Protein is traditionally associated with meat, fish and eggs. However, in recent years, consumers have been seeking new food experiences, especially when it comes to meat alternatives. As a result of this shift, alternative proteins have started to emerge globally.
Alternative protein sources include insects, plankton, seaweed and lab-grown meat cultivated from animal cells. These unconventional sources of protein are gaining popularity due to concerns over environmental impact, animal welfare and health. In the UK, regulatory approval is possible but may be complex and lengthy – and it’s only one stepping stone to the successful launch of an alternative protein product.
The steps below outline the complex regulatory landscape and product development requirements which must be successfully navigated in order to launch an innovative alternative proteins product from lab to plate.
Stage 1 – developing the product and protecting your IP
A number of partnerships between research institutes, such as universities, and production and distribution companies have been announced in the past year. Much of this research relates to methods of manufacture, such as lab-grown meat via bioprocess design, to meet the current challenges of scale and cost. In addition to manufacturing methods, research into the component products themselves, such as varieties of cell lines, scaffolds and cell culture media are also expanding areas of research that may require collaboration with appropriate research institutes.
As a relatively new technology, considering patent protection for innovations in these areas is likely to form a key part of a company's strategy to its development of lab-based meat products. Indeed, trends in patent filings indicate that this a growth area.
By considering IP (intellectual property) at an early stage, a company can consider if it requires patents to protect its inventions, or if it requires a licence or partnership with third parties that own the proprietary technology that it needs.
In contrast to traditional food products, the opportunities for patent protection will not be limited to innovative manufacturing methods or formulations, and could be available for components of the products themselves (subject to meeting the usual criteria for patentability). Ensuring that IP is given appropriate consideration will also be important for securing investment, if required.
The patent landscape for plant-based alternative protein sources is more advanced, which is a reflection of the maturity of the technologies associated with these products. A company wishing to commercialise plant-based alternatives should consider freedom to operate searches to assess the IP landscape for potential risks of infringement.
Stage 2 – getting novel food authorisation
Any food product that has not been used for human consumption to a significant degree within the UK or EU before 15 May 1997 are known as ‘novel foods’. These novel foods must get regulatory approval by the Food Standards Agency (FSA) before they can be sold in the UK. There are several types of alternative proteins which are likely to be classified as types of novel foods in the UK, these include:
- New foods, for example, foods made from novel sources such as plankton
- Traditional foods eaten elsewhere in the world, for example, insects
- Foods produced from new processes, for example, lab-grown meat.
Obtaining a novel food approval is an extensive process and differs between different jurisdictions. In the UK, a substantial amount of information is needed about the product, including the production process, its compositional data and toxicological information and allergenicity. The allergen aspect could be a particularly complex area for new alternative protein products. For example, reports have suggested that consumers with an existing crustacean allergy may also be allergic to certain types of insect protein, as both insects and crustaceans belong to the arthropod family.
Stage 3 – getting ready for launch
The product labelling and marketing will, of course, have a huge impact on the product's appeal and success. Securing registered trademark protection for the brand of any product prior to launch is highly recommended. These factors must be considered alongside the UK's food labelling and advertising regulations.
In the UK, all pre-packaged food requires labelling which displays certain mandatory information about that food product such as (but not limited to) the product name, the name and address of the manufacturer, the storage and usage conditions, ingredients, nutritional declaration and any allergen warnings.
It may be tempting to use certain terms like 'burger' or 'nuggets' to describe and advertise the alternative protein product (e.g., ‘seaweed burger’). Whilst these terms may be helpful at providing consumers with an idea of what the product is similar to in terms of how to use/cook it and comparable meat texture etc., it is important to ensure that the consumer is not mislead. If the consumer is misled about the nature of the product then this would make the advertising and labelling likely unlawful.
Care should also be taken around using protected terms such as ‘milk’ and protected geographical indications such as ‘traditional Cumberland sausage’ which benefit from specific legal definitions and cannot be used freely. It is also important to consider the legal considerations around vegetarian terminology and terms such as 'plant-based' on these products. Whilst 'plant-based' is not a defined term in law, there is risk nevertheless that consumers are likely to interpret a 'plant-based' product as not only being suitable for vegetarians but also for vegans, which may not be true for all alternative proteins.
Stage 4 – bulking up
Around this point, you'll probably need to start increasing the scale of production from the lab to commercial sale. Whilst your company might already have plenty of investors, it is important to fully appreciate the costs associated with the scaling up process, as this is a huge undertaking and commitment. If you have not already done so, now is a good time to bring more people (and investment) on board as production volumes increase. You should seek advice about the best way to structure your company and investors. It is crucial to think long-term at this stage and consider how you might expand the business and avoid a convoluted approach which is heavily tailored around the people involved.
For many alternative proteins, this is likely to mean negotiating and confirming contracts with specialist parties to replicate the existing laboratory/growth processes on a commercial scale. As part of these negotiations, you should carefully consider that typically the manufacturer takes responsibility for key aspects of the manufacturing process such as product safety (including managing cross-contamination risks) and general quality assurance. However, the company that sells the product will be liable to the consumer, even if they have subcontracted some of these responsibilities to a manufacturer. It is then important that the agreements provide the ability to limit liability, put in place HACCP obligations and checks, and pass on liabilities (including financial costs) up the supply chain appropriately.
Furthermore, companies should clearly map out their supply chains, identify potential risks and create contingency plans accordingly. A failure to meet supply demands in a timely manner could cause long term damage to a company's reputation and can also have financial consequences if onward sale quotas are not met.
Stage 5 – launch and distribution
Launching a new product can be a daunting task, particularly if it requires persuading UK consumers to try alternative proteins that are not currently familiar or widely eaten in the UK (e.g., an insect-based snack). However, as familiarity and understanding of new alternative proteins increases around the world, companies should be particularly cautious about exclusivity arrangements and the liability they have through these agreements.
This will then provide the companies with the flexibility and ongoing opportunity to continue educating consumers on their products and partner with like-minded restaurants, pop-up shops, or well-known chefs to increase their audience reach. In doing so, companies should consider the best way of governing to maximise their growth.
There is huge opportunity to launch and commercialise innovative alternative protein products in the UK. However, there a range of legal considerations at every stage in the journey.
At pre-launch, the focus is likely to be on ensuring that any intellectual property is protected and getting the necessary regulatory approvals to launch onto the UK market. During the scale-up phase, focus will be on negotiating contracts and ensuring compliance with HACCP obligations and checks.
Carefully navigating each stage of the process will put the company in the best position for a successful launch.