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 carbonate (EC: 209-942-9; Cas 598-62-9)

Annex VI, 4.1

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 VI, 2.3.7 ( description of the analytical methods for the identification of the substance)
  • 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) 
  • Annex VI, 4.1 & 4.2 (hazard classification and resulting hazard label for chronic aquatic toxicity)

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 this substance and the importance of using available literature and readacross. More information was provided in the updated dossier using available literature to comply with the OECD 408 and using studies from MnCl2 - a more soluble salt as a worse-case analysis to comply with the OECD 416 studies. The chronic environmental classification was revised.

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

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

In Q4 2017, the dossier was updated and submited with the OECD 414 study from MnCl2.  

 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. 

« Back to news


About cookies on our website

Following a revised EU directive on website cookies, each company based, or doing business, in the EU is required to notify users about the cookies used on their website.

Our site uses cookies to improve your experience of certain areas of the site and to allow the use of specific functionality like social media page sharing. You may delete and block all cookies from this site, but as a result parts of the site may not work as intended.

To find out more about what cookies are, which cookies we use on this website and how to delete and block cookies, please see our Which cookies we use page.

Click on the button below to accept the use of cookies on this website (this will prevent the dialogue box from appearing on future visits)