Regulation on Novel Foods

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According to Art. 3 (1) of Regulation (EC) 2015/2283, there are several categories for Novel Food:

  1. Food with a new or intentionally modified molecular structure, where that structure was not used as, or in, a food within the Union before 15 May 1997;
  2. Food consisting of, isolated from or produced from microorganisms, fungi, or algae;
  3. Food consisting of, isolated from or produced from material of mineral origin;
  4. 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 Union and is consisting of, 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 Union before 15 May 1997; or
    • Non-traditional propagating practices which have not been used for food production within the 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;
  5. 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 Union before 15 May 1997 and the food from those animals has a history of safe food use within the Union;
  6. Food consisting of, isolated from or produced from cell culture or tissue culture derived from animals, plants, micro-organisms, fungi or algae;
  7. Food resulting from a production process not used for food production within the 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;
  8. Food consisting of engineered nanomaterials as defined in point (f) of this paragraph;
  9. 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 for food production within the 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 as defined in point (f) of this paragraph;
  10. food used exclusively in food supplements within the 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;
Summary
  • Food with new or intentionally modified molecular structure
  • Food from microorganisms, fungi, algae, mineral origin, plants or their parts, animals or their parts
  • Food from cell or tissue cultures derived from animals, plants, microorganisms, fungi or algae
  • Food from engineered nanomaterials
  • Vitamins, minerals and other substances with a novel manufacturing process or with/from engineered nanomaterials
  • Food used exclusively in food supplements before

→ not produced in the European Union before 15 May 1997

Special regulations govern specific food groups – such as GMOs for food and feed (Regulation (EC) No 1829/2003), food enzymes (Regulation (EC) No 1332/2008), food additives (Regulation (EC) No 1333/2008), flavourings (Regulation (EC) No 1334/2008), and extraction solvents (Directive 2009/32/EC) – meaning the Novel Food Regulation does not apply to these categories.

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