Pentaerythrityl Rosinate
What Is It?
Pentaerythrityl Rosinate is the esterAn organic compound formed by the reaction of an acid with an alcohol. of rosin acids with the polyol, pentaerythritol. In cosmetics and personal care products, Pentaerythrityl Rosinate has been reported to be used in the formulation of eye shadow, mascara and makeup bases.
Why Is It Used?
Pentaerythrityl Rosinate acts as a lubricant on the skin’s surface, which gives the skin a soft and smooth appearance. It also increases the thickness of the lipidFat or fat-like substance found in the cells of plants and animals that includes fats, waxes, oils, and related compounds. (oil) portion of cosmetics and personal care products.
Scientific Facts
Pentaerythrityl Rosinate, previously called Pentaerythritol Rosinate, is produced from wood rosin, which is a by-product of paper pulping.
Safety Information
The Food and Drug Administration (FDA) permits Pentaerythrityl Rosinate to be used in chewing gumSticky, polysaccharide substances exuded by plants that are gelatinous when moist but harden on drying. base. Pentaerythrityl Rosinate is also permitted 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. as an adjuvant and production aid. The safety of Pentaerythrityl Rosinate 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 the available data were insufficient to determine the safety of Pentaerythrityl Rosinate as used in cosmetics and personal care products.
CIR Safety Review: Pentaerythritol Rosinate did not significantly absorb in the UVA or UVB portion of the light spectrum. Formulations with 10% Pentaerythrityl Rosinate produced only minimal ocular irritation.
Likewise tests of formulations with the ingredient at concentrations of 7-9.2% resulted in minimal dermal irritation. The ingredient was nonsensitizing in maximization tests. Clinical tests of formulations with the ingredient at concentrations of 7-9.6% resulted in neither irritation nor sensitization.
No data, however, were provided on possible impurities. Absent information on the actual chemical structure, the lack of information on impurities was considered significant. The absence of genotoxicity data was also considered significant. The CIR Expert Panel concluded that the data were insufficient data to determine safety and and requested additional data on impurities, genotoxicity and dermal penetration.
Link to FDA Code of Federal Regulations for Pentaerythritol ester of rosin
- http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr…
- http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr…
Pentaerthrityl Rosinate 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..
Link to the EU Cosmetic Regulation:
http://europa.eu/legislation_summaries/consumers/product_labelling_and_p…
More Scientific Information
Pentaerythrityl Rosinate is the ester of rosin acids with the polyol pentaerythritol. This ingredient is produced by the fractional distillation of crude tall oil to form rosin, which is then esterified with monopentaerythritol. In cosmetics and personal care products, Pentaerythrityl Rosinate functions as a skin conditioning agent – emollient and a viscosity increasing agent – nonaqueous.
Resources
Find out more about the regulation of Food Additives by the Food and Drug Administration
Food Ingredients and Packaging: http://www.fda.gov/Food/IngredientsPackagingLabeling/default.htm
Food Contact Substances: http://www.fda.gov/Food/IngredientsPackagingLabeling/PackagingFCS/defaul…
Substances Generally Recognized As Safe (GRAS“GRAS” is an acronym for the phrase Generally Recognized As Safe. Under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act (the Act), any substance that is intentionally added to food is a food additive, that is subject to premarket review and approval by FDA, unless the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise excluded from the definition of a food additive.): http://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/default.htm
Search the Code of Federal Regulations http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm
EU Cosmetics Inventory http://ec.europa.eu/consumers/cosmetics/cosing/