China New Food Additive Registration

      In the past, the National Health Commission of the People’s Republic of China (NHC) only accepted applications for new varieties of genetically modified microbial enzyme preparations. Other new food raw materials or new food additive varieties produced by genetically modified microorganisms could not be submitted. According to the “Food Safety Law of the People’s Republic of China”, new food additive varieties must be reviewed and approved by the health administrative department of the State Council before they can be used in food.

      In 2021, China’s national regulatory authorities officially opened the declaration path for genetically modified microorganisms (GMMs) food additives. It provides a broader space for the development and application of food additives. This change opens a commercial compliance window for biosynthesized new food additives. In this context, more and more companies are trying to declare new varieties of GMMs food additives.

Scope of New Food Additive Varieties

• Food additive varieties that are not included in the national food safety standards (GB 2760 Standard for the use of food additives and GB 14880 Standard for the use of food nutrition fortifiers);
• Not included in the types of food additives allowed for use announced by the National Health Commission;
• Food additives that expand the scope of use or dosage (referred to as “expansion”).

Applicant of New Food Additive Application

      Enterprises or individuals intending to engage in the production, operation, use or import of new varieties of food additives

Regulatory Agencies

• Accepting agency: Government Affairs Hall of the National Health Commission
• Organization for expert review and public solicitation of opinions: China National Center for Food Safety Risk Assessment
• Approval decision-making body: National Health Commission

Relevant Regulations

• Measures for the Safety Evaluation and Management of Agricultural Genetically Modified Organisms
• Regulations on the Safety Management of Agricultural Genetically Modified Organisms
• Guidelines for Safety Evaluation of Genetically Modified Microorganisms for Animal Use
• Regulations on Declaration and Acceptance of New Food Additive Varieties
• Measures for the Management of New Varieties of Food Additives
• Implementation Regulations of the Food Safety Law of the People’s Republic of China (2016 Revision)
• Food Safety Law of the People’s Republic of China
• Measures for the Management of New Varieties of Food Additives (Ministry of Health Order No. 73)
• Notice From the Ministry of Health on the Issuance of the “Regulations on Application and Acceptance of New Varieties of Food Additives”

Test Items Involved in Registration Application

• Quality specification inspection report: three batches of food additives should be inspected in accordance with the quality specification requirements and inspection methods in the application materials.
• Toxicological safety evaluation data or inspection reports: toxicological tests must be conducted in accordance with the relevant requirements in GB 15193.1-2014 “National Food Safety Standard-Food Safety Toxicological Evaluation Procedure”.

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Q&A About New Food Additive Application

Q1: How to label the dosage (unit) when applying for new food additive varieties?

A1: The dosage unit should be in g/kg (g/l), and the usage range can refer to the food range in the current national standards for food additives.

Q2: What are the technical necessity certification materials required to apply for new food additive varieties?

A2: 

• Functional categories and working mechanisms of food additives;
• Comparison of the effects of adding or not adding to the food to be added;
• Comparative data on the effects of using food additives of the same functional category;
• Other relevant technically necessary information.

      Those applying for new varieties of food spices are exempt from submitting the above-mentioned information (2) and (3).

Q4: Under what circumstances is it necessary to declare new varieties of food additives?

A4:

• Food additive varieties that are not included in GB 2760 “National Food Safety Standard for the Use of Food Additives” and GB 14880 “National Food Safety Standard for the Use of Food Nutritional Fortifiers”;
• There are no food additive varieties that have been approved for use by the national health administration department;
• It is intended to exceed the scope or excessive use of existing food additive varieties (stipulated in the above standards or relevant announcements);
• In addition, those with the same name as existing additives but inconsistent with their sources, production processes, etc. should also be subject to administrative licensing as new food additive varieties.