Endocrine Disruption Assessment for Substances Under MARA's Portfolio: Update Your SDS's/SIS's accordingly
MARA is delighted to announce the completion of the endocrine disruption evaluation work which was triggered by the concerns raised by the ECHA Assessment of Regulatory Needs Report [1] https://echa.europa.eu/assessment-regulatory-needs/-/dislist/details/0b0236e184bf9c43. MARA’s assessment which started in Q3 2023, began with robust literature review which led to testing. The outcome of the Literature analysis and testing were compared with the classification criteria defined by the Delegated Regulation (EU 2023/707) amending Classification, Labelling and Packaging (CLP) Regulation (EC) No 1272/2008.
To this this end, MARA is delighted to announce that based on available data, the Endocrine Disruption classification criteria for human health and the Environment are not met. MARA, therefore, urges all companies that bought a Letter of Access from MARA to update their SDS accordingly.
SDS section 11.2
Manganese substances within Sub-group I of the ARN (or simply start with the substance name) are not identified to be an endocrine disrupting hazard as defined by the Delegated Regulation (EU 2023/707) amending Classification, Labelling and Packaging (CLP) Regulation (EC) No 1272/2008.
Compared with the classification criteria, there was conclusive regulatory evidence to show none of the three elements required for ED classification have been met for estrogenic (E), androgenic (A), steroidogenic (S) or thyroidal (T) modalities. Inconsistent changes in these modalities were reported across the publicly available literature, but these data were largely unreliable and there was no reproducibility of the findings within robust regulatory data which investigated both EATS-mediated activity and adversity within the Sub-Group. Therefore, ED classification of the substance for human health endpoints is conclusive for non-classification according to CLP.
SDS section 12.6
Manganese substances within Sub-group I of the ARN (ARN (or simply start with the substance name) are not identified to be an endocrine disrupting hazard as defined by the Delegated Regulation (EU 2023/707) amending Classification, Labelling and Packaging (CLP) Regulation (EC) No 1272/2008.
Compared with the classification criteria, data were too minimal to draw definitive conclusions but in that which were available, none of the three elements required for ED classification have been met and therefore ED classification of the substance for environmental endpoints is not warranted on the basis of a lack of data.
For information on the actual data see the study report section of our website: https://reach-manganese.org/study_summary