Why TFDA needs the two studies on Non-traditional edible ingredient listing

Currently, a lot of international clients asked why TFDA needs 90-days sub-chronic toxicity study and teratogenicity test which they do not prepared. The key point they raised is XXX governmental agency did not require these two studies as they did apply for novel ingredient to.

For TFDA, non-traditional edible ingredient listing application, like NDI/GRAS in US and novel food in EU, will focus on the safety assessment and consumption history. There are two pathways on the application for non-traditional edible ingredient listing to TFDA, so called attachment 1 pathway and attachment 2 pathway. The choice of the pathways depends on the novelty of the ingredient. The novelty ingredient depends on the consumption history, the novelty of the process, the novelty of the species, the approval(s) got from the other governmental agency(ies).

If the status of the target ingredient belongs to higher novelty, then the attachment 2 pathway will be required. If the target belongs to lower novelty, then the attachment 1 pathway will do. If your target is required through the attachment 2 process, then 90-days sub-chronic toxicity study and teratogenicity test will be required by the written regulation published by TFDA. In this situation, there is no way to avoid the two tests even though you had GRAS from USFDA in recent years. Unless, you have had the GRAS for over 10~15 years without any adverse report.

Novel ingredient apply to TFDA