Biotech company The Cultivated B enters pre-submission process for cultured meat approval in Europe

The Cultivated B (TCB), a biotech company based in Germany and North America, has started discussions with the European Food Safety Authority (EFSA) and officially entered the pre-submission process for novel food approval. Once it submits its dossier for approval of its cultured meat sausages, it will become the first company to apply for EFSA certification for a cultivated product.

The Cultivated B is looking to seek approval for sale and human consumption of its hybrid sausages, made with plant-based ingredients and cultured meat.

According to the company, the sausages, which have been developed in collaboration with TCB’s sister company The Family Butchers, are similar to the boiled kind used in hot dogs.

“This is more than just a certification process; it’s a testament to our advanced, industrial-scale cellular agriculture technology and also a reflection of our unwavering commitment to usher in a new era of food production—one where health, taste, ethics and sustainability converge seamlessly,” said The Cultivated B CEO Dr. Hamid Noori. “The European cultivated meat sector has vast potential and considerable opportunity for growth. As this market gains prominence, our objective is to ensure consistent access to high-quality, sustainable meat for everyone. Attaining EFSA certification is a significant step in this direction.”

At the time of writing no other company has applied for EFSA approval for cultured meat. Israeli start-up Aleph Farms has applied for regulatory approval to the Swiss Federal Food Safety and Veterinary Office, to sell its cultivated meat product Aleph Cuts in Switzerland, and has also submitted a dossier to the Food Standard Agency to seek approval to sell its cultured beef steaks in the UK.

So far, only Singapore and more recently the United States have approved the sale and human consumption of cultured meat. In the US, Upside Foods and GOOD Meat are the only two cultivated meat start-ups to receive the green light from the FDA.

Member states of the EU have largely different stances on cultivated meat. Recently the Italian Senate passed a bill to ban the production, sale, and marketing of cell-based products, whilst the Netherlands has approved the pre-marketing tastings of cultured meat and fish.

In a recent interview with Food Matters Live, The Good Food Institute co-founder and President Bruce Friedrich commented: “It’s striking that Europe’s first cultivated meat applications haven’t landed in Brussels. With Italy trying to ban cultivated meat while countries like the Netherlands invest, Europe is sending mixed messages to companies who need certainty to deliver on their potential. The EU must develop a coherent strategy to support the sustainable protein sector and ensure regulatory processes are clear.”