Cultured Meat (aka Cellular Agriculture): Novel Food Compliance
This is Part 2 of the Foodtech Compliance regulatory round-up of the UK food-tech sector.
This week, CEO Neil Williams provides his analysis in respect of the regulatory submissions required to commercialise a cultured meat product in the UK:
In simple terms, cultured meat is animal meat which is produced by cultivating animal cells in a laboratory. The methods used to cultivate the meat are fascinating, finding their origin in regenerative medicine. Producing meat in this way has many benefits – environmental and ethical - over the established methods of farming animals for food. For example, if the issue of scalability is overcome, a reliance on cultured meat as opposed to meat obtained through intensive farming methods could significantly mitigate one of the main causes of climate change.
And it should be attractive to meat eaters. As cultured meat is produced using the same cells as animal tissues, it is possible to replicate the nutritional value of traditional meat. It should also be possible to replicate taste and smell. It follows that cultured meat presents a rare opportunity to combat serious global problems while requiring little in the way of change to consumer habits.
At this stage, there are no cultured meat products on the market in the EU and therefore such products are currently unavailable to consumers. However, there are many companies now developing the necessary technologies to produce a commercial product who are keen to enter the EU and UK markets.
Categorisation of cultured meat as Novel Foods - EU
It is worth considering how cultured meat would enter EU and UK markets. Cultured meat is almost inevitably going to be subject to legislation/regulation applicable to Novel Foods. This creates challenges to those seeking to enter the market with their cultured meat product(s) – although these challenges can be overcome.
Novel Foods require pre-marketing authorisation from the European Commission (EC) in order to be sold lawfully within the European Union (EU). The EC maintains a catalogue of identified Novel Foods. Regulation (EU) 2015/2283 of the European Parliament and of the Council provides the relevant definition:
“…..a Novel Food is defined as one that has not been consumed to a significant degree by humans within the Union prior to 15 May 1997...”
The EC confirms the requirement for marketing authorisation:
“Food business operators can place a novel food on the European Union market only after the Commission has processed an application for the authorisation of a novel food…”
That cultured meat will fall within the definition of Novel Foods and therefore be subject to marketing authorisation was made clear in 2018, when a European Commission representative advised the European Parliament that:
“Article 3(2)(a)(vi) of Regulation (EU) No 2015/2283(1) on novel foods stipulates that food consisting of, isolated from, or produced from a cell culture or tissue culture from animals, plants, micro-organisms, fungi or algae is considered one of the novel food categories listed in the regulation.
Cultured meat may fall in this category. In such case, it would require a pre-market authorisation which would include a safety assessment performed by the European Food Safety Authority (EFSA).”
As explained in Part 1 of our UK compliance review, the EU implements the 'Precautionary Principle' in respect of Novel Food products. This means that substantial regulatory submissions to demonstrate the safety of the product will need to be made before cultured meat products can be placed on the commercial market.
The UK has incorporated the EU Novel Food regulations into domestic law through The Novel Foods (England) Regulations 2018. Although the UK has now left the European Union, and is no longer bound by EU Regulations, the UK continues to implement the Novel Food regime domestically. Novel Food Regulation tends to be the benchmark for food standards globally, and currently there seems little evidence of the UK Government being willing to diverge from the regime.
The compliance regime in the UK is managed and monitored by the Food Standards Agency. Novel Foods in the UK has been a topic of commercial interest in recent times following the EC’s categorisation of Cannabis derivatives – specifically Cannabidiol (CBD) – as novel.
Requirements of a Novel Food submission
To understand the practical nature of the challenge faced by those bringing cultured meat to market within either the EU or UK Novel Foods regime, it is necessary to consider aspects of the authorisation process in more detail.
Novel food applications require extensive scientific data to be produced in order to establish the long-term safety position of the product. This will include toxicology and stability studies carried out by specialist laboratories.
Of equal importance to these studies will be the extraction, growing, processing and packaging etc. for the cultured meat which will need to comply with both Novel Food requirements but (as a matter of logic) also those which apply to the regulation of traditional meat. Bearing in mind the requirement to control the quality and safety of a novel food from source to consumer, other regulations are likely to come into play in order to successfully commercialise cultured meat.
For example, assuming the cells are of animal origin, then companies will need to consider Livestock and Animal Welfare Regulations which come within the scope of several different agencies. Although a good lawyer will be needed at key points, ultimately a novel food application is a highly technical, scientific submission which should be handled by a competent laboratory or regulatory consultant who not only has the depth of knowledge of the Novel Food Regulations but also the breadth of knowledge to understand what other regulations may apply.
Applications are made to the European Food Standards Authority (EFSA). Once a Novel Food Application is made it will take at least 18 months for authorisation to be granted. It is a long and expensive process, but by achieving this benchmark status, the new product can be confidently marketed around the world as being entirely safe, and of the highest quality.
When can we expect to see the first products complete this process and appear on our menus? Well, in January 2021, one Europe’s premier companies – Holland’s Mosa Meat – confirmed that it would take its product to the EFSA for approval. They are however realistic about the timeframe for commercialisation advising that the authorisation process is likely to take a number of years. Those looking to bring products to market as quickly as possible should seek focused advice from the earliest stage.