EC concerned of use of silica in nano form
The move comes after the Commission received 172 notifications for cosmetic products containing silica, hydrated silica, sylilate and silica dimethyl silylate.
These substances function as anti-foaming, anti-caking, bulking or skin-conditioning agents used in nano form in leave-on and rinse-off cosmetics, including hair, skin, lip, face, and nail products, with different concentrations and specifications.
Currently the ingredients are not regulated in Cosmetic Regulation (EC) No 1223/2009, but are reported in the Cosing database with several cosmetic functions.
"The Commission has concerns on the use of silica in nano form because of the potential high exposure in many types of products and because concerns have been raised regarding the potential for nanoparticles of silica to break out of the agglomerates and enter cells."
Thus, the body has requested the SCCS to carry out a safety assessment on the four ingredients.
Nano regulation in Europe
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.
According to the EC, 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).
The European Commission has been receiving a lot of pressure of late to close up 'loopholes' in its nanomaterial regulation by establishing a new stand-alone piece of legislation, to clear up and provide in more detail, information that failed to be provided in its second regulatory review last month.
It recently received pressure from NGOS, 'ClientEarth' and 'Friends of the Earth Germany' in the form of a proposal backed by several EU members, urging for loopholes to be 'patched up' for assessing and regulating nanomaterials.