Following the announcement last week, local health food giant BYHEALTH said it has applied to make new function claim and was the first to have done so.
China’s State Administration of Market Regulation (SAMR) announced a list of technical guidelines for health foods making new functional claims, known as “保健食品新功能及产品技术评价实施细则” in Chinese. This is a pilot program that is effective from day of announcement (August 28).
This means that companies could make new function claims outside of the existing list of 24 approved claims – provided that their applications are approved by the SAMR.
Nonetheless, the new development will allow greater wriggle room for health foods companies in their new product innovation process.
According to the announcement, any units or individuals who are already conducting research on new health foods functions could individually or collectively propose these new functions to the Center for Food Evaluation housed under SAMR.
The proposed new functions will need to be reviewed under technical guidelines set out by the SAMR.
A new functionality should fall within the following three categories: namely 1) to supplement dietary nutrient, 2) to maintain or improve the body’s health status, or 3) to reduce the risk factors of disease onset.
Research on the new functions should be conducted on health food prototypes that are newly developed for the research purpose, or conducted on existing health foods that are already approved via the registration or filling route.
The prototypes should also adhere to the safety, functionality, and quality requirements of health foods.
In addition, companies should sufficiently develop the methods for evaluating these new functions.
Before applying to make the new functional claims, they should pass the review of at least one food sampling organisation or clinical trial organisation. These organisations should meet the regulator’s requirements.
If the new functionality is approved for market launch, the individual / companies who registered the product should conduct post-market surveillance based on criteria set out by SAMR.
This includes gathering information on product sales, the types of consumers purchasing the product, and data on consumer feedback / complaints.
Asked the implications of the new guidelines, Cathy Yu, general manager, food business division at Hangzhou-based regulatory consulting firm CIRS said that the sector could stand to benefit from the new policy.
However, because there is a lot of work required for submitting new functional claims, it is not expected to be an easy task, she said.
As such, she believes that it is probably the bigger enterprises that would apply to submit new functional claims.
In addition, companies will need to design their own evaluation method when proposing new functional claims.
Thus, she believes that some of the more challenging aspects in submitting new functional claims would include clinical study resources.
BYHEALTH makes first application
China’s health foods giant BYHEALTH has made its application for new health foods functional claim on the second day of SAMR’s announcement.
The company claims to be the first to have made the application.
The claim submitted is “maintain normal platelet aggregation function and benefit blood flow health” (有助于维持正常的血小板聚集功能，有益于血流健康) for the water soluble tomato extract branded Fruitflow+ by UK firm Provexis – a commercial partner of BYHEALTH.
So far, BYHEALTH has conducted eight separate studies on Fruitflow.
“Provexis has been working with BYHEALTH for more than six years to support the planned launch of a number of Fruitflow based products in the Chinese market.
“Clinical studies conducted in China are typically required to obtain the necessary regulatory clearances in China, and a significant investment in eight separate Fruitflow studies has been undertaken at BYHEALTH's expense.
“Completed studies have shown excellent results in use for Fruitflow, and they provide strong evidence for the efficacy of Fruitflow on platelet function,” the company said in a filing to the London Stock Exchange on August 30.
Last year, findings of a Fruitflow study undertaken by BYHEALTH was published on the Journal of Functional Foods.
Conducted on middle-aged and elderly subjects, the trial showed that the supplementation of Fruitflow for seven days could decrease platelet aggregation rate.
Currently, there are 24 health claims that companies are allowed to claim for their health food products. This ranges from alleviating vision fatigue, aids in strengthening immunity, and aids in improving bone density.
This was a reduction from the former list which had 27 claims. Three claims, including “promotes lactation”, “improves growth and development”, and “improves oily skin”, were removed about three years ago.
However, in August last year, the SAMR announced it would consider new claims that could satisfy consumers’ health needs and were scientifically logical and proven.