Polybutene
What Is It?
Polybutene is a light colored, nondrying, sticky liquid. In cosmetics and personal care products, it is used in the formulation of lipstick, eye makeup and skin care products.
Why Is It Used?
Polybutene functions as a binderIngredients that hold together the ingredients of a compressed tablet or cake., epilating agentWaxes or other substances that are heated, applied to the skin, and stripped off quickly to remove unwanted hair. and viscosity increasing agent – nonaqueous.
Scientific Facts
Polybutene is the polymerA naturally occurring or synthetic molecule made up of repeating units called monomers. formed by the polymerization of a mixture of isobutenes and normal butenes. The viscosity of Polybutene increases in direct proportion to increasing chain length.
Safety Information
The Food and Drug Administration (FDA) includes Polybutene on its list of indirect food additives. For example, Polybutene may be used in pressure sensitive adhesives, in rubber articles intended for repeated use, and in paper and paperboard. The safety of Polybutene 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 Polybutene was safe as presently used in cosmetics and personal care products. In 2002, as part of the scheduled re-evaluation of ingredients, the CIR Expert Panel considered available new data on Polybutene and reaffirmed the above conclusion.
CIR Safety Review: Polybutene was not a dermal irritant or sensitizer. Acute exposure studies did not result in any significant effects. When formlations containing Polybutene were tested in clinical studies, no evidence of sensitization, irritation, phototoxicty or photosensitization were observed. The CIR Expert Panel concluded that the number and variety of toxicological studies conducted support the safe use of Polybutene in cosmetic and personal care products.
FDA: Link to Code of Federal Regulations for Polybutene
- Pressure-Sensitive Adhesives
- Rubber Articles Intended for Repeated Use
- Defoaming Agents used in the Manufacture of Paper and Paperboard
Polybutene 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..
More Scientific Information
Polybutene is any one of several polymers of isobutene and n-butene that vary according to the degree of polymerization. Synthetic polymers are large molecules prepared from relatively small chemical compounds called monomers. If only one monomerA molecule that comprises the repeating unit of a polymer. is used in the synthesis, the resulting polymer is a homopolymer.
Resources
Find out more about the regulation of Food Additives by the Food and Drug Administration
- Food Ingredients and Packaging
- Food Contact Substances
- Substances 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.)
- Search the Code of Federal Regulations
- EU Cosmetics Inventory