Novel food

Designer food is a type of novel food that has not existed on any regional or global consumer market before. Instead it has been "designed" using biotechnological / bioengineering methods (e.g. genetically modified food) or "enhanced" using engineered additives. Examples like designer egg, designer milk, designer grains, probiotics, and enrichment with micro- and macronutrients and designer proteins have been cited. The enhancement process is called food fortification or nutrification.[1][2] Designer novel food often comes with sometimes unproven health claims ("superfoods").

Designer food is distinguished from food design, the aesthetic arrangement of food items for marketing purposes.

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.[3]

Applicants can consult the guidance document compiled by the European Commission,[4] 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; or
• 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.[5]

The UK Food Standards Agency has provided guidance for companies that wish to submit a simplified novel food application.[6]

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[7] and Flora ProActiv, containing phytosterols[8][9] 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.[10]

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.[11][12] 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.[13]

The Baobab Dried Fruit Pulp novel food application, pioneered by John Wilkinson, a botanical regulatory consultant (together with his 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.[14] 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.

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.[23]

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.

• Generally recognized as safe
• Substantial equivalence

• 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
• The EU Novel Food Regulation: an unintended trade barrier

Media related to Novel food at Wikimedia Commons

• EU 2013 revision of regs