EU authorization process limits market access to Onego Bio’s fermentation-based egg protein

19 Jun 2023 --- Onego Bio is facing challenges in launching its bioidentical egg protein Bioalbumen on the EU market due to an untransparent legal process with unclear requirements. The product is said to mitigate environmental impacts by 90% and was presented at this year’s Sustainable Food Summit.

To tackle this issue, the Finnish-based company will launch its product in the US, where the process is more transparent and the product could be launched in two years.

Bioalbumen can be produced at the exact costs and performance as animal-based egg proteins, with stable production and a 90% lower environmental footprint. 

“We have to inform what precision fermentation is about,” Anna Handschuh, head of public affairs and impact at Onego Bio, tells Nutrition Insight. 

She explains that the company aims to educate the EU on the technology along with other stakeholders in precision fermentation to improve the complicated regulatory process, as the technology is still new and not well known. 

“I hope and expect the European Commission (EC) to come up with a very ambitious protein strategy because this would really help to break this up.” 

In precision fermentation, cellular organisms can produce complex molecules identical to nature, such as proteins.  

In Europe, market approval for Onego Bio’s precision fermentation product can take three to five years.Legal frameworks US, EU and Singapore 
Presenting at the conference, Handschuh shares that she expects the product to be marketable in the US in two years. 

“The process is very transparent; you get a case manager, clear requirements and scientific advice. There’s a focus only on the end product.” 

Singapore is a paradise, she continues. Here, companies get a dedicated case manager from day one who helps them through the process and gives scientific and administrative advice. The transparent market approval process takes 9-12 months and has precise requirements. 

In Europe, market approval can take three to five years. Bioalbumen needs to go through Novel Food regulation and a GMO regulation that is not up to date with the latest science, notes Handschuh. The authorization process looks at both the end product and the process. 

“We’re producing this egg white with a GMO, but there is no GMO in the end product,” she says. 

Unclear category for precision fermentation   
Handschuh highlights that Onego Bio is not receiving scientific advice due to an interpretation of EU regulation on transparency in the EU risk assessment of the food chain. Initially set up to fight pesticides, she suggests that the legislation is used against the new technology. 

In addition, she notes that the next generation of environmental risk assessments that EFSA is working on is not integrated into other reviews. 

“You have an environmental risk assessment for your food, a safety assessment and the Product Environmental Footprint, based on category rules. We don’t even have category rules for our food because these categories are only based on animal-based agriculture.” 

“This category is unclear and still not at that state that you can expect the EU to be aware and informed about. Even if its technology is mostly developed in Europe.” 

She adds that EFSA is aware of the new technology but is facing resource constraints. 

Onego Bio uses the fungus Trichoderma reesei, sugar, nitrogen and minerals to create an animal-free egg white. Advocating for alternative proteins 
Onego Bio is part of the newly formed Food Fermentation Europe (FFE), which aims to champion precision fermentation as the key to a sustainable food framework. 

“We are now trying to establish a regular dialogue with EFSA as a registered stakeholder to have the possibility to talk to EFSA on the Novel Food regulation. We also try to work with the Commission on Sustainable Food System framework,” continues Handschuh.

In addition, the FFE aims to “establish a dialogue with the EC on a modern EU protein strategy, which would be a great opportunity to make a clear statement on alternative proteins beyond only plant-based foods.”

“We are advocating for alternative proteins; we are one pillar of alternative proteins.”

As there are no regulatory issues in the US, Onego Bio and its partners in the Precision Fermentation Alliance focus on consumer education. 

“Net zero food technology” 
At the summit, Handschuh also presented the outcomes of a Life Cycle Assessment conducted in 2021, which indicated that Bioalbumen used up to 94% less land, up to 67% less water and contributed up to 87% lower greenhouse gas emissions. 

She explained that on one hectare of cultivated land, Onego Bio could produce ten times more egg protein through precision fermentation than traditional chicken egg protein at price parity. 

“It’s a net zero food technology and not recognized as such.”

“Europe is the first continent with a net zero target. Europe is leading on biodiversity and climate; Europe is leading on everything,” she continues. She adds there is no time to lose to decarbonize the food system. 

We imagine we can take the animal out of the equation, says Handshuh.At the same time, “we are having a hard time telling political decision-makers that this is a technology they should consider, especially when they talk about the Sustainable Food System Framework they will release and we are doing our best to be a part of this system.” 

Bioidentical egg protein 
Onego Bio uses the fungus Trichoderma reesei, sugar, nitrogen and minerals to create Bioalbumen, an animal-free egg white, which can be used in various sectors, including fitness products, food processing and bakery.  

Handshuh explains that Bioalbumen is a high-quality, complete protein that is identical to animal-based egg white, with a similar taste, texture and color that can have the same or improved functionalities. 

“We imagine we can take the animal out of the equation. We decouple it completely, meaning there is also no risk of infectious diseases. No antibiotics exposure, no risk of zoonotic disease driven pandemics.”

In addition, the process results in around 60% of fungal biomass material, which can be used in other industries. 

Handshuh highlights infrastructure needs to scale up to make use of the technology. Fermenters and bioreactors are needed all over Europe or worldwide, but “there are many areas we could give back to nature.”

By Jolanda van Hal