The European Food Safety Authority (EFSA) has deemed Impossible Foods‘ precision fermentation-derived heme — soy leghemoglobin — safe for consumption. Soy leghemoglobin is responsible for the famous “bleeding” meat-like color and flavor of the Impossible Burger and other beef products of the US plant-based meat company.
The additive, intended to be used as a coloring agent in meat analogs, is proposed to be included at a maximum level of 0.8%. The EFSA did not find it necessary to set an acceptable daily intake for soy leghemoglobin, as reported by Bloomberg.
Since its initiation in 2019, the approval process has involved an ongoing safety assessment, which is yet to be completed. The company’s next challenge before achieving market approval is undergoing a safety evaluation by the EFSA’s Panel on Genetically Modified Organisms.
Heme © Impossible Foods
The power of heme
Heme is an iron-containing molecule found in plants and animal muscles (myoglobin) that is said to deliver the red color and flavor of animal meat to plant-based analogs. Impossible Foods uses precision fermentation and a genetically modified yeast, Komagataella phaffii, to produce the molecule in significant volumes in fermentation tanks.
Despite regulatory successes elsewhere, including in the US, Canada, Australia, New Zealand, and Singapore, stringent EU regulations have delayed the entry of this food additive since precision fermentation ingredients are considered novel foods subject to food safety assessments and regulations. Similarly, in the UK, these novel foods need pre-market approval, and current Impossible Foods products do not contain the company’s fermented heme.
The US food tech startup Motif FoodWorks, the South Korean food ingredients company HN Novatech, and the Belgian startup Paleo are also focused on producing animal-free heme for the plant-based meat market.
© Impossible Foods
The world’s largest market
With this milestone, Impossible Foods has passed the first stage of the EU regulatory process for selling its plant-based beef products in the common market.
The EU is considered the world’s largest alternative protein market. According to WirtschaftsWoche, EU alternative protein companies — plant-based, fermentation-derived, and cultivated —attracted €289 million in investments in the first half of 2024.
In this scenario, plant-based food companies raised €79 million in the first months of 2024, with the most notable investments being in Spain’s Heura and the UK’s THIS, both focused on plant-based meat.
So far this year, Europe has seen a boom in fermentation-derived ingredients, such as Onego Bio‘s egg proteins, Melt&Marble, and NoPalm Ingredients‘ alternatives to traditional fats and oils, and Fooditive’s dairy protein casein. Notably, the French startup Gourmey introduced the first cultivated meat submission for EFSA approval last week, seeking to launch a cultivated foie gras product on the continent.
“Although heme has been consumed every day for hundreds of thousands of years, Impossible Foods discovered that it’s what makes some meat taste so meaty. We make heme using a yeast genetically engineered with the gene for soy leghemoglobin, which is derived from soy plants,” Impossible Foods states on its website.
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