Provisions (Trial) on the Declaration and Evaluation of Health Food Applications Produced Using Macroporous Adsorption Resin Separation and Purification Processes

Article 1: To standardize the review of health food produced using macroporous adsorption resin separation and purification processes, ensure their safety for consumption, and in accordance with the "Food Hygiene Law of the People's Republic of China" and the "Administrative Measures for Health Food Registration" (Trial), these Regulations are hereby established.

Article 2: Health food products produced using macroporous adsorption resin for separation and purification refer to health foods in which the macroporous adsorption resin separation and purification process is applied during both the product manufacturing process and the raw material production process.

Article 3: For health food products produced using macroporous adsorption resin separation and purification processes, in addition to submitting materials as required by relevant regulations on health foods, the following documents must also be provided:

(I) Information on Macroporous Adsorption Resins
1 Specifications for Macroporous Adsorption Resins. The standard shall include the resin name, brand/type designation, structure, synthesis raw materials (names and specifications of main raw materials, cross-linking agents, porogens, dispersants, etc.), appearance, polarity, particle size range, moisture content, wet density, dry density, specific surface area, pore size, porosity, and pore volume. It shall also specify the standard grade level of the macroporous adsorption resin.
2 Instructions for Macroporous Adsorption Resin. The instructions shall include:
Overview of macroporous adsorption resin performance, applicable scope, and list of main raw materials and additives with their names (1).
Residue (including unreacted monomers, cross-linkers, and primary additives) in (2): detection methods, limits, and regulatory basis.
(3) Usage and Precautions: Includes pre-treatment, regeneration procedures, operational guidelines, storage conditions for new macroporous adsorption resins, and troubleshooting methods for potential issues.
3, Batch Number, Production Time, Product Inspection Report.
4 Supporting documents, including copies of the macroporous adsorption resin manufacturer's business license, production permits, and details such as company name, address, and phone number.

(II) Research data on the preparation process using macroporous adsorption resin for separation and purification
1 Purpose and rationale for using macroporous adsorption resin in the preparation process for separation and purification. Provide a detailed explanation of the objectives and necessity of applying macroporous adsorption resin for separation and purification, along with relevant research or literature references.
2 Pre-treatment methods and acceptance criteria for macroporous adsorption resins. Pre-treatment involves evaluating process parameters and operating procedures, including solvent type, dosage, soaking time, flow rate, temperature, pH, etc.
3 Research data on the production process, including: selection of macroporous adsorption resin models, resin loading capacity per unit mass, adsorption capacity per unit mass, desorption capacity per unit mass, column aspect ratio (diameter-to-height), optimal loading temperature, pH, and flow rate for the extract; selection of desorption solvents and conditions; and methods for determining the desorption endpoint. These materials shall be incorporated as part of the product's manufacturing process.
4: Determination of macroporous adsorption resin regeneration methods. After use, the adsorption capacity of macroporous adsorption resin declines and requires regeneration. Based on active ingredients and the physicochemical properties of the resin, establish regeneration procedures and acceptance criteria. Applicants must develop corresponding standards and standard operating procedures (SOPs) and include them as an appendix to enterprise standards.

(3) Health supplements produced from raw materials purified using macroporous adsorption resin
For food applications, detailed information on the raw material manufacturer must be provided, along with the preparation process and comprehensive quality standards for the raw material. These standards must include limits and test reports for macroporous adsorption resin residues. Applicants must submit a test report for macroporous adsorption resin residues issued by an inspection agency accredited by the China Food and Drug Administration.

(IV) Safety Toxicology Evaluation Data
Article 4: Health foods that apply macroporous adsorption resin separation and purification processes during their production or the production of their raw materials shall comply with the following requirements:

(1) Macroporous adsorption resins must be pretreated before use. After pretreatment, organic residues in the resin must be kept within safe limits. For styrene-based resins, benzene residue must be less than 2mg/kg mg/kg and divinylbenzene less than 20 mg/kg. For other types of macroporous adsorption resins, limit standards shall be determined based on specific conditions.
(2) Generally, macroporous adsorption resins should not be used if their regenerated adsorption capacity decreases by more than 30%.
(3) For enterprises producing health food raw materials using macroporous adsorption resin purification processes, the residual content of the resin in the raw materials must be tested or verified. For raw materials prepared using styrene-based resins, the divinylbenzene content must be less than 50 μg/kg and included in the enterprise standard. If the raw material quality meets this standard, testing for macroporous adsorption resin residue in the final health food product may be waived.
(4) Establish testing methods and standards for resin residues, and include them in the enterprise standard.
(5) For health foods produced using styrene-based resin separation and purification processes, the divinylbenzene content in the final product must be less than 50 μg/kg.
(VI) In principle, do not apply macroporous adsorption resin to mixtures of multiple animal and plant raw materials.
Purification process for producing health supplements.

Article 5: The CFDA may conduct on-site assessments of macroporous adsorption resin manufacturers and enterprises using these resins to produce raw materials for health food, as necessary.

Article 6: Other types of macroporous adsorption resins shall be handled in accordance with these provisions.

Article 7: This regulation shall be interpreted by the State Food and Drug Administration.