The new Novel Food Regulation (Reg. 2015/2283) applies since 1 January 2018 in the EU. In this article Karin Verzijden and Jasmin Buijs from Axon Lawyers report on the implementation of the new Novel Food Regulation and the available guidance.
Following up on the ‘old’ Novel Food Regulation (Reg. 258/97), the new Regulation serves to streamline procedures and to regulate new technological developments. Indeed, the old Novel Food Regulation has often been criticized for not being innovation-friendly, as Novel Food authorization procedures could take various years. Moreover, new food categories such as insects as a whole and cultured meat called for an extended scope of the Regulation.
Novel foods are defined as foods which were not used for human consumption to a significant degree within the EU before 15 May 1997, and which fall under at least one of the listed categories. This list of novel food categories has been expanded from 4 to 10 under the new Regulation. Examples of added categories include foods originating from cell cultures, foods consisting of whole animals (such as insects), and foods consisting of engineered nanomaterials.
Centralized authorization procedure
Applications no longer need to be submitted to the national competent authority. As a result of the centralized authorization procedure, they are now sent directly to the European Commission. This is expected to increase the speed of the authorization procedure.
Another remarkable change is that authorizations are no longer individual. Instead, authorized novel foods are added to the EU list, which serves as a so-called ‘positive list’. Every food business operator that complies with the conditions of the authorization can place the respective novel food on the market. Also the applicant-specific novel food authorizations under the old Regulation have been included in the European Union list. This led to an initial list containing 125 entries (numbers as mentioned on the website of the European Commission).
Data Protection for 5 years
This system of generic authorizations replaces the equivalence principle, which meant that foods substantially equivalent to existing foods were not subject to authorization. To protect business interests, applicants that submit newly developed scientific data can request for data protection for 5 years. Competitors cannot benefit from the application during this period unless they are able to provide the required scientific evidence (being essential for the safety assessment of the novel food at stake) themselves.
The new Novel Food Regulation also introduces a faster notification system for traditional foods from third countries, based on history of safe food use for at least one generation (25 years). Also, the new Regulation includes a more fixed time frame for the authorization procedure than previously, with the purpose to run a full authorization procedure within eighteen months. This is a time reduction of about half as compared to the average authorization procedure under the old Regulation.
Assistance to facilitate market access under the new Novel Food Regulation comes from various angles. Since it all starts with the qualification as a novel food, there is now an official consultation procedure for food business operators (FBOs) that are uncertain whether their product or ingredient qualifies as such. They can consult the responsible authority in their Member State, which may in its turn consult responsible authorities in other Member States as well as the European Commission.
The Commission has published an overview of the responsible authorities of Member States to decide on the novel food status. For the Netherlands, this is the Novel Food Unit of the Medicines Evaluation Board (CBG-MEB) (in Dutch: Bureau Nieuwe Voedingsmiddelen van het College ter Beoordeling van Geneesmiddelen). When the responsible authority in the Member State decides the food under evaluation is not a novel food, it can be marketed without having to go through the full authorization procedure. Currently 9 national qualifications have been published (numbers as mentioned on the website of the European Commission).
Once it is clear that a food qualifies as a novel food, Commission Implementation Regulations 2017/2469 and 2017/2468 become relevant as they clarify the application and notification requirements for respectively novel foods and traditional foods from third countries. Next to the already existing EFSA guidance, the scientific requirements for novel food applications are further specified in an EFSA completeness checklist. This guidance document supports applicants in the compilation of their technical dossier and literally contains a tick box for the data required by EFSA. It also contains tables that applicants can use to summarize the results found in toxicological and human studies.
Cut-off date 1 January 2018
Foods that on the one hand fall in one of the new novel food categories under the new Novel Food Regulation, but on the other hand were lawfully placed on the market before 1 January 2018 now need to be backed by a novel food application. These foods may be continued to be placed on the market until an authorization has been obtained, which should take place by no later than 2 January 2020. Recalling that the European Commission aims to finish authorization procedures within eighteen months, FBOs having legally marketed foods that now qualify as novel, such as whole insects, must have submitted their dossiers to Brussels by now.
Actual status quo
So far, 57 applications have been made under the new Novel Food Regulation, and 3 notifications of traditional foods from third countries. A summary of the applications and notification made under the new Novel food Authorization are publicly available.
A number of applications involve insects for human consumption, which obviously does not equal the number of insect companies on the market. This difference can be explained by the fact that FBOs can now, in principle, benefit from the generic authorization of novel food applications submitted by others. Applicants may also be industry organizations. An example of the latter involves the Belgian Insect Industry Federation, which has submitted applications for different species. This is especially beneficial for smaller companies such as startups, for which it is usually not easy to start an individual authorization procedure for financial and other reasons.
Another listed application that is worth mentioning concerns the cannabis compound cannabidiol (CBD) for use in food supplements. So called ‘cannabis-infused foods’ have recently gained media attention, not only because they are a new food trend, but also because CBD and other cannabinoids are now explicitly classified as novel foods.
While not all products derived from the Cannabis sativa plant qualify as novel foods according to the EU Novel Food catalogue, an update to the Catalogue of 20 January 2019 clarifies that ‘extracts of Cannabis sativa L. and derived products containing cannabinoids are considered novel foods as a history of consumption has not been demonstrated’.
This also applies to extracts of other plants containing ‘cannabinoids [and] synthetically obtained cannabinoids’. As a result, FBOs that have placed cannabinoids containing products on the market may face enforcement. There is a grey area here, however. For instance, the European Industrial Hemp association requests that the Commission recognizes hemp extracts with naturally occurring CBD levels as traditional, not novel foods.
Finally, the new Novel Food Regulation also applies to cultured meat, being meat grown in a lab using cell culture techniques to obtain meat for consumer consumption. As this is an unprecedented technology for the production of food, it is important to establish that the controlled environment in which these foods are produced, results into safe products.
Relevance for FBO’s
As mentioned before, the Novel Food Regulation promises to be more innovation-friendly. To benefit the most from the new Regulation, FBOs starting a novel food application for authorization are strongly recommended to make use of the available guidance, especially EFSA’s completeness checklist. For smaller food companies it may be interesting to explore the possibilities to team up with other FBOs to submit applications, or to join industry associations that are active in this regard.
By way of comparison, under the old Regulation only 228 applications were submitted. Looking back at one year of the new Novel Food Regulation, it seems that it has at least lowered the threshold for filing applications. At the same time, it is yet to be seen whether all current applications (and notifications) will also lead to successful authorizations. Until this moment, 24 authorized have been granted since the new Novel Food Regulation entering into force. Taking into account the Commission’s intended 18-month time frame for authorization procedures, a more substantial evaluation could take place this summer.
Before or after
Some FBOs had the choice to submit their application either still before or after the new Novel Food Regulation became applicable. For many of them, this has been a strategic choice. When a risk assessment was provided by the competent authority of the Member State where the application was submitted and no other Member State had raised any reasoned objects to the assessment before 1 January 2018, the application has been excluded from a second risk assessment by EFSA under the new Regulation. All other applications submitted, but not finalized, before 1 January 2018, have been treated as an application under the new Novel Food Regulation from its application date.