Novel foods

Draft Commission Delegated Regulation amending Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods as regards the definition of 'engineered nanomaterials' (Text with EEA relevance). Language(s): English, French and Spanish. Number of pages: 7

The measure updates the definition of 'engineered nanomaterials' of Regulation (EU) 2015/2263 on novel foods in line with technical and scientific progress. The measure transposes the main elements of the general nanomaterial definition of Commission Recommendation 2022/C 229/01 which is in turn underpinned by extensive technical and scientific elements and developments. The act maintains the current definition size limit (< 100 nm) below which a material would be considered as a nanomaterial; 2) introduces a default threshold value of 50% of particles (by number) being at the nanoscale for a material to be considered a nanomaterial; 3) includes provisions on its applicability taking into account the external dimension and shape of the material; 4) excludes from the definition single molecules and materials with a surface to volume ratio below a certain value; 5) defines the terms 'particle', 'aggregate' and 'agglomerate'; and 6) includes only materials in solid state to exclude particles with highly dynamic external dimensions such as micelles, liposomes, or nanoscale droplets in emulsions.

In addition, the Regulation includes elements specifically aimed to address the subjectivity elements in interpreting the 'intentionally produced' notion of the current definition which have hampered its implementation.