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What are the legal pathways that creators of innovative new protein foods need to tread in Europe?

On February 25, the European Commission published a study on new opportunities for the EU plant protein market, write Katia Merten-Lentz and Thais Payan of international law firm Keller & Heckman. The study concluded that the increased consumer demand for organic and genetically modified (GM)-free supply chains, combined with a rise in the number of flexitarian, vegetarian and vegan diets, will expand markets for pulses and processed proteins.

Indeed, the world-wide demand for new and alternative proteins is driven by both the increased awareness of the negative health impact of high animal protein intake, and the environmental footprint of traditional meat production in combination with the fast-growing world population. However, the development of new products depends very much on the opportunities offered by the legal framework. Many traditional plant-based proteins are used as substitutes for meat, milk and egg. More recently, seaweeds, algae and microalgae have also been added to the range of vegetable food proteins. As the production and sourcing of plant proteins for the agri-food sector has repeatedly stimulated political debate at EU level, the European Commission recently explored how to harness the potential of EU protein plant production, responding to the needs of farmers, producers and consumers.

Other innovative food products can also be ‘new’ source of proteins, such as insects. They are traditionally recognized as normal part of the daily diet throughout the world but are quite new in the European Union. Furthermore, a new development is the introduction of ‘in vitro meat’ – meat produced by in vitro growth of animal cells. Those products are covered by the current legislation, but the EU should further clarify rules applying to new alternative proteins.

From unsafe presumption to the authorization of novel foods

New proteins might be considered as unsafe. Furthermore, since 1997 every ‘novel’ food must be specifically authorized before being placed on the European market.  To be regarded as “novel” a food or food ingredient must not have been used for human consumption to a significant degree within the EU before 15 May 1997 and must belong to one of the categories listed in the Regulation.

This list has been updated by Regulation (EU) 2015/2283. This new regulation also provides a centralized procedure and ends a number of uncertainties for food business operators willing to place new products on the EU market. It has applied since January 2018.

Beyond novelty, food business operators must be aware that the processes they use do not only lead to a “novel food” if it causes modifications of the molecular structure of the food. For instance, even if proteins have been extracted from numerous plants in the EU prior to 1997, some extraction processes may have not been used in the EU prior to 1997, which can make the extracted protein a novel food under the EU regulation.

In addition, the new phrasing provided by Regulation (EU) 2015/2283 explicitly includes dead insects, parts of them and processed insects. The Commission recently reported that since 1 January 2018 there have been a total of 25 applications for insects. Once they have been through the risk assessment process, performed by the EFSA and the European Commission, novel food might be granted a generic authorization and be marketed all around the EU.

Updating existing safety requirements

Even though they would be authorized as novel foods, new products might face others regulatory obstacles before being placed on the market.

On January 23, the European Commission decided that specific requirements are needed for food derived from insects. In order to ensure smooth functioning of the internal market, it submitted (for comments) a proposal for the processing of insects intended for human consumption. The draft regulation also clarifies the connection between the general food hygiene legislation and novel food authorization procedures. It provides that insect food operators active in processing activities shall be subject to approval by their national competent authorities1.

Since the ECJ issued its opinion on the definition of technics of genetic modification, plant-based proteins obtained from new directed mutagenesis technics, such as CRISPR, are considered as GMO. As a consequence, they do not fall under the Novel food Regulation but must comply with all the constraining requirements provided by the GMO legislation. However, the European Commission is to start reviewing the current legislation on this issue by the end of the year.

Finally, the labelling of some of the alternative proteins is under discussion at European level, since the European Commission decided to register a European Citizens’ Initiative entitled ‘Mandatory food labelling Non-Vegetarian / Vegetarian / Vegan’. Beyond general principles and information fairness, in order not to mislead the consumers, new proteins’ labelling could therefore be specifically regulated soon.

Food safety and legal certainty are key challenges for both the food industry and public institutions, but also for the final consumer. The recent development of new products raised challenging safety concerns for public bodies, which intend to follow the way forward by regulating their marketing.

However, as the European Commissioner Hogan recently said: “Good food means good business” and by identifying relevant opportunities offered by the law, food business operators are enabled to supply better food to the consumer, and more in line with new food trends.

This article was first published by EU Food Law on March 1, 2019.

Photo of Katia Merten-Lentz

Keller and Heckman food law attorney Katia Merten-Lentz was interviewed for the Le Monde article (in French) “Des insectes dans notre assiette, en toute légalité?” which reported on the recent European Commission decision on insect-based food for human consumption confirming that prior authorization is required. Keller and Heckman’s Food and Drug Practice has been monitoring this topic, for a brief history of the legislation (in English) click here and for a succinct summary of the legislation (in English) click here.

Photo of Katia Merten-LentzPhoto of Caroline Commandeur

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Edible insects are covered by the EU’s novel food regulation – but none have yet made it to the list of authorised novel foods. Legal experts from Keller and Heckman Katia Merten-Lentz and Caroline Commandeur weigh in on the the legal status of edible insects in Europe.

The importance of proteins in daily diet is now widely recognised across the world. At the same time, traditional animal sources of proteins like meat, containing all the nine essential amino acids necessary for the human diet, are becoming increasingly controversial, especially as a consequence of their big environmental footprint.

In this context, insect consumption could be an answer. Insects are complete proteins, comprising of all nine amino acids. They are also much more environmentally friendly than traditional meat production.

However, the marketing of edible insects within EU remained a sensitive issue for a long time. The legal gap on their status was only filled in 2015, with the adoption and update of the Novel Food Regulation, applicable since 2018.


Legal gap on insects’ status

In 1997, when the first Novel Food Regulation (EC) No 258/97 was adopted, it defined as ‘novel’ any food or food ingredient which had not been used for human consumption to a significant degree before 15 May 1997 and which fell under one of the categories listed by the regulation, including “food ingredients isolated from animals”.

However, it was silent regarding whole insects and ingredients from whole insects – such as whole insects flour, leading to diverging national interpretations on the legal status of these foods and ingredients.

For instance, the UK Food Standard Agency considered whole insects and their parts as not covered by Novel Food Regulation, while France, Spain and Sweden systematically considered insects, whichever their shape, as novel food requiring a pre-market authorization. The Belgium authorities adopted a tolerance policy in relation to ten insect species, and in Germany, no position was taken at federal level, leading to differentiated approaches among the different German ‘Länder’.

To fix and harmonize the legal status of edible insects across EU, the expanded definition of novel food since 2015 explicitly includes “food consisting of, isolated from or produced from animals or their parts” in the categories of food that may constitute a novel food. To dispel any doubts, recital 8 of the new novel food Regulation even states that “those categories should cover whole insects and their parts”.

Insects now clearly fall into the scope of the Novel Food Regulation, and for this reason must be specifically authorized and included in the Union list of authorized novel food, to be placed on the European market.

However, such list, established by Regulation (EU) No 2017/2470, does not contain any insects or food derived from such animals yet.


Transitional measures

The patchwork of legislation in Member States necessitated the introduction of transition arrangement to cover foods that had been legally sold prior to 2018.

Article 35(2) of Regulation (EU) No 2018/2283 details these transitional measures with respect to insects lawfully placed on the market before 1st January 2018 in Member States who previously permitted it such as Netherlands, UK, Finland or Denmark.

Such products may continue to be marketed until an Novel food authorization is granted in accordance with the new novel food rules. In other words, food business operators have to submit to the Commission either an application for authorization of a novel food (in accordance with articles 10 to 13 of the Novel Food Regulation), or a notification of a traditional food from a third country (as set out in articles 14 to 20 of the Novel Food Regulation).

There is a strict deadline for submitting their dossier: before 1 January 2019.


Strategic choice for applicants: notification and authorization procedure

Whether to seek approval via the authorization or notification procedure is an important strategic decision for food makers.

As insects are commonly part of the daily diet in other parts of the world and derived from primary production, they could theoretically fit with the definition of traditional foods from third country. If a food business operator is able to demonstrate a history of safe use for at least twenty-five years in a third country, he can opt for a simplified procedure of notification, instead of following the whole procedure of authorization.

However, this notification procedure does not prevent Member States and/or European Food Safety Authorities from making some duly reasoned safety objections to the placing on the market of the traditional food.

Taking into account recent EFSA’s publications on risk profile related to consumption of insects as food (2015) and for the house cricket (2018), which both highlighted the lack of data related to possible hazards when insects are used as food, this procedure is probably not suited for fast-track placing on the market of edible insects.

Moreover, the choice for this fast-track procedure would also prevent the applicant from requesting data protection, a possibility the standard authorization procedure normally offers.

To date, five novel foods applications regarding insects have been submitted to the European Commission: two species of crickets (acheta domesticus and gryllodes sigillatus), two types of mealworm (tenebrio molitor) and mealworm larvae products (alphitobius diaperinus).

None of EFSA’s scientific opinions on their safety have been published yet. However, the first two draft scientific opinions were discussed in early October 2018: it was considered that additional information from the applicant was needed to proceed with the scientific assessment of applications regarding dried mealworm.

In this context, even if the legal gap on their status was filled, insects will not be part of our European diet in the coming months.