The precision fermentation landscape is somewhat lopsided. While the US and Europe both have a growing number of start-ups working to replace conventional animal products with microbial-based alternatives, the former is “ahead” of Europe in terms of implementation. in the market for these products.
To date, the U.S. Food and Drug Administration (FDA) has sent out four “no questions asked” letters generally regarded as safe (GRAS) for fermentation-derived products, explained alternative protein regulatory expert Hannah Lester. , during the recent Future Food Series: Precision Fermentation webinar, co-hosted by ProVeg Incubator and Zintinus.
Lester is a regulatory manager and principal consultant at Amgen Regulatory Consulting, where approximately 50% of his clients work in precision fermentation. She is also responsible for regulatory affairs at French cultured foie gras start-up Gourmey.
“[The US] is truly ahead and are by far the leaders in terms of regulations for precision fermentation”, she told delegates.
why is this the case? And how long should entrepreneurs expect to wait for EU approval?
How Impossible Stumbled Into “GMO Territory”
To offer an example of different approaches to novel food regulation on both sides of the Atlantic, Lester drew delegates’ attention to the heme ingredient derived from Impossible Foods precision fermentation.
To develop the ingredient — which Impossible says is responsible for making conventional meat look and taste… well, meat — the company took DNA from soybean plants and inserted it into a genetically engineered yeast. modified. This yeast is then fermented to produce animal-free heme.
The Impossible Burger first launched in 2016, having been approved through the US GRAS route. In Europe, on the other hand, the company had to submit a genetically modified organism (GMO) dossier to the European Commission because its soy leghemoglobin contains host proteins in the final product.
This means, explained the regulatory expert, that the product is not “absolutely pure”. Due to the presence of these host proteins, it is classified as a GMO in the EU.
In Europe, therefore, the ingredient in Impossible is classified as a Class 3 GMO, rather than a Class 2 GMO. “It’s that distinction that takes you from a novel food to a GMO,” she continued.
Impossible submitted its European dossier in 2019. It took about 18 months for the dossier to be validated, then it was “immediately stopped”, or put on hold. The European Food Safety Authority (EFSA) has sent back the impossible to ask for more information. The case is still on hold.
That puts Impossible in an “awkward” position on this side of the pond, Lester suggested. EFSA has suggested the dossier will be put on hold by the end of 2022, but there are no guarantees. Further “clock stops” may be issued and EFSA’s deadline to complete its risk assessment pushed back.
For the principal consultant of Amgen Regulatory Consulting, there is no doubt that the product of Impossible is safe and that the industry is able to prove the safety of products derived from precision fermentation. But, she warned, if they do fall into GMO territory, then in Europe it becomes “highly political” and entrepreneurs will have “even more trouble” getting regulatory approval.
How “political” are GMOs in Europe?
At this point, the problem becomes much more important than a positive or negative risk assessment.
If EFSA’s assessment is positive, EU member states vote to approve or reject the product. Of the 27 countries currently in the EU, approval is based on a 55% majority vote. But these 55% of Member States must represent 65% of the population of the EU.
“So if France and Germany say no, it will really ruin your approval,” Lester explained.
Europeans are largely much more concerned about genetically modified foods than American populations. Several Member States, including France, Germany, Austria, Greece, Hungary, the Netherlands, Latvia, Lithuania, Luxembourg, Bulgaria, Poland, Denmark, Malta, Slovenia, Italy and Croatia have banned the cultivation of GMOs.
The regulatory expert says the EU’s GMO guidelines, which were published in 2011, are “well overdue” for a “massive update”. Ambiguous “grey areas” exist in the guidelines, making them “really tricky” for business, she continued.
“I think they need to update the guidelines and issue much clearer guidelines and focus specifically on complex products that are produced by precision fermentation where there may be host proteins present in the final product, but there is no recombinant DNA in the final product. .”
Overall, there is “enormous” work to be done, she stressed, to educate the European Commission and reach out to Member State authorities, as well as to update policy makers’ knowledge of this supposedly new area.
What’s in a name?
If approved, how will food products from precision fermentation be marketed? How will these new food ingredients appear on the packaging?
In some respects, the industry decides. “It is up to the applicant to propose labeling in their novel food application”, Lester explained.
As always, with labeling it is paramount that whatever it is called does not mislead consumers. Lester suggested that “beta-lactoglobulin of non-animal origin” for precision whey protein derived from fermentation, for example, might do the trick.
“Beta-lactoglobulin of microbial origin” could also work, she added. “It’s very clear what the product is, and that it’s not derived from an animal.”
The regulatory expert doesn’t expect applicants to be the only ones who want a say in what products derived from precision fermentation are called, however. Conventional producers, she told delegates, may well get involved.
“There is going to be opposition to what we call these products,” she pointed out. “There may be a battle ahead with traditional agricultural players and more conservative Member States who have their own agenda and want us to call these precision-fermented proteins [something else].”