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.
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.
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.