Recently, the draft of the group standard "General Principles for Postbiotic Foods" drafted by the China Health Association was released for comments. In the industry's view, my country's big health industry is in urgent need of transformation and upgrading. As an excellent health effect factor, postbiotics have broad market potential and industry paths. The formulation of this group standard will help my country's postbiotic industry develop with high quality.
Health benefits highlight the promising market prospects
The draft for comments indicates that according to the consensus statement of the International Scientific Association for Probiotics and Prebiotics ( ISAPP ) , postbiotics refer to preparations of inanimate microorganisms and / or their components that are beneficial to the health of the host, including two categories: bacterial metabolites (exopolysaccharides, organic acids, short-chain fatty acids, etc.) and bacterial components (wall teichoic acid, lipoteichoic acid, cell wall polysaccharides, etc.). Heat-inactivated probiotic cells, cell-free supernatants and other active ingredients can produce beneficial effects, such as balancing intestinal flora and regulating physiological functions. At the clinical level, products containing inactivated bacteria also play a role in the treatment of gastrointestinal diseases, including abdominal distension, diarrhea, infantile colic, etc. Inactivated bacteria can also play a role in the management of skin or respiratory allergic diseases. Postbiotic preparations have more advantages than probiotics in terms of safety, physiological effects and stability, and have very broad development potential and application prospects.
Although many studies have been conducted on postbiotics at home and abroad, especially in foreign markets, there are many applications in food, but in fact, there are no relevant standards and regulations in the world, and no regulatory agency has proposed a definition of postbiotic-containing foods or food supplements. There is also a lack of relevant standards for postbiotics in China. The current domestic probiotic food management regulations and related technical specifications are not compatible with some new research on probiotics, and there are no relevant regulations on the application of inactivated bacteria and bacterial metabolites.
At present, my country is facing an urgent need for transformation and upgrading of the health industry. As an excellent health effect factor, postbiotics have broad market prospects. In order to meet market demand and the actual production needs of enterprises and further ensure the quality and safety of products, the group standard drafting group has formulated the "General Principles for Postbiotic Foods" group standard in accordance with the requirements of the "Standardization Law of the People's Republic of China" and the "State Council's Plan for Deepening the Reform of Standardization Work" and other documents, as the basis for the production, inspection, storage and sales of enterprise products.
Filling the gaps in regulations and promoting industry development
It is understood that the current domestic standards related to postbiotic foods include T/CBFIA09001-2023 "Probiotic Products Lactic Acid Bacteria Postbiotics" issued by the China Bio-fermentation Industry Association. This standard applies to postbiotic products produced with lactic acid bacteria probiotics as strains, and the technical requirements include sensory indicators, physical and chemical indicators, and safety indicators. The standard stipulates that the sources of strains for postbiotic products mainly include the "List of Bacteria That Can Be Used in Food" and brewer's yeast, a total of 39 strains of probiotics. In addition to sensory, physical and chemical, and microbiological indicators, the technical requirements also add indicators of equivalent substances such as crude polysaccharides, organic acids, and free amino acids.
From a foreign perspective, no country has yet issued standards for postbiotic products. The European Food Safety Authority evaluates the safety of food strains through the Qualification for Safety ( QPS ) procedure , which can be applied to the evaluation of microorganisms used to prepare postbiotics. If microorganisms not included in the QPS list are used to produce food, it is necessary to apply for new resource food approval in accordance with the relevant EU regulations on the management of new resource foods.
The U.S. Food and Drug Administration ( FDA ) manages food strains and food additives through Generally Recognized as Safe ( GRAS ), adopts the " enterprise self-recognition, FDA filing system " to evaluate the safety of substances and form a GRAS list. Currently, the FDA can file products for the use of inactivated strains in food by declaring GRAS .
Japan can apply for health claims on food through three channels, namely, Food for Specific Health Use ( FOSHU ), Food with Nutrition Function Claim ( FNFC ) and Food with Function Claim ( FFC ). Currently, no related products containing inactivated microorganisms have been approved for FOSHU . FFC does not require approval, but the necessary materials such as safety, efficacy evaluation and scientific basis, production and quality management methods must be submitted to the Consumer Affairs Agency 60 days before listing . The government does not provide a license label. Currently, only a few inactivated lactic acid bacteria products have applied for FFC licenses, such as lactic acid bacteria beverages prepared by heat-killed Lactobacillus paracasei KW3110 , Lactobacillus amylovora CP1563 and Lactobacillus gasseri CP2305 .
Food Standards Australia New Zealand and the Australian Department of Health have not yet issued standards and regulations related to postbiotics. If a food needs to declare a health claim, the company must independently conduct a systematic review to confirm the relationship between the food and the health claim in accordance with the "Nutrition, Health and Related Claims" provisions of the Food Standards Code , and inform the Australian government of the evaluation results.
In the Natural Health Foods Regulations ( NHPR SOR/2003-196 ) issued by the Canadian Ministry of Justice , bacteria, fungi and their extracts or isolates whose molecular structures have not been changed can be regarded as " natural health foods ( NHP ) " . Based on this, some inactivated microbial products can submit applications to the Canadian Ministry of Health as natural health foods, and the Ministry of Health will review the product ingredients and health effects. At present, related inactivated brewer's yeast products have obtained the health claim of " helping to reduce the incidence of cold and flu symptoms " in Canada .
It is understood that the scope of application of the group standard formulated by the China Health Association this time is: foods with inactive microorganisms and / or their metabolites as raw materials. Postbiotic foods in this group standard are classified as ordinary foods, and the labels must not indicate content with health-care effects, disease prevention or treatment effects.
The postbiotics referred to in the group standard are preparations of inactivated microorganisms and / or their metabolites for food that are beneficial to the health of the host, excluding purified metabolites; postbiotic foods: foods that use postbiotics as raw materials and may or may not add other food raw materials and food additives. The strains are derived from the list of food strains issued by the National Health Commission and subsequent announcements, and should be identified and evaluated for safety at the strain level.
Industry insiders believe that the group standard will guide postbiotic food manufacturers to improve their technology and management levels, improve product quality, and thereby drive quality improvement in the entire probiotics industry; at the same time, it can promote continuous innovation among probiotic food manufacturers, promote the rapid transformation and market application of advanced results, form economies of scale, and generate good social and economic benefits.