Key messages

• Further analysis will focus on assessment processes for specific hazard criteria across frameworks; theoretical analysis of the legal texts and guidance documents to investigate the data requirements and assessment processes. Case studies will be performed on specific substances to analyse what information was required to classify a substance according to hazard criteria under Classification, Labelling and Packaging (CLP).  
• The chemical safety of plastic additives at various stages of the lifecycle of a plastic material or product often relies on knowledge of hazardous properties (e.g. according to the CLP Regulation,  or Substances of Very High Concern or banned (restricted) substances under REACH ↗ and pragmatic risk management approaches such as setting concentration limits based on what can be readily achieved by technology, without conducting a formal risk assessment.
• There are some provisions for some plastic additives in water legislation, but not necessarily in other environmental media such as air. While there is guidance on monitoring marine plastic litter, it does not cover chemicals associated with it. 

Overview

The European Union has various laws on chemicals created at different times and for different reasons. Efforts have been made to simplify these rules, but the risk assessment system remains fragmented among different laws and agencies. As they have been developed for a specific scope and different purposes, sometimes they seem to lead to inconsistencies and inefficiencies between the different regulatory frameworks. To address these issues, a more unified approach is needed, aligning with the goal of 'One substance, one assessment' within the framework of the Chemicals Strategy for Sustainability.

This project reviews representative cases of substances or groups of substances (i.e. plastic additives, biocides) to compare approaches to chemical safety and chemical risk  assessments, highlighting differences and similarities in various laws. 

These studies will help to identify ways of improving the assessment of chemical safety, including data sharing, hazard assessment methods, and effectiveness of safety measures.

The main objectives of the project are to:

• generate knowledge on substance-specific risk assessment methods and approaches performed across regulatory frameworks,  
• support the development and use of new risk assessment approaches and methods, regulatory processes, and policy developments,
• evaluate and understand differences and similarities, and subsequent implications, across legislations.

Achievements & Results

• Mapped chemicals subject to risk assessments in several regulatory frameworks. Of the 19670 chemicals identified, 9.3% were subject to assessments in more than one framework.  
• Assessing chemicals as groups spanned more frameworks compared to a single-substance approach.
• Mapped 417 plastic additives across relevant chemical legislation. Provisions for the chemical safety of plastic additives were included in 36 of 51 relevant chemical legislations. 

Policy relevance

This project provides information on inconsistencies, gaps and suggestions for harmonisation strategies, all relevant for a successful implementation of the ‘One substance, one assessment’ approach.