News
10 September 2021

Cobalt Industry EU REACH dossier updates well received by ECHA

The Cobalt REACH Consortium (CoRC) carried out a comprehensive update of EU REACH dossiers for all registered substances in Q2 2021 for submission to the European Chemicals Agency (ECHA) over the summer. The main purpose of this exercise was to implement the new harmonized classification for cobalt metal ahead of the 1 October deadline, and to update all registration files in line with CoRC’s Metals and Inorganics Sectorial Approach (MISA) commitments. All uses covered in the cobalt metal dossier could be demonstrated as safe following this update.

The hazard conclusions and classification in cobalt metal registration dossier were aligned with the new harmonized classification as Carcinogen 1B (H350) ‘all routes’, Reproductive toxicant 1B (H360F), Mutagenic 2 (H341) and industry’s self-classification as Reproductive toxicant 2, H361 (developmental toxicity).  The overall reproductive toxicity classification for cobalt metal is now Reproductive toxicant 1B, H360Fd.

Co metal and other Co substances dossiers were updated to include new data generated as part of the ongoing research program. Composition profiles were revised to reinforce the REACH identification of some of the most complex substances. All human health read-across documentation was updated with the argumentation as to why cobalt metal is retained in CoRC read-across approaches, but the harmonized classification will not be read-across to other Co substances in the respective read-across groups.

New Derived No Effect Levels (DNEL)[1] were derived for systemic carcinogenicity (inhalation, oral and dermal) and implemented in Exposure Scenarios. The justification for dermal sensitization read-across approach was aligned with ECHA Read-Across Assessment Framework (RAAF). Dermal exposure assessment was added based on the approach used for nickel. Environmental read-across justification was further improved to better fit with the RAAF format requirements.

The Predicted No Effect Concentration (PNEC) [2] for freshwater compartment was updated to reflect the reduction of assessment factor (AF) from 3 to 2 resulting in a higher PNEC value of 1.06 mg Co/L. Exposure Scenarios were therefore revised based on the most recent PNEC for freshwater, environmental emissions, and tonnage data, as well as to reflect the changes to use descriptions. New documentation was prepared to describe the classification strategy for aquatic endpoints for cobalt metal and provide justification for the use of split entries for the massive vs powder form of Co metal.

The CoRC’s MISA workplan was subsequently revised to reflect the status of dossier updates and to include an action plan for improving robustness of exposure assessment. The updated workplan and progress made with the updates of REACH dossiers was very well received by ECHA.

 

[1] Dose of Co substance which leads to no adverse effect on the organism exposed via inhalation, oral intake, or skin exposure.

[2] Concentration of Co substance which leads to no adverse effect on organisms present in a given environmental compartment (e.g., freshwater, sediments, soil, etc.).