China Proposes Expanding Dosage Forms and Excipients for Coenzyme Q10 and Melatonin Health Food Filing

China’s SAMR is proposing to add powder and oral liquid as permissible dosage forms for Coenzyme Q10 health foods, and oral liquid for Melatonin, under the filing pathway. The draft regulation also introduces new lists of approved excipients for these new dosage forms, expanding formulation options for manufacturers.

On September 19, 2025, China's State Administration for Market Regulation (SAMR) released the Supplementary Dosage Forms and Excipients for Health Food Raw Material Filing Products of Coenzyme Q10 and Melatonin (Draft for Comment). The proposal aims to expand the range of available dosage forms and excipients for health foods using Coenzyme Q10 or Melatonin as single ingredients under the filing pathway. The public consultation period for the draft is open until October 28, 2025.

This initiative is an update to the 2021Dosage Forms and Technical Requirements for Health Food Raw Material Filing Products of Coenzyme Q10 and Other Five Raw Materials. According to the drafting explanation, the changes are intended to meet the practical production needs of the industry and further advance the dual-track (registration and filing) management system for health foods.

1. Proposed Changes for Coenzyme Q10

For health foods produced with Coenzyme Q10 as a single raw material, the draft proposes the following additions:

New Dosage Forms: Powder and oral liquid would be added to the list of permissible dosage forms.
Additional Excipients: The following excipients would be approved for use in the new dosage forms, in addition to those already listed in the 2021 regulation:

For Powder: Fruit and vegetable powder (the specific variety must be clearly stated), maltodextrin.
For Oral Liquid: Fructose, polyglycerol fatty acid esters, caprylic/capric triglyceride, sodium octenyl succinate starch, white granulated sugar.

2. Proposed Changes for Melatonin

For health foods produced with Melatonin as a single raw material, the proposed changes are:

New Dosage Form: Oral liquid would be added as a permissible dosage form.
Additional Excipients: The following excipients would be approved for use in oral liquid products, supplementing the existing list from the 2021 regulation:

For Oral Liquid: Xylitol, citric acid, potassium sorbate, sucrose, sodium benzoate.

The proposed changes, if adopted, will offer greater flexibility in product development for manufacturers of Coenzyme Q10 and Melatonin health foods in China. This move reflects SAMR's ongoing efforts to refine and expand the health food filing system to better align with market and industry demands. However, please note that currently only domestic Coenzyme Q10 and Melatonin products are eligible for the filing pathway.

For businesses looking to navigate the health food filing or registration process in China, ChemLinked offers comprehensive consulting services to ensure compliance with the latest regulatory requirements.