America is full speed ahead in the regulation of precision-fermentation-derived food, but Europe has yet to approve its first company. Why the difference?
Alternative protein regulatory expert Hannah Lester (from Amgen Regulatory Consulting) says the precision fermentation landscape is hugely unbalanced between the two regions. The U.S. Food and Drug Administration (FDA) has approved various fermentation-derived products through the “generally regarded as safe” (GRAS) distinction.
The European Food Safety Authority (EFSA), though, says proteins made using precision fermentation aren’t pure. The EU labels them as genetically modified organisms (GMOs).Alt protein companies disagree with this description.
For example, one of the largest precision-fermented products, Impossible Burger, was required to submit a GMO dossier to the EFSA. Lester says labeling these products as GMO has become “highly political” and is full of gray areas.. She adds that both areas will face pushback on how precision fermentation products are named.
“There is going to be opposition about what we call these products,” Lester says. “There may be a battle ahead with the traditional farming stakeholders and more conservative member states who have their own agenda and want us to call these proteins derived by precision fermentation [something else].”
Read more (Food Navigator)