The Official Journal of the European Union has published the final Novel Foods Regulation (Regulation 2015/2283) text. The legislation was passed by the European Parliament in October by a vote of 359-202, with 127 abstentions and was ratified by the Council of the European Union.
The Regulation replaces a 1997 regulation with updated rules, matching the progresses 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.'
For more information on this or any other regulations, visit NIA's Regulatory Monitoring Database
, a tool for NIA members which tracks regulatory requirements for nanomaterials in Europe and around the world.