China CFSA Collects Public Comments on Seven New Food Additives including Hydroxytyrosol, 3’-SL and 6’-SL

On March 13, 2024, China National Center for Food Safety Risk Assessment (CFSA) issued 7 new food additives for public comment, including 2 new food additives, 3 new food nutrition enhancers, 1 food additive with expanded scope, and 1 food nutrition enhancer with expanded scope. Comments are welcomed before April 13, 2024. Details are as follows:

New food additives (2 types)

1) Hydroxytyrosol

S.N.	Food additive	Function	Category number	Food category/ name	Maximum level (g/kg)	Remark
1	Hydroxytyrosol	Antioxidant	02.01.01	Plant oils and fats	0.05	—

The quality specifications apply to the food additive Hydroxytyrosol, which is prepared through catalytic conversion, separation and purification of the fermentation broth of Corynebacterium glutamicum using Tyrosine as the raw material.

2) Methylene chloride

S.N.	Processing aid	Function	Applicable scope
1	Methylene chloride	Extracting solvent	Tea decaffeination process (residue ≤ 2 mg/kg)

The quality specifications apply to the food additive methylene chloride that is prepared by reacting chloromethane, obtained under the catalysis of zinc chloride using methanol and hydrochloric acid as raw materials, with chlorine to generate various methane chlorides, followed by distillation.

New food nutrition enhancers (3 types)

1) 2’-fucosyllactose, 2’-FL

The maximum levels, scope of use and quality specifications shall meet the requirements outlined in NHC Notice No. 8 of 2023, excluding Appendix C. The production strain information is given in the Table below:

Table 1 Information on the production strain of 2’-fucosyllactose

Nutrition enhancer	Source	Donor
2’-fucosyllactose	Escherichia coli BL21 star (DE3)	Escherichia coli O126 a

^a refers to the donor of α-1, 2-fucosyltransferase

2) 3’-Sialyllactose sodium salt, 3’-SL

Applicable scope and maximum levels:

Category number	Food category/name	Maximum level	Remark
13.01.01	Infant formula	0.11-0.24 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 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.
13.01.02	Older infants and young children's food
13.01.03	Infant formula for special medical purposes

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 safety assessment and comply with the requirements specified in Appendix C.

Appendix C Information on the production strain of 3’-SL

Nutrition enhancer	Source	Donor
3’-Sialyllactose sodium salt	Escherichia coli W NEO3	Saccharomyces cerevisiae a, Synechocystis sp. b, Rhodobacter capsulatus c, Pasteurella multocida d and Neisseria lactamica e

^a refers to the donor of N-acetylglucosamine 6-phosphate N-acetyltransferase

^b refers to the donor of N-acetylglucosamine-2-epimerase

^c refers to the donor of N-acetylserotonin synthase

^d refers to the donor of Adenosine 5’-monophosphate-N-acetylneuraminate synthase

^e refers to the donor of Alpha-2,3-sialyltransferase

3) 6’-Sialyllactose sodium salt, 6’-SL

Applicable scope and maximum levels:

Category number	Food category/name	Maximum level	Remark
13.01.01	Infant formula	0.14-0.40 g/L (count as 6’-SL and the ready-to-eat state, for powdery products, the level of use should be increased by times of brewing)	When mixed with 2’-fucosyllactose (2’-FL), Lacto-N-neotetraose (LNnT), 3’-Sialyllactose sodium salt (3’-SL), galacto-oligosaccharide (GOS), fructo-oligosaccharide (FOS), polyfructose and raffinose, the total amount shall not exceed 64.5 g/kg.
13.01.02	Older infants and young children's food
13.01.03	Infant formula for special medical purposes

The quality specifications apply to the food nutrition enhancer 6’-Sialyllactose sodium salt prepared through fermentation, purification, drying, and other processes using lactose and glucose as raw materials. The production strain of 6’-SL shall undergo safety assessment and comply with the requirements specified in Appendix C.

Appendix C Information on the production strain of 6’-SL

Nutrition enhancer	Source	Donor
6’-Sialyllactose sodium salt	Escherichia coli W NEO6	Saccharomyces cerevisiae a, Synechocystis sp. b, Pasteurella multocida c, Photobacterium damselae d and Rhodobacter capsulatus e

^a refers to the donor of N-acetylglucosamine 6-phosphate N-acetyltransferase

^b refers to the donor of N-acetylglucosamine-2-epimerase

^c refers to the donor of Adenosine 5’-monophosphate-N-acetylneuraminate synthase

^d refers to the donor of Alpha-2,6-sialyltransferase

^e refers to the donor of N-acetylneuraminate synthase

Food additive with expanded scope (1 type)

S.N.	Name	Function	Category number	Food name/ category	Maximum level (g/kg)	Remark
1	Polyglycerol polyricinoleate (polyglycerol esters of interesterified ricinoleic acid) (PGPR)	Emulsifier	01.05.03	Formulated cream	10.0	—

Food nutrition enhancer with expanded scope (1 type)

S.N.	Name	Category number	Food name/ category	Maximum level (g/kg)	Remark
1	(6S)-5-methyltetrahydrofolic acid, glucosamine salt	13.05	Foods for special dietary purpose excluding 13.01-13.04 (nutrition supplements for pregnant and lactating women only)	It shall comply with the provisions regarding folic acid specified in GB 31601 National Food Safety Standard - Nutrition Supplements for Pregnant and Lactating Women	—

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