The Novel Foods Regulation 258/97 is one of the main legal instruments to regulate innovation in the area of food in the European Union.
A novel food is a (newly developed or marketed) food that has not been on the EU market prior to 1997. One of the key aspects of the Regulation is that it requires pre-market approval prior to the marketing of a novel food to make sure safety is assured.
There are currently two different procedures to obtain novel foods’ authorisation. Both require a substantial amount of scientific substantiation, investments in time and resources to achieve market clearance.
In January 2008, the Commission published a proposal to review the Novel Food Regulation.
One element in this proposal of specific interest to fruit juices, is the potential new specific category and procedure that could be applied to traditional food from Third countries having a “history of food use” (in the normal diet for at least one generation). This category could particularly concern exotic fruits not consumed in Europe before 1997. However after 3 years of discussion, the negotiation on the revision of the Novel Food Regulation has finally stopped as the European Parliament and the Council failed to reach an agreement. This means that Regulation (EC) No 258/97 from May 1997 remains in force.
Positive elements introduced by the proposed revised text will therefore not be further processed, such as a centralised EFSA assessment which would decrease the length of the evaluation procedure, an introduction of a simplified procedure for ingredients originating from a 3rd country with a history of safe use, or clarifications of definitions like the 'nanomaterials’.
It still remains to be seen what will be the next steps of the European Commission and whether there will be a new separate legislation/guidelines covering clones or nanomaterials in order to put aside those contentious issues and be able to agree on the revision of the Novel Food Regulation. The Commission is supposed to introduce a new proposal on Novel Foods