Summary of cultivated meat regulation
- Regulatory barriers create uncertainty and deter investment in cultivated meat
- Stringent UK and EU frameworks slow approvals but strengthen consumer trust
- UK regulatory sandbox accelerates learning and boosts confidence in cultivated meat
- EU restrictions and limited pre submission guidance hinder novel food progress
- Regulatory streamlining expected as Europe seeks competitiveness and clearer approval pathways
Things are not easy for the alternative protein sector, and this is especially true for cultivated meat. Despite significant progress, a number of problems still loom large.
One of the most significant of these is regulation. Regulatory barriers can restrict what start-ups can do, can put off investors, and can cast a pall of uncertainty over the sector.
In the UK and EU, this is particularly true. There, standards are more stringent than in other geographies, such as the US, Australia, and Singapore.
How is regulation influencing the sector? What could change in the near future?
What regulatory challenges face cultivated meat?
Regulation is one of the greatest challenges facing alternative proteins in general, and cultivated meat in particular. It is a burgeoning industry: frameworks are still being drawn up, and regulators are still attempting to understand how these next-gen products work.
One of the main regulatory challenges faced by cultivated meat is the unpredictable and often slow nature of product approval timelines, explains Hannah Lester, founder and CEO of Atova Regulatory Consulting.
These long timelines can create scepticism from investors, making it harder for cultivated meat start-ups to survive until they get approval.
“It’s very difficult for a regulator to commit to a timeline”, explains Lester. Approval time, or even whether a product is approved, depends on the quality of the dossier submitted, meaning that a timeline is nearly impossible to predict.
Why investment is hard to come by
Meanwhile, uncertainty in approval timelines creates greater risk for investors, explains Vicky Grinnell, food tech and futures lead for Lloyds Corporate and International.
“Where approval pathways are clearly defined, capital can price risk more efficiently. Where they are ambiguous or protracted, the investor base narrows to higher-risk equity.
“Over time, regulatory clarity influences not just investment returns, but where industrial capacity is physically built.”
Indeed, lack of funding has led a range of cultivated meat start-ups, including Meatable and SciFi Foods, to go under.
While regulation in places such as the UK and EU are more stringent than in many other geographies, and have a higher burden of proof, the payoff may be significant.
Consumers are more likely to trust a product that has come from a more stringent regulatory framework, suggests John-Felipe Murphy, regulation and scale-up manager at the Bezos Centre for Sustainable Protein.
Consumer trust in the food system is increasingly in decline, with many people demanding transparency.
Regulatory sandboxes: UK and EU
One of the primary tools which aim to boost novel food approval are regulatory sandboxes. These offer start-ups the space to test their products without regulatory barriers.
The UK Food Standards Agency (FSA) has set up a regulatory sandbox for cultivated meat. The cultivated meat sandbox aims to understand the processes and the risks of cultivated meat.
Its sandbox been building confidence in the sector, and allowed the regulator to learn a lot from industry. Before this, regulators were more isolated from this innovation, as it happened inside companies rather than in academia.
These types of innovative programmes have led to more interest and even more investment in alternative proteins in the UK, says Bezos Centre’s Murphy.
The UK is expected to have its first cultivated meat approval shortly after the end of the regulatory sandbox. This could be as early as next year, Atova’s Lester suggests.
Europe is more cautious. Some member states see alternative protein technologies in a negative light, says Bezos Centre’s Murphy.
In its recent Biotech Act, the EU ruled out the use of regulatory sandboxes for novel foods. This has been “a blow to the industry”, says Lester. She hopes that future iterations of the Biotech Act may change this.
What’s the future for novel foods in Europe?
The current regulatory landscape in Europe will stay stagnant. The European Commission is motivated to help streamline regulation due to the pressure of competition, says Lorena Savani, director of biotech and protein thematic leadership at the organisation EIT Food.
The Commission is well aware that regulation needs to be streamlined, she says. Otherwise, innovation may go outside Europe.
Shortly after being appointed executive director of the European Food Standards Authority (EFSA), Dr Nikolaus Kriz explained that one of the key barriers holding back novel food approvals is the lack of pre-submission talks.
Greater contact between applicants and EFSA would help the latter be better prepared, and give the former greater knowledge and insight into the application process, he explained.
Currently, the pre-submission advice that EFSA can give is limited in scope, explains Atova’s Lester. At the moment, it can only give advice on the regulatory framework and guidance; it cannot give specific advice on study design, or point out issues with one’s regulatory strategy.
However, this will likely change soon, she predicts, as both EFSA and the European Commission recognise that pre-submission advice could help improve the quality and completeness of applications.
Widening the scope of the pre-submission advice that EFSA can give would be “a massive step forward”, she suggests. Engaging closely with the regulator helps applicants to build a better quality dossier.
