Novel Food

The term novel food refers to food that was not used for human consumption to a significant degree within the European Union (EU) prior to 15 May 1997 and that can be categorised as falling under at least one of the food categories listed in the Novel Food Regulation (EU) 2015/2283.

Novel foods are only authorised in the EU if they do not pose a risk to human health. The European Food Safety Authority (EFSAshort forEuropean Food Safety Authority) is responsible for the scientific assessment. Authorisation is granted by the EU Commission. A simplified authorisation procedure applies to the European market for traditional foods from third countries. Since 1 January 2018, all authorised novel foods have been listed in a so-called Union list and may be placed on the European market if the specified conditions of use, labelling requirements and specifications are met.

The European Commission's Novel Food Catalogue is intended to help in deciding whether or not a food is novel within the meaning of the Regulation. If a food business operator is unsure about the classification of a food as a novel food, it may consult the competent authority of the respective Member State in which it first wishes to market the food.

The responsible body in line with the Novel Food regulation is the European Food Safety Authority (EFSAshort forEuropean Food Safety Authority). On a national level, the Federal Office of Food Safety and Consumer Protection (BVLshort forGerman Federal Office of Consumer Protection and Food Safety) is responsible in Germany. When requested to do so by the BVLshort forGerman Federal Office of Consumer Protection and Food Safety, the German Federal Institute for Risk Assessment (BfRshort forGerman Federal Institute for Risk Assessment) conducts a risk assessment with the goal of establishing whether there are any justified objections to the food in question with regard to safety. The BfRshort forGerman Federal Institute for Risk Assessment forwards its risk assessment to the BVLshort forGerman Federal Office of Consumer Protection and Food Safety in the course of the External Link:notification process.

Accordingly, 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 Union before 15 May 1997
• 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, except when the food has a history of safe food use within the European 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 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 use within the European 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 as defined in point (f) of this paragraph
• 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 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 as defined in point (f) of this paragraph
• Food used exclusively 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

Traditional foods from countries outside the European Union (third countries) which were not consumed in any significant quantities before 1997 are also subject to the Novel Food regulation (e.g. baobab fruit pulp).

Authorised novel foods included in the European Union list may only be placed on the market as such or used in or on food if they comply with the conditions and labelling requirements established in the list. This list of novel foods authorised to be placed on the market in the European Union (“Union list”) is prepared by the European Commission and updated continuously. An essential prerequisite for the authorisation of a novel food and its inclusion in the Union list by the EU Commission is that the food does not pose a safety risk to human health on the basis of the available scientific data.

Two different processes are fundamentally intended for the placing of novel foods on the market:

• Authorisation process in line with Article 10 of the Novel Food regulation (EU) 2015/2283
  The process for authorising the placing on the market of a novel food in the European Union and updating of the Union list in line with Article 9 is either introduced by the EU commission itself or at the request of an applicant to the EU Commission. An application for authorisation must contain scientific data among other things to prove that the novel food does not pose a safety risk to human health.
• Notification processes for traditional foods from third countries in line with Articles 14 and 16 of the Novel Food regulation (EU) 2015/2283.
  Applicants who intend to market a traditional food from a third country in the European Union can notify the EU Commission to this effect instead of adhering to the authorisation process outlined in Article 10.
  In notification processes, the applicant must provide proof of the safety of the traditional food by producing data on its composition. There must also be proof of experience of its use over a period of at least 25 years. The food in question must be part of the conventional diet of a significant number of persons.

Electronic applications should be submitted to the External Link:EU Commission.

More information on the External Link:Novel Food regulation and classification of a food as a novel food can be found at the websites of the European Commission (in the so-called External Link:Novel Food Catalogue) and External Link:BVL.