Polyacrylamide

Polyacrylamide is a polymer of acrylamide monomers. In cosmetics and personal care products, Polyacrylamide is used in the formulation of may product types including skin cleansers, moisturizers, lotions and creams, self tanning products, makeup, and hair care and nail care products.

The Food and Drug Administration (FDA) allows Polyacrylamide (with less than 0.2% acrylamide monomer) to be used as a film former in the imprinting of soft-shell gelatin capsules. The FDA also allows Polyacrylamide to be used as a denture adhesive which is considered a medical device.

The Cosmetic Ingredient Review (CIR) Expert Panel had previously published a review of the safety of Polyacrylamide, concluding that it was safe as a cosmetic ingredient as currently used. In 2003, because of concern regarding potential effects of residual acrylamide monomer, the CIR Expert Panel considered available new data on Polyacrylamide and acrylamide and reassessed its safety. The CIR Expert Panel reaffirmed the safety of Polyacrylamide as a cosmetic ingredient in the practices of use and concentrations, and they recommended that acrylamide monomer in cosmetic and personal care products should be less than 5 ppm.CIR Safety Review: The CIR Expert Panel noted that Polyacrylamide polymers do not penetrate the skin due to their large size. The CIR Expert Panel evaluated available safety test data on this ingredient and concluded that Polyacrylamide itself was safe as used in cosmetics and personal care products. The CIR Expert Panel recognized that trace amounts of acrylamide monomer are present in Polyacrylamide material used in cosmetics and personal care products and these amounts vary (average of 0.02-0.03%) based on the form in which Polyacrylamide is supplied. The CIR Expert Panel was concerned about acrylamide because some data suggest that it may be a carcinogen. The CIR Expert Panel did not believe that acrylamide was a genotoxic carcinogen in the usual manner, and that several risk assessment approaches have overestimated human risk.

The CIR Expert Panel concluded that it was appropriate to limit acrylamide levels and established an upper limit of 5 ppm acrylamide residues in cosmetics and personal care products.

FDA: Link to Code of Federal Regulations for Polyacrylamide
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...

The use of Polyacrylamide in cosmetics in the European Union is restricted to the conditions described in Annex III, Part I and may be used in body-care leave-on products and other cosmetic products with maximum residual acrylamide content of 0.1 mg/kg and 0.5 mg/kg, respectively.
Link to the EU Cosmetics Directive: http://ec.europa.eu/enterprise/cosmetics/html/consolidated_d...

The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) of Australia prepared an assessment of acrylamide and considered that dermal absorption of acrylamide from cosmetics and personal care products was negligible. http://www.nicnas.gov.au/publications/car/pec/pec23/pec_23_f...

The Joint FAO/WHO Expert Committee on Food Additives recommends that appropriate efforts to reduce acrylamide concentrations in foodstuffs should continue.
http://www.inchem.org/documents/jecfa/jeceval/jec_41.htm

Last modified 23 months ago