Article 1

Point (t) of Article 2(2) of Regulation (EU) No 1169/2011 is replaced by the following:

1. (t)

   ‘“engineered nanomaterial” means any intentionally manufactured material, containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1 nm to 100 nm.

By way of derogation:

1. (a)

   food additives covered by the definition set out in the first paragraph shall not be considered as engineered nanomaterials, if they have been included in the Union lists referred to in Article 4 of Regulation (EC) No 1333/2008 by Commission Regulations (EU) No 1129/2011^f1 and (EU) No 1130/2011^f2;

2. (b)

   fullerenes, graphene flakes and single wall carbon nanotubes with one or more external dimensions below 1 nm shall be considered as engineered nanomaterials.

   For the purposes of the definition set out in the first paragraph:

   1. (i)

      “particle” means a minute piece of matter with defined physical boundaries;

   2. (ii)

      “agglomerate” means a collection of weakly bound particles or aggregates where the resulting external surface area is similar to the sum of the surface areas of the individual components;

   3. (iii)

      “aggregate” means a particle comprising of strongly bound or fused particles;

   4. (iv)

      “intentionally manufactured” means that the material is manufactured to perform/fulfil a specific function or purpose;.’.