On Friday 11 December a new Regulation No 2015/2283 on Novel Food was published. Its aims are to clarify the definition of Novel Food, simplify the applicable procedure for market entry, centralise it at European level, and render it more transparent. The Regulation modifies existing rules dating back to 1997 for the introduction of Novel Food into the EU thus keeping up with scientific developments. Its purpose is also to create a more favourable environment for Novel Food and ingredients.
The term, Novel Food, describes food which was not used for human consumption to a significant degree within the EU before 15 May 1997. In other words, it covers innovative or newly-developed food products, but also natural food products, coming from outside Europe and which EU citizens are not used to consuming.
This Regulation reforms the former authorisation procedure whereby one had to ask a Member State to authorise the introduction of a Novel Food into the EU. Member States were until now responsible for risk assessment procedures and for deciding whether additional assessment needed to be done by the EFSA and the European Commission.
In this regard, this new text sets up a new centralised and simplified procedure for introducing Novel Food into the EU (article 10) which is managed at European level by the European Commission rather than by the Member States. Furthermore, it also establishes a “Union List” identifying clearly and with transparency all authorised Novel Food in the EU, which will be updated each time a new authorisation is given.
Also, this Regulation provides a more precise definition of Novel Food and broadens its scope, adding new categories to those that already exist.
What is a Novel Food according to the new Regulation?
- Food with a new or intentionally modified molecular structure
- Food containing microorganisms or nanomaterials
- Food containing insects or food of mineral origin (such as fungi or algae)
- Food deriving from cloned animals
- Food obtained through a production process which did not exist before 15 May 1997 and which leads to significant changes in the composition or structure of the food
- Traditional food from third countries derived from primary production and with a history of safe use for at least 25 years, regardless of whether or not it is processed food, and for which a simplified procedure is established (article 14).
e.g.: natural ingredients originating from third countries and which European citizens are not yet used to consume (for instance Açaï berries, Chia seeds or certain types of Cranberries)
This new Regulation will apply from 1 January 2018, but the Commission’s implementing power will enter into force before that, through nine implementing acts and one delegated act covering, amongst other matters, procedural steps for the new authorisation process for market entry, enlarging the definition of Novel Food, establishing the new Union List, also providing specific administrative and scientific requirements for applications to comply with.
Click here to access the new Regulation.