CIRS FAQ: Is There Any Protection Period for Newly Approved New Food Additives? Vol. 06, 2023

From years of regulatory compliance experience, we’ve translated a selection of some frequently asked questions on the applications of new food raw materials (novel food) and new food additives to help you understand the current requirements in China.

Q1: If we produce an approved additive by the fermentation of a genetically modified microorganism (GMM), where the production process is different from the approved one, can we carry out MARA’s safety assessment only instead of the application of the additive?

A1: No. When applying for GMM food additives, the applicant must submit the following two sets of materials respectively as required:

• Safety assessment materials for GMM; and
• Application dossiers for a new food additive.

The Ministry of Agriculture and Rural Affairs of China (MARA) is only responsible for the safety assessment of GMMs. However, compared with the approved additive, your production process is different. Such differences require a full review and approval procedure for the final product additive.

For more information about GMM food additive applications: Genetically Modified Microorganism Food Additive Registration in China

Q2: Further to Q1, is it necessary to provide technical necessity materials in the new food additive applications?

A2: Yes. During the application procedure, the dossiers for food additives produced by GMM will be reviewed by the National Health Commission (NHC), including its technical necessity materials.

For more information about the application of new food additives: NHC New Food Additive Registration in China

Q3: Why are some test methods of newly approved food raw materials made public in their approval announcements while others are not?

A3: For food raw materials which can be tested according to corresponding existing national standards, there is no need to disclose their test methods.

As for food raw materials whose indicators are unique or without referable national standards, the enterprises should provide or develop new test methods and their validation reports. Once passing the review, these test methods will be made public in the approval announcement.

Q4: How do you apply for a substance which is an artificial mixture? Do you separate into pure substances, or as a mixture?

A4: Separately. In China, only single pure substances can be accepted and approved as new food additives, and there is no application and approval case for compound food additives. Furthermore, up until now, there have been no artificial mixture products included among the products applied for new food raw materials.

Q5: Is there any protection period for a newly approved food additive?

A5: No. Up to now, those approved new food additive products have never been provided any protection period.

If you need any assistance or have any questions, please contact us via service@cirs-group.com.

Further Information

Vol. 01, 2023 FAQs on Health Food Registration and Filing in China

Vol. 02, 2023 The Precondition to Health Food Application in China

Vol. 03, 2023 Applicants’ Qualifications for the Registration of New Food Raw Material (Novel Food) in China

Vol. 04, 2023 Technical Requirements for New Food Additives Applications in China

Vol. 05, 2023, Can Food for Special Medical Purposes Be Entrusted to Other Enterprises for Production?