Aqueous Extract of Seed of Broccoli Case

Brassica company had innovated powerful novel ingredient, aqueous extract of seed of Broccoli, and would like to launch it in Taiwan. Broccoli, of course, is a general food and can be consumed daily. Extract of Broccoli seed, however, does not have human consumption history over 25 years since it is produced by a patented process.

SCG had suggested that it should apply for non-traditional food ingredient approval via so called attachment-2 process with Taiwan FDA while Brassica decided to apply for traditional food ingredient approval via so called attachment-1 process with TFDA. Of course, the documents (especially for safety assessment like 90-days feeding test or even genotoxicity test) are not required for attachment-1 process while these are required for attachment-2 process. SCG was consigned to do so for Brassica. TFDA had refused the application 7 months later with official document saying you should go with the attachment-2 process.

One years later, after Brassica was done with the required safety assessment tests, consigned SCG to apply with TFDA again via the attachment-2 process. Two years later, SCG had helped Brassica finally got the approval letter from TFDA.