Česká a slovenská asociace pro speciální potraviny (ČASP)

This is to inform you that EFSA has launched a call for genotoxicity data on sorbitol (E420 i) 

Deadline for registering interest to provide data is 24 July 2023
Deadline for the submission of data is 3 January 2024

The requested data cover data on toxicology and specifically missing data related to an in vitro micronucleus test performed following the more recent version of the relevant OECD guideline (TG 487).

A preliminary assessment did not highlight the need for additional data to be generated, so sorbitol was not included in the latest call for data on genotoxicity. However, a substantial proportion of the genotoxicity studies available were completed prior to current OECD test guidelines, thus resulting in limitations. The need for this additional genotoxicity data was  identified.

In the event of a negative response in the assay, the assessment could be completed and sorbitols considered not genotoxic. In the event of positive results, an in vivo follow-up would be needed in accordance with EFSA Guidance. 

If you are using sorbitol in your products, we trust you will inform your suppliers to undertake appropriate action.

Information on the call can be found here: https://www.efsa.europa.eu/en/call/call-data-genotoxicity-data-sorbitol-e-420-i

It is gradually becoming clear what the Commission is intending to do.

This is to inform you that at yesterday’s EFSA NDA panel meeting (open to observers), two topics of importance to food supplements were discussed and adopted.