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Latest Developments in Human Milk Oligosaccharides (HMO)

from CIRS by

China,Food,HMO,Additive,Nutrition,Flavouring

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

07.04

Puffed food

0.2

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.

If you have any needs or questions, please contact us at service@cirs-group.com.

  

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