Since TFA was detected in the drinking water of the Neckar region in 2016, authorities have been intensively examining the substance across disciplines. TFA is not only released by large industrial facilities — in 2016 and 2017, it was also identified as a degradation product of several active substances in pesticides. It is also known that certain fluorinated greenhouse gases, such as the refrigerant R1234yf, can degrade almost completely to TFA in the atmosphere . TFA has been detected in German water for years, with concentrations continuing to increase.
“Harmonised classification is an important tool for communicating hazards and forms the basis for risk management. With our proposal, we are laying an important foundation for reducing the environmental inputs of this persistent and hazardous chemical and lowering the associated risks,’ says Dr. Kerstin Heesche-Wagner, Head of the Federal Office for Chemicals.
The BfR considers TFA to be toxic to reproduction. The proposed official hazard class is ‘Reproductive Toxicity, Category 1B,’ with the hazard warnings H360Df: ‘May cause harm to the unborn child. May impair fertility.’ It is important to note that this is initially a purely hazard-based classification. It does not provide any information about actual health risks on its own, as the amount of the substance absorbed is a key determinant.
‘The toxicological effects were only detected in animal models at TFA concentrations significantly higher than those found in the environment. Currently, there are no expected adverse health effects from consuming water or food contaminated with TFA,’ says BfR President Andreas Hensel. ‘The new classification is an important step in preparing further measures to ensure that this remains the case in the future.’
The UBA classify TFA as very persistent and very mobile (vPvM: very persistent, very mobile).
Substances with vPvM properties do not easily degrade in the environment and often do not bind to sediments or activated carbon filters. Therefore, removing such substances from drinking water requires considerable technical effort. In 2023, as an initiative of the UBA, this new hazard class was introduced into European chemicals regulation to help protect drinking water resources; also introduced was the hazard statement EUH451: ‘May cause very long-lasting and diffuse contamination of water resources.’ UBA President Dirk Messner considers harmonised hazard classification urgently needed: ‘The number and volume of chemicals that degrade to TFA are steadily increasing. Releases into the environment must be reduced as quickly as possible to sustainably protect both the environment and drinking water resources.’
The new data on TFA has implications for numerous national and European applications. For instance, the approval of TFA-forming plant protection products is under review. As a result, TFA input from agriculture could be significantly reduced. Likewise, TFA emissions from refrigerants could be quickly reduced, since viable alternatives like hydrocarbons, CO₂, ammonia or air are already commercially available.
What happens next with the German proposal for harmonised classification?
ECHA has now published the German dossier on harmonised classification and labeling (CLH), which can be commented on within a period of six weeks. After this period, the ECHA's Risk Assessment Committee (RAC) will discuss the dossier submitted by the German authorities and any comments received. Within 18 months, the RAC's opinion will be submitted to the European Commission, which will prepare a corresponding draft regulation to adapt the CLP Regulation (Regulation for the adaptation to technical progress, ATP).
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