The unique Specialty Foods regulations in the Great Chinese Areas – especially for Taiwan and Mainland China

Newton Yau

In terms of so called “specialty food” including dietary supplements, functional foods, pharmaceuticals, capsule and tablet foods, health foods, infant formula foods, elderly foods, foods for special medical purposes, foods for sport nutrition etc., will be regulated in special regulations both in Taiwan by Taiwan FDA/TFDAand Mainland China by SAMR/CFDA.

  1. Capsule and tablet foods : means all foods that in type of capsule or tablet which consumers are not able to expect what ingredient(s) will be.
  2. Foods for special medical purposes : means those foods design for diabetic, cancers, chemotherapy, and so on.

Some international companies will choose Taiwan as a trial for the huge market in Mainland China. To get the food regulation compliance in Taiwan (Taiwan food compliance) become a need recently. As mentioned above, all the specialty food will need to get approval letter or registration number before you can export to Taiwan. The most confusing one is the category of capsule and tablet foods. You need to register with TFDA even you only have common food ingredients in it. You are even not able to sell it as general food in Mainland China. This means that officers in both areas do not believe general food/common food/regular food/conventional food should be in a capsule or tablet form.

Infographic to distinguish the categories of
Specialty Foods with TFDA/CFDA

You will need enough scientific supporting documents for these specialty food. The test report done in the original country can be the reference evidence when you deal with TFDA while they only accept the test done in Mainland China as you deal with CFDA.

TFDA regulation compliance
CFDA regulation compliance