Dossier submission and History:

The lead dossier was submitted in 2010 with no testing proposals. In 2013 a compliance check was initiated, requesting more details with regard to the following information requirements/updates:

• Annex IX, 8.6.2 (Sub-chronic study - 90days, Oral route, OECD 408)
• Annex IX 8.7.2 (pre-natal developmental study, oral route, OECD 414)
• Annex X, 8.7.3 (two-generation reproductive toxicity study, oral route, OECD 416 or an extended one generation reproductive toxicity study, OECD 443)

By Q4 2013 the consortium secretariat on behalf of the lead registrant had responded to the ECHA’s draft decision concerns, highlighting the lack of need for such animal-intensive studies for a substance that is not bioavailable.

After a second correspondence between ECHA and the lead registrant, the third correspondence was a compliance check final decision concluding that the following studies should be conducted:

• Annex IX, 8.6.2 (Sub-chronic study - 90days, Oral route, OECD 408)
• Pre-natal developmental toxicity study (Annex IX, 8.7.2.; test method: EU B.31/OECD 414) in rats or rabbits, oral route - readacross from FeMn slag

While a decision on the two-generation reproductive toxicity study endpoint was still pending, the dossier for this substance was updated with the above mentioned studies in Q3 2017 and successfully went through the compliance check.

In Q4 this year (2017), the Commission  requested that the lead registrant submits a dossier update with a testing proposal for an EOGRT study with a justiIfcation for the relevant cohort. 

An updated dossier was submitted - February 2018 with a justification on the lack of need for such an animal intensive study. This justification was accepted by the ECHA.

In Q1, 2019, all co-registrants that had met their financial obligations were provided with the following:

1) Updated CSR

2) Exposure scenarios for their eSDS

3) Updated CLP classification.

In Q3 2020 the dossierwas updated with a new classification. This update was triggered by a classifcation emanating from a Pre-natal developmental toxicity study (Annex IX, 8.7.2.; test method: EU B.31/OECD 414) in rats, oral route for FeMn slag - same readacross category. For more information contact reach@manganese.org or the ECHA  registration portal.

Note: Post 2018, the consortium will no longer invoice co-registrants  for ECHA requested studies retrospectively. All compliance check related work will require co-registrants to contribute their share before any dossier update work can begin. 

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