Status Analysis on Application and Approval of New Food Raw Material (Novel Food) in China

Updated on 21 Apr. 2020

In July 2007, Former Ministry of Health issued the Administrative Measures on New Resource Food, which was effective as of December 1, 2007. At that time, the new food raw material (Novel Food) was called “new resource food” in China.

Afterwards, the Administrative Measures for the Safety Review of New Food Raw Materials came into force on October 1, 2013. Since then, the “new resource food” was replaced with “new food raw material” (hereinafter called NFRM), the definition and scope of NFRM were also revamped in accordance with the Food Safety Law of the People's Republic of China.

In response to the changes from "New Resource Food" to "New Food Raw Material", CIRS Group summarized the acceptance and approval of NFRM from 2008 to the present in China, coupled with the interpretation of the impact of the changes of regulations and policies on the acceptance and approval of NFRM.

1. Analysis on acceptance of NFRM

From 2008 to April 15, 2020, the National Health Commission of the People’s Republic of China (NHC, former NHFPC) has publicly accepted 365 NFRMs, including 258 domestic NFRMs and 107 imported NFRMs.

Table 1 Acceptance Numbers of NFRM in China

Note: The data were collected from NHC

The application of NFRM in China can be divided into two stages. The first stage is “new resource food” stage (from 2007 to 2013), and the second stage is the “new food raw material” stage (from 2014 till now).

On the whole, the acceptance numbers of NFRM in stage one are larger than that in stage two. According to the analysis of CIRS group, the Administrative Measures on New Resource Food modified the approval object from products to raw materials or ingredients, meanwhile, the approval process was simplified for new resource food, which promoted the enthusiasm of enterprises to develop new resource food.

The situation of the acceptance of NFRM during the transition period (2013-2014) was quite different. In 2013, the acceptance number of NFRM was 71, which is the highest ever, while only two products were accepted in 2014. Generally, in order to avoid the negative impact of policy changes, many enterprises will accelerate the declaration in accordance with the old management measures before they are replaced. However, in the early stage of the implementation of new regulation, enterprises are usually conservative on the declaration and need a certain adaptation and understanding on the new regulations.

2. Review and approval of NFRM

2.1 Recommendation for approval

Totally 128 NFRMs have been announced on the NHC’s website from 2008 to April, 2020, including 105 animal & plant sourced new materials and 23 microorganism sourced new materials.

By the graph, it can be seen that the number of approved NFRM achieved the highest level in 2014, but no product was approved in 2015. The reasons may be as follows: 1) The acceptance number of NFRM in 2014 was small; 2) NFRM application has been more difficult, resulting from the procedure: releasing the draft to the public for comments and conducting on-site inspection; 3) Restructure of resources of related authorities.

In 2018, at the time of institutional reforms and changes in functions of NHC, the number of NFRM applications and reviews has decreased. However, in the second half of 2018, there were still two raw materials approved, which shows that the relevant review work on NFRM was proceeding steadily. After this, three NFRMs were also approved in 2019.

2.2 Termination of review

Except for “recommendation for approval”, totally 47 NFRMs were published with the result of “termination of review”. In addition to the “substantially equivalent”, there are two other status which are also considered as “termination of review”: “managed as general food” and “managed as local specialty food”.

Table 2 Examples of termination of review catalogs

From Table 2, it can be seen that new food raw materials with long-term consumption history or eating habit can be managed as general food or local specialty food.

For enterprises, the permission of “substantially equivalent”, “managed as general food” and “managed as local specialty food” are also meaningful. In a sense, these can be seen as a form of approval for NFRM product.

3. Conclusion

As the member of "Three New Foods", New Food Raw Material (New Resource Food) has the most complex and strict declaration requirements and official review, which usually takes 2-3 years from acceptance to final approval. In addition to the nature of the raw material and the history of its use, adequate R&D materials and safety assessment materials are also essential to shorten the review period to some extent. Applicants should strengthen their understanding and implementation of the regulations and policies to apply for the declaration.

For more information about new food raw material registration, please click New Food Raw Material Registration in China.

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