China Proposes Approving One New Food Additive and Expanding Use Scope of Two Food Additives

The China National Center for Food Safety Risk Assessment (CFSA) published the Invite for Response to the Proposed Approval of Three New Food Additives Including 2′-Fucosyllactose，2′-FL (关于公开征求2′-岩藻糖基乳糖等3种食品添加剂新品种意见) on 23 August 2023.

Public consultation on the proposal will be open until 18 September 2023.

3E Review

The proposal, once adopted, would approve the following new food additive:

• 2′-Fucosyllactose (2′-岩藻糖基乳糖), sourced from Corynebacterium glutamate ATCC 13032 (谷 氨 酸 棒 状 杆 菌ATCC 13032), provided by Pseudopedobacter saltans (盐渍假杆菌)

The proposal would expand the use scope of two permitted food additives:

• L-Alanine (L-丙氨酸), allowed for use as a flavor enhancer in juice, with maximum use limit of 6 g/kg
• Propylene glycol alginate (海藻酸丙二醇酯), allowed for use as a thickener in cellophane noodles and tapioca pearls, with maximum use limit of 1.5 g/kg
  Once the proposal is adopted, these three food additives will be permitted for designated use purposes in China, provided that they are in compliance with all restrictions and quality specifications as prescribed under the proposal.

Background Information

New food additives refer to those not listed in GB 2760 and also not approved by the National Health Commission's (NHC) published announcements, or those approved additives that are intended for new use purposes outside of the allowed scope. Manufacturers, sellers, users, or importers of new food additives must apply for the NHC's approval on these new food additives and submit the following dossiers:

• Name of the food additive, functions, use amount, and scope of use
• Materials that prove the technical necessity and use effect
• Quality specifications, manufacturing method, and testing method of the food additive
• Safety assessment documents, including raw materials, sources, chemical and physical properties, manufacturing methods, toxicology assessments, and testing reports on quality standards
• Labels, instruction sheets, and samples of the food additive
• Other supporting documents that prove the food additive is allowed for manufacture and use in other countries (region), or allowed by international organizations
• Companies that apply for new use purposes for those approved food additives are exempted from submitting the safety assessment documents.

Chinese importers that apply for new food additives imported for the first time should also submit the following additional materials:

Materials that can prove the food additive is allowed for manufacture or sale in the exporting country (region), issued by government authorities
Materials that are issued by the foreign manufacturing country (region) that certify inspection or recognition of the manufacturing company
Companies must apply for approval through the NHC's online platform. Once the new food additive is reviewed and approved, the NHC will make public announcements that officially approve the substance, with designated food standards and restrictions imposed. China's CFSA will review the approval application on the NHC's behalf.

Companies are advised to view the following regulations regarding the approval and compliance requirements of new food additives in China:

• Food Safety Law (食品安全法)
• Enforcement Rules of China Food Safety Law (食品安全法实施条例)
• Management Measures on New Food Additives (食品添加剂新品种管理办法)
• Rules on the Application and Review of New Food Additives (食品添加剂新品种申报与受理规定)

The text of the regulations mentioned above is provided in Insight for Chemicals' Full Text module for companies to review. If only the Chinese version is provided, companies can request the English translation at Support@3eco.com.

3E Analysis

Companies that operate in the food industry should note that China recently issued a proposal to approve one new food additive and expand the use scope of two approved food additives. It is recommended that affected parties review the proposal (see Related Document) and submit their comments to zqyj@cfsa.net.cn at the CFSA by 18 September 2023.