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Latest developments in human milk oligosaccharides (HMO)

On October 28, 2022, two human milk oligosaccharides (HMO) products (2’-fucosyllactose and Lacto-N-neotetraose) of E. coli origin passed the technical review of the China National Center for Food Safety Risk Assessment (CFSA) Expert Review Committee and are now open for public comments. CIRS Group has provided detailed information about the acceptance and review information of HMO products in China:

No.	Acceptance information (date/acceptance code)	Review information/status	Current status
1	2021.07.02 卫食添新申字(2021)第0028号 2’-fucosyllactose (Synthesis)	2021.07.26: NHC issued an extension notice. 2021.10.21: CFSA collected public comments on 2’-FL. 2021.11.22: NHC issued an extension notice. 2022.01.18: NHC issued an extension notice.	Waiting for the submission of supplementary information.
2	2021.10.18 卫食添新申字(2021)第0048号 2’-fucosyllactose	2021.11.22: NHC issued an extension notice. 2022.01.18: NHC issued an extension notice. 2022.04.15: CFSA collected public comments on 2’-FL. 2022.06.13: NHC issued an extension notice. 2022.07.28: NHC issued an extension notice. 2022.10.28: CFSA again opens for public comments of 2’-FL.	Open for public comments.
3	2021.11.03 卫食添新申字(2021)第0050号 2’-fucosyllactose	2021.11.22: NHC issued an extension notice. 2022.01.18: NHC issued an extension notice. 2022.04.15: CFSA collected public comments on 2’-FL 2022.06.13: NHC issued an extension notice. 2022.07.28: NHC issued an extension notice. 2022.10.28: CFSA again collected public comments on 2’-FL	Open for public comments.
4	2021.10.18 卫食添新申字(2021)第0049号 Lacto-N-neotetraose	2021.11.22: NHC issued an extension notice. 2022.01.18: NHC issued an extension notice. 2022.03.23: NHC issued an extension notice. 2022.06.13: NHC issued an extension notice. 2022.07.28: NHC issued an extension notice. 2022.10.28: CFSA collected public comments on LNnT.	Open for public comments.

Among them, 2’-FL completed its first public consultation in the first half of 2022. This is the second time this substance is open for public comments. CIRS Group has made a detailed comparison between the contents of the two consultations. There are two main changes:

1) Dosage and range of use: Dosage varied based on pure products. The requirements for the total amount of oligosaccharides are added in the remarks column, which is: When mixed with LNnT, oligo-galactose, oligofructose, polyfructose, and raffinose, the total amount of this substance must not exceed 64.5 g/kg.

2) Quality specification requirements: the requirement for endotoxin has been newly added (endotoxin ≤ 10 EU/mg).

Summary of additives subject to public comments

On October 28, 2022, CFSA issued ten new food additives passing the technical review and open for public comments.

There are eight new food additives:

one new food additive,
four new food enzymes,
one new food flavoring, and
two new food nutrition enhancers.

There are also two kinds of food additives with expanded use.

The deadline for public comments is November 16, 2022. Relevant information is as follows:

1. New food additive (1 type)

No.	Name	Function	Category number	Food name/category	Maximum level (g/kg)
1	Potassium Polyaspartate	Stabilizer, coagulant	15.03.01	wine	0.3 g/L

2. New food enzymes (4 types)

No.	Name	Source	Donor
1	Protease	Trichoderma reesei	Malbranchea sulfurea
2	Phospholipase A2	Trichoderma reesei	Aspergillus fumigatus
3	Maltogenic amylase	Saccharomyces cerevisiae	Geobacillus stearothermophilus
4	Lactase（beta-galactosidase）	Papiliotrema terrestris	—

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

3. New food flavoring (1 type)

No.	Name	Function	Category number	Food name/category	Maximum level (g/kg)
1	2-Hexylpyridine	Flavors prepared for food	—	Formulated into food flavors for all types of food (except the food category in Table B.1 of GB 2760-2014)	Appropriate level as required in production

4. New food nutrition enhancers (2 types)

No.	Name	Category number	Food name/category	Maximum level (g/kg)	Note
1	2’-fucosyllactose, 2’-FL	01.03.02	Modified milk powder (limited to milk powder for children)	0.7-2.4 g/L (Count as pure products. In the ready-to-eat state, the powdered product should increase the usage amount according to the reconstituted multiple.)	When mixed with Lacto-N-neotetraose, oligo-galactose, oligofructose, polyfructose, and raffinose, the total amount of this substance does not exceed 64.5 g/kg.
		13.01.01	Infant formula foods
		13.01.02	Older infants and young children formula
		13.01.03	Infant formula food for special medical purposes
2	Lacto-N-neotetraose, LNnT	01.03.02	Modified milk powder (limited to milk powder for children)	0.2-0.6 g/L (Count as pure products. In the ready-to-eat state, the powdered product should increase the usage amount according to the reconstituted multiple)	When mixed with 2’-FL, oligo-galactose, oligofructose, polyfructose, and raffinose, the total amount of this substance does not exceed 64.5 g/kg.
		13.01.01	Infant formula foods
		13.01.02	Older infants and young children formula
		13.01.03	Infant formula food for special medical purposes

5. Food additives with expanded scope (2 types)

No.	Name	Function	Category number	Food name/category	Maximum level (g/kg)	Note
1	Sodium cyclohexyl sulfamate (also known as cyclamate)	Sweetener	07.04	Paste for fillings and surfaces of baked goods (for baked goods fillings only)	2.0	Calculated as cyclohexyl aminosulfonic acid
1	Sodium cyclohexyl sulfamate (also known as cyclamate)	Sweetener	07.04	Puffed food	0.2	Calculated as cyclohexyl aminosulfonic acid
2	Vitamin E	Antioxidants	06.03.02.04	Batter (e.g., drag batter for fish and poultry), powder, frying powder	0.2	—

Please refer to the website at the end of this article for details on quality specifications and inspection methods.

Reference website: CFSA openly solicited opinions on 10 new food additives, including potassium polyaspartate.

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Latest Developments in Human Milk Oligosaccharides (HMO)