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Precision fermentation: Navigating the legalities

Article-Precision fermentation: Navigating the legalities

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The introduction of alternative proteins onto the European market is being thwarted by GM issues and lengthy authorisation procedures. We caught up with two legal experts to find out more about the regulatory situation and prospects for precision fermented foods in Europe.

Precision fermentation is not a new technology. For years scientists have been using this method to produce enzymes, amino acids, and rennet that are used in food production either as processing aids or food ingredients.

However, in recent years, precision fermentation has come to the fore for its potential to generate alternative proteins, fats, and other ingredients such as flavours and colours that can be produced in a sustainable way. Products containing ingredients identical to dairy and meat – but produced with microbes – are already reaching consumers in the US and Asia.

Europe is lagging behind in this respect; although many human milk oligosaccharides produced by precision fermentation are approved as novel foods in the EU, there have been no approvals for proteins derived from precision fermentation.

The EU is known worldwide for its stringent approach to food regulation, but in the case of precision fermentation, it seems the slower pace of adoption is not solely down to the regulators.

Dearth of applications for novel food approval

Justyna Pałasińska, who is regulatory affairs director for human nutrition at Argenta Barcelona, told this publication: “I think there is a misconception because, in my opinion, it isn’t actually that difficult to get a precision fermentation ingredient authorised on the EU market. It is more that there haven’t been many applications for precision fermented proteins.”

Indeed, Hannah Lester, CEO and principal consultant at Atova Consulting, confirmed that to date, there have only been two novel food dossiers submitted to the European Commission (EC) for beta-lactoglobulin - one filed by Perfect Day which is currently in the validation phase at the European Food Safety Authority (EFSA), and one submitted by Remilk, which was considered invalid due to the failure to notify studies correctly to EFSA.

Lester said that, frustratingly, Perfect Day’s dossier is still under EFSA validation and has been since September 2022.

“This means EFSA has not even started its risk assessment yet. The reasons could be that the dossier submitted is not fully compliant with the EFSA novel food requirements, or that some pivotal data or studies are missing,” she said.  

Lengthy process

There are various explanations for this low number of applications in Europe. For one, the novel food process is lengthy.

“The timeline from submission to approval should be 1.5 years, but in reality the average timeline is 2.5 years,” said Lester.

In contrast, she said the GRAS (Generally Recognised as Safe) timeline is 10 to 12 months on average and that, to date, seven precision fermentation derived proteins have received a no questions letter from the US Food and Drug Administration (FDA) after following the GRAS pathway.

Pałasińska confirmed there is certainly some hesitancy to embark on the novel food process knowing that it is quite long, but said the bigger problem is that companies are not always ready to commit to a final scaled up version of their product.

“One of the frustrating aspects of novel foods is that applicants are expected to test the product they intend to place on the market. In many cases, companies are not ready to pick the one product they are going to commercialise first,” she said.

“And with technology in this area evolving so quickly, for many of our clients, the manufacturing process and the finished product they have today might look different tomorrow. Therefore, it doesn’t make sense to submit an application now as they may need to submit a new one in the future when the product and process have been refined.”