From our years of regulatory compliance experience, we’ve translated a selection of some frequently asked questions on new food additive applications to help you understand the current requirements in China.
Q1: When applying for a new food additive, how can an enterprise prepare materials or dossiers proving that the substance is technically necessary and effective?
According to the Notice on Regulating the Administration of New Food Additives Licensing (NHC Notice of No. 29, 2011), when applying for new food additives, the materials or documents that can prove the technical necessity are essential, and should include the following parts:
(1) The functional category and mechanism of food additives;
(2) Contrast analysis on adding the food additive to food before and after;
(3) Contrast analysis on the effects of adding the food additive compared with one in the same category; and
(4) Other materials and documents related to technical necessity.
If you are applying for a new flavoring, you are exempt from submitting the above-mentioned items (2) and (3).
Detailed interpretations of the technical necessity for the application of new food additives.
Q2: Will the success rates vary with the usage scope in new food additive applications?
Generally speaking, the wider usage scope the applicant applies for, the more technical necessary materials the applicant needs to provide. If there is no sufficient supportive data on the technical necessity and foreign approval basis, the success rate of the application may be affected.
Q3: What is the guidance document for the preparation of toxicology evaluation dossiers in new food additive applications?
Toxicological tests should be carried out according to the requirements in Part 4 of the National Food Safety Standard – Toxicological Assessment Procedure for Food Safety (GB 15193.1-2014). Different types of new food additives have different test requirements.
Read more about toxicology test requirements: The Requirements of Toxicology Tests on the Registration of Health Food and “Three New” Food Products in China
Q4: When applying for genetically modified microorganisms food additives, what points will the Ministry of Agriculture and Rural Affairs and National Health Commission place more weight on?
Compared with other common food additives, the application of genetically modified microorganisms (GMM) food additives is more complicated, and shall be evaluated by the following two authorities:
(1) Ministry of Agriculture and Rural Affairs of China (MARA) is responsible for the safety assessment of GMMs, including assessing the safety of receptors, genetic engineering, and the final products produced by GMMs.
(2) The National Health Commission of China (NHC) is responsible for the review and approval of the food additive produced by GMMs, as well as the evaluation of the related technical necessity and safety dossiers.
Q5: 2-Fucosyllactose (2’-FL) has been applied for several times, do other enterprises or individuals still need to be subsequent applicants?
A5: Yes. Considering that enterprises may produce 2’-FL by different genetically modified production strains, which vary in sources and donors, and different operations for production, safety assessments should be conducted for each 2’-FL.
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