China Consults on Procedures for Evaluating the Safety of Bacterial Cultures for Food Use

On February 13, 2023, China opened 38 national food safety standards for consultation, involving standards related to complementary baby foods, foods for special medical purposes (FSMP), food additives, food contact materials (FCM), contaminants, etc. Any comments can be sent back prior to March 20, 2023 via online system. Read the full list of the 38 standards and analysis to other standards at China Unveils 38 National Food Safety Standard Drafts.

This article focuses on the consultation draft of "Procedures for Evaluating the Safety of Bacterial Strains for Food Use" (official link; for users who cannot open the official link, you may visit ChemLinked Regulatory Database).

Major Content

At present, there’s no national standard in China regulating the safety evaluation procedures of bacterial strains for food use. To formulate this national standard, the expert team referred to the Guidelines for the Evaluation of Probiotics in Food drafted by FAO/WHO in 2002, the novel food supervision requirements in EU and a document released by US FDA named Guidance for Industry: Recommendations for Submission of Chemical and Technological Data for Food Additive Petitions and GRAS Notices for Enzyme Preparations. Actually, this is the second draft opening for public feedback, following the public consultation of the first draft in 2021.

Just like the first version, this consultation draft stipulates the application scope, terms and definitions, basic materials needed for safety evaluation, evaluation method, the way to judge test results, and six annexes to explain the involved test and determination methods. But there are some important revisions.

First, the application scope is changed. The new draft is proposed to be applicable to the safety evaluation of live microbial cultures (including bacteria, filamentous fungi, yeast, actinomycetes bacteria and single-celled algae) for food and/or food additive use; and is not applicable to genetically modified microorganisms. Compared to the first version, the new draft deletes “health food” and “novel food ingredient” from the application scope. Without being expounded in the compilation explanation, the deletion can lead to different understandings. As health food is still a kind of food, for people who haven't read the first consultation draft, they may think this draft is applicable to food including health food. However, for people who find the differences between the two drafts, they may believe health food is excluded from the draft due to the deletion, and also health food can be subject to a separate document Technical Guideline for Safety Testing and Assessment of Bacterial Cultures Used in Health Food Raw Materials. ChemLinked has submitted this feedback to the online platform and asked for further clarification.

Second, basic materials needed for safety evaluation are revised, including the materials related to the taxonomy of bacterial culture. Materials related to genetic stability are newly required.

Third, requirements become more flexible. For example, the draft deleted many requirements related to whole genome sequencing so that enterprises can provide data based on practice. Moreover, besides the test methods specified in the draft, stakeholders are also allowed to adopt other methods which have equivalent effect.

Last, the judgment for the safety evaluation result is optimized. For example, the principle to judge a safe bacterial culture is expanded to three conditions. The judgement to drug resistance is more rigorous.

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