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Tuesday, July 12, 2022Regulation

"1 substance, 1 assessment": the horizontal legislative proposal on data

"1 substance, 1 évaluation" : la proposition législative horizontale sur les données

The fourth part of the “1 substance, 1 assessment” (1S1A) initiative, which the European Commission presented in its entirety at the information session organised on 1 June 2022: the horizontal legislative proposal on data on chemical substances. Accessibility, re-use, interoperability, transparency and confidentiality: all these aspects were detailed by An Jamers from DG Environment.

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The idea for this proposal stems from the results of several evaluations of policies and regulations applied in the context of chemicals management in Europe. This is because they have highlighted the existing barriers to access and (re)use of data:
• Entities involved in safety assessments of chemicals are not always aware of what information is available, where it is available and how it can be used
• Rights of re-use are sometimes too restrictive
• Interoperability and accessibility of data are insufficient
• Different transparency rules are applied according to the stages of the assessment, the data and the regulatory texts
• Academic studies are not sufficiently exploited

To address these issues, the Commission has identified a number of actions to be implemented under the Chemicals Strategy for Sustainability (CSS):
• Better streamline the flow of data on chemicals between the EU and national authorities
• Remove legislative barriers to the re-use of data
• Make data available in appropriate formats and tools to ensure interoperability
• Extend the relevant principles of open data and transparency that already exist in the food safety sector to other legislation on chemicals
• Establish a data generation mechanism to allow European and …

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