When it comes to sustainable food, Clean Meat (i.e In-Vitro or Cultured Meat) is considered by many to be the future. But although Clean Meat is promising in terms of sustainability and new sales markets, the regulatory hurdles that producers and retailers must overcome before entering the EU market are many and varied. This article examines the challenges arising from the European Novel Food Regulation, European GMO law, and the special German requirements for the labelling and advertising of nontraditional meat products.
A. Products and stage of development
In the EU, technical marketability of Clean Meat is within reach. Artificially produced chicken meat was recently approved in Singapore. In 2013, a research team from Maastricht University presented its first burger from the lab. While the production costs at that time amounted to EUR 250,000, a clean burger can now be sold for less than USD 10. When they go on sale, costs should decrease even more (in July 2020, a prominent Clean Meat company in the Netherlands announced that its cost of production had fallen by 88%).
The advantages of Clean Meat are manifold and could outperform conventional meat products on every level: CO2 emissions are reduced, factory farming is not necessary and natural resources are saved. Consuming Clean Meat can also be healthier for the consumer since there is less risk of contaminants (e.g. no antibiotics are used) and the amount of cholesterol is lower. The shift to Clean Meat is a response to increased demand for meat as meat consumption steadily grows, greater sensitivity for animal welfare and the fight against climate change. It is therefore not surprising that there is also strong investment in Clean Meat in the EU. A European Clean Meat start-up attracted investments totalling nearly nine figures.
B. Regulation on genetically modified food
When it comes to selling Clean Meat in the EU, the first question to be answered is: Does the food contain genetically modified organisms (GMOs)? If the answer is yes, the food must be authorised by the European Commission.
In general, it can be said that when it comes to marketing food in the EU, there are hardly any higher hurdles than those set by the GMF Regulation. The approval procedure of the EU Commission is complex and time-consuming. Taking into account the time and effort required for the application (including the performance of studies, etc.), the participation of national authorities, the assessment by the European Food Safety Authority (EFSA) and the approval by the EU Commission, the approval process may be considerably longer than 12 months. In individual cases, approval may take years.
However, despite the hurdles and required effort, good preparation, professional knowhow and the right partners can bring success.
C. Novel Food Regulation
Even though Clean Meat does not contain genetically modified material, it requires approval. This is because in almost all cases Clean Meat qualifies as Novel Food in the sense of the Novel Food Regulation (see statement of the EU Commission). These requirements are slightly less strict than those set down in the genetic engineering law. An approval is granted to a novel food if it does not pose a safety risk to human health, does not mislead consumers and, if it is intended to replace another food, does not differ from it in a way that would cause nutritional disadvantages for individuals when consumed normally.
Also, in connection with the authorisation of a novel food, the duration of the approval procedure must be taken into account. According to official information, it can take 18 to 24 months for a novel food product to receive final approval (or to be rejected). While this is a long time (especially considering that the products may not be marketed in the EU in the meantime), patience will be rewarded. In the event of approval, the applicant can obtain an exclusive right of use for five years in order to amortise development and application costs.
A food business operator should not fear having to go through both processes (i.e. GMF Regulation and Novel Food Regulation). If GMO approval is required, Novel Food Regulation approval is not necessary.
D. Labelling and advertising
The labelling and advertising of Clean Meat is a national issue. Although European Law (i.e. Food Information Regulation (EU) 1169/2011 [FIR] and Unfair Commercial Practices Directive 2005/29/EC) comprehensively regulates food labelling and advertising law, the question of whether the consumer understands labels and advertising is determined by national standards. The question of how a foodstuff is to be named and how it may be advertised can only be answered in each member state. In the following section, we demonstrate problematic points arising in this context from German standards.
I. Name of the food
According to Art. 17 FIR, pre-packaged foodstuffs must be provided with the name of the food. The name should provide information about the type of food and its special characteristics. In Germany, the guidelines of the German Food Book (Deutsches Lebensmittelbuch) are especially relevant when it comes to the naming of food in accordance with Art. 17 FIR. A non-governmental commission adopted these nonlegislative guidelines, which have no binding effect, but are frequently referred to by authorities and courts when it comes to the question of a food product's correct and non-misleading name.
Although neither the guidelines for meat nor the guidelines for vegetarian and vegan foods are likely applicable to Clean Meat (since this food does not come from a slaughtered animal or any part of an animal), some conclusions can be drawn from the regulations. According to the guidelines for vegetarian and vegan food, meat-typical terms such as "fillet" and "steak" are not acceptable for non-meat products (i.e. products that do not come from slaughtered animals). The current guidelines seem to reflect that vegetarian products previously had no meat-typical characteristics. This policy, however, may not be sustainable in this form in light of new technical developments.
Consequently, it will be a challenge to label Clean Meat products with risk-free names, but still accurately describe each product. Each individual case must be examined and it must be determined whether names like "Burger", "Schnitzel" and "Steak" can be applied to Clean Meats.
In the context of advertising, it is particularly important to prevent consumers from being misled about the production method of the respective meat product (i.e. traditional or invitro). For example, it could be problematic if the packaging of a Clean Meat product shows animals in a green landscape. Consumer knowledge about nutritional values and the health advantages (or disadvantages) of Clean Meat vis-à-vis conventional meat will be limited when marketing begins. Hence, precise information will need to be communicated.
III. Other labelling issues
Finally, it should be noted that there are special labelling obligations for genetically modified food. For example, labels must explicitly state that the product or parts of it have been genetically modified.
It cannot be denied that the marketing of Clean Meat faces potential high legal hurdles. Besides the challenges for approvals, issues related to labelling and advertising also persist. However, if these challenges are understood and a product's entry into the market is carefully prepared, these hurdles can be overcome in an economically reasonable way.
Heike Blank, Jonas Kiefer, CMS Germany