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On June 13, China State Administration for Market Regulation (SAMR) opened a consultation draft of Standards for Hygienic Physical and Chemical Examination of Health Food[1] to public feedback. The standards are to fill the void left by the now defunct Technical Standards for Testing & Assessment of Health Food (2003 version) which was rescinded by National Health Commission on June 7, 2018[2]. Any comments shall be submitted to SAMR prior to July 10, 2019.
Historical Lack of Health Food Evaluation Standards
The Technical Standards for Testing & Assessment of Health Food(2003 version) was an essential document for the evaluation of health food. It was rescinded in 2018 effectively bringing to a halt the toxicological, physico-chemical and safety assessment of health food registration applications.
The technical standards were divided into three parts:
evaluation procedure and test methods of health food functionality;
evaluation procedure and test methods of health food safety and toxicology;
test methods of health food active ingredients and hygiene index.
Evaluation procedures and test methods of health food safety and toxicology was open to public feedback in April 4 this year (read previous news here)[3]. They are Health Food Toxicology Evaluation Procedure Standards[4]and Health Food Strain Pathogenicity Evaluation Procedure Standard[5].
Test methods of health food active ingredients and hygiene indexes, namely Standards for Hygienic Physical and Chemical Examination of Health Food[6] are currently undergoing public consultation.
So far, the new standards to assess health food functions have not been released. Junfan Chen of the food technical division at REACH24H Consulting Group told ChemLinked that 42 domestic health foods were registered in 2019, however, it is important to note that the applications for these products were submitted prior to Technical Standards for Testing & Assessment of Health Food (2003 version) being rescinded in 2018.
Consultation Draft of Physico-chemical Assessment Standards
The draft document contains a total of 129 pages and 6 chapters. It specifies test items and health food and raw materials hygiene indexes. The outline is:
Chapter 2 Test methods of 25 active ingredients and representative ingredients
Chapter 3 Determination of 11 solvents’ residue
Chapter 4 Determination of stimulant and prohibited ingredients
Chapter 5 Hygienic test items of different ingredient forms and products with specific raw materials
Chapter 6 Test items of active ingredients and characteristic in products with specific raw materials
For English version of the consultation draft, please contact ChemLinked for translation service.
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