In 2019, the State Administration for Market Regulation (SAMR) issued a series of regulations on health food, to promote the operation of the dual track system of health food: registration and filing, and further clarify the management requirements. CIRS group takes you through the signals released by these regulatory documents.
Health food regulations released in 2019
Date of issue / implementation
Implemented on 2019.10.01
Implemented on 2020.01.01
Declaration and Review of Probiotic Health Food(Draft)
Issued on 2019.03.20
Issued on 2019.03.28
Pathogenicity Assessment Procedure of Strains for Health Food (Draft)
Rules for On-Site Verification of Special Food Registration (Trial) (Draft)
Issued on 2019.07.17
Health Food Filing Lists will be Expanded
On 1 April, 2019, SAMR issued a draft on adding 5 raw materials including Coenzyme Q10, Melatonin, Fish oil, Broken Ganoderma lucidum spore powder and Spirulina into the Health Food Raw Material Directory, and corresponding health functions involve “enhancing immune”, “antioxidant”, “assisting blood lipids reduction”, and “sleep improvement”. Soon afterwards the Supplement List of Available Excipients for Heath Food Filing was issued for public comments. 17 new excipients such as soybean lecithin, curcumin, fruit and vegetable powder, etc., are planned to be added to the excipient list.
This is the first time that non-“vitamin/mineral supplements” get the opportunity to enter the health food filing list. It can be expected that with the expansion of filing list, filing products in China will become the main trend.
Speed of Health Food Registration Approval is Rapidly Increasing
With the implementation of the Administrative Measures on Health Food Registration and Filing, the approval of health food registration products was almost stagnant in China. In the whole year of 2018, only 10 products were approved for registration. The new changes in health food registration policy and China’s state institutional reforms are the key reasons for the significant decrease.
Since 2019, the approval of registered products has increased greatly compared with 2018. As of October 22, a total of 668 products were approved in terms of new product registration (181 products), registration renewal (414 products), registration alteration (55 products) and technology transfer (18 products), as shown in the figure 1 below.
Overall, comparing to 2018, China's health food registration approval work has been steadily carried out in this year, and the number of products backlogged in the technical review stage is decreasing. It is expected that more products will get the registration approval in succession.
Figure 1 Number of approved registered health food in 2019
Evaluation Methods of Registration Products are Released One by One
Technical Standards for Testing & Assessment of Health Food (2003 version) (hereinafter referred to as “the Green Book”) was abolished in July, 2018. After then, the tests which conducted in accordance with the Green Book are unrecognized for the application of health food registration. Due to this situation, many enterprises suspended the registration tests of new products.
In order to guarantee the normal operation of health food inspection and application, SAMR organized a comprehensive revision on the Green book. In this year, 3 drafts including Toxicological Assessment Procedure of Health Food, Pathogenicity Assessment Procedure of Strains for Health Food, and Hygienic and Physicochemical Inspection Specifications for Health Food have been issued for public comments.
It is reported that the draft on health food functional evaluation methods will be released for public comments soon. To provide a smooth transition, as CIRS learned from the 3rd China Health Food Conference held in Zhuhai on 17 October, 2019, the old methods may not be modified greatly, and temporarily used as one of the choices of function evaluation methods. Meanwhile, all released function evaluation methods are planned as recommended methods rather than mandatory, and custom methods could be selected after thorough evaluation and verification. All information are subject to official release. Let's look forward to the release of the final version.
Any Unit or Individual can Give Advice on Health Function Directory or Health Food Raw Materials Directory
The Administrative Measures on Health Food Raw Material Directory and Function Directory has come into force on 1 October 2019. According to this regulation, any unit or individual could give advice on new health functions or listing new food ingredients into filing scope in China. After the technical examination and public demonstration by Chinese authorities, those meeting the requirements can be included in relevant directories.
This is a completely new regulation in China, which shows the Chinese government's more opening attitude towards health food management. It encourages enterprises to innovate and can make full use of social resources for scientific research, thereby promoting the high quality development of the health food industry.
So far this year, new health food policies in China are continuously released, and the speed of product approval has been accelerated, which are all favorable factors for the industry development.
However, the application and marketing of health food still cannot be taken lightly. On the one hand, China authorities pay great attention to the R&D materials during the technical review of registration products, and sufficient scientific literature support is a focus of the review. Therefore, when preparing the registration dossier, enterprises shall attach importance to the collection of scientific literatures. On the other hand, SAMR is strengthening the management of health food labeling (e.g., warning statements and complaint hotline etc. information shall be marked on the Chinese labels of health foods from 1 January, 2020), and cracking down the behavior of false propaganda, in order to strengthen the main responsibility of enterprises and protect the consumer rights, which are conducive to the long-term development of the industry.
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