Functional health food includes “food” with specific health functions. In other words; it is food supplements that are suitable for consumption of specific groups of people and has the effect of regulating human body functions. The functional claims must be among the 27 approved claims, including “Weight Loss”, “Increase Bone Density” etc. Functional health food can be registered at CFDA and obtain a “Blue Hat” CFDA Certificate – enabling the product to be sold in China.
The complexity of obtaining the CFDA certificate depends on the function claim of the health food – and thereby the tests required proving the claimed effect and safety of the product.
Foreign companies wishing to obtain a Blue Hat certificate for their functional health food must first perform an ingredient screening to ensure that the ingredients and content levels are compliant with CFDA regulations. Secondly, the products must undergo various tests performed at CFDA appointed laboratories. Finally, the application should be submitted to CFDA for final approval. The time and resources spend on obtaining a CFDA “Blue Hat” certificate varies with the function claims. It normally takes 2-4 years to complete and the price varies between USD60 – 120,000.