The MCRA platform for EU regulatory actions: governance, user guidance and FAIRification

The Monte Carlo Risk Assessment (MCRA) platform is a web‐based tool that can be used for the cumulative risk assessment of pesticides. As underlined by the Transparency Regulation, interoperability and open access to data and tools is essential to ensure transparency and sustainability of EU food chain risk assessments.

The transparency of MCRA was achieved by open‐source publication of the source code of the model implementations and defining a governance structure for the MCRA software. The aim of the governance structure is to ensure sustainability and quality of the MCRA software, allow for further development of the software with new models and functionality, and support implementation of cumulative risk assessment according to the requirements described in EU Regulation No. 396/2005. The governance described in Part 1 of this report indicates how decisions on the regulatory aspects within MCRA are taken. It also describes how future development needs of MCRA in the context of the DG SANTE – EFSA action plan or in the context of future regulatory implementation requirements for cumulative risk assessment set by the European Commission are identified.

The MCRA software consists of two packages: the MCRA core library and the MCRA web platform. The MCRA core library contains the model implementations and is publicly available to increase transparency and stimulate interoperability with models developed by co‐creators. The MCRA web platform ensures accessibility of a user‐friendly interface for conducting cumulative risk assessments following harmonized regulatory requirements. Part 2 of this report provides guidance on how to use the MCRA core models and Part 3 supplies a framework for interoperability of the MCRA model.

This publication is linked to the following EFSA Supporting Publications article: http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2023.EN-8376/full