Vinyl Caprolactam/VP/Dimethylaminoethyl Methacrylate Copolymer
U.S. Food and Drug Administration (FDA)
The U.S. Food and Drug Administration (FDA) has reviewed the safety of acrylates copolymer, ethylene/acrylic acid copolymer, ethylene/sodium acrylate copolymer, acrylates/va copolymer, styrene/acrylates copolymer, ethylene/methacrylate copolymer, polyacrylic acid, ammonium polyacrylate and sodium polyacrylate, and permits their use as indirect food additives for use in coatings of food packaging. The safety of copolymers and polymers that contain the acrylic acid monomer has been assessed by the
Expert Panel for Cosmetic Ingredient Safety
The Expert Panel for Cosmetic Ingredient Safety evaluated the scientific data and concluded that acrylates copolymer, ammonium acrylates copolymer, ammonium va/acrylates copolymer, sodium acrylates copolymer, ethylene/acrylic acid copolymer, ethylene/calcium acrylate copolymer, ethylene/magnesium acrylate copolymer, ethylene/sodium acrylate copolymer, ethylene/zinc acrylate copolymer, ethylene/acrylic acid/va copolymer, acrylates/pvp copolymer, acrylates/va copolymer, steareth-10 allyl, ether/acrylates copolymer, acrylates/steareth-50 acrylate copolymer, acrylates/steareth-20 methacrylate copolymer, acrylates/ammonium methacrylate copolymer, styrene/acrylates copolymer, styrene/acrylates/ammonium methacrylate copolymer, ammonium styrene/acrylates copolymer, sodium styrene/acrylates copolymer, acrylates/hydroxyesters acrylates copolymer, methacryloyl ethyl betaine/acrylates copolymer, lauryl acrylate/va copolymer, va/butyl maleate/isobornyl acrylate copolymer, ethylene/methacrylate copolymer, vinyl caprolactam/vp/dimethylaminoethyl methacrylate copolymer, sodium acrylates/acrolein copolymer, vp/dimethylaminoethylmethacrylate copolymer, amp-acrylates copolymer, polyacrylic acid, ammonium polyacrylate, potassium aluminum polyacrylate, potassium polyacrylate, and sodium polyacrylate were safe for use in cosmetics and personal care products when formulated to avoid skin irritation.
The Expert Panel considered these ingredients to be similar in that they are large copolymers and polymers, uniformly produced in chemical reactions that leave very little residual monomer.
Typical levels of residual acrylic acid were less than 20 ppm, although levels of 1000 ppm are found occasionally. Odor from residual monomers causes producers of these ingredients to keep levels as low as possible. The Expert Panel noted that these very large copolymers and polymers exhibited little toxicity. Acrylates copolymer did produce skin irritation, but no evidence of sensitization was found.
Although there appears to be a large variation in the mix of monomers used in the synthesis of these copolymers and polymers, they are similar in that the polymers, except for dermal irritation, are not significantly toxic. Residual monomer levels are kept as low as possible. Although the monomers may produce adverse effects under some circumstances, the levels found in cosmetics and personal care products are not considered to present a safety risk.
Acrylates copolymer and all related 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 Union.