In a startling policy u-turn, on Aug. 17, 2018, State Administration for Market Regulation (SAMR) published a notification permitting the issuance of temporary permits for unregistred special foods, just two months after China's General Administration of Customs (GAC) detailed the exhibition prohibition list and restriction list for CIIE exhibition, which stipulated that registration or filing of infant formula and health food and registration of overseas dairy manufacturers was required for all exhibitors.
Manufacturers of infant formulae or health food who have not obtained registration approval may apply for a temporary access permit with Shanghai Food and Drug Administration if they have obtained a hygiene certificate issued by the relevent food safety authority in the country of origin. Shanghai FDA will have experts review formulae of products and issue permits if formulae are considered safe. Overseas onsite inspection is not required for a temporary permit.
Situation | Registration of overseas infant formula manufacturer | Registration (or filing) of formula | Need to apply for temporary access permit? | Approach |
1 | √/—* | √ | × | Normal |
2 | √ | × | √ | Exhibition (CBEC) |
3 | × | √ | √ | Exhibition (CBEC) |
4 | ×/— | × | √ | Exhibition (CBEC) |
*health food is not required for registration of overseas manufacturer.
Temporary permit only let manufacturers have their own exhibition where consumers can order products via CBEC platforms, but are not allowed to buy, pick up, or try goods on site.
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