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EU Risk Assessment Committee to Reevaluate Lithium Compounds' Reproductive Toxicity Classification

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The ECHA Committee for Risk Assessment (RAC) has been requested to review its previous classification of lithium carbonatelithium chloride, and lithium hydroxide with regard to reproductive toxicity. In a note addressed to Mr. Roberto Scazzola, Chairman of the Committee for Risk Assessment, the RAC has been asked to reconsider the classification it adopted on September 16, 2021.

The background of the request stems from the 2021 classification where the RAC categorized these lithium compounds as toxic for reproduction category 1A. This classification encompassed adverse effects on development, sexual function, fertility, and effects on or via lactation.

However, following the initial classification, industry stakeholders provided additional information related to the epidemiology of cardiac malformation and conducted an analysis of this data. They suggested that this new publication might challenge the causal link between lithium exposure during pregnancy and cardiac malformations.

This new information, which was not considered during the RAC's initial opinion, has prompted the call for a reevaluation of the classification for reproductive toxicity. .



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