On the 8th of August 2020, a team of 22 scientists from the Horizon 2020 GRACIOUS consortium published a paper describing a novel science-based Framework for grouping and read-across of nanomaterials.
A Framework for grouping and read-across of nanomaterials – supporting innovation and risk assessment.
A main objective of the GRACIOUS Framework is to streamline the risk assessment process in order to enable practical application of grouping, leading to read-across and classification of nanomaterials (NMs)/nanoforms (NFs) while reducing time, costs and animal testing.
Designed to be compatible with REACH and flexible to incorporate other regulatory provisions, the Framework facilitates steering safe innovation.
The concept of the Framework is built around applying grouping and read-across based on hypotheses development and assessment. The Framework provides an initial set of hypotheses for the grouping of NFs which take into account the identity and use(s) of the NFs, as well as the purpose of grouping.
The Framework – Step-by-Step
As a starting point, users define the purpose of grouping and collect basic information about a nanomaterial, followed by a selection of a hypothesis. They then test whether or not the hypothesis is justified using Integrated Approaches to Testing and Assessment (IATA). IATA are structured approaches that integrate and weight different types of data for the purposes of performing hazard identification and/or safety assessment of a chemical or group of chemicals. Users needing to develop their own user-defined hypothesis (and IATA) are also supported by the Framework. In addition, the IATA guides acquisition of the information needed to support read-across. In the final step, if the available data supports the hypothesis, with sufficient certainty for the particular decision context, read-across from similar nanomaterials may be possible.
The GRACIOUS Framework was developed following comprehensive discussions and stakeholder consultations with key stakeholders from regulation such as ECHA, EFSA, Health Canada, industry representative such as BASF, Solvay among others and world-class experts from the academic nanosafety community.
The scientific publication available on NanoToday provides more insight into the GRACIOUS Framework and how to use it in practice. The publication is free to access, and can be viewed here: https://www.sciencedirect.com/science/article/pii/S1748013220301109?dgcid=author
H2020 project GRACIOUS in collaboration with BIORIMA and Patrols are organising their final conference under the umbrella of NanoTox 2021 conference, held in Edinburgh between 20th and 22nd April. Abstract submissions for the NanoTox opened on 1st September 2020. Abstracts can be submitted under any of the 6 themes:
1. Hazard Characterisation of Nanomaterials and Advanced Materials
2. Alternative Methods for Nanomaterial Hazard Testing
3. Release and Exposure to Nanomaterials and Advanced Materials
4. Risk Assessments of Nanomaterials and Advanced Materials, and their Governance
5. Safe(r) by Design (SbD) of Nanomaterials and Advanced Materials
6. Open Topics
Authors will be notified of their abstract acceptance on the week beginning the 1st February 2021.
For more details on the NanoTox 2021 abstract process please click here: https://nanotox2021.org/abstracts/
Dr Stella Stoycheva