How Will the New Technical Guidelines Influence Health Food Registration?

On Nov. 5^th, ChemLinked wrote about China publishing three new guidelines on health food testing and assessment. This article however clarifies the technical details and analysis on the three new guidelines.

According to Administrative Measures for Registration and Filing of Health Foods, health food registration applicants should submit evaluation document on product safety and health food function. Such evaluation document includes:

1. Evaluation materials on the safety of non-listed raw materials and the product;

2. Evaluation materials on the health care function test of non-listed raw materials and the product;

3. Evaluation materials on the consumption of the product by human beings;

4. Testing report on the functional ingredients or characteristic ingredients, hygiene and stability;

5. Testing report on strain identification, strain virulence, etc;

6. Testing report involving stimulants and illegal drugs.

* Non-listed means not listed in the Health Food Raw Materials Directory.

The three guidelines published this time mainly affect document number 1, 4, 5, and 6 listed above.

• Technical Guideline for Toxicological Testing and Assessment of Health Foods and Their Raw Materials (2020)

Compared with the 2003 technical standard, the 2020 technical guideline for toxicological testing and assessment emphasizes on document requirements for the test substances, design principle of testing plans, processing method of test substances, selection of test items and determination of results.  

The key change is that one of the toxicological tests is changed from the 30-day feeding test to 28-day oral toxicity test, which means there will be more test items and higher test expenses. Part of the test comparison is as follows.

• Technical Guideline for Physicochemical and Hygienic Examination and Assessment of Health Food (2020)

This guideline applies to testing for health food registration and filing. It stipulates basic hygienic testing requirements for health food, its raw materials and auxiliary materials, test method of characteristic ingredients or functional ingredients, determination requirements of solvent residue and prohibited ingredients.

Regarding test method of characteristic ingredients or functional ingredients, this guideline lists detailed test methods for ingredients such as L-carnitine, α-Linolenic acid, etc., and recommends GB standard test methods such as GB/T 22252 for coenzyme Q10, GB/T 5009.170 for melatonin, GB/T 5009.197 for nicotinamide and caffeine, etc. It is worth noting that these test methods for functional ingredients are recommended test methods, not compulsory. Registration applicants can choose appropriate test methods that fit their products.

• Technical Guideline for Safety Testing and Assessment of Bacterial Strains Used in Health Food Raw Materials (2020)

This guideline is a new evaluation procedure supplementing current health food regulatory system. It evaluates pathogenicity of bacterial strains used in health food raw materials. In 2019, SAMR consulted on Application and Evaluation Rules of Probiotics Related Health Food, which was the first time required to provide pathogenicity testing report of bacterial strains.

Evaluation methods and document requirements are included in this new guideline. The evaluation methods include whole genome sequencing, animal pathogenicity test, and toxin-producing test. Some of the required documents are as follows.

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