Probiotics health food registration reviewguidelines will be revised

Recently, the General Administration ofMarket Regulation (GAMR) revealed in the "Response to Proposal No. 7177 ofthe Fifth Session of the Thirteenth National People's Congress" that inorder to further standardize the registration requirements of probiotic healthfood, improve the quality and safety efficacy level of probiotic health foodand promote the high-quality development of the industry, GAMR is organizing torevise the "Guidelines for Registration and Review of Probiotic HealthFood".

Compared with the "Probiotic HealthFood Declaration and Review Regulations (for Trial Implementation)" issuedby the former State Food and Drug Administration in 2005, the followingcontents have been added and revised: the definition of probiotics has beenadded and the definition of probiotic health food has been revisedsimultaneously; as the safety and efficacy of different strains of the samestrain are not entirely consistent, the management of probiotic raw materialsfor health food has been changed from As the safety and efficacy of differentstrains of the same strain are identical, the management of probiotic rawmaterials for health food is raised from the level of "strain" to thelevel of "strain"; the number of live bacteria within the shelf lifeis raised from not less than 106 (6th power of 10) CFU/mL (g) to not less than107 (7th power of 10) CFU/mL (g), so as to ensure Product in the validityperiod of continuous effectiveness; clarify the qualifications of the strainidentification agencies, etc.

Implementation of the registration reviewand approval system management

The Food Safety Law provides that themanagement of food in China is divided into two categories of special food andgeneral food, taking different management methods. Health food, food forspecial medical purposes and infant formula belongs to the special food, exceptfor other foods are commonly known as ordinary food, and ordinary food can notbe functional claims, if the claim is illegal.

Zhang Yongjian, director of the Food and DrugIndustry Development and Supervision Research Center of the Chinese Academy ofSocial Sciences, said in an interview with China Consumer News that there aremany types of probiotics, and people's understanding of the health effects ofeach type of probiotic and the relationship between the amount and effect isdeepening and improving. More and more extensive application of probioticsdepends on relevant theoretical research and clinical trials, which need moresolid and powerful authoritative evidence, from this perspective, science andtechnology is the first productivity to promote the development of probioticfood industry.

Zhang Yongjian pointed out that probioticfood with functional claims in China means health food, and in order to ensurethe safety and effectiveness of the product, it is necessary to manage the typeof probiotic strains, the quantitative-effect relationship with human health,the degree of biological activity and safety in use, in order to safeguard thelegitimate rights and interests of consumers. At present, probiotic health foodproducts need to go through the registration review and approval of the GeneralAdministration of Market Regulation before they can be marketed and sold, andfor this reason, a list of strains that can be used as well as an evaluationmethod has been developed.

Wang Hesong, secretary-general of theHealth Care Advisory Service Committee of the China Health Care Association,said in an interview with China Consumer News that, compared with other commonapproval health food products, the management regulations and supportingtechnical standards of probiotic health food products are in the stage ofupdating iteration and gradual improvement, and more declaration informationand test items are required, which makes the test cycle of probiotic healthfood products longer and The difficulty of filing is higher.

Promote the dual-track system ofregistration and filing

In recent years, China has activelyexplored the inclusion of probiotic raw materials into the health foodingredients directory, and gradually promote the management of probiotic healthfood filing system.

The person in charge of the GeneralAdministration of Market Regulation said that in order to promote thedual-track system of registration and filing of health food, the GeneralAdministration of Market Regulation, in conjunction with the National HealthCommission, issued the "health food raw materials directory and healthcare function directory management methods" to raw material directory andfunctional directory as a grip to further strengthen the production andmanagement, social governance. On the basis of research, relevant units orindividuals can propose the inclusion of health food raw material catalog andhealth care function catalog, and those that meet the requirements will beincluded in a timely manner. At the same time, diversified market players areencouraged to participate in the development of the directory and open up newpaths for research and development of health care functions. Encourageenterprises to both inherit traditional Chinese medicine health theory andfully apply modern biomedical technology to research and develop new functionalnew products to promote the high-quality development of the health foodindustry.