Probiotics regulations under review in China as regulator SAMR 'plays catch-up'
The SAMR recently issued a draft entitled Provisions for Declaration and Review of Probiotic Health Food, asking for comments to be submitted before April 20 this year.
At the moment, the declaration and review of probiotic health food is based on an earlier draft named Provision for Declaration and Review of Probiotic Health Food (Trial), which was implemented on July 1 2005.
Old versus new
In order to educate companies on key information, the product safety and chemical management consulting firm, Chemical Inspection and Regulation Service (CIRS), has published a comparative analysis between the existing trial draft and the proposed draft.
One of the four main changes made in the new draft is that it determines a clearer definition of what 'probiotics' are. In its analysis, the CIRS stated: "Probiotics refer to living microorganisms which are beneficial to human health when ingested in sufficient quantities. (As such) probiotics are required to be living microorganisms."
The definition of probiotic health foods is also modified, whereby health foods produced with 'dead' bacteria and microbial metabolites will no longer be classified as 'probiotic health food'.
The CIRS analysis stated: "Probiotic health food is a kind of microbial product that takes probiotics as the main functional ingredient, and adds necessary excipients."
Thirdly, the new draft requires several of the declaration dossiers submitted to be supplemented: they must provide the basis for the use of specific probiotic strains, along with raw material inspection reports. They are also required to provide research reports, scientific literature and other such evidence related to probiotic functions based on specific strains.
Lastly, the new draft has done away with some of the existing information under the current draft, namely that "the list of probiotics for health food is issued by the State Food and Drug Administration", and that "it is not recommended to produce probiotics in liquid form".
Instead, the new draft states that "bacteria (strains) for food issued by the competent authorities can be used for probiotic health food".
The draft further states: "In terms of health food produced with dead bacteria and microbial metabolites, their general name shall be 'functional components', instead of (referring to) the probiotics being used.
"In addition, product names should also comply with the 56th of Administrative Measure on Health Food Registration and Filing."
The 56th of Administrative Measure on Health Food Registration and Filing states that "the name of health food shall be composed of the trademark name, general name and attribute name."
SAMR 'playing catch-up'
Cathy Yu, GM (Food Business Division) at the CIRS told NutraIngredients-Asia: "We are expecting responses from manufacturers, distributors, scientists and anyone whose job involves probiotics or probiotic health foods.
"Previously, probiotic health foods included both live and dead cultures, and metabolites, but the new draft only includes live cultures. The SAMR would like to make a distinction between probiotic products containing live cultures and probiotic cultures that do not.
"We think this would be good for consumer, because they will be better equipped to make a more informed choice when purchasing probiotic products."
Jeff Crowther, executive director of trade body Health Products Association – China (HPA-China), told NutraIngredients-Asia that the association had submitted several documents to the SAMR for its review of probiotics regulations.
He said, "A lot of people don't know but probiotics is a huge business in China, though most of it is within the dairy industry — only a small proportion is within the supplement industry.
"Probiotics is a growing industry; it will be found in more and more products, especially when they are spore-based and heat-resistant, therefore making them suitable for different foods and supplements."
He added that in light of growing Chinese interest in probiotics, the government felt the need to "get ahead of the game", especially with regards to the different strains, where they were sourced, and how they were being developed.
He further said probiotics would spread from China's dairy industry and find their way into more health foods and supplements, in tandem with the increasing opportunities brought on by rising consumer interest.
"It really depends on consumer demands and the innovations that will be pushed forward. Regulations are usually lagging behind and have to catch up with these trends. But I will say that in 14 years of living in China, I've never seen the government work so quickly to try to get a handle on the industry."
One reason for the SAMR’s need to play catch-up, he said, was that the Chinese probiotics sector did not feature strongly among products with blue-hat registration. As such, approvals for such products were being outstripped by consumer demand and new innovations.
"Most blue hat-registered products are basic items that have been in the market for years. A lot of the new products launched around the world can't get approved here because some of their ingredients are not yet approved here, and blue hat registration takes a long time."
The SAMR has been seeking to tighten regulations for health foods and supplements in China, having most recently started a public consultation to review health food claims in the country.
