901:3-31-07. Approval of substances for use in the preparation of product  


Latest version.
  • (A) No chemical substance may be used in the preparation of any product unless it is approved in this part or by regulation 901:3-31-06 and 901:3-31-11 or by the director in specific cases.

    (1) No product shall bear or contain any substance which would render it adulterated or which is not approved in regulation 901:3-31-06, 901:3-31-11 or by the director in specific cases.

    (2) The substance specified in the following charts 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 regulation and regulations 901:3-31-02 through 901:3-31-04. In addition to the substances listed in the following chart, regulations 901:3-31-06 and 901:3-31-11 specify other substances that are acceptable in preparing specified products.

    Class of substance

    Substance

    Purpose

    Products

    Amount

    Anticoagulants

    Citric acid Sodium citrate

    To prevent clotting

    Fresh beef blood

    0.2 percent-with or without water. When water is used to make a solution of citric acid or sodium citrate added to beef blood not more than 2 parts of water to 1 part of citric acid or sodium citrate shall be used.

    Antifoaming Agent

    Methyl polysili-cone

    To retard foaming

    Soups

    10 parts per million

            

    Rendered fats Curing pickle

    do.

    50 parts per million.

    Antioxidants

    BHA (butylated

    To retard

    Dry sausage

    0.003 per cent

    ]

    and oxygen

    hydroxyanisole)

    rancidity

      

    based on

    ] 0.006 percent

    interceptors

            

    total weight

    ]in nation [sic].

      

    BHT (butylated

    do

    do

    do

    ]

      

    hydroxytoluene)

            

    ]

      

    Propyl gallate

    do

    do

    do

    ]

      

    BHA (butylated

    do

    Rendered

    0.01 percent

    )

      

    hydroxyanisole).

      

    animal fat

      

    )

            

    or a

      

    )

            

    combination of such fat

      

    )

            

    and vegetable

      

    )

            

    fat.

      

    )

      

    BHT (butylated

    do

    do

    do

    )

      

    hydroxytoluene)

            

    ) 0.02 percent in )combination.

      

    Glycine.

    do

    do

    do

    )

      

    Propyl gallate.

    do

    do

    do

    )

      

    Resin fuaiac.

    do

    do

    do

    )

      

    Tocopherols.

    do

    do

      

    0.03 percent. A 30 percent concentration of tocopherols in vegetable oils shall be used when added as an anti-oxidant to products designated as "lard" or "rendered pork fat."

      

    BHA (butylated

    do

    Fresh pork

    0.01 percent]

    ] 0.02 percent

      

    hydroxyanisole)

      

    sausage, brown

    based on fat]

    ] combination

            

    and serve

    content

    ]based on

            

    sausage, pre-grilled

      

    ]fat content

            

    beef patties,

      

    ]

            

    and fresh

      

    ]

            

    sausage made

         
            

    from beef or beef and pork

         
      

    BHT (butylated

    do

    do

    do

    ]

      

    hydroxytoluene)

            

    ]

      

    Propyl gallate

    do

    do

    do

    ]

      

    BHA (butylated

    do

    Dried meats

    0.01 per cent

    ]

      

    hydroxytoluene

         

    based on

    ] 0.01 percent in

               

    total weight

    ]combination

      

    BHT (butylated

    do

    do

    do

    ]

      

    hydroxytoluene)

               
      

    Propyl gallate

    do

    do

    do

    ]

    Binders

    Algin

    To extend and stabilize product

      

    Breading mix; sauces

    Sufficient for purpose

      

    Carrageonan

    do

      

    do

    do

      

    Carboxymethyl cullulose (cellulose gum)

    do

      

    Baked pies

    do

      

    Gums, vegetable

    do

      

    Egg roll

    do

      

    Methyl cellulose Isolated soy protein

    To extend and to stabilize product (also carrier) To bind and product

    Meat and vegetable patties extend Sausage, as provided for in Part 319 of this sub-chapter.

      

    0.15 per cent 2. per cent

               

    Imitation sausage; nonspecific loaves; soups; stews.

    Sufficient for purpose

      

    Sodium caseinate

    do

      

    do

    do

      

    Whey (dried)

    do

      

    do

    do

    Bleaching agent

    Hydrogen peroxide

    To remove color

      

    Tripe (substance must be removed from product by rinsing with clear water).

    do

    Catalysts (substances must be eliminated during process)

    Nickel

    To accelerate chemical reaction

      

    Rendered animal fats or a combination of such fats and vegetable fats

    do

      

    sodium amide

    Rearrangement of fatty acid radicals

      

    do

    do

      

    Sodium methoxide

    do

      

    do

    do

    Coloring agents (natural)

    Alkanet, annatto, carotene, cochineal, green chloro-phyl, saffron and tumeric [sic]

    To color casings or rendered fats; marking and branding product.

      

    Sausage casings, oleomargarine shortening, marking or branding ink on product.

    Sufficient for purpose (may be mixed with approve artificial dyes or harm-less inert material such as common salt and sugar).

    Coloring agents (artificial)

    Coal tar dyes approved under the Federal Food, Drug, and Cosmetic Act (Opera-tor must furnish evidence to officer in charge that dye has been certified for use in connection with foods by the Food and Drug Administration).

    do

      

    do

    Sufficient for purpose (may be mixed with approve natural coloring matters or harmless inert material such a common salt or sugar).

      

    Titanium dioxide

    do

      

    Canned ham salad spread and creamed type canned products.

    0.5 percent

    Cooling and retort water treatment agents

    Calcium

    To prevent staining on exterior of canned goods

      

    Any.

    Sufficient for purpose

      

    Citric acid

    do

      

    do

    do

      

    Dioctyl sodium sulfosuccinate

    do

      

    do

    0.05 percent

      

    Disodium calcium ethylenediamine-tetraacetate

    do

      

    do

    Sufficient for purpose

      

    Disodium ethyl-

    do

      

    do

    do

      

    enediamine-tetraacetate

               
      

    Disodium phos-phate

    do

      

    do

    do

      

    Ethylenediamine-tetraacetic acid

    do

      

    do

    do

      

    Isopropanol

    do

      

    do

    0.002 percent

      

    Potassium pyro-phosphate

    do

      

    do

    Sufficient for purpose

      

    Propylene glycol

    do

      

    do

    do

      

    Sodium bicarbonate

    do

      

    do

    do

      

    Sodium carbonate

    do

      

    do

    do

      

    Sodium dodecyl-benzene

    do

      

    do

    0.05 percent

      

    sulfonate

               
      

    Sodium gluconate

    do

      

    do

    Sufficient for purpose

      

    Sodium hexameta-phosphate

    do

      

    do

    do

      

    Sodium lauryl-sulfate

    do

      

    do

    0.05 percent

      

    Sodium metasilicate

    do

      

    do

    Sufficient for purpose

      

    Sodium n-alkylbenzene sul-fonate (alkyl group predominantly C12 and C13 and not less than 95 per-cent C10 to C16).

    do

      

    do

    0.05 percent

      

    Sodium bisulfate

    To inhibit corrosion on exterior of canned goods

      

    do

    0.001 percent

      

    Sodium nitrite (The dry nitrite must be decharacterized with 0.05 percent powdered charcoal or 0.03 percent nigrosine. Bulk decharacterized sodium nitrite when in cook room shall be held in a locked container conspicuously labeled "Decharac-terized Sodium Nitrite-to be used by authorized personnel only.")

    do

      

    do

    600 parts per million

      

    Sodium pyrophos-phate

    To prevent staining on canned goods.

      

    do

    0.05 percent

      

    Sodium tripoly-phosphate

    do

      

    do

    do

      

    Zinc oxide

    do

      

    do

    0.01 percent

      

    Zinc sulfate

    do

      

    do

    do

    Curing accelerators; must be used only in combination with curing agents

    Sodium acid pyro-phosphate.

    To accelerate color fixing

      

    Frankfurters, wieners, vienna, bolo-gna, garlic bolo-gna, knockwurst, and similar products.

    Not to exceed, alone or in combination with other curing accelerators, the following: 3 ozs. in 100 lbs. of the meat or meat and meat byproducts, content of the formula; nor 0.5 percent in the finished product.

    Curing agents

    Ascorbic acid

    To accelerate color fixing or preserve color during storage.

      

    Cured pork and beef cuts, cured comminuted meat food product.

    75 ozs to 100 gals. pickle at 10 percent pump level; 3/4 oz to 100 lbs. 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 signigicant [sic] amount of moisture to the product).

      

    Erythorbic acid

    do

      

    do

    do

      

    Glucono delta lac-tone

    To accelerate color fixing

      

    Cured, comminuted meat or meat food product. Genoa salami

    8 ozs. to each 100 lbs. of meat or meat byproduct 16 ozs. to 100 lbs. of meat ( 1.0 per-cent).

      

    Sodium ascorbate

    To accelerate color fixing or preserve color during storage.

      

    Cured pork and beef cuts, cured comminuted meat food product.

    87.5 ozs. to 100 gals. pickle at 10 per-cent pump level; 7/8 ozs. to 100 lbs. 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

      

    do

    do

      

    Citric acid or sodium citrate

    do

      

    do

    May 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.

      

    Sodium or potassium nitrate.

    Source of nitrate

      

    Cured products

    7 lbs. to 100 gals. pickle; 3 1/2 ozs. to 100 lbs. meat (dry cure); 2 3/4 ozs. to 100 lbs. chopped meat.

      

    Sodium or potassium nitrite (sup-plies 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 color

      

    do

    2 lbs. to 100 gals. pickle at 10 percent pump level; 1 oz. to 100 lbs. meat (dry cure); 1/4 oz. to 100 lbs. chopped meat and/or meat byproduct. The use of nitrites, nitrates, or combination shall not result in more than 200 parts per million calculated as sodium nitrite, in finished product.

    Denuding agents; may be used in combination Must be removed from tripe by rinsing with safe water.

    Lime (calcium oxide, calcium hydroxide).

    To denude mucous membrane

      

    Tripe.

    Sufficient for purpose.

      

    Sodium carbonate

    do

      

    do

    do

      

    Sodium gluconate

    do

      

    do

    do

      

    Sodium hydroxide

    do

      

    do

    do

      

    Sodium metasilicate

    do

      

    do

    do

      

    Sodium persulfate

    do

      

    do

    do

      

    Trisodium phosphate

    do

      

    do

    do

    Emulsifying agents

    Acetylated mono-glycerides

    To emulsify product

      

    Shortening

    do

      

    Diacetyl tartaric acid esters of mono and digyl-cerides [sic.]

    do

      

    Rendered animal fat or a combination of such fat with vegetable fat.

    do

      

    Glycerol-lacto stearate, oleate, or palmitate

    do

      

    do

    do

      

    Lecithin

    To emulsify product (also as antioxidant).

      

    Oleomargrine, shortening.

    do

      

    Mono and diglyc-erides (glycerol palmitate, etc.)

    To emulsify product

      

    Rendered animal fat or a combination of such fat with vegetable fat.

    Sufficient for purpose in lard and shortening; 0.5 percent in oleomargarine

      

    Polyglycerol esters of fatty acids (polyglycerol esters of fatty acids are restricted to those up to and including the decaglycerol esters and other-wise meeting the requirements of § 121.1120(a) of the Food Additive Regulations).

    do

      

    Rendered animal fat or a combination of such fat with vegetable fat when used is not precluded by standards of identity or composition

    Sufficient for purpose

      

    Polysorbate 80 (polyoxyethylene (20) sorbitan monooleate.)

    do

      

    Shortening for use in nonstandardized baked goods baking mixes. icings, filings, and toppings and in the frying of foods.

    1 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

    do

      

    Rendered animal fat or a combination of such fat with vegetable fat.

    Sufficient for purpose.

      

    Polysorbate 60 (polyoxyethylene (20) sorbitan monostearate).

    do

      

    Shortening for use in nonstandardized baked goods, baking mixes, icings, fillings, and toppings and in the frying of foods.

    1 percent when used alone If used with polysorbate 80 the combined total shall not exceed 1 percent.

      

    Stearyl-2-lactylic acid.

    do

      

    Shortening to be used for cake icings and fillings.

    3.0 percent

      

    Stearyl monoglyc-eridyl citrate

    do

      

    Shortening

    Sufficient for purpose

    Flavoring agents; protectors and developers

    Program approved artificial smoke flavoring.

    To flavor product.

      

    Various.

    do

      

    Program approved smoke flavoring.

    do

      

    do

    do

      

    Autolyzed yeast extract.

    do

      

    do

    do

      

    Harmless bacteria starters of the aci-dophilus type, lac-tic acid starter or culture of Pedic-coccus cere visiae.

    To develop flavor,

      

    Dry sausage, pork roll, thuringer, lebanon bologna, cervelat, and sa-lami.

    0.5 percent.

      

    Benzoic acid, sodium benzoate

    To retard flavor reversion

      

    Oleomargarine.

    0.1 percent

      

    Citric acid

    To protect flavor.

      

    do

    Sufficient for purpose.

         

    Flavoring.

      

    Chili con carne.

    Sufficient for purpose.

      

    Corn syrup solids, corn syrup, glucose syrup.

    To flavor

      

    Chili con carne, sausage, ham-burger, meat loaf, luncheon meat, chopped or pressed ham.

    2.0 percent individually or collectively, calculated on a dry basis.

      

    Dextrose.

    To flavor product

      

    Sausage, ham and

    Sufficient for

               

    cured products.

    purpose

      

    Diacetyl

    do

      

    Oleomargarine

    do

      

    Disodium guanylate

    do

      

    Various

    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.

    Sufficient for purpose.

      

    Monosodium glutamate

    do

      

    do

    do

      

    Sodium sulfoacetate derivative of mono and diglyc-erides.

    do

      

    do

    0.5 percent

      

    Sodium Sodium [sic] tripoly-phosphate

    To help protect flavor

      

    "Fresh Beef" "Beef for Further Cooking." "Cooked Beef," and similar products which are frozen after processing.

    do

      

    Mixtures of sodium tripolyphos-phate and sodium hexameta-phosphate

    do

      

    do

    do

      

    Sorbitol

    To flavor, to facilitate the removal of casings from product and to reduce cara-melization and char-ring.

      

    Cooked sausage labeled frankfurter, frank, furter, wiener, knockwurst

    Not more than 2 percent of the weight of the formula excluding the formula weight of water or ice; not permitted in combination with corn syrup, and/or corn syrup solids.

      

    Starter distillate

    do

      

    Oleomargarine

    Sufficient for purpose.

      

    Stearyl citrate

    To protect flavor

      

    do

    0.15 percent.

      

    Sugars (sucrose and dextrose).

    To flavor product.

      

    Various.

    Sufficient for purpose

    Gases

    Carbon dioxide solid (dry ice).

    To cool product

      

    Chopping of meat, packaging of product.

    do

      

    Nitrogen

    To exclude oxygen

      

    Sealed container

    do

    Hog scald agents; must be removed by subsequent cleaning operations.

    Caustic soda

    To remove hair

      

    Hog carcasses

    do

      

    Dioctyl sodium sulfosuccinate

    do

      

    do

    do

      

    Lime

    do

      

    do

    do

      

    Methyl poly-silicone

    do

      

    do

    do

      

    Sodium carbonate

    do

      

    do

    do

      

    Sodium dodecyl-benzene sulfonate

    do

      

    do

    do

      

    Sodium hexameta-phosphate

    do

      

    do

    do

      

    Sodium lauryl sulfate.

    do

      

    do

    do

      

    Sodium metasili-cate

    do

      

    do

    do

      

    Sodium n-alkylbenzene sul-fonate (alkyl group predominantly C12 and C13 and not less than 95 per-cent C10 to C16).

    do

      

    do

    do

      

    Sodium sulfate

    do

      

    do

    do

      

    Sodium tripoly-phosphate

    do

      

    do

    do

      

    Sucrose.

    do

      

    do

    do

      

    Trisodium phos-phate

    do

      

    do

    do

    Miscellaneous

    Potassium sorbate

    To retard mold growth

      

    Dry sausage

    2.5 percent in water solution may be applied to casings after stuffing or casings may be dipped in solution prior to stuffing.

         

    To preserve product and to retard mold growth.

    Oleoma preserve or margrgarine

    0.1 percent arine by weight of the finished oleomargarine or margarine.

      
      

    Calcium disodium, EDTA (calcium disodium ethylenediaminetetraace-tate).

    To preserve product and to protect flavor.

      

    do

    75 parts per million by weight of the finished oleomargarine or margarine.

      

    Propylparaben (propyl p-hydrosy bensoate).

    To retard mold growth

      

    Dry sausage

    3.5 percent in water solution may be applied to casings after stuffing or casings may be dipped in solution prior to stuffing.

      

    Sodium bicarbonate

    To neutralize excess acidity, cleaning vegetables.

      

    Rendered fats, soups, curing pickle.

    Sufficient for purpose.

      

    Calcium

    To retard mold

      

    Pizza crust.

    ] 0.32 percent alone or in

      

    propionate

    growth

         

    ]combination based on

    ]weight of the flour used.

      

    Sodium propionate

    do

      

    do

    ]

      

    Sodium hydroxide

    To decrease amount of cooked out juices.

      

    Cured hams, pork shoulder picnics and loins, canned hams and pork shoulder picnics, and products covered by § 319.104(d); chopped ham and bacon.

    May be used only in combination with phosphates in ratio of four parts phosphate to one part sodium hydroxide; the combination shall not exceed 5 percent in pickle at 10 percent pump level; 0.5 percent in product.

    Phosphates.

    Disodium phos-phate

    do

      

    do

    5 percent of phosphate in pickle at 10 percent pump level; 0.5 percent of phosphate in product (on clear solution may be injected into product).

      

    Monosodium phosphate

    do

      

    do

    do

      

    Sodium hexameta-phosphate

    do

      

    do

    do

      

    Sodium tripoly-phosphate

    do

      

    do

    do

      

    Sodium pyro-phosphate

    do

      

    do

    do

      

    Sodium acid pyro-phosphate

    do

      

    do

    do

    Proteolytic enzymes

    Aspergillus oryzae

    To soften tissue

    Beef cuts

      

    Solutions consisting of water, salt, monosodium glutamate, and approved proteolytic enzymes applied or injected into cuts of beef shall not result in a gain of more than 3 percent above the weight of the untreated product.

      

    Aspergillus flavus oryzae group

    do

      

    do

    do

      

    Bromelin

    do

      

    do

    do

      

    Ficin

    do

      

    do

    do

      

    Papain

    do

      

    do

    do

    Refining agents (must be eliminated during process of manufacturing).

    Acetic acid

    To separate fatty acids and glycerol

      

    Rendered fats

    Sufficient for purpose

      

    Bicarbonate of soda

    do

      

    do

    do

      

    Carbon (purified charcoal).

    To aid in refining of animal fats

      

    do

    do

      

    Caustic soda (sodium hydroxide).

    To refine fats

      

    do

    do

      

    Diatomaceous earth; Fuller's earth.

    do

      

    do

    do

      

    Sodium carbonate

    do

      

    do

    do

      

    Tannic acid

    do

      

    do

    do

    Rendering agents

    Tricalcium phos-phate

    To aid rendering

      

    Animal fats

    do

      

    Trisodium phos-phate

    do

      

    do

    do

    Artificial sweeteners Synergists (used in combination with anti-oxidants).

    Saccharin Citric acid

    To sweeten product.

    To increase effectiveness of antioxi-dants

      

    Bacon

    Lard and shorten-ing

    0.01 per cent 0.01 percent alone or in combination with anti-oxidants in lard or shortening.

               

    Dry sausage.

    0.003 percent in dry sausage in combination with antioxidants.

               

    Fresh pork sausage

    0.01 percent on basis of fat content, in combination with antioxidants.

               

    Dried meats.

    0.01 percent on basis of total weight in combination with antioxidants.

      

    Malic acid

    do

      

    Lard and shortening

    do

      

    Monoisopropyl citrate

    To increase effectiveness of antioxi-dants

      

    Lard, shortening, oleomargarine, fresh pork sausage, dried meats.

    0.02 percent

      

    Phosphoric acid

    do

      

    Lard and shortening.

    0.01 percent

      

    Monoglyceride citrate

    do

      

    Lard, shortening, fresh pork sausage, dried meats.

    0.02 percent

    (B) 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 Italian brand 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 regulation no. 901:3-31-11

    (2) Sorbic acid, calcium sorbate, sodium sorbate, and other sorbate salts or sorbic acid may not be used in cooked sau-sage 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-hydroxy-benzoate), calcium propionate, sodium propionate, benzoic acid, and sodium benzoate may be used in or on any product only as provided in the chart in Part (A)(2) of this regulation or as approved by the director in specific cases.

    (C) Samples of products, water, dyes, chemicals, etc., to be taken for examination:

    Samples of products, water, dyes, chemicals, preservatives, spices, or other articles in establishment shall be taken, without cost to the department, for examination, as often as may be deemed necessary for the efficient conduct of the inspection.


Effective: 10/27/2017
Five Year Review (FYR) Dates: 8/11/2017
Promulgated Under: 119.03
Statutory Authority: 3715.02
Rule Amplifies: 3715.59, 3715.60, 3715.62
Prior Effective Dates: 5/11/1974