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Disclaimer: This document does not present future project calls as part of the EFSA work programme, or any future position of EFSA. It aims to support the development of a roadmap for action and its content can be subject to change. 

# ANNEX 3 

# Theme (concept) paper –  Building a European Partnership for next generation, systems-based Environmental Risk Assessment 

# Revised theme paper in light of the comments received from the European Commission (DG SANTE), ENVI Agencies, EU Member States and EFSA’s Scientific Committee members in the phases 1 & 2 of EFSA’s consultation process 

## Vision: 

By 2022, the European Partnership for Environmental Risk Assessment (PERA) has: 

• Brought together partners of relevant sectors across regulatory silos and improved the cooperation  on regulatory environmental risk assessment (ERA) between these partners. 

By 2030, PERA has: 

• Facilitated the transition to next generation, systems-based ERA through the co- development of new and complementary  tools and  methods , and the sharing of data (including their findability, accessibility, interoperability, and reuse) and expertise . 

## Background: 

In line with sectoral legal requirements, the ERA of regulated products (such as biocides, chemicals, pesticides, pharmaceuticals, feed additives and genetically modified organisms) is typically performed on a single substance/compound or product basis, for a specific type of use, in the European Union (EU). While the EU has made substantial progress on achieving environmental protection with the exiting ERA paradigm, frameworks for the ERA of single substances/compounds or products are increasingly challenged by the scientific community and society. Such frameworks are claimed to have fallen out of step with scientific knowledge  and progress 1 . Moreover, they are not always in line with n ew policy targets 2 and society needs 3 that demand for more sustainable solutions  to protect the environment. 

In addition , environmental policies in different sectors have developed independently and at different times, and are implemented by different institutions, leading to inconsistencies between different regulatory frameworks and potential policy gaps. For regulatory ERAs this fragmentation can lead 

