Q&As on Promotional Barriers and Key Compliance Points for Functional Food and Food with Medical Properties

On August 18, 2023, we hosted a free webinar in Chinese and Japanese on the promotional barriers and compliance key points for functional food and food with medical properties. A lot of questions were raised during the webinar so we have collected questions and made a Q&A summary as follows:

Q: Is it possible to register one ingredient as new food raw materials and new health food raw materials at the same time? Or, is just one application allowed?

A: Your substances can be registered both as new food raw materials and new health food raw materials at the same time.

Q: Are there any content requirements for medicinal herbal extracts from TCM (traditional Chinese medicine) applied as food raw material?

A: When there are no specific requirements on the contents of raw materials, the contents of the medicinal herbal extracts are determined based on the final product (such as the definition of final products, quality specifications outlined in the final product standards, etc.). China also has some requirements for some particular ingredients. Taking cultivated ginseng as an example, its recommended daily intake (RDI) must be no more than 3g. As a result, when this ingredient is used as food material, its contents must be determined based on the RDI of the ginseng products.

Note: Extracts can be used as common food raw materials only when they haven’t undergone refinement processes.

Q: Since Lactococcus lactis subsp. is included in the List of Strains that Can Be Used in Food, can I apply for its postbiotics in general food and dietary supplements？

A: No. Currently, you have to register it as new food raw material.

Q: How can we judge whether one product is low-sugar or sugar-free, is it according to the carbohydrate content or sugar content? Or are either acceptable?

A: Either criterion is acceptable according to GB 28050. In the nutrition facts label, when only carbohydrates are indicated, it can be judged based on the carbohydrate content. However, if both carbohydrates and sugar are indicated in the nutrition facts label, then it should be based on the sugar content.

Q: Are there any requirements on the minimum percentage of sugar or sugar substitute content in China?

A: According to GB 17399, candies are defined as sweet food primarily made from ingredients such as sugar, syrup, or sweeteners. The standard doesn’t explicitly specify the percentage that “primary ingredients” should account for, but generally, the combined proportion of various sugars, syrups, and sweeteners comprises the largest percentage of the product.

Q: When indicating an invention patent, is it necessary to include “Chinese” before “invention patent” or “patent for utility model”? Can we omit “Chinese”?

A: The patent number and type should be indicated according to the Advertising Law of the People’s Republic of China. The patent type should be indicated according to the patent certificate, and “Chinese” can be omitted.

Q: What regulations do cross-border e-commerce products need to comply with? Are they governed by the regulations of the country of production?

A: Yes, these products should comply with the relevant regulations of the country of origin.

Q: If the food additives intended for use in food for special dietary purposes are not specified in GB 2760, can they still be used?

A: You can further check if there are any specific provisions in relevant national food safety standards. For instance, according to the Food Safety National Standard General Rules of Sports Nutritious Foods (GB 24154-2015), for sports nutritious foods, the usage of food additives can be referenced from the types and amounts specified in GB 2760, or similar food categories. Therefore, in terms of sports nutritious foods, if a certain food additive is not permitted within the same category (special dietary foods), you can further check whether it is permitted for use in a similar category (e.g., protein bars could be considered similar to pastries).

Q: May I indicate the efficacy of the raw materials (traditional Chinese medical materials) in the outer package of food with medicinal properties?

A: The efficacy of the raw materials for such food often implicates the functions including disease prevention, treatment, or health functions. The labeling requirements for such products are quite strict. So, it is not advisable to indicate such information on product packaging. For promotional purposes, it is better to promote such information in other materials (such as web pages) while clearly indicating reliable sources and references.

Q: If 100 mg of vitamin C is added to a beverage following GB 2760, would it be permissible to state “with vitamin C” on the label?

A: Yes, but we do not recommend it. Vitamin C can be used not only as a food additive but also as a nutrition enhancer. Making such claims on the label could lead consumers to misunderstand the role of vitamin C as a nutrition enhancer in the product. Therefore, it is advisable not to emphasize vitamin C.

Q: Is it necessary to include specifications for individual pre-packaged food products?

A: According to GB 7718, if multiple individual pre-packaged food items are inside one outer packaging, the outer packaging should indicate both the net content and the specifications. For single pre-packaged food items, the term “specifications” refers to the net content. As a result, there is no need to mention specifications for individual pre-packaged food items; indicating the net content is enough.

Q: If there are patents related to specific processes, is it permissible to indicate the details of these specific processes on the product packaging?

A: Yes. However, the content indicating this specific process should not imply or suggest functions related to disease prevention, treatment, health benefits, or meeting the special needs of people with specific diseases.

If you are interested in global hot topics of food compliance, our webinars will be unmissable to you. We have made a list of all the free webinars we plan to hold in 2023 for your reference: CIRS Food – Upcoming Free Webinars in 2023.

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