Formo, Those Vegan Cowboys partner to bring cost parity with animal-based casein

This could make the manufacture of precision fermentation dairy alternatives more scalable and cost-effective and potentially speed up regulatory approvals.

Germany-based Formo and Dutch biotech firm Those Vegan Cowboys both specialise in precision fermentation of proteins suitable for cheesemaking. Each company has been refining its processes over the last few years and are at similar junctures as they gear up to scale production and apply for regulatory approval with the European Food Safety Authority (EFSA).

The two companies are also among the founding members of Food Fermentation Europe, an industry alliance set up to promote the development and acceptance of fermentation-derived food and food ingredients, including by acting as a unified voice with regulators.

The partnership between the two spans efforts across strain engineering, bioprocessing and large-scale production of caseins. Around 60 scientists – comprising bioprocess engineers, strain developers and engineers, VPs and heads of R&D, fermentation scientists, analytics teams, and protein engineers - from both biotech companies will unite to form a single research team.

“Formo and Those Vegan Cowboys are forming a unique, joint research & development partnership focusing on speeding and scaling up the development and industrialization of animal-free casein,” Formo’s Chistian Poppe told DairyReporter. “Both companies are and remain fully independent. They will also fully independently develop their cheese products - i.e., food science and product development - and independently market and commercialize them. The Joint R&D partnership focuses on the ingredient / bioprocessing and strain engineering part of the value chain.”

On how the partnership came about, Poppe added: “Raffael [Wohlgensinge, Formo founder] and Hille [van der Kaa, CEO of Those Vegan Cowboys] have known each other for a long time. Both have upheld an open dialogue over the years. They hold the same beliefs regarding the urgency to change our food system towards a more sustainable and healthier one and both believe that science is what gets humanity to that goal. Through the foundation and work on trade association Food Fermentation Europe, they've started working on joint products, mainly on advocacy initiatives on an EU level.

“This growing bond led to initial open conversations about the general upsides of start-ups creating synergies and working together to get to their joint goals faster. They realized that the path to scale-up casein production and optimize bioprocesses are fields in which the benefits can be huge.

More concrete conversations began in Summer 2023, he added, when the heads of R&D and the respective executives nailed down all of the benefits and concluded that a joint development partnership would constitute a major value driver for both parties.

Formo and Those Vegan Cowboys have hinted at the possibility of lodging joint dossiers with EFSA, a move that could potentially speed up the regulatory approval process. Asked how likely this is to happen – and when it would likely take shape – Poppe responded: “Working together on speeding up the regulatory pathway is a key pillar of the collaboration.

“In workshops and conversations with EFSA, they have stated that the only thing slowing them down is a lack of bandwidth and that joint applications would be very much preferred.

“We are developing together, we are sharing data together and we have the best regulatory experts in-house, who will craft a best-in-class novel food dossier for animal-free casein.”

However, no manufacturer has yet achieved regulatory approval for novel food products such as precision fermentation-derived casein in the EU.

On paper, an approval should take around 17 months from submitting the dossier to the European Commission, but there are several hurdles. Mathilde Do Chi of food law and regulatory consultancy Vegan Food Law told a Food and Bio Cluster conference this January: “First, you submit the dossier to the European Commission and they have a month to decide what products your dossier is valid. Then EFSA has 9 months to complete a risk assessment – but there are regularly pauses, when EFSA asks for more information from the applicants. And whenever they request additional information, they will give the applicant between three to six months to provide that information, and them the regulatory assessment starts again.

“Once this is done, we have the European Commission that adds 7 months to publish all about sustainable food authorization, regardless of the opinion of EFSA.

“So even if a particular dossier has EFSA’s approval, the Commission can very much decide not to authorize the product.”

So far, there have been two applications regarding precision fermentation-derived whole milk proteins – one from Israeli startup Remilk, submitted in 2023, and Perfect Day’s from 2022. Do Chi said Remilk’s application had been dismissed over non-compliance with an administrative requirement, while Perfect Day’s is yet to be assessed by EFSA.

Meanwhile, precision fermentation-derived dairy products and ingredients can be sold in the US, Singapore and South Africa, with the States the leading market for precision fermentation dairy.