Safety of Polyethylene Microspheres:
Source: http://www.cosmeticsinfo.org

The safety of Polyethylene has been assessed by the Cosmetic Ingredient Review (CIR) Expert Panel. The CIR Expert Panel evaluated the scientific data and concluded that Polyethylene was safe for use in cosmetics and personal care products.

The Food and Drug Administration (FDA) allows Polyethylene to be used in chewing gum base provided its molecular weight is between 2,000 and 21,000. FDA also includes Polyethylene and modified Polyethylenes on the list of permitted indirect food additives. For example, Polyethylene may used as a component of paperboard in contact with food, and modified Polyethylenes can be used as basic components of food containers.

CIR Safety Review:
The CIR Expert Panel concluded that Polyethylene was safe for use in cosmetic and personal care products. They noted the large molecular size of Polyethylene polymers used in cosmetics and personal care products and did not expect significant dermal absorption of Polyethylene. They noted that a lack of significant dermal absorption would limit systemic exposure to Polyethylene.

The CIR Expert Panel was concerned that information on residual impurities remaining from the polymerization process was not available. However, the CIR Expert Panel considered the processes by which low density Polyethylene is made from ethylene, and in the United States, ethylene is 99.9% pure. Therefore, the concentration of impurities in any final polymer would be so low as to not raise toxicity issues. Furthermore, safety tests of cosmetic-grade Polyethylene have consistently failed to identify any toxicity.

FDA: Link to Code of Federal Regulations for Polyethylene
Title 21, Volume 3, Part 172, Subpart G, Section 172.615; Food Additives Permitted for Consumption

Title 21, Volume 3, Part 176, Subpart B, Section 176.180; Indirect Food Additives: Paper and Paperboard
Title 21, Volume 3, Part 177, Subpart B, Section 177.1600; Indirect Food Additives: Polymers, Polyethylene Resins
Title 21, Volume 3, Part 177, Subpart B, Section 177.1610; Indirect Food Additives: Polymers, Polyethylene, chlorinated
Title 21, Volume 3, Part 177, Sbupart B, Section 177.1615, Polyethylene, flourinated
Title 21, Volume 3, Part 177, Subpart B, Section 177.1620; Indirect Food Additives: Polymers, Polyethylene, oxidized

Polyethylene 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_dir.htm

The 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.

Learn more about safety of cosmetic and personal care ingredients.