CIRS FAQs: Can the Production Process be Changed after Approval of New Food Raw Materials? Vol. 07, 2024

From our years of regulatory compliance experience, we’ve translated a selection of some frequently asked questions on new food raw materials and new food additives to help you gain a clearer understanding of the current requirements in China.

Q1: What are the technical necessity tests required during the application for food additives? And how should they be conducted?

A1: Announcement No. 29 of 2011 on Regulating the Licensing Management of New Food Additives issued by the former Ministry of Health (MOH) outlines the materials requirements for technical necessity tests. In addition to the mechanism introduction and other necessary materials, the focus is on setting up the following two aspects: (1) a comparison of the effects with and without the additive in the intended food; and (2) a comparison of the additive’s effectiveness with other food additives of the same functional category.

Applicants need to design key technical indicators to evaluate the effectiveness of the product. This is to demonstrate that, compared to products without this additive or those with other additives of the same function, the applied product indeed shows superior performance in terms of effectiveness, food safety, economic benefits, and environmental friendliness, thereby justifying the necessity of its application. Therefore, technical necessity materials are crucial in the application of food additives.

Q2: How are food raw materials and additives defined, and how do you choose the category for application?

A2: Raw materials need to possess the characteristics of being edible, safe, and nutritious, with the starting point being their safety for human consumption to determine whether to set a recommended amount or not. Additives, on the other hand, emphasize functional roles in processing, such as preservation or sweetening; the amount used should be as minimal as possible to achieve the desired effect. In addition to these criteria, companies can also consider the product’s consumption habits or approved usage abroad, as well as market promotion needs, to choose the appropriate application category.

Q3: If a certain raw material has already been approved abroad but has a different production process than that used overseas, should the selection of toxicological evaluation tests for application follow the requirements for products with no traditional consumption habits or those for products used in certain countries abroad?

A3: The Regulations on the Application and Acceptance of New Food Raw Materials clearly stipulates the principles for selecting toxicological evaluation tests, which depend on the consumption status of the substance both domestically and internationally. When referencing foreign approvals, China requires a high level of consistency of the substance (taking into account various aspects such as quality specifications and production processes). If the production process differs from that of the foreign product, the safety data, including toxicological information, must be considered with greater rigor.

Q4: Are there any restrictions on the production process for new food raw material applications, and can the process be changed after approval?

A4: The production process of approved new food raw materials will be included in the official announcement, which means that unauthorized changes are not permitted. If the actual production process used differs from the approved one or does not comply with the described process in the announcement, the applicant must reapply and submit the new process for review.

Q5: Are there any specific batch requirements for samples used in toxicological testing and those used for quality specification testing regarding “three new foods”?

A5: There are no explicit requirements in the relevant application and acceptance regulations. However, it is recommended that the batch number of samples used for toxicological testing should be one of the three batches used for quality specification testing.

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

Further Information

CIRS FAQ: Is It Necessary to Establish Animal Function Evaluation Methods while Applying for New Health Functions? Vol. 01, 2024

CIRS FAQ: Can Approved New Food Raw Materials Be Used in FSMP? Vol. 02, 2024

CIRS FAQ: Can Different Companies Use the Same Formula to Apply for Health Food Filing? Vol. 3, 2024

CIRS FAQ: Which FSMP are Eligible for Inclusion in the Priority Review and Approval Process? Vol. 4, 2024

CIRS FAQ: For Food Additives Listed in GB 2760 involving New Synthetic Biology Processes, Is Only the Safety Assessment from the Ministry of Agriculture Required? Vol. 05, 2024

CIRS FAQ: Can the Registration Certificates of Filing Products Be Transferred? Vol. 06, 2024