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On February 10, 2023, China National Center for Food Safety Risk Assessment (CFSA) issued a draft for public consultation on several new food additives, which contains the latest development in the review of 2’-fucosyllactose. In 2022, trending topics such as “2’-fucosyllactose (2’-FL)”, “Lacto-N-neotetraose (LNnT)”, and “collecting public comments” have given rise to many discussions, also making the public wonder about the application progress of these substances.

To clarify the compliance process of HMOs in China, CIRS Group has provided detailed information about the relevant application progress as follows.

Ⅰ. 2’-fucosyllactose (Synthesis): issued for public comments

No.

Acceptance information

(time/acceptance number)

Review information/Status

2021.07.02

卫食添新申字(2021) No. 0028

2’-fucosyllactose

(Synthesis)

2021.07.26: NHC issued a notice on delaying review

2021.10.21: CFSA collected public comments

2021.11.22: NHC issued a notice on delaying review

2022.01.18: NHC issued a notice on delaying review

According to the previous draft issued for public consultation, the 2’-fucosyllactose (synthesis) is prepared by reaction of L-fucose and D-lactose and applied for use in formulated milk powder (Food Cat. No.01.03.02, limited to milk powder for children) with a usage amount of 1.2 g/L (counts as the ready-to-eat state, for powdery products, the level of use should be increased by brewing time.)

The approval of 2’-FL (synthesis) has not progressed since the issuance of the notice on delaying review in January 2022.

No.

Acceptance information

(time/acceptance number)

Review information/Status

2021.10.18

卫食添新申字(2021) No. 0048

2’-fucosyllactose

2021.11.22: NHC issued a notice on delaying review

2022.01.18: NHC issued a notice on delaying review

2022.04.15: CFSA collected public comments

2022.06.13: NHC issued a notice on delaying review

2022.07.28: NHC issued a notice on delaying review

2022.10.28: CFSA collected public comments

2023.01.19: NHC issued a notice on delaying review

2021.11.03

卫食添新申字(2021) No.0050

2’-fucosyllactose

2021.11.22: NHC issued a notice on delaying review

2022.01.18: NHC issued a notice on delaying review

2022.04.15: CFSA collected public comments

2022.06.13: NHC issued a notice on delaying review

2022.07.28: NHC issued a notice on delaying review

2022.10.28: CFSA collected public comments

2023.01.19: NHC issued a notice on delaying review

2022.11.15

卫食添新申字(2022) No.0085

2’-fucosyllactose

2023.01.19: NHC issued a notice on delaying review

2023.01.05

卫食添新申字(2023) No.0003

2’-fucosyllactose

2023.02.10: CFSA collected public comments

2023.03.15: NHC issued a notice on delaying review

Ⅱ. 2’-fucosyllactose (Fermentation): several related products have been issued for public comments

Until now, three types of 2’-FL fermented from different sources have been issued for public comment. The same standard requirements as they should meet, but their production strains are different as shown in the table below:

Nutrition enhancer	Source	Donor
2’-fucosyllactose	E. coli K-12 DH1 MDO	Helicobacter spp. ^a
	E. coli K-12 MG1655	Helicobacter spp. ^a
	E. coli BL21(DE3)	Neisseria spp. ^a
^a is the donor of α-1, 2-fucosyltransferase

According to the latest notice issued for public comments, the maximum usage level and applicable scopes of 2’-FL (fermentation) are as follows:

Name	Cat No.	Food name/category	Maximum level	Remark
2’-FL	01.03.02	Modified milk powder (for children only)	0.7-2.4 g/L (In terms of ready-to-eat status, the usage of powdery products shall be increased according to the preparation ratio.)	When used in combination with LNnT, GOS, Fructo-oligosaccharide, FOS, and raffinose, the total amount shall not exceed 64.5 g/kg.
	13.01.01	Infant formula
	13.01.02	Formula for older infants and young children
	13.01.03	Infant formula for special medical purposes

Ⅲ. Lacto-N-neotetraose (Fermentation): having been issued for public comments

No.

Acceptance information

(time/acceptance number)

Review information/Status

2021.10.18

卫食添新申字(2021) No. 0049

Lacto-N-neotetraose

2021.11.22: NHC issued a notice on delaying review

2022.01.18: NHC issued a notice on delaying review

2022.03.23: NHC issued a notice on delaying review

2022.06.13: NHC issued a notice on delaying review

2022.07.28: NHC issued a notice on delaying review

2022.10.28: CFSA collected public comments

2023.01.19: NHC issued a notice on delaying review

Lacto-N-neotetraose (LNnT) is a nutrition enhancer prepared through fermentation, purification, drying, and other processes by using lactose as raw materials. The LNnT application was first submitted in 2021. After several times of dossier supplements, it was released for public comments in October 2022. In January 2023, the NHC issued a notice on delaying review again.

According to the notice issued for public comments, the information on production strain, maximum usage level, and applicable scopes of LNnT are as follows:

Nutrition enhancer

Source

Donor

Lacto-N-neotetraose

E. coli K-12 DH1 MDO

Neisseria spp. ^aand Helicobacter spp.^b

^a is the donor of β-1,3-N-acetylglucosaminyltransferase

^bis the donor of β-1,4-galactosyltransferase

Name	Cat No.	Food name/category	Maximum level	Remark
LNnT	01.03.02	Modified milk powder (for children only)	0.2-0.6 g/L (In terms of ready-to-eat status, the usage of powdery products shall be increased according to the preparation ratio.)	When used in combination with 2’-FL, GOS, Fructo-oligosaccharide, FOS, and raffinose, the total amount shall not exceed 64.5 g/kg.
	13.01.01	Infant formula
	13.01.02	Formula for older infants and young children
	13.01.03	Infant formula for special medical purposes

Epilogue

According to the available data released by NHC and CFSA, as to HMO substances, there are only 2’-FL and LNnT that have been on their way to approval by now. However, as a “celebrity” in food raw materials these years, enterprises are showing great interest in the application of HMOs, and it is believed that more and more HMO substances will keep up with 2’-FL and LNnT in China.

If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.

Further Information

Infant Formula Milk Powder Registration

Latest Compliance Advances of Human Milk Oligosaccharides (HMOs) in China

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The Application Progress of Human Milk Oligosaccharides (HMOs) in China

Ⅰ. 2’-fucosyllactose (Synthesis): issued for public comments

Ⅱ. 2’-fucosyllactose (Fermentation): several related products have been issued for public comments

Ⅲ. Lacto-N-neotetraose (Fermentation): having been issued for public comments

Epilogue