On January 13, 2022, SAMR issued five drafts about the permitted health functions and the corresponding evaluation methods for functional health food to solicit opinions for the second time. The deadline for public comment is February 12, 2022. The important information in these drafts are as follows:
1. Seven functions will be removed, and related products shall stop production immediately from the date of issuing the announcement
The seven functions include “facilitating milk secretion”, “improving child growth”, “improving skin oil content”, and “tumor suppression”, “assisting tumor suppression”, “anti-mutation”, “delaying senescence” (which were no longer approved by former Ministry of Health). Products with these functions shall stop production immediately from the date of issuing the announcement, and products already produced can be sold to the end of the shelf life.
However, according to the explanation "for approved health foods whose health functions have been all removed, their functions can be changed according to Health Food Registration and Filing Regulation” mentioned in the official interpretation of these drafts, and Table 1 (please see below), CIRS expects that the function of "delaying senescence" can be changed to "anti-oxidant".
2. For the products whose function was evaluated according to the official methods issued in 1996, it is necessary to redo/supplement functional tests and apply for registration change
This announcement requires that: in addition to the above 7 functions, approved health functions that have not been removed or included in the Health Function Directory (such as immune regulation) shall be adjusted according to the latest requirements. For the products whose function was evaluated according to the official methods issued in 1996, it is necessary to redo/supplement functional tests according to Table 1 and apply for registration change (involving 8 health functions). A new registration certificate will be issued when the product can meet the requirements.
Products which do not need to redo/supplement tests shall be adjusted according to corresponding interpretation, and the registration change is not required.
3. The transition period for the registration changes may be five years
The announcement mentions that: after 5 years from the issuing date of this announcement, products whose health functions are not included in Health Function Directory shall not be produced or sold. Therefore, CIRS expects that the transition period for the registration changes for above products may be five years.
4. The overall requirements on functional assessments remain unchanged
It is known that the functional assessment of health food includes animal test and (or) human feeding trials, depending on the specific health functions. Compared with the old version (methods issued in 2003), the requirements on animal test and (or) human feeding trials remain unchanged for the 24 existing health functions in the new drafts. For example, it is still required to carry out animal test for the function that helps to enhance immune, and animal test and human feeding trials are still required for function that contributes to anti-oxidation.
Table 1: Corresponding adjustment specifications to Health Function
Old health functions
New health functions
Functional tests that need to be redone/supplemented when the product function was evaluated according to the methods issued in 1996
Immune regulation, Enhancing immune
Help to enhance immune
Redo animal test
Delaying senescence, Anti-oxidative
Help to anti-oxidative
Supplement human feeding trial test
Memory improvement, Assisting memory improvement
Assisting memory improvement
If the wechsler memory scale is used in the human feeding trial, redo human feeding trial test according to the current regulations
Eyesight improvement, Alleviating eye fatigue
Alleviating eye fatigue
Clear and nourish the throat, Clear the throat
Clear and nourish the throat
Help to improve sleep
Anti-fatigue, Alleviating physical fatigue
Alleviating physical fatigue
If pole-climbing test is used in the animal test, redo animal test according to the current regulations
Anti-anoxia, Enhancing anoxia endurance
Redo animal test
Reducing body weight
Help to control body fat
Redo functional test
Improving osteoporosis, Increasing bone density
Helps to increase bone density
Improving malnutrition anemia, Improving iron-deficiency anemia
Improving iron-deficiency anemia
Beauty (eliminating acne), Eliminating acne
Help to eliminate acne
Beauty (eliminating skin chloasma), Eliminating skin chloasma
Help to eliminate skin chloasma
Beauty (improving skin water content/oil content), Improving skin water content
Help to improve skin water content
Improving gastrointestinal function (regulating gastrointestinal tract flora), Regulating gastrointestinal tract flora
Help to regulate gastrointestinal tract flora
Improving gastrointestinal function (facilitating digestion), Facilitating digestion
Help to facilitate digestion
Improving gastrointestinal function (embellish aperient bowel), Facilitating feces excretion
Help to embellish aperient bowel
Improving gastrointestinal function (assisting the protection from gastric mucosal injury), Assisting the protection from gastric mucosal injury
Assisting the protection of gastric mucosa
Regulate blood lipids (reduce total cholesterol, reduce triglycerides), Assisting blood lipids reduction
Help to maintain healthy blood lipid levels (cholesterol / triglycerides)
Redo human feeding trial test
Regulate blood sugar, Assisting blood sugar reduction
Help to maintain healthy blood sugar levels
Regulate blood pressure, Assisting blood pressure reduction
Help to maintain healthy blood pressure levels
Protection from chemical liver injury, Assisting the protection from chemical liver injury
Assisting the protection from chemical liver injury
Anti-radiation, Assisting protection from irradiation hazard
Assisting protection from ionizing radiation hazard
Redo animal test
Alleviating lead excretion
Help to alleviate lead excretion
1. If the original functional evaluation methods were collaborative standards or without regulatory basis, and there are substantial scientific differences with the new methods (2022 version), the functional test shall be redone.
2. For the products in production and on sale, when it is required to redo or supplement functional test, the human consumption analysis report issued by a third-party inspection agency can be provided.
3. Products which do not need to redo/supplement tests shall be adjusted according to the interpretation of Health Function Directory, and registration change is not required.
Reference: SAMR Notice (2022.01.13)