China’s National Health Commission (NHC) has issued a new round of regulatory review updates covering the country’s “Three New Foods” framework, which includes new food raw materials, new food additives and new food-related products.

According to CIRS Group, the latest update includes 10 extension notices requiring applicants to submit supplementary materials following technical review by the China National Center for Food Safety Risk Assessment (CFSA), as well as six review opinions.

Among the ingredients receiving extension notices are several of particular interest to the nutrition and functional ingredient industries:

• 3-Fucosyllactose (3-FL)
• Galactooligosaccharides (GOS)
• Lacto-N-tetraose (LNT)
• Fermentation-derived thaumatin
• Steviol Glycoside RM
• Beta-carotene

The extension notices mean additional information is required as part of the regulatory review process and should not be interpreted as final rejections.

Separately, CFSA issued review opinions recommending that approval not be granted for several applications. These include dried leaves and dried flowers of Dendrobium devonianum as new food raw materials, as well as applications involving lactase (β-galactosidase) and Osmanthus Ear Glycolipid as new food additives.

What this means for the dietary supplement industry

The update is particularly relevant to international ingredient companies monitoring opportunities in China. Ingredients such as 3-FL, GOS and LNT are important to the rapidly developing microbiome, infant nutrition and functional food sectors, while steviol glycosides, beta-carotene and fermentation-derived ingredients have broader applications across food and nutrition products.

Companies pursuing new ingredient approvals in China should also note that an extension notice can be a normal part of the review process, requiring additional technical documentation before an application can proceed.

CIRS group is an HPA global regulatory strategic partner.

Source: CIRS Group & HPA-Global

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