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

Manganese dioxide (EC: 215-202-6; Cas: 1313-13-9)

The lead dossier for this substance was submitted in 2010, with no testing proposals. In October 2013 however a compliance check was initiated, requesting information on the following information requirements/updates:

  • Annex IX 8.7.2 (pre-natal developmental study, inhalation route, OECD 414)
  • Annex X, 8.7.3 (two-generation reproductive toxicity study, inhalation route, OECD 416 or an extended one generation reproductive toxicity study, OECD 443)
  • Annex I (Chemical Safety Assessment/ Chemical Safety Report – Revision of DNEL)

After two responses to the draft decision in which the Secretariat (on behalf of the lead registrant) justified the use of MnCl2 data so as to comply with the two-generation request and the lack of any need to conduct a pre-natal study, a final decision was reached in March 2015. The final decision requested that the following information be submitted by September 2016:

  • Annex IX 8.7.2 (pre-natal developmental study, inhalation route, OECD 414)
  • Annex I (Chemical Safety Assessment/ Chemical Safety Report – Revise consumer uses and DNEL for workers and the general population)

The dossier was submitted on time. The information requested in the final decision and a letter confirming compliance with the dossier evaluation request was received in February 2017. An updated dossier and CSR with ES is now available from the consortium secretariat.

ECHA's request to update this dossier in January 22, 2018 http://consortium.manganese.org/news/article/four-manganese-substances-short-listed-by-the-echa-as-substances-of-potenti encouraged a review of the 2017 version of the lead dossier with specific attention to reproductive toxicity endpoints. The consortium concluded that, the 2017 submitted dossier addressed ECHA's concerns appropriately hence there was no need for another spontaneous update. 

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