Sodium Hyaluronate Open for Public Comments - Regulatory News - Food & Food Contact Materials

On 3 September, 2020, China National Center for Food Safety Risk Assessment (CFSA) opened public comment for sodium hyaluronate. The deadline for public comments is 3 October, 2020.

Detailed information of the substance

Name	Sodium Hyaluronate
Basic information	Source: Streptococus equi subsp.zooepidemicus Structure: Molecular formula: (C14H20NNaO11)n, n: 200-10000 Molecular Weight: 8.02×104 —4.01×106
Production process	Using glucose, yeast powder, peptone as the culture medium, fermented from Streptococus equi subsp.zooepidemicus.
Recommended intake	≤200 mg/d
Quality requirement	Property	White granule or powder
	Sodium hyaluronate content	≥87.0%
	Moisture	≤10.0%
	PH	6.0-8.0
	Ash	≤13.0%
Other information	1. Application scope include: Milk and dairy product, Beverages, Alcohol, Cocoa products, chocolate and its product (including imitations and chocolate substitutes), candy, Frozen drinks, but not include infant and young children food. 2. Food safety indicators must meet the following requirements： Pb/(mg/kg): ≤0.5 As/(mg/kg): ≤0.3

Interpretation:

Sodium hyaluronate is a sodium salt fermented from Streptococus equi subsp.zooepidemicus with the culture medium made from glucose, yeast powder, peptone. It is a straight-chain polymeric Amylose.

Sodium hyaluronate was approved as new resource food in 2008 in China, and it was used as health food raw material. At present, sodium hyaluronate and its products are allowed to be used in food or dietary supplements in Japan, South Korea, the United States, the European Union, Australia, New Zealand and Brazil. Based on the approval status in other countries and international organizations, the application scope of sodium hyaluronate is expanded to milk and dairy product, beverages, alcohol, cocoa products, chocolate and its product (including imitations and chocolate substitutes) and candy, frozen drinks, but not include infant and young children food.

According to the Food Safety Law of the People’s Republic of China and Administrative Measures for the Safety Review of New Food Raw Materials, sodium hyaluronate has passed the safety assessments review of the National Health Commission. The new food raw material production shall produce and use in accordance with the contents of the announcement and meet the food safety requirements.

The food safety index of the raw material shall be implemented in accordance with the announcement.

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Reference:

CFSA Official News

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