Bioiberica’s DAOgest Authorised as Novel Food Ingredient

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GettyImages - histamine intolerance / Paul Bradbury (Getty Images)

Bioiberica’s diamine oxidase (DAO) enzyme ingredient, DAOgest, has been granted Novel Food Status by the European Commission, making it commercially available in Europe with immediate effect.

This authorisation opens up new possibilities for European formulators to create food supplement solutions that cater to histamine intolerance, an emerging gastrointestinal condition affecting an estimated 1-3% of the global population.

The global life science company specialising in the research of high biological and therapeutic value molecules for the pharmaceutical, nutraceutical, and food industries, launched DAOgest in 2022.

DAO is naturally present in the gastrointestinal tract, where it breaks down ingested histamine from food. When the body fails to produce sufficient DAO enzymes, symptoms of histamine intolerance can arise due to excess histamine in the body, leading to allergy-like reactions.

Histamine intolerance is projected to drive the demand for DAO-based solutions at a compound annual growth rate (CAGR) of 10.4% from 2020 to 2028.

Antonio Vendrell, marketing director at Bioiberica, explains: “We are facing a situation in the market where a large percentage of the population is not aware of this health issue.”

He believes that the granting of Novel Food Status to DAOgest will build awareness of ways to combat histamine intolerance, noting: “We need to promote this health solution and raise awareness of histamine intolerance itself.”

Vendrell explains that one way to educate is via B2B platforms, providing information for Bioiberica partners on the effects of DAOgest through training programs. 

The other way Bioiberica is raising awareness, is through publicly accessible material and infographics about histamine intolerance 

DAOgest research

One in-vitro study Bioiberica conducted, concluded: “The supplementation of DAO extract with vitamin C increases the enzymatic activity of DAO. 

“Results suggest that dietary supplementation with DAO from pig kidney and vitamin C might help in reducing symptoms associated with histamine intolerance.” 

Vendrell explains that, with its efficacy demonstrated at a low dose of only 4.2mg per serving, the DAOgest ingredient can help manage symptoms associated with histamine intolerance, including sneezing, hives, and gastrointestinal issues.

He stated: "At Bioiberica, we are dedicated to developing solutions that address emerging health issues, and with the Novel Food status granted to DAOgest, we are thrilled to witness the positive impact it can bring to European consumers affected by histamine intolerance.”

Novel Food Status 

Novel Food status refers to the regulatory designation given to a food or food ingredient that was not widely consumed in the European Union (EU) before May 15, 1997. 

Being granted Novel Food status confers credibility, market access, consumer trust, and opportunities for growth and innovation.

It establishes a solid foundation for companies to develop and promote their products while complying with regulatory requirements.

Vendrell notes: “The Novel Food registration opens the door for providing solutions into the European market, and it helps us to provide support for the regulatory processes that we have in other markets such as Central South America.”