Updated regulations are simplifying the authorization process for traditional foods entering European markets from non-member state countries. In their article, “Nouveaux aliments des pays tiers : un premier bilan encourageant”, which appeared in Les Marchés on January 25, 2019, Katia Merten-Lentz and Caroline Commandeur discuss the new regulations and their potential impact on the food market moving forward. To read the full article, click here.
Where does laboratory produced meat fit in the regulatory frameworks of the US and the European Union?
Meat produced in a laboratory is close to coming to market, raising questions about the regulatory hurdles the US and EU may put in place
Published 11 Dec 2018 at EU Food Law
On 16th November 2018, the US Department of Agriculture and the US Food and Drug Administration announced that they had reached an agreement on a joint regulatory framework on laboratory made, cultured meat, also called in vitro meat. The Agencies have not yet revealed which framework will apply to this new way of making meat, but their respective roles have been clarified, as Katia Merten-Lentz of international law firm, Keller & Heckman, reports.
Cultured meat, or in vitro meat, is a form of cellular agriculture allowing the growth of meat from animal cells. Over the last few years, the price of producing this meat has dropped drastically, raising the possibility of these meats hitting the market.
However, these developments have also raised questions about their regulatory status, safety and labelling issues.
The statement released by the USDA and the FDA in November is another step towards the setting up of a regulatory framework regarding in vitro meat. The agencies have decided to oversee jointly the production of in vitro meat , according to their regular competencies: the FDA will oversee the first stages regarding cell-culture technology, and USDA the production and labelling of in vitro-meat. The joint statement of USDA and FDA does not explain which regulatory status will be applied to lab meat. But this status – as well as labelling issues – will have to be settled before the meat is placed on the market.
Regulatory status and safety assessment of meat in vitro
The US and EU regulatory framework regarding meat in vitro will differ.Regarding the US, several hypotheses can be explored. The first important hurdle is that it is arguably difficult to consider that in vitro meat fits in the definition of “meat product” as defined in the Federal Meat Inspection Act (FMIA), since FMIA assumes a meat food product is derived from a carcass.
If FMIA is inapplicable to culture meat, the rules regarding conventional foods would probably apply, and the FDA’s Biotechnology Policy could provide some help in analysing the status of cultured meat.
It is also possible that in vitro meat could be considered to be a food additive.
The current method for growing in vitro meat consists of using a cell culture medium or scaffold, which is a structure where the cells attach to in order to allow growth, and cellular growth factors.
As explained by the Food and Drug Law Institute , the FDA may consider that these substances are food additives, since they are intentionally added to a food.
If it is the case, they will have to be authorised, unless they meet the two so called GRAS criteria (generally recognized as safe) i.e.: there is a reasonable certainty of no harm; and the intended use of the substance in food must be recognised as safe by qualified experts based on publicly available scientific information (general recognition standard).
Moreover, the safety of the primary cells used would also have to be asserted, since they are genetically modified cell lines. This may pose a hurdle, as, according to the US Consumers Union, “these lines exhibit the characteristics of a cancerous cell”.
In the EU, the regulatory status of in vitro meat has already been settled: it will have to be authorised as a novel food at the European level.
Indeed, in vitro meat falls under a relevant category in the Novel Foods Regulation that explicitly refers to food produced from cell culture or tissue culture derived from animals.
In its answer to a parliamentary question on this topic in October, the European Commission confirmed that in vitro meat may fall in this category and must then be considered as a novel food.
In the EU, the regulatory status of in vitro meat has already been settled: it will have to be authorised as a novel food at the European level.
For being authorised as a novel food, the producers of in vitro meat will have to file an application which must include all relevant data.If the product is deemed safe after a scientific assessment by the European Food Safety Authority (EFSA), the Commission can enact a Regulation to authorise in vitro meat. The Commission recently confirmed that no application for the authorisation of in vitro meat has been received so far.
Therefore, in vitro meat cannot yet be placed on the market, and any such meat would be seized by the authorities.
This is what happened in December 2017, when tasting experiments of cultured meat made by the company JUST were organized in the Netherlands, and the Dutch Safety Authority sealed the products to prevent them from being consumed.
Issues regarding labelling
The Novel Foods Regulation states that when novel foods are added to the Union list of authorized novel food, there can be requirements regarding labelling, in order to fully inform the consumer, for instance by describing the food or its composition. It is more than likely that specifications will be added for in vitro meat.
In any case the EU Regulation on Food Information to Consumers (also known as ‘the FIC Regulation’) will apply to in vitro meat once it is authorised, but its application may prove challenging.
For instance, there is an obligation to indicate on the label the denomination of a food, but there are unsolved issues regarding the denomination of in vitro meat.
Since this food is not on the market yet, there is no legal name and no customary name either. Many names already coexist (in vitro meat, cultured meat, clean meat, lab meat, etc.), and the choice of the name is quite touchy.
Since the FIC Regulation’s main objective is to ensure that fair, clear and precise information is provided to the consumers – for instance about the manufacturing or production method – it seems very likely that operators will have to ensure that the product name makes clear that the meat has been grown in a lab.
Moreover, in vitro meat does not comply with the current European definition of “meat”. According to the FIC Regulation, the definition of meat – for labelling purpose – is: ‘skeletal muscles of mammalian and bird species recognised as fit for human consumption with naturally included or adherent tissue (…)’. In vitro meat neither consists of “skeletal muscles” (‘muscles under the voluntary control of the somatic nervous system’) nor of ‘naturally’ included or adherent tissues, so it would mean that the term ‘meat’ could not be used in the current state of the EU legislation.
For the EU, probably only the submission of a novel food application to EFSA could start a process towards a regulatory framework.
The exact same issue applies for the US as in vitro meat does not comply exactly with the definition of “meat food product” under FMIA. In the EU, there are also specific issues regarding the labelling of meat that will be difficult to apply to in vitro meat.
Several regulations make the indication of the country of origin or place of provenance of meat mandatory. However, for in vitro meat, since there is no animal being born, reared or slaughtered, it will be virtually impossible to apply this disposition.
In the US, the public is given the opportunity to comment on the regulatory issues regarding lab meat until 26 December 2018. The expected statements that will follow from the public agencies will hopefully reveal for operators the first outlines for a regulatory framework for in vitro meat.
For the EU, probably only the submission of a novel food application to EFSA could start a process towards a regulatory framework.
This article was published at Foodnavigator.com.
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.
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.
Originally published 5 July 2018 at www.foodnavigator.com
The new EU novel food regulation aims to make it easier to get innovative food solutions to the European Market. But this left some concerned that a lack of confidentiality could deter investment in innovation. Katia Merten-Lentz, partner at Keller and Heckman, looks at the latest protections that have been put in place.
Since 1997, every novel food must be specifically authorized before being placed on the European market. However, since January 2018 and application of the new novel foods, such authorization is not granted to the sole applicant anymore. Now, once a novel food is officially included in the Union list of authorized novel foods, any food business operator may market it within the EU.
In order not to discourage new technologies and innovations in food production, as they could reduce the environmental impact of food production, enhance food security and bring benefits to consumers, data protection and confidentiality of information provided in support of a novel food application have been introduced by Regulation 2015/2283.
Applicants may request confidential treatment of certain information where disclosure of such information may harm their competitive position. This opportunity applies not only in the context of applications and notification to support the placing on the European market of a novel food, but also for the consultation process for determination of novel food status. The Commission rules on the request, and in case of disagreement, the applicant has the opportunity to withdraw its application within three weeks, during which the confidentiality is observed.
When submitting the dossier, applicants must indicate which information they wish to be treated as confidential and provide verifiable justification to substantiate this request – knowing that some basic details, such as identity of the applicant, name and description of the novel food, or the summary of the studies submitted, cannot be treated as confidential.
In addition, newly developed scientific evidence or scientific data supporting a novel food application may be denied to support a subsequent application, where data protection is requested and supported by appropriate and verifiable information. Notably, the applicant must justify exclusive right of reference to the proprietary scientific data or evidence and the novel food could not be assessed – and therefore authorized, without the submission of such data.
Where the Commission concedes data protection, and latter approves the placing on the EU market of the novel food, it would grant, by exception, an individual and exclusive authorization to the applicant. In that case, the Union list specifies the date of inclusion, the name and address of the applicant and the end date of data protection. During the five-year period of data protection, which begins from the date of inclusion of the novel food in the Union list, only the specified applicant may place it on the market. When the period expires, protection cannot be renewed.
Concession of data protection does not prevent other food business operators to submit a dossier to seek, without reference to the proprietary scientific evidence or scientific data protected, authorization for marketing of the novel food. They may also try to obtain agreement of the initial applicant to refer to the specific protected data, or to directly market the novel food.
Importantly, the above-mentioned provisions on data protection only apply to applications for authorization. In that respect, food business operators, who wish to benefit from data protection for traditional foods from third countries, need to follow the common authorization process, which requires more numerous, specific and different information than the simplified notification and specific authorization they may however opt for. This specific point is likely to explain why for various insects, common authorizations were recently submitted, instead of simple notifications.
Novel food and health claims requests
Specific provision was also introduced by Regulation 2015/2283, where the applicant submits to the Commission two applications related to a novel food – one for placing it on the market and another one to use a specific health claim related to it, in accordance with Regulation (EC) 1924/2006 on nutrition and health claims made on foods. If the two applications are accompanied with a request for data protection, and in order to make it possible for the respective data protection periods to run concurrently, the applicant is now allowed to request the Commission to suspend the authorization procedure for novel food, until the Authority adopts its opinion on the health claim.
To conclude, the new Regulation on novel foods introduces interesting tools to support innovative food business operators, by giving them competitive advantage, through the data protection of their innovative researches submitted upon novel food authorizations. However, these rules may be already challenged, by the forthcoming revision of the General Food Law Regulation, which aims to strengthen transparency of scientific studies in the whole food safety area, including obviously novel foods.
Cet article a été publié sur Agra Alimentation, le média des enjeux de stratégiques et financiers de l’agroalimentaire.
Le nouveau règlement (UE) n°2015/2283 sur les aliments nouveaux, est entré en vigueur le 1er janvier 2018. Tout en intégrant expressément, de nouvelles catégories d’aliments, telles que les insectes, ou les nanomatériaux, il harmonise et simplifie la procédure d’autorisation de mise sur le marché de ce type de denrées et apparait, dès lors, davantage comme un outil, plutôt qu’un obstacle à l’innovation.
Il convient de rappeler qu’un aliment nouveau (ou novel food) est défini depuis 1997, sur la base de deux critères : le fait qu’il n’ait pas été consommé de manière régulière avant le 15 mai 1997, et qu’il appartienne à au moins une des catégories listées dans le texte. Cette approche n’est pas modifiée par le nouveau règlement.
En effet, les nouveaux aliments font l’objet d’une présomption de nocivité, leur innocuité doit donc être établie préalablement à leur mise sur le marché. L’objectif affiché de la nouvelle réglementation est notamment de mettre en place une procédure d’autorisation qui soit plus efficace, rapide et transparente, tout en maintenant un niveau de sécurité élevé.
Définition élargie sur le statut novel food
Tout en reprenant la définition traditionnelle des aliments nouveaux, comme étant toute denrée alimentaire dont la consommation humaine était négligeable au sein de l’Union avant le 15 mai 1997, le nouveau règlement vient compléter les catégories auxquelles peuvent appartenir ces substances.
Il intègre ainsi, les aliments d’origine minérale, issus de culture cellulaires ou composés de nanomatériaux, ainsi que les aliments fabriqués, isolés ou produits à partir d’animaux.Les insectes sont donc désormais considérés – sans ambiguïté – comme des aliments nouveaux.
Néanmoins, il appartient aux seuls opérateurs qui souhaitent commercialiser un aliment possiblement « nouveau », de déterminer si celui-ci relève, ou pas, du règlement. Le nouveau règlement prévoit, à cet égard, qu’ils pourront consulter les autorités nationales sur le statut novel food d’un aliment, tout en assurant la confidentialité des données fournies.
Procédure d’autorisation préalable plus simple et rapide
Les demandes de mise sur le marché doivent désormais être soumises directement à la Commission européenne, qui en publie un résumé. ÀA ce titre, quinze demandes ont déjà été déposées depuis le début de l’année.
L’Agence européenne de sécurité alimentaire (EFSA) procède alors à l’évaluation scientifique du nouvel aliment en vérifiant si la composition de l’aliment et ses conditions d’utilisation ne présentent aucun risque en matière de sécurité pour la santé humaine dans l’Union.
A ce titre, elle préconise que les dossiers soumis incluent des données sur la composition, sur les propriétés nutritionnelles, toxicologiques et allergènes, mais également, des informations relatives au processus de fabrication et aux utilisations du nouvel aliment.
Le nouveau règlement a largement accéléré la procédure d’autorisation, qui devrait durer au total 18 mois.
Procédure simplifiée pour les aliments traditionnels en provenance des pays tiers
Pour certains aliments « exotiques », le nouveau règlement prévoit que les demandeurs doivent être en mesure de choisir une procédure plus rapide et plus simple.
Il s’agit des « aliments traditionnels en provenance de pays tiers », issus de la production primaire, qu’il s’agisse d’aliments transformés ou non, qui ont un historique d’utilisation sûre en tant que denrées alimentaires, dans au moins un pays extérieur à l’UE, pendant une période de 25 ans au minimum.Le plus souvent, il s’agit d’aliments fabriqués à partir de plantes, de micro-organismes ou de champignons.
Le demandeur peut simplement notifier l’aliment à la Commission européenne, sans avoir à effectuer de tests couteux pour justifier son innocuité. A ce titre, deux notifications ont déjà été déposées pour les baies d’Hasak et le fonio blanc en mars 2018.
La Commission transmet le dossier aux Etats-membres et à l’EFSA, qui ont alors 4 mois pour formuler des « objections de sécurité dument motivées », c’est-à-dire une déclaration scientifique indiquant en quoi l’aliment traditionnel pourrait présenter un risque pour la santé humaine.
Dans cette hypothèse, le demandeur a la possibilité de transformer sa notification en demande d’autorisation « normale », tout en répondant aux objections soulevées. L’EFSA est saisie pour avis et dispose alors de 6 mois pour évaluer des risques selon une approche différente : une analyse restreinte, axée sur l’historique d’utilisation sûre.
Au lieu et place d’autorisations nominatives, le nouveau règlement a mis en place une liste de l’Union compilant exhaustivement toutes les autorisations déjà données, ainsi que celles que la Commission sera amenée à délivrer dans le futur. Mais désormais, ces autorisations seront génériques.
La protection des données fournies par le demandeur
Afin de contrebalancer, quelque peu, le caractère désormais générique des autorisations « novel food », le demandeur peut désormais solliciter un droit de référence exclusif pour les données scientifiques nouvellement établies qu’il fournit et ce, pour une durée de 5 ans. Cependant, cette possibilité n’est pas prévue dans le cadre de la procédure simplifiée pour les aliments traditionnels.
En conclusion, et bien qu’il soit à la fois, difficile de résumer cette nouvelle réglementation en quelques paragraphes, mais surtout d’en tirer des conséquences avec un recul de seulement quelques mois, on peut néanmoins déjà considérer que ce nouveau cadre règlementaire va permettre aux opérateurs d’envisager plus sereinement toute innovation.
En effet, les ambitions affichées de la Commission européenne d’accompagner désormais les opérateurs plutôt que de les freiner, trouve déjà une illustration dans la plus grande visibilité quant à la durée des procédures proposées, la protection des données désormais proposée ou encore, la mise en place de cette « notification » pour aliments des pays tiers. Tout cela semble de très bon augure.
This article was originally published in Food Navigator.
Could new novel food rules open up the European market to a wave of exotic foods and ingredients? Katia Merten-Lentz, partner at international law firm Keller and Heckman, believes a streamlined process offers potential to increase innovation around ‘traditional’ food.
Unlike its predecessor, under which all novel foods were subjected to the same rules, the new Novel Food Regulation (2015/2283) introduces the notion of ‘traditional foods from a third country’. By laying down specific rules for food that fall into this category, the regulation aims to facilitate their entry onto the EU market.
What is a ‘traditional food from a third country’?
A traditional food from a third country is defined as a “novel food which is derived from primary production (…) with a history of safe food use in a third country”.
According to this definition, a traditional food is, first and foremost, a novel food. This term refers to food that was not consumed within EU before 1997.
It must also fall into one of the categories explicitly mentioned in the Regulation. Notably, traditional foods can be categorised as food consisting of, isolated from or produced from: microorganisms, fungi or algae; plants of their parts; animals and their parts or cell culture of tissue culture derived from animals, plants, micro-organisms, fungi or algae.
The other six categories of novel foods mentioned by the Regulation, mainly refer to technological progress and therefore cannot be considered as traditional food.
A traditional food from a third country should be derived from primary production, articulated in General Food Law Regulation 178/2002: “The production, rearing or growing of primary products including harvesting, milking and farmed animal production priori to slaughter, hunting, fishing and the harvesting of wild products”.
Lastly, a traditional food must have a history of safe food use in at least one non-EU country. In other words, its safety must be confirmed with compositional data and experience of continued used in the customary diet of a significant number of people in at least one third country for at least 25 years.
Simplified authorisation procedure
Like every other novel food, a traditional food from a third country needs a pre-market authorisation to be able to be sold or used in the EU.
However, articles 14 to 20 of Regulation 2015/2283 completed by Commission Implementing Regulation 2017/2468 that specify administrative and scientific requirements concerning traditional foods from third countries, introduce a special procedure for their safety assessment.
Instead, instead of following the normal procedure for authorizing a novel food, a food business operator may opt to submit to the Commission a simple notification of his intention to place on the EU market a traditional food from a third country. The Commission will then forward this notification to all the Member States and EFSA. These parties can then submit duly reasoned safety objections within four months.
In case of any safety objection, the applicant may convert the notification into a formal application for which a safety evaluation will be requested from EFSA. Otherwise, the traditional food will be directly authorised by the European Commission.
The total time length of these two simplified procedures should be four to fifteen months. The classical procedure took take nearly twice as much time. Also, the content of the dossier, even when converted in a genuine application, has been reduced.
First test: fonio and haskap berries
Since the new Novel Food Regulation entered into force in January, two notifications have been submitted to the European Commission: one for fonio (decorticated grains of a small seeded cereal, historically used in West-Africa as a substitute for rice) and one for haskap berries (consumed at least in Japan over past 25 years according to the applicant).
The way these notifications will be handled will be a first real test. It is likely to foreshadow the practice that will be developed by the authorities. We will see if fonio and haskap berries can be legally marketed in the EU in the coming months.
Cet article a été publié sur Les Marchés, le Média de l’alimentaire.
Le récent développement du commerce alimentaire en ligne suscite à la fois enthousiasme et inquiétudes quant aux conséquences juridiques d’une vente qui se caractérise par l’absence physique à la fois du vendeur et du consommateur. L’Europe se penche sur la question.
En février 2018, la Commission européenne a publié un rapport sur le premier programme de coordination des contrôles du commerce alimentaire en ligne. Les autorités nationales ont été invitées à examiner près de 11 000 sites Internet proposant certaines denrées dans leur pays. L’enquête rapporte 428 offres de nouveaux aliments non autorisés, 351 compléments alimentaires avec des allégations non conformes et 779 offres manifestement non conformes à la législation européenne.
Il convient de rappeler que la législation alimentaire européenne harmonise les règles applicables à la sécurité, à l’hygiène, mais également à l’étiquetage des denrées alimentaires destinées à la consommation. Cependant, l’émergence de nouveaux modes de commercialisation soulève des questions pratiques quant au respect de ces dispositions et au maintien d’une concurrence loyale entre les opérateurs du marché agroalimentaire.
Respect des règlements Inco et «novel food»
Au-delà du marketing, des exigences sont applicables au contenu des denrées. La vente alimentaire en ligne est définie en droit européen comme une « technique de communication à distance », c’est-à-dire tout moyen qui, sans présence physique et simultanée du fournisseur et du consommateur, peut être utilisé pour la conclusion du contrat entre eux. Ainsi, l’emballage de la denrée et sa présentation sur le site Internet du vendeur restent soumis aux dispositions du règlement Inco.
Les informations obligatoires doivent donc être fournies avant la conclusion de l’achat et figurer sur le support de la vente à distance, c’est-à-dire sur le site Internet. Elles doivent aussi être transmises au moment de la livraison. La vente en ligne doit, en outre, respecter les règles spécifiques d’étiquetage en ce qui concerne les allégations nutritionnelles et de santé. Seules les allégations autorisées au niveau européen et listées comme telles par la Commission européenne peuvent être mentionnées en ligne, comme sur l’emballage des aliments.
Enfin et aussi logiquement, les « nouveaux aliments » qu’ils soient vendus en ligne ou via des circuits traditionnels de distribution, doivent respecter les règles spécifiques du régime « novel food ». Pour rappel, la mise sur le marché d’aliments nouveaux est soumise à une procédure d’autorisation préalable harmonisée à l’échelle européenne et, par conséquent, seules les substances autorisées peuvent être légalement commercialisées.
Adaptation des contrôles officiels
Le respect des règles de sécurité et d’hygiène et les contraintes logistiques constituent le premier frein au développement du commerce alimentaire en ligne. Le législateur européen a explicitement soumis les produits achetés en ligne au nouveau règlement sur les contrôles officiels, qui s’appliquera à compter du 14 décembre 2019. Ainsi, les autorités nationales pourront commander des produits en ligne sans s’identifier et utiliser les produits achetés en tant qu’échantillons officiels.
La non-conformité des produits vendus en ligne pourra entraîner des sanctions qui seront désormais calculées en fonction des gains économiques réalisés ou d’un pourcentage du chiffre d’affaires et qui s’appliqueront indépendamment du lieu d’établissement de l’exploitant.Les contrôles s’étendront donc aux produits en provenance de pays tiers.
Eu égard au nombre d’infractions constatées, le rappel que l’usage du commerce en ligne n’exonère nullement les opérateurs du respect de la législation alimentaire semblait nécessaire. Il apparaît manifeste que les autorités nationales vont être de plus en plus fermes à l’égard des produits mis en vente en ligne et rétablir ainsi une plus saine concurrence sur le marché.
This article was originally published in EU Food Law.
Since the 1st January 2018, the new Regulation (EU) No 2015/2283 on novel foods has applied within the EU, replacing previous outdated rules issued from Regulation (EC) No 258/97, which framed these specific foods for nearly twenty years. The new Regulation significantly differs from its predecessor, which was full of restrictions. With this new legislation, food business operators are now equipped with the tools for facilitating innovation, as Katia Merten-Lentz, of international law firm Keller & Heckman, writes.
Since 1997, European legislation has always defined a Novel Food based on two cumulative criteria. First, it should be ‘novel’, meaning that the given food – or ingredient – was not used for human consumption to a significant degree within the European Union before the introduction of the legislation on the 15th May 1997. Second, the Novel Food Regulation only applies to those foods falling into one of the categories explicitly mentioned by the Regulation.
In the new Regulation, those two requirements have remain unchanged but their scope has expanded, since the number of categories of possible novel food has increased from four to ten. Food consisting of engineered nanomaterials and food of mineral origin or cell culture are some of the new categories of food covered by Regulation (EU) 2015/2283.
In addition, the main uncertainties regarding some specific foods are now clarified. For instance, whole insects were not clearly defined as novel food under the previous Regulation, which only covered ‘part of animal’. In the new regulation, whole insects are definitely included, falling into the expanded corresponding category of ‘food consisting of, isolated from or produced from animal or their parts’.
For those foods where a doubt would remain, a genuine procedure to rule whether a food is novel or not was introduced. According to Article 4, the Member State authorities where the food is first intended to be marketed may rule whether it must be considered as a novel food, and Article 5 empowers also the European Commission to decide, on its own initiative or upon a request of a Member State, on the novel status of a particular food.
Union list of authorized novel foods
Every food falling into the scope of the Novel Food Regulation must be specifically authorized and included in a unique list of authorized novel foods, before being placed on the European market (Article 6). Every entry of the list corresponds to a given authorized novel food and conditions under which it can be placed on the EU market. Once a novel food is included in the Union list, any food business operator may market it, under the conditions laid down in the Union list.
The initial Union list was established by the European Commission implementing regulation (EU) 2017/2470 and includes all novel foods already authorized. It will be updated each time a novel food is added or removed from the list, or when the conditions of commercialization have changed.
This new system replaces the former and very strict individual authorization which has applied for twenty years. It provides all food business operators, and in particular, small and medium-sized enterprises (SME), with the opportunity to boost their innovation and competitiveness, without having to build an expensive and time-consuming ‘notification dossier’ each time they want to use a novel food already authorized.
Centralized and fast-track procedure of authorization
Every novel food requires a safety assessment and then an authorization, before being placed on the European market. Previously, it was first handled by individual Member States, and then, by the European Commission and the other Member States, who generally requested an additional scientific opinion from the European Food Safety Authority (EFSA). The latter step, supposed to be optional, had in practice become automatic, leading to an unnecessary duplication of the safety assessment, the first to be performed by the national authorities, the second by the European authorities.
But this defect was fixed by the new Regulation, since all applications are now submitted to the European Commission, and the scientific assessment, if requested, is systematically realized by the EFSA, for the purpose of compressing the total time of the procedure from three to five years under the previous rules to around 18 months now. In particular, the new Regulation introduces very strict time frames for each step of the procedure: for instance, EFSA’s opinion must be delivered within nine months, which may be extended only in duly justified cases, where additional information from the applicant is requested.
Simplified procedure for traditional foods from third countries
Some foods, ‘novel’ for Europeans, are in other parts of the world part of the daily diet of the population. Taking this matter of fact into consideration, the new Regulation gives the opportunity for such traditional foods from third countries, derived from primary production and with a history of safe use for at least twenty-five years, to benefit from a simplified procedure of notification. The choice to opt for this procedure of notification, instead of following the whole procedure of authorization, is left to the applicant.
This procedure of notification, which did not exist under the previous rules, is intended to take between four to thirteen months at most. If there are no duly reasoned safety objections submitted by any Member State or the EFSA, the Commission must authorize the traditional food concerned and update the Union list within four months following a notification submitted to the Commission by an applicant. In case of such objections, the applicant may convert the notification into a simplified application for authorization, by adding to the information already provided in the notification, documented data relating to the objections submitted. In this last hypothesis, EFSA is required to adopt its opinion within six months, being three month faster than for the standard procedure.
Data protection and confidentiality provisions
Lastly, the new Regulation also takes into account, for business operators, the very sensitive issue of data protection and confidentiality of their innovative research. According to Article 23, applicants may request confidential treatment of certain information submitted, which extends to information submitted in the context of the consultation process for determination of novel food status, where disclosure of such information may harm their competitive position.
In addition, newly developed scientific evidence or scientific data supporting the application will not be authorized to support a subsequent application during a period of five years. In case data protection is conceded by the Commission, the applicant is granted an individual authorization for placing on the market of a novel food for a limited duration of five years, by way of exception to the generic authorizations.
To be granted, various requirements must be met. In particular, the applicant shall have exclusive right of reference to the proprietary scientific data or evidence and the novel food could not have been assessed and authorized without the submission of such data.
To conclude, even if the two main key-concepts of the Novel Food Regulation – naming the two criteria definition and premarket authorization – do not change with the application of the new rules, the new Regulation introduces various interesting changes to support innovative food business operators and make placing of the market of novel foods clearer, easier and faster.