Toluene

The Food and Drug Administration (FDA) has reviewed the safety of Toluene and permits its use as an indirect food additiveIndirect food additives are additives that may become part of the food in trace amounts due to its packaging, storage or other handling. For example, minute amounts of packaging substances may find their way into foods during storage.. For example, Toluene may be used as a component of adhesives and coatings, paper and paperboard, and polymers that have contact with food. The safety of Toluene has been assessed by 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. The CIR Expert Panel evaluated the scientific data and based concluded that Toluene was safe as a cosmetic ingredient in the present practices of use and concentration. In 2005, as part of the scheduled re-evaluation of ingredients, the CIR Expert Panel considered available new data on Toluene and reaffirmed the above conclusion.

CIR Safety Review:

Two studies with Toluene showed positive clastogenic effects but the purity of the test samples was not reported, making it difficult to assess the significance of these effects. More definitive studies were carried out and Toluene did not induce cancer in any of the eight studies evaluated. Although Toluene is a potential skin irritant, no skin irritation or sentization has been observed in cosmetic products containing up to 33% Toluene. However, the sole cosmetic use of Toluene is in products intended to be applied directly to the nail. Therefore, human skin exposure to this ingredient will be minimal under conditions of cosmetic use.

THe CIR Expert Panel noted that benzene, a carcinogen may be a possible impurity in Toluene, and they indicated that products formulated with Toluene should be benzene-free. Based on the safety data and the limited skin exposure from nail products containing Toluene, the CIR Expert Panel concluded that Tolene was safe as used.

FDA: Link to the FDA Code of Federal Regulations for Toluene http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr…

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr…

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr…

Currently, Toluene 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 Cosmetic Regulation: http://europa.eu/legislation_summaries/consumers/product_labelling_and_packaging/co0013_en.htm

In its opinion adopted on October 10, 2006, the European Commission’s Scientific Committe on Consumer Products (SCCP) concluded that the presence of Toluene as a solvent in nail cosmetics does not pose a risk to the health. The European Commission will eventually adapt this opinion into the Cosmetics Directive.

Link to the SCCP Opinion: http://ec.europa.eu/health/ph_risk/committees/04_sccp/docs/sccp_o_076.pdf

The Joint FAO/WHO Expert Committee on Food Additives has not restricted the daily intake of Toluene. http://www.inchem.org/documents/jecfa/jecmono/v16je24.htm