IL-072 – Insolubility of Silica and its Classification as Nanomaterial (Update of IL-069)

Dear All,

As reported in the recent IL-069, the SCCS released a new interpretation regarding the classification of silica as ‘Nanomaterial’. This one has a considerable impact on all cosmetic brands using Silica in their products and it mainly affects the make-up product category.

Indeed, the SCCS strongly contradicts the position of the industry and concludes that Silica is insoluble and therefore may qualify as ‘nanomaterial’ if more than 50 % of its particles has a size below 100 nanometers. Please, note that this letter applies to Silica but also the related materials that follow: Hydrated Silica, Silica Dimethyl Silylate, Silica Silylate, Silica Dimethicone Silylate, Silica Caprylyl Silylate and, Silica Cetyl Silylate.

The Belgian Ministry of Health (BIORIUS’ Supervisory Authority) confirmed that this new interpretation must be applied immediately. The Belgian Authorities do not exclude the possibility of a new interpretation in the future but, in the meantime, the SCCS Opinion must be strictly applied.

The French Authorities reported at a meeting with the European Commission that cosmetic products will have to be withdrawn from the French market in case they contain:

  • Silica considered as a nanomaterial in the light of the new SCCS interpretation
  • but declared as non-nanomaterial at the time they were placed on the market.

This very strict position is raising high concerns and Cosmetics Europe (the European trade association) is expected to challenge the SCCS interpretation soon. A successful resolution of this problem is hoped but, in the meantime, BIORIUS and its clients have to cope with these two regulatory obligations in case the particle size of the used Silica is below the cut-off limit:

  • The “nano” status of this Silica must be highlighted in the list of ingredients to be labeled on the cosmetic product. The traditional way to do it is to label “SILICA [NANO]”.
  • Cosmetic products containing this nano-form of Silica will be subject to a specific notification to the European Commission by the Responsible Person 6 months prior to being placed on the market. This specific notification is a complicated exercise that will come with additional expenses for the cosmetic brand.

To the best of our knowledge, the Belgian Authorities seem to have a different point of view as the French ones and would consider that these products already placed on the European market do not have to be withdrawn and only the list of ingredients (and Product Information File) should be updated. Shade extensions would qualify as “products already placed on the European market”.

We hope that this letter will be of help and stay at your disposal for any questions related to this topic. Should you have any questions, please, feel free to contact your dedicated Account Manager.

Best regards,

Dr. Fred Lebreux