Novel food means any food that was not used for human consumption to a significant degree within the European Union before 15 May 1997 and that falls under at least one of the following categories.
- Food with a new or intentionally modified molecular structure, where that structure was not used as, or in, a food within the European Union before 15 May 1997
- Food consisting of, isolated from or produced from micro-organisms, fungi or algae
- Food consisting of, isolated from or produced from materials of mineral origin
- Food consisting of, isolated from or produced from plants or their parts, except when the food has a history of safe food use within the European Union and is consisting of, is isolated from or produced from a plant or a variety of the same species obtained by:
- traditional propagating practices which have been used for food production within the European Union before 15 May 1997, or
- non-traditional propagating practices which have not been used for food production within the European Union before 15 May 1997, where those practices do not give rise to significant changes in the composition or structure of the food affecting its nutritional value, metabolism or level of undesirable substances.
- Food consisting of, isolated from or produced from animals or their parts, except for animals obtained by traditional breeding practices which have been used for food production within the European Union before 15 May 1997, and the food from those animals has a history of safe food within the Union.
- Food consisting of, isolated from or produced from cell culture or tissue culture derived from animals, plants, micro-organisms, fungi or algae.
- Food resulting from a production process not used for food production within the European Union before 15 May 1997 which gives rise to significant changes in the composition or structure of a food, affecting its nutritional value, metabolism or level of undesirable substances.
- Food consisting of engineered nanomaterials.
- Vitamins, minerals and other substances used in accordance with Directive 2002/46/EC, Regulation (EC) no. 1925/2006 or Regulation (EU) no. 609/2013, where:
- a production process not used within the European Union before 15 May 1997 has been applied as referred to in point (a) (vii) of this paragraph, or
- they contain or consist of engineered nanomaterials.
- Food exclusively used in food supplements within the European Union before 15 May 1997, where it is intended to be used in foods other than food supplements as defined in point (a) of Article 2 of Directive 2002/46/EC.
Exceptions
The following foods do not fall under the definition of novel foods:
- Genetically modified foods that fall within the scope of Regulation (EC) no. 1829/2003
- Foods when and insofar as they are used as:
- food enzymes falling within the scope of Regulation (EC) no. 1332/2008
- food additives falling within the scope of Regulation (EC) no. 1333/2008
- food flavourings falling within the scope of Regulation (EC) no. 1334/2008
- extraction solvents used or intended to be used in the production of foodstuffs or food ingredients and falling within the scope of Directive 2009/32/EC.