Marketing and authorisations for novel foods in Europe – where are we now?

Novel foods are foods that were not consumed in the UK or EU before 15 May 1997. Many alternative protein products require this authorisation before they can be sold in UK and the EU. What are the trends in applications being made in the EU and Great Britain? And what are the regulatory considerations businesses marketing novel foods need to consider with regard to the naming of their products?

Exploring meat terminology for cultivated meat: navigating naming challenges

Cultivated meat and other novel alternatives to meat have enormous potential to revolutionise human diets, and address environmental and ethical concerns associated with conventional meat production. However, as this industry gains momentum, a critical question arises: what terminology can be used to describe cultivated meat products when selling to consumers?

Can terms like "steak" and "burger" be used for cultivated meat, or are they exclusive to traditionally reared meat? Can this product even be called "meat" on its label and in advertising? At present, there is no definitive answer to this question, given the nascent nature of the industry.

Existing regulation

The existing regulations governing meat terminology are contained in the Products Containing Meat etc. (England) Regulations 2014. This prohibits the use of certain names for products containing meat. According to these regulations, "meat" is defined as the "skeletal muscles of mammalian and bird species fit for human consumption, including naturally included or adherent tissue, but excluding mechanically separated meat".

It is not clear whether this definition covers cultivated meat and there are likely to be arguments both ways. For example, while this definition was not originally intended to encompass cultivated meat, it could be argued that cultivated meat is technically the skeletal muscles of a mammal or bird from a scientific perspective; though not coming directly from the animal. On the other side of the coin, the way in which the definition is drafted suggests that it is intended to apply to meat which has been traditionally reared – and cultivated meat does not involve removing meat from an animal for human consumption.

Other considerations

Even if the industry is successful in establishing that cultivated meat is not meat in the way envisaged by the regulations above, there will still be other legal considerations. These include:

1. Avoiding misleading consumers: how should cultivated meat and other alternatives be labelled in order not to mislead consumers? Can they be labelled as "meat" without further words being included? It is likely that use of this term will be challenged so that "meat" will mean a product derived from slaughter of a living animal. It is likely that pressure groups will argue that consumers could be misled if cultivated products are labelled as meat – in much the same way they already challenge use of dairy terminology and similar for alternative products. In the long term this may be resolved by consumer education, but in the short term, additional clarification will probably be necessary. Additionally, from an intellectual property (IP) perspective, brands are prohibited from registering trade marks which are of such a nature to create an actual or sufficiently serious risk to deceive the average consumer, for instance as to the nature, quality or geographical origin of the goods or services. Increasingly, IP authorities are rejecting applications for trade mark registrations on this basis.
2. Using a legal name: Every food product must have a "legal name" on the label. If a food has a name prescribed by law, it must be used. Unless new legislation is brought, there is currently no legally mandated name for cell-grown meat and similar. In the absence of legislation, a customary name can be employed – one that is widely understood by consumers and that has been established over time – or failing that a descriptive name can be used. In the short term, it seems likely that brands of cultivated meat will need to describe the product on the label. In practice, this will means setting out that the product is made by cultivating meat cells in a lab. Over time, a customary name is likely to emerge.
3. Complying with labelling requirements: Standard labelling requirements remain applicable. These include informing consumers about the presence of sweeteners (such as aspartame), sugars, colourings, liquorice, caffeine, and/or polyols. Additionally, a comprehensive list of ingredients must be provided, and allergens must be clearly labelled.
4. Keeping an eye on new regulation: Businesses should be aware that this is a new area from a regulatory perspective and it is entirely possible that a new regulatory regime might be brought in to regulate the labelling of cultivated meat.

As cultivated meat and other alternatives to meat continue to evolve, companies should navigate the naming challenges responsibly. By adhering to consumer expectations, regulatory guidelines and labelling requirements, businesses can ensure transparency and build trust in this exciting new sector.

Recent applications and approvals

Recent highlights of applications and snapshots of authorisations made in Great Britain and the EU are trending towards foods which are designed to be added to food products in order to increase their nutrient content.

These include the following:

Great Britain

In Great Britain, the Food Standards Agency (FSA) authorised MBio, Monaghan Mushrooms for its Vitamin D2 mushroom powder on 15 May 2023. This product serves as a wholefood vegan source of Vitamin D, aimed at boosting vitamin D intake among consumers. It represents a step in providing alternative sources of essential nutrients in meat free foods.

In August 2023, Aleph Farms became the first UK company to apply to the FSA for approval to sell cultivated beef steaks. This follows the business's submission in Sweden in July 2023.

The EU

In the EU, in January 2023, the Commission authorised Cricket One Co Ltd to place its house cricket partially defatted powder onto the EU market. The powder can be used in a variety of food products, including multigrain bread and rolls, crackers and breadsticks, cereal bars, dry pre-mixes for baked products, pizza and pasta-based products.

The Commission authorised Société des Produits Nestlé S.A. to place iron milk caseinate onto the EU market in May 2023. This is a type of protein derived from milk and is rich in amino acids and iron. It can be used in a variety of products, including milk and dairy powder products, cereal bars, stock cubes and soft drinks marketed in relation to physical exercise.

In October 2023, the Commission authorised Kyowa Hakko Bio Co., Ltd to place its 6'-Sialyllactose sodium salt (6’-SL), a human milk oligosaccharide (HMO), onto the EU market. The approval allows the 6'-SL to be used in a variety of food categories, including infant formula, foods for medical purposes and food supplements from 13 November 2023.

Chr. Hansen A/S Boege Alle submitted an EU application for the authorisation of a change of the proposed uses and use levels for 3’-sialyllactose (3’-SL) sodium salt produced from a microbial source. 3'-SL is a human-identical milk oligosaccharide ("HiMO"). HiMOs are identical to HMOs. The applicant seeks to increase the use levels of 3'-SL in infant formula and food supplements for infants and young children, bringing them closer to the natural levels found in human breast milk. This application highlights efforts to enhance the nutritional quality of infant nutrition products.

Solar Foods Oy submitted an EU application for the authorisation of a microbial protein-rich powder intended for use as an ingredient in various food groups. While the powder is not intended to replace any specific food entirely, it offers a protein alternative that may partially replace the consumption of meat and meat derivatives. This application reflects the growing demand for sustainable and innovative protein sources.