The proposed changes are being made to the existing guidelines, which have been in place since 1999.
Three key changes have been proposed, a regulatory consultancy firm told NutraIngredients-Asia.
First, changes made to the safety testing are made to align with the international standards, specifically, the ‘Guidelines for the Testing of Chemicals’ of the Organisation for Economic Co-operation and Development (OECD).
Second, the TFDA has proposed for to conduct safety testing on health foods products in Good Laboratory Practice (GLP) labs. The personnel conducing the test must also be trained and have experience in food safety or toxicology.
This newly proposed guideline might lead to extra costs for companies which want to register their health foods in Taiwan, Julia Ji, the founder and director of regulatory consultancy firm My Associates pointed out.
“The proposed changes are good for the health foods manufacturers because the requirements are now clearer.
“However, the cost of product safety testing could increase, because some manufacturers might not have GLP labs or personnel with the required expertise to do the testing, and so, they will need to engage third party GLP labs,” she said.
She pointed out that the registration of just one health food product could go up to NTD$1m (US$33k), which is also a reason why some companies would rather go through the notification process to get their product out in the market as a general food.
In this case, such products will not be able to make specific health claims, as this is only applicable to health foods.
With this proposed rule, she added that companies might need to spend a longer time to complete health foods registration, since there might not be plenty of GLP labs available in the first place. This might lead to a long queue for product safety testing, she added.
The deadline for the public consultation is in mid-May.
The draft has also spelled out details on various types of animal testing.
This included the 28-day feeding toxicity test, 90-day feeding toxicity test, carcinogenicity study, reproduction study, and teratogenicity study.
The draft has also limited the testing of the health foods on animals to two ways, via oral gavage or directly adding the product into the animal feed or drinking water.