*1.3. Control Banding Approach Applied to Engineered Nanomaterials*

The control banding approach has been widely recommended for the selection of exposure controls for engineered nanomaterials. This approach is particularly useful for controlling workplace exposure to potentially hazardous agents with unknown or uncertain toxicological properties and where quantitative exposure estimations are lacking [6–9].

Already in 2009, the National Institute for Occupational Safety and Health NIOSH) published an extensive review about control banding [4]. There are several control banding tools available, such as NanoSafer, Stoffenmanager-Nano, NanoTool, Precautionary Matrix, ANSES, etc., which can lead to different results [8,9]. In the present study, the ISO Technical Specification ISO/TS 12901-2:2014 was chosen as it is an internationally recognized method.

The control banding process, as defined in ISO/TS 12901-2:2014, involves several elements, including information gathering, assignment of nano-objects to a hazard band based on a comprehensive evaluation of all available data, description of potential exposure characteristics based on workplace scenarios, definition of recommended work environments and handling practices by applying control banding methods, and evaluation of the control strategy or risk banding. Factors such as toxicity, in vivo biopersistence, the ability of particles to reach and be deposited in various regions of the respiratory tract, and their potential to elicit biological responses are considered when assigning a hazard band to each material. Actual exposure measurement data and the potential for dust generation during processes are also taken into account when defining exposure scenarios at the workplace.

A new registration system for nanomaterials has been introduced under REACH Regulation, which took effect in January 2020 (Commission Regulation (EU) 2018/1881 of 3 December 2018). It is recommended that chemical suppliers incorporating nanomaterials provide more information on hazards and risk mitigation measures in safety data sheets based on the guidelines provided in ISO/TR 13329:2012. This information is necessary for the implementation of the control banding approach [10].

More recently, the new Commission Regulation (EU) 2020/878 was introduced on 18 June 2020, which amends Annex II to REACH, providing requirements for compiling safety data sheets used to provide safety information on hazardous chemical substances and mixtures in the EU. This regulation, which came into full force in January 2023, provides more detailed requirements to be included in the safety data sheets of chemicals that include nanoforms.
