Pursuant to Article 4 of Novel Food Regulation (EU) 2015/2283, food business operators are required to verify whether a food they intend to place on the Union market falls within the scope of this Regulation. In practice, this means that operators must determine the novel food status of a food before it is placed on the market, i.e. whether it is a novel food or not.
According to the Food Act (297/2021, section 6), the food business operator itself is responsible for ensuring that the food is safe and complies with food regulations. In novel food matters, he also has the responsibility to find out and, if necessary, prove the history of the use of the food or its ingredient before 1997. In particular, in the case of ingredients for which food use is not so well known, the operator should verify whether they are considered novel foods.
How do you know if a product is a novel food? A food is not considered a novel food if it has been used for human consumption to a significant degree within the European Union prior to 15 May 1997, when the Novel Food Regulation came into force. The interpretation is not affected by the use of the product for human consumption in other parts of the world or by other uses, such as use as medicine or cosmetics. If no significant history of use is found, food is considered a novel food in principle and thus falls within the scope of the Novel Food Regulation.
The European Commission's website provides more detailed guidance on the principles of a significant history of use assessment in the Information and Guidance Document "Human Consumption to a Significant Degree".
Procedure for determining novel food status
If a food business operator is unsure whether or not a food falls within the scope of the Novel Food Regulation despite its investigations, it should consult the Member State in whose territory it intends to place the food on the market for the first time. The food business operator must provide the necessary information to the Member State to determine whether the food is covered by the Novel Food Regulation. Consultation requests in Finland are sent to the Finnish Food Authority (kirjaamo@ruokavirasto.fi).
The consultation request shall be sent electronically to the Member State and shall contain the following items:
- Cover letter
- Technical dossier
- Supporting documentation
- Explanatory note clarifying the purpose and relevance of the submitted documents
Further details of the consultation request, together with the templates of the cover letter and the technical dossier, can be found in Commission Implementing Regulation (EU) 2018/456.
Upon receipt of a request for consultation, the Member State shall:
- Verify without delay whether the request for consultation meets the requirements laid down for it and, if necessary, request that it be completed within the time limit.
- Determine the status of the novel food within four months after the request for consultation has been considered as valid. When taking a decision, a Member State may request additional information from the food business operator or consult other Member States and the Commission.
The Commission shall publish without delay a decision taken by a Member State on the novel food status of a food on its website.
- Union list of authorised novel foods
- EuroFIR-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.
- Finnish Food Authority'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 (in German) The lists on the page (Stofflisten des Bundes und der Bundesländer) contain plants and parts of plants, as well as fungi and algae, including their known history of use as food. The possible medicinal use of the plant/mushroom/algae is also mentioned. There are four lists (xls):
- Plants and plant parts A-K (Pflanzenliste - Einträge A-K, 2. Auflage)
- Plants and plant parts L-Z (Pflanzenliste - Einträge L-Z, 2. Auflage)
- Mushrooms (Pilzliste, 2. Auflage)
- Algae (Algenliste, 2. Auflage)
- Austrian list of plants with a history of use as tea (in German, Kapitel B 31 Tee und teeähnliche Erzeugnisse).
- Danish list of wild plants (in Danish).
Even in the case of products with a history of use for human consumption in some EU member state, the food business operator should take into account any national regulations that might restrict its use. For example, in some member state the product can be considered a medicine.
Useful information about the safety of different plants can be obtained from the following sources, for example:
1. 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.
2. 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.
3. List of plants published by Finnish Poison Information Centre.