New EU Guidance Documents on Authorization of Novel and Traditional Foods Now Available

In November 2015, the European Union (EU) adopted a new regulation on novel food, (EU) 2015/2282, which replaces a previous 1997 regulation. Novel food refers to food that Europeans have not consumed to a significant degree prior to May 1997. It includes food from new sources and food obtained through the application of new technologies. Traditional food is a subset of novel foods and refers to food traditionally consumed in countries outside of the EU. Examples include chia seeds, baobab fruit, insects and water chestnuts.

The new novel food regulation introduces a centralized assessment and authorization procedure. The two guidance documents on novel food and traditional food, published by the European Food Safety Authority (EFSA), explain what information is required to conduct a risk assessment of these foods. They also clarify how the information should be presented in order for EFSA to assess the safety of the novel or traditional food. For novel food, information should include data on the compositional, nutritional, toxicological and allergenic properties of the food, along with information on the production process and proposed uses and use levels. For traditional food, applicants need to present evidence of safe use of the food in at least one country outside of the EU for a period of at least 25 years.

The new novel food regulation comes into effect in January 2018. The guidance document on novel food and the guidance document on traditional food from third countries will assist applicants in preparing the necessary documentation under the new regulation.