Hydrolyzed Soy Protein

What Is It?

Glycine soja (soybean) proteinA naturally occurring complex organic substance present in relatively high amounts in meats, fish, eggs, cheese, legumes. Made of carbon, hydrogen, oxygen, and nitrogen, and sometimes sulfur and phosphorus., hydrolyzed soy protein, hydrolyzed soy protein extractThe mixture of substances drawn out of a material by solution, heat, or another physical or chemical process., hydrolyzed soy milk protein, glycine soja peptideA group of compounds made up of amino acid chains. An ingredient name containing the term peptide is usually synthetic., glycine max (soybean) polypeptide and soy amino acids are ingredients obtained from the soybean plant, glycine soja. Polypeptides are chains of amino acids, the building blocks of proteins. Hydrolyzed proteins are proteins that have been broken down into smaller chains of amino acids by reaction with water. Soy Amino Acids result when soy protein is completely hydrolyzed.

Why Is It Used?

In cosmetics and personal care products, soy proteins and peptides may be used safely in body, hand, face and neck products, hair conditioners, hair dyes and colors, wave sets, shampoos, other hair care products, skin care products and mascara.

The following functions have been reported for Soybean protein-derived ingredients:

• Film formerIngredients that dry to form a thin coating on the skin, hair or nails. – soybean peptide
• Hair conditioning agentIngredients that enhance the appearance and feel of hair, by increasing hair body, suppleness, or sheen, or by improving the texture of hair that has been damaged physically or by chemical treatment. – soybean protein, soybean peptide, hydrolyzed soy protein, soy amino acids
• Skin-conditioning agent – miscellaneous – soybean protein, hydrolyzed soy protein, hydrolyzed soy milk protein, hydrolyzed soy protein extract , soybean peptide, soy amino acids
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• Surfactants – emulsifying agent – soybean protein

Scientific Facts

Plant-derived (botanical) ingredients were among the very first cosmetics. Dating back to ancient times, they have been used as natural colorants, plant juices for soothing and protecting from insect pests, and fragrant oils for imparting odor. Using plants as a source of cosmetic ingredients was the only way to produce products for cleaning, moisturizing, covering up blemishes and even treating minor skin conditions before our knowledge of science allowed the creation of new materials to advance what nature offers.

Safety Information

U.S. CIR

The Cosmetic Ingredient ReviewThe Cosmetic Ingredient Review (CIR) was established in 1976 as an independent safety review program for cosmetic ingredients. The CIR Expert Panel consists of independent experts in dermatology, toxicology, pharmacolgy and veterinary medicine. The CIR includes participation by the U.S. Food & Drug Administration and the Consumer Federation of America. (CIR) Expert Review Panel reviewed the safety of six soy proteins and peptides used in cosmetics in 2015 and concluded that they were safe under the current practices of use.

The Expert Panel noted that soy proteins are known food allergens that can elicit allergic reactions when eaten by individuals with sensitivity to soy. However, the Panel was not concerned that such reactions would be caused by dermal (skin) exposure, because these ingredients are water soluble, would not penetrate the skin, and have molecular weights that are well below that which would elicit such reactions. The Panel reviewed studies showing no skin irritation or allergic skin reactions in animals or human subjects, and no reported cases of Type I allergic reactions in humans from cosmetic use, all of which supported their safety conclusion for these ingredients. Because some people are allergic to soybeans, the FDA Food Allergen Labeling and Consumer Protection Act requires that all food containing soybeans be clearly labeled.

The safety of several other hydrolyzed plant proteins used in cosmetics also has been reviewed by the CIR Expert Panel. The Panel concluded that hydrolyzed corn protein, hydrolyzed rice protein, hydrolyzed wheat glutenA mixture of proteins obtained from wheat and other cereal grains; usually adhesive., hydrolyzed wheat protein and hydrolyzed silk are all safe for use in cosmetics.

U.S. FDA

Many products in the food supply contain soy proteins and peptides, including tofu, soymilk, soynuts, and edamame (green soybeans). Soy protein is also found in veggie burgers and in fortified pastas and cereals. In addition, the FDA has approved other uses of soy-containing substances in the food supply. For example, FDA has determined that the use of peptones as direct food substances is considered Generally Recognized as Safe (GRAS“GRAS” is an acronym for the phrase Generally Recognized As Safe. Under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act (the Act), any substance that is intentionally added to food is a food additive, that is subject to premarket review and approval by FDA, unless the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise excluded from the definition of a food additive. ). These GRAS peptones are defined as “the variable mixture of polypeptides, oligopeptides, and amino acids that are produced by partial hydrolysisDecomposition of a chemical compound into smaller constituents by reaction with water. of …soy protein isolate…” (21 CFR §184.1553). Additionally, soybean protein (described as glycine soja (soybean) protein) is GRAS for substances migrating to food from paper and paperboard products (21CFR §182.90). Hydrolyzed Soy Protein is permitted for use as an indirect food additiveIndirect food additives are additives that may become part of the food in trace amounts due to its packaging, storage or other handling. For example, minute amounts of packaging substances may find their way into foods during storage. as a component of paper and paper board.

The FDA’s Select Committee on GRAS Substances (SCOGS) concluded that there is no evidence in the information available on soy protein isolate that demonstrates, or suggests reasonable grounds to suspect, a hazard to the public when it is used at current levels or levels that reasonably might be expected in the future.

European Union (EU)

Glycine soja (soybean) protein, hydrolyzed soy protein, hydrolyzed soy protein extract, glycine soja (soybean) peptide and soy amino acids may be used in cosmetics and personal care products marketed in Europe according to the general provisions of the Cosmetics Regulation of the European UnionUnder the general provisions of the cosmetics regulation of the EU, ingredients appearing on the following function-specific annexes must comply with the listed restrictions and/or specifications: colorants (Annex IV), preservatives (Annex V), UV filters (Annex VI) and other ingredients with specific concentration limits and/or other restrictions (Annex III). Ingredients specifically prohibited from use in cosmetic products are listed in Annex II. Other ingredients listed in the EU cosmetic ingredient database (CosIng) may be used without restrictions..

Botanical and botanically-derived ingredients used in the formulation of cosmetics are generally mild and safe. Such materials have been used for a long time and, based upon this experience, their safety is well understood. As with any cosmetic ingredient, prior to marketing the finished cosmetic product, the safety of each botanical ingredient must be substantiated in accordance with 21 CFR 740.10. In selecting botanical ingredients for use in cosmetic products, formulators rely on the extensive history of their preparation and use. It is important to follow good manufacturing practices (GMP) to make sure the ingredient composition is consistent from one batch to another and to make sure that the ingredient does not degrade or grow microorganisms. There are many different references that describe the safety and use of botanical preparations.

Resources

Find out more about the regulation of Food Additives by the Food and Drug Administration

Find out more about the history of using plants to obtain beneficial materials: