Request a Demo
Speaking at the 15th Chemical Regulatory Annual Conference (CRAC) held on November 16, 2023 in Shanghai, Catherine Cornu, the Senior Scientific Officer of European Chemicals Agency (ECHA), introduced the trends in European chemicals management originating from the Commission’s Chemicals Strategy for Sustainability.
One Substance, One Assessment
Currently, risk assessment of chemicals is fragmented across different legal frameworks, depending on the use of chemical. This disparity can often lead to different assessment outcomes of the same chemical. For instance, pesticides, biocides, industrial chemicals are regulated under different EU directives and regulations with different environmental protection goals and assessment strategies.
To ensure coherence, harmonization and effectiveness of safety assessments of chemicals across legislation, ECHA has proposed a more integrated and holistic assessment of chemicals - “One Substance, One Assessment” (OS-OA) approach, which is built upon three main principles:
A central coordination mechanism
Improved coordination and re-attribution of tasks to agencies
Increased data access to authorities and public
"A key step of the OS-OA is CLP revision," highlighted Ms. Catherine, "specifically to ensure that CLP remains a central piece for hazard classification."
Widened mandate towards chemical safety
Under the OS-OA approach, ECHA is delegated with new tasks such as the revision of Batteries Regulation and Packaging and Packaging Waste Directive (94/62/EC). European Commission proposed to reattribute task to ECHA on industrial emissions, water protection (EQS, Water Framework and Groundwater Directives), toys, end-of-life vehicles, etc.
These new tasks are considered fit the core focus of the ECHA’s work on chemicals in terms of use of substance in specific products, the route of exposure assessed and type of sectors covered, and will bring maximized synergies and coherence with ongoing activities based on the data flow, existing expertise, processes, procedures, methodologies, IT tools managed by the Agency.
Grouping of Substances
Apart from OS-OA approach, ECHA is actively working on the grouping of substances as part of its Integrated Regulatory Strategy (IRS). It is aimed to treat related substances consistently, achieve predictable regulatory action and also support REACH &CLP processes.
In particular, multiple restriction proposals on grouping of substances have been submitted from 2022-2023. These include:
Per- and polyfluoroalkyl substances (PFAS) in firefighting foams
Medium-chain chlorinated paraffins (MCCP) and other substances containing chloroalkanes (C14 to C17)
Creosote and Creosote related substances
N,N-dimethylacetamide (DMAC) and 1-ethylpyrrolidin-2-one (NEP)
Bisphenols and their salts
A plethora of approaches can be applied in grouping substances for restrictions:
Similar chemical structure (e.g. nonylphenol, diisocyanates, PFHxA)
Common hazard properties, and/or same exposure route (e.g. CMRs in consumer mixtures (28-30), D4/D5 (70), tattoo ink (75))
Substances that contain hazardous constituents (e.g. PAHs, chloroalkanes)
Other common properties (e.g. microplastics)
Group for a specific use (e.g. PFAS in firefighting foams)
By restricting substances in groups, it will enhance risk reduction capacity and avoid regrettable substitution, which brings long-term certainty for industry.
Alongside the advantages, there are also accompanying challenges. Ms. Catherine highlighted that the extensive range of sectors impacted creates additional difficulties in gathering information. Moreover, the wide array of chemicals and the density of data contribute to the potential size of dossiers, as demonstrated by the PFAS restriction proposal, which spans a colossal 2000 pages. Considering the substantial amount of input received during consultations, it is evident that ECHA faces a laborious task ahead.
Cross-cutting enforcement
In addition, Ms. Catherine mentioned that ECHA is committed to conduct cross-cutting enforcement. For example, the REACH-EN-FORCE (REF) Project-12 will investigate how companies fulfil the registration, authorisation and restriction obligations for products and chemicals they import from outside the EU. The manual will be available by the end of 2023 and the inspection will commence in 2024.
The enforcement will prioritize on companies and products with the highest risk of non-compliance, as well as chemical substances that are identified with the hazard characteristics of Endocrine Disruptors for Human Health (ED HH) and Endocrine Disruptors for Environmental Health (ED ENV).
"Under REF-12 Project, If a product is found to fail to comply with the EU REACH registration requirements by the Customs, there are potential consequences such as product destruction or return to the exporter. Furthermore, any non-compliant product that is sold online in the EU market will be removed, and the corresponding webpage will be deactivated." Highlighted Henrik Hedlund, President of the Forum for Exchange of Information on Enforcement at the CRAC.
“It is essential for stakeholders to invest in overall compliance and be ready for cross-cutting enforcement”, says Ms. Catherine.
