On 25 November 2015, the new European Regulation on novel foods (Regulation (EU) 2015/2283) was adopted. The text was published in the Official Journal dated 11 December 2015. While the text entered into force on the last day of 2015, most of the regulation provisions will only become applicable from 1 January 2018.
However, the Commission is in charge of enacting several implementing measures by the time the regulation becomes fully applicable, notably in respect of :
- the procedure for the determination of novel food status, in particular the consultation between food business operators and Member States, between Member States and the Commission and between the Member States amongst themselves;
- the administrative and scientific requirements for new novel food applications and for applications concerning traditional foods from third party countries; and
- a list of already approved novel foods.
Even though the regulation will only be effective as of 2018, food business operators need to be aware of some crucial changes which the regulation brings:
Definition of 'novel food'
The definition of 'novel food' has been updated and its scope has been clarified. The concept of novel food now explicitly encompasses whole insects and their parts, as well as food consisting of certain micelles or liposomes. Detailed categories are provided for in the regulation that include, for example, food with a new or intentionally modified molecular structure, food from cell or tissue cultures derived from animals, plants, microorganisms, fungi or algae, food from microorganisms, fungi or algae and food from material of mineral origin.
Furthermore, under the regulation, a food will be considered a novel food where it results from a production process not used for food production within the EU before 15 May 1997, which gives rise to significant changes in the composition or structure of the food, affecting its nutritional value, metabolism or level of undesirable substances. Such processes include, for example, nanotechnology.
One of the main administrative changes brought by the new regulation is the centralization of the novel food approval procedure. The Member States will not assess novel food applications anymore, this task will now be undertaken by the European Food Safety Authority ("EFSA"). It will be possible, once a novel food is approved, to impose post-market monitoring requirements on the food product e.g. to monitor the use of the authorised novel food to ensure that the use is within safe limits as established in the risk assessment by the EFSA.
A data protection regime is introduced, that aims to stimulate research and development and thus innovation within the agri-food industry, by protecting the information and data gathered by applicants in support of their application for a novel food. Importantly, the newly developed scientific evidence and proprietary data provided in support of a novel foods application will benefit from a non-renewable 5-year period of data protection if the applicant requests it and the data is eligible for protection.
The criteria for eligibility are as follows: (i) the newly developed scientific evidence or scientific data was designated as proprietary by the initial applicant at the time the first application was made, (ii) the initial applicant had exclusive right of reference to the proprietary scientific evidence or scientific data at the time the first application was made, and (iii) the novel food could not have been assessed by the EFSA and authorised without the submission of the proprietary scientific evidence or scientific data by the initial applicant.
During the 5-year period of data protection, the protected data and information collected by an initial applicant will not be authorised to be used by a subsequent applicant without the agreement of the initial applicant. However the above is on the understanding that the protection of scientific data provided by an applicant will not prevent other applicants from applying for a novel food to be included on the EU list on the basis of their own scientific data or by referring to the protected data with the agreement of the initial applicant.
Simplified approval route
Another key feature of the regulation is the creation of a simplified approval route for 'traditional food from third countries'. To benefit from this simplified procedure, a history of safe food use in a third party country will need to be demonstrated. These foods, which may benefit from the simplified route provided they are exclusively derived from primary production, will need to have been consumed in at least one third party country for at least 25 years as a part of the customary diet of a significant number of people. The simplicity of the procedure will widely depend on the way these criteria will be applied in practice. They may be further clarified in due course, either through guidance documents, or case law.
Role of the Member States
The role of the Member States under the new regulation is reduced in comparison to their role under the current regulation, but it should not be understimated. Not only will they be involved, where required, in the procedure for determination of novel food status, but they will also be in charge of enacting rules on effective, proportionate and dissuasive penalties applicable to infringements of the new regulation, and will be in charge of taking all measures necessary to ensure that the rules are implemented.
Regulation (EU) 2015/2283 thus brings a lot of significant changes to the novel foods regulatory landscape, but quite a few elements still need further clarification from the Commission and EFSA between now and the effective entry into force of the regulation in 2018 before it's possible to assess the full impact of the legislation. The introduction of a data protection regime and a simplified procedure for traditional foods from third countries, as well as the qualification of certain products as a novel food based on their production process rather than their mere intrinsic characteristics, will most probably raise interesting legal questions in the years to come.