In June 2022, the European Commission (EC) published the “Commission Recommendation 2022/C 229/01 on the definition of nano material”. It replaces and builds on the 2011 “Commission Recommendation 2011/696/EU”

It has been applied to allow for a better definition of nano material for legislative and policy purposes and to harmonise the term “nanomaterial” in a regulatory context. The recommendation suggests a line of action without any obligations.

In response to the Recommendation, the Joint Research Centre (JRC) has created a guidance to support the implementation of the definition. The guidance explains how the terms and concepts used in the EC nanomaterial definition should be interpreted, as well as establishing technologies and measurement processes. In addition to the above, it further builds on the JRCs Science for Policy Reports (EUR 29647, 29942). It replaces EUR 29647 (Recommendation 2011/696/EU), whilst updating on the EUR 29942 (how to identify nanomaterials through measurement). The report presents all parties with detailed information, allowing them to better understand the nano definition as well as clarifying key terms and concepts.

The legal definitions of nanomaterial (nanoform) in the following regulations are planned to be updated and harmonised with the new definition in recommendation 2022/C 229/01. Examples of the regulations impacted include Regulation EC No 1907/2006, on the Restriction, Evaluation, Authorisation, and restriction of chemicals (REACH), Biocidal Products Regulation (EU) No 528/2012 (BPR) and the Medical Devices Regulation (EU) 2017/745.

Recommendation 2022/C 229/01 states that a substance is a nano material if it meets the following basic EC nanomaterial criteria

• It consists of solid particles.
• It is a natural, incidental or manufactured substance.
• 50 % or more of its constituent particles fulfil at least one of the following conditions:
  • One or more external dimensions of the particle are in the size range 1 nm to 100 nm
  • The particle has an elongated shape, such as a rod, fibre or tube, where two external dimensions are smaller than 1 nm and the other dimension is larger than 100 nm
  • The particle has a plate-like shape, where one external dimension is smaller than 1 nm and the other dimensions are larger than 100 nm
• The definition specifies one additional property, the volume specific surface area (VSSA), which can be used to demonstrate that a given particulate material is not a nanomaterial. The corresponding exclusion criterion is a VSSA of less than 6 m2 /cm3.

It is important to note that the EC Nanomaterial definition alone cannot differentiate between hazardous and non-hazardous nanomaterials as a definition based only on size cannot differentiate between such materials. The updated definition of a nanomaterial is similar to the previous recommendation with differences laid out in table 1 of JRC’s guidance.

Article Contributor

Katherine Peabody – Reach Project Manager