The three approved probiotic strains are lactobacillus helveticus R0052, bifidobacterium infantis R0033, and bifidobacterium bifidum R0071 from Lallemand Health Solutions. The strains are isolated from dairy products, infant gut, and adult gut respectively.
All of the strains are approved for use in infant foods, said a statement from the National Health Commission (NHC). Since they are only approved for use in foods and not health foods, they are not allowed to make health claims.
Besides passing safety tests in China, the strains have also gained the Generally Recognised as Safe (GRAS) status in the US.
"This endorsement is a prodigious regulatory achievement given the limited number of strains that made it to that elitist list of only 12 strains, including these three,” Solange Henoud, global regulatory affairs director at Lallemand told NutraIngredients-Asia.
The Chinese authorities also said that products containing these three strains have previously been approved for use in infants in countries such as Canada, Poland, and Australia.
According to figures collated by regulatory consultancy firm CIRS, China has approved a total of 137 health foods that contain probiotics as its main ingredient as of April this year.
The majority contain lactobacillus acidophilus (81 products), followed by bifidobacterium longum (33 products) and streptococcus thermophilus (25 products).
Most of the products contain at least two strains, with bifidobacterium and lactobacillus acidophilus as the most commonly seen combination, with 28 products containing such combination.
However, compared to the other countries, the number of bacteria species that could be used in China is fewer, but the authorities are aiming to expand research capabilities, which could speed up the approval rate, according to regulatory expert Lilian Fan from Antion China.
A search on NHC shows that the last time a new bacteria strain was approved for as a new food raw material was in May last year. The strain approved was lactobacillus curvatus and is isolated from traditional fermented meat products.
It was approved for use in fermented meat, fermented dairy, and dairy products, but not in infant food due to a lack of safety information.
Another novel ingredient
The plant oriental penthorum, also known as penthorum Chinense pursh, was also approved as a novel food ingredient.
It is widely grown in various parts of China, including Sichuan, Guangdong, Zhejiang, Hubei, and Yunnan.
Its leaves and stem could be brewed in water and drank as a beverage.
However, as information regarding its safety in infants, children, pregnant and nursing mothers are lacking, they are not advised to consume the product, and the product caution should be reflected on the labelling.