Research and product development is active in the food sector and results in the continuous reformation of the world of foods – lots of new products are introduced to the market. Ever more exotic food plants, which have not been previously used for human consumption in the EU are also being imported to the EU market from non-member countries. As suggested by their name, novel foods are new products intended for use as food.
The safety of foods has primarily been based on a long history of use and no safety assessments have been required from conventional foods before they are placed on the market. The situation has changed in this respect in the past decades. Scientists, legislators and consumers have become concerned about the potential risks of e.g. new food ingredients or exotic fruit. For this reason it was considered necessary to establish specific authorisation procedures for novel foods.
Pursuant to Regulation (EC) No 258/97 of the European Parliament and of the Council, which was adopted in May 1997, the safety of the consumption of foods with no prior history of use within the EU area must be verified before they are authorised. This Novel Food Regulation 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 manufactured using nanotechnology also fall within the scope of the Regulation on Novel Foods. More information about nanotechnology can be found on Evira's web site.
Only authorised novel foods may be placed on the market
The safety of novel foods must be assessed before they are allowed to be introduced to the consumers. The marketing of a novel food is authorised under a common decision of all the EU countries. The authorisation is granted on an application containing a clarification of the safety of the product pursuant to the conditions approved in the Community. Novel food authorisation is granted to a specific operator. After the novel food has been granted marketing authorisation, products that are substantially equivalent can be placed on the market through a facilitated novel food notification procedure.
Authorised novel foods include e.g. certain foods with added plant sterols, Morinda citrifolia juice (= noni juice), krill oils and algae oils that are rich in Omega 3 fatty acids, as well as fruit products processed by means of high-pressure pasteurisation. Various operators have obtained novel food authorisations for these foods.
Stevia plant (Stevia rebaudiana) and nangai nuts (Canarium indicum) are examples of foods that the Commission has not authorised and which therefore may not be placed on the market as novel foods. Cnidium monnieri, yacon (Smallanthus sonchifolius) and SIL-Q Gold Turkey Tail Mushroom (Coriolus versicolor) are also considered to be novel foods, which at least so far have not been authorised and may not be marketed as foods within the European Union.
Evira considers it a serious fault to place on the market a non-authorised product. In this case the operator is usually required to withdraw the product from the market.