China Publishes New Guidelines on Health Food Testing and Assessment

On October 31, 2020, China State Administration for Market Regulation ("SAMR") published three health food related technical guidelines for testing and assessment, which took effect immediately. ^[1] The three guidelines are:

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

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

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

Background Info

In 2018, China abolished Technical Standards for Testing & Assessment of Health Food (2003). The 2003 technical standards included contents of functional evaluation, toxicological evaluation and functional ingredient evaluation on health foods. Since its abolition in 2018, test reports based on the 2003 technical standards could no longer be considered as support of technical review for health food registration.

In April 2019, SAMR once revealed drafts on health food toxicology and strain pathogenicity evaluation standards (predecessors of the toxicological testing guideline and bacterial strain testing guideline published this time) for public comments.

Main Contents

The three new guidelines are considered to replace partial content of the 2003 technical standards on toxicological evaluation and functional ingredient evaluation while there is still no replacement for the functional evaluation content.

1. Toxicological testing guideline

Compared with the 2003 technical standards, the 2020 toxicological testing guideline has expanded the test substances from "health food products" to "health food products or health food raw materials". The general toxicological testing items have also been changed from "acute oral toxicity test, genetic toxicity test, and 30-day feeding test" to "acute oral toxicity test, three genetic toxicity tests and 28-day oral toxicity test". 28-day oral toxicity tests on more items than 30-day feeding test, which means stricter toxicological test will be performed on health food.  

It is worth noting that in the 2019 draft of toxicological guideline, health food using substances listed in the Health Food Raw Materials Directory as raw materials that were produced by traditional food manufacturing techniques, eaten via the traditional method and with a compliant recommended consumption amount, were expected to be exempted from toxicological tests. While in the 2020 guideline, such products still need to perform toxicological tests.

2. Bacterial strain testing guideline

The Technical Guideline for Safety Testing and Assessment of Bacterial Strains Used in Health Food Raw Materials includes new content that the 2003 technical standards did not cover. It stipulates the test method and evaluation procedure on pathogenicity of bacteria, filamentous fungi and yeast used as health food raw materials.

According to this guideline, if the animal test shows that the test substance is pathogenic, or it produces high levels of toxic metabolism which will affect human health through long-term intake, the test substance should not be used in health foods.

3. Physicochemical and hygienic examination guideline

The physicochemical and hygienic examination guideline replaces the content of functional ingredient evaluation in the 2003 technical standards. It specifies that it is applicable to health food registration examination and health food filing examination. A brief comparison is shown below.