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

Classification in accordance with the EC 2011/696/EU recommendation

Are you looking to rule whether or not your powders are nanometric? The European Commission (EC) recommendation on the definition of nanomaterials (2011/696/EU) published on October 18, 2011, provides the answer.

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…)

Classification following the W.Wohlleben decision tree

The aim of this analysis is to classify raw materials as “nanomaterials” or “non-nanomaterials” following the decision tree published in the “Journal of Nanoparticle Research” on 02/11/2017, written by W.Wohlleben, “Reliable Nanomaterial classification of powders using the volume specific surface area method”.

The given definition is as follows : “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.”

This method is manly used for very dispersed raw materials (containing both nanoparticles and particles a few hundred microns across), which makes it possible to avoid microscopic problems, including the choice of magnification that can affect one group or another during the counting process.

Implementation is done in steps :

  • Step 1 : BET specific surface area measurement and Helium Pycnometry density measurement
  • Step 2 : Qualitative and morphological testing of particles by SEM
  • Step 3 : PSD of raw materials by SEM

Our nanomaterial classification and characterization techniques

FILAB can assist you in studying and characterizing your raw materials and finished products to allow you to classify them based on these definitions.

The techniques we use are as follows :

  • ICP-AES et ICP-MS : trace element and chemical composition analysis of nanomaterial-based substances
  • SEM FEG EDX : nanoparticle size and shape measurements
  • XRD : structural analysis
  • Laser Granulometry : particle count and size distribution
  • BET : specific surface area measurement
  • Helium Pycnometry : density measurement
  • SP-ICP-MS : nanoparticle detection
  • DLS : nano-emulsion and stability testing of a suspension by Zeta Potential titration 

*The scope of our services covers :  

  • Nanoparticle size and shape distribution using SEM-EDX
  • Nanoparticle size determination using SP-ICP-MS

(Details available at www.cofrac.fr – accreditation n°1-1793)

If you wish to call on our experts to carry out analyses, you can request a free quote online here.

For more information, feel free to contact us via email at contact@filab.fr or over the phone by calling +33 (0)3 80 52 32 05

Thank you !

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