2024 Version of Health Food Registration Regulations Sparks Controversy

On October 11, 2024, the State Administration for Market Supervision and Administration officially promulgated the Dosage Forms and Technical Requirements for Health Food archival Products (2024 version) (Draft for Comment) and the Provisions on Available excipients and Their Use for Health Food Archival Products (2024 version) (Draft for comment), and solicited comments and suggestions from all walks of life. The submission deadline for this round is November 10, 2024. The comment draft released this time is based on the current implementation of the "Dosage Forms and Technical Requirements for Health food record Products (2021 version)" and the "Health food record products available excipients and their use Regulations (2021 version)", and has been thoroughly supplemented, revised and improved. The following will be detailed for the specific revision content for reference.

1. Supplement and revision of dosage forms, main production processes and technical requirements of health food archival products

(1) The product dosage form (or food form) and the main production process allowed for filing

1. Compared with the 2021 version, this revision adds three new dosage forms: mixture, tea agent (bagged tea agent) and paste. These new dosage forms are designed for the filing of ginseng, American ginseng, Ganoderma lucidum and other products, and the addition is based on the "Technical Requirements for Health Food Raw materials Ginseng and American Ginseng Ganoderma for filing products" issued by the State Administration for Market Supervision and Administration on April 30, 2024. Its main production process covers mixing, filtration, dissolution, preparation, constant volume, filling, sterilization, packaging and other links.

2. In addition, two kinds of food forms of confectionery products and beverages are added, and the main production processes of these two forms are described in detail. For example, the production of confectionery products involves several steps such as sol, sugar melting, boiling, mixing, allocation, filtration, aeration and molding. The production of beverages includes mixing, dissolving, blending, filtration, carbonation (aeration), sterilization, filling, packaging and other processes.

(2) Filing requirements for the use of dosage forms

1. In view of the supporting documents of the raw material catalog that have been published, the solvent extraction of raw materials is allowed, the revision adds supplementary descriptions of the corresponding processes such as extraction and concentration and the main process parameters, so as to better meet the market demand.

2. The production process is further supplemented, and it is clear that the main process can be flexibly selected according to the actual production situation of the product, and can be reused if necessary; The key processes need to be clear about the specific process parameters to ensure product quality.

(3) Technical requirements for filing dosage forms

1. Formulations such as tablets, hard capsules, soft capsules, oral solutions (oral liquid and drops), teas, poultices, mixtures and granules belong to the scope of the current Chinese Pharmacopoeia, and the technical requirements that they should meet are listed in detail.

2. The technical requirements of powder products have been adjusted, including the edible method and the expression of particle size.

3. Added the technical requirements of confectionery products, beverages and other food forms, covering product specifications, technical requirements indicators, product name requirements and other content, and listed the list of other available accessories other than the "Health food record products available accessories and use Regulations". At the same time, the technical requirements of gel candy in the 2021 version of the document are integrated into the technical requirements of candy products, and its technical indicators remain unchanged.

Second, the health food record products available accessories and the use of supplementary amendments

(1) Adjustment of the list of auxiliary materials

1. Combination of excipients list: In view of the update of the national standard for rock sugar, single crystal rock sugar and polycrystal rock sugar are merged into one entry, and the total number of excipients list is reduced from 197 to 196.

2. Excipient standard replacement: 17 excipient standards such as β-cyclodextrin have been updated and replaced to meet the latest national standard requirements.

3. New auxiliary materials standards: Combined with the newly released national standards, 8 auxiliary materials standards such as ethanol/alcohol have been added to expand the scope of application of auxiliary materials.

4. Improvement of excipient standards: The standard basis of 19 excipients such as dibutylhydroxytoluene (BHT) has been improved to further improve the standardization of the use of excipients.

(2) Regulations on the use of auxiliary materials

1. The daily consumption limits set for solid and liquid formulations in the 2021 version of the document have been removed to more flexibly meet market demand.

2. The descriptions of footnotes and document descriptions are standardized and refined to improve the readability and guidance of documents.