Analysis on Application Approval of New Food Additives in the First Half of 2021 - Regulatory News - Food & Food Contact Materials

As of the end of June 2021, the National Health Commission of the People's Republic of China (NHC) issued three announcements (No.9, 2020; No.2, 2021; No.5, 2021) by the form of “Three New Food” with a total of 37 products approved including new food raw materials (novel food), new food additives, and food-related products (new food contact substances). Among them, 17 new food additives (including expanded use) were approved.

Besides, from websites of NHC and China National Center for Food Safety Risk Assessment (CFSA), in the first half of 2021, a total of 25 new food additives applications were accepted, and 22 new food additives (including expanded use) passed the technical evaluation and were issued for public comments.

CIRS Group will take you to the detailed information about the acceptance and approval of new food additives in China in the first half of 2021 as following.

1. Name list of new food additives accepted in the first half of 2021 (25 types)

In the first half of 2021, a total of 25 new food additives (including expanded use) applications were accepted by NHC. The acceptance numbers are all "衛食添新申字", and there is no distinction between domestic and imported products.

Among them, Beta-glucanase (衛食添新申字(2021)第0003號) and Vegetable carbon black (衛食添新申字(2021)第0006號) accepted the decision of not granting the administrative license on 13 April, 2021, Potassium sorbate (衛食添新申字(2021)第0011號) accepted decision of not granting administrative license on 18 June,2021.

No	Acceptance Date	Acceptance Code	Name of New Food Additives
1	2021-01-08	衛食添新申字(2021)第0001號	Glutaminase
2	2021-01-08	衛食添新申字(2021)第0002號	Advantame
3	2020-01-11	衛食添新申字(2021)第0003號	Beta-glucanase
4	2021-01-20	衛食添新申字(2021)第0004號	Curdlan
5	2021-01-20	衛食添新申字(2021)第0005號	Glutamine transaminase
6	2021-01-25	衛食添新申字(2021)第0006號	Vegetable carbon black
7	2021-01-25	衛食添新申字(2021)第0007號	Sucralose
8	2021-03-03	衛食添新申字(2021)第0008號	Capsicum oleoresin/ Chili oleoresin
9	2021-03-03	衛食添新申字(2021)第0009號	Capsanthin/Chili Red
10	2021-03-03	衛食添新申字(2021)第0010號	Capsanthin/Chili Red
11	2021-03-08	衛食添新申字(2021)第0011號	Potassium sorbate
12	2021-03-15	衛食添新申字(2021)第0012號	Vegetable carbon black
13	2021-03-18	衛食添新申字(2021)第0013號	Recombinant Human Lactoferrin
14	2021-03-19	衛食添新申字(2021)第0014號	Maltogenic amylase
15	2021-03-22	衛食添新申字(2021)第0015號	Lipase
16	2021-03-22	衛食添新申字(2021)第0016號	Lactases
17	2021-03-26	衛食添新申字(2021)第0013號	Phospholipase A1
18	2021-04-12	衛食添新申字(2021)第0017號	Sucralose
19	2021-05-17	衛食添新申字(2021)第0018號	Curcumin
20	2021-05-27	衛食添新申字(2021)第0019號	Silicon dioxide
21	2021-06-01	衛食添新申字(2021)第0020號	Quinoline yellow aluminum lake
22	2021-06-02	衛食添新申字(2021)第0021號	Pulullan
23	2021-06-04	衛食添新申字(2021)第0022號	Potassium acesulfame
24	2021-06-04	衛食添新申字(2021)第0023號	Potassium acesulfame
25	2021-06-16	衛食添新申字(2021)第0024號	Nisin

2. Name list of new food additives passed the technical review and were issued for public comments in the first half of 2021 (22 types)

In the first half of 2021, 22 new food additives passed the technical review of CFSA and were issued for public comments. These include 12 new food enzymes, 1 new food flavouring, 8 existing food additives with expanded use and 1 existing food processing aid with expanded use. In addition to a few additives that are newly accepted in 2021 (such as glutaminase), most of the products which were issued for public comments have been publicly accepted by NHC in 2020. (Refer to Analysis on Application Approval of New food Additives in 2020).

1) Name list of new food enzymes (12 types)

No	Name	Source	Donor	Approval Status (By the end of June 2021)
1	4-α-glucanotransferase	Aeribacillus pallidus	—	Passed the technical review and issued public comments on 18th February, 2021.
2	Alpha-amylase	Aspergillus niger	Rhizomucor pusillus
3	Polygalacturonase	Trichoderma reesei	Aspergillus tubingensis
4	Pectin esterase	Trichoderma reesei	Aspergillus tubingensis
5	Phosphoinositide Phospholipase C	Bacillus licheniformis	Pseudomonas sp.
6	Phospholipase C	Bacillus licheniformis	Bacillus thuringiensis
7	Xylanase	Trichoderma reesei	Thermopolyspora flexuosa
8	Glucoamylase	Aspergillus niger	Gloeophyllum trabeum
9	Lipase	Trichoderma reesei	Fusarium oxysporum
10	Protease	Anoxybacillus caldiproteolyticus	—	Passed the technical review and issued public comments on 12th April, 2021.
11	Glutaminase	Bacillus licheniformis	Bacillus licheniformis
12	Xylanase	Trichoderma reesei	Aspergillus niger var. tubingensis

Note: The quality specification of enzymes should meet the requirements of the "National Food Safety Standard, Food Additives and Enzyme" (GB 1886.174).

2) Name list of new food flavouring (1 type)

No	Name	Function	Category number	Food name/category	Maximum level (g/kg)	Approval Status (By the end of June 2021)
1	Thaumatin	Flavours prepared for food	—	Formulated into food flavors for all types of food (except food category in Table B.1 of GB 2760-2014)	Appropriate level as required in production	Passed the technical review and issued public comments on 12th Apr., 2021

3) Name list of food additives with expanded scope (8 types)

No	Name	Function	Category number	Food name/category	Maximum level (g/kg)	Approval Status (By the end of June 2021)
1	Sucralose	Sweetener	08.03.01	Sauced meat products	0.35	Passed the technical review and issued for public comments on 18th Feb., 2021
2	Advantame	Sweetener	14.04	Carbonated drinks	0.006	Passed the technical review and issued for public comments on 12th Apr.,2021
3	Glutamine transaminase	Stabilizer and coagulator	01.02.02	Flavored fermented milk	0.3
3	Glutamine transaminase	Stabilizer and coagulator	01.06.01	Unripened cheese	0.3
4	Curdlan	Stabilizer,coagulator and thickener	08.02.01	Conditioned meat products (raw meat with added ingredients)	Appropriate level as required in production
			14.06.03	instant coffee
			16.03	collagen casing
5	Capsanthin/ Chili Red	Colorant	08.02.01	Conditioned meat products (raw meat with added ingredients)	Appropriate level as required in production
6	Sucrose fatty acid esters	Emulsifier	01.05.01	Light cream	2.5
7	Capsanthin/ Chili Red	Colorant	16.07	Other (only for Konjac gel processing)	Appropriate level as required in production	Passed the technical review and issued for public comments on 28th May, 2021
8	Capsicum/ Chili oleoresin	Flavor enhancer, colorant	16.07	Other (only for Konjac gel processing)	Appropriate level as required in production

4) Name list of processing aids with expanded scope (1 type)

No	Name	Function	Usage scope	Approval Status (By the end of June 2021)
1	White oil (liquid paraffin)	Release agent, lubricating agent	Processing technology of fresh yeast products (The maximum level is 1.5g /kg)	Passed the technical review and issued for public comments on 28th May, 2021

3. Name list of approved new food additives in the first half of 2021(17 types)

In the first half of 2021, 17 types of new food additives were approved by NHC, which include 6 new food enzymes for food industry, 1 new food nutrition enhancers, 1 new processing aids, 6 existing food additives with expanded scope, 1 existing food nutrition enhancers with expanded scope, and 2 existing processing aids with expanded scope. CIRS has summarized relevant information below:

1) Name list of approved new food enzymes (6 types)

No	Name	Source	Donor	Acceptance information, public comment and approval announcements (By the end of June 2021)
1	Beta-amylase	Bacillus licheniformis	Bacillus flexus	Accepted on 12th March, 2020, Acceptance number: 衛食添新申字(2020)第0006號; Passed the technical review and issued for public comments on 13th Jul., 2020; 7th January, 2021, officially approved by Announcement No.9 of 2020.
2	Alpha-amylase	Bacillus licheniformis	Cytophaga sp.	No accepted information was found; Passed the technical review and issued for public comments on 27th Sept., 2020; 20th February, 2021, officially approved by Announcement No.2 of 2021.
3	Protease	Bacillus subtilis	Thermus Aquaticus	No accepted information was found; Passed the technical review and issued for public comments on 12th Nov., 2020; 20th February, 2021, officially approved by Announcement No.2 of 2021.
4	Lactase	Bacillus subtilis	Bifidobacterium bifidum	Accepted on 26th May, 2020, Acceptance number: 衛食添新申字(2020)第0026號; Passed the technical review and issued for public comments on 27th Sept., 2020; 20th February, 2021, officially approved by Announcement No.2 of 2021.
5	Protease	Bacillus subtilis	Bacillus amyloliquefaciens	No accepted information was found; Passed the technical review and issued for public comments on 25th Dec., 2020; 25th April, 2021, officially approved by Announcement No.5 of 2021.
6	Phosphoinositide phospholipase C	Pseudomonas fluorescens	Microorganisms encoding the phosphoinositolipase C gene isolated from soil	Accepted on 21st July, 2020, Acceptance number: 衛食添新申字(2020)第0042號; Passed the technical review and issued for public comments on 25th Dec., 2020; 25th April, 2021, officially approved by Announcement No.5 of 2021.

Note: The quality specification of enzymes should meet the requirements of the "National Food Safety Standard, Food Additives and Enzyme" (GB 1886.174).

2) Name list of approved new food nutrition enhancers (1 type)

No	Name	Category number	Food Name/ category	Maximum level (g/kg)	Acceptance information, public comment and approval announcements (By the end of June 2021)
1	vitamin K2 (Synthetic method)	01.03.02	Modified milk powder(limited to milk powder for children)	420 μg/kg–750 μg/kg	No accepted information was found; Passed the technical review and issued for public comments on 1st Jun.,2020; 7th January, 2021, officially approved by Announcement No.9 of 2020.
1	vitamin K2 (Synthetic method)	01.03.02	Modified milk powder (limited to milk powder for pregnant and puerpera)	340 μg/kg–680 μg/kg

3) Name list of approved new processing aid (1 type)

No	Name	Function	Usage scope	Acceptance information, public comment and approval announcements (By the end of June 2021)
1	Nitrous oxide	Propellant, Foaming agent	01.05 Processing of cream (light cream) and similar products; 02.02 Processing of water-oily fat emulsified products (vegetable milk only); Processing of fat emulsified products other than 02.02, including mixed or flavored fat emulsified products (vegetable cream only)	Accepted on 8th April, 2019, Acceptance number: 衛食添新申字(2019)第0031號; Passed the technical review and issued for public comments on 1st Jun., 2020; 7th January, 2021, officially approved by Announcement No.9 of 2020.

4) Name list of approved food additives with expanded scope (6 types)

No	Name	Function	Category number	Food Name/ category	Maximum level (g/kg)	Note	Acceptance information, public comment and approval announcements (By the end of June 2021)
1	Gum ghatti	Emulsifier	13.05	Other food for special dietary use (only for foods for special medical purpose of for people over 10 years old)	3.0	—	Accepted on 11th May, 2018, Acceptance number: 衛食添新申字(2018)第0011號; Passed the technical review and issued for public comments on 13th Jul., 2020; 7th January, 2021, officially approved by Announcement No.9 of 2020.
2	Sodium alginate (SA)	Stabilizer	13.05	Other food for special dietary use (only for foods for special medical purpose of 13 months -10 years old)	1.0	Products suitable for children aged 13-36months	Accepted on 20th January,2020, Acceptance number: 衛食添新申字(2020)第0005號; Passed the technical review and issued for public comments on 1st Jun., 2020, 27th Sept., 2020; 7th January, 2021, officially approved by Announcement No.9 of 2020.
2	Sodium alginate (SA)	Stabilizer	13.05		Appropriate level as required in production	Products suitable for people aged 37 months to 10 years old
3	Silicon dioxide	Anti-caking agentt	04.04.03	Other soy products (only for bean curd powder)	15.0	—	Accepted on 30th April,2020, Acceptance number: 衛食添新申字(2020)第0018號; Passed the technical review and issued for public comments on 27th Sept., 2020; 20th Feb., 2021, officially approved by Announcement No.2 of 2021.
4	Tomato red	Colorant	05.02.02	Other candy except for Gum-based candy	0.25	—	Accepted on 5th August,2020, Acceptance number: 衛食添新申字(2020)第0044號; Passed the technical review and issued for public comments on 12th Nov., 2020; 20th Feb., 2021, officially approved by Announcement No.2 of 2021.
4	Tomato red	Colorant	12.10.02	Semi-solid blended condiment	0.125	—
5	Curdlan	Thickener	04.01.02.05	Jam	Appropriate level as required in production	—	(Note: the approval announcement of this substance is a collection of two applications) A total of two acceptances, accepted on 17th Aug.,2020, 23rd Oct. 2020, acceptance numbers are respective: 衛食添新申字(2020)第0046號，衛食添新申字(2020)第0060號; Passed the technical review and issued for public comments on 27th Sept.,2020 and 12th Nov., 2020; 20th February, 2021, officially approved by Announcement No.2 of 2021.
			04.04.01.05	New bean curd product (puffed soy protein food, soybean meat, etc.)
			06.05.02.04	Starch-based snack
			16.07	Other (only for Konjac gel product)
6	Tamarind polysaccharide gum	thickener	04.01.02.05	Jam	5.0	—	No accepted information was found; Passed the technical review and issued for public comments on 27th Sept., 2020; 20th Feb., 2021, officially approved by Announcement No.2 of 2021.
			04.01.02.08.05	Fruitcake	20.0	—
			14.02.03	Fruit/vegetable juice (puree) beverage	3.0	Count as the state of ready to drink, for solid beverage, the level of use should be increased by times of dilution

5) Name list of approved food nutrition enhancers with expanded scope (1 type)

No	Name	Category number	Food Name/ category	Maximum level (g/kg)	Acceptance information, public comment and approval announcements (By the end of June 2021)
1	6S-5-methyltetrahydrofolate calcium	13.05	Other special dietary foods except 13.01~13.04 (only for nutritional supplements for pregnant, lactating women and sports nutrition foods)	The usage should comply with the relevant requirements of GB 31601-2015 and GB24154-2015	No accepted information was found; Passed the technical review and issued for public comments on 27th Sept., 2020; 20th Feb., 2021, officially approved by Announcement No.2 of 2021.

6) List of approved processing aids with expanded scope (2 types)

No	Name	Function	Usage scope	Acceptance information, public comment and approval announcements (By the end of June 2021)
1	Butane	propellant	Processing technology of spray release oil for bakery food	Accepted on 6th August,2020, Acceptance number: 衛食添新申字(2020)第0045號; Passed the technical review and issued for public comments on 12th Nov., 2020; 20th Feb., 2021, officially approved by Announcement No.2 of 2021.
2	Phosphoric acid(wet-process)	Nutrients for refining, degumming and fermentation	Oil processing technology, fermentation technology	Accepted on 16th Jun.,2020, Acceptance number:衛食添新申字(2020)第0032號,衛食添新申字(2020)第0033號； Passed the technical review and issued for public comments on 12th Nov., 2020; 20th Feb., 2021, officially approved by Announcement No.2 of 2021.

Based on the analysis on the application approval of new food additives in the first half of 2021, it can be seen that there are a large number of new enzymatic products (35.3% of 17 approved products and 54.5% of 22 products issued the public comments). At the same time, nitrous oxide, the only new type of food processing aids, was approved in this year (a total of 17 have been approved since 2015, and the rest 16 products are for expanded scope).

There are three main stages of applying for a new food additive:

NHC accepts the application.
CFSA runs a technical review and issue public comments.
If everything goes well, NHC will approve the application.

Generally, it will take approximately 1 year to apply for a new food additive. But when it comes to the application for expanding usage scope, the timeline may be shortened. CIRS warmly suggested that related enterprises should get well-prepared before the application to make sure that the products could pass the technical review successfully and get approved.

If you have any needs or questions, please contact us at service@cirs-group.com.

Note: There may be omissions and errors in the data statistics process because of the change of the official website. The data in this article is for reference only. Please refer to the official information published by the government.