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

We’ve translated a selection of some frequently asked questions on new food raw material (novel food) applications to help you understand the current requirements in China.

Q1: Who can be the qualified applicant for the registration of new food raw materials in China?

A1: According to the New Food Raw Material Registration and Acceptance Regulation, any enterprise or individual can be the applicant for a new food raw material.

The applicant is not limited to the manufacturer and can be in a different country from the manufacturer. For example, it is acceptable when a domestic enterprise is to register a new food raw material produced by an overseas manufacturer. All that needs to do is to make the relationship between the applicant and manufacturer clear to the reviewing center.

Q2: How to register a new food raw material whose production process is different from that of an approved one? What are the differences compared with a new food raw material registration?

A2: When registering a new food raw material whose production process is different from that of an approved one, the “substantial equivalence” can be a good choice for the applicant. A substantially-equivalent material’s registration dossiers and procedures are basically the same as a new material.

The point lies that the applicant needs to make a comparison between his substance and the approved one, whose scientific data in its approval announcement can even be a reference for the former, such as the usage scopes and maximal usage levels.

Q3: How to apply for expanding the usage scope of an approved new food raw material? Is there any test requirement?

A3: Being different from the new food additive application, there are no designed requirements to the application dossier of new food raw material with expanded usage scope. So, the applicant needs to submit all the required application materials according to the New Food Raw Material Application and Acceptance Regulation, including test reports.

But if the applicant of an approved new food raw material wants to further apply for expanding the usage scope, he can consider both the specific usage scope and the previous test reports to assess the feasibility.

Q4: Is there any additional requirements to the application dossiers of strains that can be used for infants and young children?

A4: When applying for strains that can be used for infants and young children, it is required to be taxonomically specific to strain number. Seeing that the target groups are infants and young children who are vulnerable, the applicant should provide, in addition to the generally required dossiers according to the New Food Raw Material Application and Acceptance Regulation, more related edible safety data, such as infants and young children clinical research data.

Q5: New food additive or new food raw material? How to decide which category shall company apply for?  

A5: It is difficult to have a standard answer for determining whether a substance is suitable to be registered as a new food material or a new food additive. It needs to be judged by comprehensive analysis of the specific substances. The following are some suggestions from CIRS:

1) What is the purpose of the substance? Improvement of process or nutrition supplement?

Food additives are substances used to improve process or food quality, while food ingredients are more emphasized on nutrition properties of the substance.

2) Is the substance regulated as a new food material or a food additive abroad?

Applicants can refer to the approval situation abroad (e.g. the United States, the EU, etc.) to see whether the substance is regulated as a food raw material or a food additive.

3) Is it consumed directly?

Generally speaking, people would not eat food additives directly but add them to food for indirect consumption.

4) Is it produced by genetically modified microorganisms?

At present, substances produced by genetically modified microorganisms can not be registered as new food raw materials in China, so if a substance is produced by genetically modified microorganisms, it can only be assessed for the application feasibility as a new food additive.

If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com. 

To know more details, please watch our previous playback on  New Food Raw Materials or New Food Additives? How Should Enterprises Choose the Direction of Application?