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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

Cet article a été publié sur Agra Alimentation, le média des enjeux de stratégiques et financiers de l’agroalimentaire.

 

CJUE > Les nouvelles techniques de sélection végétale engendrent-elles des OGM au sens du droit européen? Saisie de cette question par le Conseil d’État français en 2015, la Cour de justice de l’Union européenne (CJUE) vient de répondre par la positive, en décidant, le 25 juillet 2018, que les organismes obtenus au moyen de techniques/méthodes de mutagenèse, constituent des organismes génétiquement modifiés au sens de la directive OGM.

Depuis 2001, en application de la directive dite OGM, un organisme génétiquement modifié est défini comme « un organisme, à l’exception des êtres humains, dont le matériel génétique a été modifié d’une manière qui ne s’effectue pas naturellement par multiplication et/ou par recombinaison naturelle ».

À ce titre, il doit faire l’objet d’une autorisation préalable de mise sur le marché. De plus, l’utilisation d’une variété végétale génétiquement modifiée n’est possible que si toutes les mesures appropriées ont été prises pour éviter les risques pour la santé humaine et l’environnement…

Cependant, jusqu’à présent, les organismes issus de certaines techniques, telles que la mutagénèse, bénéficient d’une exemption et ne sont pas soumises aux obligations (contraignantes) de la directive OGM. En effet, contrairement à la transgénèse, la mutagénèse ne nécessite pas l’insertion d’ADN étranger dans un organisme vivant et, par conséquent, l’organisme obtenu n’est pas considéré comme un OGM.

Mais cette exemption ne concerne que des méthodes de mutagénèse dites conventionnelles ou aléatoires, appliquées in vivo, afin de créer des variétés tolérantes aux herbicides (VrTH) et utilisées depuis des décennies, sans engendrer de risques identifiés pour l’environnement, ou la santé.

Or, de nouvelles techniques/méthodes sont apparues ces dernières années. Certaines d’entre elles sont aujourd’hui appliquées in vitro ou de manière ciblée, afin de provoquer une mutation précise dans un gène, et leur distinction d’avec un OGM semble de plus en plus ténue.

 

Une distinction entre les méthodes « traditionnelles » et les méthodes « nouvelles »

Interrogée en premier lieu sur l’application de la directive OGM à ces nouvelles techniques, la Cour de Justice a, tout d’abord, considéré que, dans la mesure où les techniques de mutagenèse modifient le matériel génétique d’un organisme d’une manière qui ne s’effectue pas naturellement, les organismes obtenus par mutagenèse sont des OGM.

Néanmoins, en ce qui concerne l’exemption prévue par la directive, la cour opère une distinction entre les techniques de mutagénèse dites « traditionnelles » et les nouvelles techniques.

Contrairement aux techniques de mutagénèse qui ont été traditionnellement utilisées pour diverses applications et dont la sécurité est avérée depuis longtemps, les nouvelles techniques de mutagénèse « dirigée » permettent d’obtenir les mêmes effets que la transgénèse et de produire des variétés génétiquement modifiées « à un rythme et des proportions sans commune mesure avec ceux résultant de l’application de méthodes traditionnelles de mutagénèse aléatoire ».

Leur dissémination pourrait donc produire des effets irréversibles sur l’environnement, ce qui contreviendrait aux principes énoncés par la directive, à savoir le principe de précaution et de protection de la santé humaine et de l’environnement.

Aussi, aux termes d’une lecture rigoureuse du texte de la directive et de ses objectifs, la Cour a décidé que les organismes issus de nouvelles techniques de mutagénèse, ne peuvent pas bénéficier de l’exemption prévue par la directive et doivent donc être soumis aux procédures d’autorisation préalable.

 

La réglementation des organismes obtenus par mutagénèse traditionnelle

La Cour n’a pas remis en cause l’exemption dont bénéficient les organismes issus de mutagénèse traditionnelle Et a même ajouté que les variétés végétales obtenues à partir de ces organismes pourront être utilisées sans que des mesures spécifiques n’aient à être prises.

Mais les États membres restent libres d’adopter des législations nationales spécifiques afin de les soumettre aux obligations prévues par la directive OGM, ou à d’autres obligations.

Du droit à l’innovation

Bien qu’elle éclaire les industriels sur le statut juridique des organismes issus de nouvelles techniques de mutagénèse, cette décision contredit à la fois les conclusions de l’avocat général Bobek et l’avis du Haut Conseil français des biotechnologies de novembre 2017, et peut donc surprendre.

De surcroît, le cadre réglementaire auquel il les soumet, est très contraignant et limite la possibilité de prendre en compte les perspectives réelles de développement des biotechnologies dans le secteur semencier.

Cela étant, cette décision devrait permettre à la Commission européenne – qui n’a pas de pouvoir d’interprétation de la législation – d’avancer enfin sur l’évaluation de ces nouvelles techniques (attendue pour fin 2018) et éventuellement, l’élaboration d’une réglementation spécifique.

Photo of Katia Merten-Lentz

This article was originally published in EU Food Law.

ANALYSIS

Should organisms developed through new plant breeding techniques (NPBTs) be considered GMOs under EU law and be subject to the strict GMO approval process? The European Court of Justice (ECJ) is expected to issue a judgement on this issue, which will indicate if the existing GMO legislation needs to be updated, writes Katia Merten-Lentz of international law firm, Keller and Heckman.

The term NPBTs describes scientific methods for the genetic engineering of plants to enhance desired traits like drought tolerance and pest resistance, by modifying the DNA of the seeds and plant cells. These techniques have significantly evolved over time, allowing faster and more precise results than conventional plant-breeding techniques.

Legislative framework
In the EU, the deliberate release into the environment of GMOs and their placing on the market is regulated by Directive 2001/18/EC (GMO Directive).

Article 2(2) of the GMO Directive defines a genetically modified organism as “an organism, with the exception of human beings, in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination”.

For the organisms within its scope, the GMO Directive provides for an authorisation requirement preceded by an environmental risk assessment.
However, according to Article 3 of the GMO Directive, it is not applicable to organisms obtained through certain techniques of genetic modification listed in Annex I B, such as ‘mutagenesis’.

The GMO Directive does not provide a definition of mutagenesis, but it is generally understood as a technique that mimics the natural process of mutations and induces mutations. Mutagenesis does not entail the insertion of foreign DNA into a living organism, however, it involves an alteration of the genome of a living species.
In the context of NPBTs, it is important to note that the GMO Directive attaches great importance to the precautionary principle. For instance, Recital 5 provides that “[t]he protection of human health and the environment requires that due attention be given to controlling risks from the deliberate release into the environment of genetically modified organisms (GMOs)”.

In addition, Article 23 of the GMO Directive contains a safeguard clause allowing Member States to provisionally restrict or prohibit the use of a GMO on their territory where as a result of new or additional information or “reassessment existing information on the basis of new or additional scientific knowledge”, the Member States have detailed grounds for considering that a GMO constitutes a risk to human health or the environment.

Legal proceedings
In France, the Environmental Code excludes organisms obtained through mutagenesis from the GMO regulation by virtue of Article D531-2.

Nevertheless, in December 2014, Confédération paysanne, a French agricultural union representing small-scale farming, together with other associations have challenged the legality of this article and brought an action before the Conseil d’État.

According to Confédération paysanne and associations which supported them, mutagenesis techniques have significantly evolved since the adoption of the GMO Directive. Current methods allow, for instance, to obtain seeds resistance to certain herbicides only, and the use of such products poses risk to the environment and to human and animal health.

To ascertain whether organisms resulting from traditional and new forms of mutagenesis have to be subject to the GMO legislation, the French Conseil d’État made a reference for a preliminary ruling to the European Court of Justice (‘ECJ’).

In October 2017, the ECJ convened a hearing in a grand chamber, which was followed by an Opinion of Advocate General Michal Bobek published on 18 January 2018. The Advocate General concluded that there is no need to update the GMO legislation, noting that organisms obtained by mutagenesis are, in principle, exempted from the obligations under the GMO Directive.

Although the opinion of an Advocate General is not binding, it is rarely ignored by the Court. However, the ECJ’s ruling, which was expected in May, has been delayed.

Current debate
On the one hand, supporters of NPBTs, such as the biggest farmers’ association in the EU, Copa-Cogeca, argue that plants obtained through the NPBTs techniques in question could also be the products of conventional cross-breeding techniques and therefore cannot be considered as genetically modified organisms (GMOs).

In addition, some Member States, such as the Netherlands, believe that the new plant breeding techniques should not come under the GMO legislation as they are as safe as traditional breeding.

On 7 September 2017, the Netherlands made a proposal to improve the exemption mechanism for genetically modified plants under the GMO Directive.
According to the Dutch proposal, the current regulatory framework has a disproportionate impact on costs and creates barriers to the use of innovative technologies. Furthermore, the lack of legal certainty leads to an increased “disharmonisation as regards the application of the GMO Directive to products resulting from the use of NPBTs”.

On the other hand, the organic food sector generally insists that NPBTs should fall within the scope of the GMO legislation. Some of the stakeholders believe that these new biotechnology-driven techniques were developed by the seed industry in response to consumers’ massive rejection of GMOs obtained through long-established techniques.

NGOs like Greenpeace claim that if NPBTs were not regulated under the EU GMO Directive, there is a danger that existing legislation does not cover the risks NPBTs pose to the environment.

The results of the recent research entitled “European consumer healthiness evaluation of ‘Free-from’ labelled food products” conducted by ETH Zurich and European Food Information Council aimed to find out how various free-from labels, including free of GMOs, shape perceptions of foods seem to be particularly relevant in this context.

As stated in the report on the research, which was released in December 2017, French respondents, for instance, were very receptive to GMO-free claims. The debate was intensified when on 28 March, the US Department of Agriculture (USDA) issued a statement regarding the state-of-play on NPBTs. According to the statement, the USDA “does not regulate or have any plans to regulate plants that could otherwise have been developed through traditional breeding techniques as long as they are not plant pests or developed using plant pests”.

Conclusion
Many in the food industry believe EU GMO legislation must apply to the new plant-breeding techniques, as otherwise European consumers, farmers and breeders would not be able to avoid GMOs.

Others warn EU policymakers to take immediate action and encourage innovative new plant breeding techniques following the US decision not to regulate them.

The interpretation of the existing law by ECJ is likely to influence the Commission’s stance on the need for an update of the GMO legislation with regards to the NPBTs. Moreover, some argue that the ruling which puts to the test precautionary principle may have an impact on genetic engineering in general.