Still Valid! Nine Functional Evaluation Methods for Health Food You should NOT Ignore - Regulatory News - Food & Food Contact Materials

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In recent years, trapped in the lack of functional evaluation methods, the registration progress of health food has stalled. However, there are still nine valid, but easy to ignore, functional evaluation methods. If you are feeling a little uncertain, this article can help you gain a clear new insight into health food registration in China.

1. Background: The repeal of the Technical Regulations for Health Food Inspection and Evaluation (2003 Version)

In July 2018, the National Health Commission (NHC) announced the repeal of the Technical Regulations for Health Food Inspection and Evaluation (2003 Version), resulting in the registration of most health food products being brought to a standstill. Subsequently, the State Administration for Market Regulation (SAMR) organized to revise the functional evaluation methods for health food and has opened it for public consultation twice. However, the official version has not yet been released.

2. Chance: Nine valid methods for functional evaluation

In 2012, the State Food and Drug Administration issued a Notice about revising nine functional evaluation methods involving anti-oxidative and other eight health functions. In August 2022, the Notice was issued again by the SAMR and remained in effect, so the registration of new products with the nine health functions can still be carried out normally.

At present, the new technical regulation for functional evaluation methods keep failing to be enacted yet. Developing new health food based on the nine health functions and applying for registration can be a good choice for health food manufacturers to launch new products on the market.

Table 1 shows the specific information on the nine health functions and their required functional evaluation tests:

Table 1: Test Requirements for the Nine Valid Health Functions

Number	Health Function	Animal function test and (or) human trial test
1	Anti-oxidative	Animal function test + Human trial test
2	Assisting the protection of gastric mucosa	Animal function test + Human trial test
3	Assisting blood sugar reduction	Animal function test + Human trial test
4	Alleviating eye fatigue	Human trial test
5	Improving iron-deficiency anemia	Animal function test + Human trial test
6	Assisting blood lipids reduction	Animal function test + Human trial test
7	Alleviating lead excretion	Animal function test + Human trial test
8	Reducing body weight	Animal function test + Human trial test
9	Clearing the throat	Animal function test + Human trial test

3. Readiness: Test requirements for health food registration and application of new health function

Considering that the registration of health food is currently at the mercy of the release of new functional evaluation methods, enterprises can sift new products with health functions mentioned above. Meanwhile, enterprises can also learn more about test requirements for the 24 health functions according to the Directory of Health Function Available to Claim for Non-Nutrition Supplement Health Food (2022 version) (Draft) and to be prepared for seizing the market.

Furthermore, enterprises with solid technical strength can pay close attention to the release of the Detailed Rules for Technical Evaluation of New Functions of Health Foods (Trial), get out of the limited 24 health functions, and expand into new health food markets.

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