2021 GA Meeting May 12th, 14:00-15:30

2020 GA MEETING

 

The 2020 GA meeting which normally takes place in May was postponed to November 4th due to the global pandemic. The November 4th meeting which was virtual saw 20 attendees and lasted an hour as most of the GA mandated task/decisions were addressed by way of votes prior to the meeting. Chaired by Interim Chairman Dr Bernd Friede, the meeting though brief was effective with some key decisions taken as follows:

Some highlights:

  • Executive Committee: A new Executive team was endorsed with the 2nd Vice-Chairman becoming the Chairman and Secretary General maintained to ensure continuity
  • Non-EU letter of Access Fees: Letter of Access fees and administration fees for non-EU REACH-Like regulations per substance, per legal entity for non-MARA members was established
  • Members involvement in Non-EU regulations: MARA members wishing to register substances in non-EU REACH-like regulations will only pay administration fees as they own the data generated by MARA
  • Technical update: Three dossiers updated this year lead to a new classification for manganese based UVCB’s
  • 2020 Workplan and budget were ratified in Q1, 2020 via round robin votes.

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. 

There were no ECHA request in 2019. No work was therefore carried out on this dossier. However, an SDS temeplate has been prepared (Q3, 2019) for industry's use. This can be provided to you upon request - contact reach@manganese.org

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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