‘Blue-hat’ charm: Sirio Pharma gains approval for three probiotics formulations

By Tingmin Koe

- Last updated on GMT

Sirio Pharma has gained for 'blue-hat' status for three of its probiotic formulation. ©Getty Images
Sirio Pharma has gained for 'blue-hat' status for three of its probiotic formulation. ©Getty Images

Related tags China Probiotics regulations

Sirio Pharma has obtained the ‘blue-hat’ approval for three of its probiotic formulations. The company now has ‘blue-hat’ certificates for four of its probiotic formulations in total.

The three probiotics, trademarked as Quan xin, An Yijia, and Wewow, come in powder form and their ‘blue-hat’ status is effective until early 2025.

Both Quan xin and An yi jia use the probiotic strains La-5 and BB-12 and are approved for strengthening the immune system in children and teenagers. Wewow is approved for modulating the gut microbiome.

The company's first probiotic which obtained the 'blue-hat' status is Qi Mei probiotics powder, aimed at women with intestinal dysfunction. 

The Chinese contract manufacturer said that the certifications would be “very beneficial” ​for its business development, as there were not many ‘blue-hat’ probiotics available in the market.

“Obtaining the certification is very beneficial because probiotics is one of the key categories that we are focusing on.

“Also, most of the probiotics sold in China are classified as general foods. This means that there are very few probiotics with the ‘blue-hat’ status currently,” ​Austin Gao, sales director of APAC told NutraIngredients-Asia.

According to our report​ last year, out of the 17,600 health foods that have obtained the ‘blue-hat’ certificate, only 124 are probiotics.

The ‘blue hat’ certification is well-known for its rigorous and time-consuming application process. This explains why the filing track is preferred.

However, under the filing track, only the ingredients stated in the Health Food Raw Material Directory can be used, which sets a limitation on the types of ingredients that could be used to develop new products.

Gao said that the company spent about five years in obtaining certifications for the three probiotics, while other health foods tend to take three years.

A key factor is because there is a need to submit data on product stability and such data on probiotics required a longer time to obtain.

Worth the effort

Despite the amount of time and effort required, Gao said the company still saw value in gaining the ‘blue-hat’ certificates, not least because the products can carry functional health claims and also enter the pharmacy retail.

“Moreover, ‘blue-hat’ products are not only limited for sale in pharmacies. The truth is, there are a lot of customers who are adopting an omni-sale channel approach and want to sell their products both online and offline.

“And ‘blue-hat’ offers them the opportunity to develop more retail channels, entering both online and offline platforms,” ​he said.

He added that there has been both domestic and international interest towards the company’s ‘blue-hat’ products.

Overall, the company now has over 120 ‘blue-hat’ certificates spanning across different health foods formulations, providing benefits for immune-boosting, gut health, memory, and fatigue problems.

In addition, it has over 50 certificates obtained via the filing track.

Industry interest

Last month, we reported that GNC has started to sell four of its ‘blue-hat’ supplements in China’s pharmacies​ via a partnership with Renmintongtai, the pharmacy chain of Harbin Pharmaceutical Group.

Norwegian krill oil supplier Aker BioMarine has also applied for the ‘blue-hat’ status​ as it believes that gaining the certification will help boost krill oil awareness in China.

Overcoming challenges

On top of going through a long application process, there is also no guarantee that a company will be able to obtain a ‘blue-hat’ certificate eventually.

“Indeed, it is not easy to apply for the ‘blue-hat’ certificate, that is why many companies feel that they would need to invest a lot in the process.

“One thing is that it has set very high standards on the supporting documents required, as well as the scientific evidence and product stability,”​ Gao said.

He pointed out that it would be helpful to maintain close communication with the scientific review panel and provide additional supporting documents promptly.

“Maintaining close communication, addressing questions and providing additional documents that the scientific review panel has requested at the first instance is helpful in speeding up the process.”

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