German company aims for the first EU approval for cell-cultured meat

The Cultivated B (Heidelberg, Germany) is the first company in the world to pre-register a partially cell-based meat product with the European Food Safety Authority (EFSA) for approval as a novel food. The Cultivated B is only the manufacturer of plant protein and pork from cell culture. It was developed by The Plantly Butchers. Both companies are subsidiaries of the food manufacturer InFamily Foods, which since 2022 is responding to falling demand for meat and sausage products produced by its subsidiary The Family Butchers by adding culture-based protein products to its portfolio.

Since globally applicable guidelines for assessing food safety are currently being developed by the FAO and the manufacturers of alternative protein products, industry experts expect approval of the hybrid hot dog product produced by The Cultivated B in specially developed bioreactors in 18 months at the earliest. Previous approval times for novel food products in the EU “are between 18 and, at worst, 48 months,” says industry expert Tanja Bogumil, whose Berlin-based Lovely Day Foods GmbH produces vegan eggs.

According to industry association The Food Institute, EFSA’s testing of novel foods provides a thorough, evidence-based assessment of food safety and nutritional value. In Singapore and the USA, where two cell cultured chicken meat products were recently approved, the approval time is “well under 12 months,” according to Bogumil, which is why most alternative protein manufacturers are aiming for initial approval there.

In order to give European producers of cell culture and microbial protein products an incentive to set up shop, the government of the Netherlands passed a regulation in the summer that allows tastings of fermenter-produced meat and seafood before EFSA approval. In contrast to the EFSA approval, it only takes two weeks until approval for the tasting, which is important for manufacturers, is available. This means they receive an indication of whether their product will be successful before it starts marketing. One reason for the liberal regulation in the Netherlands is certainly that the development of cell-cultured meat began there. The cell-based burger developed by MosaMeat founder Mark Post at University Maasricht was offered for tasting in London back in 2013 – in a very small group and under restrictive conditions.

Bogumil describes both the Dutch tasting regulation and the EFSA registration of the hybrid hot dog by The Cultivated B as “a remarkable milestone for the entire European novel food sector.” In collaboration with cultured meat producers and industry representatives, the government of the Netherlands has presented a code of conduct that allows tastings in controlled environments. “This can serve as a model for Germany so that it doesn’t run the risk of falling behind,” said Bogumil. Neither Mark Post’s cell-cultured burger nor The Cultivated B’s hot dog are vegan products – fetal bovine serum is used in their production. The production of the animal-free alternative saves more than 70% CO₂ and 65% water as well as a lot of agricultural land. According to Bogumil, as meat production reaches planetary limits, “a complete decoupling of meat production from agriculture” is necessary.