On January 17, the National Food Evaluation Center under the State Administration for Market Regulation (SAMR) updated three Q&A topics regarding health food ingredients.
Q1. If an ingredient is included in the health food ingredient catalog but the daily dosage in the product exceeds the specified range, how should such products be registered or filed?
A：- Products with ingredients exceeding the catalog’s dosage limits should be analyzed case by case.
– For products already approved for registration or accepted before the catalog’s publication, manufacturers should adjust the daily dosage within the catalog limits and switch to filing management.
– If a company insists on exceeding the dosage limits, they can continue to apply for product registration. The evaluation will consider factors such as long-term safety, the necessity of the increased dosage for product efficacy (with supporting research), and ingredient quality.
– If safety can be ensured and the increased dosage adds significant value to the product’s function, registration may be granted, with subsequent updates to the ingredient catalog.
Q2. If an ingredient is included in the health food ingredient catalog, but the claimed health function is not within the allowed scope for filing, how should such products be registered or filed?
A：- According to the Food Safety Law, the health food ingredient catalog must include ingredient names, dosage, and corresponding functions.
– If the claimed function is not listed, the product can still be submitted for registration.
– For products approved before the catalog’s release with single-ingredient formulations not matching the catalog’s functional claims, registration holders may adjust their claims and dosages accordingly.
Q3. If an approved registered product contains an ingredient listed in the health food ingredient catalog, but the dosage form is not within the allowed scope for filing, how should such products be registered or filed?
A：- Registered products can apply for renewal before expiration.
– If the dosage form is deemed reasonable and safe, efforts will be made to expand the catalog to include it.
– Once the expanded dosage form is officially published, the product can transition from registration to filing management, after which the original registration certificate will be canceled.
– During the transition, if the registration certificate expires before the official inclusion of the new dosage form, the product will remain valid under a special note in the regulatory system. (Source: National Food Evaluation Center, SAMR)
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