NIA Report on the RAC-72 CLH WG

Dr. Blanca Suarez-Merino
1 min read

Summary

  • European regulators are moving toward a Category 1 repeated dose toxicity classification for all forms of synthetic amorphous silica via inhalation, a designation that carries significant compliance implications.

  • Animal studies consistently showed lung inflammation and tissue damage at concentrations well below the threshold that normally triggers a Category 1 classification.

  • The proposal covers all SAS types regardless of how they are manufactured, meaning pyrogenic, precipitated, colloidal, and gel forms are all in scope.

  • Human workplace studies were too compromised by confounding factors to be used either way, leaving animal data to drive the classification outcome.

Focusing on item Silica, amorphous, fumed, cryst.-free; Pyrogenic, synthetic amorphous silica, nano, Silica gel, pptd., cryst.-free; Precipitated silica, silica gel, colloidal silica, amorphous, nano

By Blanca Suarez Merino Director of Regulatory Affairs

NOTE: This document and all appended documents are confidential to registered NIA Members.

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