1. What are "Three New Foods" and how are they regulated in China?

"Three New Foods" refer to "new food ingredients," "novel food additives," and "novel food-related products" as listed in Article 37 of the "Food Safety Law of the People's Republic of China."

In accordance with the Food Safety Law and its implementing regulations, the "Administrative Measures for the Safety Review of New Food Ingredients," the "Administrative Measures for Novel Food Additives," and the "Administrative Provisions for the Licensing of Novel Food-Related Products," China implements an administrative licensing system for "Three New Foods." This means that utilizing new food ingredients to produce food, or producing novel food additives or novel food-related products, requires submitting a safety assessment dossier to the State Council's administrative department for health. The State Council's administrative department for health is required to organize a review within 60 days from receiving the application; those conforming to food safety requirements are approved and announced, while those not conforming are denied permission with a written explanation provided.

Currently, the National Health Commission (NHC) is responsible for the administrative licensing of "Three New Foods." The NHC has designated the China National Center for Food Safety Risk Assessment (CFSA) to be responsible for organizing the technical review and evaluation of "Three New Foods," among other tasks.

2. Is compliance with the recommended consumption amount and maximum usage levels for new food ingredients mandatory?

The establishment of the recommended consumption amount, scope of use, and maximum usage levels for new food ingredients announced in "Three New Food" announcements is based on currently available information, including patterns of human consumption, toxicological studies, research on nutritional and physiological effects, and reference to international approvals and applications. These parameters are determined following safety assessments and technical reviews. Adhering to these specified recommended consumption amounts, scopes of use, and maximum usage levels sufficiently safeguards public health.

For new food ingredients where the announcement explicitly specifies a recommended consumption amount, scope of use, and maximum usage level, enterprises must strictly comply with these requirements during production, and relevant regulatory departments will conduct supervision accordingly. Consumers are advised to follow the recommended consumption amounts provided in the announcements.

3. Can new food ingredients be used in special dietary foods (including sports nutrition foods)?

According to the "National Food Safety Standard for the Labelling of Prepackaged Foods for Special Dietary Uses" (GB 13432-2013), special dietary foods are those processed or formulated specifically to meet particular physical or physiological conditions and/or the special dietary needs associated with diseases or disorders. Main categories include infant formula foods, complementary foods for infants and young children, foods for special medical purposes, and other special dietary foods (including sports nutrition foods).

New food ingredients whose announcements explicitly include "special dietary foods" within their scope of use can be used as raw material sources for special dietary foods. Their use must comply with the relevant standards and announcement stipulations.

For new food ingredients whose announcements do not explicitly indicate that their scope of use includes special dietary foods, their use should follow the provisions and requirements stipulated in the relevant standards for special dietary foods. Food production and operations must strictly adhere to relevant laws, regulations, standards, and announcements.

Source: China National Center for Food Safety Risk Assessment (CFSA)