7 Pa. Code § 1.328. Approved substances.

§ 1.328. Approved substances.

(a)  Under appropriate declaration as required in Subchapter H (relating to marking and labeling) 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 and glucose syrup), wood smoke, vinegar, flavorings, spices, sodium nitrate, sodium nitrite, potassium nitrate, potassium nitrite, and other substances specified in the table in subsection (b) of this section, under the conditions, if any, specified in this Subchapter or Subchapter H (relating to marking and labeling).
   (2)  Other harmless artificial flavorings with the approval of the Department in specific cases.
   (3)  Coloring matter and dyes other than those specified in the table in subsection (b) 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 Department. When any coloring matter or dye is applied to casings, there shall be no penetration of coloring into the product. When any coloring matter or dye is added to meat fat shortening containing artificial flavoring, the product shall be packed in conventional, round shortening containers having a capacity no greater than three pounds.
(b)  —
   (1)  The substances specified in the following table are acceptable for use in the preparation of products if they are used for the purposes indicated, within the limits of the amounts stated and under other conditions specified in this Chapter. In addition to the substances listed in the table, Subchapter J (relating to product standards of identity) specifies other substances that are acceptable in preparing specified products.

Classbeg of
Substance
Substance
Purpose
Products
Amount

Anticoagulants Citric acid Sodium citrate To prevent clotting Fresh beef blood 0.2%–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 two parts of water to one part of citric acid or sodium citrate shall be used.

Antifoaming agent Methyl polysilicone To retard foaming Soups Rendered fats Curing pickle 10 parts per million. 10 parts per million. 50 parts per million.

Antioxidants and oxygen interceptors BHA (butylated hydroxyanisole) To retard rancidity Dry sausage 0.003% based on total weight
} 0.006% in combination

BHT (butylated hydroxytoluene). do
do
do

Propyl gallate do
do
do

BHA (butylated hydroxyanisole). do
Rendered animal fat or a combination
of such fat and vegetable fat. 0.01% }

BHT (butylated hydroxytoluene). do
do
do 0.02% in combination

Glycine do
do
do

Nordihydroguaiaretic acid (NDGA) do
do
do

Propyl gallate do
do
do

Resin guaiac do
do
do

Tocopherols do
do
0.03%. A 30% concentration of tocopherols in vegetable oils shall be used when added as an antioxidant to products designated as “lard” or “rendered pork fat.”

BHA (butylated hydroxyanisole) do
Fresh pork sausage, brown, and serve sausage, pregrilled beef patties, and fresh sausage made from beef or beef and pork.
0.01% based on fat content } 0.02% combination based on fat content

BHT (butylated hydroxytoluene) do
do
do

Propyl gallate do
do
do

BHA (butylated hydroxyanisole) do
Dried meats 0.01% based on total weight
} 0.01% in combination

BHT (butylated hydroxytoluene) do
do
do

Propyl gallate do
do
do

Classbeg of
Substance
Substance
Purpose
Products
Amount

Binders Algin To extend and stabilize product Breading mix; sauces. Sufficient for purpose

Carrageenan do
do
do.

Carboxmethyl cellulose (cellulose gum) do
Baked pies do

Gums, vegetable do
Egg roll do

Methyl cellulose To extend and to stabilize product (also carrier) Meat and vegetable patties 0.15%

Isolated soy protein To bind and extend product 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 Triple (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 chlorophyl, saffron and tumeric 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 approved artificial dyes or harmless inert material such as common salt and sugar)

Coloring agents (artificial) Coal tar dyes approved under the Federal Food, Drug, and Cosmetic Act (operator 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 approved natural coloring matters or harmless inert material such as common salt or sugar)

Titanium dioxide do
Canned ham salad spread and creamed type canned products 0.5%

Cooling and retort water treatment agents Calcium chloride To prevent staining on exterior of canned goods Any Sufficient for purpose

Citric acid do
do
do

Diotyl sodium sulfosuccinate do
do
0.05%

Disodium-calcium ethylenediaminetetraacetate do
do
Sufficient for purpose

Disodium ethyl-
enediaminetetraacetate do
do
do

Disodium phosphate do
do
do

Ethylendiaminetetraacetic acid do
do
do

Isopropanol do
do
0.002%

Potassium pyrophosphate do
do
Sufficient for purpose

Propylene glycol do
do
do

Sodium bicarbonate do
do
do

Sodium carbonate do
do
do

Sodium dodecylbenzene sulfonate do
do
0.05%

Sodium gluconate do
do
Sufficient for purpose

Sodium hexametaphosphate do
do
do

Sodium laurysulfate do
do
0.05%

Sodium metasilicate do
do
Sufficient for purpose

Sodium n-alkybenzene sulfonate (alkyl group predominantly C₁₂ and C₁₃ and not less than 95% C₁₀ to C₁₆) do
do
0.05%

Sodium nitrite (The sodium nitrite must be decharacterized with 0.05% powdered charcoal. Bulk decharacterized sodium nitrite when in cook room shall be held in locked metal bin or container conspicuously labeled “Decharacterized sodium nitrite—To be used by authorized personnel only.”) To inhibit corrosion on exterior of canned goods do
600 parts per million

Sodium pyrophosphate To prevent staining on canned goods do
0.05%

Sodium tripolyphosphate do
do
do

Zinc oxide do
do
0.01%

Zinc sulfate do
do
do

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% pump level ¾ oz. to 100 lbs. meat or meat byproduct; 10% 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
do
do

Glucono delta lactone To accelerate color fixing Cured, comminuted meat or meat food product 8 ozs. to each 100 lbs. of meat or meat byproduct

Genoa salami 16 ozs. to 100 lbs. of meat (1.0%)

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% pump level; 7/8 ozs. to 100 lbs. meat or meat byproduct; 10% 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% solution used to spray surfaces of cured cuts prior to packaging to replace up to 50% of the ascorbic acid, erythorbic acid, sodium ascorbate, or sodium erythorbate that is used

Curing agents (Continued) Sodium or potassium nitrate Source of nitrite Cured products 7 lbs. to 100 gals. pickle; 3½ ozs. to 100 lbs. meat (dry cure); 2¾ ozs. to 100 lbs. chopped meat.

Sodium or potassim nitrite (supplies of sodium nitrite andpotassium 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% pump level; 1 oz. to 100 lbs. meat (dry cure); ¼ 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 nitrite in finished product.

Denuding agents; may be used in combination. Must be removed from tripe by rinsing with potable water Lime (calcium oxide, calcium bydroxide) 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 monoglycerides To emulsify product Shortening do

Diacetyl tartaric acid esters of mono and diglycerides 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 anti-oxidant) Oleomargarine, shortening do

Mono and diglycerides (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% in oleomargarine

Polyglycerol esters of fatty acids (polyglycerol esters of fatty acids are restricted to those up to and including the decaglycerol esters and otherwise meeting the requirements of 21 CFR § 121.1120(a) do
Rendered animal fat or a combination of such fat with vegetable fat when use 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, fillings, and toppings and in the frying of foods 1.0% when used alone. If used with polysorbate 60 the combined total shall not exceed 1.0%

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 (polyoxeyethylene (20) sorbitan monostearate) do
Shortening for use in nonstandardized baked goods, baking mixes, icings, fillings, and toppings and in the frying of foods 1.0% when used alone. If used with polysorbate 80 the combined total shall not exceed 1.0%

Steryl-2-lactylic acid do
Shortening to be used for cake icings and fillings 3.0%

Steryl monoglyceridyl citrate do
Shortening Sufficient for purpose

Flavoring agents; protectors and developers Program approved artificial smoke flavoring¹ To flavor product Any Sufficient for purpose

Program approved smoke flavoring¹ do
do
do

Autolyzed yeast extract do
do
do

Harmless bacteria starters of the acidophilus type, lactic acid starter or culture of Pediococcus cere vislae To develop flavor Dry sausage, pork roll, thuringer, lebanon bologna, cervelat, and salami 0.5%

Benzoic acid, sodium benzoate To retard flavor reversion Oleomargarine 0.1%

Citric acid To protect flavor do
Sufficient for purpose

Corn syrup solids, corn syrup, glucose syrup To flavor Chili con carne, sausage, hamburger, meat loaf, luncheon meat, chopped or pressed ham 2.0% individually or collectively, calculated on a dry basis

Dextrose To flavor product Sausage, ham and cured products Sufficient for purpose

Diacetyl do
Oleomargarine do

Disodium guanylate do
do
do

Disodium inosinate do
do
do

Hydrolyzed plant protein do
Any do

Isopropyl citrate To protect flavor Oleomargarine 0.02%

Malt syrup To flavor product Cured products 2.5%

Milk protein hydrolysate do
Any Sufficient for purpose

Monosodium glutamate do
do
do

Sodium sulfoacetate derivative of mono and diglycerides do
do
0.5%

Sodium tripolyphosphate To help protect flavor “Fresh Beef,” “Beef for Further Cooking,” “Cooked Beef,” and similar products which are frozen after processing do

Mixtures of sodium tripolyphosphate and sodium hexametaphosphate do
do
do

Starter distillate do
Oleomargarine Sufficient for purpose

Stearyl citrate To protect flavor do
0.15%

Sugars (sucrose and dextrose) To flavor product Any 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

Dioctyle sodium sulfosuccinate do
do
do

Lime do
do
do

Methyl polysilicone do
do
do

Sodium carbonate do
do
do

Sodium dodecylbenzene sulfonate do
do
do

Sodium hexametaphosphate do
do
do

Sodium lauryl sulfate do
do
do

Sodium metasilicate do
do
do

Sodium n-alkylbenzene sulfonate (alkyl group predominantly C₁₂ and C₁₃ and not less than 95% C₁₀ to C₁₆ do
do
do

Sodium sulfate do
do
do

Sodium tripolyphosphate do
do
do

Sucrose do
do
do

Trisodium phosphate do
do
do

Miscellaneous Potassium sorbate To retard mold growth Dry sausage 2.5% 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 Oleomargarine or margarine 0.1% by weight of the finished oleomargarine or margarine

Calcium disodium, EDTA (calcium disodium ethylenediaminetetracetate) To preserve product and to protect flavor do
75 parts per million by weight of the finished oleomargarine or margarine.

Propylparaben (propyl p-hydroxybenzoate) do
do
3.5% 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 propionate To retard mold growth Pizza crust

}
0.32% alone or in 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; chopped ham; and bacon May be used only in combination with phosphates in ratio of 4 parts phosphate to one part sodium hydroxide; the combination shall not exceed 5.0% pickle at 10% pump level; 0.5% in product

Phosphates Diosodium phosphate To decrease amount of cooked-out juices Cured hams, pork shoulder picnics and loins, and canned hams and pork, shoulder picnics, and products covered by § 1.271 (12), and similar products; chopped ham, and bacon 5.0% of phosphate in pickle at 10.0% pump level; 0.5% of phosphate in product (only clear solution may be injected into product)

Monosodium phosphate do
do
do

Sodium hexametaphosphate do
do
do

Sodium tripolyphosphate do
do
do

Sodium pyrophosphate do
do
do

Sodium acid pyrophosphate 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 3.0% above the weight of the untreated product.

Aspergillus flavusoryzae 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 Bicarbonate of soda Carbon (purified charcoal) To separate fatty acids and glycerol do
To aid in refining of animal fats Rendered fats do
do
Sufficient for purpose do
do

Caustic soda (sodium hydroxide) To refine fats do
do

Diatomaceous earth; Fuller’s earth do
do
do

Sodium carbonate do
do
do

Tannic acid do
do
do

Rendering agents Tricalcium phosphate To aid rendering Animal fats Sufficient for purpose

Trisodium phosphate do
do
do

Artificial sweeteners Saccharin To sweeten product Bacon 0.01%

Synergists (used in combination with antioxidants) Citric acid To increase effectiveness of antioxidants Lard and shortening 0.01% alone or in combination with anti-oxidants in lard or shortening

Dry sausage 0.003% in dry sausage in combination with anti-oxidants

Fresh pork sausage 0.01% on basis of fat content, in combination with antioxidants

Dried meats 0.01% on basis of total weight in combination with antioxidants

Malic acid do
Lard and shortening do

Monolsopropyl citrate To increase effectiveness of antioxidants Lard, shortening oleomargarine, fresh pork, sausage, dried meats do

Phosphoric acid do
Lard and shortening 0.01%

Monoglyceride citrate do
Lard, shortening, fresh pork sausage, dried meats 0.02%

   (2) The following substances listed in the table are proprietary products and a list thereof can be obtained from the Technical Services Division, Consumer and Marketing Service, United States Department of Agriculture, Washington, D.C. 20250.
     (i)   Program approved artificial smoke flavoring.
     (ii)   Program approved smoke flavoring.

Cross References

   This section cited in 7 Pa. Code §  1.329 (relating to use of substance which misleads); 7 Pa. Code §  1.391 (relating to corned beef); 7 Pa. Code §  1.396 (relating to chopped ham); 7 Pa. Code §  1.401 (relating to general); and 7 Pa. Code §  1.444 (relating to corned beef hash).

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Classbeg of Substance	Substance	Purpose	Products	Amount
Anticoagulants	Citric acid Sodium citrate	To prevent clotting	Fresh beef blood	0.2%–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 two parts of water to one part of citric acid or sodium citrate shall be used.
Antifoaming agent	Methyl polysilicone	To retard foaming	Soups Rendered fats Curing pickle	10 parts per million. 10 parts per million. 50 parts per million.
Antioxidants and oxygen interceptors	BHA (butylated hydroxyanisole)	To retard rancidity	Dry sausage	0.003% based on total weight	}	0.006% in combination
	BHT (butylated hydroxytoluene).	do	do	do
	Propyl gallate	do	do	do
	BHA (butylated hydroxyanisole).	do	Rendered animal fat or a combination of such fat and vegetable fat.	0.01%	}
	BHT (butylated hydroxytoluene).	do	do	do		0.02% in combination
	Glycine	do	do	do
	Nordihydroguaiaretic acid (NDGA)	do	do	do
	Propyl gallate	do	do	do
	Resin guaiac	do	do	do
	Tocopherols	do	do	0.03%. A 30% concentration of tocopherols in vegetable oils shall be used when added as an antioxidant to products designated as “lard” or “rendered pork fat.”
	BHA (butylated hydroxyanisole)	do	Fresh pork sausage, brown, and serve sausage, pregrilled beef patties, and fresh sausage made from beef or beef and pork.	0.01% based on fat content	}	0.02% combination based on fat content
	BHT (butylated hydroxytoluene)	do	do	do
	Propyl gallate	do	do	do
	BHA (butylated hydroxyanisole)	do	Dried meats	0.01% based on total weight	}	0.01% in combination
	BHT (butylated hydroxytoluene)	do	do	do
	Propyl gallate	do	do	do