Document OE1aD5Xj2mBn7jQ460ZkG7zvw

Ref. Ares(2019)3587548 - 04/06/2019 Genx is not a Substance of Very High Concern 1. Since 2012, Chemours is using the GenX technology to produce fluoropolymers, which are essential to a wide range of applications, such as in cars, smartphones and medical devices. This new chemistry is not hazardous to human health and the environment and its scientific name is HFPO-DA or C3 dimer acid. 2. The recent proposal to list GenX as a Substance of Very High Concern (SVHC) under Article 57(f) of REACH, argues on equivalent concern to the hazards listed in Article 57 (a) to (e) because of its alleged mobility into groundwater and long-range transport in aquatic environments. However, these are not official criteria, whereas numerous toxicological studies prove that low levels of GenX do not pose risk to human health or fulfill Article 57 (a) to (e) criteria. 3. GenX is being brought under the SVHC process, without proper regulatory steps. Article 57(f) is used as the legal basis for GenX, before guidelines on environmental impact for its interpretation are issued. More so, the Substance Evaluation process has not been completed. 4. Scientific data have been collected for over a decade to evaluate the safety of GenX. The data were collected from studies designed to identify potential effects from short-term and long-term exposures, including studies on genetic material, fetal development, reproductive performance and cancer. The data have been reviewed by state agencies, independent bodies and published in peer-reviewed scientific journals. These studies demonstrated that GenX as a polymer processing aid is safe for its intended use. 5. GenX does not bioaccumulate in humans. The 2018 study conducted by the North Carolina Department of Health and Human Services, in conjunction with the U.S. Centers for Disease Control and Prevention, demonstrated that GenX substances were not present in the blood of people, residing within one mile of a facility that uses (or produces) GenX, who may have been exposed to the substance through air or water disposition. 6. The argument on broad long-range transport of the substance throughout Europe is flawed. Following Chemours' investments on effective emission control technologies, trends in contrast suggest that the environmental presence of GenX will continue to decrease over time. 7. Chemours globally is working to abate 99% of air and water emissions of GenX by the end of 2020, and at least 80% of all organic fluorinated compound emissions by 2023, towards a goal of 99% overall.