China CFSA Proposes Five New Food Additives, Including 2'FL for Infant Formula [Historical Resources Included]

The compliance with food additives legislation is undeniably important when it comes to food safety and food imports in China. Every year, numerous imported food was shut out of the Chinese market for the illegal use of food additives. One of the major compliance takeaways is only use permitted food additives in China. Besides the positive list in GB 2760, China proposes new food additives for solicitation of comments from time to time. This article collects the latest and historically proposed food additives to keep you up-to-date with the updates and changes regarding Chinese food additives regulations.

Latest Update: February 10, 2023

As per the notice released on February 10, 2023, China CFSA opened five new food additives for public comments, including two new enzyme preparations, one new nutrition fortifier, one food additive with expanded application scope, and one processing aid with expanded application scope. Comments can be sent to [email protected] before March 8, 2023.

Two new enzyme preparations

Enzyme	Source	Donor
beta-amylase	Bacillus flexus	/
Lysophospholipase (lecithinase B)	Trichoderma reesei	Aspergillus nishimurae

One nutrition fortifier

Nutrition fortifier	Source	Donor
2'-fucosyllactose	E. coli BL21(DE3)	Neisseria spp.^a

Notes: ^a refers to α-1,2-fucosyltransferase donor. Besides, the proposed use requirements for 2'-fucosyllactose remain the same as the notice released on October 28, 2022.

One food additive with expanded application scope

Name	Function	Food classification no.	Food category	Maximum usage amount (g/kg)	Notes
Sanzan Gum	Thickener, stabilizer and coagulator	01.01.03	Modified milk	0.5	/
		03.01	Ice cream, ice cream bar	1.5	/
		14.03.03	Compound protein drinks	0.75	Measured in ready-to-drink state. The usage can be increased for solid beverages according to the dilution ratio.
		14.08	Flavored drinks	0.5

One processing aid with expanded application scope

Processing aid	Function	Application scope
Sulfuric acid	Neutralization and soap removal	Processing technology of oil

December 8, 2022

October 28, 2022

On October 28, 2022, China National Center for Food Safety Risk Assessment (CFSA) issued a notice to open 10 new food additives for public comments, including 1 new food additive, 1 new food flavoring, 2 new nutrition fortifiers, 4 new enzyme preparations and 2 food additives with expanded application scope. Any comments can be sent to [email protected] before November 28, 2022.

1 new food additive

Name	Function	Food classification no.	Food category	Maximum usage amount (g/kg)
Potassium Polyaspartate	Stabilizer and coagulator	15.03.01	Wine	0.3g/L

1 new food flavoring

Name	Food classification no.	Food category	Maximum usage amount (g/kg)
2-Hexylpyridine	/	All kinds of food (except food categories in Table B.1 of GB 2760-2014)	As necessary for the production

2 new nutritional fortifiers

Name	Food classification no.	Food category	Usage amount	Notes
2'-fucosyllactose, 2'-FL	01.03.02	Modified milk powder (limited to milk powder for children)	0.7 – 2.4g/L (Measured in pure products and ready-to-eat state. The usage can be increased for powdered products that need to be diluted before intake.)	When mixed with LNnT, GOS, FOS, polyfructose and raffinose, the total amount of such substances shall not exceed 64.5g/kg.
	13.01.01	Infant formula
	13.01.02	Follow-up infant and young children formula
	13.01.03	Infant formula for special medical purpose
Lacto-N-neotetraose, LNnT	01.03.02	Modified milk powder (limited to milk powder for children)	0.2 – 0.6g/L (Measured in pure products and ready-to-eat state. The usage can be increased for powdered products that need to be diluted before intake.)	When mixed with 2'-FL, GOS, FOS, polyfructose and raffinose, the total amount of such substances shall not exceed 64.5g/kg.
	13.01.01	Infant formula
	13.01.02	Follow-up infant and young children formula
	13.01.03	Infant formula for special medical purpose

4 new enzyme preparations

Name	Source	Donor
Protease	Trichoderma reesei	Malbranchea sulfurea
Phospholipase A2	Trichoderma reesei	Aspergillus fumigatus
Maltogenic amylase	Saccharomyces cerevisiae	Geobacillus stearothermophilus
Lactase (beta-galactosidase)	Papiliotrema terrestris	/

Specification of enzyme preparations shall conform to GB 1886.174 National Food Safety Standard Food Additive Enzymes for Food Industry.

2 food additives with expanded application scope

Name	Function	Food classification no.	Food category	Maximum usage amount (g/kg)	Notes
Sodium cyclamate	Sweetener	07.04	Bakery food fillings and surface battering (bakery food filling only)	2.0	As cyclohexyl aminosulfonic acid
Sodium cyclamate	Sweetener	16.06	Puffed food	0.2	As cyclohexyl aminosulfonic acid
Vitamin E	Antioxidant	06.03.02.04	Flour pastes (e.g., flour pastes used for fish and poultry meat), coating and frying flour	0.2	/

August 20, 2022

July 1, 2022

April 15, 2022

January 29, 2022

December 8, 2021

October 21, 2021

August 6, 2021

May 28, 2021

April 12, 2021

February 18, 2021

December 25, 2020

November 12, 2020

September 27, 2020

July 13, 2020

June 1, 2020

February 20, 2020

2019

2018

2017

2016

Name	Food classification no.	Food name	Usage amount
Vitamin B1	14.04.02.01	Beverages for special purposes (including sports beverage and nutrient beverage)	2mg/kg-5mg/kg
Vitamin B2	14.04.02.01	Beverages for special purposes (including sports beverage and nutrient beverage)	2mg/kg-5mg/kg
Taurine	14.04.02.01	Beverages for special purposes (including sports beverage and nutrient beverage)	0.1g/kg-0.6g/kg
Ascorbyl palmitate (enzymatic)	As a compound source of Vitamin C, the use scope and amount of use shall comply with the provisions of GB 14880.

Food nutrition fortifier	Food category no.	Food category	Usage amount
L-Se-methylselenocysteine	Refer to GB 14880
10 fortifiers in total: L-Cysteine, L-Cysteine Hydrochloride Monohydrate, L-Cysteine Monohydrochloride, L-Cystine, L-Histidine, L-Histidine Hydrochloride Monohydrate, L-Lysine Hydrochloride, L-Lysine acetate, L-Phenylalanine, L-Threonine	13.01.01	Infant formula	Refer to GB 10765
	13.01.02	Follow-up infant and young children formula (limited to follow-up infant formula)	Refer to GB 10766
	13.01.03	Infant formula foods for special medical purposes	Refer to GB 25596
	13.03	Food for special medical purposes (except the categories in 13.01)	Refer to GB 29922

Food additive	Function	Food category no.	Food category	Maximum usage amount
1. Fumaric acid 2. Sodium acetate	Acidity regulator	08.02.02	Cured meat products (e.g., salt meats, cured meats, dried salted duck, Chinese ham and sausage)	As necessary for the production
		08.03.02	Smoked, roasted and grilled meat
		08.03.03	Fried meat
		08.03.05	Meat Sausage
		09.02.02	Frozen coating products
		09.04.02	Cooked or fired aquatic products
		09.04.03	Smoked, baked aquatic products

China CFSA Proposes Five New Food Additives, Including 2'FL for Infant Formula [Historical Resources Included]

Two new enzyme preparations

One nutrition fortifier

One food additive with expanded application scope

One processing aid with expanded application scope

One new enzyme preparation

One new nutritional fortifier

One food additive with expanded application scope

Three nutritional fortifiers with expanded application scope/usage amount

1 new food additive

1 new food flavoring

2 new nutritional fortifiers

4 new enzyme preparations

2 food additives with expanded application scope

Enzyme	Source	Donor
D-psicose 3-epimerase	Bacillus subtilis	Ruminococcus sp. CAG55