Nylon-11
What Is It?
Nylon-6, Nylon 6/12, Nylon-11, Nylon-12, Nylon-66, Nylon-611 and Nylon-12/6/66 Copolymer are all polymers made of repeating units linked by amide bonds. In cosmetics and personal care products, the Nylon ingredients are used in the formulation of body and hand preparations, eye makeup, mascara, nail polish, and skin fresheners. Nylon-12 and Nylon-66 can also be found in bath products, deodorants, face makeup, indoor tanning preparations, lipsticks, moisturizers, night skin care products, paste masks, skin care products and suntan products.
Why Is It Used?
The following functions have been reported for the Nylon ingredients.
AbsorbentIngredients that have the capacity to absorb or soak up liquids. – Nylon 6/12, Nylon-611
Bulking agentNon-reactive, solid ingredients that are used to dilute other solids, or to increase the volume of a product. – Nylon-6, Nylon 6/12, Nylon-11, Nylon-12, Nylon-66
Film formerIngredients that dry to form a thin coating on the skin, hair or nails. – Nylon-12/6/66
Copolymer Opacifying agentSubstances that reduce the clear or transparent appearance of cosmetic products. Some opacifying agents are used in skin make-up for hiding blemishes. – Nylon-6, Nylon 6/12, Nylon-11, Nylon-12, Nylon-66
Scientific Facts
The Nylon ingredients are all synthetic polymers. Polymers are high molecular weight molecules with repeating units prepared from relatively small chemical compounds called monomers. Nylon was discovered in 1935 and has diverse uses, including in clothing and rope, due to its unique properties as a flexible solid.
Safety Information
The safety of Nylon polymers 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 these ingredients were safe as used in cosmetics and personal care products. The Food and Drug Administration (FDA) reviewed the safety of Nylon resins and approved their use as indirect food additives. Nylon resins may be used as components of single and repeated use food contact surfaces.
CIR Safety Review:
The CIR Expert Panel noted that based on the size of the Nylon polymers, Nylon has little potential to penetrate the skin. The CIR Expert Panel did express concern about the potential toxicity of monomerA molecule that comprises the repeating unit of a polymer. impurities that may be found with the Nylon polymerA naturally occurring or synthetic molecule made up of repeating units called monomers.. Therefore, in addition to reviewing data on the Nylon polymers, the CIR Expert Panel reviewed data on the monomers, caprolactam and dodecanolactam. Data reviewed by the CIR Expert Panel did not reveal significant toxic effects following exposure to either the Nylon polymers or the monomers. The monomers were not genotoxic. Caprolactam was not carcinogenic. Products containing Nylon ingredients were not significant dermal irritants or sensitizers. Based on the available data, the CIR Expert Panel concluded that the Nylon polymers are safe for use in cosmetics and personal care products.
Link to FDA Code of Federal Regulations for Nylon resins http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr…
The Nylon 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..
Link to the EU Cosmetic Regulation: http://europa.eu/legislation_summaries/consumers/product_labelling_and_packaging/co0013_en.htm
More Scientific Information
All the Nylon ingredients are polyamides. Nylon 6/12 is a polyamide formed by the reaction of caprolactam and dodecyllactam. Nylon-12 is a polyamide derived from 12-aminododecanoic acid. Nylon-66 is a polyamide formed by the reaction of adipic acid with hexylenediamine. Nylon-12/6/66 is a copolymer formed from the monomers used in the manufacture of Nylon-12, Nylon-6, and Nylon-66.
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/default.htm
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 FDA 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/