Styrene/Acrylates copolymer (nano) and Sodium styrene/Acrylates copolymer (nano)

WG on Nanomaterials in Cosmetics
SCCS members: U. Bernauer (Chair of the WG), L. Bodin, Q. Chaudhry (SCCS Chair), P.J. Coenraads (SCCS Vice-Chair), M. Dusinska, E. Gaffet, E. Panteri, Ch. Rousselle, M. Stepnik, S. Wijnhoven
SCHEER members: P.H.M. Hoet, W.H. de Jong (Rapporteur)
SCCS external experts: N. von Götz, A. Simonnard
Contact: SANTE-C2-SCCSec [dot] europa [dot] eu (SANTE-C2-SCCS[at]ec[dot]europa[dot]eu)
On request from: European Commission
SCCS Number: SCCS/1595/18
Adopted on: 21-22 June 2018

Conclusion of the opinion:

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 exposure conditions.

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.

2. SCCS is requested to 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.

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.

Keywords:

SCCS, scientific opinion, Styrene/Acrylates copolymer (nano) CAS No 9010-92-8, EC No 927-710-1, Sodium styrene/Acrylates copolymer (nano) CAS No 9010-92-8, Regulation 1223/2009

Opinion to be cited as:

SCCS (Scientific Committee on Consumer Safety), Opinion on Styrene/Acrylates copolymer (nano) and Sodium styrene/Acrylates copolymer (nano), 21 February 2018, SCCS/1595/2018.