Human Milk Oligosaccharides (tsv11天时娱乐s) stand as a vital category of naturally occurring nutrients found in breast milk. Currently, there are over 200 known structures of tsv11天时娱乐s, with six types being extensively researched, of which the nutritional necessity and safety have gained broad international recognition.
Notably, in tsv11天时娱乐, there’s widespread attention on four compliant tsv11天时娱乐s:
- 2’-fucosyllactose (2’-FL);
- lacto-N-neotetraose (LNnT);
- 6’-sialyllactose sodium salt (6’-SL); and
- 3’-sialyllactose sodium salt (3’-SL).
To clarify the compliance advances of tsv11天时娱乐s in tsv11天时娱乐, CIRS Group has summarized detailed application and approval status as follows.
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As of now, one type of lacto-N-neotetraose (LNnT) and three types of 2'-fucosyllactose (2’-FL) have obtained approval. Specifically, the approved 2’-FL are all prepared through fermentation sources, with the same standard requirements but differing production strains. Details are shown in the table below:
Name | Approval date | Source | Donor |
2023.10.7 | E.coli K-12 DH1 MDO | Helicobacter spp. a | |
E.coli K-12 MG1655 | Helicobacter spp. a | ||
E.coli BL21(DE3) | Neisseria spp. a | ||
2023.10.7 | E. coli K-12 DH1 MDO | Neisseria spp. a and Helicobacter spp. b | |
a is the donor of α-1, 2-fucosyltransferase b is the donor of β-1,4-galactosyltransferase |
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It can be seen from the table below that the synthetically derived 2’-FL has faced another extension since January 2022, with no further public review progress after supplementing dossiers. On a different note, a fermentation-based 2’-FL was just open for public comments on August 23, this year. If all progresses smoothly, it’s highly likely to be one of the next batch of approved tsv11天时娱乐s.
Name | Acceptance number | Acceptance date | Latest updates |
2’-FL (Synthesis) | 卫食添新申字(2021) No. 0028 | 2021.7.2 | 2021.10.21 2022.1.18 NHC issued a notice on delaying the review |
2’-FL Source: ATCC 13032; Donor: Pseudopedobacter saltans a | 卫食添新申字(2023) No. 0045 | 2023.7.14 | 2023.8.23 |
a is the donor of α-1, 2-fucosyltransferase |
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According to the information released on the Administrative Service Platform of the National Health Commission (NHC), in addition to the tsv11天时娱乐s already approved and issued for public comments, there are eight tsv11天时娱乐s currently undergoing technical review, which include four types of 2’-FL, two types of 6’-SL, and two types of 3’-SL. Details are shown in the table below:
Name | Acceptance number | Acceptance Date | Latest public review status |
2’-FL | 卫食添新申字(2022) No. 0085 | 2022.11.15 | 2023.1.19 NHC issued a notice on delaying the review |
2’-FL | 卫食添新申字(2023) No. 0058 | 2023.9.19 | / |
2’-FL | 卫食添新申字(2023) No. 0059 | 2023.9.20 | / |
2’-FL | 卫食添新申字(2023) No. 0061 | 2023.9.20 | / |
6’-SL | 卫食添新申字(2023) No. 0033 | 2023.5.4 | 2023.6.6 NHC issued a notice on delaying the review |
6’-SL | 卫食添新申字(2023) No. 0046 | 2023.7.17 | 2023.8.4 Delivering a notification of review opinion |
3’-SL | 卫食添新申字(2023) No. 0047 | 2023.7.17 | 2023.8.4 NHC issued a notice on delaying the review |
3’-SL | 卫食添新申字(2023) No. 0062 | 2023.9.21 | / |
Warm Reminder
Since the inception of tsv11天时娱乐 compliance in tsv11天时娱乐, major dairy enterprises have been gearing up for action. With the recent introduction of 2’-FL and LNnT, numerous leading brands have promptly launched new products. It’s worth mentioning that the current offerings are tsv11天时娱乐s-enriched children's milk powder. The introduction of infant formula with added tsv11天时娱乐s will require formula adjustments or registration, requiring a certain time period. With the anticipated approval of more tsv11天时娱乐 substances, the infant formula industry is likely to witness a significant upgrade in formulas.
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