In the past, China’s regulators have been toying with the idea of adding some more ingredients to the Health Food Raw Materials List for finished supplement recording or filing process. At present, only basic vitamins and minerals are allowed to be used for recording process. If the product contains ingredients other than the approved vitamins / minerals, it would then need to apply for health food product registration or what is known in the industry as a “Blue Hat” registration.
According to a recent announcement, China’s State Administration of Market Regulation (SAMR) is considering to add Coenzyme Q10, Melatonin, Fish oil, Wall-broken Ganoderma Lucidum spore powder and Spirulina into Health Food Raw Materials List. This decision dates back to March of 2019 where the government was gathering opinions. However there was no mention in the announcement of when or how this would go into effect. Although a small step, it is certainly one moving in the right direction.
The major differences between recording and registration of supplements are the following:
Registered “Blue Hat” products are able to make an approved health claim whereas Recorded products have the generic claim of nutritional support. There is a list of 27 approved health claims to choose from for registered products.
Time it Takes to Get Approval
Recorded products typically take less than a year, whereas “Blue Hat” registrations can take 3-5 years. Timing varies greatly on the product in question, ingredients used, how prepared the company is with required documents and who is doing the recording / registration. Currently there is a sizeable back up on approvals, so we aren’t see many new registered (Blue Hat) products hitting the market especially from international companies.
Again this really depends on many factors including the product, ingredients and what claims are being made as well as who is conducting the procedures. Most companies use consulting agents when applying. Agents charge varying fees to assist companies with this process, which can be anywhere from 20 – 50 percent of the total costs involved.
In general, recorded products will cost less than $20k and registered products will cost on average $100k or more.