On October 31, 2020, the State Administration for Market Regulation (SAMR) issued Guidelines for Inspection and Evaluation of Physicochemical and Hygienic Indicators of Health Food (2020) (hereinafter referred to as “2020 Guidelines”).
Technical standards for testing &assessment of health food (2003) (hereinafter referred to as “2003 Technical Standards”) was abolished in July 2018. After then, the functional assessment, toxicological assessment and functional component inspection of health food lacked technical guidelines. 2020 Guidelines is an important technical guideline to provide the testing methods of functional /characteristic component of health food. In order to help enterprises obtain the key information, CIRS interpreted the guidelines from the following aspects: the major content, the scope of application and the main testing methods.
1. Major content and Scope of Application
Compared with the 2003 Technical Standards, the determination of solvent residues and illegal adulterants were added in 2020 Guidelines.
If the raw materials are plant extracts or organic solvents used or introduced indirectly in the processing of raw materials and excipients, the organic solvents should comply with GB 2760 Appendix C or other relevant regulations. Enterprises can include solvent residue tests in technical requirements of raw materials or products according to product quality control needs, and adopt “Part Ⅲ Determination of solvent residues” in 2020 Guidelines.
The determination of illegal adulterants shall comply with “Part IV Determination of illegal adulterants” in 2020 Guidelines.
2. Main Testing Methods
(1) Testing Methods of Functional /Characteristic Component
(2) Determination of Solvent Residues
2020 Guidelines stipulates the gas chromatography methods of 9 kinds of solvent residues in health food: n-butanol, 2-methyl-1-propanol, n-hexane, methylbenzene, p-xylene, o-xylene, styrene, 1, 2-diethylbenzene, divinylbenzene.
(3) Determination of Illegal Adulterants
2020 Guidelines summarizes possible illegal adulterants in health food and their testing methods. Regulatory authorities will continue to update illegal adulterants and testing methods.
The testing methods of functional /characteristic component in 2020 Guidelines are recommended, and applicants should choose the suitable methods when testing the functional /characteristic component in the product. Compared with the 2003 Technical Standards, testing methods of tyrosol, total anthraquinone, 10-hydroxy-2-decenoic acid, gypenoside XL IX, total triterpenes, cordycepin and D-mannitol were added in 2020 Guidelines. Meanwhile, some testing methods were deleted and some that are retained in 2020 Guidelines were modified. For example, in the “Determination of salidroside and tyrosol in health food”, the testing method of tyrosol was added, the detection limit, linear range and testing method “polarography” were deleted. If relevant functional /characteristic components are involved in the products, health food enterprises should carefully study the relevant testing methods and carry out inspection/tests with reference to the latest testing methods.
The contents of 2003 Technical Standards include: assessment procedures and testing methods of 27 health functions, assessment procedures and testing methods of 18 health food toxicological tests, testing methods of 27 functional components and hygiene test. After it was abolished, the test report using the methods listed in 2003 Technical Standards cannot be used to apply for health food registration.
Recently, SAMR officially issued Guidelines for Toxicological Test and Evaluation of Health Food and Its Raw Materials (2020), Guideline for Safety Inspection and Evaluation of Strains Used as Health Food Raw Materials (2020), Guidelines for Inspection and Evaluation of Physicochemical and Hygienic Indicators of Health Food (2020). After the release of the three regulations, there are official reference for toxicological evaluation and functional component inspection of health food, and only the testing methods for health functions haven’t been issued yet.
In general, relevant inspection regulations for health food are gradually improved. CIRS believes that the testing methods of health functions will be issued soon, further boosting health food industry
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