Innovation in the plant proteins space: regulatory environment and launch strategies for plant-based foods in Europe

Plant-based products and vegetable alternatives to dairy and animal protein-based products have been around for a while already. Initially based on tofu, seitan and others, their success and the growing consumer interest in diets based on less traditional animal proteins has led to high diversification and has stimulated research in new alternatives.

Consumer demand is growing, in a context where the (re)introduction of a significant vegetal component into the diet is often perceived and presented both as having nutritional and health benefits, but also as contributing to the development of more sustainable consumption patterns and more in line with a certain conception of animal welfare.

In the context of the accelerating development of these vegetable alternatives and broadening of the offer on the market, the regulatory framework applicable to these products must be a focus of attention for food business operators.

Market access for plant-based foods: to be or not to be novel
The introduction of new plant proteins on the market as an ingredient in foodstuffs does often not require food business operators to complete any particular prior formality vis-à-vis the competent authorities. In such case, the ingredients must simply meet the basic requirements applicable to any food ingredient, i.e. they must be safe and therefore not present a risk to human health.

On the other hand, this relative flexibility of access to the market only applies to foodstuffs which were consumed to a significant degree before 15 May 1997, which are not, for that reason, 'novel foods' within the meaning of the European food regulations. If, on the contrary, an ingredient has been consumed in the European Union only in negligible quantities before 15 May 1997, then the novel food regulation is likely to apply to it.  

In addition, particular attention must be paid to technologically innovative products, since, depending on the production or processing methods used, a plant variety which might at first sight be regarded as having a traditional use because it can be shown that it was consumed in certain forms before 15 May 1997, may in fact still fall within the scope of the rules on novel foods. Indeed, a plant-derived food will be considered as a novel food when it results from a production process which was not used for the production of food in the Union before 15 May 1997 and which brings about significant changes in the composition or structure of the food affecting its nutritional value, metabolism or level of undesirable substances. It should be noted that genetically modified foods fall under a separate regulatory framework - and it should be recalled here that the Court of Justice considered in a ruling of 2018 that CRISPR-type genome editing techniques fall within the scope of Community law on genetically modified organisms.

Any ingredient or food falling within the scope of the novel food regulation may only be placed on the market subject to prior authorisation, which will result, following an evaluation procedure by the European Commission and EFSA, in the inclusion of the novel food in the EU list of novel foods.

These regulatory requirements may at first glance resemble an obstacle course. However, the purpose of these requirements is to ensure a high level of protection of human health and consumer interests, while at the same time ensuring the proper functioning of the European internal market. Moreover, although the preparation and submission of a complete dossier requires a significant investment in terms of human and economic means, a mechanism of regulatory data protection is provided by the regulations. Under certain conditions, the novel food regulation allows the first operator who obtains a novel food authorisation to benefit from exclusive rights on certain data submitted in support of its application for a novel food authorisation for a period of up to 5 years from the date of inclusion of the ingredient or food in the Union list of novel foods. Beyond that period, or where a novel food is authorised without exclusive rights being granted, the authorisation will be generic in the sense that any food business operator will be able to place the authorised product on the market - subject to compliance with any special specifications and requirements, particularly in terms of labelling, imposed by the authorisation decision.

For 'exotic' plant products, another route to the market is also available, namely a notification procedure, open to traditional foods from third countries. However, this route applies only to products from primary production for which it can be demonstrated that they have been used in one or more non-European countries for at least 25 consecutive years. This notification procedure does not qualify for the administrative data protection regime, so that any approved notification allows any operator to market the product as soon as its inclusion in the Union list is effective and applicable.

Currently, a number of applications for authorisation of plant-based ingredients as novel foods are pending before the European Commission. These include ingredients made from duckweed, rapeseed or coffee husk (commonly known as 'cascara'). The evaluation of these applications by EFSA is ongoing, which means that the authorisation of these ingredients is not expected before several months - as a reminder, EFSA has a period of 9 months (subject to suspension) to evaluate the dossiers submitted to it, and the European Commission has a period of 7 months, once it has received the opinion (favourable or unfavourable to authorisation) from EFSA, to prepare a draft final decision on the application for authorisation.

The status of any plant-based ingredients, and the production and processing methods of the ingredient thus need to be carefully assessed, as it can have a significant impact on the timing of the launch of a new product or category.

Preparing for the launch: leave no stone unturned
The definition of a recipe for a product intended for the European market does not only involve checking the suitability of each of its components in light of the regulations on novel foods. In fact, each ingredient, added nutrient and possible additive must be taken into account to determine whether a given product composition is marketable on the European market.

Furthermore, depending on the country(-ies)/market(s) where the launch is planned, local regulatory requirements, defined at national level, very often have to be taken into account in addition to the EU-harmonised rules.

Product marketing: risks and opportunities
The validation of the formulation of an innovative plant-based product is often concomitant with the definition of the segment in which the product will be positioned from a marketing point of view. In this respect, the regulatory framework is not short of general and specific requirements, which define a certain number of obligations for operators in terms of information to be provided to consumers, and frame those elements of communication that it does not define in a prescriptive manner.

As regards plant-based food products, there are many topics to be covered, both in terms of the designation of the products and in terms of communication and labelling elements relating to the characteristics of these products. The designation of plant-based products using product names referring to meat or dairy products for example, raises difficulties. The recast of the European Regulation on the common organisation of agricultural markets has sparked intense debate as regards the use of such designations. While an amendment related to the use of meat designations was rejected in plenary, another amendment that aimed at restricting the use of dairy terms for the designation of plant-based foods further than what existing regulations have already been providing for the past 30 years has remained on file until the Parliament withdrew it late May 2021. 

Sufficient thought must nonetheless be given to the way a plant-based food product is designated, to avoid the pitfalls and inconveniences associated with measures that would result in newly launched product having to be removed from the shelves, or at least re-labelled as a result of a regulatory action triggered by a competent authority initiative or a competitor complaint. Such issues can sometimes jeopardise all or part of the commercial project built around the product, and can in any event expose the concerned operator to potentially significant financial and reputational risk.

Of note, if the project aims to produce or market an organic product, another aspect of regulation will have to be integrated into the reflection on regulatory compliance, namely the detailed rules on organic production.

Plant-based products are often formulated in such a way that their labelling and advertising can include nutrition or health claims that highlight their particular properties and benefits, and draws the consumers' attention to these features. However, in this area too, a cautious approach is of paramount importance, partly because the conditions for the use of nutrition and health claims are strictly defined by the regulations, but also because the status of health claims relating to botanicals involves specific difficulties, particularly because of the "on hold" status of many applications for authorisation of such health claims.

Finally, it should be noted that the regulations on health claims on the one hand, and on novel foods on the other, have points of convergence that offer specific opportunities. Indeed, the administrative data protection regime mentioned above for novel foods has in fact been taken over by the European legislator as a mirror to the administrative data protection regime that was already in place for health claims, and the novel foods regulation makes it possible to optimise the protection mechanism thus offered by both regulations. Concretely, where an applicant seeks authorisation of a novel food and of a particular health claim relating to this novel food, in case both the novel food ingredient and the claim are authorised and data protection is granted to the applicant for both, it is possible for the applicant to have the resulting data exclusivity period start to run only from the moment that the product can actually be marketed, i.e. when it is included in the EU list of novel foods. This implies, however, that the applicant requests at the right moment that the novel food assessment be suspended while the application for authorisation of the health claim is being examined. In this way, the applicant for novel food authorisation will be able to benefit not only from exclusivity in relation to the ingredient but also in relation to the health claim made on that ingredient.

At the end of this quick overview, let us recall that strategic planning is necessary for the launch of any food product, in order to draw the maximum potential from the available regulatory tools and to avoid as much as possible the often costly and time-consuming compliance pitfalls. It should also be noted that alignment and coordination of this regulatory strategy with the food business operator's intellectual property strategy - both from a trademarks and patents perspective - is key to the commercial performance of the product both in the short and the long term.

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