The safety of nano Styrene/Acrylates copolymer and nano Sodium Styrene/Acrylates copolymer still raises question marks

“Nanomaterial” means an insoluble or biopersistent and intentionally manufactured material on a scale from 1 to 100 nm. According to Article 16 of the Regulation (EC) No 1223/2009 any cosmetic product containing nanomaterials shall be notified to the European Commission six months prior to their placement on the EU market.

The Commission received 8 notifications of cosmetic products containing Styrene/Acrylates copolymer and Sodium Styrene/Acrylates copolymer, that accordingly to applicants were used in nano-coated form in leave-on cosmetics (lotions, creams, emulsions) with a maximum concentration of 0,06%. According to the information given by the applicants nano Styrene/Acrylates copolymer and nano Sodium Styrene/Acrylates copolymer were used to coat the slimming agent Theophyllisilane C.

Since the safety of nano Styrene/Acrylates copolymer and nano Sodium Styrene/Acrylates copolymer raised concerns to the Commission, the SCCS (Scientific Committee on Consumer Safety) was asked to provide a full risk assessment.

At the plenary meeting held on 21st – 22nd June 2018, the SCCS was not able to conclude on the safety of nano Styrene/Acrylates copolymer and nano Sodium Styrene/Acrylates copolymer due to lack of essential information such as molecular weight, partition coefficient (Log Pow), use frequency and potential exposure. Furthermore, the applicants submitted information about a nearly finished product consisting of a nanomaterial shell and encapsulated active ingredient, while for the purpose of the safety evaluation the data should have been provided separately for all the styrene/acrylate nanospheres, including any incapsulated substances.

In conclusion, it is imperative that the safety assessment of cosmetic products containing nanomaterials not only considers the safety of individual components (for instance, the encapsulating material and the encapsulated content), but also the safety of all components when put together in the form of a nano-sized entity.

Should you wish to have more information, Obelis remains at your disposition. With 30 years of regulatory experience, it will be our pleasure to help and advise you on regulatory updates for the EU market, SCCS opinions and cosmetic ingredients in the EU. If you would like to know more on cosmetics products regulatory compliance, please contact us.

Silvia Ziliotti

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