The New Novel Food Regulation - What You Need to Consider
On 31st December 2015, a new Novel Food Regulation came into force. The new Novel Food Regulation (EU) 2015/2283 became effective on 1st January 2018 and replaces Regulation (EC) No 258/97. It has received widespread public attention, as insects that come onto the market as foodstuffs are now also covered by the new regulation and must be tested in advance.
What is Novel Food?
The term ‘Novel Food’ covers newly introduced foodstuffs. These are all foodstuffs that had not yet been used or consumed before 15th May 1997 to any significant extent in the European Union as part of human consumption, and which can be assigned to a food category specified in the Novel Food Regulation. These include the foodstuffs made of
- micro-organisms, fungi or algae
- plants or parts of plants
- animals or their parts
- technologically produced nanomaterials
Which New Rules does Regulation (EU) 2015/2283 Contain?
The definition of Novel Food will be clarified. Any ambiguities surrounding the scope of the previously applicable Novel Food Regulation will be removed. Among others, preparations from insects, foodstuffs from cell or tissue cultures and products of mineral origin are part of the definition and therefore clearly within the scope of the regulation.
The evaluation and approval process for Novel Food will be streamlined and thereby accelerated. The evaluation of applications for approval currently carried out in the individual member states will in future be carried out centrally by the European Food Safety Authority (EFSA). Thus, the approval procedure is running at the European level. In addition, the approvals are not related to the applicant as was done previously, but are general and as such, to the advantage of all distributors.
As part of the approval procedure, there is a Union list drawn up and maintained by the Commission. Only novel foodstuffs approved and listed as part of the Union list may be marketed as such, subject to the established conditions and labelling provisions.
Traditional food from third countries can be more easily imported into the EU single market.
What are the Transitional Arrangements in the Interim?
The transitional measures are described in Art. 35 Regulation (EU) 2015/2283. These include two cases:
- Approval procedures, which started before the date of the new regulation coming into force but where the approval procedure is still ongoing. For these "old” Novel Foods, the Commission adopts the approval procedure already established in accordance with the old regulation and decides on the applications.
- Approval procedures, which are only required now due to the extension of the scope of the new regulation. For these "new” Novel Foods", i.e. the foodstuffs that were marketable under conventional law prior to the entry into force of the new Novel Food Regulation, an application for approval must be submitted no later than 2nd January 2020. Before the expiry of this period, the food in question is therefore legally marketable without any application.
Do You Have Any Questions?
Our account manager Dr Zein Jennah Abbas will be happy to answer your questions and provide you with detailed information on the Novel Food sector.
