The Impossible Burger 2.0, a plant-based vegan burger that tastes like real beef. Copyright © Robyn Beck/AFP/Getty Images
4. The Regulatory Landscape in the EU
Public policymakers may take different approaches to encouraging – or inhibiting – innovation in the meat analogue industry. Firstly, they may impose strict rules on conventional corporate practices, forcing businesses to innovate. Secondly, they may create the conditions within which innovation brings a competitive advantage, for example, by introducing additional standards related to corporate practices or products, or through the introduction of sustainability criteria in public procurement policies – such that those who do not innovate risk missing out on market opportunities. Thirdly, they may introduce or maintain certain procedural, economic or political barriers to innovation and to the marketing of innovative solutions or products.
In the EU, where many of the frontrunners in plant-based ‘meat’ and cultured-meat innovation are located, current regulation and policy are largely supportive of investments and innovation in alternative proteins. In 2012, the European Commission adopted a flagship strategy, Innovating for Sustainable Growth: A Bioeconomy for Europe, in which it committed to developing new technologies, processes and markets in support of a sustainable, low-emissions, resource-efficient food system. A regulation adopted in 2017 has committed the European Commission to ‘review the supply and demand situation for plant proteins in the EU and to explore possibilities to further develop their production in an economically and environmentally sound way’. Moreover, in late 2018, the European Commission presented what has become known as its ‘EU Protein Plan’, which encourages the production of alternative proteins for human consumption, and notes that a number of existing EU policy instruments ‘provide options for strengthening the development of EU-grown plant proteins’.A 2018 expert report, commissioned by the Directorate-General of Research and Innovation, identified the development of new meat alternatives as an important pathway to achieving the EC’s Food 2030 Initiative, to deliver a climate-smart, sustainable food system in Europe.
Public policymakers may take different approaches to encouraging – or inhibiting – innovation in the meat analogue industry.
The following section briefly outlines how plant-based ‘meat’ and cultured meat are – or may be – regulated by EU legislation. It identifies principal areas of uncertainty for regulators and meat-alternative developers with regards to their licensing and industrialization within the EU.
EU regulation: the broad picture
EU Food Law (Regulation EC No. 178/2002) sets the general principles and objectives of protecting human life, health and consumer interests and ensuring fair practices in food trade, undertaking a precautionary approach and enabling the free movement of food within the EU. Since its entry into force in 2002, innovation in the food sector has been tightly regulated across the EU. The 178/2002 Regulation was drafted in the wake of a series of food safety scares in the late 1990s and early 2000s, including the outbreak of bovine spongiform encephalopathy (BSE), and it established the European Food Safety Agency (EFSA), an independent body tasked with ensuring the safety of foods placed on the European market and of informing the development of EU-wide food policy. Today, the EFSA supports the EC in the approval of ‘novel’ foods, being inter alia an adviser to the EC on the safety of products to be placed on the EU market.
EU Novel Food Regulation
Newly developed foods are regulated under the Novel Food Regulation. ‘Novel’ foods are those that do not have a history of consumption in the EU before 15 May 1997 (the date on which the first Regulation on novel foods entered into force), either owing to new ingredients or to previously unused production processes. The Regulation is concerned with the safety of foods on the EU market and ensures that novel food products are: (a) safe to consume; (b) labelled properly so as not to mislead consumers; and (c) not nutritionally disadvantageous when compared with any existing food they seek to replace. The approval of novel whole foods – as opposed to food allergens or chemicals contained in foods – is regulated using a risk-based approach; testing for the presence of hazardous elements is just one of several checks that novel foods must go through before they are licensed for the EU market.
Testing for the presence of hazardous elements is just one of several checks that novel foods must go through before they are licensed for the EU market.
On 1 January 2018, a revised iteration of the Novel Food Regulation, (EU) No. 2015/2283 (replacing Regulation (EC) No. 258/97 and Regulation (EC) No. 1852/2001), entered into force. This aimed to address certain areas of ambiguity and to streamline and centralize the authorization process. Under the revised regulation, the average timeline for approval is expected to drop from 3–4 years to 1.5–2 years, and companies may now request that the data collated and used in support of their application – provided it is proprietary and exclusive – be protected for a period of five years. This process will, in theory, be more streamlined as a consequence of a shift away from an applicant-specific approach to approval towards generic product approval (reducing the long-term procedural burden for the European Commission by preventing duplicate applications), and also as a consequence of the centralization of the safety assessment process under the European Commission and the EFSA as opposed to its devolvement to member state authorities (Figure 3).
Other changes include the introduction of a light-touch process for approval of traditional foods that have a history of safe food use in non-EU countries, the explicit inclusion of whole insects as novel foods (only insect parts having been explicitly included under the previous iteration of the Regulation), and the introduction of a category for ‘food consisting of, isolated from or produced from cell culture or tissue culture derived from animals, plants, microorganisms, fungi or algae’.
Figure 3: Novel Food Regulation: overview of approval process under Regulation 2015/2283
What the Novel Food Regulation means for meat analogues
In 2007, an assessment of the EU Novel Food Regulation’s impact on private-sector willingness to launch new food products identified four key characteristics of a regulatory environment that encourage innovation: firstly, efficient and transparent procedures for assessment and approval; secondly, a consistent and limited timeframe for approval; thirdly, financial incentives for innovation and approval, including the recouping of R&D costs; and fourthly, certainty regarding the legal status of the approved novel product.
The 2018 revision of the Novel Food Regulation sought to ensure the first two of these conditions by setting out a clear process for product authorization and streamlining that process to enable more rapid approval of products for market. The third condition – financial incentives for innovation – lies outside of the scope of the Novel Food Regulation itself, though the provision for five years’ data protection for proprietary, newly developed scientific evidence or data supporting the application offers a degree of financial assurance for manufacturers by protecting their competitive advantage for a time-limited period.
The fourth condition – certainty regarding the legal status of the approved product – is more readily met for manufacturers of cultured meat than plant-based ‘meat’ products. While cultured meat is mentioned explicitly under the Novel Food Regulation, there is less clarity around whether plant-based ‘meat’ products are considered as novel foods in the EU. For the majority of the plant-based ‘meat’ products currently available in the EU, the component ingredients have a long history of consumption in Europe or in third countries. What renders the products ‘novel’ is the innovative processes by which these ingredients are manipulated to create a product that is – or aims to be – indistinguishable from meat. These new processes raise questions regarding the appropriate quality and safety standards to be applied, including those relating to the ingredients. In cases where these starting materials do not themselves have a history of use in Europe or in third countries, plant-based ‘meat’ products may be considered a novel food and therefore subject to the Novel Food Regulation.
Rules on the labelling of food products in the EU are laid out in the Food Information to Consumers Regulation (FIC) (EU Regulation No. 1169/2011). The regulation on the provision of food information to consumers states that:
Food information shall not be misleading … by suggesting, by means of the appearance, the description or pictorial representations, the presence of a particular food or an ingredient, while in reality a component naturally present or an ingredient normally used in that food has been substituted with a different component or a different ingredient.
The FIC Regulation requires that clear, precise and easily understandable food labelling be provided to enable consumers to make an informed choice and to ensure the ‘safe use of food, with particular regard to health, economic, environmental, social and ethical considerations’. The name of the food should be its legal name (names that may only be used on a product if it meets certain conditions stipulated in the Regulation) but if there is no such name, then the name of the food shall be its customary name (a name by which it is commonly known by EU consumers, without need for further explanation). If neither a legal nor a customary name exists, then a descriptive name (a name describing what the product is or contains) of the food must be provided.
In the case of novel foods, further labelling requirements may be imposed on manufacturers. The Novel Food Regulation No. 2015/2283 states that, when a novel food is added to the EU list of authorized novel foods, further requirements may follow relating to product labelling to ensure that consumers are fully informed of its nature, either in the description of the food or in information on its composition.
What product labelling regulation means for meat analogues
Labelling is one of the main regulatory bottlenecks for plant-based ‘meat’ options already on the market and the same is likely to be true for cultured-meat products. Policymakers, meat analogue producers and incumbents in the meat industry alike all want to ensure – for cultural, health and safety, and marketing reasons – that their products are easily identified and attractive to consumers. The specific nature of meat analogue products, however, raises difficult questions with regard to the legal or customary name under which they may be marketed. In the absence of specific regulations on plant-based ‘meat’ or cultured meat, the general labelling rules laid out in the FIC Regulation will apply. While the basic principles of product information provided to consumers – that it be clear, precise, easy to understand and not misleading – apply equally to plant-based ‘meat’ and cultured meat, issues relating to product labelling differ considerably between the two.
Studies indicate that the way in which these products are marketed will have a material impact on consumer demand. Approaches to labelling and marketing that highlight the environmental benefits of meat analogues as compared with conventional meat is expected to be a particularly effective way of appealing to the preferences and values of meat-reducing consumers (as opposed to those already following a vegetarian or vegan lifestyle). The legal, customary or descriptive name for cultured meat is likely to have a particularly marked impact on consumer demand: recent surveys have demonstrated that the use of the terms ‘clean’ and ‘slaughter-free’ has been shown to increase the acceptability of cultured meat, while ‘lab-grown’ is more likely to deter potential consumers. Any stipulations relating to the permitted positioning of meat analogues in-store – alongside conventional meat or separate to it – may similarly impact positively or negatively on sales.
The use of terms usually associated with conventional meat – ‘steak’, ‘fillet’, ‘bacon’, ‘sausage’, and so on – in the labelling of plant-based products has been subject to scrutiny and, in some cases, restriction in certain EU member states. Central to the argument against the use of meat-related terms such as ‘burger’ and ‘Schnitzel’ has been the assertion that their use risks confusing or misleading consumers.
In April 2018, the French National Assembly passed an amendment to the country’s Rural Code, stating that designations associated with animal products cannot be used to market food products of which a significant part is vegetable-based. To justify this change, members of Parliament referred to a decision by the European Court of Justice (ECJ) issued in June 2017 on the use of terms like ‘soy milk’ and ‘vegan cheese’. In this case, concerning the German company TofuTown, the ECJ ruled that sales designations for dairy products cannot be used to market purely plant-based products since Regulation No. 1308/2013, establishing a common organization of the markets in agricultural products, defines ‘cheese’, ‘milk’ and similar designations as coming from an animal. The ECJ did not, however, comment on meat products. Regulation No. 1308/2013 does not define meat-related terms such as ‘steak’ or ‘burgers’, and EU law does not explicitly forbid the use of these meat-related terms. These terms could, in principle, be used for plant-based products so long as their use does not mislead consumers.
Arriving at a consensus among policymakers regarding a definition for meat analogues and requirements for their labelling is likely to be challenging.
In Germany, a 2017 appeal to the German Food Code Commission (DLMBK) by the German food minister and national farmers’ and butchers’ associations to restrict the use of terms such as ‘vegan Schnitzel’ and ‘vegetarian Bratwurst’ led to the publication of new guidance in August 2018. The guidance, from the DLMBK, indicates that terms relating to whole animals or to specific parts of animals – such as ‘ham’ or ‘sausage’ – may not be used for meat substitutes, and that references to names such as ‘Schnitzel’, ‘goulash’ or ‘meatballs’ may only be made if the substitute products are sufficiently similar in taste.
In an opinion published in October 2017, the EC recognized that greater clarity is needed and, as part of its Regulatory Fitness and Performance Programme, it announced that a review of the labelling of vegan and vegetarian food will begin in 2019. The Commission will likely prepare an implementing act, specifying how these foods may be labelled, as indicated in Article 26 of the FIC Regulation. In November 2018, the European Commission set in motion a European Citizens’ Initiative on mandatory labelling of food as non-vegetarian, vegetarian or vegan to which Europeans may register their support. Should one million statements of support be received within a year, from at least seven member states, the European Commission will be required either to commit to implementing such mandatory labelling or explain its reason for not doing so. Arriving at a consensus among policymakers regarding a definition for meat analogues and requirements for their labelling is
nevertheless likely to be challenging for the EU multi-levelled governance system: labelling decisions will need to be coordinated with processes in all member states, where cultural views of meat and meat alternatives vary considerably.
The naming and labelling of in vitro meat raises two key issues: firstly, whether a product’s name and label should be required to indicate clearly the process of its production; and secondly, whether in vitro meat can and should be referred to as ‘meat’.
As in vitro meat is not yet authorized for the EU market, there is no agreement on its legal name. There are already a range of names given to meat products grown in vitro both by those developing the technologies and by social commentators: cultured meat, clean meat, lab-meat are all commonly used, but these are not ‘customary names’ as defined by the FIC Regulation. Given that the key objective of the FIC Regulation is to ensure that fair, clear and precise information is provided to consumers – including on the method of manufacture or production – it seems likely that operators in the EU will need to ensure that the consumer is made aware via the product label that the meat in question was grown in vitro rather than by conventional production processes, and that the legal name of the product will need to indicate this. This transparency requirement may be reinforced by the Novel Food Regulation: in vitro meat is a novel food and will require authorization under the procedure laid out under the Novel Food Regulation No. 2015/2283. It appears likely, therefore, that the addition of in vitro meat to the EU list of authorized novel foods will be accompanied by a specification that the production process be evidenced on the product label.
Anticipating whether operators marketing in vitro meat will be permitted to label their products as ‘meat’ is more difficult. Under the FIC Regulation, for labelling purposes, meat is defined as ‘skeletal muscles of mammalian and bird species recognised as fit for human consumption with naturally included or adherent tissues’. The application of this definition to in vitro meat will likely be up for debate: cultured meat may not be considered ‘skeletal muscle’ (which the Regulation in turn defines as ‘muscles under the voluntary control of the somatic nervous system’) nor does it consist of ‘naturally included or adherent tissues’ owing to the production process involved. If such a conclusion were reached, the term ‘meat’ could not be applied to in vitro meat under current EU legislation. If, on the other hand, it were determined that in vitro meat could be defined as ‘meat’ under the FIC Regulation, further issues would need to be addressed, not least whether operators would be required to indicate a country of origin or place of provenance of the slaughtered animal, as is expected of operators marketing meat produced by conventional means.
As noted in a recent article exploring the challenges in bringing cultured meat to market, the degree of contestation over how cultured meat should be referred to reflects a deeper disagreement over what exactly cultured meat is and how it should be positioned in relation to conventional meat. Decisions relating to the terminology permitted in the marketing of future cultured-meat products will likely be influenced not only by technical considerations but by political arguments too: permission for manufacturers of cultured meat to label their products as ‘meat’ with few additional caveats would likely meet with resistance from the traditional livestock industry; a decision to require that those manufacturers label their product as ‘artificial muscle proteins’ or similar may be expected to prompt a similar degree of resistance from the meat analogues industry.
Regulation of GMOs and good manufacturing practice
Food containing GMOs, or produced from a GMO source material, is subject to separate approval under Regulation No. 1829/2003 and does not come under the Novel Food Regulation. According to EU regulations, the decision to allow the import or production of a GM crop in any given member state may be taken on the basis of a risk-based safety assessment, as well as economic and consumer acceptance factors. Depending on whether the production process of cultured meat is considered to approximate pharmaceutical production more than food manufacture, cultured-meat production plants may also be subject to good manufacturing practice (GMP) guidelines. (GMP is an international system for quality and consistency control that aims to mitigate residual risks arising from pharmaceutical production that cannot be ruled out based solely on final product testing).
What GMO regulation and GMP guidelines mean for meat analogues
The decision to regulate either a plant-based ‘meat’ or cultured-meat product under GMO regulation would have implications for manufacturers, including specific stipulations for environmental and human safety assessments and product labelling. Perhaps more importantly, the use of GMOs in meat analogues is likely to dampen demand among European consumers who continue to negatively view genetic modification in food.
For most plant-based ‘meat’, the component ingredients have a history of consumption in the EU and the production techniques are already commonly used. Companies including Beyond Meat and Moving Mountains are already selling their ‘bleeding’ plant-based ‘meat’ products in EU countries without prior authorization under the Novel Food Regulation, though a retrospective decision to require that they be assessed and approved under the Regulation remains a possibility. In the case of the plant-based ‘Impossible Burger’, it remains unclear whether the Novel Food Regulation or Regulation No. 1829/2003 on GM food and feed would apply. ‘Heme’ (the key ingredient in the ‘Impossible Burger’, which supplies the characteristic taste and aroma of meat and which is carried in SLH) is produced through cell culture using genetically engineered yeast. Under the definition of the Novel Food Regulation, ‘heme’ may be considered a novel ingredient as it is produced ‘from cell/tissue culture derived from plants, animals, microorganisms, fungi or algae’. But, while the burger itself does not contain any genetically engineered material, its use in the production process will likely mean it must be regulated under the GMO Regulation. Certain methods of producing cultured meat also involve the use of GM organisms, raising similar questions around the regulatory pathway under which they would fall. Until such time as meat analogues produced using GM organisms are authorized for sale and consumption the EU, their import from non-EU producers will not be permitted.
The use of FBS in manufacturing practices for medicinal products has been discouraged globally under GMP protocols and under the EU Good Cell Culture Principles (GCCP). The use of FBS is further discouraged under EU regulations relating to the use of chemicals (Regulation No. 1907/2006 on the Registration, Evaluation, Authorisation and Restriction of Chemicals – REACH) and, where the foetus from which serum is harvested is not first killed, under regulations to protect animals used for scientific purposes (EU Directive No. 2010/63/EU).
- In the EU, cultured meat will be regulated under the Novel Food Regulation unless GMOs are used in the production process. In this case, and in the case of plant-based ‘meat’ techniques that make use of GMOs, products will likely be controlled under Regulation No. 1829/2003 on GMOs in food and feed.
- Plant-based ‘meat’ may not require authorization under the Novel Food Regulation if the component ingredients and processing techniques have a history of use in the EU. In the case of the Impossible Burger, which contains plant ‘heme’ produced using GM yeast, authorization under either the Novel Food Regulation or the GMO Regulation is likely to be required.
- Labelling requirements and restrictions are regulated under the FIC Regulation but there remains a high degree of uncertainty around how plant-based ‘meat’ and cultured meat may be named and marketed. Restrictions on the use of meat-like names for plant-based products in France and Germany indicate that future decisions taken at the EU level on meat analogue labelling are likely to be highly politicized.