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Regulatory Updates

China Unveils Key Points for Replacing "Dual-No" Health Food Registration Certificates
Publication date:2024-11-04

 

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On November 1, China’s State Administration for Market Regulation (SAMR) released key review guidelines for implementing the replacement of health foods that lack "expiration dates and product technical standards" (referred to as “dual-no” products). This initiative aims to standardize legacy registrations, improve documentation, and unify regulatory standards. Through re-certification, SAMR will assign expiration dates, regulate health claims, and align registrations with production licenses and oversight, reinforcing compliance responsibilities for manufacturers and regulators.

 

Products requiring certificate replacement include all "卫食健字" labeled items and certain "国食健字" items approved during the 2003-2005 regulatory transition, as specified by the Health Function Catalogue Allowed for Health Food Claims - Nutrient Supplements (2023 Edition) and other associated regulations.

 

During the transition period (within five years from August 31, 2023), registrants of Chinese “dual-no” products on the market must apply for re-certification. For imported “dual-no” products, eligible registrants may also apply, with review authorities conducting overseas inspections if needed.

 

The re-certification channel has 3 years and 10 months remaining, so eligible companies are urged to begin re-certification soon.