CALL FOR DATA ON INGREDIENTS: 'Styrene/ Acrylates Copolymer (Nano)’and 'Sodium Styrene/ Acroylates Copolymer (Nano)’ - Regulation (EC) 1223/2009 Published on: 24/03/2015
Call for data on ingredients: 'Styrene/Acrylates Copolymer (Nano)' and 'Sodium Styrene/Acrylates Copolymer (Nano)' in the framework of Regulation (EC) 1223/2009 of the European Parliament and of the Council of Cosmetic Products
Internal market and Industry, Public Health.
Any interested parties, including: Member State Authorities; manufacturers of cosmetic products; producers of the substances concerned; and relevant industry and consumers associations.
Period of consultation: 25 March to 30 June 2015
Article 2(1)(k) of Regulation (EC) No 1223/2009 establishes that “nanomaterial" means an insoluble or biopersistent and intentionally manufactured material, with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm.
That definition covers only materials in the nano-scale that are intentionally made, and are insoluble/partially-soluble or biopersistent (e.g. metals, metal oxides, carbon materials, etc), and it does not cover those that are soluble or degradable/non-persistent in biological systems (e.g. liposomes, emulsions, etc).
Article 16 of the Cosmetics Regulation requires any cosmetic product containing nanomaterials to be notified to the Commission, six months prior to being placed on the market, and Article 19 requires nano-scale ingredients to be labelled (name of the ingredient, followed by ‘nano’ in brackets). If there are concerns over the safety of a nanomaterial, the Commission shall refer it to the Scientific Committee on Consumer Safety (SCCS) for a full risk assessment.
The Commission has received several notifications of body and face care products containing the ingredient ‘Styrene/Acrylates copolymer’(nano) CAS 9010-92-8 and 'Sodium styrene/Acrylates copolymer' (nano) CAS n. 9010-92-8, EC n. 310-104-0. These ingredients ‘Styrene/Acrylates copolymer’ and 'Sodium styrene/Acrylates copolymer ‘ as such are not regulated in Cosmetic Regulation (EC) No 1223/2009 but they are reported in the Cosing database with cosmetic functions as film forming, opacifying and viscosity controlling. According to the applicant the ingredients are used as skin conditioning in nano form with a lowest cut of 20nm and at maximum concentration up to 0.06% in cosmetic products.
Action proposed by the Commission
The Commission has concerns on the use of ‘Styrene/Acrylates copolymer’ (nano) and 'Sodium styrene/Acrylates copolymer'(nano) because of the potential toxicity for nanoparticles that may enter into cells and because the data submitted by the applicants seems to be insufficient to carry out a full risk assessment. The dossier shall be in line with the SCCS's Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation (8th revision) and with SCCS Guidance on the safety assessment of nanomaterials in cosmetics .
In order to prepare requests for scientific opinions to the Scientific Committee on Consumer Safety (SCCS) interested parties are invited to submit any relevant scientific information on the safety of ‘Styrene/Acrylates copolymer’(nano) CAS n. 9010-92-8 and 'Sodium styrene/Acrylates copolymer'(nano) CAS n. 9010-92-8, EC n. 310-104-0 used in cosmetic products and, in particular data regarding all toxicological end-points and an indication on the suggested concentration safe limits for these ingredients.
In view of the above, the Commission would like to invite any interested parties, including authorities of the Member States, manufacturers of cosmetic products, producers of ‘Styrene/Acrylates copolymer’ (nano) and 'Sodium styrene/Acrylates copolymer' (nano), relevant industry and consumers associations, to submit their contribution.
How to submit your contribution
Any comments should be sent with the reference:
STYRENE/ ACRYLATES COPOLYMER (nano)’ and 'SODIUM STYRENE/ ACRYLATES COPOLYMER (nano)'
by post or e-mail by 30 June at the latest to:
Directorate General Internal Market, Industry, Entrepreneurship and SMEs
Unit/I4, Health Technology and Cosmetics,
Jean-André de Mot, 24, Office 02/082