Novel Food

The term "novel foods" is defined in Regulation (EU) 2015/2283 (Novel Food regulation), repealing Regulations (EC) 258/97 and (EC) 1852/2001.

Definition of novel food according to the Novel Food regulation
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).

Authorisation of novel food in line with the Novel Food regulation
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 EU Commission.

More information on the 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 Novel Food Catalogue) and BVL.

Involvement of the BfR
The responsible body in line with the Novel Food regulation is the European Food Safety Authority (EFSA). On a national level, the Federal Office of Food Safety and Consumer Protection (BVL) is responsible in Germany. When requested to do so by the BVL, the German Federal Institute for Risk Assessment (BfR) 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 BfR forwards its risk assessment to the BVL in the course of the notification process.

Union list for novel food in the EU
The authorisation of a novel food and its inclusion in the Union list by the EU Commission depend on the following conditions:

1. Based on the available scientific data, the food does not involve a safety risk to human health
2. Consumers will not be misled by the intended use of the food, especially if the food is to replace another and there is a significant change to the nutritional value
3. If the food is intended to replace another food, it does not differ from that food in such a way that normal consumption thereof would be of disadvantage to the consumer with regard to nutrition.

The Union list contains all novel foods already authorised in the European Union. It lists their conditions of use, labelling requirements and specifications. All authorisations have general validity, i.e. they are valid throughout the EU. The list is updated continuously by the European Commission by adding newly authorised novel foods.

Opinions prepared by the European Food Safety Authority (EFSA) within the scope of the Novel Food regulation are published on the EFSA website.