Calls for data on the potential toxicity of Styrene/Acrylates Copolymer, Sodium Styrene/Acroylates Copolymer and Colloidal Silver nanoparticles used in cosmetics products
The consultation period for submitting relevant data on the use of “Styrene/ Acrylates Copolymer (Nano)”, “Sodium Styrene/ Acroylates Copolymer (Nano)” and “Colloidal Silver (Nano)” in cosmetics products to the European Commission is between the 25th of March 2015 and 30th of June 2015.
Member State Authorities, manufacturers of beauty products, producers of the substances concerned, and relevant cosmetics industry and consumers associations are invited to provide their feedback.
Nanomaterials are defined, by the Cosmetics Regulation (EC) No 1223/2009, as insoluble or bio-persistent and intentionally manufactured material (e.g., metals, metal oxides, carbon materials, etc.), with one or more external dimensions, or an internal structure, between 1 and 100 nm. It does not include materials that are soluble or degradable/non-persistent in biological systems (e.g., liposomes, emulsions, etc.).
Cosmetic products containing nanomaterials should be notified to the European Commission by the responsible person six months prior to being placed on the market. All nanomaterials should be clearly indicated in the list of ingredients. Specifically, the names of such ingredients should be followed by the word ‘nano’ in brackets (Article 16 and 19 Cosmetics Regulation (EC) No 1223/2009).
The European Commission has received several notifications of body and face care products where the “Styrene/Acrylates copolymer [Nano]”, CAS n. 9010-92-8, and the “Sodium styrene/Acrylates copolymer [Nano]” , CAS n. 9010-92-8, are used as skin conditioning in ‘nano’ form with a lowest cut of 20nm and at maximum concentration up to 0.06%, and where the “Colloidal Silver [Nano]”, CAS n. 7440-22-4, is used as antimicrobial in ‘nano’ form with a lowest cut off particle size of 1 nm and at maximum concentration up to 1.0%.
The potential toxicity of the ‘nano’ particles and the aim to guarantee the safety of nanomaterials for use in the relevant categories of beauty products raises the concern of the European Commission that is planning to request a full risk assessment of reasonably foreseeable exposure conditions by the Scientific Committee on Consumers Safety (SCCS).
For this purpose the European Commission invites any interested parties to submit any relevant scientific information, in particular regarding all toxicological end-points and a suggestion on the concentration limits for the use of these ingredients, because the data submitted by the applicants is insufficient to carry out a full risk assessment.
Cosmetics manufacturers and their designated EU Responsible Person shall closely follow the developments of the risk assessments on the mentioned ingredients in order to ensure the beauty product safety and its regulatory compliance.
How to submit your contribution
Any comments should be sent with the reference:
‘COLLOIDAL SILVER (nano)’
‘STYRENE/ACRYLATES COPOLYMER (nano)’ and ‘SODIUM STYRENE/ACRYLATES COPOLYMER (nano)’
by post or e-mail by 30 June 2015 at the latest to:
Directorate General Internal Market, Industry, Entrepreneurship and SMEs
Unit/I4, Health Technology and Cosmetics,
Jean-André de Mot, Office 02/082