/ / Legal x-rays

By Giorgos Skampoulos, Associate LL.M.

Novel foods have become increasingly established in the dietary choices of consumers worldwide in recent decades. Since their spread is not a fact that can be ignored, both EU and US legislators have established a modern framework so as to regulate the emerging issues in an authentic way. Although the two regulations are similar in a number of aspects, they show some notable differences.

At the level of the European Union, where the provisions of Regulation 2015/2283 apply, the authorisation procedure for novel foods is carried out at a central level, while the individual Member States have only supporting and sanctioning powers to ensure compliance with the overall legislative framework. The European Commission plays a key role, assisted by the European Food Safety Authority. On the contrary, in the US legal order there is no specific legislation, as the binding rules have been formulated by the competent assessment body, which is the Food and Drugs Administration (FDA).

According to the specific provisions of EU Regulation 2015/2283, novel foods, regardless of the ingredients they contain and the production methods used, are treated in a uniform manner and undergo an authorisation procedure, which requires an application by the company concerned. The European Authorities check the completeness and validity of the application and amend the EU list of novel foods accordingly, a body which includes both approved and rejected novel foods. In the US legal order, by contrast, any new and unknown food ingredient is directly assigned by the FDA either to the category of food additive or to the category of generally recognised as safe, a distinction which is ignored at European level, where the uniform treatment applies. For food additives there is an approval procedure which either allows or prohibits the placing of new foods on the US market, while for generally recognised food additives there is a notification procedure based on the current scientific evidence of safety and quality. It is clear that if the product has already been marketed in Europe, there is a strong indication of safety and quality.

A notification procedure, however, also exists within the EU for traditional foods from third countries that are considered novel foods in the Union only when they come from primary production. For these foods, a simpler notification procedure is followed, but if unsuccessful, the operator concerned must follow the authorisation procedure.

In conclusion, although the two legal orders show some similarities (approval procedure, notification regime), the European regulation seems more complete as, on the one hand, it includes among novel foods also foods derived from new production methods, which is not the case in the US legal order and, on the other hand, Regulation 2015/2283 has promoted as far as possible a uniform treatment of novel foods produced within the EU.