Polyacrylamide

What Is It?

Polyacrylamide is a polymerA naturally occurring or synthetic molecule made up of repeating units called monomers. 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.

Why Is It Used?

Polyacrylamide dries to form a thin coating on the skin, hair, or nails. When used in hair care products, Polyacrylamide helps hair hold its style by inhibiting the hair’s ability to absorb moisture. In makeup, Polyacrylamide holds together the ingredients of a compressed tablet or cake. It can also be found in sunscreen products to aid in retaining sunscreen on the skin after immersion in water. Small Polyacrylamide beads may be used in skin cleansing products as an abrasiveIngredients used for abrading, smoothing or polishing, such as emery or pumice..

Scientific Facts

Polyacrylamide is a long chain of acrylamide molecules that is available in one of three forms: white solid (beads or powder), aqueous solution, and inverse emulsionA mixture of two liquids that normally cannot be mixed, in which one liquid is dispersed in the other liquid as very fine droplets. Emulsifying agents are often used to help form the emulsion and stabilizing agents are used to keep the resulting emulsion from separating. The most common emulsions are oil-in-water emulsions (where oil droplets are dispersed in water) and water-in-oil emulsions (where water droplets are dispersed in oil). (in water droplets coated with surfactantAn ingredient that helps two substances that normally do not mix to become dissolved or dispersed in one another. Also called a surface active agent. and suspended in mineral oil). Acrylamide forms in food, such as french fries, when it is cooked at high temperatures.

Safety Information

The Food and Drug Administration (FDA) allows Polyacrylamide (with less than 0.2% acrylamide monomerA molecule that comprises the repeating unit of a polymer.) to be used as a film formerIngredients that dry to form a thin coating on the skin, hair or nails. in the imprinting of soft-shell gelatin capsules. The FDA also allows Polyacrylamide to be used as a denture adhesiveIngredients that unite or bond surfaces together. which is considered a medical device. 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 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

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 Cosmetic Regulation:
http://europa.eu/legislation_summaries/consumers/product_labelling_and_p…

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_full_report_p…

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

More Scientific Information

Polyacrylamide is a homopolymer of acrylamide monomers used as a binderIngredients that hold together the ingredients of a compressed tablet or cake., film former, abrasive, and hair fixativeIngredients that help hair hold its style by inhibiting the hair?s ability to absorb moisture. in cosmetics and personal care products. Some reports describe the use of Polyacrylamide as a foam builder and stabilizer in shampoos and foam baths, as well as a lubricant and emollient in soaps and lotions.

Resources

The European Commission’s Scientific Committee on Cosmetic Products and Non-Food Products Intended for Consumers’ opinion paper on Acrylamide residues in cosmetics
http://ec.europa.eu/health/ph_risk/committees/sccp/docshtml/sccp_out95_e…

The European Commission’s Scientific Committee for ToxicologyToxicology is the study of the adverse effects of chemical and physical agents on living organisms., Ecotoxicity, and the Environment (CSTEE) conducted a risk assessment of acrylamide and concluded that the exposure to humans should be kept as low as possible.
http://www.eu.nl/health/ph_risk/committees/sct/docshtml/sct_out88_en.htm

The European Commission’s Scientific Committee on Food (SCF) concluded that acrylamide levels in food should be as low as reasonably achievable.
http://ec.europa.eu/food/fs/sc/scf/out131_en.pdf

EU Cosmetics Inventory http://ec.europa.eu/consumers/cosmetics/cosing/

Search the FDA Code of Federal Regulations http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm