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Safety and Inspection Serv. (, ), USDA § 318.7

(3) Hog and casings intended (other than shell eggs) which have not for use as containers of product may be been so inspected and passed for whole- treated by soaking in or applying someness shall not be used in the prep- thereto sound, fresh pineapple or aration of such meat food products. papain or bromelin or pancreatic ex- (10) Dry products which are in- tract to permit the contained tended for use as ingredients of meat in these substances to act on the cas- food products shall be considered ac- ings to make them less resistant. The ceptable for such use only when pro- casings shall be handled in a clean and duced in a plant approved by the De- sanitary manner throughout and the partment under the regulations in 7 treatment shall be followed by washing CFR part 58, and when found to be and flushing the casings with sound and otherwise acceptable when sufficiently to effectively remove the presented for use. Dry milk products substance used and terminate the enzy- prepared in a plant not so approved matic action. shall not be used in the preparation of (4) On account of the invariable pres- such meat food products. ence of bone splinters, detached spinal (11) [Reserved] cords shall not be used in the prepara- (12) Ingredients for use in any prod- tion of edible product other than for uct may not bear or contain any pes- rendering where they constitute a suit- ticide chemical or other residues in ex- able raw material. cess of level permitted in § 318.16. (5) Testicles if handled as an edible (13) Use of ‘‘Mechanically Separated product may be shipped from the offi- (Kind of Poultry),’’ as defined in cial establishment as such, but they § 381.173 of this chapter, in the prepara- shall not be used as an ingredient of a tion of meat food products shall accord meat food product. with § 381.174 and all other applicable (6) Tonsils shall be removed and shall provisions of this subchapter. not be used as ingredients of meat food products. [35 FR 15586, Oct. 3, 1970, as amended at 38 FR (7) Blood from prepared in 14368, June 1, 1973; 38 FR 29214, Oct. 23, 1973; accordance with § 310.20 of this sub- 39 FR 1973, Jan. 16, 1974; 41 FR 23702, June 11, chapter may be used as an ingredient 1976; 49 FR 19623, May 9, 1984; 50 FR 6, Jan. 2, 1985; 60 FR 55982, Nov. 3, 1995] of a meat food product for which a standard is prescribed in part 319 of § 318.7 Approval of substances for use this subchapter, if permitted by such in the preparation of products. standard, and may be used in any meat food product for which no such stand- (a)(1) No substance may be used in ard is prescribed in part 319 of this sub- the preparation of any product unless chapter if it is a common and usual in- it is approved in paragraph (c)(4) of this gredient of such product. section or elsewhere in part 318 or in (8) Intestines shall not be used as in- part 319 of this subchapter, or by the gredients in any meat food product for Administrator in specific cases. which a standard is prescribed in part (2) Approval of new substances or 319 of this subchapter and shall not be new uses or new levels of use of ap- used in other products unless the prod- proved substances may be granted by ucts are labeled in accordance with the Administrator if: § 317.8(b)(3) of this subchapter. (i) The substance has been previously (9) Poultry products and egg products approved by the Food and Drug Admin- (other than shell eggs) which are in- istration (FDA) for use in meat or tended for use as ingredients of meat meat food products as a , food products shall be considered ac- color additive, or as a substance gen- ceptable for such use only when identi- erally recognized as safe and is listed fied as having been inspected and in title 21 of the Code of Federal Regu- passed for wholesomeness by the De- lations, parts 73, 74, 81, 172, 173, 179, 182 partment under the regulations in 7 or 184. CFR part 59 or 9 CFR part 362 or 381 (ii) Its use is in compliance with ap- and when found to be sound and other- plicable FDA requirements; and wise acceptable when presented for use. (iii) The Administrator has deter- Poultry products and egg products mined that:

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(A) The use of the substance will not spectrometry before being considered render the product in which it is used positive. If, during the interval re- adulterated or misbranded or otherwise quired for the Department to analyze not in compliance with the require- the confirmatory samples by gas ments of the Act; and chromotography and mass spectrom- (B) Its use is functional and suitable etry, changes are made in processing for the product and it is permitted for procedures which are expected to result use at the lowest level necessary to ac- in no confirmable levels of complish the stated technical effect as in pumped pro- determined in specific cases. duced by these new procedures, an es- (3) Whenever the Administrator de- tablishment may submit samples to termines that approval of a new sub- USDA for analysis upon prior notifica- stance or new use or new level of use of tion and arrangements with USDA. If, an approved substance should be grant- however, an establishment furnishes ed in accordance with paragraph (a)(2) USDA with laboratory results from of this section, the Administrator shall testing five consecutive lots of pumped issue a final rule amending the chart of bacon produced under the new proce- substances in paragraph (c)(4) of this dures and the testing is performed by section to include the additional sub- the USDA methodology and proce- stance or new use of the substance, and dures, those results will be utilized in any technical effect or change in level making the determination concerning of use of the substance. the product produced under the new (4) No product shall bear or contain procedures. Should the results of these any substance which would render it tests reveal that confirmable levels of adulterated or misbranded, or which is nitorosamines are not indicated in any not approved in part 318 or part 319 of of the five consecutive lots, the con- this subchapter, or by the Adminis- firmation analysis by USDA shall be trator in specific cases. terminated and the establishment shall (b) Requirements for the use of ni- revert to normal monitoring status. In trite and ascorbate or sodium the event the test results continue to erythorbate (isoascorbate) in bacon. indicate nitrosamines, however, USDA shall not be used in curing shall proceed in its confirmation anal- bacon. ysis on the original samples taken for (1) Pumped bacon. With respect to confirmation. If any one of the original bacon injected with curing ingredients samples collected by USDA for con- and massaged bacon: sodium firmation if found to contain confirm- shall be used at 120 parts per million able levels of nitrosamines, all pumped (PPM) ingoing or an equivalent bacon in the producing establishment amount of shall be and all future production will be re- used (148 PPM ingoing); and 550 PPM of tained. The Department shall sample sodium ascorbate or sodium and analyze such retained pumped erythorbate (isoascorbate) shall be bacon for nitrosamines on a lot by lot used. Sodium ascorbate or sodium basis. A production lot shall be that erythorbate have a molecular weight of pumped bacon produced by the estab- approximately 198. Hydrated forms of lishment in any single shift. Samples these substances shall be adjusted to from any lot of pumped bacon under re- attain the equivalent of 550 PPM of so- tention found to contain nitrosamines dium ascorbate or . at a confirmable level shall cause the (2) The Department shall collect lot of pumped bacon to be disposed of samples of pumped bacon from produc- in a manner to assure it will not form ing plants and analyze them for the nitrosamines when cooked. Such dis- level of nitrosamines by the Thermal posal may include incorporation of the Energy Analyzer (TEA). In the event uncooked pumped bacon as an ingredi- that a TEA analysis indicates that a ent of another meat food product pro- confirmable level of nitrosamines vided it is processed for eating without might be present, additional samples further preparation in a manner to pre- shall be collected and analyzed by gas clude the formation of nitrosamines. chromatography. Presumptive positive Bacon subsequently produced shall not results must be confirmed by mass be retained because of nitrosamines if

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the operator of the establishment (4) The Department shall collect makesadjustments in the processing of samples of bacon from plants producing the product and laboratory results ob- under paragraph (b)(3) of this section tained by TEA analysis of samples and analyze them for the level of from five consecutive normal sized lots nitrosamines. Samples shall be ran- of pumped bacon indicates that the domly selected throughout the produc- product being produced contains no tion of a lot. The actual sampling plans confirmable levels of nitrosamines. and methods of analysis that are used These tests from five consecutive nor- will result in approximately the same mal sized lots of pumped bacon shall be likelihood as under paragraph (b)(2) of conducted by the Department: Pro- this section of having a presumptive vided, however, That if the establish- positive result when the true mean ment furnishes the Department with level of nitrosamines in a production the results of tests conducted under lot is 10 ppb. In the event of a presump- the methodology and procedures used tive positive result, the plant shall be- by the Department, such test results come subject to the provisions of para- will be utilized in making the deter- graph (b)(2) of this section. mination concerning the (5) Immersion cured bacon. Immersion content of the product. All tests of cured bacon may be placed in a pumped bacon for nitrosamines under solution containing , nitrite and this subparagraph shall be made on flavoring material or in a container pumped bacon cooked 340 °F. for 3 min- with salt, nitrite and flavoring mate- utes on each side. In order to deter- rial. shall not exceed mine that no confirmable levels of 120 ppm ingoing or an equivalent nitrosamines are present in a sample amount of potassium nitrite (148 ppm tested, the testing must be performed ingoing) based on the actual or esti- by methodology and procedures that mated skin-free green weight of the would detect the presence of any bacon bellies. nitrosamines at 10 PPB. (6) Bacon made with dry curing mate- (3) Notwithstanding the provisions of rials. With respect to bacon made with paragraph (b)(1) of this section, sodium dry curing materials, the product shall nitrite may be used at: be cured by applying a premeasured (i) 100 ppm ingoing (potassium nitrite amount of cure mixture to the bacon at 123 ppm ingoing); and 500 ppm so- belly surfaces, completely covering the dium ascorbate or sodium erythorbate surfaces. Sodium nitrite shall not ex- (isoascorbate) shall be used; provided ceed 200 ppm ingoing or an equivalent that the establishment has a partial amount of potassium nitrite (246 ppm quality control program as provided in ingoing) in dry cured bacon based on § 318.4(d) that results in compliance the actual or estimated skin-free green with this provision, or weight of the bacon belly. (ii) A predetermined level between 40 (c) Under appropriate declaration as and 80 ppm (potassium nitrite at a required in parts 316 and 317 of this sub- level between 49 and 99 ppm); 550 ppm chapter, the following substances may sodium ascorbate or sodium be added to products: erythorbate (isoascorbate); and addi- (1) Common salt, approved tional or other similar fer- (sucrose, cane or beet ), mentable at a minimum sugar, dextrose, invert sugar, , of 0.7 percent and an inoculum of lactic solids, (corn syrup, glucose acid producing such as syrup and fructose), , vin- Pediococcus acetolactii or other bacteria egar, flavorings, , sodium , demonstrated to be equally effective in sodium nitrite, , po- preventing the growth of botulinum tassium nitrite, and other substances at a level sufficient for the pur- specified in the chart in paragraph pose of preventing the growth of botu- (c)(4) of this section may be added to linum toxin; provided that the estab- products under conditions, if any, spec- lishment has a partial quality control ified in this part or in part 317 of this program as provided in § 318.4(d) that subchapter. results in compliance with this provi- (2) Other harmless artificial sion. flavorings may be added to products

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with the approval of the Administrator (4) The substances specified in the in specific cases. following chart are acceptable for use (3) Coloring matter and dyes other in the preparation of products, pro- than those specified in the chart in vided they are used for the purposes in- paragraph (c)(4) of this section may be dicated, within the limits of the applied to products, mixed with ren- amounts stated and under other condi- dered , applied to natural and artifi- tions specified in this part and part 317 cial casings, and applied to such cas- of this subchapter. In addition to the ings enclosing products, if approved by substances listed in the following the Administrator in specific cases. chart, part 319 of this subchapter speci- When any coloring matter or dye is ap- fies other substances that are accept- plied to casings, there shall be no pene- tration of coloring into the product. able in preparing specified products.

Class of substance Substance Purpose Products Amount

Acidifiers ...... ...... To adjust acidity ...... Various 2 ...... Sufficient for purpose.3 ...... do ...... do ...... Do. Glucono delta-lactone ...... do ...... do ...... Do. ...... do ...... do ...... Do. Phosphoric acid ...... do ...... do ...... Do. Tartaric acid ...... do ...... do ...... Do. Anti-coagulants ...... Citric acid ...... To prevent clotting .... Fresh blood of live- 0.2 percent with or without stock. water. When Water is used to make a solution of citric acid added to blood of live- stock, 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 agent .. Methyl polysilicone ...... To retard foaming ...... ...... 10 parts per million. Rendered ...... Do. Curing pickle ...... 50 parts per million.

Antioxidants and BHA (butylated hydroxy- To retard rancidity ..... Dry ...... 0.003 percent .006 percent intercep- anisole). based on in com- tors. total weight. bination. BHT (butylated hydroxy- ...... do ...... do ...... do ...... toluene). Propyl gallate ...... do ...... do ...... do ...... TBHQ (tertiary ...... do ...... do ...... do ...... 0.006 percent butylhydroquinone). in com- bination only with BHA and/or BHT. BHA (butylated hydroxy- ...... do ...... Rendered fat 0.01 percent 0.02 percent anisole). or a combination of in com- such fat and vege- bination. table fat. BHT (butylated hydroxy- ...... do ...... do ...... do ...... toluene). Glycine ...... do ...... do ...... do ...... Propyl gallate ...... do ...... do ...... do ...... Resin guaiac ...... do ...... do ...... do ...... TBHQ (tertiary ...... do ...... do ...... do ...... 0.02 percent butylhydroquinone). in com- bination only with BHA and/or BHT.

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Tocopherols ...... do ...... do ...... 0.03 percent. A 30 percent concentration of tocopherols in vegetable shall be used when added as an to products designated as ``'' or ``rendered fat.'' ...... do ...... Dry sausage, semidry Not to exceed 0.03 percent sausage, dried based on fat content. Not , uncooked or used in combination with cooked fresh sau- other . sage made with and/or pork, uncooked or cooked Italian sau- sage products, uncooked or cooked , uncooked or cooked meat toppings, brown and serve sausage, pregrilled beef pat- ties, and restruc- tured meats.

BHA (butylated hydroxy- ...... do ...... Fresh pork, sausage, 0.01 percent 0.02 percent anisole). brown and serve based on in com- , fresh fat content. bination based on products, pregrilled fat content. beef , fresh sausage made from beef or beef and pork, cooked or raw pizza topping and cooked or raw meatballs. BHT (butylated hydroxy- ...... do ...... do ...... do ...... toluene). Propyl gallate ...... do ...... do ...... do ...... TBHQ (tertiary ...... do ...... do ...... do ...... 0.02 percent butylhydroquinone). in com- bination only with BHA and/or BHT based on fat con- tent. BHA (butylated hydroxy- ...... do ...... Dried meats ...... 0.01 percent 0.01 percent anisole). based on in com- total weight. bination. BHT (butylated hydroxy- ...... do ...... do ...... do ...... toluene). Propyl gallate ...... do ...... do ...... do ...... TBHQ (tertiary ...... do ...... do ...... do ...... 0.01 percent butylhydroquinone). in com- bination only with BHA and/or BHT.

BHA (butylated hydroxy- ...... do ...... or oleo- 0.02 percent (by wt. of the anisole). margarine. finished product) individ- ually or in combination with other antioxidants approved for use in margarine. BHT (butylated ...... do ...... do ...... Do. hydroxytol-) uene). Octyl gallate ...... do ...... do ...... Do. Propyl gallate ...... do ...... do ...... Do. Dodecyl gallate ...... do ...... do ...... Do. Ascorbyl palmitate ...... do ...... do ...... Do. 245

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Ascorbyl stearate ...... do ...... do ...... Do. TBHQ (tertiary ...... do ...... do ...... 0.02 percent alone or in com- butylhydroqui- bination only with BHA and/ none). or BHT based on fat or content.

Class of substance Substance Purpose Products Amount

Binders and ex- Agar-agar ...... To stabilize and thick- Thermally processed 0.25 percent of finished prod- tenders. en. canned jellied meat uct. food products Algin ...... To extend and sta- Breading mix; sauces Sufficient for purpose in ac- bilize product cordance with 21 CFR 172.5. A mixture of sodium al- To bind meat pieces Restructured meat Sodium alginate not to ex- ginate, calcium car- food products. ceed 1.0 percent; calcium bonate and calcium carbonate not to exceed lactate/lactic acid (or 0.2 percent; and lactic acid/ glucono delta-lactone) calcium lactate (or glucono delta-lactone) not to ex- ceed 0.3 percent of product formulation. Added mixture may not exceed 1.5 per- cent of product at formula- tion. Ingredients of mixture must be added dry. ...... To bind and extend Bockwurst ...... 3.5 percent individually or col- product. lectively with other binders. Calcium reduced dried ...... do ...... Sausages as provided Do. skim milk. in part 319...... do ...... do ...... , chili 8 percent individually or col- con carne with lectively with other binders. beans...... do ...... do ...... with meat- 12 percent individually or col- balls and sauce, lectively with other binders. spaghetti with meat and sauce and similar products ...... To extend and sta- Breading mix; sauces Sufficient for purpose in ac- bilize product cordance with 21 CFR 172.5. Carboxymethyl ...... do ...... Baked pies ...... Do. (cellulose gum) Cereal ...... To bind and extend Sausages as provided 3.5 percent individually or col- product. in part 319, lectively with other binders. bockwurst ...... do ...... do ...... Chili con carne, chili 8 percent individually or col- con carne with lectively with other binders. beans Dried milk ...... do ...... Sausage as provided 3.5 percent individually or col- in part 319. lectively with other binders...... do ...... do ...... Chili con carne, chili 8 percent individually or col- con carne with lectively with other binders. beans (rennet) treated To bind and extend Sausages as provided 3.5 percent total finished calcium reduced dried product. in part 319. product. (Calcium lactate skim milk and calcium required at rate of 10 per- lactate cent of binder)...... do ...... do ...... Imitation sausages, Sufficient for purpose in ac- nonspecific loaves, cordance with 21 CFR soups, 172.5 (Calcium lactate re- quired at rate of 10 percent of binder). Enzyme (rennet) treated ...... do ...... Imitation sausages, Sufficient for purpose in ac- sodium caseinate and nonspecific loaves, cordance with 21 CFR calcium lactate soups, stews 172.5. (Calcium lactate re- quired at rate of 25 percent of binder). Gums, vegetable ...... do ...... Egg roll ...... Sufficient for purpose in ac- cordance with 21 CFR 172.5.

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Class of substance Substance Purpose Products Amount

Methyl cellulose ...... To extend and to sta- Meat and vegetable 0.15 percent. bilize product (also patties. carrier) Isolated soy ...... To bind and extend Sausage as provided 2 percent. product. in Part 319, bockwurst ...... do ...... do ...... Imitation sausages, Sufficient for purpose in ac- nonspecific loaves, cordance with 21 CFR soups, stews 172.5...... do ...... do ...... Chili con carne, chili 8 percent individually or col- con carne with lectively with other binders. beans ...... do ...... do ...... Spaghetti with meat- 12 percent individually or col- balls and sauce, lectively with other binders spaghetti with meat and extenders. and sauce and similar products Sodium caseinate ...... do ...... Imitation sausages, Sufficient for purpose in ac- nonspecific loaves, cordance with 21 CFR soups, stews 182.1748 and 21 CFR 172.5...... do ...... do ...... Sausage as provided 2 percent in accordance with in Part 319.. 21 CFR 182.1748...... do ...... do ...... Chili con carne, chili 8 percent individually or col- con carne with lectively with other binders beans and extenders in accord- ance with 21 CFR 182.1748...... do ...... do ...... Spaghetti with meat- 12 percent individually or col- balls and sauce, lectively with other binders spaghetti with meat and extenders in accord- and sauce and ance with 21 CFR similar products 182.1748. Dry or dried whey ...... To bind or thicken ..... Sausage as provided 3.5 percent individually or col- in Part 319, lectively with other binders bockwurst and extenders. Reduced lactose whey ...... do ...... do ...... Do. Reduced minerals whey ...... do ...... do ...... Do. Whey protein con- ...... do ...... do ...... Do. In accordance with 21 centrate. CFR 184.1979c. Dry or dried whey ...... do ...... Imitation sausages, Sufficient for purpose in ac- nonspecific loaves, cordance with 21 CFR soups, stews 172.5. Reduced lactose whey ...... do ...... do ...... Do. Reduced minerals whey ...... do ...... do ...... Do. Whey protein con- ...... do ...... do ...... Do. In accordance with 21 centrate. CFR 184.1979c. Dry or dried whey ...... do ...... Chili con carne, chili 8 percent individually or col- con carne with lectively with other binders beans, pork or beef and extenders. with sauce Reduced lactose whey ...... do ...... do ...... Do. Reduced minerals whey ...... do ...... do ...... Do. Whey protein con- ...... do ...... do ...... Do. In accordance with 21 centrate. CFR 184.1979c...... do ...... To bind meat pieces Restructured meat 3.5 percent individually or col- food products, lectively with other binders whole muscle meat and extenders. In accord- cuts ance with 21 CFR 184.1979c. Soy flour ...... To bind and extend Sausage as provided 3.5 percent individually or col- product. in Part 319, lectively with other binders bockwurst and extenders. Soy protein concentrate ...... do ...... do ...... Do. Starchy vegetable flour ...... do ...... do ...... Do. Vegetable starch ...... do ...... do ...... Do. ...... do ...... do ...... Do. In accordance with 21 CFR 184.1322. dextrin ...... do ...... do ...... Do. In accordance with 21 CFR 184.1277. Soy flour ...... do ...... Chili con carne, chili 8 percent individually or col- con carne with lectively with other binders beans and extenders.

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Class of substance Substance Purpose Products Amount

Soy protein concentrate ...... do ...... do ...... Do. Starchy vegetable flour ...... do ...... do ...... Do. Vegetable starch ...... do ...... do ...... Do. Wheat gluten ...... do ...... do ...... Do. In accordance with 21 CFR 184.1322. Tapioca dextrin ...... do ...... do ...... Do. In accordance with 21 CFR 184.1277. Soy flour ...... do ...... Spaghetti with meat- 12 percent individually or col- balls and sauce, lectively with other binders spaghetti with meat and extenders. and sauce and similar products Soy protein concentrate ...... do ...... do ...... Do. Wheat gluten ...... do ...... do ...... Do. In accordance with 21 CFR 184.1322. Tapioca dextrin ...... do ...... do ...... Do. In accordance with 21 CFR 184.1277. Xanthan gum ...... To maintain uniform Meat sauces, Sufficient for purpose in ac- viscosity; suspen- or sauces and cordance with 21 CFR sion of particulate meats, canned or 172.5. matter, frozen and/or refrig- stability; freeze- erated meat , thaw stability. canned or frozen meat stews, canned chili or chili with beans, pizza top- ping mixes and bat- ter or breading mixes. Carrageenan ...... To prevent purging of Cured pork products Not to exceed 1.5 percent of brine solution. as provided in 9 product formulation; not CFR 319.104. permitted in combination with other binders ap- proved for use in cured pork products; in accord- ance 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 ap- proved for use in cured pork products; in accord- ance with 21 CFR 172.892. Sodium caseinate ...... do ...... do ...... Not to exceed 2 percent of product formulation; not permitted in combination with other binders ap- proved for use in cured pork products; in accord- ance 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 ap- proved for use in cured pork products. Carrageenan, To prevent purging of Cured pork products In combination, not to exceed bean gum, and Xan- solution.. as provided in 9 0.5 percent of product for- than gum blend.. CFR 319.104(d).. mulation; not permitted in combination with other binders approved for use in cured pork products; in ac- cordance with 21 CFR 172.620, 172.623, 172.626, 184.1343, and 172.695. Bleaching agent ..... Hydrogen peroxide ...... To remove color ...... Tripe (substance must be removed from product by rinsing with clear water).

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Class of substance Substance Purpose Products Amount

Catalysts (sub- Nickel ...... To accelerate chemi- Rendered animal fats Do. stances must be cal reaction. or a combination of eliminated during such fats and vege- process). table fats. Sodium amide ...... Rearrangement of ...... do ...... Do. radicals. ...... do ...... do ...... Do. Coloring agents Alkanet, annatto, caro- To color casings or Sausage casings, ole- Sufficient for purpose (may (natural). tene , green rendered fats; omargarine, short- be mixed with approved ar- chlorophyl, saffron marking and brand- ening, marking or tificial dyes or harmless and tumeric. ing product. branding ink on inert material such as com- product. mon salt and sugar). Coloring agents (ar- Color additives listed in ...... do ...... do ...... Sufficient for purpose (may tificial). 21 CFR Part 74, Sub- be mixed with approved part A of Part 82, natural coloring matters or Subpart B (operator harmless inert material must furnish evidence such as common salt or to inspector in charge sugar). that color additive has been certified for use in connection with by the Food and Drug Administra- tion). Titanium dioxide ...... do ...... Canned 0.5 percent. spread and creamed type canned products. Curing accelerators' Ascorbic acid ...... To accelerate color Cured pork and beef 75 oz to 100 gal pickle at 10 must be used fixing or preserve cuts, cured percent pump level; 3¤4 oz only in combina- color during storage. comminuted meat to 100 lb meat or meat by- tion with curing food product. product; 10 percent solu- agents. tion to surfaces of cured cuts prior to packaging. (The use of such solution shall not result in the addi- tion of a significant amount of moisture to the product.) ...... do ...... do ...... Do. Fumaric acid ...... To accelerate color Cured, comminuted 0.065 percent (or 1 oz to 100 fixing. meat or meat food lb) of the weight of the products. meat or meat byproducts, before processing. Glucone delta lactone ... To accelerate color Cured, comminuted 8 oz to each 100 lb of meat fixing. meat or meat food or meat byproduct. product. Genoa ...... 16 oz to 100 lb of meat (1.0 percent). Sodium acid ...... do ...... Frankfurters, wieners, Not to exceed, alone or in pyrophosphate. vienna, bologna, combination with other cur- garlic bologna, ing accelerators, the follow- knockwurst, and ing: 8 oz in 100 lb of the similar products. meat, or meat and meat byproducts, content of the formula; nor 0.5 percent in the finished product. Sodium ascorbate ...... To accelerate color Cured pork and beef 87.5 oz to 100 gal pickle at fixing or preserve cuts, cured 10 percent pump level; 7¤8 color during storage. comminuted meat oz to 100 lb meat or meat food product. byproduct; 10 percent solu- tion to surfaces of cured cuts prior to packaging. (The use of such solution shall not result in the addi- tion of a significant amount of moisture to the product.) Sodium erythorbate ...... do ...... do ...... Do.

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Class of substance Substance Purpose Products Amount

Citric acid or sodium cit- ...... do ...... do ...... May be used in cured prod- rate. ucts or in 10 percent solu- tion used to spray surfaces of cured cuts prior to pack- aging to replace up to 50 percent of the ascorbic acid, erythorbic acid, so- dium ascorbate, or sodium erythorbate that is used. Curing agents ...... Sodium or potassium ni- Source of nitrite ...... Cured products other 7 lb to 100 gal pickle; 31¤2 oz trate. than bacon. Ni- to 100 lb meat (dry cure); trates may not be 23¤4 oz to 100 lb chopped used in baby, jun- meat. ior, and toddler foods. Sodium or potassium ni- To fix color ...... Cured products. 2 lb to 100 gal pickle at 10 trite. (Supplies of so- may not be percent pump level; 1 oz to dium nitrite and po- used in baby, jun- 100 lb meat (dry cure); 1¤4 tassium nitrite and ior, or toddler foods. oz to 100 lb chopped meat mixtures containing and/or meat byproduct. The them must be kept use of nitrites, nitrates, or securely under the combination shall not result care of a responsible in more than 200 parts per employee of the es- million of nitrite, calculated tablishment. The spe- as sodium nitrite, in fin- cific nitrite content of ished product. Except that such supplies must nitrites may be used in be known and clearly bacon only in accordance marked accordingly). with paragraph (b) of this section. Denuding agents; Lime (calcium oxide, To denude mucous Tripe ...... Sufficient for purpose. may be used in calcium hydroxide) membranes. combination. Sodium carbonate...... do ...... do. Do. Must be removed Sodium Citrate ...... do ...... do ...... Do. from tripe by rins- Sodium gluconate ...... do ...... do ...... Do. ing with potable ...... do ...... do ...... Do. water.. Sodium persulfate ...... do ...... do ...... Do. Sodium silicates (ortho, ...... do ...... do ...... Do. meta, and sesqui). Trisodium ...... do...... do. Do. Emulsifying agents Acetylated To emulsify product ... ...... Do. monoglycerides. Diacetyl tartaric acid ...... do ...... Rendered animal fat Do. of mono- and or a combination of diglycerides. such fat with vege- table fat. -lacto stearate, ...... do ...... do ...... Do. oleate, or palmitate. Lecithin ...... To emulsify product Oleomargarine, short- 0.5 percent in oleomargarine; (also as an Anti- ening, various meat use in other productsÐsuf- oxidant). food products. ficient amount for emulsi- fication. Mono and diglycerides To emulsify product ... Rendered animal fat Sufficient for purpose in lard (glycerol palmitate, or a combination of and shortening; 0.5 percent etc.). such fat with vege- in oleomargarine. table fat; oleo- margarine. Mono and diglycerides ...... do ...... Margarine or oleo- 0.5 percent. of fatty acids margarine. esterified with any of the following acids: acetic, acetyltartaric, citric, lactic, tartaric, and their sodium and calcium ; the so- dium sulfoacetate de- rivatives of these mono and diglycerides.

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Class of substance Substance Purpose Products Amount

Polygylcerol esters of ...... do ...... Rendered animal fat Sufficient for purpose for ren- fatty acids or a combination of dered animal fat or com- (polygylcerol esters of such fat with vege- bination with vegetable fat; fatty acids are re- table fat when use 0.5 percent for oleo- stricted to those up to is not precluded by margarine. and including the standards of iden- decaglycerol esters tity or composition; and otherwise meet- oleomargaine. ing the requirements of § 172.854(a) of the Food Additive Regula- tions). 1,2-propylene glycol ...... do ...... Margarine or oleo- 2.0 percent. esters of fatty acids. margarine. Polysorbate 80 ...... do ...... Shortening for use in 1 percent when used alone. If (polyoxyethylene (20) nonstandardized used with polysorbate 60 sorbitan monooleate). baked goods, bak- the combined total shall not ing mixes, icings, exceed 1 percent. fillings, and top- pings and in the fry- ing of foods. Propylene glycol mono ...... do ...... Rendered animal fat Sufficient for purpose. and diesters of fats or a combination of and fatty acids. such fat with vege- table fat. Polysorbate 60 ...... do ...... Shortening for use in 1 percent when used alone. If (polyoxyethylene (20) nonstandardized used with polysorbate 80 sorbitan monostea- baked goods, bak- the combined total shall not rate). ing mixes, icings, exceed 1 percent. fillings, and top- pings and in the fry- ing of foods. Stearyl-2-lactylic acid ...... do ...... Shortening to be used 3.0 percent. for cake icings and fillings. Stearyl monoglyceridyl ...... do ...... Shortening ...... Sufficient for purpose. citrate. Film forming agents A mixture consisting of To reduce cooler Freshly dressed meat Formulation may not exceed water, sodium algi- shrinkage and help carcasses. Such 1.5% of hot carcass weight nate, calcium chlo- protect surface. carcasses must when applied. Chilled ride, sodium bear a statement weight may not exceed hot carboxymethyl-cel- ``Protected with a weight. lulose, and corn syrup film of water, corn solids. syrup solids, so- dium alginate, cal- cium chloride and sodium carboxymethyl-cel- lulose. Flavoring agents; Artificial smoke flavoring To product ...... Various 2 ...... Do. protectors and developers. Smoke flavoring ...... do ...... do ...... Do. Autolyzed yeast extract ...... do ...... do ...... Do. Harmless bacteria start- To develop flavor ...... Dry sausage, pork 0.5 percent. ers of the acidophilus roll, thuringer, leb- type, lactic acid start- anon bologna, er or culture of , and salami. Pediococcus cerevisiae. Harmless lactic acid To prevent growth of Bacon ...... Sufficient for purpose. producing bacteria. Clostridium botu- linum. Benzoic acid (sodium, To retard flavor rever- Margarine or oleo- 0.1 percent individually, or if potassium and cal- sion. margarine. used in combination or with cium salts). and its salts, 0.2 percent (expressed as the acids in the wt. of the finished foods).

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Class of substance Substance Purpose Products Amount

Calcium lactate ...... To protect flavor ...... Cooked semi-dry and 0.6 percent in product formu- dry products includ- lation. ing sausage, imita- tion sausage, and non-specific meat food sticks. Citric acid ...... Flavoring ...... Chili con carne ...... Sufficient for purpose. Corn syrup solids, corn To flavor ...... Sausage, , Sufficient for purpose. syrup, glucose syrup. meat loaf, luncheon meat, chopped or pressed ham. Dextrose ...... To flavor product ...... Sausage, ham and Sufficient for purpose. cured products. Diacetyl ...... do ...... Oleomargarine ...... Do. Disodium guanylate ...... do ...... Various 2 ...... Do. Disodium inosinate ...... do ...... do ...... Do. Hydrolyzed plant protein ...... do ...... do ...... Do. Isopropyl citrate ...... To protect flavor ...... Oleomargarine ...... 0.02 percent. Malt syrup ...... To flavor product ...... Cured products ...... 2.5 percent. Milk protein hydrolysate ...... do ...... Various 2 ...... Sufficient for purpose. ...... do ...... do ...... Do. Monoammonium glu- ...... do ...... do ...... Do. tamate. Sodium sulfoacetate de- ...... do ...... do ...... 0.5 percent. rivative of mono and diglycerides. Sodium tripoly-phos- To help protect flavor ``Fresh Beef,'' 2 ``Beef 0.5 percent of total product. phate. for Further Cook- ing,'' ``Cooked Beef,'' Beef Patties, Meat Loaves, Meat Toppings, and simi- lar products derived from pork, lamb, , mutton, and which are cooked or fro- zen after process- ing. Mixtures of sodium ...... do ...... do ...... Do. tripolyphosphate and sodium metaphosphate, insol- uble; and sodium , glassy. Sorbitol ...... To flavor, to facilitate Cooked sausage la- Not to exceed 2 percent of the removal of cas- beled frankfurter, the weight of the formula, ings from product, frank, furter, wiener, excluding the formula and to reduce and knockwurst; weight of water or ice, carmelization and cured pork and when used in accordance charring. pork products, as with 21 CFR 184.1835. provided in part 319 of this subchapter. Starter distillate ...... To help protect flavor Oleomargarine ...... Sufficient for purpose. Stearyl citrate ...... To protect flavor ...... do ...... 0.15 percent. Sugars (sucrose and To flavor product ...... Various 2 ...... Sufficient for purpose. dextrose). Potassium lactate ...... To flavor product ...... Various meat and Not to exceed 2 percent of meat food products, formulation; in accordance except infant for- with 21 CFR 184.1639. mula and infant food.2 ...... do ...... do ...... Not to exceed 2 percent of formulation; in accordance with 21 CFR 184.1768. Sodium acetate ...... To flavor products ..... Various ...... Not to exceed 0.12 percent of formulate in accordance Sodium diacetate ...... do ...... do ...... Not to exceed 0.1 percent of formulate in accordance with 21 CFR 184.1754 Gases ...... solid To cool product ...... Chopping of meat, Do. (dry ice). packaging of prod- uct.

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Class of substance Substance Purpose Products Amount

Liquid ...... Contact freeze ...... Various ...... Sufficient for purpose Nitrogen ...... To exclude oxygen .... Sealed container ...... Do. Hog scald agents; Caustic soda ...... To remove hair ...... Hog carcasses ...... Do. must be removed Dimethylpolysiloxane ...... do ...... do ...... Do. by subsequent Dioctyl sodium sulfo- ...... do ...... do ...... Do. cleaning oper- succinate. ations. Disodium-calcium ethyl- ...... do...... do. Do. enediamine- tetraacetate. Disodium phosphate ...... do ...... do ...... Do. Ethylenediamine- ...... do ...... do ...... Do. tetraacetic acid (so- dium salts). Lime (calcium oxide, ...... do ...... do ...... Do. calcium hydroxide). Potassium hydroxide ...... do ...... do ...... Do. Propylene glycol ...... do ...... do ...... Do. Soap (prepared by the ...... do ...... do ...... Do. reaction of calcium, potassium, or sodium with rosin or fatty acids of natural fats and oils). Sodium acid ...... do ...... do ...... Do. pyrophosphate. Sodium carbonate ...... do ...... do ...... Do. Sodium dodecylbenzene ...... do ...... do ...... Do. sulfonate. Sodium gluconate ...... do ...... do ...... Do. Sodium ...... do ...... do ...... Do. hexametaphosphate. Sodium lauryl sulfate ...... do ...... do ...... Do. Sodium mono and ...... do ...... do ...... Do. dimethylnaphthalene sulfonate (molecular weight 245±260). Sodium n-alkylbenzene ...... do ...... do ...... Do. sulfonate (alkyl group predominantly C12 and C13 and not less than 95 percent C10 and C16. Sodium pyrophosphate ...... do ...... do ...... Do. Sodium silicates (ortho, ...... do ...... do ...... Do. meta, and sesqui). Sodium sulfate ...... do ...... do ...... Do. Sodium ...... do ...... do ...... Do. tripolyphosphate. Sucrose ...... do ...... do ...... Do. Triethanolamine ...... do ...... do ...... Do. dodecylbenzene sulfonate. Trisodium phosphate ...... do ...... do ...... Do. Miscellaneous ...... Ascorbic acid, erythorbic To delay discoloration Fresh beef cuts, fresh Not to exceed, singly or in acid, citric acid, so- lamb cuts, and combination, 500 ppm or dium ascorbate and fresh pork cuts. 1.8 mg/sq inch of product sodium citrate, singly surface of ascorbic acid (in or in combination accordance with 21 CFR under quality control. 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 prod- uct surface of citric acid (in accordance with 21 CFR 182.6033), or sodium cit- rate (in accordance with 21 CFR 182.6751). d- and dl- To inhibit nitrosamine Pump-cured bacon .... 500 ppm; by injection or sur- alphatocopherol. formation. face application.

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Class of substance Substance Purpose Products Amount

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 a 10 per- cent water solution prior to stuffing. Silicon dioxide ...... Processing aid/dis- Tocopherol-containing At level not to exceed 4.0 persant. bacon curing pre- percent in the dry mix. mixes. Sorbic acid (sodium, po- To preserve product Margarine or oleo- 0.1 percent individually, or if tassium, and calcium and to retard mold margarine. used in combination or with salts). growth. benzoic acid or its salts, 0.2 percent (expressed as the acids in the wt. of the finished foods). Calcium disodium, To preserve product ...... do ...... 75 parts per million by weight EDTA (calcium diso- and to protect flavor. of the finished oleo- dium ethylene- margarine or margarine. diaminetetraacetate). Propyl paraben (propyl To retard mold growth Dry sausage ...... 3.5 percent in water solution p-hydroxybenzoate). may be applied to casings after stuffing, or casings may be dipped in solution prior to stuffing. ...... To neutralize excess Rendered fats, soups, Sufficient for purpose. acidity, cleaning curing pickle. vegetables. Calcium propionate ...... To retard mold growth Pizza crust ...... 0.32 percent alone or in com- bination based on weight of the flour brace used. Sodium propionate ...... do ...... do ...... Do. Sodium hydroxide ...... To decrease the Meat food products May be used only in com- amount of cooked containing phos- bination with in out . phates. a ratio not to exceed one part sodium hydroxide to four parts phosphate; the combination shall not ex- ceed 5 percent in pickle at 10 percent pump level; 0.5 percent in product. Disodium phosphate ...... do ...... Meat food products 5 percent of phosphate in except where other- pickle at 10 percent pump wise prohibited by level; 0.5 percent of phos- the Federal meat phate in product (only clear inspection regula- solution may be injected tions. into product). Monosodium phosphate ...... do ...... do ...... Do. Sodium metaphosphate, ...... do ...... do ...... Do. insoluble. Sodium , ...... do ...... do ...... Do. glassy. Sodium ...... do ...... do ...... Do. tripolyphosphate. Sodium pyrophosphate ...... do ...... do ...... Do. Sodium acid ...... do ...... do ...... Do. pyrophosphate. Dipotassium phosphate ...... do ...... do ...... Do. Monopotassium phos- ...... do ...... do ...... Do. phate. Potassium ...... do ...... do ...... Do. tripolyphosphate. Potassium ...... do ...... do ...... Do. pyrophosphate. Citric acid (sodium and To acidify ...... Margarine or oleo- Sufficient for purpose. potassium salts). margarine. Lactic acid (sodium and ...... do ...... do ...... Do. potassium salts). L±Tartaric acid (sodium ...... do ...... do ...... Do. and sodium potas- sium salts). Adipic acid ...... do ...... do ...... Do. Phosphoric acid ...... do ...... do ...... Do. Hydrochloric acid ...... do ...... do ...... Do. Sodium bicarbonate ...... To alkalize ...... do ...... Do.

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Class of substance Substance Purpose Products Amount

Sodium carbonate ...... do ...... do ...... Do. Sodium hydroxide ...... do ...... do ...... Do. Potassium carbonate ...... do ...... do ...... Do. Potassium bicarbonate ...... do ...... do ...... Do. Citric acid ...... To preserve cured Cured pork cuts ...... Not to exceed 30 percent in color during storage. 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 ap- plied only once to the prod- uct.) Sodium citrate buffered To inhibit the growth Cured and uncured, Not to exceed 1.3 percent of with citric acid to a pH of micro-organisms processed whole- the formulation weight of of 5.6. and retain product muscle meat food the product in accordance flavor during stor- products, e.g., ham. with 21 CFR 184.1751. age. Glycerine ...... Humecant ...... Shelf stable (Can Be Not to exceed 2 percent of stored at room tem- the formulation weight of perature) meat the product in accordance .. with 21 CFR 182.1320 Proteolytic enzymes Aspergillus oryzae ...... To soften tissues ...... Raw meat cuts ...... Solutions consisting of water and approved proteolytic enzymes applied or in- jected into raw meat cuts shall not result in a gain of more than 3 percent above the weight of the untreated product. Aspergillus flavusoryzae ...... do ...... do ...... Do. group. Bromelin ...... do ...... do ...... Do. Ficin ...... do ...... do ...... Do. Papain ...... do ...... do ...... Do. Refining agents Acetic acid ...... To separate fatty Rendered fats ...... Sufficient for purpose. (must be elimi- acids and glycerol. nated during process of manu- facturing). Bicarbonate of soda ...... do ...... do ...... Do. Carbon (purified char- To aid in refining of ...... do ...... Do. coal). animal fats. Caustic soda (sodium To refine fats ...... do ...... Do. hydroxide). Diatomaceous ; ...... do ...... do ...... Do. Fuller's earth. 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. Sources of radiation Ionizing radiation limited To control Trichinella Pork carcasses, or Minimum absorbed dose of to gamma rays from spiralis. fresh or previously 0.3 kiloGray (30 kilorads) to -60 or cesium- frozen cuts of pork a maximum absorbed dose 137. carcasses that have of 1 kiloGray (100 kilorads). not been cured or heat-processed. Artificial sweetners ...... To sweeten product .. Bacon ...... 0.01 percent. Synergists (used in Citric acid ...... To increase effective- Any product permitted Not to exceed 0.01 percent combination with ness of antioxidants. to contain anti- based on fat content. antioxidants). oxidants as pro- vided in this part. Malic acid ...... do ...... Lard and shortening .. 0.01 percent based on total weight in combination with antioxidants. Monoisopropyl citrate ...... do ...... Lard, shortening, ole- 0.02 percent. omargarine, fresh pork sausage, dried meats. Phosphoric acid ...... do ...... Lard and shortening .. 0.01 percent.

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Class of substance Substance Purpose Products Amount

Monoglyceride citrate ...... do ...... Lard, shortening, 0.02 percent. fresh pork sausage, dried meats. Tenderizing agents Aspergillus oryzae ...... To soften tissue ...... Raw meat cuts ...... Solutions consisting of water and approved proteolytic enzymes applied or in- jected into raw meat cuts shall not result in a gain of more than 3 percent above the weight of the untreated product. Aspergillus flavus ...... do ...... do ...... Do. oryzae group. Bromelin ...... do ...... do ...... Do. Ficin ...... do ...... do ...... Do. Papain ...... do ...... do ...... Do. Potassium chloride ...... do ...... do ...... Not more than 3 percent of a 2.0 molar solution. Magnesium chloride ...... do ...... do ...... Not more than 3 percent of a 0.8 molar solution. Calcium chloride ...... do ...... do ...... Not more than 3 percent of a 0.8 molar solution. Potassium, magnesium ...... do ...... do ...... A solution of approved inor- or calcium chloride. ganic 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 , 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 ac- complish 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 sodium benzoate may be used in or on any product if it conceals damage or any product only as provided in the inferiority or makes the product ap- chart in § 318.7(c)(4) or as approved by pear to be better or of greater value the Administrator in specific cases. than it is. Therefore: (Approved by the Office of Management and (1) Paprika or oleoresin paprika may Budget under control number 0583–008) not be used in or on fresh meat, such as , or comminuted fresh meat food [35 FR 15586, Oct. 3, 1970] products, such as chopped and formed EDITORIAL NOTE: For FEDERAL REGISTER ci- steaks or patties; or in any other meat tations affecting § 318.7, see the List of CFR food products consisting of fresh meat Sections Affected in the Finding Aids sec- (with or without ), except tion of this volume. chorizo sausage, and except other meat EFFECTIVE DATE NOTE: At 62 FR 61620, food products in which paprika or oleo- Nov. 19, 1997, § 318.7(c)(4) was amended by resin paprika is permitted as an ingre- adding the entry for ‘‘Carrageenan, Locust dient in a standard of identity or com- bean gum, and Xanthan gum blend’’ under position in part 319 of this subchapter. the class ’’Binders and extenders’’, effective January 20, 1998. (2) Sorbic acid, calcium sorbate, so- dium sorbate, and other salts of sorbic § 318.8 and other sub- acid may not be used in cooked sausage stances permitted in product for ex- or any other product; sulfurous acid port only; handling; such product and salts of sulfurous acid may not be not to be used for domestic food used in or on any product and or purposes. may not be used in or on (a) Preservatives and other sub- fresh product; except that potassium stances not permitted in domestic sorbate, propylparaben (propyl p-hy- product under the regulations in this droxybenzoate), calcium propionate, subchapter may be used in the prepara- sodium propionate, benzoic acid, and tion and packing of product intended

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