- Michalopoulou & Associates
As we continue to add new foods to our diets or introduce new ways of preparing food, consumers all around EU need to be sure that any novel food coming to our tables is safe. In this framework, we should examine the provisions of the new Novel Food Regulation (EU) 2015/2283 that is applicable as of January 1st 2018. So, let’s give you some answers on some crucial questions concerning the new Regulation.
What is novel food?
Novel food is defined as food that has not been consumed to any significant degree in the EU before 15 May 1997. Specifically, this can be newly developed, innovative food or food produced using new technologies and production processes, as well as food traditionally eaten outside of the EU (including insects as well as parts of them such as legs, wings, etc.).
What are the main changes that the new Regulation brings?
The new Novel Food Regulation expands the categories of novel foods (Article 3) and establishes a Union list of authorized novel foods. The authorization procedure becomes more efficient and safer as innovative food can be delivered to market more quickly without unnecessary trade barriers. The main provision of the new Regulation is the creation of a centralized authorization system that gives the applicants greater certainty, simplicity and speed during the authorization process. The European Food Safety Authority (EFSA)’s role is to conduct a scientific risk assessment for the novel food application in case the novel food is liable to have an effect on human health; the Commission’s role is to manage the files of each applicant and propose the authorization of a novel food which is found to be safe. The new Novel Food Regulation also introduces a faster and structured assessment procedure for traditional foods coming to the EU from third countries. It is EFSA’s role to carry out a scientific risk assessment of traditional food from third countries before they are introduced to the EU market. This kind of traditional food will be allowed to be placed on the market on the basis of a notification by the food business operator if it’s demonstrated as being historically safe (more than 25 years) and there are no safety concerns raised by neither EU Member States nor EFSA. Moreover, an e-submission system/portal (https://ec.europa.eu/food/safety/novel_food/e-submission_en) has been developed to facilitate the on-line submission of novel foods applications and/or traditional foods notifications. With this system the applicants will be able to follow-up their applications from the submission until the outcome. Finally, the regulation includes data protection provisions, which guarantee that newly developed scientific evidence and proprietary data cannot be used for the benefit of another application for 5 years following novel food’s authorization.
Who is responsible for determining the novel food status of a food?
Economic/Food business operators hold the primary responsibility for verifying whether or not the food they intend to place on the EU market falls within the scope of the novel food Regulation. If there is any doubt, they should check the status that has their food in the Member State in which they are going to place it for the first time on the market.
Does an application for the authorization of a novel food differ from a notification for the authorization of a traditional food?
There is no difference in terms of submission and processing between the two as the new Regulation requires the applicant to submit an application for a novel food or a notification for a traditional food to the Commission via the online e-submission portal. However, they differ in the data and information requirements as far as safety is concerned. The application for the authorization of a novel food must contain extensive safety data and toxicological studies supporting the safety of the novel food, while the notification of a traditional food puts emphasis on establishing the safety of the traditional food on the history of its consumption in a third country (for more than 25 years).
What are the provisions for authorization for use in the EU?
Necessary condition for the authorization for use in the EU of a novel food is the fact that it does not present a risk to public health, is not nutritionally disadvantageous when replacing a similar food and does not misleading to the consumer. Before the authorization, a scientific assessment takes place in order to ensure its safety. The authorization sets out the conditions for its use, its designation as a food, specific labelling requirements (where appropriate) and post-market monitoring requirements (where appropriate).
Is there any provision concerning confidentiality in the new novel food regulation?
Article 23 of the Novel Food Regulation sets out the conditions and requirements for applicants who request confidential treatment of certain information submitted with applications for authorization of a product. As with data protection, the Commission must assess and decide on each request and inform the applicant and Member State. But, some information (name of applicants, novel food, conditions of use, summaries of studies, analysis methods, etc.) cannot be claimed as confidential, so applicants who disagree with the Commission’s position can withdraw their application.
Will the new Novel Food Regulation affect innovation in the food sector?
The new Novel Food Regulation aims to help innovators and economic operators create and insert to the EU market new food products and at the same time maintain a high level of consumer safety. Furthermore, the data protection provisions protect the interests of companies producing this kind of products and strengthen the competitiveness between them; at the same time innovation is encouraged in the food sector, and creation of new jobs and growth opportunities are around the corner.
We strongly believe that this Regulation will bring novel foods to the center of attention and will stimulate the companies’ interest in order to implement new methods of preparing food while positively contributing to the food’s sector growth and innovation. Such exciting legal developments set the pace for great changes and challenges in the food sector, in an era where the thrive of technology and the 4th Industrial Revolution are radically transforming our way of living.