Novel Food - European Union

European Union

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.

The FSA has provided guidance for companies that wish to submit a simplified novel food application.

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.