Preparatory Work for Special Food Registration/Filing in China

Some may be unfamiliar with the term "special food" because it was stipulated in the revision of Food Safety Law of People's Republic of China in 2015. It refers to infant formula, health food and food for special medical purposes that are subject to more stringent supervision than average foods. As of March 2018, a newly established Special Food Safety Supervision Department under SAMR is now in charge of the drafting and enforcement of regulations on special food. (Read news about SAMR 3 stipulation scheme here)

Special Food Legal Underpinnings

Relevant Regulations and Measures for Registration/Filing

Chapter 4 of Food Safety Law proposes requirements for three categories of special foods from the perspective of supervision. To coordinate the supervision requirements and to set up a well-established oversight system for special food, former China Food and Drug Administration (now State Administration for Market Regulation, SAMR) formulated corresponding regulations and administrative rules for special foods.

The health food regulatory framework and associated regulatory requirements have been implemented and dynamically modified over the course of the last 2 decades. The current dual-track management system (registration or filing) is a relatively new development and previously all health food products regardless of characteristics required registration.

A total of 5 measures about infant formula registration, 9 about health food and 8 about FSMP offer comprehensive registration guidance to stakeholders. In this article, registration of overseas dairy manufacturer/factory will not be discussed (read tips for that here). And for FSMP and health food, Principles of Naming of Food for Special Medical Purposes (Trail) and Health Food Naming Guideline are now open to public feedback, the deadline for the latter consultation period will end on Nov.16, 2018.

Application Dossier Requirements and Review Protocols

The SAMR issues certificate of registration/filing according to the result of application review. The administrative measures for the three products all clarify the applicable scope, application procedure, time, labeling, instruction book, monitoring, and legal liability. Objectives of review carried out by the government also vary from product to product (refer to table below).

Another issue that most stakeholders are concerned about is: how long will it take to register/file (see table below). It is important to remember that any materials required by authorities during review shall be submitted in full within 3 months. (Differs from previous 5 month deadline and freedom to make multiple supplementations).

In March the former food administration, the CFDA was dissolved. Following this we saw the formation of the new food ministry, the SAMR which is now tasked with oversight on special foods, the review and approval of health food registration bearing functional claims has been put on the backburner. So far in 2018 only 3 products have been approved. Additional factors contributing to the reduced number of approvals in 2018 include:  

1. By the time Administrative Measures of Health Food Registration and Filing took effect on Jul. 1, 2016, its subsidiary regulations such as detailed rules on examination had not been published, so relevant work centered on acceptance and review of application had not been carried out until the end of 2016/the beginning of 2017.

2. Before Jul. 2016, former CFDA (now SAMR) approved quite a number of health food products under previous regulations. Roughly ten thousand health food registration applications had been addressed by the time CFDA set about handling new registration cases.

3. In the first half of 2017, CFDA focused on nutrient supplement applications

4. In Aug. 2017, a new IT system for health food registration was officially launched, and applications which were submitted just before that were required to be submitted again.

5. In H2 2017, CFDA finalized its dual track system for filing of nutrient supplements and registration of products bearing permitted functional claims and began the task of application review.

Despite all the preparatory work made by government departments to optimize the health food regulatory system processing of previously submitted applications is still relatively slow because：

• Products that were accepted under old rules and are now in the final steps of registration approval need to supplement required documents based on the new requirements.

• Some overseas products have passed technical review and need overseas on-site inspection, however, on-site inspection takes time, inspection authorities have limited capacity and many of the finer details associated with onsite inspection are still being clarified.

• Human clinical trial requirements to establish efficacy and safety are still being developed so products which require clinical data are currently not being considered

• The rate of registration dossier and application rejection has also increased due to the increased stringency of review.

Documentation Requirements

Materials to be prepared are stipulated in Items and Requirements of Application Materials for Registration of Infants and Young Children Milk Powder Formula Recipes (Trial), Guidance to the Application of Health Food Registration (Trial), Guidance to Health Food Filing (Trial), and Requirements for Application Materials for Registration of Foods for Special Medical Purpose (Trial). The number of required materials vary for the three types of products, referring to the following table.

There is a differential prioritization of certain documents which varies between the different categories of special food and this tends to reflect the corresponding uses of the different product categories, the market conditions and the overall social importance of the products. The food safety law offers the most basic reference outlining the differing prioritization of documentation between the special food categories.

For infant formula the focus is on the scientificity and safety of infant milk powder formulation, so applicants should provide recipe R&D and justifications for ingredient selection in reports.

For health food and FSMP, the review tends to focus on the overall product, so relevant applicants are asked to provide product R&D reports. Additionally, Food Safety Law article 75 rules that “function claims of health foods shall be scientifically justified and consumption of products shall not cause acute, subacute or chronic damage to human”, therefore evaluation materials about the safety and functions of health foods are mandatory during registration/filing.

For FSMPs if an applicant wishes to register a nutritionally complete formula food, he or she should submit clinical trial reports, according to former FDA decree No.24-2016.

There are also some other required documents for registration of special foods. (see table below)

Status quo of health foods

Data source: chemlinked f-list, former CFDA website

In 2018, 243 infant milk powder products, 15 FSMPs and 3 health food products have been granted approval as of October. No imported health foods with function claims have been registered this year.

The 2015 Food Safety Law is a historical milestone in the development of health industry, it defines three high-risk foods as “special food”, and established a relatively mature regulatory system. Under stringent supervision, the industry gains is gaining credibility and all sectors demonstrating excellent growth.