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Regulatory situation of HMOs in various countries

Each country has its own standards for the control of HMOs (human milk oligosaccharides), which means that HMOs must meet the requirements of the country's standards in order to be marketed in that country. In China, HMOs is managed according to new varieties of nutritional fortifiers, while the United States manages HMOs as a Generally Recognized as Safe (GRAS) substance, while the European Food Safety Agency (hereinafter referred to as the "EU") and the Australian and New Zealand Food Standards Agency (hereinafter referred to as "ANZ") manage HMOs as a new food ingredient.

Approval status of international HMOs

Types approved by HMOs

The United States and the European Union have approved the application of 7 HMOs, including 2 '- FL, 3-FL, LNT, LNnT, 3' - SL, 6 '- SL, and a mixture of 2' - FL/difucosyllactose (DFL). The United States has also approved the application of the mixed ingredient lacto-N-fucopentaose lLNFP-1/2 '- FL. Types approved for use by HMOs in some countries and regions

At present, the production processes of HMOS approved by the United States and the European Union mainly include microbial fermentation, chemical synthesis, and enzyme synthesis. Microbial fermentation based on bioengineering bacteria such as Escherichia coli and yeast has become a favored "darling" in today's HMOs production process due to its advantages of low production cost and low environmental pollution. Currently, the vast majority of approved HMOs are obtained through fermentation methods. Only 2 '- FL and LNnT have been approved for two production processes in the United States and the European Union: fermentation and chemical synthesis; 3 '- SL has approved two production processes in the United States, fermentation and enzyme synthesis; HMOs approved for use in other countries and regions are all produced by fermentation method.

Application scope approved by HMOs

At present, HMOs has been approved and widely used by Dongguo, playing a crucial role in infant formula food, dietary supplements, and special medical purpose foods. At the same time, it has also been approved for addition to regular food, promoting the high-quality upgrading of dairy products, baked goods, beverages, coffee, tea and other foods. As a highly sought after "potential stock" on the C-end today, HMOs contains significant development potential. It can be said that whoever masters HMOs has the market.

Approved usage of HMOs

The composition and content of HMOs vary among individuals and are influenced by factors such as lactation period, genetic factors, and geography. Therefore, the demand for HMO usage varies among different countries and regions. The approved usage of HMOs is personalized for babies from different countries. According to the content of HMOs in the breast milk of mothers from different countries and regions, the approved dosage for different HMO components also varies depending on their level of content in breast milk. For example, the United States and Australia approved 2 '- FL and LNnT for use in infant formula, with maximum usage levels of 2.4 g/L and 0.6 g/L, respectively, while the EU approved 2' FL and LNnT have maximum usage levels of 1.2 g/L and 0.6 g/L, respectively, in infant formula. Let babies from different countries and regions also feel the care and care of mothers from food.

In addition, the differences in the definition and classification of food categories among countries, as well as the differences in food consumption data used as the basis for safety exposure assessments, result in different food application ranges and maximum usage levels in each country.

Regulatory situation of HMOs in various countries

In China, in order to ensure the safety of HMOs used in infant formula food, enterprises and professional institutions including Hongmu Biotechnology have conducted a lot of work and evaluation verification on the safety of HMOs used in infant formula food, including the safety evaluation of genetically engineered bacteria involved in HMO production and the safety evaluation of HMOs themselves. The safety evaluation verification has laid the foundation for successful approval in China.

As of now, 2 '- fucosyllactose has been released for acceptance information 10 times, and lactose-N-neotetraose has been released once. 2' - fucosyllactose, as the HMOs variety with the highest content, is also the most popular.

On October 7, 2023, the National Health Commission issued a notice on 15 "three new foods" including peach gum, which includes two HMOs substances 2 '- fucosyllactose and lactose-N-neotetraose. Its application scope can be used as a food nutritional enhancer in formulated milk powder (limited to infant milk powder), infant formula food, and special medical infant formula food. The approved doses of 2 '- FL and LNnT for immediate consumption are 0.7~2.4 g/L and 0.2~0.6 g/L, respectively.

The official approval of HMOs will inject new momentum into the innovation and upgrading of products in China's food industry, which is of great significance for supporting early life nutrition research, promoting high-quality development and industrial upgrading in areas such as infant formula food and special medical purpose formula food in China.

In October 2023, Synaura 2 '- FL (2′-fucosyllactose) won the first batch of the Health Commission and became the only local approved enterprise in China. It has a new milestone significance in the research and application of HMOs. Synaura is willing to carry the local innovation mission, continue to promote the vigorous development of local biological synthesis technology, and help China become the flag benchmark of the fourth industrial wave.

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Regulatory situation of HMOs in various countries

Approval status of international HMOs

Regulatory situation of HMOs in various countries

Regulatory situation of HMOs in various countries

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