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June 26, 2018

EC Committee Publishes Final Opinion on Nano Styrene/Acrylates and Sodium Styrene/Acrylates Copolymers

Lynn L. Bergeson Carla N. Hutton

On June 25, 2018, the European Commission’s (EC) Scientific Committee on Consumer Safety (SCCS) published its final opinion on styrene/acrylates copolymer (nano) and sodium styrene/acrylates copolymer (nano).  The EC received eight notifications of cosmetic ingredients containing the copolymers in nano forms.  According to the applicants, the ingredients are used in nano-coated form in leave-on cosmetic products with maximum reported concentration limits of 0.06 percent.  According to the opinion, the EC has concerns over safety of the use of sodium styrene/acrylates copolymer (nano) and styrene/acrylates copolymer (nano) in cosmetic products.  The EC requested that SCCS give its opinion on the safety of the nanomaterial styrene/acrylates copolymer and sodium styrene/acrylates copolymer when used in leave-on cosmetics products with a maximum concentration limit of 0.06 percent, taking into account the “reasonably foreseeable exposure conditions.”  In the final opinion, SCCS states that it cannot conclude on the safety of any of the three styrene/acrylate copolymer nano-entities submitted by the applicants.  According to SCCS, the data submitted are insufficient to evaluate possible toxicity.  Regarding use, it was reported that the nano-entities, as present in Nanospheres 100 Theophyllisilane C (SA), were used for encapsulation of a slimming agent Theophyllisilane C.  SCCS notes that according to the information provided by the applicants, the formulation might be used in health products like milks, emulsions, creams, lotions, and solutions.  No data on the use frequency were provided, however, so the potential exposure could not be estimated based on a use scenario.  In addition, SCCS states, the submitted information was based on a (nearly) finished product consisting of a nanomaterial shell (Nanosphere 100) and encapsulated active ingredients (Theophyllisilane C and Algisium C2 (SA) methylsilanol mannuronate).  For the formulation Nanospheres 100 D.S.H. C.N (SA), no information on composition was submitted.  Data should be provided separately for all of the three styrene/acrylate nanospheres, including any encapsulated substances.  The EC requested that SCCS also address any further scientific concerns with regard to the use of styrene/acrylates copolymer and sodium styrene/acrylates copolymer in nano form in cosmetic products.  SCCS states:  “For applications as evaluated in this Opinion, it is imperative that the safety assessment not only considers safety of the individual components (e.g. the encapsulating material and the encapsulated contents), but also the safety of all the components when put together in the form of a nano-sized entity.”