The SCCS concludes the following:
1. In view of above, and taking into account the scientific data provided, the SCCS is
requested to 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%, taking into account the reasonably foreseeable
The SCCS cannot conclude on the safety of any of the three styrene/acrylate copolymer
nano-entities submitted by the Applicants. 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. According to the information provided by the Applicants, the formulation
might be used in health products like milks, emulsions, creams, lotions and solutions.
However, no data on the use frequency was provided, so, the potential exposure could not
be estimated based on a use scenario. In addition, 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.