Dossier update 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) readacross from SiMn slags
• Pre-natal developmental toxicity study (Annex IX, 8.7.2.; test method: EU B.31/OECD 414) in rats or rabbits, oral route

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 Q4 2017.

ECHA rejected the updated dossier in April 2018 - emphasing on the non-compliance of the 90days oral toxicity endpoint. A statement of Non-Complaince ( SONC) was sent to the lead registrant and the Spanish member state. The Lead Registrant and Mara's secreteriat are meeting with the Spanish CA on June 4th, 2018 to address the issue. 

The updated dossier was submitted earlier this year (Q1 2019) with new available data, new justification for readacross in alignment with ECHA RAAF guidance. 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.

The ECHA reveiw of the Q1 submitted dossier lead to the request for  a Pre-natal developmental (PND) toxicity study (Annex IX, 8.7.2.; test method: EU B.31/OECD 414) in rats or rabbits, oral route. This study started in Q3, 2019 and was completed in June 2020.

In Q3, 2020, the dossier was updated with the new PND data which led to a classification. 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.