In recent years, there has been an increasing interest in Human milk oligosaccharides (HMOs). 2’-fucosyllactose (2'-FL) is the most abundant oligosaccharide in human milk. As a typical representative ingredient of HMOs, it has been approved for use in food in many countries and regions, such as the EU, the US and Australia and New Zealand.
Now, it also has good news in China： on February 10, 2022, the Chinese National Health Commission (NHC) started another public comment on 2'-FL. It is proposed to use 2'-FL produced by E. coli BL21(DE3) ((Neisseria spp.) as a transferase donor) as a nutritional fortification (NHC Application For New Food Additive Varieties (2023) No. 0003).
I.Status of regulations for 2'-FL in China
In China, 2'-FL has not been officially approved for use as a general food ingredient. However, as early as August 10, 2016, an attempt was made to make an application for this substance (NHC Application For New Food Additive Varieties (2016) No. 0040).
Of all applications, one chemically synthesized source, and three microbial fermentation sources of 2'-FL are in the comment stage.
Application status of different 2'-FL | |||
(NHC Application For New Food Additive Varieties) | |||
Application Info: | Source | Transferase donors | Application Progress Update |
Microbial fermentation sources | |||
(2023) No. 0003 | E. coli BL21(DE3)#1540 | Not publicly available | 2016.08.15：The first public consultation, intended for infant formula, formula for older infants and toddlers. Proposed usage amount: 1-17g/kg. No follow-up updates. |
(2021) No.0048 | E. coli DH1 MDO | Helicobacter spp. | 2022.10.28：The second public consultation, intended to be used for prepared milk powder (for children only), infant formula, formula for older infants and toddlers, formula for infants for special medical purposes. Proposed usage amount: 0.7-2.4 g/L.a) b) 2023.01.19：Posting of extension notice information |
(2021) No.0050 | E. coli K-12 MG 1655 | Helicobacter spp. | |
(2022) No.0085 | Not publicly available | Not publicly available | 2023.01.19：Posting of extension notice information |
(2023) No.0003 | E. coli BL21（DE3） | Neisseria spp. | 2023.02.10：The first public consultation, intended to be used for prepared milk powder (for children only), infant formula, formula for older infants and toddlers, formula for infants for special medical purposes. Proposed usage amount: 0.7-2.4 g/L.a) b) |
Chemical synthesis source | |||
(2021) No.0028 | Chemical synthesis | None | 2021.10.21：The first public consultation, intended to be used for prepared milk powder (for children only). Proposed usage amount: 0.7-2.4 g/L. a) 2022.01.18：Posting of extension notice information |
Notes: a) The amount used is in ready-to-eat condition. For powdered products, increase the amount of use by the dilution of the brew. b) When mixed with lactose-N-neotetrasaccharide, oligogalactose, oligofructose, polyfructose and Raffinose, the total amount of such substances shall not exceed 64.5g/kg | |||
II.Status of regulations for 2'-FL in other countries and regions
Globally, 2'-FL has been approved for use in food in several countries and regions. ZMUni summarizes the status of regulations in major countries and regions such as the United States and the European Union.
Countries and regions | Current Status | Based on | |||||||||||||||||||||||||||||||||||||||
USA | A number of 2'-FL (single or mixed ingredient products) have been notified as "Generally Recognized as Safe" (GRAS) by the U.S. Food and Drug Administration (FDA).
The scope of use includes Infant and toddler formula, as well as baked goods, dairy products, beverages and other food categories. The amount of use varies depending on the application unit and the scope of use requirements. | Generally Recognized as Safe (GRAS) database | |||||||||||||||||||||||||||||||||||||||
EU | 2'-FL is included in the (EU) 2015/2283 list of novel foods, consisting of:
The range of use includes infant formula, dietary supplements, fermented dairy products, coffee, tea, etc. The amount of use specified in different food categories varies, with the maximum individual amount in infant and older infant formula being 1.2 g/L (based on ready-to-eat products). When mixed with lactose-N-neotetrasaccharide, the maximum amount of 2'-FL is 0.6 g/L, and the ratio of 2:1 should be met in the final product. | （EU）2015/2283 | |||||||||||||||||||||||||||||||||||||||
Australia and New Zealand | The following approved 2'-FLs are included in the ANZ Food Standards Code.：
All three of the above can only be used in Infant and toddler formula products. When used alone, the maximum amount is 96mg/100kJ. When mixed with lactose-N-neotetrasaccharide (LNnT), the maximum use of 2'-FL and LNnT should be 96mg/100kJ in total, and the content of LNnT should not exceed 24mg/100kJ. | Australia New Zealand Food Standards Code -Schedule 26 Food produced using gene technology | |||||||||||||||||||||||||||||||||||||||
Canada | Canada has approved the following three 2'-FL as novel foods：
The above three sources of 2'-FL in their respective permitted food categories are added to the maximum use level of 1.2g/L. | Novel foods including genetically modified (GM) foods database | |||||||||||||||||||||||||||||||||||||||
Brazil | Brazil approved the following five 2'-FLs as novel foods：
The scope of use includes Infant and toddler formula, pasteurized and ultra-high temperature sterilized milk, fermented milk, milk beverages and other food categories. The amount used varies depending on the declared unit and the range of use. | ANVISA-Approved New Foods, New Ingredients, Probiotics and Enzymes | |||||||||||||||||||||||||||||||||||||||
Taiwan, China | The following sources of 2'-FL are allowed in Taiwan, China：
Use is limited to infant and older infant formulae and milk powder or similar products intended for children under 7 years of age. The use limit is 1.2 g/L, calculated as ready-to-eat or in the state in which it is prepared for consumption according to label directions. | Announcement No. 1091303448 on December 16, 109 of the Republic of China; Announcement No. 1101301211 on June 16, 110 of the Republic of China; Amendment No. 1111303588 on February 7, 112 of the Republic of China | |||||||||||||||||||||||||||||||||||||||
Singapore | The maximum use level in infant formula is 1.2g/L. | Singapore Food Regulations Special Part Purpose Foods 252 Infant formula |
ZMUni can provide related services for companies：
* Application for GRAS in the USA
* Application for EU Novel food
* Application for Brazil Novel food
* Application for New food ingredient in China
* Other Customised compliance consultation
Information source：
1.China National Center for Food Safety Risk Assessment（CFSA）
2.U.S. Food and Drug Administration（FDA）
3.European Commission（EC）
4.Food Standards Australia New Zealand（FSANZ）
5.Novel foods including genetically modified (GM) foods database
6.Brazilian Health Regulatory Agency (ANVISA)
7.Taiwan Food and Drug Administration (TFDA)
8Singapore Food Regulations
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