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 and animals, which have not been previously used for human consumption in the EU are being imported to the EU market from non-member countries. New ways of utilising wild plants are also emerging to an increasing extent. 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 foods. For this reason it was considered necessary to establish specific authorisation procedures for novel foods.
The first Novel Food Regulation of the European Parliament and of the Council, Regulation (EC) No 258/97, was adopted in May 1997. Pursuant to the Regulation, the safety of the consumption of foods with no prior history of use within the EU area must be verified before they are authorised. The Novel Food Regulation has been reformed and the new Regulation (EU) 2015/2283 was adopted on 1 January 2018. The 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:
1. Food with a new or intentionally modified molecular structure;
2. Food consisting of, isolated from or produced from microorganisms, fungi or algae;
3. Food consisting of, isolated from or produced from material of mineral origin;
4. Food consisting of, isolated from or produced from plants or their parts;
5. Food consisting of, isolated from or produced from animals or their parts;
6. Food consisting of, isolated from or produced from cell culture or tissue culture derived from animals, plants, micro-organisms, fungi or algae;
7. Food resulting from a production process not used for food production within the Union before 15 May 1997, which gives rise to significant changes in the composition or structure of a food, affecting its nutritional value, metabolism or level of undesirable substances;
8. Food consisting of engineered nanomaterials;
9. Vitamins, minerals and other substances used in accordance with Directive 2002/46/EC, Regulation (EC) No 1925/2006 or Regulation (EU) No 609/2013;
10. Food used exclusively in food supplements within the Union before 15 May 1997, where it is intended to be used in foods other than food supplements as defined in point (a) of Article 2 of Directive 2002/46/EC;
Foods manufactured using nanotechnology, wild plants and insects, for example, also fall within the scope of the Regulation on Novel Foods. More information can be found about nanotechnology, wild plants and insects on Finnish Food Authority's web site.
Only authorised novel foods may be placed on the market
The safety of novel foods is assessed before they are allowed to be introduced to the consumers. The safety assessment is carried out by the European Food Safety Authority EFSA and marketing is authorised under the decision of the Commission. The authorisation is granted on an application containing a clarification of the safety of the product pursuant to the conditions approved in the Community.
Foods that have been traditionally used in third countries and verified to be safe can be placed on the market through a simplified novel food notification procedure.
The Commission maintains a Catalogue of authorised novel foods.
Authorised novel foods include e.g. certain foods with added plant sterols, Morinda citrifolia fruit juice (= noni juice), krill oils and algae oils that are rich in omega fatty acids, chia seeds (Salvia hispanica) as well as fruit products processed by means of high-pressure pasteurisation. The safety of these foods has been assessed and novel food authorisation has been granted for these foods.
Nangai nuts (Canarium indicum), Monnier's snowparsley (Cnidium monniere) and Coriolus mushroom (Coriolus Versicolor) are examples of foods that are considered to be novel foods but have not been granted novel food authorisation. These products may not be placed on the market within the EU as novel foods.
Finnish Food Authority considers it a serious fault to place on the market a non-authorised novel food. It will in every case result in a request for clarification, and usually in the withdrawal of the product from the market.