Trimanganese tetraoxide (Mn3O4) dossier Recieves a Statement of Non-Compliance (SONC)
The registered substance trimanganese tetraoxide (Mn3O4) received a Statement of Non-Compliance (SONC) from ECHA in April 2018. ECHA’s dissatisfaction was on the “lack” of compliance with the Pre-natal Developmental (PND) endpoint. A PND study was requested for this substance by ECHA in its final decision. The study could not be completed on time to meet ECHA's dossier update deadline. The study took longer than anticipated due to several unusual but minor skeletal foetal deformations. These deformations have led the substance to be classified as a Repro Cat 2.
The lead registrant with the support of Mara drew up a plan to update the dossier with this new PND information and liaised accordingly with the Belgian CA. The dossier was updated on August 17th and passed the completeness check. We await confirmation on compliance in accordance with final decision request from ECHA.