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European Union
A novel food is defined as a type of food that does not have a significant history of consumption within the European Union prior to May 1997 [See, RECUERDA GIRELA, M.A., Seguridad Alimentaria y Nuevos Alimentos, Régimen jurídico-administrativo. Thomson-Aranzadi, Cizur Menor, 2006].
Novel food applications are processed according to the Novel Foods Regulation, which among other stipulations states 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.
Among the novel food applications are transgenic foods, cholesterol-lowering foods, and foods for which approval is sought mainly because they are less expensive for the food industry to produce.
Companies can also seek approval through the substantial equivalence application procedure. The applicant has to show that their product is substantially equivalent to an existing product on the market, for example a novel extract of an existing fruit or herb. This has been used to great success by companies involved in the manufacture and marketing of nutraceuticals and oral cosmeceuticals.
Canada
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 notification be made to the Health Canada by the company who wants to sell the product prior to the marketing or advertising of a novel food. 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.[1]
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.
See also
References
- FSA: Novel Food Assessments
- Text of the Novel Foods Regulation
- Discussion group on Novel Foods Approval
- BioPortal | Novel Foods
- The EU Novel Food Regulation: an unintended trade barrier, <http://news.bioversityinternational.org/index.php?itemid=1153>
