Several Manganese Substances - Possible Restriction and/or Authorisation

As REACH enters deeply into its E phase (Evaluation), the review of dossiers on their own or in groups by the ECHA has prompted several compliance checks requests which for the past years have been addressed by the Mn Consortium via updating dossier waivers, improving/strengthening of the readacross justifications or conducting new studies as the case may be. However, lately although no new specific request has emanated from ECHA's reviews, more worrisome concerns have been published in the ECHA Assessment of Regulatory Needs report (7 December 2021, version 1.0 [1]). 

The report covers several organic and inorganic substances with 14 Mn-based substances referred to as “Simple Manganese Compounds" and highlight concerns regarding reproductive potential, neurotoxic potential (STOT RE) and aquatic toxicity potential for the 14 substances listed (https://echa.europa.eu/assessment-regulatory-needs).

As MARA spent Q1 2022 reviewing, analysis and looking for possible solutions to address the issues raised in this report by way of recruiting experts in the areas of concern (a task force) and conducting a SWOT analysis in the dossiers both within the content of each dossier and the consistency or lack of it across dossiers, ECHA published another document called the restriction road map http://COMMISSION STAFF WORKING DOCUMENT Restrictions Roadmap under the Chemicals Strategy for Sustainability). In this report Mn substances are in pool 2 - potential restriction. The report highlights similar concerns as the assessment of regulatory needs report including some mention of Endocrine disruption potential for the said Mn substances.

While dates and members states working on the aforementioned concerns/activities are yet to be determined, MARA must be proactive not only in terms of updating ALL its lead dossiers but also must work hand in hand with the regulators to address all potential concerns by way of issuing position papers or face-of-face meetings. A clear workplan will made available to all registrants. 

We look forward to a very busy second part of the year and request that all registrants remain alert, provide MARA with any information requested and send in their contributions promptly in cash or in kind (company experts could join task forces) as the need arises.