Frequently asked questions regarding novel foods
1. What is a novel food?
– Novel foods refer to products which prior to May 1997 have not been used for human consumption to a significant degree within the Community. The time point is based on the Regulation of the European Parliament and the Council (EC No. 258/97) having been adopted on 15 May 1997. Also foods and food ingredients to which has been applied a production method not currently used, where that method gives rise to significant changes in the composition or structure of the foods or food ingredients which affect their nutritional value, metabolism or level of undesirable substances, are considered novel foods. Nanotechnology, for example, is such a method.
The novel food authorisation of the European Commission is required for placing a novel food on the market within the European Union.
2. How can one know if novel food authorisation is required for a product or ingredient?
– Novel food authorisation is required, if the product or ingredient has not been used for human consumption to a significant degree prior to May 1997. The responsibility for establishing, and if necessary, proving the product's history of use rests with the food business operator.
One source of information that can be used for this purpose is the Novel Food Catalogue of the Commission. It contains information about different foods and food ingredients with respect to their novel food status. Other good information sources are listed under Establishing of novel food status of the food.
3. How to apply for novel food authorisation?
– A novel food can gain access to the market through two different procedures. The application procedure is used for novel foods introduced for the first time to the food market in the EU. The marketing authorisation is then granted on the operator's application, which shall contain clarification of the safety of the product according to the criteria approved in the Community. The simplified notification procedure can be used for products, which have been traditionally and safely consumed in a third country for at least 25 years.
More information about Applying for novel food authorisation.
4. Is novel food authorisation required, if an equivalent product has been authorised previously?
– Yes. The concept of "substantially equivalent" used in the old Regulation is not used any more, but authorisation shall be applied for through the application procedure. However, authorisation is no longer operator-specific, which means that all operators can place novel foods included in the Union Catalogue of authorised novel foods on the market.
5. How can one know if novel food authorisation has already been granted to a product or ingredient?
– The Commission maintains the Novel Food Catalogue which is a list of authorised novel foods.
6. Did Evira authorise the marketing and use of insects or wild herbs as foods at the beginning of 2018?
- Evira has not prohibited or authorised the marketing or use of foods considered to be novel foods. These are governed by EU legislation which prohibits the marketing and use of unauthorised novel foods as food within the entire area of EU. Insects or wild herbs with a history of significant food use in the EU area prior to 1997 can be marketed and used as food. The operator is liable to demonstrate the history of food use. If no significant history of food use can be demonstrated, the novel food authorisation needs to be applied for insects or wild herbs also in 2018.
More information about the reformed Novel Food Regulation and the changes introduced in it is provided on the "Novel Food Regulation reform" website.
7. Are exotic fish and meats novel foods? – Fish and meats are governed by the Novel Foods Regulation just like any other foods. If they have no history of use as food to a significant degree in the area of the EU prior to 1997, they are considered novel foods. But if they have been used as food to a significant degree in some EU member state, they are not considered novel foods.
8. Why are plant sterols that reduce cholesterol considered novel foods, but plant stanols that have the same effect are not?
– Plant stanol esters were introduced to the market in Benecol products prior to May 1997 and therefore do not meet the definition of a novel food.
9. Is it legal to sell Chia seed in Finland?
– The seeds of the Chia plant (Salvia hispanica) and food products containing them are novel foods. More information about the acceptability of products containing Chia as food is presented in the Commission's Catalogue under "Use of Chia seeds in foods"
10. May I pick and eat wild herbs growing in my back yard?
– Collection of wild plants for personal use is part of the universal right to roam. It is not restricted by any legislation. Anybody can pick and eat wild herbs, at one’s own risk of course. If herbs are collected on a commercial scale, for example sold in shops or restaurants, the provisions of food legislation apply.
11. May the stalks of rosebay willowherb be used as food, just like asparagus?
– Yes. Young stalks of rosebay willowherb are not considered a novel food, and so they may be freely used as food. Together with food operators, Evira has prepared a list of the most important edible Finnish wild plants and plant parts and their permitted use in foods https://www.evira.fi/en/foodstuff/manufacture-and-sales/common-requirements-for-composition/novel-foods/the-use-of-finnish-wild-plants-as-food/
12. Is it permissible to export lichen to other EU countries for use as food?
– The use of lichen for food is not permitted and so it may not be exported to the EU Member States either. However, certain species of lichen may be used in food supplements and tea-like products as well as for seasoning and decoration. For example, while reindeer lichen (Cladonia rangiferina) may be used in food supplements, its more extensive use in food would require a novel food authorisation. The star-tipped reindeer lichen (Cladonia stellaris) is a novel food and needs to be specifically authorised for food use. Iceland moss (Cetraria islandica) may be used in Finland in tea or as a spice or food decoration. However, as this interpretation applies to Finland only, other Member States may see it differently. More general use is subject to novel food authorisation.
13. Is Chaga mushroom (Inonotus obliquus) considered a novel food?
– Chaga mushroom (Inonotus obliquus) is in the EU considered a novel food, which may only be used broken or as an aqueous or ethanol extraction in the food supplements referred to in the Food Supplements Regulation. Chaga mushroom may also be sold and marketed at least in Finland as a tea-type product (herbal tea). In this context herbal tea refers to a brewed drink prepared by aqueous extraction of fresh or dried plant or plant part, and used in the same way as tea or coffee. However, no gas or sugar may be added in the drink. The use of Chaga mushroom in other foods (so-called "conventional" foods, such as smoothies, beverages, protein powders, bread or cocoa), however, is forbidden until the marketing authorisation referred to in Novel Food Regulation (EU) 2015/2283 has been applied for and granted to it.
14. Is it permissible to market the South-American sweetleaf herb in Finland?
–Sweetleaf (Stevia rebaudiana) is considered a novel food. Its dried leaves and aqueous leaf extracts may only be used in food supplements conforming to the Food Supplement Regulation. Additionally, sweetleaf may be sold and marketed in Finland as a tea-like product (herbal tea). For the purposes of this regulation, herbal tea means an aqueous leaf extract made from a fresh or dried plant or plant parts and consumed like tea or coffee. The use of sweetleaf in other foods (‘regular foods’ like yogurts or baked products) is forbidden unless a market approval issued under the Novel Food Regulation (EU) 2015/2283 is obtained for the product. Please note! The use of steviol glycosides as a sweetener made from the sweetleaf extract is permitted under the EU laws. For more information on steviol glycosides, go to the Steviol glycosides site (in Finnish).
15. May products containing noni plant be marketed in Finland?
– Yes, but only authorised noni products. The authorised noni products are listed in the Union Catalogue.
16. Is ginseng a novel food?
– Of the different ginseng varieties, the Panax ginseng variety is known to have been used for human consumption within the EU prior to May 1997, which means it is not a novel food. Of the other ginseng varieties, the Panax notoginseng, Panax pseudoginseng and Panax quinquefolius varieties have only been used as food supplements. Their use is permitted in food supplements, but a novel food authorisation would be required to extend their use to other foods.
17. Are exotic Goji and Acai berries novel foods?
– No, they are not. The Acai berry (Euterpe oleracea) found in South America and the Goji berry (Lycium barbarum) found in Asia are not considered novel foods according to the Commission's list of novel foods and thereby they can be sold as foods.
18. May yacón or foodstuff made from yacón be sold and marketed in Finland?
– Now it is permitted, the situation changed as of the beginning of 2014. A history of significant food use of yacón roots or Smallanthus sonchifolius in the EU before 1997 has been demonstrated, and thus it is no longer considered novel food.
19. What is quorn?
– Quorn is the leading brand of mycoprotein-containing foods in England. Any food rich in protein and processed from an edible fungus is considered to be mycoprotein. Quorn is sold widely in Europe and elsewhere in the world as part of a vegetarian diet. Quorn is not considered a novel food.
20. Is high pressure pasteurisation a method considered to fall under the Novel Food Regulation?
– In the case of high pressure pasteurisation as a production method, it needs to be considered specifically in each case whether it falls under the Novel Foods Regulation. If the use of the high pressure technology does not give rise to any significant changes in the composition or structure of the end-products which affect their nutritional value, metabolism or level of undesirable substances, the method is not considered a novel method as referred to in the Novel Foods Regulation (EU) 2015/2283, Article 3, Item 2. a). The operator must assess, and if necessary, prove how the method affects the end-product.