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the 1st January 2018, the new Regulation (EU) No 2015/2283 on novel foods has applied within the EU, replacing previous outdated rules issued from Regulation (EC) No 258/97, which framed these specific foods for nearly twenty years.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.