What it's about:
The Federal Office for Chemicals (BfC) at the German Federal Institute for Occupational Safety and Health (BAuA) is the German authority responsible for the European chemicals regulation REACH and the CLP Regulation on classification and labelling of hazardous substances. In cooperation with the German Federal Environment Agency (UBAshort forGerman Environment Agency) and the German Federal Institute for Risk Assessment (BfRshort forGerman Federal Institute for Risk Assessment), the BfC has submitted a dossier to the European Chemicals Agency (ECHAshort forEuropean Chemicals Agency) in accordance with the CLP Regulation to harmonize the hazard classification of trifluoroacetic acid (TFA). TFA belongs to the group of per- and polyfluorinated alkyl substances (PFAS). Since the German authorities consider the substance to have reprotoxic and environmentally harmful properties, it is to be classified accordingly. The German proposal is currently undergoing a consultation and technical assessment process.
Since the detection of TFA in the drinking water of the Neckar region in 2016, the German authorities have been working intensively and across disciplines on this substance. TFA not only originates from large industrial plants, but was also identified in 2016 and 2017 as a degradation product of various active ingredients in pesticides. It is also known that certain fluorinated greenhouse gases, like the refrigerant R1234yf, may partially and completely degrade into TFA in the atmosphere. TFA has been detected in German waters for years – and the trend is rising.
“The harmonized classification is an important instrument in hazard communication and a basis for risk management. With our proposal, we are establishing an important basis for reducing the entry of this persistent and concerning chemical into the environment and the associated risks," says Dr. Kerstin Heesche-Wagner, head of the BfRshort forGerman Federal Institute for Risk Assessment Federal Office for Chemicals.
The BfRshort forGerman Federal Institute for Risk Assessment's assessment of TFA is that it is reprotoxic. The proposed official hazard class is “Toxic to reproduction, category 1B” with the hazard statements H360Df: “May damage the unborn child. Suspected of impairing fertility”. It should be noted that this classification is initially a pure hazard classification. It is not an indication of actual health risks, because the amount of the substance ingested is also crucial for this.
“The toxicological effect was only detectable in animal models at TFA concentrations that were significantly above the concentrations found in the environment. Therefore, adverse health effects are not currently expected when water or food contaminated with TFA is consumed,” says BfRshort forGerman Federal Institute for Risk Assessment President Professor Andreas Hensel. “The new classification is an important step in preparing further measures to ensure that it stays this way in the future.”
The UBAshort forGerman Environment Agency's assessment of TFA is that it is very persistent and very mobile (vPvM). Substances with vPvM properties are difficult for the environmental system to break down and they hardly bind to sediments or activated carbon filters. Drinking water treatment requires a high level of technical effort to remove such substances. The new hazard class was introduced into the European chemicals legislation at the initiative of the UBAshort forGerman Environment Agency as recently as 2023 to protect drinking water resources, with the hazard statement EUH451: “May cause very long-lasting and diffuse pollution of water resources”. UBAshort forGerman Environment Agency President Dirk Messner deems the harmonized hazard classification to be urgently necessary: “The number and quantities of chemicals that degrade to TFA are constantly increasing. Emissions into the environment must be reduced as quickly as possible in order to sustainably protect the environment and drinking water resources.”
The new data on TFA has an influence on many national and European areas of application. For example, the approvals of TFA-forming plant protection products are currently being reviewed. This could significantly reduce TFA inputs from agriculture. TFA inputs from refrigerants could also be quickly reduced, as market-ready alternatives such as hydrocarbons, carbon dioxide, ammonia or air are already available.
What is the next step for the German proposal for harmonized classification?
The ECHAshort forEuropean Chemicals Agency has now published the German dossier for harmonized classification and labelling (CLH), which can be commented on within a period of six weeks. Following this, the ECHAshort forEuropean Chemicals Agency's Scientific Committee for Risk Assessment (RAC) will discuss the dossier of the German authorities and the comments received. The opinion of the RAC is submitted to the EU Commission within a period of 18 months, which then prepares a corresponding draft regulation to adapt the CLP Regulation (regulation on adaptation to technical progress, ATP).
Further information
- ECHAshort forEuropean Chemicals Agency page with the ongoing CLH consultation External Link: Go to page
- UBAshort forGerman Environment Agency background paper 2021 “Reducing the input of chemicals into water – Trifluoracetate (TFA) as a persistent and mobile substance with many sources” (only available in German) External Link: Go to page
About the BfRshort forGerman Federal Institute for Risk Assessment
The German Federal Institute for Risk Assessment (BfRshort forGerman Federal Institute for Risk Assessment) is a scientifically independent institution within the portfolio of the Federal Ministry of Food and Agriculture (BMELshort forGerman Federal Ministry of Food and Agriculture) in Germany. The BfRshort forGerman Federal Institute for Risk Assessment advises the Federal Government and the States (‘Laender’) on questions of food, chemicals and product safety. The BfRshort forGerman Federal Institute for Risk Assessment conducts independent research on topics that are closely linked to its assessment tasks.
About the Federal Institute for Occupational Safety and Health (BAuA)
The BAuA is a governmental research institution under the authority of the BMAS. It conducts research, advises politicians and promotes the transfer of knowledge in the field of occupational safety and health. In addition, the institution fulfils sovereign tasks in the field of chemicals legislation and product safety. Around 750 employees work at the sites in Dortmund, Berlin and Dresden.
About the German Environment Agency (UBAshort forGerman Environment Agency)
The German Environment Agency is Germany's central environmental authority. The UBAshort forGerman Environment Agency is concerned with ensuring that there is a healthy environment in Germany in which people can live as far as possible protected from harmful environmental impacts, such as pollutants in the air or water. Its tasks include collecting data on the state of the environment, researching interrelationships, creating forecasts for the future and using this knowledge to advise the German government, such as the Federal Ministry for the Environment, on its policies.