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

Updated on 20 Jan. 2022

China,Food,Additive,Approval,Registration

In 2021, the National Health Commission of the People's Republic of China (NHC) issued five announcements (No.9, 2020; No.2, 2021; No.5, 2021; No.6, 2021; No.9, 2021) for the approval of new food additives, with 35 new food additives (including expanded use) approved.

Besides, from websites of NHC and China National Center for Food Safety Risk Assessment (CFSA), in 2021, a total of 63 new food additives applications were accepted, and 49 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 2021 as following.

1. List of new food additives application acceptance in 2021 (63 products)

In 2021, a total of 63 new food additives (including expanded use) applications were accepted by NHC. The acceptance numbers are all shown as "衛食添新申字", and no distinction between domestic and imported products.

Some new products, especially those that applied in the first half of the year have passed the technical review by CFSA and were issued for public comments. Besides, a few new products were officially approved in 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	2021-01-11	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	Chili oleoresin
9	2021-03-03	衛食添新申字(2021)第0009號	Paprika red
10	2021-03-03	衛食添新申字(2021)第0010號	Paprika 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	Plant-derived 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	Turmeric
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
26	2021-06-28	衛食添新申字(2021)第0025號	Carbon dioxide
27	2021-06-29	衛食添新申字(2021)第0026號	Lutein
28	2021-07-02	衛食添新申字(2021)第0027號	Phospholipase A1
29	2021-07-02	衛食添新申字(2021)第0028號	2'-Fucosyllactose(2'-FL) (synthetic)
30	2021-07-07	衛食添新申字(2021)第0029號	β-Amylase
31	2021-07-07	衛食添新申字(2021)第0030號	Sodium sulfide pentahydrate
32	2021-07-07	衛食添新申字(2021)第0031號	Pyrrolidinyl-[1,2e]-4H -2,4-dimethyl-1,3,5-dithiazine
33	2021-07-07	衛食添新申字(2021)第0032號	Glutaminase
34	2021-07-08	衛食添新申字(2021)第0033號	lnositol (Cyclohexanehexol)
35	2021-07-12	衛食添新申字(2021)第0034號	D-ribose
36	2021-08-10	衛食添新申字(2021)第0035號	Polyoxyethylene(20) Sorbitan Monooleate(Polysorbate 80)
37	2021-08-23	衛食添新申字(2021)第0036號	Urea
38	2021-08-27	衛食添新申字(2021)第0037號	Protease
39	2021-09-06	衛食添新申字(2021)第0038號	Monascus color
40	2021-09-17	衛食添新申字(2021)第0039號	Protease
41	2021-09-17	衛食添新申字(2021)第0040號	β-glucanase
42	2021-09-17	衛食添新申字(2021)第0041號	Trehalase
43	2021-09-17	衛食添新申字(2021)第0042號	Vitamin K（Vitamin K2）
44	2021-09-22	衛食添新申字(2021)第0043號	Sucralose
45	2021-09-22	衛食添新申字(2021)第0044號	Tomato red
46	2021-09-29	衛食添新申字(2021)第0045號	6S-5-methyltetrahydrofolate calcium
47	2021-10-08	衛食添新申字(2021)第0046號	Tea polyphenol palmitate
48	2021-10-13	衛食添新申字(2021)第0047號	Silicone modified polyether
49	2021-10-18	衛食添新申字(2021)第0048號	2'-Fucosyllactose(2'-FL)
50	2021-10-18	衛食添新申字(2021)第0049號	Lacto-N-Neotetraose
51	2021-11-03	衛食添新申字(2021)第0050號	2'-Fucosyllactose(2'-FL)
52	2021-11-03	衛食添新申字(2021)第0051號	N-acetylneuraminic acid
53	2021-11-09	衛食添新申字(2021)第0052號	Glycose Oxidase
54	2021-11-09	衛食添新申字(2021)第0053號	Lactase
55	2021-11-11	衛食添新申字(2021)第0054號	Polydimethyl siloxane
56	2021-11-16	衛食添新申字(2021)第0055號	L-Arginine Hydrochloride
57	2021-11-16	衛食添新申字(2021)第0056號	L-Arginine- aspartic acid
58	2021-11-16	衛食添新申字(2021)第0057號	L-Arginine
59	2021-11-18	衛食添新申字(2021)第0058號	Vegetable carbon black
60	2021-11-18	衛食添新申字(2021)第0059號	L-Alanine
61	2021-12-15	衛食添新申字(2021)第0060號	Turmeric
62	2021-12-29	衛食添新申字(2021)第0061號	Caffeine
63	2021-12-30	衛食添新申字(2021)第0062號	Curdlan

2. List of new food additives which passed the technical review and were issued for public comments in 2021 (49 products)

In 2021, 49 of new food additives passed the technical review of CFSA and were issued for public comments. These include 3 new nutrition enhancers, 1 new food flavor, 1 new food additive, 21 new enzymes and 23 existing food additives with expended use (including 1 nutrition enhancer, 4 processing aids and 18 food additives).

1) List of new food nutrition enhancers (3 products)

No	Name	Category number	Food name/category	Maximum level	Approval Status (As of the end of 2021)
1	2′-Fucosyllactose (synthetic)	01.03.02	Modified milk powder (limited to milk powder for children)	1.2 g/L (Count as the state of ready to eat, for powdery products, the level of use should be increased by times of brewing)	Passed the technical review and issued public comments on 21st October, 2021
2	D-ribose	13.05	Other special dietary foods except 13.01~13.04 (only for sports nutrition foods)	≤33 g/kg
2	D-ribose	14.04.02.01	beverages for special uses (only for sports drinks)	≤8.0 g/kg (Count as the state of ready to drink)
3	lnositol (Cyclohexanehexol)	01.03.02	Modified milk powder (limited to milk powder for children)	210 mg/kg~250 mg/kg
		14.02.03	Fruit /vegetable juice(meat) beverages (including fermented products)	60 mg/kg~120 mg/kg
		14.04.02.02	Flavored drink	60 mg/kg~120 mg/kg
		13.0	Foods for special dietary uses	Refer to relevant standards for special dietary foods

2) List of new flavor (1 type)

Name

Function

Category number

Food name/category

Maximum level (g/kg)

Approval Status

(As of the end of 2021)

Thaumatin

Flavoring

—

Used in various foods after being formulated into flavors (Except for the food category in Table B1 of GB 2760-2014)

Appropriate level as required in production

Passed the technical review and issued public comments on 12th April, 2021;

22th October,2021, officially approved by Announcement No.9 of 2021.

3) List of new food enzymes (21 products)

No	Name	Source	Donor	Approval Status (As of the end of 2021)
1	4-α-glucanotransferase	Aeribacillus pallidus	—	Passed the technical review and issued public comments on 18th February,2021; 26th July,2021, officially approved by Announcement No.6 of 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 22th October,2021, officially approved by Announcement No.9 of 2021.
11	Glutaminase	Bacillus licheniformis	Bacillus licheniformis
12	Xylanase	Trichoderma reesei	Aspergillus niger var. tubingensis
13	Phospholipase A1	Aspergillus oryzae	Valsaria rubricosa	Passed the technical review and issued public comments on 6th August,2021
14	Maltogenic amylase	Bacillus licheniformis	Geobacillus stearothermophilus
15	Glucose oxidase	Trichoderma reesei	Penicillium amagasakiense
16	Lipase	Trichoderma reesei	Aspergillus niger var. tubingensis
17	β-fructofuranosidase	Aspergillus fijiensis	—	Passed the technical review and issued public comments on 21st October, 2021
18	Lactase	Bacillus subtilis	Lactobacillus delbrueckii subsp. bulgaricus
19	Phytase	Aspergillus niger	Aspergillus tubingensis
20	Phospholipase A1	Aspergillus niger	Talaromyces leycettanus	Passed the technical review and issued public comments on 8th December,2021
21	Glucose oxidase	Aspergillus niger	Penicillium chrysogenum

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

4) List of new food additive (1 type)

Name

Function

Category number

Food name/category

Maximum level (g/kg)

Approval Status

(As of the end of 2021)

Quinoline yellow aluminum lake

Colorant

05.03

Coatings for candy and chocolate products(only for candy)

0.3

(Measured as quinoline yellow)

Passed the technical review and issued public comments on 21st October, 2021

5) List of food nutrition enhancer with expanded scope (1 type)

Name

Category number

Food name/category

Maximum level

Approval Status

(As of the end of 2021)

Vitamin K (Vitamin K2)

01.03.02

Modified milk powder(Milk powder for children, pregnant and puerpera are excluded)

340 μg/kg ~680 μg/kg

Passed the technical review and issued public comments on 21st October, 2021

13.03

Formula foods for special medical purposes (excepted for those mentioned in 13.01)

Refer to the regulation of vitamin K1 in GB 29922

6) List of processing aids with expanded scope (4 products)

No	Name	Function	Usage scope	Approval Status (As of the end of 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 public comments on 28th May,2021
2	White mineral oil(liquid paraffin)	Release agent, lubricating agent	Processing technology of fresh yeast products (The maximum level is 0.1 g /kg)	Passed the technical review and issued public comments on 6th August,2021
3	Polyacrylamide	Flocculating agents	Processing technology of salt	Passed the technical review and issued public comments on 21st October, 2021
4	Polydimethyl siloxane	Antifoaming agents	Yeast processing products production and processing technology (The maximum level is 0.1 g /kg, measured as polydimethyl siloxane)	Passed the technical review and issued public comments on 8th December,2021

7) List of food additives with expanded scope (18 products)

No	Name	Function	Category number	Food name/ category	Maximum level (g/kg)	Approval Status (As of the end of 2021)
1	Sucralose	Sweetener	08.03.01	Sauced meat products	0.35	Passed the technical review and issued public comments on 18th February,2021
2	Advantame	Sweetener	14.04	Carbonated drinks	0.006	Passed the technical review and issued public comments on 12th April,2021; Except for No.3, other products were officially approved by Announcement No. 9 of 2021 (22nd October,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	Paprika 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	Paprika red	Colorant	16.07	Other (only for Konjac gel processing)	Appropriate level as required in production	Passed the technical review and issued public comments on 28th May,2021; 22nd October,2021, officially approved by Announcement No. 9 of 2021
8	Chili oleoresin	Flavor enhancer, colorant	16.07	Other (only for Konjac gel processing)	Appropriate level as required in production
9	Silicon dioxide	Anti-caking agent	04.04.03	Other soy products (only for soy protein powder or modulated soy protein powder)	15.0	Passed the technical review and issued public comments on 6th August,2021
10	Carbon dioxide	Other	01.02.02	Flavored fermented milk	Appropriate level as required in production
11	Turmeric	Colorant	06.03.02.04	Batter (Such as batter containing fish and poultry), coating flour, powder used for food frying	0.25(Measured as curcumin)
12	Nisin	Preservative	04.04.01.03.02	Pot-stewed semi-dried tofu	0.5
13	Sucralose	Sweetener	04.04.01.05	New soy products (puffed soy protein food, soybean meat, etc.)	0.4
14	Vegetable carbon black	Colorant	01.02.02	Flavored fermented milk	5.0
14	Vegetable carbon black	Colorant	04.01.02.05	Jam	5.0
15	Magnesium chloride	Flavoring agent	06.07	Instant rice and flour products	Appropriate level as required in production	Passed the technical review and issued public comments on 21st October,2021
			6.08	Frozen rice and flour products
			12.10	Compound condiment
16	Lutein	Colorant	01.01.03	Modified milk	0.05
16	Lutein	Colorant	01.02.02	Flavored fermented milk	0.05
17	Tomato red	Colorant	09.02.03	Frozen surimi and its products (including fish balls, etc.)	0.08(Measured as Lycopene)	Passed the technical review and issued public comments on 8th December,2021
17	Tomato red	Colorant	09.04	Cooked aquatic products (Can be directly consumed)	0.08(Measured as Lycopene)
18	Sucralose	Sweetener	01.06.04	Processed cheese	0.2

3. List of approved new food additives in 2021(35 products)

In 2021, 35 new food additives were approved by NHC, which include 1 new food nutrition enhancer, 1 new processing aid, 1 new food flavor, 18 new food enzymes, 14 existing food additives with expanded scope(including 1 existing food nutrition enhancer and 2 existing processing aids)

Due to applications for the same product is accepted more frequently and the lack of clear information on the scope of use, the information on some approved products is missing. CIRS summarized relevant information below:

1) List of approved new food nutrition enhancer (1 type)

No	Name	Category number	Food Name/ category	Maximum level (g/kg)
1	Vitamin K2 (Synthetic method)	01.03.02	Modified milk powder(limited to milk powder for children)	420 μg/kg–750 μg/kg
Modified milk powder (limited to milk powder for pregnant and puerpera)	340 μg/kg–680 μg/kg

Name

Category number

Food Name/ category

Maximum level (g/kg)

Vitamin K2

(Synthetic method)

01.03.02

Modified milk powder(limited to milk powder for children)

420 μg/kg–750 μg/kg

Modified milk powder (limited to milk powder for pregnant and puerpera)

340 μg/kg–680 μg/kg

2) List of approved new processing aid (1 type)

No	Name	Function	Usage scope
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)

Name

Function

Usage scope

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)

3) List of new flavor (1 type)

No	Name	Function	Category number	Food name/category	Maximum level (g/kg)
1	Thaumatin	Flavoring	—	Used in various foods after being formulated into flavors (Except for the food category in Table B1 of GB 2760-2014)	Appropriate level as required in production

4) List of approved new food enzymes (18 products)

No	Name	Source	Donor
1	Beta-amylase	Bacillus licheniformis	Bacillus flexus
2	Alpha-amylase	Bacillus licheniformis	Cytophaga sp.
3	Protease	Bacillus subtilis	Thermus Aquaticus
4	Lactase	Bacillus subtilis	Bifidobacterium bifidum
5	Protease	Bacillus subtilis	Bacillus amyloliquefaciens
6	Phosphoinositide phospholipase C	Pseudomonas fluorescens	Microorganisms encoding the phosphoinositolipase C gene isolated from soil
7	4-α-glucanotransferase	Aeribacillus pallidus	—
8	α-amylase	Aspergillus niger	Rhizomucor pusillus
9	Polygalacturonase	Trichoderma reesei	Aspergillus tubingensis
10	Pectinesterase	Trichoderma reesei	Aspergillus tubingensis
11	Phosphoinositide Phospholipase C	Bacillus licheniformis	Pseudomonas sp.
12	Phospholipase C	Bacillus licheniformis	Bacillus thuringiensis
13	Xylanas	Trichoderma reesei	Thermopolyspora flexuosa
14	Glucoamylase	Aspergillus niger	Gloeophyllum trabeum
15	Lipase	Trichoderma reesei	Fusarium oxysporum
16	Protease	Anoxybacillus caldiproteolyticus	—
17	Glutaminase	Bacillus licheniformis	Bacillus licheniformis
18	Xylanase	Trichoderma reesei	Aspergillus niger var. tubingensis

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

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

No	Name	Category number	Food Name/ category	Maximum level (g/kg)
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 in GB 31601-2015 and GB24154-2015

6) List of approved food additives with expanded scope (11 products)

No	Name	Function	Category number	Food Name/ category	Maximum level (g/kg)
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
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)
2	Sodium alginate (SA)	Stabilizer	13.05		Appropriate level as required in production (Products suitable for people aged 37 months to 10 years)
3	Silicon dioxide	Anti-caking agentt	04.04.03	Other soy products (only for bean curd powder)	15.0
4	Tomato red	Colorant	05.02.02	Other candy except for Gum-based candy	0.25
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
			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
			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)
7	Advantame	Sweetener	14.04	Carbonated beverage	0.006(Count as the state of ready to drink)
8	Curdlan	Stabilizer, coagulator and thickener	08.02.01	Conditioning meat products (raw meat with conditioning materials)	Appropriate level as required in production
			14.06.03	Instant coffee
			16.03	Collagen casings
9	Paprika red	Colorant	08.02.01	Conditioning meat products (raw meat with conditioning materials)	Appropriate level as required in production
9	Paprika red	Colorant	16.07	Other food (only for product of Konjac gel)	Appropriate level as required in production
10	Chili oleoresin	Flavor enhancer, colorant	16.07	Other food (only for product of Konjac gel)	Appropriate level as required in production
11	Sucrose fatty acid esters	Emulsifier	01.05.01	Cream	2.5

7）List of approved processing aids with expanded scope (2 products)

No	Name	Function	Usage scope
1	Butane	propellant	Processing technology of spray release oil for bakery food
2	Phosphoric acid(wet-process)	Nutrients for refining, degumming and fermentation	Oil processing technology, fermentation technology

Summary

There are three main stages of applying for a new food additive: Firstly, NHC accepts the application. Secondly, CFSA runs a technical review and issue public comments. Finally, if everything goes well, NHC will approve the application. Generally, it will take approximately 1 year to apply for a new food additive. While if the application is about expending usage scope, the timeline may be shorter.

Compared with 2020, the number of products accepted in 2021 decreased by 10, and products issued for public comments increased by 22, of which new food enzymes accounted for 53.1%. Meanwhile, based on the analysis on the application approval of new food additives in 2020&2021, it can be seen that the new varieties are mainly enzymes and nutrition enhancers, the number of products with expanded scope are still large. This also reflects the rapid growth on these two kinds of products with the rapid development of bioengineering technology and technological innovation industry.

In the past, the NHC only accepted the applications for new food enzymes derived from genetically modified microorganism, but at the beginning of 2021, they allowed the application of new varieties of genetically modified microorganism food additives (GMM food additive). This means that enterprises can currently submit applications for additives or enzymes products produced through genetically modified technology. Up to now, many products have submitted the application and are waiting for technical review. If you have any needs or questions about the GMM food additive, 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.