Discussions with the Swedish Chemical Agency (KEMI) regarding their proposal following the review of the 2020 Assessment Of Regulatory Needs Report published by ECHA

The publication of the Assessment of Regulatory Needs Report (ARN) by the ECHA (2020) and the Restriction Road Map Report by the Commission highlighted concerns related to Reprotoxic, Neurotoxicity (STOT), Endocrine Disruption and Ecotoxicity upon the exposure of several inorganic manganese substances.

These reports triggered a further evaluation by the SwedishChemical Agency (Kemi) under the Risk Management Option Analysis (RMOA) scheme.

The Kemi preliminary conclusion after further analysis of the data available in the publicly disseminated REACH registrations is that CLH proposal(s) for STOT RE 1 (CNS), H370, and Repr. 2, H361fd, could be considered justified for these simple manganese compounds in sub-group I.

In Response, MARA with the help of FieldFisher Law firm wrote to Kemihighlighting concerns on the type and quality of data evaluated as well as some legal issues surrounding the grouping methodology and more.

Kemi’s response was somewhat favourable detailing that:

(i)they are currently not planning to submit a CLH proposal on manganese compounds and

(ii) so far, they have not been contacted by other Member States regarding this matter.

 Furthermore, they underline that, should they decide to develop a CLH proposal in the future, they will adhere to Article 5 of the CLP Regulation, as proposed in the letter to them.

Meaning they agree to identify all relevant information to determine if the substance poses any physical, health, or environmental hazards, as outlined in Annex I to Regulation 1272/2008 ("CLP Regulation").

Also, they agree to consider all information from the registration dossier (IUCLID and CSR) and evaluate all available data to ensure it is adequate, reliable, and scientifically valid. In other words, they will discinguish between reliable and non-reliable data, as requested.

MARA continues to watch this space. For more detail information Contact reach@manganese.org