Should Bacterial Cultures in the List for Health Food Adapt to the New Taxonomy for Food and Baby Food?

In China, there are three positive lists related to bacterial cultures in the food sector. They are

In terms of the ingredient compliance of health food, it is permitted to use the bacterial cultures listed in “Bacterial Cultures Permitted in Foods” or “Probiotics Permitted in Health Food”. Actually, most species detailed in the list for health food are also included in the list for general foods. Please note, bacterial cultures permitted in foods, which refer to general foods, can be used in health food but bacterial cultures only permitted in health food cannot be used in other food categories.

On August 25, 2022, China’s National Health Commission (NHC) amended the lists of permitted bacterial cultures in (regular) foods and baby foods. The amendment systematically adjusts the names and classification of bacterial cultures in line with international regulations and the latest research. A two-year grace period is given for bacterial cultures whose classifications and names are changed. In this context, should the bacterial cultures permitted in the list for health food adapt to the new taxonomy for food and baby food, or shall it remain unchanged?

To answer this question, it is necessary to understand why the list of “Probiotics Permitted in Health Food” is not updated by NHC this time. The three lists mentioned above are all first released by the former Ministry of Health. The list of probiotics permitted in health food was released quite early in 2001 and updated in 2003. Later in 2010 and 2011, the formal Ministry of Health released the lists for bacterial cultures permitted in food and baby food respectively, and further updated the two lists afterwards. In 2013, the Ministry of Health and another authority were incorporated into the National Health and Family Planning Commission (NHFPC). In 2018, China underwent government institutional reform. Ever since then, replacing the role of the former NHFPC, the National Health Commission has taken charge of the food safety work including formulating food safety standards, undertaking safety reviews of food raw materials, etc. Therefore, it is NHC’s responsibility to amend the two lists of bacterial cultures permitted in foods and baby foods. However, when it comes to the management of health food, things are a little different. After the institutional reform, China’s State Administration Market Regulation (SAMR) is now the major authority supervising the safety and quality of health food, such as revising the raw material directory for health food. In another word, the list of “Probiotics Permitted in Health Food” shall be supervised by SAMR currently.

Go back to the first question, “shall the bacterial cultures permitted in health food follow the new taxonomy for regular food and baby food?” To answer this question, ChemLinked reached out to officials from SAMR. An official from the special food bureau of SAMR, the authority takes charge of this issue, told ChemLinked that bacterial cultures in health food is supposed to go align with the new taxonomy and they will discuss it in details. Another official from the Center for Food Evaluation of SAMR (CFE) explains their evaluation criteria for this case—when evaluating the registration application of a new health food product, if the legal basis of using permitted bacterial cultures is the list of “Bacterial Cultures Permitted in Food”, it is necessary for enterprises to follow the new taxonomy. If the legal basis for using bacterial culture is the list of “Probiotics Permitted in Health Food", then it is allowed to use the old taxonomy since the notice released around 2003 is not repealed at present. Based on the information ChemLinked collected at present, our suggestion for this question is to follow the new taxonomy when using permitted probiotics in health food. As a two-year grace period is given, there is still time to have further confirmation with the special food bureau of SAMR. Please stay tuned with ChemLinked.