The Protein Brewery was provided the authorization for its first novel mycelium ingredient, Fermotein (Rhizomucor pusillus), to be placed on the European Union (EU) market.
The vote on the product saw all 27 member states vote in favour of the product through the EU’s Novel Food regulation. Through the vote, the product becomes the first novel mycelium ingredient authorized for the EU market.
For the company, the process has been six years in the making, after first submitting its dossier in May 2020 to the European Commission.
Fermotein is a whole-food mycoprotein ingredient combining protein, prebiotic fibre, micronutrients, and bioactives (spermidine and ergothioneine), The Protein Brewery states on its website. The product is approved for use across food and beverage categories serving health and wellness, including being formulated into active nutrition products, bakery and snack products, and dairy alternatives.
The initial rollout for the product will first be focused on the active nutrition categories, Thijs Bosch, CEO of The Protein Brewery, told NutraIngredients.
“The main advantage for active nutrition formulators is that the nutrition story translates directly: one ingredient, complete protein, fiber, and fungal bioactives, with no allergens requiring labelling and a clean profile,” he said.
Through the regulation, the company holds exclusive rights to the scientific studies and data supporting Rhizomucor pusillus for a period of five years, in addition to the patented production process required to create the product.
“The exclusivity means that during this period, no other applicant can reference our safety dossier to bring Rhizomucor pusillus mycelium to the EU market without our agreement, which gives us certainty as we invest in scaling capacity, deepening our science base, and supporting our customers through their formulation and launch work,” explained Yvonne Dommels, The Protein Brewery’s nutrition and regulatory affairs director.
Once this five-year period has passed, the company expects to have cemented a leadership position based on “supply, science, and customer relationships rather than regulatory exclusivity alone,” she added.
Scaling up capacity for broader rollout
Fermotein has already been made available for commercial sale in the U.S. and Singapore. The company is also working on authorization in the UK, Canada, Australia, and New Zealand, with an approval decision in the UK expected later this year.
In order to meet the potential demand across these countries, The Protein Brewery is scaling up its production capacity at its manufacturing site in Breda, the Netherlands. The company expects to supply 600 metric tonnes (MT) of Fermotein in 2027 from this facility, expanding to a projected capacity of greater than 2,000 MT by 2029.
The strain IP that the company is working with is a fast-growing extremophile that does well at high temperature and low pH, allowing for the fermentation process to take place in non-sterile fermenters, Bosch explained. This allows for lower capital and operating costs compared with sterile biotech fermentation, while also allowing for larger fermenter sizes, he added.
To hit capacity targets to 2029, the company is making “significant capex investments” at the Breda facility, and the team working at the site has also grown to support the build-out, Bosch said.
