CLP Classification Proposal of SAS- ASASP Position

ASASP has consistently underlined that the current ECHA RAC Opinion on SAS contains fundamental scientific and regulatory limitations that require further clarification, notably related to substance identity and scope, mechanistic assumptions regarding silanol groups and ROS (Reactive Oxygen Species) and the human relevance of rat inhalation findings.

ASASP reiterated at CARACAL that these scientific issues must be carefully considered to ensure a robust and scientifically sound basis for any potential harmonised classification. More broadly, these concerns point to limitations in the current CLP assessment framework, highlighting the need for a more tailored methodological approach to particulate materials before progressing further.

ASASP supports a science-based and proportionate application of CLP and remains committed to constructive engagement with Member States, the Commission, and ECHA on the assessment of particulate materials such as SAS. In line with this position and considering the need identified for further expert input in this area,
ASASP proposes the establishment of a dedicated expert group on particulate materials which would provide an appropriate framework to address key methodological aspects, including particle characterisation, exposure relevance and interpretation of inhalation studies and thereby support a consistent and transparent application of CLP.

This request aligns with the recommendations of the Particles Platform of the creation of an expert group on particles under the auspices of ECHA, comprising of representatives cefic from ECHA, academia, and industry.