Article 2
For the purpose of this Decision, the following definitions shall apply:
‘ingoing substances’ means substances intentionally added, by-products and impurities from raw materials in the final product formulation (including water-soluble foil, if used);
‘primary packaging’ means:
for single doses in a wrapper that is intended to be removed before use, the individual dose wrapping and the packaging conceived so as to constitute the smallest sales unit of distribution to the final user or consumer at the point of purchase, including label where applicable;
for all other types of products, packaging conceived so as to constitute the smallest sales unit of distribution to the final user or consumer at the point of purchase, including label where applicable;
‘microplastic’ means particles with a size of below 5 mm of insoluble macromolecular plastic, obtained through one of the following processes:
a polymerisation process such as e.g. polyaddition or polycondensation or a similar process using monomers or other starting substances;
chemical modification of natural or synthetic macromolecules;
microbial fermentation;
‘nanomaterial’ means a natural, incidental or 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 1-100 nm ( 2 ).
( 2 ) Commission Recommendation 2011/696/EU of 18 October 2011 on the definition of nanomaterial (OJ L 275, 20.10.2011, p. 38).