Novel foods
The world of food products is under constant renewal. Research and product development efforts are vigorous in the food sector and new products are constantly being introduced. This results in the creation of new concepts, such as novel foods.
As suggested by their name, novel foods are new products intended for use as food. Regulation (EC) No 258/97 of the European Parliament and of the Council, which was adopted in May 1997 (15 May 1997), defines the word "novel food" as follows: Novel foods refer to products which prior to May 1997 have not been used for human consumption to a significant degree within the Community and which fall under the following categories:
- foods and food ingredients with a new or intentionally modified primary molecular structure;
- foods and food ingredients consisting of or isolated from micro-organisms, fungi or algae;
- foods and food ingredients consisting of or isolated from plants and food ingredients isolated from animals, except for foods and food ingredients obtained by traditional propagating or breeding practices and having a history of safe food use;
- foods and food ingredients to which has been applied a production process not currently used, where that process 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.
Foods and food ingredients containing genetically modified organisms or produced from genetically modified organisms were previously also included within the scope of the Novel Food Regulation. At present genetically modified food and feed are governed by Regulation (EC) No 1829/2003, which was published on 18 October 2003.
Novel foods include e.g. foods containing plant sterols, isomaltulose sweeteners and Morinda citrifolia fruit juice (=noni juice). These foods have obtained novel food authorisation and their safety has been assessed before the authorisation was granted.
Information about authorisation novel foods is provided in the catalogue on the right-hand side margin of the page.
Novel Food Catalogue
The Novel Food Catalogue is a database maintained by the Commission containing history information about the use as food of products of plant or animal origin or other products. The Catalogue is designed as an indicative source of history information on the use of the product.
The products are in the Novel Food Catalogue divided into four different categories based on their history of use:
- products of which it is known that they have been used as food or a food ingredient within the area of the European Community to a significant degree before 15 May 1997;
- products of which it is known that they have been used as food supplements in the area of the European Community before 15 May 1997 (note that the expansion of the use to other foods requires novel food authorisation)
- products of which there is no knowledge of a history of use as a food or food ingredient in the area of the European Community before 15 May 1997, and which are considered to be products that require novel food authorisation; and
- the history of use of the product in the area of the European Community has been discussed, but a final classification has not yet been made, as it requires further information.
The classification is based on the discussions undertaken by the Novel Foods Experts Group, which is subject to the Commission, and on the information the Group had at its disposal at the time. The members of the Novel Food Expert Group are various experts on novel foods from the EU Member States. The classification of the products may change if new reliable information emerges on the history of use. If a food business operator has information on the history of use of products classified in the catalogue as novel foods, they are requested to approach Food Safety Authority Evira.
Even though some products have a history of use as a food in some EU member countries, the food business operator should take into account any national regulations limiting the use. In some Member Countries the product can be considered medicinal, for example.
Only authorised novel foods may be placed on the market
Evira considers it a serious fault to place on the market a product considered a novel food if an authorisation has not been applied for in accordance with the Novel Food Regulation and the product's safety has not been assessed. The discovery of an unauthorised novel food on the market will lead to a request for clarification. If the food operator cannot demonstrate the history of use of the product, the product will have to be withdrawn from the market, as the safety of the product as food has not been ascertained pursuant to the Novel Food Regulation.