With this status, the new product—known as YoyiC Galacto-oligosaccharides Probiotic Drink (优益C低聚半乳糖益生菌饮品)—is allowed to make health claims.
In this case, two health claims have been approved, namely “aids in modulating the gut microbiome” and “aids in digestion”.
Like other products in the YoyiC line, the new product contains Mengniu’s proprietary probiotic strain Lacticaseibacillus paracasei PC-01.
The “blue-hat” status is given to health foods by China’s State Administration of Market Regulation (SAMR) either via the health food filing or registration track.
The filing track is applicable to “low risk” products containing ingredients listed in the Health Foods Raw Materials Directory, while the registration track is a more expensive and time-consuming route applicable to products containing ingredients not listed in the Directory.
According to information obtained from SAMR’s health foods registration database, each 100 ml bottle of the product contains 50 billion CFU of Lacticaseibacillus paracasei and 1,000 mg of galacto-oligosaccharides (GOS) and is suitable for use among people who suffer from indigestion and intestinal dysfunction but not for infants, toddlers, pregnant women, or breastfeeding mothers.
The suggested usage is one bottle twice daily. The product must be refrigerated at 2 to 6 degree Celsius and has a shelf life of 25 months.
According to Mengniu, the health claims approval establishes its new YoyiC probiotic as a health food and not a general beverage.
Work on the product started 12 years ago, when the company’s R&D team studied the stability of the probiotic and worked on improving the synergistic effects of the GOS and probiotic, as well as balancing the product’s mouthfeel and functionality.
Clinical research on PC-01
The company also stepped up clinical trials on PC-01 about three years ago, Dr. Wendy Yang, senior scientist at Mengniu Dairy, previously told NutraIngredients.
One of its latest clinical trials was a 28-day study involving over 1,000 participants, assessing the effects of taking 100 billion CFU of PC-01 on indigestion, bloating and upper abdominal pain.
In 2022, the company also studied PC-01’s anti-allergy effects.
The purpose of conducting clinical studies is to prove how yogurt drinks, when formulated with functional ingredients, can serve as a functional beverage instead of a snack—which is what a yogurt drink is widely perceived as in China, Dr. Yang told NI.
Mengniu’s six ‘blue-hat’ products
Based on data retrieved from SAMR’s health foods registration database, Mengniu has a total of six “blue hat” products.
The product, Mengniu GuanYiRu Fermented Dairy (蒙牛冠益乳发酵乳) was the company’s first yogurt drink approved to make the claims “modulate gut microbiome, strengthen immunity” in July 2021. It contains the probiotic strains Bifidobacterium animalis subsp. lactis BB-12, Lactobacillus delbrueckii subsp. bulgaricus, Streptococcus thermophilus and fructo-oligosaccharide.
The other four products include a synbiotic milk powder that claims to “strengthen immunity”, a liquid milk that claims to “strengthen bone density”, a second liquid milk claiming to “aid in lowering blood lipids” with the use of plant sterols and α-Linolenic acid (ALA) and a third liquid milk claiming to “strengthen immunity” with the use of beta-glucan.
“The certification of YoyiC not only confirms Mengniu’s continued leading capability in the functional health food field, but also accelerates the industry’s transformation towards functionalization and specialization,” the company stated.
