2019 GA meeting May 8 in Madrid

2018 GA MEETING

The 2018 GA meeting which took place on Thursday 3 May 2018 in Brugge, Belgium saw an increase in attendance from 2017. Hosted by Prince-Erachem, the meeting which lasted 5 hours saw several deliberations related to the last REACH deadline and its consequences thereafter including the possible re-structuring of the consortium.  Some key decisions taken by way of vote are as follows:

Some highlights:

  • Future structure of Mara: A more streamline structure to be established if the organisation is to continue functioning infinitely or in the event of a complete closure its mandate and members to be incorporated within the Mn trade association –The IMnI. Discussions are still on-going  
  • Collaboration: A clearly defined pathway for collaboration between Mara and the IMnI was established
  • Data-sharing Regulation: Approval of the reimbursement structure (to be executed in phases) in accordance with regulation 2016/9
  • Approval of the 2018 workplan and budget

Slags, SiMn-manufacturing (EC: 273-733-9; Cas 69012-33-5)

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. We await ECHA's response. 

 

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