Regulations and nanomaterials: what are the requirements for your industrial products?

Belonging to the science of infinitely small things (1nm = 0,000 000 001 m), Nanomaterials are a source of great technological innovations. The nanometric scale offers different properties (chemical, physical, biological, optical, mechanical…) to those observable at our macroscopic scale. This is the reason of their emergence in many fields such as cosmetics, electronics, automobiles, health products and also food products.

However, the risks they pose to our health and that of the environment are not yet fully known. Due to this, declarations and regulations have been implemented to evaluate these risks and to ensure the traceability of nanomaterials. 

Nanomaterials: what are the relevant regulations and declarations?

The primary objective of regulations surrounding nanomaterials is to ensure the traceability of these substances. EC 1223/2009 was the first regulation to make it mandatory to label “nano” ingredients taking the form of nanoparticles in ingredients. EC 528/2012 then made it mandatory to label “nano” ingredients in biocide products. On the 13th of December 2014, EC 1169/2011 made it mandatory to label “nano” ingredients in food products. The purpose of these “nano” labels is to establish a way of monitoring the use of nanomaterials and to make sure that the general public are aware of what they are consuming.

Today the three most important regulations surrounding nanomaterials covering all industrial fields are:

  • Nanometric classification in accordance with EC 2011 and the Wohllebe decision tree
  • R-Nano declaration
  • REACH regulations

Other regulations exist and are applicable to specific fields:

  • EC 1223/2009 cosmetics regulations
  • INCO 1169/2011 food regulations

The definitions and specifications to abide by can change depending on regulations which greatly complicates analytical approaches.

FILAB can assist you in understanding the challenges surrounding nanomaterials and in the characterization of your products

To face these challenges, FILAB with its team of regulatory and scientific nanomaterial experts can help you classify and characterize your nanoparticulate substances in accordance with different definitions, regulations or declarations.

FILAB is also a member of the AFNOR/X47 “Nanotechnologies” commission 

Our laboratory uses, amongst other things, analytical techniques specific to nanomaterials:

  • ICP-AES and ICP-MS: analysis of trace elements from the chemical composition of a nanomaterial-based product.
  • SEM-FEG-EDX: determination of the size and shape of nanoparticles
  • XRD: Structural analysis
  • Laster Granulometry: particle count and size distribution measurements
  • BET: specific surface measurements
  • Helium Pycnometry: density measurements
  • SP-ICP-MS: nanoparticle detection
  • DLS: nano-emulsion measurements and stability analysis of suspension using Zeta Potential titration. 

FILAB laboratory also provides the following services:

  • Development and validation of analytical methods specific to nanomaterials
  • Analysis of container/contents interactions
  • Literature and regulatory reviews
  • Analytical training for your teams
  • Nanomaterial regulatory consulting

*The scope of our accreditations covers:  

  • The distribution of nanoparticle sizes and shapes using SEM-EDX
  • The determination of nanoparticle sizes using SP-ICP-MS

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

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

The positive aspects of FILAB

  • A highly qualified team

  • Responsiveness in responding to and processing requests

  • A complete analytical park of 2100m²

  • Tailor-made support

Thank you !

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