Food Additives and Cosmetics
Evaluation of an application to use Fullerene C60 as a food additive
Report no: 2010: 41
An application to use Fullerene C60 as a food additive does not fulfil the requirements for being evaluated by the EU Commission and EFSA.
This is the conclusion of an evaluation performed by the Panel on Food Additives, Flavourings, Processing Aids, Materials in Contact with Food and Cosmetics of the Norwegian Scientific Committee for Food Safety (VKM) on a request from the Norwegian Food Safety Authority (Mattilsynet).
The applicant has applied for a permission to use Fullerene C60 as an admixture/antioxidant in salmon- and fish oil and claims improved storage stability of fish oil in the presence of this preservative. Fullerene C60 is of particle nature (nanoparticle).
An application of the same product for the same use was submitted to the Norwegian Food Safety Authority by the company in 2006. This first application underwent a preliminary evaluation by VKM, which concluded that the application could not be assessed due to lack of data and poor presentation.
Based on the comments from VKM to the first application, the company has now submitted a new application with an updated dossier to the Norwegian Food Safety Authority.
VKM was requested to consider if the documentation and data in the updated dossier from the applicant is sufficient for the application to be submitted to the EU Commission and EFSA for further evaluation.
The VKM Panel has evaluated if the new application fulfils “Guidance on Submissions for Food Additive Evaluations by the Scientific Committee on Food (SCF, 2001)” which is used by the European Food Safety Authority in such evaluations.
The VKM Panel has concluded that the dossier is poorly presented and the summarised data are difficult to understand. Most of the key safety data are lacking and the relevance of some of the summarised data are questioned.
The VKM Panel is therefore of the opinion that the application does not fulfil the requirements for being evaluated by the EU Commission and EFSA.