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In 2021, China has expanded the health food filing dictionary, some functional ingredients such as Coenzyme q10 has been officially included in the filing dictionary, also DHA and protein may be included in the filing dictionary soon. A series of new regulations are assisting the health food filing to a new stage. However, the functional evaluation test method for the registration process has not been implemented, how do the enterprises plan for new product registration becomes the focus. In the meanwhile, the authorities have published many food supplement label related regulations, and many of them have the big impact on the health food labels from 2022.
In 2021, the National Health Commission of the People's Republic of China (NHC) issued five announcements (No.9, 2020; No.2, 2021; No.5, 2021; No.6, 2021; No.9, 2021) for the approval of new food additives, with 35 new food additives (including expanded use) approved. Besides, from websites of NHC and China National Center for Food Safety Risk Assessment (CFSA), in 2021, a total of 61 new food additives applications were accepted, and 49 new food additives (including expanded use) passed the technical evaluation and were issued for public comments.
In 2021, the National Health Commission of the People's Republic of China (NHC) issued 3 announcements (No.9, 2020; No.5, 2021; No.9, 2021) for the approval of new food raw materials (novel food), with 8 substances approved. Besides, the websites of NHC and China National Center for Food Safety Risk Assessment (CFSA) shows that a total of 25 new food raw materials applications were accepted, 6 of public comments on ingredients were issued, and 11 of ingredients review were terminated.
In 2021, the National Health Commission of the People's Republic of China (NHC) issued 4 announcements (No. 9, 2020, No. 2, 2021, No. 6, 2021, and No. 9, 2021) for the approval of new food-related products (herein "new food contact additives and resins"). Totally, 37 new food contact additives and resins (including expanded use) are approved. Besides, from the website of NHC and China National Center for Food Safety Risk Assessment (CFSA), a total of 56 new food contact additives and resins application were officially accepted and 46 food contact additives and resins (including expanded use) were issued for public comments.
On 12th Apr. 2021, the General Administration of Customs, P.R.China (GACC) issued the Registration and Administration of Overseas Manufacturers for Imported Foods (GACC Decree No.248), which has come into force as from 1st Jan. 2022. From 1st Jan, 2022, food products imported into China without the GACC registration have the potential risks to be held by the local customs in China. In the past six months, there have been some updates from GACC regarding this registration obligation including the online registration system and the relevant guidance. Currently, it’s challenging for many overseas companies due to the limited time and registration process.
In 2021, Chinese authorities issued a series of health food regulations to support the implementation of the dual-track system of health food registration and filing. CIRS has comprehensively summarized the key points of health food regulations issued in 2021, and made an outlook on the development trend in 2022.
On January 13, 2022, SAMR issued five drafts about the permitted health functions and the corresponding evaluation methods for functional health food to solicit opinions for the second time. The deadline for public comment is February 12, 2022. The important information in these drafts are as follows:
Until now, totally 81 FSMP products have been approved in China, including 52 domestic products and 29 foreign products. Among the 81 approved products, the dosage forms of 62 products are powder, and only 19 products are liquid. In terms of product type, as shown in the figure below, 36 of them are infant formula for special medical purposes, 25 are nutritionally incomplete food, and 20 are nutritionally complete food. While specific nutritionally complete food have not been approved until now.
On January 7, 2022, State Administration for Market Regulation (SAMR) issued the Notice on Strengthening the Quality and Safety Supervision of Solid Beverages (Notice of No.46, 2021), which put forward many new requirements for the labels of solid beverages. The Notice will be implemented from June 1, 2022. Related enterprises are recommended to make preparations for label rectification in advance.
In order to help enterprises better understand the filing status of health food (dietary supplement) in China, CIRS counted the data of filed products published in 2021 and made an analysis for your reference.