Approval of Novel-Food

Many consumers find it questionable from a viewpoint of healthy eating habits whether artificial foods, designer foods and food substitutes are even desirable.
„Novel Foods“ are foods or food ingredients that have not been used for human consumption to any significant degree in the European Union (or even in regions comparable to the EU area, such as North America and Canada, but not regions such as South America Africa, India, China, whose populations differ significantly from European consumers in terms of dietary habits and physical constitution) before the cut-off date of 15.05.1997 (entry into force of Novel Food Regulation). Additives, flavorings and gene foods, among others, are excluded from the scope of the Novel Food Regulations.

Sachverständigen Büro Lebensmittelrecht Lebensmittelzulassung

Originally, the Novel Food Regulation was created to protect consumers from technological and genetically modified foods in view of the increasing mechanization in food production. In order to cover not only primarily genetically modified foods (e.g. yogurt with genetically modified live cultures) in this regulation, other foods and food ingredients were added, such as:

  • with a new or intentionally modified molecular structure (e.g. fat substitutes),
  • consisting of or isolated from microorganisms, fungi or algae (e.g. oil from microalgae),
  • 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 (e.g. produced by means of non-traditional propagating practises, or by means of new production processes, such as nanotechnology);
  • in the production of which a non-traditional process has been used, if the process has caused a significant change in the composition or structure affecting its nutritional value, metabolism or level of undesirable substances (e.g. enzymatic conversion processes).

After the scope of regulation for genetically modified foods had greatly increased, this group was removed from the Novel Food Regulation and organized in independent regulations as of 2003. What remained was a dubious and also trade-inhibiting structure: it does not seem necessary in terms of legal policy to protect consumers from exotic plant foods, nuts and algae products.

The new technological possibilities of food production lead on one hand to considerable changes in the composition or structure of the food, but on the other hand they also become more and more an important economic factor and furthermore often allow for the possibility of at least a temporary monopoly on modified food ingredients.

An amendment in November 2015 included, among others:

  • food consisting of, isolated from or produced from material of mineral origin,
  • food consisting of, isolated from or produced from cell culture or tissue culture derived from animals, plants, microorganisms, fungi or algae,
  • food consisting of engineered nanomaterials.

Special rules apply to foods with a documented history of the safety of the food in a third country (“continued use for at least 25 years as part in the customary diet of a significant number of persons in at least one third country”) or to “traditional foods from a third country“.

Frequent cases of doubt are regularly dealt with in the responsible committee at the European Commission and the results are collected in the so-called Novel Food Catalog.
Novel foods are in principle considered to always be food and thus, accordingly must have food-typical properties as well as nutrition-specific, physiological effects, they must be safe and must not mislead the consumer. In addition, they should not differ from the food they are intended to replace in such a way that their consumption would cause nutritional deficiencies for the consumer.

Since December 2017, various implementing regulations of the European Commission have established Union lists of approved novel foods, which are publicly available and searchable.

Important: Novel foods are generally subject to approval or notification.
Foods containing a non-approved novel food ingredient are not considered marketable. Special conditions and legal regulations apply to the import, or the use of Novel-Food ingredients in manufacturing. Compliance with the various legal provisions is subject to the manufacturer’s, importer’s or distributor’s duty of care.

Consulting services Novel-Food

Product checking to determine marketability in the manufacture or import novel-food

The range of services offered by Food & Cosmetic Consult GmbH as an expert office includes the services described under consulting services marketability check.

In addition, we offer special consulting services for food and dietary supplements with regard to marketability in the European Union:

  • queries of delimitation: is a particular food or ingredient considered to be a Novel-Food?
  • checking of formulation for possible Novel-Food ingredients,
  • review and evaluation of raw material specifications,
  • preparation and implementation of an application for approval as a Novel-Food,
  • expert opinions on special issues and objections (counter opinions).

Please note: Written checking reports and hints relating to labeling elements are given in German. We will only provide a written translation into English for an additional fee if expressly requested. We can conduct verbal advice and discussions in English.

You are of course also welcome to use the contact form to get in touch.
For free initial information, we are also happy to offer a callback service.