Four Manganese substances short-listed as substances of Potential Concern
Due to the UN GHS classification of some manganese based substances in Japan, ECHA will be reviewing the dossiers for the following manganese based substances with specific attention to their uses/exposure in relation to reproductive toxicity: manganese, manganese dioxide, manganese carbonate and manganese dinitrite. ECHA is inviting registrants to review their dossiers. All updates have a proposed February 2018 deadline.
How will Mara handle this request?
Inview of the importance of the highlighted concerns, Mara will reveiw the lead dossiers for all 4 subsstances (listed in Fig 1 below) with particular attention to their uses/exposure and their reporductive effect potential.
Short term strategy - Lead dossier specific:
- The dossiers for MnCO3 and MnO2 were under substance compliance checks with ECHA requesting at least 2 new reproductive studies. To comply with this, these dossiers were updated either with studies from a more soluble serrogate or with new studies. Both dossiers were updated about a year ago. Mara, therefore considers them to be up-to-date. Therefore, this new request from ECHA will trigger only a minor/targetted review.
- The Mn(NO3)2 was updated in Dec 2017. This dossier was updated spontaneously due to new available data ( same data used to comply with the demands mentioned in the compliance check for MnCO3 and MnO2. . This recent request from ECHA will trigger a minor/targetted review.
- The Mn dossier has not been updated since 2010. Therefore, a significant amount of work is required to bring this dossier up-to-date including aspects related to IUCLID 5 to 6 migration. To do a thorough job, Mara will be requesting for more time or updating this dossier quickly with specific attenttion to uses/exposure and reproductive endpoints with a view of updating the entire dossier more thoroughly by end of Q2, 2018.
- The outcome of these dossier reviews - thorough or minor will be reported to all SIEF members via the Mara website NEWS portal.
Long Term Stratedy - dealing with regulatory "creeping":
- Mara will seek to obtain the Japanese study that has triggered such concerns and review it for strengths and weakness.
- Mara through its Japanese members will seek to begin dialogue with the Japanese authorities with the aim of sharing MARA’s reproductive toxicity studies and with the hope of reaching a mutual agreement on an appropriate classification of the aforementioned manganese based substances.
Joint Dossiers: Your consortium encourages you to update your dossiers with particular attention to tonnages and uses.
Lead Dossiers: All four lead dossiers will be reviewed and updated accordingly if need be based on the outcome of the review. The outcome willbe comminicated to all SIEF members via this portal.
Overall, reproductive toxicity happens to be the endpoint that Mara has a good handle on, in the sense that Mara owns three OECD, GLP compliance studies related to reproduction and development. This endpoint also happens to be Mara’s Secretrary General's strength with regards to her regulaotry expertice and peer-reveiw publications - https://www.ncbi.nlm.nih.gov/pubmed/27670927 . This combination of GLP studies and SG’s experience puts MARA’s at an advantage to address these concerns.
Fig 1: List of Mn substances highlighted by ECHA as 2018 substances of potential concern