Finnish biotech firm seeks EU novel food approval for mycoprotein ingredient

Enifer claims to be the first Nordic company to seek approval from the European Food Safety Authority (EFSA) for its mycoprotein ingredient, positioning itself to enter the European market.

“Mycoproteins such as PEKILO®Pet contain 60% protein, with up to 15% fungal beta-glucan, which is a food-quality fiber that can enhance the gut health of pets,” notes Heikki Keskitalo, Enifer Co-Founder and Business Development Manager.

Furthermore, the mycoprotein ingredient boasts hypoallergenic and sustainable qualities.

In 2020 and 2022, the company collaborated with pet food giant Nestlé Purina and aquafeed producer Skretting to conduct product testing for pet food and aquaculture feed.

Earlier this year, Enifer secured over €30 million to establish a new production facility in Finland. The company aims for an annual production volume of 3,000 tons of the mycoprotein ingredient.

Targeted markets

The biotech firm is first targeting Europe and the UK, where its protein solution is listed on the catalogue of feed materials and can, therefore, be used commercially.

In the EU, any ingredient not consumed in significant amounts before 1997 is considered novel food and requires EFSA approval, which Enifer has anticipated. The company estimates that approval will take up to 3 years.

“The EU’s regulatory process is widely considered the most rigorous globally,” explains CEO and co-founder Simo Ellilä. “With that safety data in hand, we are then able to seek approval in other markets as well.”

Other horizons

Enifer also aims to expand the footprint of its mycoprotein ingredient for pet food applications in Singapore and the US.

In Singapore, the regulatory timeline is expected to be shorter, while in the US, the GRAS (Generally Recognized as Safe) status offers a quicker route than achieving full approval from the US Food and Drug Administration (FDA).

However, the American market remains complicated due to recent changes in pet food regulatory guidelines following the termination of the Memorandum of Understanding (MoU) between the Association of American Feed Control Officials (AAFCO) and the FDA. “We are waiting for clarity before taking further steps,” concludes Ellilä.