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On November 26, 2020, SAMR (State Administration for Market Regulation) released the official version of “Special Food Registration Onsite Inspection Requirements (Interim) [1],” which came into force on the same day. Compared to the consultation draft (CL News [2]) released on July 17, 2019, most contents remain the same except for the following fourrevisions:
1. Particular requirements for health food were added to Article 3.
It stipulated that during the inspection, health food should be in a state of pilot-scale (or scale above) production.
The registration application of health food should be classified into different risk levels based on the specific situations of the products. The inspection form of health foods will be determined based on the risk level classification.
2. The responsible authority of on-site inspection was changed.
Different from the consultation draft, Center for Food Evaluation, State Administration for Market Regulation [3] (CFE) is now the only responsible authority for the organization and implementation of on-site inspections, the establishment of special food inspector pool, the formulation of detailed onsite-inspection rules, etc.
Besides, only the inspection team organized by CFE can carry out the on-site inspection. Third-party institutes are not qualified according to the official text. (Relevant sentences were deleted in the official text).
ChemLinked believes the revision of these two points are for the purposes of better supervision and management of the whole on-site inspection procedures.
3. More notification forms were adapted to inform applicants of the onsite inspection schedule.
Besides written notification, CFE will also use its information system or website to inform applicants of the onsite inspection schedule. For applicants who cannot receive the onsite inspection due to force majeure, they can apply for the extension with written applications.
4. Follow-up measures were added after the on-site inspections.
To enterprises that failed to pass the on-site inspection, they should rectify the non-compliant items within ten workdays and report it to the provincial SAMR department. The provincial SAMR department should take an acceptance review of the items being rectified and submit the report to CFE. Details of the follow-up measures of overseas on-site inspections are not disclosed.
Notes and Precautions:
The official language during the overseas on-site inspection is Chinese, so the inspection materials needed during the inspection shall be written in Chinese. Applicants shall also equip enough on-site interpreters and be responsible for any possible translation errors.
Further on-site inspection specifications will be formulated later.
View the consultation draft for more info.
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