Polymethyl Methacrylate

What Is It?

Polymethyl Methacrylate, Methyl Methacrylate Crosspolymer and Methyl Methacrylate/Glycol Dimethacrylate Crosspolymer are polymers, which mean that they are large compounds made up of small repeating units called monomers. Polymethyl Methacrylate contains only one monomerA molecule that comprises the repeating unit of a polymer., methyl methacrylate, while the cross polymers also include the cross linking monomer ethylene dimethacrylate. These polymers are used in eye makeup, other makeup, as well as hair and nail care products.

Why Is It Used?

Polymethyl Methacrylate, Methyl Methacrylate Crosspolymer and Methyl Methacrylate/Glycol Dimethacrylate Crosspolymer function as film formers in cosmetic and personal care products. Methyl Methacrylate Crosspolymer may also function as a viscosity increasing agent – nonaqueous.

Scientific Facts

In addition to its use in cosmetics and personal care products and medical devices, Polymethyl Methacrylate can be made into large clear sheets for use instead of glass. In the form of large sheets, Polymethyl Methacrylate may be called acrylic glass.

Safety Information

The Food and Drug Administration (FDA) has approved Polymethyl Methacrylate for use in medical devices including intraocular lenses, bone cement, dental fillers and dermal fillers. These devices are placed directly into the body and are intended to remain in the body for long periods of time. The FDA also permits Polymethyl Methacrylate 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 and polymers that come into contact with food.

The safety of Polymethyl Methacrylate, Methyl Methacrylate Crosspolymer and Methyl Methacrylate/Glycol Dimethacrylate Crosspolymer 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 that scientific data and concluded that these polymers were safe as cosmetic ingredients.

CIR Safety Review:

In their review of the safety of Polymethyl Methacrylate, Methyl Methacrylate Crosspolymer and Methyl Methacrylate/Glycol Dimethacrylate Crosspolymer as used in cosmetics, the CIR Expert Panel considered FDA’s assessment of Polymethyl Methacrylate as used in medical devices. The CIR Expert Panel determined that the Polymethyl Methacrylate used in cosmetics and medical devices is substantially the same, and that use of implantable medical devices results in much greater exposure than use in cosmetics.

As the polymers are too big to penetrate the skin, the main concern of the CIR Expert Panel was the level of monomer in the polymerA naturally occurring or synthetic molecule made up of repeating units called monomers.. Levels of monomer were reported to be less than 100 ppm. This is a level lower than levels shown to result in dermal sensitization.

Based on the safe use of these polymers in implantable medical devices, and information indicating low levels of monomer in the cosmetic ingredients, the CIR Expert Panel concluded that Polymethyl Methacrylate, Methyl Methacrylate Crosspolymer and Methyl Methacrylate/Glycol Dimethacrylate Crosspolymer were safe for use as cosmetic ingredients.

FDA: Link to Code of Federal Regulations for Polymethyl Methacrylate Use as an indirect food additive

Polymethyl Methacrylate, Methyl Methacrylate Crosspolymer and Methyl Methacrylate/Glycol Dimethacrylate Crosspolymer 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

The Polymethyl Methacrylate and its crosspolymers used in cosmetic products are in the form of small beads or a fine powder. The size of this material is too big to penetrate the skin.

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 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/