Under current EU legislation, any food that hasnot been used for human consumption to a significant degree within the EU ("history of safe consumption") before 15 May 1997, irrespective of the date of accession of the Member States to the European Union, and that falls into at least one of the defined categories, is classified as a "novel liver product" (Article 3 of the Regulation).
The food business operator must verify whether the food to be placed on the market falls within the scope of the Regulation or not. In case of uncertainty, the competent authority of the Member State where the potentially novel food is first to be placed on the market must be consulted. Appropriate information must be provided for the determination of the status. For this purpose, procedural steps for the consultation as well as further requirements for the information to be provided have been laid down (Implementing Regulation (EU) 2018/456).
The general criteria for the definition of novel foods remain unchanged. These may include, but are not limited to, foods
- With a new or deliberately modified molecular structure
- from micro-organisms, fungi or algae
- from materials of mineral origin
- from plants or parts of plants
- from animals or their parts
- from cell or tissue cultures
- produced by a novel and non-standard process
- from engineered nanomaterials
- which are vitamins, minerals and other substances which are considered to be non-novel exclusively in food supplements and are now to be used in other foodstuffs.