PEG-100

The Food and Drug Administration (FDA) permits Triethylene Glycol to be used 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. in adhesives, polymers and as a component of coatings in contact with food. The safety of Triethylene Glycol and other polyethylene glycols 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 concluded that Triethylene Glycol and the polyethylene glycol ingredients were safe for use in cosmetics and personal care products.

CIR Safety Review:

The CIR Expert Panel noted that in general, the polyethylene glycol (PEG) ingredients have a low order of oral and dermal toxicity. Lower molecular weight PEG ingredients were minimally absorbed and higher molecular weight PEGs (PEG-75 and greater) were not absorbed through intact skin. The PEGs were minimally irritating to human skin, and were not sensitizers. The available data indicated that the PEGs were not mutagenic or carcinogenic.

During its first review of the PEG ingredients, the Expert CIR Panel reviewed studies which reported kidney toxicity in severely burned patients treated several times each day with a PEG-based antimicrobial cream. The PEG content of the antimicrobial cream was determined to be the causative agent. However, no evidence of systemic toxicity occurred in studies with intact skin. Additional penetration data reviewed during the second CIR review of the PEG ingredients indicated that penetration is only significantly increased when both the top layer and underlying layers of the skin are severely damaged, which occurs in second and third degree burns.

Based on this new information, the CIR Expert concluded that the PEG ingredients are safe for use in cosmetic products. Small amounts of 1,4-dioxane, a by-product of ethoxylation, may be found in polyethylene glycol ingredients including the polyethylene glycol ingredients. The potential presence of this material is well known and can be controlled through purification steps to remove it from the ingredients before blending into cosmetic formulations.

FDA: Link to Code of Federal Regulations for Triethylene Glycol

• Adhesives 
• Resinous and polymeric coatings 
• Cellophane 

More information about 1,4-dioxane, including what the Food and Drug Administration (FDA) is doing to assure that cosmetics do not contain unsafe levels of 1,4-dioxane. The PEG ingredients may be used in cosmetics and personal care products marketed in Europe according to the general provisions of the Cosmetics Regulation of the European UnionUnder the general provisions of the cosmetics regulation of the EU, ingredients appearing on the following function-specific annexes must comply with the listed restrictions and/or specifications: colorants (Annex IV), preservatives (Annex V), UV filters (Annex VI) and other ingredients with specific concentration limits and/or other restrictions (Annex III). Ingredients specifically prohibited from use in cosmetic products are listed in Annex II. Other ingredients listed in the EU cosmetic ingredient database (CosIng) may be used without restrictions..

EU Cosmetic Regulation