Novel foods are foods or ingredients which were not used for human consumption to a significant degree within the Union before 15 May 1997. Food items introduced to the EU market after this date are considered novel, and must be approved by the EU Commission and EFSA before being marketed.
Foods produced using nanotechnology or cloning are considered novel, as are foods which are commonly produced outside the EU but not typically consumed within the EU.
Among other things, Novel foods are recorded in the EU Novel food catalogue. Before these foods are marketed legally within the EU, a safety assessment must be authorized under Novel Foods Regulation (Regulation (EU) No 2015/2283). Article 3 states, that e.g. if a food has undergone a molecular modification, been produced using fungi or algae, or has been produced using foreign plants or cell tissue from animals, and this product was not commonly and significantly consumed by humans before 1997, it is a novel food. Examples of novel foods include exotic fruits (e.g. noni fruit), fermented soybeans, and insects.
The Union list is a regulation in which Novel Foods is listed, including conditions of use and anything else that has to be indicated on the label. Please find the Union list here.
The Novel Foods Regulation states that in order to be marketable, a novel food must:
- be safe to consume
- correctly labelled.
Also, the consumption of the novel food shall not be nutritionally disadvantageous for the consumer if it is intended to replace another food product.
If there is uncertainty over the novelty of a food, the manufacturer will have to contact the respective authority (ex. BVL in Germany) and then the country specific authority will consult all EU member states and a unanimous decision is made. The European Food Safety Authority (EFSA) is in charge of scientifically assessing foods which are considered novel. Approval is subsequently granted by the EU commission if the assessment meets the standards outlined the aforementioned EU Regulation.
Although the novel foods legislation is seen as a cornerstone to food safety, various EU member states have raised objections to the novel food procedure. The argument is that the novel food procedure is not clear and transparent enough, and the assessments of foods can take years. For this reason, the EU revised the regulations in 2008 to overhaul the definition of novel foods. A centralized authorization procedure was requested, which would simplify the testing process. Changes would include that foods which have a safe track-record in 3rd world countries, would not be subject to extensive testing. This is a topic that is still being debated to this day.
Novel Food vs. Functional Food
Functional foods are foods which contain additional nutrients which offer physiological and psychological benefits. Some additional nutrients that functional foods may contain consist of certain minerals, vitamins, or fibres. Although functional foods contain added nutrients, they are not considered to be novel foods (unless they contain a novel food ingredient). Some examples of functional foods include probiotic yoghurt with bacterial cultures or fruit juices/ soft drinks, but also margarine with sterols.
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