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

In July 2007, Former Ministry of Health issued the Administrative Measures on New Resource Food, which was effective as of December 1, 2007. During that time, the new food raw material (NFRM) was called as “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 renamed NFRM and its definition & scope were also be revamped in accordance with the Food Safety Law of the People's Republic of China.

From “new resource food” to “NFRM”, how many new food raw materials applications were accepted and how many new food raw materials was approved? What are the influences of changes in regulations on acceptance and approval number of NFRM? CIRS group has collected and summarized relevant information from 2008 to the present, and made a status analysis on acceptance and approval of NFRM in China.

1. Analysis on acceptance of NFRM

From 2008 to the end of 2017, totally of 357 NFRMs were accept by National Health Commission of the People’s Republic of China (NHC, former NHFPC), including 250 domestic NFRMs and 107 imported NFRMs. Up to now, there is no NFRM accepted in 2018.

Table 1 Acceptance Numbers of NFRM in China

Year

2008

2009

2010

2011

2012

2013

2014

2015

2016

2017

Total

Domestic NFRM

27

48

24

50

25

44

1

11

12

8

250

Imported NFRM

14

22

5

11

14

27

1

9

3

1

107

Total

41

70

29

61

39

71

2

20

15

9

357

Remark: The data were collected from NHC.

New Food Raw Material,Application,China,Food,Material

The application of NFRM in China could be divided into two stages. Stage one: “new resource food” stage (from 2007 to 2013); Stage two: “new food raw material” stage (from 2014 to now).

On the whole, the acceptance number of NFRM in stage one was larger than that of stage two. CIRS group speculated that it is related to the revision of Administrative Measures on New Resource Food. The simplification of the review procedures has promoted the enthusiasm of enterprises for the development of new resource food.

The acceptance number 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. However, there were only two products accepted in 2014. In general, before the implementation of new regulations, many enterprises will speed up the application according to the old regulation, in order to avoid the negative impact of policy changes. Meanwhile, there will be a while before the acceptance of new regulations, and many enterprises may keep a conservative attitude, and will not submit the application immediately.

2. Review and approval of NFRM

2.1 Recommendation for approval

A total of 123 NFRMs have been announced on the NHC’s website in the decade from 2008 to 2017, which including 101 animal & plant sourced new materials and 22 microorganism sourced new materials.

New Food Raw Material,Application,China,Food,Material

By the graph, it can be seen that the number of approved NFRMs achieved the highest level in 2014, and no product was approved in 2015. The reasons may be as following: 1) The acceptance number of NFRM in 2014 was small; 2) The difficulty of NFRM application have been increased, such as adding the procedures of draft for comments and on-site inspection; 3) Restructure of resources of related authorities.

2.2 Termination of review

Except for “recommendation for approval”, 44 NFRMs were published with the result of “termination of review”. In addition to the “substantially equivalent” situation in the termination of review, there are also two situations, “managed as general food” and “managed as local specialty food”.

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

3. Status analysis on acceptance and approval of NFRM in 2018

In 2018, no NFRM registration has been accepted or approved. However, CFSA have released the drafted approval of Nostoc sphaeroides and Angelica keiskei. Previously, there were four products (Dendrobii Officinalis Flos, Lactobacillus Curvatus, Aroniae Melanocarpae Fructus, Dendrobii Officinalis Folium) published for public comments in 2017. It can be speculated that the NFRM approval announcement is around the corner, and CIRS will keep focusing on it.

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

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