Cellulose Gum

The Food and Drug Administration (FDA) includes Ethylcellulose, Hydroxypropylcellulose, Methyl Ethylcellulose and Hydroxypropyl Methylcellulose on its list of multipurpose additives allowed to be directly added to food. FDA also permits Cellulose and a number of modified cellulose polymers to be used as indirect food additives. For example, Cellulose, Cellulose Acetate Butryate, Cellulose Acetate Propionate, Cellulose Gum, Hydroxyethylcellulose, Hydroxyethyl Ethylcellulose, Hydroxypropyl Methylcellulose and Methylcellulose can be used in adhesives in contact with food. As substances migrating to food from paper and paperboard products, FDA considers Cellulose Acetate and Ethylcellulose to be 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.). The FDA has also approved the use of Cellulose Gum, Hydroxyethylcellulose, Hydroxypropyl Methylcellulose and Methylcellulose for use as ophthalmic demulcents in over-the-counter (OTC) drug products for the eyes.

When used in an OTC drug product Hydroxypropyl Methylcellulose must be called Hypromellose. The safety of Cellulose, Calcium Carboxymethyl Cellulose, Carboxymethyl Cellulose Acetate Butyrate, Carboxymethyl Hydroxyethylcellulose, Cellulose Acetate, Cellulose Acetate Butyrate, Cellulose Gum, Cellulose Acetate Propionate, Cellulose Acetate Propionate Carboxylate, Cellulose Succinate, Cetyl Hydroxyethylcellulose, Ethylcellulose, Hydrolyzed Cellulose Gum, Hydroxybutyl Methylcellulose, Hydroxyethylcellulose, Hydroxyethyl Ethylcellulose, Hydroxypropylcellulose, Hydroxypropyl Methylcellulose, Methylcellulose, Hydroxypropyl Methylcellulose Acetate/Succinate, Methylcellulose, Methyl Ethylcellulose, Methyl Hydroxyethylcellulose, Microcrystalline Cellulose, Potassium Cellulose Succinate and Sodium Cellulose Sulfate has been assessed by 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 Panel. The CIR Expert Panel evaluated the scientific data and concluded that these ingredients were safe as cosmetic ingredients.

CIR Safety Review:

The CIR Expert Panel noted that in addition to the use of the cellulose ingredients in cosmetics and personal care products, they were widely used in food, pharmaceuticals and industrial products. Large doses of Methylcellulose and Cellulose Gum administered orally as laxatives produced no toxic effects in humans. The cellulose derivatives pass essentially unchanged through the gastrointestinal tract following oral administration. They are practically nontoxic when administered by inhalation or by oral, intraperitoneal, subcutaneous, or dermal routes. Subchronic and chronic oral studies indicated that the cellulose derivatives were nontoxic. No significant developmental or reproductive effects were demonstrated. Ocular and dermal irritation studies showed that the cellulose derivatives were minimally irritating to the eyes and nonirritating to slightly irritating to the skin when tested at concentrations up to 100%. No mutagenic activity of these ingredients was demonstrated.

The cellulose derivatives at concentrations up to 100% were nonirritating to mildly irritating, nonsensitizing, and nonphotosensitizing when evaluated in clinical studies. The CIR Expert Panel concluded that Cellulose, Calcium Carboxymethyl Cellulose, Carboxymethyl Cellulose Acetate Butyrate, Carboxymethyl Hydroxyethylcellulose, Cellulose Acetate, Cellulose Acetate Butyrate, Cellulose Gum, Cellulose Acetate Propionate, Cellulose Acetate Propionate Carboxylate, Cellulose Succinate, Cetyl Hydroxyethylcellulose, Ethylcellulose, Hydrolyzed Cellulose Gum, Hydroxybutyl Methylcellulose, Hydroxyethylcellulose, Hydroxyethyl Ethylcellulose, Hydroxypropylcellulose, Hydroxypropyl Methylcellulose, Methylcellulose, Hydroxypropyl Methylcellulose Acetate/Succinate, Methylcellulose, Methyl Ethylcellulose, Methyl Hydroxyethylcellulose, Microcrystalline Cellulose, Potassium Cellulose Succinate and Sodium Cellulose Sulfate were safe for use as cosmetic ingredients.

Links to FDA Code of Federal Regulations for Cellulose and modified cellulose polymers

• Ethyl Cellulose 
• Hydroxypropyl Cellulose 
• Methyl Ethyl Cellulose
• Hydroxypropyl Methylcellulose 
• Adhesives 
• Substances Migrating to Food from Paper and Paperboard Products 
• Ophthalmic Demulcents 

Cellulose, and modified cellulose polymers may be used in cosmetics and personal care products marketed in the European Union according to the general requirements of the Cosmetics Regulation of the European Union.

EU Cosmetic Regulation

The Joint FAO/WHO Expert Committee on Food Additives has established an Acceptable Daily Intake of 0-25 mg/kg body weight for the sum total of modified celluloses: Hydroxypropylcellulose, Methylcellulose, Methyl Ethylcellulose, Hydroxypropyl Methylcellulose and Cellulose Gum.