In 2019, plant-based meat has achieved its commercial breakthrough – in restaurants, fast food chains and in retail. At the same time, so-called cell-based, in-vitro or cultured meat is intensively researched. Not at least due to environmental and animal welfare benefits, the market for non-animal-based meat is expected to grow rapidly. But which regulatory requirements do food business operators have to consider when marketing artificial meat products in the European Union? And what regulatory impact do investors need to consider in their investment decisions?
Requirements for placing the products on the market
While the specific legal requirements for placing artificial meat products on the European market depend on the individual product and its ingredients, they can be burdensome, especially compared to other jurisdictions. In particular, this concerns products that contain or consist of novel and/or genetically modified ingredients as these require prior authorisation, and this is usually accompanied by costs and delays.
Both Regulation (EU) 2015/2283 on novel foods and Regulation (EC) No 1829/2003 on genetically modified food and feed require that an application for authorisation is only granted if the applicant proves that (i) the product does not pose a safety risk to human health (novel food) or does not have adverse effects on human health, animal health or the environment (genetically modified food), (ii) the product or its intended use does not mislead the consumers and (iii), if the product is intended to replace another food, it does not differ from that food in such a way that its normal consumption would be nutritionally disadvantageous to the consumer. While the authorisation procedure for novel foods normally takes between 18 and 24 months, the procedure for genetically modified organisms is even more complex and time-consuming, and in the end, it is often also more expensive for the applicants. If a food ingredient qualifies as novel and at the same time as a genetically modified organism, authorisation only under the latter regime is required. In this context it is noted that the European Court of Justice decided in July 2018 that organisms produced by genome editing methods (such as CRISPR) are generally considered genetically modified even if no foreign DNA has been inserted.
Naming and further regulatory requirements
The legal landscape for artificial meat products contains many more areas of practical relevance. One relates to the naming of artificial meat products. As there is no designated legal name for these products under European Union law, they have to be named with their customary name or by describing the product. In this context, food business operators and investors should be aware of potential national requirements. For example, in Germany, the Guidelines for Vegan and Vegetarian Food with a Similarity to Food of Animal Origin of the German Food Code Commission establish a rather complex framework for the different types of products, so that names such as ‘vegan sausage’ and ‘vegan salami’ are treated differently and some products may even have to be marketed with complicated names such as ‘soy-based vegetarian salad in the style of a meat salad’. Overall, however, there are ongoing political and legal debates on the European level – and also in the US – on whether and how artificial meat products can be marketed with names traditionally associated with animal source foods.
Apart from naming questions, food business operators may have to observe the patent landscape in order to assess their freedom to operate. Filing patents themselves may further be an appropriate instrument to secure their investments.
Outlook
Artificial meat products possess enormous potential not only for innovators and investors but also for the environment, animal welfare and conscious consumers. Although food business operators and investors are faced with a rather complex regulatory landscape within the European Union, compliance can be reached when navigated with care.
To learn more about the regulatory environment of artificial meat, please read our full article in ZLR 3/2019, 359 (German) or EFFL 4/2019, 323 (English), and visit our Freshfields regulatory website here.
Co-author: Marvin Bartels, Berlin
