines in pumped bacon produced by these new procedures, an establishment may submit samples to USDA for analysis upon prior notification and arrangements with USDA. If, however, an establishment furnishes USDA with laboratory results from testing five consecutive lots of pumped bacon producedunder the new procedures and the testing is performed by the USDA methodology and procedures, those results will be utilized in making the determination concerning the product produced under the new procedures. Should the results of these tests reveal that confirmable levels of nitorosamines are not indicated in any of the five consecutive lots, the confirmation analysis by USDA shall be terminated and the establishment shall revert to normal monitoring status. In the event the test results continue to indicate nitros-amines, however, USDA shall proceed in its confirmation analysis on the original samples taken for confirmation. If any one of the original samples collected by USDA for confirmation if found to contain confirmable levels of nitrosamines, all pumped bacon in the producing establishment and all future production will be retained. The Department shall sample and analyze such retained pumped bacon for nitrosamines on a lot by lot basis. A production lot shall be that pumped bacon produced by the establishment in any single shift. Samples from any lot of pumped bacon under retention found to contain nitrosamines at a confirmable level shall cause the lot of pumped bacon to be disposed of in a manner to assure it will not form nitrosamines when cooked. Such disposal may include incorporation of the uncooked pumped bacon as an ingredient of another meat food product provided it is processed for eating without further preparation in a manner to preclude the formation of nitrosamines. Bacon subsequently produced shall not be retained because of nitrosamines if the operator of the establishment makesadjustments in the processing of the product and laboratory results obtained by TEA analysis of samples from five consecutive normal sized lots of pumped bacon indicates that the product being produced contains no confirmable levels of nitrosamines. These tests from five consecutive normal sized lots of pumped bacon shall be conducted by the Department: Provided, however, That if the establishment furnishes the Department with the results of tests conducted under the methodology and procedures used by the Department, such test results will be utilized in making the determination concerning the nitrosamine content of the product. All tests of pumped bacon for nitrosamines under this subparagraph shall be made on pumped bacon cooked 340 °F. for 3 minutes on each side. In order to determine that no confirmable levels of nitrosamines are present in a sample tested, the testing must be performed by methodology and procedures that would detect the presence of any nitrosamines at 10 PPB.

(3) Notwithstanding the provisions of paragraph (b)(1) of this section, sodium nitrite may be used at:

(i) 100 ppm ingoing (potassium nitrite at 123 ppm ingoing); and 500 ppm sodium ascorbate or sodium erythorbate (isoascorbate) shall be used; provided that the establishment has a partial quality control program as provided in § 318.4(d) that results in compliance with this provision, or

(ii) A predetermined level between 40 and 80 ppm (potassium nitrite at a level between 49 and 99 ppm); 550 ppm sodium ascorbate or sodium erythorbate (isoascorbate); and additional sucrose or other similar fermentable carbohydrate at a minimum of 0.7 percent and an inoculum of lactic acid producing bacteria such as Pediococcus acetolactii or other bacteria demonstrated to be equally effective in preventing the growth of botulinum toxin at a level sufficient for the purpose of preventing the growth of botulinum toxin; provided that the establishment has a partial quality control program as provided in § 318.4(d) that results in compliance with this provision.

(4) The Department shall collect samples of bacon from plants producing under paragraph (b)(3) of this section and analyze them for the level of nitrosamines. Samples shall be randomly selected throughout the production of a lot. The actual sampling plans and methods of analysis that are used will result in approximately the same likelihood as under paragraph (b)(2) of this section of having a presumptive positive result when the true mean level of nitrosamines in a production lot is 10 ppb. In the event of a presumptive positive result, the plant shall become subject to the provisions of paragraph (b)(2) of this section.

(5) Immersion cured bacon. Immersion cured bacon may be placed in a brine solution containing salt, nitrite and flavoring material or in a container with salt, nitrite and flavoring material. Sodium nitrite shall not exceed 120 ppm ingoing or an equivalent amount of potassium nitrite (148 ppm ingoing) based on the actual or estimated skin-free green weight of the bacon bellies.

(6) Bacon made with dry curing materials. With respect to bacon made with dry curing materials, the product shall be cured by applying a premeasured amount of cure mixture to the bacon belly surfaces, completely covering the surfaces. Sodium nitrite shall not exceed 200 ppm ingoing or an equivalent amount of potassium nitrite (246 ppm ingoing) in dry cured bacon based on the actual or estimated skin-free green weight of the bacon belly.

(c) Under appropriate declaration as required in parts 316 and 317 of this subchapter, the following substances may be added to products:

(1) Common salt, approved sugars (sucrose, cane or beet sugar), maple sugar, dextrose, invert sugar, honey, corn syrup solids, (corn syrup, glucose syrup and fructose), wood smoke, vinegar, flavorings, spices, sodium nitrate, sodium nitrite, potassium nitrate, potassium nitrite, and other substances specified in the chart in paragraph (c)(4) of this section may be added to products under conditions, if any, specified in this part or in part 317 of this subchapter.

(2) Other harmless artificial flavorings may be added to products with the approval of the Administrator in specific cases.

(3) Coloring matter and dyes other than those specified in the chart in paragraph (c)(4) of this section may be applied to products, mixed with rendered fat, applied to natural and artificial casings, and applied to such casings enclosing products, if approved by the Administrator in specific cases. When any coloring matter or dye is applied to casings, there shall be no penetration of coloring into the product.

(4) The substances specified in the following chart are acceptable for use in the preparation of products, provided they are used for the purposes indicated, within the limits of the amounts stated and under other conditions specified in this part and part 317 of this subchapter. In addition to the substances listed in the following chart, part 319 of this subchapter specifies other substances that are acceptable in preparing specified products.
Class of substanceSubstancePurposeProductsAmountAcidifiersAcetic acidTo adjust acidityVarious 2Sufficient for purpose.3Citric acid......do......doDo.Glucono delta-lactone......do......doDo.Lactic acid......do......doDo.Phosphoric acid......do......doDo.Tartaric acid......do......doDo.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 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 blood of livestock, not more than 2 parts of water to 1 part of sodium citrate shall be used.Antifoaming agentMethyl polysiliconeTo retard foamingSoups
Rendered fats
Curing pickle

10 parts per million.

Do.

50 parts per million.

Antioxidants and oxygen interceptorsBHA (butylated hydroxyanisole)To retard rancidityDry sausage0.003 percent based on total weight.006 percent in combination.BHT (butylated hydroxytoluene)......do......do......doPropyl gallate......do......do......doTBHQ (tertiary butylhydroquinone)......do......do......do0.006 percent in combination only with BHA and/or BHT.BHA (butylated hydroxyanisole)......doRendered animal fat or a combination of such fat and vegetable fat0.01 percent0.02 percent in combination.BHT (butylated hydroxytoluene)......do......do......doGlycine......do......do......doPropyl gallate......do......do......doResin guaiac......do......do......doTBHQ (tertiary butylhydroquinone)......do......do......do0.02 percent in combination only with BHA and/or BHT.

Tocopherols......do......do0.03 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.”......doDry 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 sausage, pregrilled beef patties, and restructured meats Not to exceed 0.03 percent based on fat content. Not used in combination with other antioxidants.

BHA (butylated hydroxyanisole)......doFresh 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 meatballs0.01 percent based on fat content0.02 percent in combination based on fat content.BHT (butylated hydroxytoluene)......do......do......doPropyl gallate......do......do......doTBHQ (tertiary butylhydroquinone)......do......do......do0.02 percent in combination only with BHA and/or BHT based on fat content.BHA (butylated hydroxyanisole)......doDried meats0.01 percent based on total weight0.01 percent in combination.BHT (butylated hydroxytoluene)......do......do......doPropyl gallate......do......do......doTBHQ (tertiary butylhydroquinone)......do......do......do0.01 percent in combination only with BHA and/or BHT.

BHA (butylated hydroxyanisole)......doMargarine or oleomargarine0.02 percent (by wt. of the finished product) individually or in combination with other antioxidants approved for use in margarine.BHT (butylated hydroxytol-)......do......doDo.uene).Octyl gallate......do......doDo.Propyl gallate......do......doDo.Dodecyl gallate......do......doDo.Ascorbyl palmitate......do......doDo.Ascorbyl stearate......do......doDo.TBHQ (tertiary butylhydroqui-

none).

......do......do0.02 percent alone or in combination only with BHA and/or BHT based on fat or oil content.

Class of substanceSubstancePurposeProductsAmountBinders and extendersAgar-agarTo stabilize and thickenThermally processed canned jellied meat food products0.25 percent of finished product.AlginTo extend and stabilize productBreading mix; saucesSufficient 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 piecesRestructured meat food productsSodium 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. Ingredients of mixture must be added dry.BreadTo bind and extend productBockwurst3.5 percent individually or collectively with other binders.Calcium reduced dried skim milk......doSausages as provided in part 319Do.......do......doChili con carne, chili con carne with beans8 percent individually or collectively with other binders.......do......doSpaghetti with meatballs and sauce, spaghetti with meat and sauce and similar products12 percent individually or collectively with other binders.CarrageenanTo extend and stabilize productBreading mix; saucesSufficient for purpose in accordance with 21 CFR 172.5.Carboxymethyl cellulose (cellulose gum)......doBaked piesDo.CerealTo bind and extend productSausages as provided in part 319, bockwurst3.5 percent individually or collectively with other binders.......do......doChili con carne, chili con carne with beans8 percent individually or collectively with other binders.Dried milk......doSausage as provided in part 3193.5 percent individually or collectively with other binders.......do......doChili con carne, chili con carne with beans8 percent individually or collectively with other binders.Enzyme (rennet) treated calcium reduced dried skim milk and calcium lactateTo bind and extend productSausages as provided in part 3193.5 percent total finished product. (Calcium lactate required at rate of 10 percent of binder).......do......doImitation sausages, nonspecific loaves, soups, stewsSufficient for purpose in accordance with 21 CFR 172.5 (Calcium lactate required at rate of 10 percent of binder).Enzyme (rennet) treated sodium caseinate and calcium lactate......doImitation sausages, nonspecific loaves, soups, stewsSufficient for purpose in accordance with 21 CFR 172.5. (Calcium lactate required at rate of 25 percent of binder).Gums, vegetable......doEgg rollSufficient for purpose in accordance with 21 CFR 172.5.Methyl celluloseTo extend and to stabilize product (also carrier)Meat and vegetable patties0.15 percent.Isolated soy proteinTo bind and extend productSausage as provided in Part 319, bockwurst2 percent.......do......doImitation sausages, nonspecific loaves, soups, stewsSufficient for purpose in accordance with 21 CFR 172.5.......do......doChili con carne, chili con carne with beans8 percent individually or collectively with other binders.......do......doSpaghetti with meatballs and sauce, spaghetti with meat and sauce and similar products12 percent individually or collectively with other binders and extenders.Sodium caseinate......doImitation sausages, nonspecific loaves, soups, stewsSufficient for purpose in accordance with 21 CFR 182.1748 and 21 CFR 172.5.......do......doSausage as provided in Part 319.2 percent in accordance with 21 CFR 182.1748.......do......doChili con carne, chili con carne with beans8 percent individually or collectively with other binders and extenders in accordance with 21 CFR 182.1748.......do......doSpaghetti with meatballs and sauce, spaghetti with meat and sauce and similar products12 percent individually or collectively with other binders and extenders in accordance with 21 CFR 182.1748.Dry or dried wheyTo bind or thickenSausage as provided in Part 319, bockwurst3.5 percent individually or collectively with other binders and extenders.Reduced lactose whey......do......doDo.Reduced minerals whey......do......doDo.Whey protein concentrate......do......doDo. In accordance with 21 CFR 184.1979c.Dry or dried whey......doImitation sausages, nonspecific loaves, soups, stewsSufficient for purpose in accordance with 21 CFR 172.5.Reduced lactose whey......do......doDo.Reduced minerals whey......do......doDo.Whey protein concentrate......do......doDo. In accordance with 21 CFR 184.1979c.Dry or dried whey......doChili con carne, chili con carne with beans, pork or beef with barbecue sauce8 percent individually or collectively with other binders and extenders.Reduced lactose whey......do......doDo.Reduced minerals whey......do......doDo.Whey protein concentrate......do......doDo. In accordance with 21 CFR 184.1979c.......doTo bind meat piecesRestructured meat food products, whole muscle meat cuts3.5 percent individually or collectively with other binders and extenders. In accordance with 21 CFR 184.1979c.Soy flourTo bind and extend productSausage as provided in Part 319, bockwurst3.5 percent individually or collectively with other binders and extenders.Soy protein concentrate......do......doDo.Starchy vegetable flour......do......doDo.Vegetable starch......do......doDo.Wheat gluten......do......doDo. In accordance with 21 CFR 184.1322.Tapioca dextrin......do......doDo. In accordance with 21 CFR 184.1277.Soy flour......doChili con carne, chili con carne with beans8 percent individually or collectively with other binders and extenders.Soy protein concentrate......do......doDo.Starchy vegetable flour......do......doDo.Vegetable starch......do......doDo.Wheat gluten......do......doDo. In accordance with 21 CFR 184.1322.Tapioca dextrin......do......doDo. In accordance with 21 CFR 184.1277.Soy flour......doSpaghetti with meatballs and sauce, spaghetti with meat and sauce and similar products12 percent individually or collectively with other binders and extenders.Soy protein concentrate......do......doDo.Wheat gluten......do......doDo. In accordance with 21 CFR 184.1322.Tapioca dextrin......do......doDo. In accordance with 21 CFR 184.1277.Xanthan gumTo 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.Carrageenan To prevent purging of brine solution Cured pork products as provided in 9 CFR 319.104 Not to exceed 1.5 percent of product formulation; not permitted in combination with other binders approved for use in cured pork products; in accordance with 21 CFR 172.620, 172.623, and 172.626.Food starch modified ......do ......do 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 172.892.Sodium caseinate ......do ......do 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.Isolated soy protein ......do ......do Not to exceed 2 percent of product formulation; not permitted in combination with other binders approved for use in cured pork products.Carrageenan, Locust bean gum, and Xanthan gum blend.To prevent purging of solution.Cured pork products as provided in 9 CFR 319.104(d).In combination, not to exceed 0.5 percent of product 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.Bleaching agentHydrogen peroxideTo remove colorTripe (substance must be removed from product by rinsing with clear water)Catalysts (substances must be eliminated during process)NickelTo accelerate chemical reactionRendered animal fats or a combination of such fats and vegetable fatsDo.Sodium amideRearrangement of fatty acid radicals......doDo.Sodium methoxide......do......doDo.Coloring agents (natural)Alkanet, annatto, carotene cochineal, green chlorophyl, saffron and tumericTo color casings or rendered fats; marking and branding productSausage casings, oleomargarine, shortening, marking or branding ink on productSufficient for purpose (may be mixed with approved artificial dyes or harmless inert material such as common salt and sugar).Coloring agents (artificial)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)......do......doSufficient for purpose (may be mixed with approved natural coloring matters or harmless inert material such as common salt or sugar).Titanium dioxide......doCanned ham salad spread and creamed type canned products0.5 percent.Curing accelerators’ must be used only in combination with curing agentsAscorbic acidTo accelerate color fixing or preserve color during storageCured pork and beef cuts, cured comminuted meat food product75 oz to 100 gal pickle at 10 percent pump level; 3/4 oz to 100 lb meat or meat byproduct; 10 percent solution to surfaces of cured cuts prior to packaging. (The use of such solution shall not result in the addition of a significant amount of moisture to the product.)Erythorbic acid......do......doDo.Fumaric acidTo accelerate color fixingCured, comminuted meat or meat food products0.065 percent (or 1 oz to 100 lb) of the weight of the meat or meat byproducts, before processing.Glucone delta lactoneTo accelerate color fixingCured, comminuted meat or meat food product8 oz to each 100 lb of meat or meat byproduct.Genoa salami16 oz to 100 lb of meat (1.0 percent).Sodium acid pyrophosphate......doFrankfurters, wieners, vienna, bologna, garlic bologna, knockwurst, and similar productsNot to exceed, alone or in combination with other curing accelerators, the following: 8 oz in 100 lb of the meat, or meat and meat byproducts, content of the formula; nor 0.5 percent in the finished product.Sodium ascorbateTo accelerate color fixing or preserve color during storageCured pork and beef cuts, cured comminuted meat food product87.5 oz to 100 gal pickle at 10 percent pump level; 7/8 oz to 100 lb meat or meat byproduct; 10 percent solution to surfaces of cured cuts 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......do......doDo.Citric acid or sodium citrate......do......doMay be used in cured products or in 10 percent solution used to spray surfaces of cured cuts prior to packaging to replace up to 50 percent of the ascorbic acid, erythorbic acid, sodium ascorbate, or sodium erythorbate that is used.Curing agentsSodium or potassium nitrateSource of nitriteCured products other than bacon. Nitrates may not be used in baby, junior, and toddler foods7 lb to 100 gal pickle; 31/2 oz to 100 lb meat (dry cure); 23/4 oz to 100 lb chopped meat.Sodium or potassium nitrite. (Supplies of sodium nitrite and potassium nitrite and mixtures containing them must be kept securely 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 colorCured products. Nitrites may not be used in baby, junior, or toddler foods2 lb to 100 gal pickle at 10 percent pump level; 1 oz to 100 lb meat (dry cure); 1/4 oz to 100 lb chopped meat and/or meat byproduct. The use of nitrites, nitrates, or combination shall not result in more than 200 parts per million 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) Sodium carbonate

Sodium Citrate

Sodium gluconate

Sodium hydroxide

Sodium persulfate

Sodium silicates (ortho, meta, and sesqui)

Trisodium phosphate

To denude mucous membranes

......do

Tripe

......do

Sufficient for purpose.

Do.

Emulsifying agentsAcetylated monoglyceridesTo emulsify productShorteningDo.Diacetyl tartaric acid esters of mono- and diglycerides......doRendered animal fat or a combination of such fat with vegetable fatDo.Glycerol-lacto stearate, oleate, or palmitate......do......doDo.LecithinTo emulsify product (also as an Antioxidant)Oleomargarine, shortening, various meat food products0.5 percent in oleomargarine; use in other products—sufficient amount for emulsification.Mono and diglycerides (glycerol palmitate, etc.)To emulsify productRendered animal fat or a combination of such fat with vegetable fat; oleomargarineSufficient for purpose in lard and shortening; 0.5 percent in oleomargarine.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......doMargarine or oleomargarine0.5 percent.Polygylcerol esters of fatty acids (polygylcerol 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)......doRendered animal fat or a combination of such fat with vegetable fat when use is not precluded by standards of identity or composition; oleomargaineSufficient for purpose for rendered animal fat or combination with vegetable fat; 0.5 percent for oleomargarine.1,2-propylene glycol esters of fatty acids......doMargarine or oleomargarine2.0 percent.Polysorbate 80 (polyoxyethylene (20) sorbitan monooleate)......doShortening for use in nonstandardized baked goods, baking mixes, icings, fillings, and toppings and in the frying of foods1 percent when used alone. If used with polysorbate 60 the combined total shall not exceed 1 percent.Propylene glycol mono and diesters of fats and fatty acids......doRendered animal fat or a combination of such fat with vegetable fatSufficient for purpose.Polysorbate 60 (polyoxyethylene (20) sorbitan monostearate)......doShortening for use in nonstandardized baked goods, baking mixes, icings, fillings, and toppings and in the frying of foods1 percent when used alone. If used with polysorbate 80 the combined total shall not exceed 1 percent.Stearyl-2-lactylic acid......doShortening to be used for cake icings and fillings3.0 percent.Stearyl monoglyceridyl citrate......doShorteningSufficient 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% of hot carcass weight when applied. Chilled weight may not exceed hot weight.Flavoring agents; protectors and developersArtificial smoke flavoringTo flavor productVarious 2Do.Smoke flavoring......do......doDo.Autolyzed yeast extract......do......doDo.Harmless bacteria starters of the acidophilus type, lactic acid starter or culture of Pediococcus cerevisiaeTo develop flavorDry sausage, pork roll, thuringer, lebanon bologna, cervelat, and salami0.5 percent.Harmless lactic acid producing bacteria To prevent growth of Clostridium botulinumBacon Sufficient for purpose.Benzoic acid (sodium, potassium and calcium salts)To retard flavor reversionMargarine or oleomargarine0.1 percent individually, or if used in combination 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 non-specific meat food sticks 0.6 percent in product formulation.Citric acidFlavoringChili con carneSufficient for purpose.Corn syrup solids, corn syrup, glucose syrupTo flavorSausage, hamburger, meat loaf, luncheon meat, chopped or pressed hamSufficient for purpose.DextroseTo flavor productSausage, ham and cured productsSufficient for purpose.Diacetyl......doOleomargarineDo.Disodium guanylate......doVarious 2Do.Disodium inosinate......do......doDo.Hydrolyzed plant protein......do......doDo.Isopropyl citrateTo protect flavorOleomargarine0.02 percent.Malt syrupTo flavor productCured products2.5 percent.Milk protein hydrolysate......doVarious 2Sufficient for purpose.Monosodium glutamate......do......doDo.Monoammonium glutamate......do......doDo.Sodium sulfoacetate derivative of mono and diglycerides......do......do0.5 percent.Sodium tripoly-phosphateTo 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 processing0.5 percent of total product.Mixtures of sodium tripolyphosphate and sodium metaphosphate, insoluble; and sodium polyphosphates, glassy......do......doDo.SorbitolTo flavor, to facilitate the removal of casings from product, and to reduce carmelization and charringCooked sausage labeled frankfurter, frank, furter, wiener, and knockwurst; cured pork and pork products, as provided in part 319 of this subchapterNot 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 distillateTo help protect flavorOleomargarineSufficient for purpose.Stearyl citrateTo protect flavor......do0.15 percent.Sugars (sucrose and dextrose)To flavor productVarious 2Sufficient for purpose.Potassium lactate To flavor product Various meat and meat food products, except infant formula and infant food.2Not to exceed 2 percent of formulation; in accordance with 21 CFR 184.1639.Sodium lactate ......do ......do Not to exceed 2 percent of formulation; in accordance with 21 CFR 184.1768.Sodium acetateTo flavor productsVariousNot to exceed 0.12 percent of formulate in accordanceSodium diacetate......do......doNot to exceed 0.1 percent of formulate in accordance with 21 CFR 184.1754GasesCarbon dioxide solid (dry ice)To cool productChopping of meat, packaging of productDo.Liquid nitrogenContact freezeVariousSufficient for purposeNitrogenTo exclude oxygenSealed containerDo.Hog scald agents; must be removed by subsequent cleaning operations Caustic soda

Dimethylpolysiloxane

Dioctyl sodium sulfosuccinate

Disodium-calcium ethylenediamine-tetraacetate

To remove hair

......do

Hog carcasses

......do

Do.

Disodium phosphate ......do ......do Do.Ethylenediamine-tetraacetic acid (sodium salts) ......do ......do Do.Lime (calcium oxide, calcium hydroxide) ......do ......do Do.Potassium hydroxide ......do ......do 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 Ascorbic acid, erythorbic acid, citric acid, sodium ascorbate and sodium citrate, singly or in combination under quality control 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).d- and dl-alphatocopherolTo inhibit nitrosamine formationPump-cured bacon500 ppm; by injection or surface application.Potassium sorbateTo retard mold growthDry sausage10 percent in water solution may be applied to casings after stuffing or casings may be dipped in a 10 percent water solution prior to stuffing.Silicon dioxideProcessing aid/dispersantTocopherol-containing bacon curing premixesAt level not to exceed 4.0 percent in the dry mix.Sorbic acid (sodium, potassium, and calcium salts)To preserve product and to retard mold growthMargarine or oleomargarine0.1 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).Calcium disodium, EDTA (calcium disodium ethylene-diaminetetraacetate) To preserve product and to protect flavor......do75 parts per million by weight of the finished oleomargarine or margarine.Propyl paraben (propyl p-hydroxybenzoate)To retard mold growthDry sausage3.5 percent in water solution may be applied to casings after stuffing, or casings may be dipped in solution prior to stuffing.Sodium bicarbonateTo neutralize excess acidity, cleaning vegetablesRendered fats, soups, curing pickleSufficient for purpose.Calcium propionateTo retard mold growthPizza crust0.32 percent alone or in combination based on weight of the flour brace used.Sodium propionate......do......doDo.Sodium hydroxideTo decrease the amount of cooked out juicesMeat food products containing phosphatesMay 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.Disodium phosphate......doMeat food products except where otherwise prohibited by the Federal meat inspection regulations5 percent of phosphate in pickle at 10 percent pump level; 0.5 percent of phosphate in product (only clear solution may be injected into product).Monosodium phosphate......do......doDo.Sodium metaphosphate, insoluble......do......doDo.Sodium polyphosphate, glassy......do......doDo.Sodium tripolyphosphate......do......doDo.Sodium pyrophosphate......do......doDo.Sodium acid pyrophosphate......do......doDo.Dipotassium phosphate......do......doDo.Monopotassium phosphate......do......doDo.Potassium tripolyphosphate......do......doDo.Potassium pyrophosphate......do......doDo.Citric acid (sodium and potassium salts)To acidifyMargarine or oleomargarineSufficient for purpose.Lactic acid (sodium and potassium salts)......do......doDo.L-Tartaric acid (sodium and sodium potassium salts)......do......doDo.Adipic acid......do......doDo.Phosphoric acid......do......doDo.Hydrochloric acid......do......doDo.Sodium bicarbonate To alkalize......doDo.Sodium carbonate......do......doDo.Sodium hydroxide......do......doDo.Potassium carbonate......do......doDo.Potassium bicarbonate......do......doDo.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 182.1033. (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 the product.)Sodium citrate buffered with citric acid to a pH of 5.6To inhibit the growth of micro-organisms and retain product flavor during storageCured and uncured, processed whole-muscle meat food products, e.g., hamNot to exceed 1.3 percent of the formulation weight of the product in accordance with 21 CFR 184.1751.GlycerineHumecantShelf stable (Can Be stored at room temperature) meat snacks.Not to exceed 2 percent of the formulation weight of the product in accordance with 21 CFR 182.1320Proteolytic enzymesAspergillus oryzaeTo soften tissuesRaw meat cutsSolutions consisting of water and approved proteolytic enzymes applied or injected into raw meat cuts shall not result in a gain of more than 3 percent above the weight of the untreated product.Aspergillus flavusoryzae group......do......doDo.Bromelin......do......doDo.Ficin......do......doDo.Papain......do......doDo.Refining agents (must be eliminated during process of manufacturing)Acetic acidTo separate fatty acids and glycerolRendered fatsSufficient for purpose.Bicarbonate of soda......do......doDo.Carbon (purified charcoal)To aid in refining of animal fats......doDo.Caustic soda (sodium hydroxide)To refine fats......doDo.Diatomaceous earth; Fuller's earth......do......doDo.Sodium carbonate......do......doDo.Tannic acid......do......doDo.Rendering agentsTricalcium phosphateTo aid renderingAnimal fatsDo.Trisodium phosphate......do......doDo.Sources of radiationIonizing radiation limited to gamma rays from cobalt-60 or cesium-137To control Trichinella spiralisPork carcasses, or fresh or previously frozen cuts of pork carcasses that have not been cured or heat-processedMinimum absorbed dose of 0.3 kiloGray (30 kilorads) to a maximum absorbed dose of 1 kiloGray (100 kilorads).Artificial sweetnersSaccharinTo sweeten productBacon0.01 percent.Synergists (used in combination with antioxidants)Citric acidTo increase effectiveness of antioxidantsAny product permitted to contain antioxidants as provided in this partNot to exceed 0.01 percent based on fat content.Malic acid......doLard and shortening0.01 percent based on total weight in combination with antioxidants.Monoisopropyl citrate......doLard, shortening, oleomargarine, fresh pork sausage, dried meats0.02 percent.Phosphoric acid......doLard and shortening0.01 percent.Monoglyceride citrate......doLard, shortening, fresh pork sausage, dried meats0.02 percent.Tenderizing agentsAspergillus oryzaeTo soften tissueRaw meat cutsSolutions consisting of water and approved proteolytic enzymes applied or injected into raw meat cuts shall not result in a gain of more than 3 percent above the weight of the untreated product.Aspergillus flavus oryzae group ......do......doDo.Bromelin ......do......doDo.Ficin ......do......doDo.Papain ......do......doDo.Potassium chloride......do......doNot more than 3 percent of a 2.0 molar solution.Magnesium chloride......do......doNot more than 3 percent of a 0.8 molar solution.Calcium chloride......do......doNot more than 3 percent of a 0.8 molar solution.Potassium, magnesium or calcium chloride......do......doA solution of approved inorganic chlorides injected into or applied to raw meat 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 substance is approved may be obtained upon inquiry addressed to the Standards and Labeling Division, Meat and Poultry Inspection Technical Services, 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 § 317.4.

(d) No substance may be used in or on any product if it conceals damage or inferiority or makes the product appear to be better or of greater value than it is. Therefore:

(1) Paprika or oleoresin paprika may not be used in or on fresh meat, such as steaks, or comminuted fresh meat food products, such as chopped and formed steaks or patties; or in any other meat food products consisting of fresh meat (with or without seasoning), except chorizo sausage, and except other meat food products in which paprika or oleoresin paprika is permitted as an ingredient in a standard of identity or composition in part 319 of this subchapter.

(2) Sorbic acid, calcium sorbate, sodium sorbate, and other salts of sorbic acid may not be used in cooked sausage or any other product; sulfurous acid and salts of sulfurous acid may not be used in or on any product and niacin or nicotinamide may not be used in or on fresh product; except that potassium sorbate, propylparaben (propyl p-hydroxybenzoate), calcium propionate, sodium propionate, benzoic acid, and sodium benzoate may be used in or on any product only as provided in the chart in § 318.7(c)(4) or as approved by the Administrator in specific cases.

(Approved by the Office of Management and Budget under control number 0583-008)

                    
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