Regulatory roundup of 2023, and what can we expect from 2024?

Without doubt, 2023 was another exciting year for the regulatory world! We saw UPSIDE Foods and GOOD Meat receive green lights to market their cultivated chicken in the USA, and we saw Remilk and Imagindairy receive no questions letters from the US FDA for their recombinant betalactoglobulin.

In Europe, we saw encouraging signals from the EFSA, indicating it is getting ready for the first cultivated meat/seafood dossiers, and we saw a lot more from them in terms of stakeholder engagement. The first tasting framework for cultivated meat prior to EU approval was adopted in the Netherlands, which could serve as a blueprint for other Member States. Meanwhile, Aleph Farms became the first cultivated meat company to seek novel food approval in Switzerland and the UK. In addition, the UK Food Standards Agency (FSA) doubled down on its support of alternative proteins and food innovation by performing an in-depth review of its current novel food framework and updating its dossier submission platform. We also saw the FSA publish a dedicated webpage for cell-cultivated foods, stating that cultivated meat is not defined as ‘meat’ but a ‘product of animal origin’. The webpage also confirms that tastings for R&D purposes are permitted.

Vow became the first to submit a novel food dossier to Food Standards Australia and New Zealand (FSANZ), and received positive feedback from the risk assessment of its cultivated quail in December 2023. There will now be two rounds of public consultation before its product is approved for sale.

We saw the Singapore Food Agency (SFA) update its novel food guidelines, making the requirements and process for performing tastings clearer. SFA also hosted another roundtable event in October, bringing together experts to discuss what the perfect dataset and dossier would look like for novel foods from cultivated meat, precision fermentation and microbial biomass. We also saw Vital Meat submit its novel food dossier to the SFA.

The Food and Agriculture Organisation (FAO) published its highly anticipated report on the Food Safety Aspects of Cell-Based Foods, which provides a great framework for cultivated meat/seafood risk assessment, and the UK FSA also published a report on the identification of hazards in cultivated meat.

I expect to see the next tranche of cultivated meat and seafood approvals come

So, what does 2024 hold? Well, it’s set to be a regulatory rollercoaster! In the USA, I expect to see the next tranche of cultivated meat and seafood approvals come. The timelines are a little uncertain as there were some major changes to the Center for Food Safety and Applied Nutrition team in 2023, but I’m hopeful we will see things move again by Q2.

I predict we will see the first cultivated meat dossiers submitted to the EC/EFSA during the first half of the year. I also hope to see Perfect Day’s dossier pass the EFSA validation stage (it has been stuck for 13 months!), as well as some movement on the Impossible Foods soy leghaemoglobin dossier.

EFSA is set to publish its draft novel food guidance for public consultation early this year, which will hopefully include more detailed guidance for cultivated foods and precision fermentation, along with further information on accepted approaches to toxicity testing and allergenicity. We will also keep pushing for meaningful pre-submission advice and faster timelines in the EU!

We will also find out what the UK’s revised novel food framework will look like and the timelines for implementation! This could be a gamechanger and set the UK up to be a world leader in alternative/complementary proteins.

We will see the outcome of Vow’s dossier in Australia and New Zealand, and hopefully see its product available on the market ASAP!

The regulatory framework for cultivated meat and seafood in Japan should be unveiled, paving a route to market for those keen to expand into other markets. We’ll also see companies working on precision fermentation-derived products and cultivated meat/seafood seek approval in other regions such as Canada, the Middle East, India, and South America.

Finally, we saw a lot of negative news in the latter half of 2023, with certain media outlets questioning the safety of cultivated meat and EU countries pre-emptively banning ‘synthetic’ food and cultivated meat before it has even been approved. We are also seeing certain US states making moves to ban cultivated meat as well. Against this backdrop, we must go above and beyond to demonstrate that these products are safe and nutritious.

However, I am confident we will get there if we employ rigorous science-based risk assessments and follow the latest principles of food safety. So, here’s to a 2024 full of regulatory approvals!

Dr Hannah Lester is the CEO of Atova Regulatory Consulting and also Head of Regulatory Strategy at Gourmey. This article is republished from the Q1 2024 edition of Protein Production Technology International, the industry's leading resource for alternative proteins. To subscribe to all future editions, please click here