On 25 November, 2015 the European Commission published a new novel food regulation replacing the existing legislation (Regulation 258/97) which requires pre-market authorisation of ingredients not consumed in the European Union to a significant degree by humans before 1997. Regulation (EU) 2015/2283 will come into force 1 January 2018.
Under the new regulation, all applications will be evaluated by the European Food Safety Authority (EFSA) instead of individual Member State Competent Authorities. An accelerated notification process is also established for traditional foods from non-EU countries. Authorisations issued on the basis of newly developed scientific evidence and proprietary data will be granted a 5 year exclusivity during which this information may not be used for the benefit of another application without the permission of the applicant.