Nanometric classification of raw materials and finished products : how is FILAB able to assist you ?

However, this recommendation is not a regulatory definition as can often be found in cosmetic and food regulations. Seeing the lack of regularization of definitions and in the absence of a threshold in these regulations, the recommendation is currently used in the majority of cases as a basic reference.

The definitions given are as follows : 

“(2) Nanomaterials 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  nm-100  nm.”

“(5)[…] A material should be considered as falling under the definition in point 2 where the specific surface area by volume of the material is greater than 60 m2/cm3. However, a material which, based on its number size distribution, is a nanomaterial should be considered as complying with the definition in point 2 even if the material has a specific surface area lower than 60 m2/cm3.”

Download the EC 2011/696/EU Recommendation

The main goal is to give a reliable assessment of the nanometric or non-nanometric status of raw materials or finished products. Based on the recommendations and requirements of the EC regarding the measurement of nanomaterials, the purpose of this study is to classify the material at the nanometric scale (Nano or non-Nano) in order to meet the current regulatory requirements (Cosmetic (EC) 1223/2009, INCO 1169/2011…)