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The Future

The Regulatory Minefield of Novel Foods

Novel foods like cultivated meat, insects and microbial protein could become future staples to help shape a more sustainable food system, but getting them to market is no easy feat. Find out how regulatory processes can prevent new foods from making it to your plate - for good and bad.

In the European context, novel foods are any food not consumed “significantly” in the European Union before May 1997.1 This includes new foods, food from new sources, new substances used in food, and new ways and technologies for producing food.1 Some of the more recent examples you may have heard of include chia seeds, algae-based foods, baobab fruit and yellow mealworms - the latter declared safe to eat by the EU in 2021.1

Depending on the region, foods with a long history of human consumption elsewhere can also be considered novel. For example, people have been eating insects for millennia - just not in modern-day Europe or the USA. Similarly, invasive species like jellyfish can also be considered novel foods, even though they’ve been traditionally consumed widely outside the EU (and still are). But given their late introduction to European markets, they’ll still need approval before becoming commercially available in Europe.2

But whether it’s a new lab-made substance or a traditional food from afar, all novel foods face the same regulatory process for approval for human consumption in the EU.

How are novel foods approved?

According to the current regulations, all novel foods face a three-step process to get approval for human consumption in the EU:3

  1. Companies submit an application to the European Commission.

  2. The European Food Safety Authority (EFSA) then does a risk assessment of the substance and publishes an opinion within 9 months on whether it should be approved for human consumption.

  3. The Commission then has 7 months to decide whether to make the product commercially available.

To get approval, the food must be safe for consumers, properly labelled to prevent consumers from being misled, and, if intended to replace another food, should not be nutritionally inferior to the original food.4 In some cases, that means some novel foods - even those that are potentially more sustainable than conventional alternatives - will never make it to market.

Find out more about novel food regulations

What’s new with novel food regulation?

New regulations implemented in 2018 have liberalised the novel food approval process, leading to a wave of more than 240 new applications. Wolfgang Gelbmann, a scientific officer in the novel foods team of the European Food Safety Authority (EFSA), told FoodUnfolded, “This is more than EFSA received in the entire period from its establishment in 2002 to 2018.”

But even with new more streamlined regulations, approval is still a multistep process that takes at least 17 months, and the arduous nature of the process has led to complaints from novel food producers that the EU is falling behind other regions. It doesn’t help that two cultivated meat products were approved for human consumption in the US in June 2023, while the Netherlands is the only country to allow pre-approval tastings of such products in Europe.5

At FoodNavigator’s Protein Vision event in June 2023, the co-founder of novel food company MATR Foods, Leonie Jahn, warned that the European approval process was “highly limiting what can be done and how fast and viable the business plan is”.6

However, regulators say that detailed checks are necessary to ensure the safety of our food. Gelbmann told FoodUnfolded: “The EU has some of the strongest food safety standards in the world, and EFSA’s priority is to ensure that all novel foods that reach the tables of consumers are safe for human consumption. We won’t compromise on safety.”

With no indication of relaxing safety measures, it raises questions about how novel food applicants are expected to navigate this regulatory maze, and whether a compromise could be made to allow room for new and potentially useful foods to access markets without sacrificing safety.

Why some foods never make it to market

The most common reason novel foods do not get approval is insufficient information to ensure they are safe for human consumption. The EFSA, says Gelbmann, frequently requests additional information such as compositional analysis and toxicology tests after receiving a dossier for review and gives the applicant up to 6 months to produce the data. These tests must take place in certified laboratories - meaning the tests cannot be done by an applicant’s private lab or a university lab - and produce consistent and reliable data, says Gelbmann.

The EFSA must also be notified of all studies and tests supporting a novel food application before the experiment takes place to ensure there is no selection bias in the results and to comply with the EU’s transparency regulation. Failure to comply with this regulation, which came into force at the end of March 2021, has resulted in the termination of at least 10 novel food approval applications.7

Novel foods can also be rejected at the application stage due to high levels of toxicity or other factors that mean the substance is not suitable for human consumption. Some foods that have been rejected include yellow/orange tomato extract, whole seeds of oilseed rape and both common and swollen duckweed.8,9,10 Duckweed, however, can be fed to livestock as some products are safe for animal, but not human consumption.11

Animal feed regulations differ from those for novel foods for human consumption, and the approval process is meant to be quicker - EFSA have 6 months, instead of 9 months, to publish an opinion on the product's safety.12

How can we regulate foods that are eaten elsewhere?

Novel foods don’t just include substances most people have never heard of. Jellyfish are considered a delicacy in Vietnam, South Korea, China and Japan, but are not commonly eaten in Europe. Insects, meanwhile, are eaten in Brazil, Mexico, Ghana, Thailand and China, and are steadily becoming more common in Europe, the UK and the US. These naturally occurring foods still face the same, or similar, regulatory approvals as new foods like cultivated meat and microbial protein.

In Europe, there is a fast-track route for traditional food approval, which involves submitting a notification of intent to the European Commission with scientific evidence that the substance is safe for human consumption.13 However, Managing Director of the UK Edible Insects Association (UKIA), Dr Nick Rousseau, told FoodUnfolded that this is a notoriously difficult process.

“It’s not clear what level of scientific evidence is necessary to secure traditional food approval, and I understand most applications, at least to the FSA in the UK, are rejected,” he said. “The checks involved are disproportionate to the risk faced by consumers. A solution could be different levels of scrutiny for different substances, depending on how widely they are eaten. This would mean the full process of checks wouldn’t be necessary.”

Is the process different outside the EU?

In short, the answer is yes. Novel food approval processes are generally much quicker in Asia and North America. For example, two lab-grown meats have been approved for commercial sale in the US, but none have yet received approval from EFSA.

USA

In the US, differences are made between some novel foods and substances that can be approved as “Generally Recognised as Safe” (GRAS).14 Substances can be labelled GRAS through a self-assessment process rather than through a regulatory body like EFSA. Ingredients which are GRAS for a particular use can then be sold for that use without pre-market approval.

GRAS helps remove the regulatory burden of the FDA approval process from food manufacturers, but it can mean substances come to market without thorough toxicity testing.15

Other foods - like additives and substances expected to become a component of food such as Melatonin, Picamilon and Tianeptine - must be submitted to the Food and Drug Administration (FDA) for pre-market approval in a process similar to the one in the EU.

UK

The UK’s process is currently similar to the one in the EU, but the Food Standards Agency (FSA) has been advised to reform the system to streamline the approval of alternative proteins.16 For example, an FSA report produced by Deloitte encourages reforms to give faster approval for foods sold lawfully elsewhere or considered low-risk.16 The report says this will help the UK “keep pace with innovation” and bring to market more sustainable food choices that are increasingly of interest to consumers.

Singapore

Singapore has one of the fastest approval processes globally. This is partly because of Singapore’s ambitious 30 by 30 goal for the state to produce 30% of the population’s food needs domestically by 2030.17 The government plans to produce 30% of the state’s nutritional needs with less than one per cent of land set aside for farming, meaning Singapore will likely have to rely on novel food sources that can be produced in small spaces.17

Singapore is a city-state with only 734.3 km² of land, meaning there is very little space available for traditional agriculture.

With countries like the USA and Singapore racing ahead, some critics say the EU is falling behind in the novel foods industry. But to what extent is red tape preventing novel foods from coming to market in the EU?

Are regulations getting in the way of EU novel foods?

Complaints about how long the EU’s novel food approval process takes are not new. In recent years, start-up founders have said that the system is not transparent enough and prevents companies from developing viable business plans.6,18 Dr Rousseau, of UKIA, told FoodUnfolded the approvals process was “very hard for small businesses, which is what most novel food start-ups are, to navigate”.

The second complaint of many novel food producers is that the approval process may prevent potentially sustainable foods from coming to market.18 Sue Garfitt, CEO of The Protein Brewer, writing in The Grocer last year, asked whether policymakers are “truly aware of how important sustainable food innovation is for tackling climate change and achieving a sustainable future?” A particularly relevant question after a March 2023 study found diets that relied on novel foods for protein had up to 88% less Global Warming potential and 83% less land use.19

However, the jury is still out on whether novel foods are genuinely more sustainable than foods from traditional agriculture, since many are not yet cultivated at a comparable scale. Many novel foods come with their own sustainability challenges - for example, some need huge amounts of electricity to produce, whereas crops get their energy from sunlight directly.

One thing novel food companies do appear to agree on, however, is that no compromises should be made when checking that novel foods are safe and healthy for human consumption.

Gelbmann told FoodUnfolded that EFSA “cannot compromise on consumer safety, but of course, we are always looking at ways we can make the system as efficient as possible. That is why we are in constant dialogue with stakeholders to ensure the requirements are clear. We support companies to ease the application process by providing guidance, pre-submission advice, organising stakeholder meetings and information sessions.”

With the rush of novel food applications since 2018, time will tell whether start-ups are waiting too long to bring their products to market or if European supermarkets will soon be stocking insects, cultivated meat, or jellyfish.

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References
  1. Turck, Bresson, Burlingame, Dean, Faireweather-Tait, Heinonen, et al. EFSA. “Guidance on the preparation and presentation of an application for authorisation of a novel food in the context of Regulation (EU) 2015/2283”. Accessed 31 January 2024.
  2. EFSAchannel (2017). “What is novel food?”. EFSA YouTube. Accessed 31 January 2024.
  3. Zenger News (2023). “Following USDA Approval Of Cultured Meat For Human Consumption, Race Is On To Manufacture Product At Scale”. Forbes. Accessed 31 January 2024.
  4. Morrison (2023). “EU novel foods regulation ‘hindering innovation’ in meat alternatives sector”. FoodNavigator. Accessed 31 January 2024.
  5. Almagro, Gosalbez, Sandwalk Bioventures (2023). “Novel foods: Half of new applications terminated for the same reason”. NutraIngredients Europe. Accessed 31 January 2024.
  6. EFSA Panel on Nutrition, Novel Foods and Food Allergens (2023). “Safety of yellow/orange tomato extract as a novel food pursuant to Regulation (EU) 2015/2283”. EFSA. Accessed 31 January 2024.
  7. EFSA Panel on Nutrition, Novel Foods and Food Allergens (2023). “Safety of whole seeds of oilseed rape (Brassica napus L emend. Metzg.) as a novel food pursuant to Regulation (EU) 2015/2283”. EFSA. Accessed 31 January 2024.
  8. EFSA Panel on Nutrition, Novel Foods and Food Allergens (2022). “Safety of Lemna minor and Lemna gibba whole plant material as a novel food pursuant to Regulation (EU) 2015/2283”. EFSA. Accessed 31 January 2024.
  9. Perrett (2023). Duckweed highlighted as potential protein source for use in animal feed”. Feed Navigator. Accessed 31 January 2024.
  10. EFSA (Undated). “Application procedures for feed additives”. EFSA. Accessed 31 January 2024.
  11. EFSA (2023). “Novel food and traditional food applications”. EFSA. Accessed 31 January 2024.
  12. Leatherhead Food Research (Undated). “In Focus, gaining pre-market approvals for new ingredients and food additives, enzymes and flavourings”. EFSA. Accessed 31 January 2024.
  13. University of Washington (Undated). “EDGE scientists argue for updating food safety regulations”. Department of Environmental and Occupational Health Sciences. Accessed 31 January 2024.
  14. Food Standards Agency (Undated). “Novel Foods Regulatory Framework Review: Executive Summary”. FSA. Accessed 31 January 2024.
  15. Singapore Food Agency (2022). “A sustainable food system for Singapore and beyond”. Food for Thought. Accessed 31 January 2024.
  16. Garfitt (2023). “Europe must speed up the route to market for novel food technologies”. The Grocer. Accessed 31 January 2024.
  17. Mazac, Järviö, Tuomisto (2023). “Environmental and nutritional Life Cycle Assessment of novel foods in meals as transformative food for the future”. Sci Total Environ. Accessed 31 January 2024.
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