Regulations on Use of Soy Protein with Food Products

As with all foods, soy protein products are under the watchful eye of federal and state regulatory agencies. Usage and labeling guidelines are outlined in the following information. For further inquin'es on any of the following regulations, please refer to the Soy Protein Council's Soy Protein Products: Characteristics, Nutritional Aspects and Utilization. Contact the Council at 1255 23rd St. NW, Washington, D.C. 20037; phone (202) 467-6610.

Meat and Poultry Products

The U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) has established guidelines for the application of soy proteins in meat and poultry products.

Soy proteins are permitted alone, or in combination withother binders, up to 8 percent in chili, 12 percent in meatballs and 12 percent in Salisbury steaks. The FSIS permits the use of flours, grits, concentrates, isolate and texturized forms at levels sufficient for formulating soups, stews, scrappie, tamales, meat pies, imitation sausage and non-specific loaves.
Use of soy flour is allowed in sausage products having astandard of identity, alone or in combination with permitted additives, not to exceed a total of 3.5 percent. Soy protein isolate is permitted at 2 percent and soy protein concentrate is permitted at 3.5 percent with appropriate labeling.
For injected whole muscle pork products, FSIS mandatesthat brine preparation must be formulated in such a way that the finished product meets a minimum of 17 percent protein content.
Meat items containing textured proteins must bear productlabels with an ingredient statement approved by the FSIS. Current regulations prefer that unflavored proteins be labeled Textured (Soy Flour), (Soy Protein Concentrate) or (Soy Protein Isolate). Fortified, colored, uncolored and flavored ingredients should be labeled Textured Vegetable Protein Product* (soy flour, concentrate or isolate, caramel color, salt, flavor, etc. ).

A ratio rule is in place and administered by the FSIS that requires the labeling, as part of the main panel product name, to be based on the ratio of dry soy ingredient to uncooked meat. In the highest level of use (ratios exceeding one part dry soy ingredients to 10 parts uncooked meat), the soy protein ingredient must be made part of the descriptive name as well as appear in the ingredient statement. At intermediate usage levels (ratios not to exceed one part dry soy ingredients to 10 parts uncooked meat), the soy protein ingredient must be listed as a subtitle contiguous to the product name as well as in the ingredient statement. In the lowest levels of use (ratios not to exceed one part dry soy ingredients to 13 parts uncooked meat), the soy protein ingredient (commonly textured) must be listed in the ingredient statement only. If the prepared food provides less nutrition than the traditional meat product without an added soy protein ingredient, then other labeling requirements may be imposed. When the soy ingredients do form part of the revised products' name, formulated, standard of identity foods generally still require the maintenance of traditional meat levels.

The National School Lunch Program allows vegetable proteins in combination with meat, poultry or fish as a meat alternate to achieve part of the minimum requirement of 2 ounces (edible portion as served) of cooked meat. The proportion of hydrated vegetable protein products* (hydrated to 18 percent protein, fortitled with vitamins and minerals and manufactured according to USDA specifications), may not exceed a ratio of 30 parts fully hydrated vegetable protein product to 70 parts uncooked meat, fish or poultry. The only exception relates to Nutrient Standard Menu Planning where the food product consists of 100 parts hydrated vegetable protein products* and no uncooked meat products. The soy protein ingredient that meets the fortification specifications of the USDA School Lunch regulations must include the added nutrients in the ingredient listing on the label.

*The USDA refers to soy protein as vegetable protein product.

Whats in a Name?
Standard of Identity Issues

The Food and Drug Administration has issued a tentative final regulation concerning the common or usual name for the class of protein foods prepared predominantly from cereal and vegetable products and used as replacement for meat, poultry, seafood, eggs and cheese. This regulation has proposed the following:

When the product contains: Requirements:

1. Less than 65% protein by weight Include name of source and the term "flour"

2. 65% or more protein by weight but less than 90% Include "____ protein concentrate" with the blank filled in by source of protein

3. 90% or more protein by weight Include "____ protein isolate" or "isolated ____ protein" with blank filled in by source

1. Alternatively, the product name could include a term that accurately describes the physical form of the product instead of, or in addition to, the term "flour." For example, "soy granules" or "soy flour granules." The term protein shall not be included in this name.

2. The name may include a term that describes the physical form of the products, like "bits" or "granules."

3. The name may include a term that describes one physical form of the product, like "bits" or "granules."

Bakery Products and Pasta

FDA Standards of Identity for enriched bread allow the use of up to 3 percent nonfat milk solids or soy flour as optional ingredients. There is no limitation in non-standardized breads. FDA Standards of Identity permit 0.5 percent enzyme-active soy flour in bread dough to increase mixing tolerance and to strengthen gluten proteins.

FDA Standards of Identity for pasta products permit fortification with soy protein. When soy flour is added to fortified macaroni, U.S. regulations require an inclusion of 12.5 percent minimum.

Dairy Products and Margarine/Edible Spreads

Soy flour is part of the FDA Standards of Identity for margarine and it can be used in all types of edible spreads (e.g., replacement in peanut spreads and candy fillings). Current U.S. federal and state dairy laws greatly restrict competition by modified or imitation dairy products and retard new developments in this area.

Formulated Foods

No FDA Standards of Identity prohibit the use of soy protein ingredients in the development of a wide variety of nonmeat/poultry foods, including ready-to-eat cereals, side dishes, soups, cooking sauces and condiments, "add meat" meal entrees, cookies, snacks, non-standard breads and other bakery products. In these particular cases, ingredient labeling regulations apply universally. This is also the case on the descriptive main panel labeling if the soy ingredient "characterizes" the food. Nutritional and health benefits associated with soy protein products can be highlighted in this area.

When the product contains:	Requirements:
1. Less than 65% protein by weight	Include name of source and the term "flour"
2. 65% or more protein by weight but less than 90%	Include "____ protein concentrate" with the blank filled in by source of protein
3. 90% or more protein by weight	Include "____ protein isolate" or "isolated ____ protein" with blank filled in by source
1. Alternatively, the product name could include a term that accurately describes the physical form of the product instead of, or in addition to, the term "flour." For example, "soy granules" or "soy flour granules." The term protein shall not be included in this name. 2. The name may include a term that describes the physical form of the products, like "bits" or "granules." 3. The name may include a term that describes one physical form of the product, like "bits" or "granules."