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.”