To date, two companies have submitted novel food applications to the European Food Safety Authority (EFSA) for precision fermentation-derived dairy proteins. Here’s what we know so far.
Perfect Day the first to seek EFSA nod for animal-free dairy
The first precision fermentation-derived dairy protein player to seek novel food approval in the EU was Perfect Day. The US-based company is a pioneer in animal-free dairy, becoming the first to receive regulatory approval for its precision fermentation-derived whey protein on home soil.
Having received the US FDA greenlight back in 2020, FoodNavigator understands the company submitted a novel food application to EFSA in 2022. This application, however, has yet to be assessed.
According to EFSA, the application did not pass the completeness check. “We check that the application is valid and meets requirements for the necessary information to be included,” an EFSA spokesperson told FoodNavigator.
“If information is missing or the application fails to meet any of the requirements, we go back to the applicant who must provide the necessary information or make the necessary changes. That is what happened in this case.”
Perfect Day did not respond to a request for comment.
Precision fermentation: What is it and how does it produce dairy?
Precision fermentation enables the programming of microorganisms, such as yeast, to produce complex organic molecules, such as dairy. The idea is that by using microbial cells as the production host, virtually any ingredient can be made, at scale.
The technology is currently used to produce a range of different molecules, including sugars found in breastmilk known as human milk oligosaccharides (HMOs), insulin for diabetics, and rennet for cheese production.
No matter the end goal, the process is largely the same: a specific molecular sequence is inserted into the microorganism to give instructions to produce the desired molecule when fermented. These molecular sequences are derived from a digitised database rather than taken directly from the relevant animals or plants.
At the end of the fermentation process, the resulting compounds are filtered out, separating them from the microorganism that produced them.
Remilk follows suit with whey protein submission
The following year, in 2023, Israeli animal-based dairy company Remilk also filed for novel food approval in the EU. The submission concerned Beta-lactoglobulin, the major whey protein of cow and sheep’s milk, and the yeast in question, Komagataella phaffi.
Remilk has since received a ‘non suitability’ letter from EFSA, explaining deficiencies in the application. “In short, one of the requirements is for applicants to notify studies,” explained the EFSA spokesperson.
“If they fail to do so, [or] it comes with a delay without a proper justification, a dossier can be declared not suitable/not valid.”
From Remik’s perspective, this is just part of the process. “Feedback and response between submitters and the regulatory authority receiving the submissions is part of the process in our experience,” CEO Aviv Wolff told this publication. “We’ve resubmitted to EFSA and look forward to working with them.”
Remilk has received regulatory approval in Israel, Singapore, and the US.
Why have so few animal-free dairy companies submitted to EFSA?
Perfect Day and Remilk are not the only two companies to have submitted novel food applications for precision fermentation ingredients for the dairy category. Human milk oligosaccharides (HMOs) – which are sugars naturally found in breastmilk – have successfully gone through EU novel food approval in this way, as has rennet for cheese production.
But FoodNavigator understands these companies are the only two to have submitted applications for precision fermentation-derived dairy proteins. With a host of start-ups working in this space, should EFSA be preparing for many more?
Actually, start-ups – including those based in the EU – are tempted to submit first in Singapore and/or the US, as regulatory agencies in those countries are known for their quicker and ‘easier’ procedures, according to Katia Merten-Lentz, founder and partner of Food Law Science and Partners.
A good example is Singapore-based TurtleTree, which has obtained Self-GRAS for animal-free lactoferrin in the US, and has its eyes set on both US and Singapore markets for commercialisation.
“It’s a fact that other safety authorities in the world are more transparent and open to discussions with food business operators,” Merten-Lentz told FoodNavigator. “On top of this general remark and on a more scientific standpoint, EFSA requires five samples, whereas elsewhere three are enough. It makes a huge difference in terms of quantity to produce for a start-up before it’s at scaling stage, and thus from a financial point of view.”
The food law expert stressed this is not specific to precision fermentation dossiers, but rather the case for all novel food submissions.
But the overall obstacle in the precision fermentation regulatory race could be the subsequent GMO status of the resulting products, explained Merten-Lentz, if they are not sufficiently deprived form the recombinant DNA following the genetic engineering of their microbial strains.
Once submitted, how long does an EFSA novel food approval process take?
Another reason companies may be hesitant to submit for novel food approval in the EU comes down to the approval process itself. In countries such as Singapore and Israel, the decision to approve the commercialisation of a novel food is decided by and for one country only.
The EU, on the other hand, is made up of 27 Member States and they all have a say.
The new novel food regulation, which came into force January 2018, is thought to ‘considerably’ improve the timeline of a submission – which is now clearly indicated as lasting around 18 months, explained Merten-Lentz. Prior to 2018, no timeline was listed and a submission ‘could last years’, she added.
Around 240 novel food applications have been submitted to EFSA since the implementation of the new novel food regulation in 2018.
Now EFSA will provide its final opinion within nine months. But if the dossier is not complete or fails to provide strong enough evidence to back it up, EFSA can ‘stop the clock’ and delay the procedure.
The ‘stock the clock’ procedure enables EFSA to put the assessment on hold for a given time, which depends on the type of information missing. If once that information is submitted EFSA still considers the submission incomplete, the ‘clock’ can remain on hold.
“An EU novel food submission is not a ‘walk in the park’, but is totally feasible and can be successful once companies understand all requirements,” explained Merten-Lentz.
“The key to making it the shortest time possible is to strongly build the submission dossier, which must be considered as additional time for companies.”