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Takehome:
- The “Examination Details of Health Food Production Licensing” have been finalized, and the production license requirements of health food raw material extracts and compound nutrients have been newly added.
On Dec. 14, 2016, China CFDA finalized the “Examination Details of Health Food Production Licensing” (see CL news report on May 23, 2016 for the draft release), which will be formally implemented from Jan. 1, 2017.
Production licensing examination should be carried out according to technical requirements including product formula, production technology and quality standards as well as health food product inspection information.
“GB 17405-1998 Good Manufacturing Practice for Health Foods” specifies 140 examination items for health food production. However, some of the examination items are not implementable and need to be revised and improved. Based on this 32 examination items have been added in this new regulation, including the requirements for production batch, OEM production, raw material extracts and compound nutrients, etc.
Production license of health food raw material extracts and compound nutrients
Prior to this regulation health food raw material extracts and compound nutrients were not included into the scope of health food production licensing. In the finalized version, the requirements for production license application for extracts and compound nutrients have been newly added and relevant examination procedure and technical standards are detailed. During the application, health food registration/filing certificate should be submitted, as well as the materials indicating the production technology, quality standard, etc. of the raw material extracts and compound nutrients.
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