The European Commission has put forward a proposal to amend Regulation (EC) No 440/2008, focusing on adapting chemical test methods to recent technical advancements. This initiative signifies a proactive step towards aligning chemical safety regulations with contemporary scientific understanding and ethical considerations.
Background of the Amendment
Regulation (EC) No 440/2008, pivotal in defining test methods for assessing various properties of chemicals, is set for a significant update. These modifications are driven by the European Commission’s commitment to the Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH) established by Regulation (EC) No 1907/2006.
Key Features of the Proposed Amendment
Inclusion of New Test Methods: Seven additional test methods are proposed to be integrated into the Annex of Regulation (EC) No 440/2008. These methods address basic physicochemical properties, in vitro testing for immunotoxicity and skin sensitisation, and enhanced ecotoxicity assessments.
OECD's Role: The amendment reflects the incorporation of new and revised guidelines from the Organisation for Economic Co-operation and Development (OECD), ensuring the EU's alignment with global standards.
Ethical Considerations: A notable aspect of this amendment is its emphasis on reducing animal testing, in line with Directive 2010/63/EU.
Updating Existing Methods: To keep pace with scientific advancements, the draft proposes updating existing methods and removing outdated versions from the regulation.
The proposed changes aim to synchronise with related EU legislation, particularly Regulation (EC) 1272/2008. This includes updating test methods for physicochemical properties and ensuring consistency across regulations.
New Test Methods
The seven new test methods proposed to be added to the Annex of Regulation (EC) No 440/2008, as part of the European Commission's draft amendment, are as follows:
- OECD Test Guideline 126: This is a new test method for determining the basic physicochemical properties of substances. Specifically, it addresses the Determination of the Hydrophobicity Index of Nanomaterials Through an Affinity Measurement.
- OECD Test Guideline 444A: This method relates to in vitro immunotoxicity and is titled "In Vitro Immunotoxicity: IL-2 Luc Assay."
- OECD Test Guideline 442C: Another method focusing on in vitro testing, specifically for skin sensitisation. It is known as "In Chemico Skin Sensitisation: Assays addressing the Adverse Outcome Pathway key event on covalent binding to proteins."
- OECD Test Guideline 442E: This method also deals with in vitro skin sensitisation and is titled "In Vitro Skin Sensitisation assays addressing the Key Event on activation of dendritic cells on the Adverse Outcome Pathway for Skin Sensitisation."
- OECD Test Guideline No. 240: This is an ecotoxicity assessment method known as the "Medaka Extended One Generation Reproduction Test (MEOGRT)."
- OECD Test Guideline 218: Another ecotoxicity testing method titled "Sediment-Water Chironomid Toxicity Using Spiked Sediment."
- OECD Test Guideline 219: This method, related to ecotoxicity, is titled "Sediment-Water Chironomid Toxicity Using Spiked Water."
Stakeholder Engagement and Next Steps
The European Commission has actively engaged with relevant stakeholders in drafting this amendment. Stakeholders have until 9 January 2024 to respond to the proposal. The final regulation will be effective twenty days after its publication in the Official Journal of the European Union.
This amendment holds significant implications for the chemical industry, regulatory bodies, and research institutions. It underscores the need for continuous innovation in chemical testing methodologies, prioritising both safety and scientific progress.
