Reliability and relevance evaluations of REACH data.

Area of Science:

• Chemical safety assessment
• Regulatory science
• Toxicology

Background:

• Regulatory authorities use REACH assessments to identify chemicals of concern.
• Systematic and transparent hazard and risk assessments are crucial for regulatory action.
• The European Chemicals Agency (ECHA) provides guidance for data evaluations under REACH.

Purpose of the Study:

• To investigate how registrants evaluate and report data under REACH.
• To assess the systematicity and transparency of data evaluations for repeated dose toxicity.
• To identify areas for improvement in ECHA's guidance and procedures.

Main Methods:

• Analysis of repeated dose toxicity data from the REACH registration database for 60 substances.
• Evaluation of the systematicity and transparency of reported data evaluations.
• Review of ECHA guidance concerning data reliability and relevance.

Main Results:

• The current REACH data evaluation system is neither systematic nor transparent.
• The framework prioritizes reliability over relevance, and guidance on their combination is unclear.
• Justifications for reliability are often vague, based on default assumptions (e.g., GLP, test guidelines), and lack transparency.
• Poor reporting is sometimes incorrectly equated with methodological deficiencies.

Conclusions:

• ECHA's procedures and guidance for data evaluation under REACH require significant improvement.
• Enhanced guidance is needed to ensure systematic and transparent assessments, integrating both reliability and relevance.
• Improvements are essential for robust and trustworthy chemical risk assessments.