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The National Health Commission of China issued Notice No. 2020-09 (卫生健康委员会公告2020年第9号) (the notice) on 28 December 2020. The notice approved three new food ingredients in China. These newly approved ingredients may now be used in food products manufactured in or imported into China, provided that the use thereof complies with the restrictions imposed under the notice.
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The following new food ingredients have been approved under the notice:
- Isaria cicadae Miq. fruiting body (artificial cultivation) (蝉花子实体(人工培植))
- Sodium Hyaluronate (透明质酸钠)
- Lactobacillus kefiranofaciens subsp. kefiranofaciens (马乳酒样乳杆菌马乳酒样亚种)
Additional restrictions, including maximum daily dosage and quality specifications, for these food ingredients are stipulated under the notice as well.
Article 37 of China's Food Safety Law sets up the regulatory framework for new food ingredients in China. Specifically, Article 37 requires food manufacturers that utilize new food ingredients to produce food products in China to file a new food ingredient petition and submit the required safety assessment results, etc. of these ingredients. New food ingredients may only be used after they are cleared by the National Health Commission. The same requirement applies to importers of food products that are produced using new food ingredients.
To further implement this requirement under the Food Safety Law, the National Health and Family Planning Commission (now the National Health Commission) issued three rules and regulations to provide additional details on the safety assessment of new food ingredients:
- Management Measures on the Safety Review of New Food Ingredients (新食品原料安全性审查管理办法) (the management measures)
- Rules on the Petition and Acceptance of New Food Ingredients (新食品原料申报与受理规定)
- Procedures on the Safety Assessment of New Food Ingredients (新食品原料安全性审查规程)
The management measures define a new food ingredient as a food item that is not traditionally consumed in China, including the following:
- Animals, plants and microorganisms
- Ingredients extracted from animals, plants and microorganisms
- Food ingredients that have their original structures modified
- Other newly developed food ingredients
Food items that are traditionally consumed in China refer to products that have been served as packaged or non-packaged food products in China for at least 30 years and are not listed in the Pharmacopoeia of the People's Republic of China. New food ingredient must possess the characteristics of food. As defined under Article 150 of the Food Safety Law, food refers to final products and ingredients that are edible/drinkable and are suitable for human consumption. Items that are traditionally consumed both as a Chinese medicine and a food also fall under the scope of food as regulated under the law. Please note that items that are only intended for use in the cure or treatment of diseases are not considered food.
As a general requirement, the management measures require new food ingredients to provide proof of the necessary nutritional value as well as that they are not toxic or hazardous to human health.
In addition to defining new food ingredients, the management measures outline the required documents that must be submitted to support a new food ingredient petition, as well as the timelines for reviewing these petitions. No new food ingredients may be used in the manufacture of food products unless they have passed the safety assessment conducted by the National Health Commission.
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Companies operating in the food industry should note that China recently approved three new food ingredients. These ingredients may now be used in food products manufactured or imported into China, provided that all applicable restrictions are in compliance.