Novel Foods Regulation with Nano-specific Provisions was approved by the European Parliament


The Regulation on Novel Foods 2013/0435(COD) aims to replace 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. The Plenary session of the European Parliament approved the Novel Foods Regulation, the text will be ratified by the Council of the European Union before it enter into force.

In the text that was approved by Member of Parliament, “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.'


Here you can find the text approved:



Date of the last update: 31/03/2016