EU Court Upholds Regulation on Reproductive Toxicity Classification for DTPA

Background of the Case

The applicants, manufacturers and importers of DTPA (N-carboxymethyliminobis(ethylenenitrilo)tetra(acetic acid)) and its sodium and potassium salts, sought annulment of the regulation classifying DTPA as a presumed human reproductive toxicant. DTPA, widely used in detergents, textiles, and industrial processes, was labelled with the hazard statement "H360D" (may damage the unborn child).

Key Legal Arguments

The applicants argued that the classification was flawed due to:

• A lack of intrinsic properties causing reproductive toxicity.
• Insufficient evidence linking DTPA to specific reproductive harm.
• The absence of an impact assessment by the Commission.

They also highlighted procedural inadequacies, including a lack of public consultations and failure to address interspecies differences in reproductive effects.

Court's Findings

The General Court validated the classification, emphasising the following:

• Scientific Basis: The European Chemicals Agency’s Risk Assessment Committee (RAC) demonstrated a plausible mode of action linking DTPA to reproductive toxicity through induced zinc deficiency, which impacts foetal development.
• Maternal Toxicity: The Court rejected claims that observed foetal effects were secondary to maternal toxicity, stating the evidence indicated direct developmental harm.
• Procedural Compliance: The Court found no legal requirement for an additional impact assessment under EU regulations. It affirmed that public consultations adequately addressed the classification proposals.