Polyethylene

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.

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.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.

Polyethylene was negative in genotoxicity studies. The CIR Expert Panel noted that some studies showed tumor formation when solid pieces of Polyethylene were surgically implanted into the body. This solid-state carcinogenicity effect was not considered relevant for Polyethylene as used in cosmetics and personal care products. The available data supported the conclusion that Polyethylene was safe for use in cosmetics and personal care products.

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

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_d...