Completion of two Substance Evaluations

The conclusion document, developed in cooperation with ECHA, addresses concerns regarding persistence, mobility, and toxicity (PMT). However, concerns about endocrine disruption still remain. Since restrictions are already in place or forthcoming for the degradation product PFHxA and PFAS in general—and given that PFHpA has been identified as a Substance of Very High Concern (SVHC) due to its PBT properties—sufficient risk management measures are taken or into progress.

The evaluation of Sepisol Fast Blue 85219, which began in 2017, has also been completed. In September 2023, the registrant submitted the data required under a draft decision from 2019. The study revealed that further testing would be needed to examine PBT/vPvB concerns in more detail. The registrant subsequently decided to cease production. Although this does not eliminate the concern for the substance, the absence of a registrant means that no further data can be requested. As a result, the full hazard or risk profile has not been established, but with the end of production and import, future exposure within the EU will be reduced.

Bureau REACH prepared the conclusion document in coordination with ECHA. ECHA published the document on 15 March.