Talking precision fermentation regulation with Hannah Lester

Precision fermentation is a hot topic in food tech right now. However, in order for us to see fermentation-derived products (such as animal-free cheese) on supermarket shelves, they’re first going to have to secure regulatory approval. Dr Hannah Lester, Head of Regulatory Affairs at Gourmey and the CEO of Amgen Regulatory Consulting, recently joined the ProVeg Incubator as a mentor. We sat down with her to talk about the ins and outs of novel foods in Europe.

What do we want? Animal-free cheese! When do we want it? Just as soon as it’s approved!

Sustainable protein companies such as Formo and Remilk are using precision fermentation in innovative ways to develop animal-free versions of well-loved foods such as cheese. On the other side of the coin, consumers are chomping at the bit to try these products, with one survey showing that over 70% of people are already keen to buy this kind of animal-free cheese, even though it hasn’t hit the market yet.

Some countries, such as Singapore, are racing ahead with building the regulatory frameworks for novel foods, including fermentation-derived cheese. Last year, Singapore also famously became the first country in the world to approve the sale of cultured meat.

In Europe, the process is still a bit further behind. The regulatory challenges in the EU involve understanding how the European Commission and other authorities view cultured products and what data they want to see to demonstrate safety.

Navigating novel food regulations

During our Future Food Series: Precision Fermentation webinar , we spoke with Dr Hannah Lester about the regulation of alt-proteins products. Hannah is the Head of Regulatory Affairs at Gourmey and the CEO of Amgen Regulatory Consulting. Her job involves advising companies (mainly startups) on how to get their product through regulatory approval, which she does by helping them to build the safety data needed to convince regulatory authorities that their product is safe to enter the food chain.

precision fermentation regulation will be crucial for startups such as Formo
Cheese produced by precision fermentation from ProVeg Incubator alumnus Formo

This kind of role is particularly important as it can be very tricky navigating the regulations and understanding exactly what the regulators are looking for. Hannah recently signed up as a mentor with the ProVeg Incubator. We spoke with her about regulation  of alt-proteins and the future of novel foods in Europe.

What led you to work in alt-protein food regulation?

My background is in veterinary parasitology and epidemiology, and I did a master’s degree in veterinary public health. This opened my eyes to how meat is produced and how food (specifically animal-derived products) is regulated. As part of the MSc programme, I visited a lot of abattoirs and was truly horrified by the way they animals transport, handle, and ‘process’ animals.

In 2016, I started working for Pen & Tec Consulting, a food-and-feed regulatory consulting company, where I initially worked on animal-feed registrations. Then came the updated EU novel-food regulation in 2018. I saw this as an opportunity to start working in this area.

Then, in 2019, while attending the KindEarth.Tech conference in Amsterdam, I discovered the nascent world of alternative proteins and met so many incredible companies working on alternatives to conventionally-farmed meat. That was a lightbulb moment for me and, from that point on, I became obsessed! In 2022, I decided to set up my own consulting company focusing solely on alternative proteins. That’s how Amgen Regulatory Consulting was born.

What are the main highlights of working as a regulatory advisor?

For me, it’s working with so many amazing people that have such incredible vision and want to make a difference. I also really love helping companies navigate the complex world of regulations and finding solutions for them in order to get their products to market sooner .

Precision fermentation regulation will be crucial to the future of alt dairy
It is hoped that precision-fermentation-derived products can replicate the stretchiness and flavour of animal-based versions

What are the biggest challenges for startups when it comes to cell-ag and precision fermentation regulation?

Trying to guess how the European Commission and the European Food Safety Authority view cell-cultured meat products. We also need to understand what data they want to see in order to demonstrate safety (e.g. 90-day subchronic toxicity study in rats).

Another major challenge and one that is unknown is how the EC will view products derived from modified cell lines. It’s unclear whether the final products will be classified as genetically modified and thus fall under the GMO regulation. If cell-cultured products fall under the novel-food regulation then we are looking at 1.53 years to approval. However, if these products need to be authorised as GMOs, then we are looking at 3+ years to approval.

What needs to happen for precision-fermentation companies to be able to take products to market in Europe?

Precision fermentation products are not new in the EU. We have many examples of products such as food enzymes that have already been approved. There are also some recently approved novel foods that utilise precision fermentation (e.g. human milk oligosaccharides derived from modified strains of E. coli).

Founding team of precision fermentation startup Formo
Founding team of precision fermentation startup Formo

The big issue with precision fermentation in the EU is being able to demonstrate an absence of host-strain DNA in the final product (<10ng/ml). A good example is Impossible Foods leghemoglobin, which received a no-questions letter from the US FDA, confirming its status as Generally Recognized as Safe (GRAS). However, in the EU, Impossible Foods had to submit a GMO dossier. This was because of the presence of host strain DNA in the final product. The GMO dossier that Impossible submitted in 2019 is still under EFSA evaluation!

What is your top piece of advice for a startup working on precision-fermentation tech right now?

You need to focus on the safety of your production strain. Ideally go for a strain that has QPS status (Qualified Presumption of Safety). This can mean that certain safety tests can be waived. Also, you really need to think about the purity of the protein. You need to ensure that there is no host DNA in the final product.

What are your predictions for the near future of the alt-protein industry?

It will continue to grow, and new companies will find solutions to produce all kinds of animal proteins and fats.  My biggest prediction is that we will see the first cell-cultured products approved in the US this year. This will give a strong signal to other countries that these products are safe and an even stronger signal to investors that may have been unsure about investing up until now.

If you want to learn more about precision fermentation regulation and the future of animal-free dairy, be sure to check out the recording of our webinar on this topic.

You might also like: