Authorisation and use of novel foods and food ingredients have been harmonised in the European Union since 1997 when Regulation (EC) No 258/97 on novel food and novel food ingredients was adopted. Novel food is food not consumed to a significant degree in the European Union prior to 15 May 1997 and which falls under one of the categories listed in the Regulation (e.g. food consisting of or isolated from micro-organisms, fungi or algae).
The new Novel Foods Regulation (2015/2283) was adopted in November 2015.
The Regulation replaces the 1997 regulation with updated rules, matching the progress made in the sector. It adds foods consisting of ‘engineered nanomaterials’ to the list of criterion to be considered for novel foods and therefore subjected to pre-market authorisation.
In the text, 'engineered nanomaterials' are defined as:
'(f) "engineered nanomaterial" means any intentionally produced material that has one or more dimensions of the order of 100 nm or less or that is composed of discrete functional parts, either internally or at the surface, many of which have one or more dimensions of the order of 100 nm or less, including structures, agglomerates or aggregates, which may have a size above the order of 100 nm but retain properties that are characteristic of the nanoscale.
Properties that are characteristic of the nanoscale include:
(i) those related to the large specific surface area of the materials considered; and/or
(ii) specific physico-chemical properties that are different from those of the non-nanoform of the same material.'
The European Food Safety Authority (EFSA) has drafted Guidance for the Preparation and Presentation of an Application for Authorisation of a Novel Food, which is expected to be finalised in September 2016. In relation to foods containing or consisting of "engineeered nanomaterials", the draft guidance refers to the parameters for characterisation and identification of engineered nanomaterials outlined in the 2011 EFSA Guidance on the Risk Assessment of the Application of Nanoscience and Nanotechnologies in the Food and Feed Chain.
Further information on nanotechnology and food can be found on the Food Standards Agency (FSA) website.