8 October 2019 – The European Chemicals Agency (ECHA) has published the outcome of the Substance Evaluation of MDI Mixed Isomers under the EU’s REACH Regulation, carried out by Estonia, finding that there is no need for regulatory follow-up action at EU level. ISOPA welcomes the conclusion which reaffirms that appropriate risk management measures are in place to ensure the effective protection of human health and the environment
The Substance Evaluation process under the EU’s Regulation on Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) is a process by which Member States evaluate certain substances to clarify whether their use poses a risk to human health or the environment. MDI Mixed Isomers was first listed on the Community Rolling Action Plan (CoRAP) in 2015 and assigned to the Estonian Authorities which finalised their evaluation 13 July 2019 after requesting additional data in February 2017.
The Estonian Authorities conclude that there is no need for regulatory follow-up action at EU level based on the assessed endpoints and scenarios relating to human exposure or environmental hazards and exposures. ISOPA welcomes the conclusions of the evaluation which reaffirms that risks for human health or the environment are appropriately managed.
While there is no need for regulatory follow-up, the evaluation finds full data sets are not available for certain low risk endpoints. This will be further assessed in the light of the upcoming MDI grouping project which will assess all MDI based substances in one evaluation project
ISOPA is committed to continuing to work with the Authorities to address any further questions based on the conclusions of the evaluation.
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