With so many new and exciting plant-based foods being created by food tech scientists and entrepreneurs, complying with novel food regulations is essential to getting products to market. For non-lawyers, this can be a daunting task, and specialist help is usually needed to get through the process.   

We spoke to food law consultant and founder of Vegan Food Law, Mathilde Do Chi, who advises plant-based businesses to navigate the regulations. She has worked extensively on the legal challenges of alternative proteins, as the VP of Regulatory Affairs (Vegan World Alliance and Vegan Society of Canada) and as an advisor to various companies and NGOs.   

Do Chi explained that novel food is a special category which requires special consideration: “It is food where there is no history of consumption in the country where it is to be sold. In the E.U., it includes anything that was not eaten before 1997. Similar rules exist in the UK, Australia, New Zealand, Canada and the US. To sell novel foods, companies must get regulatory approval. This applies to plant-based businesses creating new proteins or fats, cell-based meat, and precision fermentation-derived ingredients.”    

Some plant-based foods are considered novel even if there is a history of safe consumption of the original plant, but it is being used in a new way. For example, if leaves are commonly used, but a company wants to process the seeds into protein isolates. Food that is common in one country might be novel in another. So where innovators squeeze protein from grass or algae, that is a novel food and must go through the regulation process.   

This means entrepreneurs need to be aware of how their product is viewed in the territory in which they want to sell it. Mathilde Do Chi says, “They need to check the current regulations. Most countries will have a public list of products that are considered novel. If they cannot find an answer, they can contact national authorities. Just because something is authorized in one country doesn’t mean that it’s authorized in another. Even if there is a history of consumption, it will be considered novel if you want to change an ingredient. Decisions are made very much on a case-by-case basis. It can take between 18 months and three years to get through the process, depending on the quality of the application. If the authorities believe the company has not provided enough information, they will allow another six months and continue the analysis.”   

Mathilde Do Chi applies her knowledge to working with plant-based companies to help them work through the regulatory framework: “First, I check that the processes and ingredients are not novel. If I’m sure they are not, I help companies draft answers to the queries from the authorities. If they are novel, I help them write a dossier to get the product authorized. I also help identify which market will be the easiest to enter. If they want to start selling as fast as possible, I advise them on what ingredients to use from a regulatory point of view. I make sure companies have all the necessary information. And that they gather that first. Because if you apply with an incomplete dossier, the application might not even be accepted.”   

Businesses might assume that the UK is the best place to launch a new plant-based product. After all, the UK is the home of Veganuary and U.K consumers are accepting of non-traditional foods. However, the picture is different regarding novel food regulation: “At the end of the day, it’s a risk assessment, made regardless of the potential consumer acceptance. In fact, one of the best places to seek authorisation is Singapore. You can get approval in Singapore in around one year if the product is passed as safe. Singapore has more resources in place to approve products so you can get questions answered quicker than in the UK or EU.”  

Mathilde Do Chi has some tips for companies creating new foods and some general advice on naming new products: “Don’t assume the regulations will straddle different countries because they have different legal systems. It’s a matter of talking to authorities and researching to see if the product has already been sold in the same form. If it hasn’t, and the ingredient you want to use is a novel food, look at using other crops to see if you can get the same results without spending time and money getting approval. Ensure you are aware of labelling issues, where regulations differ in different territories. Be careful about using traditional names, which are often for specific products whose recipes are set in stone. The only thing you will achieve if you disregard this rule is to get sued. It’s why you have very generic terms for plant-based alternatives. For example, plant-based yoghurt is called plant-based dessert because yoghurt is a protected name in some countries. And my final piece of advice is to remember that the words you use in marketing campaigns are often regulated, so check whether you need to comply with certain conditions to use those words.”  

From fantasy to factory within the last couple of years, innovation in cell-based meat has rapidly improved. Mainstream media is awash with headlines proclaiming the arrival of cultivated steak, meatballs, and nuggets. Amongst plant-based businesses, debates have begun in earnest about the labelling of cell-based products and how they fit alongside their plant-based counterparts. 

Although not plant-based, the companies operating in this new category share some of the goals and ambitions of plant-based foods and will likely appeal to similar consumers. A 2018 Harvard study found that Attitudes towards the environment appear to be one of the most important determinants of consumers’ consumption behaviour and new food acceptance and that consumers with environmental concerns were more willing to purchase meat alternatives, such as plant-based and cultured meat. A 2022 study by the UK Food Standards Agency found that a third of UK consumers were willing to try cultivated meat, with sustainability cited as the main reason. Of those who said they would not, over a quarter said they could be persuaded if they knew it was safe.  

For consumers concerned about animal welfare, environment and health, cultured meat performs better than animal meat on all fronts. An animal is only used at the very start of the process. Far less land and resources are needed than in traditional animal agriculture and the product will undoubtedly be free of the hormones and antibiotics that intensive animal farming requires.  

So while not plant-based, cultured meat is of immense interest to the plant-based business community, and following its progress is crucial for understanding the opportunities and threats it poses. These will likely become more pressing as products go through the various stages of development, scaling, and approval, which will eventually bring them to market.  

To discuss the issues around cultivated meat the Good Food Institute (GFI) held a webinar in February 2023 to review the status of the cultivated meat industry and examine recent advances in the US.  

The discussion was timely because cultivated meat is reaching some critical milestones. Companies are moving from the lab to the bioreactor stage, attracting serious investment, and gaining approval from national authorities. Cultivated meat took a major step forward in November 2022 when US company Upside Foods got approval from the US Food and Drug Administration (USFDA)that its cultivated chicken breast is safe for human consumption. Upside still needs the go-ahead from US Department of Food Safety and Inspection Service, but the company says it is hoping to bring products to restaurants by 2023 and to supermarkets by 2028. Other companies are seeking FDA approval. California-based Good Meat has an application pending. And Two others, Netherlands-based Mosa Meat and Israel-based Believer Meats are in discussions with the agency. This follows Good Meat getting the go-ahead for the commercial sale of two of its cultivated chicken products in Singapore.  

There are reported to be around 90 companies working in the cultivated meat space and some are investing heavily in manufacturing. In Wilson, North Carolina, the world’s largest cultivated meat factory is being built by Israeli start-up Believer Meats. It will be capable of producing 10,000 tonnes of meat a year. UK Ivy Farms is planning a factory capable of producing at least 12,000 tonnes of cultivated meat. It already runs an R&D facility that can produce three tonnes per year. And in Australia Vow has unveiled a factory capable of producing 30 tonnes per year, ahead of regulatory approval.  

Investment into the sector has also grown significantly. In November 2022 Research and Markets reported that $1 billion was invested during the past 12 months. In 2020 more than $360 million was invested, six times more than in 2019. Investors include big meat companies like Tyson Foods, JBS and Cargills.  Investment has also come from wealthy individuals such as Bill Gates and Richard Branson. 

Emma Ignaszewski is the Associate Director of Industry Intelligence and Initiatives at GFI. At the recent GFI webinar on cultivated meat, she explained: “All of the largest six meat companies are involved in cultivated meat – either through acquiring companies, investing in companies, or starting their own range. JBS the largest meat company in the world has acquired a cultivated meat company and has announced the establishment of an R&D centre, saying it intends to bring cultivated meat to market by 2024.”  

 Much has been made of the “yuck factor” as a barrier to consumer acceptance. Despite the argument that a bioreactor process is less messy than conventional meat production, there is a worry that consumers will be squeamish about this except this unconventionally produced food. However, research commissioned by the GFI in December 2022 suggests these fears may be unfounded. The survey of over 1000 adults found that after the technology was explained, support for cultivated meat increased. This suggests consumer education will be very important for uptake. The aspect of cultivated meat that most appealed to consumers was the health advantage – the lack of hormones, steroids, antibiotics, and lower risk of foodborne illnesses and zoonotic diseases. 45% said they would try cultivated meat and 20% said they would buy it, which is a very promising result for something they have not seen or tasted.  

 Emma Ignaszewski told the webinar that one exciting aspect is the potential for hybrid products. One of the main barriers to consumers eating more plant-based food today is the sensory gap – that meat substitutes don’t match the tastes and textures that they are used to. Mixing cultivated meat with other plant proteins is a chance to improve the experience for consumers. “While we are in the early stage there is a chance to experiment. For example, a company could mix cultivated protein with plant-based fat. There will be products with the taste and texture of meat but the health benefits of plant-based products. Some companies have already announced products in that vein.”  

One barrier to getting accepted by vegan, vegetarian and ethical consumers, has been the use of Foetal Bovine Serum (FBS). This used to be considered necessary for turning stem cells into muscle. However, in January 2022 Mosa Meat announced that it had replaced FBS with a non-animal substitute.  

Faraz Harsini MSc PhD is a bioprocessing senior scientist at the GFI, and an expert on scaling up the cultivated meat industry. He is also the CEO of the non-profit Allied Scholars for Animal Protection. In the GFI webinar, he explained: “The supply for FBS is very limited globally and using FBS is a huge problem. It is in everyone’s interest to come up with an alternative. We don’t have a lot of information about what cultivated meat companies are using but we know that most now use substitutes.”  

In answer to the ethical question of whether cultivated meat is vegan, Faraz Harsini told Pulse that its development will undoubtedly lead to less suffering for billions of non-human animals: “Veganism is reducing the harm caused to animals. If cultivated meat reduces the demand for billions of pounds of animal flesh, then it is surely beneficial to the animals who weren’t forced to be born and later killed for their flesh. 

Cultivated meat research and technology also have a magnificent potential for replacing other animal products commonly used in pharmaceutical companies and biomedical research. This includes replacing FBS or advancing the tissue engineering field to replace animal testing.   

Is it vegan in the sense that no one was harmed in its making? The original sample still comes from an animal. But it is possible to take it from the tip of a feather or a small biopsy or blood sample. Once a cell line is established, there will be no need to go back to the animal. All further cultivated meat production will start from cells grown in culture and frozen in cell banks. The harm and inconvenience for the animals involved is far less than for animals harmed or displaced in agricultural practices. 

If the criteria is “absolutely no harm caused to anyone or anything”, then no one is really vegan, because we’re always causing harm knowingly or not to some level. But if the criteria is minimizing harm to non-human animals as much as possible and practical, then on that metric, cultivated meat would spare the lives of billions of non-human animals and will facilitate our transition from here to a world where animals are no longer raised, harmed, and killed for food!” 

Faraz Harsini is optimistic about the ability of the sector to reach the market in the next few years at a price that consumers will accept: “While there are degrees of uncertainty, we expect that by the end of this decade, cultivated meat can reach price parity, at least with luxury products. To enable scaling up and making cultivated meat as cheap as possible it will be crucial to develop better bioreactors. There is a huge opportunity for start-ups to build bioreactors specifically for cultivated meat.”  

Nine precision fermentation companies have united to form the Precision Fermentation Alliance (PFA). A new trade group to champion the process as a reliable and sustainable food system. The founding companies (Change Foods, The EVERY Co, Helaina, Imagindairy, Motif FoodWorks, New Culture, Onego Bio, Perfect Day, and Remilk) say it will be an industry voice and global association for the sector. 

Irina Gerry is Chief Marketing Officer at Change Foods and is Vice Chair of the PFA. She told Plant Based World Pulse that setting up an alliance was an obvious and necessary step: “We decided we need to join forces because we’re all commercialising similar applications of this technology. We have a lot of work to do presenting it to consumers, retailers, manufacturers, and regulators. We feel this is very much needed.”   

The idea of a joined-up approach is not new. The main precision fermentation companies have been discussing the need for a common nomenclature, description, and approach to regulation for several years. Irina Gerry explains: “We knew we needed to join forces. The only question was how quickly could we organise something. We have start-ups in different parts of the world with different worldviews, but ultimately, we are one industry and category. As sector leaders, we are engaged in a revolutionary development, and we need to be upfront and lead the conversation.”  

Precision fermentation offers a brand new consumer benefit – the experience and nutrition of animal products made without animals. The PFA recognises the need to communicate overtly, explain how it works, and answer questions. They also need to communicate to consumers with allergies, such as milk or egg proteins, about the potential for allergic reactions, given that the proteins made via precision fermentation are molecularly identical to those from animals. 

The PFA is envisaged as an accelerator that can help reduce barriers to market category entry. Irina Gerry explains: “A lot of developments are happening. Many companies, whether start-ups, large companies, or ingredient manufacturers, want to commercialise this technology, but we need regulatory pathways, investment, and a common language. Failing to sort those could slow down progress to market and consumer adoption. The PFA can prepare the road and give companies a smoother path, so they don’t have to tackle everything independently.”  

The PFA has identified three key pillars with work streams for these key priority areas. The first of these is marketing and communications. Irina Gerry says: “We need the basics: What do you call it? How do we label it? We need to be clear and upfront with consumers about what it is and isn’t.  Retailers need to know where it goes in the store. Manufacturers need to know what to tell consumers. It is a massive undertaking, starting with the basics of what we call it and how we position the category to the industry and consumers.”  

The second pillar is regulatory. Irina Gerry continues: “Food is regulated, so we must follow the requirements within each market. We want to ensure that companies commercialising these ingredients follow the regulations and that the regulators understand the technology. So we need to engage with regulators in different territories and ensure that we are as cohesive as possible.”  

The third pillar is advocacy and policy – engaging with policymakers and government institutions to reinforce the technology’s environmental benefits.  Irina Gerry adds:   “When you think about the huge transformation we need in our food system, many governments see it as a major contributor to climate change. One of the ways to address the problem is to scale this technology which is much more sustainable. But we’re competing with animal agriculture, that’s very well developed. There’s almost no infrastructure for precision fermentation. It hasn’t been used at the scale that we need it to be. So there is a tremendous role for government institutions in building infrastructure and for us in promoting policies. Individual companies can only do so much. The PFA can be a unified voice to help bring this forward with policymakers.”  

The PFA is actively recruiting new members. They are finalising their membership structure with tiers for different types of organisations, including companies and NGOs. Irina Gerry concludes: “We absolutely want to collaborate with companies across the food ecosystem, including plant-based brands. Some might end up using ingredients made via precision fermentation to boost nutritional value or functionality. Impossible Burger is a perfect example of such fusion. It is a predominantly plant-based product that uses heme made via precision fermentation to give it a meaty flavour and colour. Today, I would not characterize products made with precision fermentation proteins as plant-based, given the allergen considerations and consumer understanding of what plant-based means. They’re not the same as plant-based because they contain molecularly identical animal proteins or fats. But they’re made without animals. So it’s a new category.”