- During our recent Oceania Food Regulatory Conference, our technical expert’s outlined that enforcement of the infant formula registration policy was much more stringent now, especially for the application materials and on-site inspection. In terms of future regulation of China’s health food sector our specialists speculate that filing is likely to play a more important role going forward.
Infant formula registration is more stringent
Maxwell Heston, regulatory compliance consultant from REACH24H Consulting Group, stated that the supervision of infant formula registration is much more stringent now. Take documents proving R&D capacity for example, previously it was acceptable for an enterprise to submit a single individual R&D report of a single product line which would cover any subsequent applications for additional product lines. Under the heightened supervision, individual R&D reports are now required for each product line. In addition, on-site inspection is now a prerequisite of registration approval (previously it could be conducted after registration approval).
Health food filing to play a more important role
Yuanzhao Yu provided advice on compliance strategy and speculated on future development of health food management in China. He said filing will be a trend for health food supervision. Filing is much easier than health food registration and currently most regulations regarding health food filing are still in a trial phase, implying that the policy will be further optimized in the next few years. The development of the health food registration policy has reached somewhat of an impasse as the Technical Specification for Health Food Testing and Evaluation was abolished this year, meaning there is no reference to guide industry in terms of animal testing and clinical trials.
A huge market for imported FSMP
Yuanzhao Yu also shared his insights on FSMP regulation. Up to now, 18 FSMP products have been granted product registration approval in China. However, since the Implementation Rules for FSMP Production Permission have not been released, domestic FSMP manufacturers are not allowed to produce FSMP at they would lack the required production certificate irrespective of product approval status. This unprecedented situation offers a considerable advantage for overseas enterprise. In addition the extension of the cross border ecommerce grace period means that unregistered FSMPs can still be sold online, forgoing the requirement for imported products sold via CBEC to obtain registration approval.