Regulation (EU) 2015/2283

(Beta version)

The current provisions of union legislation on new foods are included in the regulation  (ΕU) 2015/2283, which came into effect on 1 January 2018. This regulation repealed the Regulation (EC) no 258/97 and the Regulation (EC) no 1852/2001.

Regulation (EU)2015/2283 aims to improve conditions so that businesses can more easily offer new and innovative foods to the European Union market (EU), while maintaining a high level of protection of health and consumer interests.

 

The main changes introduced by regulation (EU) 2015/2283 are the following:

  • The categories of food constituting novel foods are clarified and updated, while the definition of novel food remains the same ("novel food”: any food not widely used for human consumption within the Union before 15 May 1997).
  • Novel food approvals are general power [they are not addressed only to the applicant as foreseen in Reg. (EC) 258/97], unless they relate to an authorisation of a novel food covered by data protection.
  • Drawn Union list of novel foods approved for placing on the Union Market.
  • Established central approval procedure as applications are submitted to the European Commission (hereinafter: Commission) online via electronic submission system (e-submission system for novel foods).
  •  The safety assessment of novel foods is carried out by the European Food Safety Authority (in future: Authority) after the submission of the relevant file to the Commission. A novel food shall be approved and entered on the Union list following a proposal from the Commission and a vote in the Standing Committee on Plants, Animals, Food & Feed - toxicology sector. All procedures are subject to deadlines to ensure the smooth processing of applications.
  • A simplified approval procedure shall be established for traditional Third Country Foods with a history of safe use in a third country, notification procedure, provided that no reasoned objections to their safety have been submitted by any member state or the Authority.
  • Provisions on data protection are adopted ensuring that new scientific and industrial property data cannot be used to support another application for a period of 5 years after the authorisation of a novel food. Data protection does not apply to notifications or requests for the placing on the market of traditional foods in the EU.

 

Clarifying question-answer text on regulation (EU) 2015/2283.