On January 1, 2018, the EU’s new framework regulation 2015/2283 on Novel Foods became applicable. Regulation 2015/2283 repeals regulations 258/97 and 1852/2001.
Under the new regulation, a novel food is defined as food that has not been consumed to a significant degree in the EU before May 15, 1997 AND falls within at least one of the 10 categories listed in Article 3 of the new regulation:
- Food with a new or intentionally modified molecular structure
- Food consisting of, isolated from or produced from microorganisms, fungi or algae
- Food consisting of, isolated from or produced from material of mineral origin
- Food consisting of, isolated from or produced from plants or their parts obtained by non-traditional propagating practices if significant changes in the composition or structure of the food affect its nutritional value, metabolism or level of undesirable substances
- Food consisting of, isolated from or produced from animals or their parts obtained by non-traditional breeding techniques
- Food consisting of, isolated from or produced from cell culture or tissue culture derived from animals, plants, microorganisms, fungi or algae
- Food resulting from a new production process if significant changes in the composition or structure of the food affect its nutritional value, metabolism or level of undesirable substances
- Food consisting of engineered nanomaterials
- Vitamins and minerals and other substances used in accordance with Food Supplements Directive 2002/46/EC obtained by a new food production process or containing engineered nanomaterials
- Food used exclusively in food supplements within the EU before May 15, 1997, intended to be used in foods other than food supplements
An Information and Guidance Document on “human consumption to a significant degree” is posted on the Commission’s website.
Implementation
- Commission Implementing Regulation 2017/2470 establishes a list of authorized novel foods, corrected by Commission Implementing Regulation 2018/1023
- Commission Implementing Regulation 2017/2469 sets out administrative and scientific requirements for novel food applications
- Commission Implementing Regulation 2017/2468 sets out administrative and scientific requirements for traditional foods from third countries
- Commission Implementing Regulation 2018/456 sets out the procedural steps of the consultation procedure for determination of novel food status. For more information on the consultation procedure, see GAIN report “New EU Law on Novel Food Status Determination”.
