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 arisen many discussions, which also made public wonder about the application progress of these substances.
To clarify the compliance process of HMOs in China, CIRS Group sorts out detailed information about the relevant application progress as follows.
Ⅰ. 2’-fucosyllactose (Synthesis): having been issued for public comments
| No. | Acceptance information(time/acceptance number) | Review information/Status |
| 1 | 2021.07.02卫食添新申字(2021) No. 00282’-fucosyllactose(Synthesis) | 2021.07.26: NHC issued a notice on delaying review2021.10.21: CFSA collected public comments2021.11.22: NHC issued a notice on delaying review2022.01.18: 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 using 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 |
| 1 | 2021.10.18卫食添新申字(2021) No. 00482’-fucosyllactose | 2021.11.22: NHC issued a notice on delaying review2022.01.18: NHC issued a notice on delaying review2022.04.15: CFSA collected public comments2022.06.13: NHC issued a notice on delaying review2022.07.28: NHC issued a notice on delaying review2022.10.28: CFSA collected public comments2023.01.19: NHC issued a notice on delaying review |
| 2 | 2021.11.03卫食添新申字(2021) No.00502’-fucosyllactose | 2021.11.22: NHC issued a notice on delaying review2022.01.18: NHC issued a notice on delaying review2022.04.15: CFSA collected public comments2022.06.13: NHC issued a notice on delaying review2022.07.28: NHC issued a notice on delaying review2022.10.28: CFSA collected public comments2023.01.19: NHC issued a notice on delaying review |
| 3 | 2022.11.15卫食添新申字(2022) No.00852’-fucosyllactose | 2023.01.19: NHC issued a notice on delaying review |
| 4 | 2023.01.05卫食添新申字(2023) No.00032’-fucosyllactose | 2023.02.10: CFSA collected public comments2023.03.15: 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 comments. The same standard requirements as they should meet, 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 |
| 1 | 2021.10.18卫食添新申字(2021) No. 0049Lacto-N-neotetraose | 2021.11.22: NHC issued a notice on delaying review2022.01.18: NHC issued a notice on delaying review2022.03.23: NHC issued a notice on delaying review2022.06.13: NHC issued a notice on delaying review2022.07.28: NHC issued a notice on delaying review2022.10.28: CFSA collected public comments2023.01.19: 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 of 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. a and Helicobacter spp.b |
| a is the donor of β-1,3-N-acetylglucosaminyltransferaseb is 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 HMOs 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 HMOs substances will keep up with 2’-FL and LNnT in China. (Source: CIRS)
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