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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, 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:
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.
As of December 31, 2021, according to the Special Food Information Query Platform of the State Administration for Market Regulation (SAMR), 112 health food (dietary supplement) products got the registration approval in China in the year of 2021, including 110 new products and 2 products for technology transfer. In order to help enterprises have an overview of this kind of products in China, CIRS counted the data of the approved health food registration products in 2021, and made an analysis for your reference.
Recently, the Center for Food Evaluation of SAMR released the filing information of 17 imported health food (dietary supplement). Nearly half of these products were declared by CIRS (as the Chinese agency entrusted by the applicant), and several of them passed the technical review for one time, without any dossier modification before getting the approval.
On 20 December 2021, State Administration for Market Regulation (SAMR) issued three drafts related to health food filing, including Health Food Raw Materials Directory of Nutrition Supplement (2022 version) (Draft). Compared with current regulations, the four important changes in the drafts are as follows: 1) “DHA” is added into the “Directory of Nutrition Supplement”. As the function of this nutrient ("supply n-3 polyunsaturated fatty acids") is within the scope of “supply nutrients”, CIRS expects that overseas enterprises can also apply for the filing of DHA products in the future. 2) The combination of “Casein phosphopeptides+ Calcium” becomes the new source compounds of calcium. 3) “6S-5-methyltetrahydrofolate calcium” and “(6S)-5-methyltetrahydrofolic acid, glucosamine salt” become the new source compounds of folic acid. However, the suitable crowds of the two compounds are limited to adults, and pregnant women and lactating mothers are classified as unsuitable crowds. 4) Soybean protein isolate and whey protein are expected to be the available raw materials for health food filing, and the health function is enhancing immune. Similar to the filing of Coenzyme Q10, CIRS expects that the filing scope of health food made of the two raw materials only includes the domestic products in China, and overseas products still need to apply for health food registration.
Introduction On 13th April 2021, the General Administration of Customs, P.R.China (GACC) issued the Administration Measures on the Registration of Overseas Manufacturers of Imported Foods, which will come into force as from 1st January 2022. With the goal of helping companies have a better understanding of how GACC works, CIRS held a webinar to talk about this regulation. This webinar will have an introduction to this draft, show the documents which companies need to prepare
On December 1, 2020, the SAMR officially issued Coenzyme Q10, Melatonin, Fish oil, Broken Ganoderma lucidum spore powder and Spirulina Health Food Raw Materials Directory (hereinafter referred to as “Health Food Raw Materials Directory”). Since then, for health foods that use one of these five substances as single active ingredient: 1) Domestic product applicants should apply for filing after the release of the Health Food Raw Materials Directory, and overseas applicants
In order to help enterprises have an overview of this kind of products in China, CIRS counted the data of the approved domestic and imported health food filing products in 2020, and made an analysis for your reference. 1. The Number of Approved Filing Health Food in China According to the information released by the Center for Food Evaluation of SAMR and the Local Administration for Market Regulation, up to December 31, 2020, a total of 1817 health food products had obtained