In China, producing new food additives shall submit the safety assessment materials to the National Health Commission. There are two main requirements for new food additives application, one is that, “new food additives should pass the risk assessment to prove the safety”, and another is that, “new food additives have necessary effects in technology”. The former needs to be evaluated through toxicology tests or other methods, and the latter needs to be verified through a series of scientific data and experimental studies. Based on our experience, CIRS Group is going to interpret the key content of the technical necessity for the application of new food additives to help enterprises prepare the materials.
1. Material Composition
According to the Notice on regulating the Administration of New Food Additives, when applying for new food additives, the materials or documents that can prove the technical necessity are essential. The material should include the following parts:
(1) The functional category and mechanism of food additives;
(2) Influence of using the food additive by comparison on adding it before and after to food;
(3) Comparison on the effect of adding the same category food additives to food;
(4) Other materials related to technical necessity.
If you are applying for a new flavor, you are exempt from submitting the above-mentioned items (2) and (3). For other types of new additives, all the materials need to be submitted.
2. Key points of technical necessity
- The functional
category and mechanism of food additives
In this part, it is necessary to explain the advantages on using the additive and its mechanism (pictures may also be used to illustrate the advantages and mechanism). The specific content can be determined according to the characteristics of the application variety.
- Influence of using the
food additive by comparison on adding it before and after to food
The applicant should provide materials or documents proving that the new food additives are superior in food safety, economic benefits, environmental protection, etc. As the focus of technical necessity, it is generally recommended to conduct analysis through comparative experiments.
i. The test should include a control group (without adding the food additive) and a test group (adding the food additive, and different dosage groups can be set depending on the specific substances);
ii. The technical evaluation indicators should include objective indicators which are used to evaluate the effect of food additives, such as the indicators that can describe the functional effect, stability indicators and the indicators that reflect the impact of new food additives on main nutritional components of food.
For example: Silicon dioxide is added to milk tablet as an anti-caking agent (now approved). The technical evaluation indicators can be selected from the following items: the fluidity, caking capacity, dryness of the powder after adding different contents of silicon dioxide, and the compression of milk tablets (tablet press operation, milk tablet hardness, friability and smoothness).
iii. The description of the test results should include the changes of technical indicators used for evaluation during the test process and the differences between the control group and test group.
For example, compared with control group, the base powder added with silicon dioxide is still dry after the storage, without agglomeration, and has good fluidity. Milk tablets have good taste and glossy surface, with fewer defective and unqualified tablets, the hardness, friability and smoothness are all up to the standards.
- Comparison on the effect of adding the same category food additives to food
The information should indicate that, compared with the approved one that has the same function in the same food category, the applied new food additive has superiority on functional effect, food safety, etc. It is generally recommended to conduct analysis through comparative tests. If there is no experimental comparison, it can also refer to scientific literature and other materials.
i. The comparative test sample should be the food additives that have been approved to be used in the same food category with the same function. If there is no suitable additive, the situation needs to be explained.
ii. The test should include control groups (using one or more approved food additives with the same function of the applied one) and a test group (adding the applied food additive).
iii. Description of technical evaluation indicators and test results: the specific indicators should be selected in combination with the functional characteristics of additives, which can be consistent with the test indicators in material (2), and the test results shall be analyzed to make the advantages of new additives prominent.
- Other materials related to technical necessity
Additional explanations can be provided based on the new food additive's situation, such as other test reports or scientific research materials that can demonstrate the benefits of using this additive. The specific content depends on the applied substances.
Generally speaking, if application materials can clearly clarify the function and mechanism of new food additives, and demonstrate their superiority in food safety, cost effectiveness and environmental protection, it is considered that they possesses certain technological necessity.
In technical evaluation, review experts will check that if the application materials can demonstrate the necessity and effects of using the new food additive. Therefore, when preparing for the application of new food additives, the enterprises need to thoroughly study the technical necessity of the new additives and emphasize the advantages compared to the additives with the same functions.
For the information on the application of new food additives, please click New Food Additive Registration in China
If you have any needs or questions, please contact us at firstname.lastname@example.org.