Polybutene

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 Review (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
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS... and
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...

Polybutene may be used in cosmetics and personal care products marketed in Europe according to the general provisions of the Cosmetics Directive of the European Union.
Link to the EU Cosmetics Directive:
http://ec.europa.eu/enterprise/cosmetics/html/consolidated_d...