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 are substantially equivalent to previously authorised foods.
More information about Applying for novel food authorisation.
4. Is novel food authorisation required, if an equivalent product has been authorised previously?
– Novel food authorisation is always granted to a specific operator, but products substantially equivalent to a product that has already been authorised can be placed on the market within EU through a simplified procedure by submitting a novel food notification to the Commission.
The notification shall contain the opinion of a competent authority in some EU member state on that the product is substantially equivalent to a previously authorised product. In Finland the Novel Food Board is such a competent authority. The notification is in practice submitted to Evira, which requests an opinion on the notification from the Novel Food Board.
More information about Novel food notifications and opinions on substantial equivalence.
5. How long does the novel food application process take in all?
– Several years (2 - 4 years). The first assessment of the safety of a novel food is conducted in the member state in which the product is to be first placed on the market. The initial assessment of that member state is commented on by experts of the other member states. If a reasoned objection is made against the application for placing on the market, the matter is referred to the Commission. The Commission shall consult the European Food Safety Authority EFSA. In extreme cases the review of the application may be further referred to the EU Council. The procedure is often also prolonged due to deficient documentation submitted by the applicant. The notification process is considerably shorter (1 - 4 months).
6. How can one know if novel food authorisation has already been granted to a product or ingredient?
– A list of novel food authorisations granted by the Commission is posted on the web site of the Commission.
There are also on the market novel foods, which have been authorised on the basis of substantial equivalence. Lists of these products are posted on the web site of the Commission.
7. May insects be sold as food?
The importation, selling, marketing or growing of whole or processed insects for use as food is at present forbidden until the history of use of the species within the EU has been proven or novel food authorisation has been granted to the species. Finland follows in this matter the line of interpretation recommended by the Commission, as do most of the EU countries.
The situation may change in the EU, and thus also in Finland, if some insect species is shown to have been used as food in the area of the EU prior to the year 1997. It would then not be a novel food and could find its way to the European tables quite soon.
Legislation has no bearing on what individual people eat or drink; everybody is personally responsible for that. However, insects sold, marketed, delivered or served as food are governed by the same food regulations as any other foods. The objective of legislation is to verify that foods are safe to eat for consumers. So far the safety of no insect species has been assessed in accordance with the requirements of the Novel Food Regulation.
The Commission is working actively to resolve the insect issues. It assesses the history of use of insects as food within the EU and has asked for the assistance of the European Food Safety Authority EFSA to assess what is known about insects and their safety as food and feed. Points that have been brought up include e.g. the hygienic quality of insect production, potential allergies, the adverse effects of excessive intake of chitin and the harmful or toxic natural substances found inherently in insects.
More information about the use of insects as food is provided on the Insects as Food.
8. 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.
9. 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.
10. Is it legal to sell Chia seed in Finland?
– A specific authorisation is required for the sale and marketing of Chia (Salvia hispanica) in accordance with the Novel Food Regulation.
11. 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.
12. 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/
13. 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.
14. 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. 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 (EC) 258/97 has been applied for and granted to it.
15. . 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. However, 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 (EC No 258/97) 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).
16. May products containing noni plant be marketed in Finland?
– Yes, but only noni products of companies that have been granted authorisation. The fruit and the leaves of the noni plant (Morinda citrifolia) are considered novel foods for which novel food authorisation must be obtained before they can be placed on the market. The Commission has granted authorisation to Morinda Inc. for using the juice of the noni plant in pasteurised fruit juices (decision 2003/426/EC), to the same company for using the dried and roasted leaves of the noni plant in the production of herbal infusions (decision 2008/985/EC) and to Tahitian Noni International for the use of puree and concentrate of the fruits of the noni plant in the products referred to in Annex II of decision 2010/228/EU, such as candy, ice cream, biscuits, jams and food supplements. In addition, several companies have been granted authorisation for their noni products, such as juices, concentrates, extracts and powders, through the notification procedure referred to in Regulation (EC) No 258/97.
17. 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.
18. Is Andean raspberry (Rubus glaucus) a novel food?
– Andean raspberry (Rubus glaucus) is considered a novel food, as at present there is no information about it having been used for human consumption. Andean raspberry is not included in the Commission's list of novel foods, either.
19. 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 ((EC) No 258/97, Article 1, Item 2. f). The operator must assess, and if necessary, prove how the method affects the end-product.
20. 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.
21. 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..
22. 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.