China’s proposed changes in its food safety regulations, which also govern dietary supplements, are long on aspiration and short on specifics. That’s the opinion expressed by the Natural Products Association in comments the organization submitted to Chinese authorities recently.
“It’s an important market and getting more important by the day. I think it’s good news that China is very interested in natural products. They first looked at laws around health food in 2009 and not much has changed since then,” Daniel Fabricant, CEO of NPA told NutraIngredients-USA.
NPA has drafted eight pages of comments on China’s proposed 2014 amendment of its Food Safety Law. In its comments submitted to China’s legislative body, the National People’s Congress, the organization noted that the safety of food in and from the world’s most populous country is of critical importance in the United States.
Increasingly, ingredients used in supplements and finished foods in the US market are sourced in China, and more finished products are imported directly, too. Two fairly recent large scale instances of poisoning of ingredients in China—the melamine scandal and the case of oversulfated chondroitin—point to the risk to US consumers of tainted Chinese ingredients.
Murky lines of authority
An issue often cited when dealing with Chinese regulations is the murky question of who is actually in charge. The interplay between national and regional authorities is complex and often intransparent. NPA calls for a clear lines of national authority on the issue. Unfortunately, from the association’s point of view, the draft law would not clear this issue up.
While the law puts food safety on a national level, the actual functioning of identifying and clearing up food safety issues would consist of an interaction of the firm in question with the relevant local authorities. This could make for uneven enforcement, NPA said.
The association also observed that it is unclear how those concerns would be communicated to the national level, complicating data collection. To that end, NPA also noted that the draft law lacks any requirement for an adverse event reporting system.
“We want more detail on how those responsibilities will be parceled out between the Health Ministry, the Chinese Food and Drug Administration, and the authorities responsible for quarantine and sanitary inspection. Who will have jurisdiction? Not knowing how laws are going to be administered is a concern regardless of the nation,” Fabricant said.
Experience in dealing with US regulation, and seeing how the functioning of those regulations can turn on imprecise bits of verbiage buried within the law, led the organization to criticize the vagueness of the Chinese draft proposal.
The law contains phrases such as “reasonable equipment” and “appropriate places” making it unclear how companies might best comply with the law (and potentially giving local authorities wide latitude for enforcement). For example, it is still unclear where dietary supplements will fall. Will they continue to be classified as “health food,” or will a new category be created for them under a future amendment?
The comments also cite the imprecision of the draft law’s testing requirements. There is no description of exactly what a testing program would entail. Will it be a risk based approach, focusing more on categories of concern that are subject to economic adulteration and the inclusion of undeclared active pharmaceutical ingredients?
Will it apply to both imported raw materials and raw materials exported to the United States? “While FSL appears to be a comprehensive document in theory, many questions remain as to how the law will be implemented in practice,” NPA’s comments state.
“Knowing what we know about regulatory environments, we want to have a little more detail,” Fabricant said. “The devil is in the details. We would rather have those concerns dealt with up front rather than on the back end as the law is implemented.”