Novel food is defined as a type of food that does not have a significant history of consumption or is produced by a method that has not previously been used for food.
Novel foods or novel food ingredients have no history of “significant” consumption in the European Union prior to 15 May 1997. Any food or food ingredient that falls within this definition must be authorised according to the Novel Food legislation, Regulation (EC) No 258/97 of the European Parliament and of the Council.
A company that wishes to submit an application under this legislation should consult the guidance document compiled by the European Commission, which highlights the scientific information and the safety assessment report required in each case.
The Novel Food regulation stipulates that foods and food ingredients falling within the scope of this regulation must not:
- present a danger for the consumer,
- mislead the consumer,
- differ from foods or food ingredients which they are intended to replace to such an extent that their normal consumption would be nutritionally disadvantageous for the consumer.
There are two possible routes for authorization under the Novel Food legislation: a full application and a simplified application. The simplified application route is only applicable where the EU member national competent authority, e.g. Food Standards Agency (FSA) in the UK, believes that the novel food in question is substantially equivalent to an existing food or food ingredient.
There have been a number of products launched as a result of food or food ingredients authorised under the Novel Food legislation. Benecol, containing phytostanols and Flora ProActiv, containing phytosterols  are commercially successful products that help to reduce cholesterol levels.
Originally, the Novel Food legislation was conceived by the European Commission in response to the arrival of food products derived from GM crops. These types of GM derived food are now regulated by separate legislation, Regulation (EC) No 1829/2003 of the European Parliament and of the Council.
In its current format, exotic fruit and vegetables, which have a long history of safe use outside of the European Union, fall within the definition of a novel food. As a consequence, each of these food products must undergo a safety assessment prior to being marketed. This has long been an issue of contention for food manufacturers and producers outside the EU who view this as an economic trade barrier. A good example of this situation can be illustrated with Baobab (Adansonia digitata). This fruit is wild-harvested across Southern Africa and has a long history of use as a food amongst the indigenous tribes in this continent. Nonetheless, Baobab Dried Fruit Pulp required authorisation under the Novel Food legislation before any food products containing this ingredient could be marketed in the EU.
The Baobab Dried Fruit Pulp novel food application, pioneered by John Wilkinson of Herbal Sciences International, a botanical regulatory consultancy company, together with their client Phytotrade Africa, was also the first successful submission to demonstrate safety without the need for animal testing. Instead, this application used the history of use alongside detailed analyses of the nutritional and phytochemical components in Baobab to demonstrate safety. This has lowered the costs for approval from an average of €10 million to less than €100,000 and thus opened the EU to access non-Western fruits, vegetables and nutraceuticals while at the same time saving unnecessary animal testing.
Revision of the EU novel food regulation
In 2008, the European Parliament, European Commission, and Council of the European Union began talks to revise the regulation because it was accepted that essential elements needed to be discussed and resolved.
However, the revision came to a standstill on 28 March 2011 when the three institutions failed to reach agreement at a final conciliation meeting on the issue of cloning. Disagreement centred on the European Parliament being in favour of a total EU market ban on foods from clones and their offspring/descendants, while some members of the Council of the European Union were not in favour as they considered offspring to be bred using normal (or traditional) methods, therefore not falling under the definition of a novel food.
According to the European Parliament, it had tried to compromise, backing down on demands for a full ban on food from cloned animals and their descendants, to mandatory labelling of all food products from clones and their offspring as a bare minimum. The Council of the European Union decided that the solution presented by the European Parliament could not be implemented in practice because it would not be in compliance with the international trade rules that the European Union has signed.
The cloning technique is not banned at EU level, and since March 2011 it has been unclear if and how the institutions will move forward on a revision of the regulation. Therefore, the existing novel food regulation, adopted in 1997, remains in place.
In Canada, novel foods are regulated under the Novel Foods Regulations. The regulations define novel food as
- Products that have never been used as food,
- Foods that result from a process that has not been previously used for food, or,
- Foods that have undergone genetic modification and have new traits.
The Novel Foods Regulation requires that a company wanting to sell a novel food notify Health Canada prior to marketing or advertising the product. Pre-market notification permits Health Canada to conduct a thorough safety assessment of all biotechnology-derived foods to demonstrate that a novel food is safe and nutritious before it is allowed in the Canadian marketplace.
To date, more than 90 novel foods have been approved for sale in Canada including a number of canola, corn, cottonseed and flax crop lines. Some of the novel traits include herbicide tolerance and pest and disease resistance. In spite of the benefits brought about by the development of novel foods, there are also a number of concerns that have been raised concerning their potential impact on the environment and on human health and safety.
- Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients – consolidated version of 7.8.2009
- Commission Recommendation of 29 July 1997 concerning the scientific aspects and the presentation of information necessary to support applications for the placing on the market of novel foods and novel food ingredients and the preparation of initial assessment reports
- European Commission > Directorate General for Health and Consumers > Food and Feed Safety
- Guidelines for the presentation of data to demonstrate substantial equivalence between a novel food or food ingredient and an existing counterpart
- Commission Decision of 31 March 2004 authorising the placing on the market of yellow fat spreads, salad dressings, milk type products, fermented milk type products, soya drinks and cheese type products with added phytosterols/phytostanols as novel foods or novel food ingredients
- Commission Decision of 24 July 2000 on authorising the placing on the market of 'yellow fat spreads with added phytosterol esters' as a novel food or novel food ingredient
- Commission Decision of 31 March 2004 authorising the placing on the market of milk type products and yoghurt type products with added phytosterol esters as novel food ingredients
- Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed
- Hermann, Michael (2009). "The impact of the European Novel Food Regulation on trade and food innovation based on traditional plant foods from developing countries". Food Policy 34: 499–507. doi:10.1016/j.foodpol.2009.08.005. Retrieved 27 November 2011.
- biotrade.org[dead link]
- Advisory Committee on Novel Foods and Processes: Baobab dried fruit pulp
- Baobab Dried Fruit Pulp – An application for Novel Foods Approval in the EU as a food ingredient
- Novel Foods - Review of Regulation (EC) 258/97
- News report on failure of novel foods talks
- Statement from the Parliament on the collapse of the novel foods talks
- Statement from the Council on failure of conciliation on novel foods
- Council statement on the failure of conciliation on novel foods
- Bid to ban cloned food in EU collapses
- Statement by Commissioner Dalli on the lack of agreement in the conciliation procedure on the Novel Food Regulation
- Health Canada Factsheets and Frequently Asked Questions
- Summaries of EU legislation > Consumers > Consumer safety > Novel foods and novel food ingredients
- Text of Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients
- Overview of the breakdown of the novel food discussions
- FSA: Novel Food Assessments
- Discussion group on Novel Foods Approval[dead link]
- The EU Novel Food Regulation: an unintended trade barrier[dead link]