Establishing novel food status of a food
How can one tell if a product is a novel food? A product is not considered a novel food, if it has not been commercially used for human consumption to a significant degree within the European Union prior to 1997, when the Novel Food Regulation was adopted. The consumption of the product somewhere else in the world is not taken into account in this interpretation.
There are no comprehensive lists of novel foods or authorised products. Pursuant to the Food Act (23/2006, Section 16), the operators are in the food sector responsible for their products being safe and compliant with food regulations. As far as novel foods are concerned, the responsibility for establishing, and if necessary, also for proving the history of use of the product prior to 1997 also rests with the operator. In the case of ingredients not widely known for their use as food, in particular, the operator must verify that they are not considered novel foods. If no history of use can be established, the products are considered to be novel foods and thus fall within the scope of the Novel Food Regulation.
The Commission is preparing an Implementing Regulation regarding the determination of novel food status, i.e., the assessment of whether a food falls within the scope of the Regulation. This work is expected to be completed in early 2018.
The novel food status is always determined in cooperation with EU's novel food experts on the basis of the currently available knowledge and material. These Community-level interpretations have been recorded in the public Novel Food Catalogue maintained by the European Commission.
The Commission's Novel Food Catalogue is not exhaustive. The following public sources of information, for example, can also be utilised to establish the novel food status of a food:
- Union Catalogue of authorised novel foods
- EuroFIR-Nettox plant list (provided on the right hand side of the page). The Nettox plant list is a list of food plants drawn up in connection with an EU project. The list is in the EU also accepted as a list of plants which, as a rule, can be considered to be non-novel foods.
- Evira's list of use of Finnish wild plants as food, (in Finnish), (pdf).
- Commercial mushrooms, (in Finnish). As a rule, the commercial mushrooms included in this list are not considered to be novel foods.
- BELFRIT list. This is a harmonised list of plants approved or rejected for use in food supplements in Belgium, France and Italy.
- Italian list of other ingredients approved for use in food supplements (in Italian). The list is commonly accepted in the member countries.
- German list of plants and plant parts.
- Austrian list of plants with a history of use as tea (in German). As a rule, the use of these plants has been authorised in products of tea type.
Even in the case of products with a history of use for human consumption in some member country of the EU, the food sector operator should take into account any national regulations that restrict its use. For example, in some member country the product can be considered a medicine.
Useful information about the safety of different plants can be obtained from the following sources, for example:
- Herbal remedies in List of Medicines (Annex 2). The herbal remedies included in the List of Medicines can be used also in foods, but their medicinal status should be verified with Fimea.
- EFSA Compendium. A compendium of botanicals reported to contain naturally occurring toxins, addictive or psychotropic substances or other substances of possible concern for human health.
- List of plants published by Finnish Poison Information Centre.
- NETTOX -Plant List, (pdf)