Yordas Group

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An Introduction to the GRACIOUS Project

Kaying Tam

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Global regulatory consultants, Yordas Group have taken the lead on the Stakeholder Engagement and Dissemination Work package for the H2020 GRACIOUS Project, which kicked off in January 2018.

The main goal of the GRACIOUS project is to support the assessment of the risk posed by the ever-increasing array of nanomaterials on the market and under development. Using a framework, the aim is to streamline the process for assessing risks by logically grouping nanomaterials thereby allowing extrapolation between nanomaterials and reducing the need to assess exposure to and toxicity on a case by case basis.

Manufacturing materials at the nanoscale leads to an array of nanomaterials varying in size, morphology and surface characteristics. Due to financial, time and ethical considerations, safety testing of every unique nanomaterial for potential adverse effects is virtually impossible. This is why more efficient ways to obtain safety information are needed.

The key Project results include the GRACIOUS Framework, blueprint and wiki.

GRACIOUS Framework

GRACIOUS developed a highly innovative science-based framework to enable practical application of grouping, leading to read-across and classification of nanomaterials and nanoforms. The GRACIOUS Framework was designed to integrate industrial and regulatory grouping concepts. To ensure that the Framework would be fit for its purpose, the opinions of diverse stakeholder groups (spanning academia, regulation, industry, standardisation and NGOs among others) were sought and incorporated into the detailed design of the Framework.

GRACIOUS Framework Development Methodology

A simple overview of the GRACIOUS Framework that demonstrates the Basic Information Step, which provides an initial output of possible grouping hypotheses, followed by the more Detailed Step which gathers the evidence needed to accept or reject the proposed grouping hypotheses.

GRACIOUS Blueprint

The blueprint is a document intended for software developers who want to implement the GRACIOUS Framework. As the GRACIOUS Framework is highly complementary to risk assessment frameworks, integration of it into existing risk assessment tools or future SbD tools is considered the preferred way of automation.

Information flow diagram to show how the GRACIOUS Blueprint integrates with GRACIOUS Framework and other tools

GRACIOUS Wiki

The GRACIOUS Wiki was established to ensure that terminology was used in a consistent fashion across all parties involved in the development of the GRACIOUS Framework. It is now hosted within the Terminology Harmonizer developed by GreenDecision. The Wiki is divided into 6 sections that cover all aspects of the Framework.

Frontpage of the GRACIOUS Wiki showing the sections of the GRACIOUS Framework addressed.

The GRACIOUS project has been successfully completed, and you can now access the final results: