China CFSA Collects Public Comments on Eleven New Food Additives including 3-fucosyllactose, Fructooligosaccharide

On September 26, 2024, China National Center for Food Safety Risk Assessment (CFSA) issued 11 new food additives for public comment. It covers: five new food additives, three new food nutrition enhancers, two food additives with expanded scope, and one food nutrition enhancer with expanded scope. Comments are welcomed before October 26, 2024. Details are as follows:

New enzyme preparations for the food industry (three types)

S.N.	Enzyme	Source	Donor
1	Glutamine transaminase	Bacillus licheniformis	Streptomyces mobaraensis
2	Phosphodiesterase I	Leptographium procerum	—
3	Lipase	Komagataella phaffi	Streptomyces sp.

The quality specification requirements of enzyme preparations for the food industry should be in accordance with the provisions of National Standard for Food Safety Food Additives Enzyme Preparations for Food Industry (GB 1886.174).

New food spices (two types)

a. trans-Anethole

Functional classification: Food flavors

Applicable scope and maximum levels

Category number	Food name	Maximum level	Remark
—	Formulated into food flavors for use in various food products (except for food categories in Table B.1 of GB 2760-2014)	According to production needs	—

The requirements of this quality specification apply to the food additive trans-Anethole from propionic acid and acetic anhydride as raw materials by chemical reaction.

b. Hydroxycitronellal

Functional classification: Food flavors

Applicable scope and maximum levels

Category number	Food name	Maximum level	Remark
—	Formulated into food flavors for use in various food products (except for food categories in Table B.1 of GB 2760-2014)	According to production needs	—

This quality specification applies to the food additive hydroxycitronellal produced by chemical reaction with citronellol as raw material. The rest of the content of the National Standard for Food Safety Food Additives Hydroxycitronellal (GB 1886.117).

New food nutrition enhancers (three types)

a. 3-fucosyllactose, 3-FL

Functional classification: food nutrition enhancers

Applicable scope and maximum levels:

Category number	Food name	Maximum level	Remark
01.03.02	Infant formula	0.25-0.9 g/L (count as 3’-SL and the ready-to-eat state, for powdery products, the level of use should be increased by times of brewing)	When being mixed with 2’-fucosyllactose (2’-FL), Lacto-N-neotetraose (LNnT), 6’-Sialyllactose sodium salt (6’-SL), galacto-oligosaccharide (GOS), fructo-oligosaccharide (FOS), polyfructose and raffinose, the total amount shall not exceed 64.5 g/kg.
13.01.01	Older infants and young children's food
13.01.02	Infant formula for special medical purposes
13.01.03	Infant formula

The quality specifications apply to the food nutrition enhancer 3’-Sialyllactose sodium salt prepared through fermentation, purification, drying, and other processes using lactose and glucose as raw materials. The production strain of 3’-SL shall undergo a safety assessment and comply with the requirements specified in Appendix C.

b. β-Alanine

Functional classification: food nutrition enhancers

Category number	Food name	Maximum level	Remark
13.05	Foods for special dietary uses other than 13.01-13.04 (sports nutrition foods only)	2-4g per day	—

The requirements of this quality specification apply to β-Alanine, a food fortification agent produced by fermentation from glucose, yeast powder, or from glucose, ammonia, magnesium sulfate, and acrylic acid. The bacteria used in the production of β-Alanine should be evaluated for safety and comply with the requirements of Appendix D.

c. Fructooligosaccharide

Functional classification: food nutrition enhancers

Applicable scope and maximum levels: The scope of use and the amount of use of this substance implement the provisions of the approved fructooligosaccharide in the Standard for the Use of Food Nutritional Enrichment of the National Food Safety Standards (GB 14880).

Food additive with expanded scope (two types)

S.N.	Name	Category number	Food name	Maximum level （g/Kg）	Remark
1	Sucralose	04.01.02.08	food preserved in sugar or honey	2.8	—
2	Potassium acetylsulfonate	14.08	flavored drink	0.5	In the ready-to-drink state, the corresponding solid beverages increase the amount of use according to the dilution multiplier.

Food nutrition enhancer with expanded scope (one type)

S.N.	Name	Category number	Food name	Maximum level （g/Kg）	Remark
1	2'-fucosyllactose	13.02.01	Cereal supplements for infants and young children	2.8	—
		13.02.02	Canned food supplements for infants and young children	0.7-2.4 g/L (count as 3’-SL and the ready-to-eat state, for powdery products, the level of use should be increased by times of brewing)	When mixed with lactose-N-neotetraose, oligogalactose, oligofructose, polyfructose, and raffinose, the total amount of such substances shall not exceed 64.5g/kg.

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