Three German government agencies – the Federal Institute for Occupational Safety and Health (BAuA), the Federal Institute for Risk Assessment (BfR) and the Federal Environment Agency (UBA) – announced on May 26 that their assessment of trifluoroacetic acid (TFA) and its trifluoroacetate salts as reproductively toxic, very persistent and very mobile was officially submitted to the European Chemicals Agency (ECHA).
The announcement includes the public release of two 105-page dossiers detailing Germany’s TFA assessment, with a call for stakeholder comment. The assessment was provided to ECHA for consideration under the EU’s CLP (classification, labelling and packaging) Regulation. This regulation calls for hazardous chemicals to be properly classified and labelled on behalf of workers and consumers – what’s called harmonized classification.
One of the main sources of TFA in the environment is the oxidation of HFO-1234yf (used in car air-conditioning and refrigeration blends) and other f-gases in the atmosphere, with TFA absorbed in rainfall. TFA is also formed from the breakdown of certain pesticides and pharmaceuticals, emissions from industrial plants and other anthropogenic sources.
While it is an ultrashort-chain, two-carbon substance, TFA falls under the scientifically accepted “one fully fluorinated carbon” definition of PFAS (per- and polyfluorinated substances) established by the OECD (Organisation for Economic Co-operation and Development). As such, it acts as a “forever chemical” that persists for a very long time in the environment.
TFA has been found in human blood, usually at levels higher than that of longer-chain PFAS, and a study published last year calls TFA a “planetary boundary threat.” Longer chain PFAS with a similar chemical architecture (known as perfluoroalkyl carboxylic acids), such as eight-carbon PFOA, have been tied to harmful health impacts, including reproductive toxicity, ulcerative colitis and cancer.
The May 26 announcement was a significant step in a process that began in early 2024 when the BAuA’s Federal Office for Chemicals (BfC) informed ECHA of its intention to propose linking reproductive toxicity TFA. This was followed later in 2024 the BfC initially submitted its proposal.
Consultation and expert evaluation of the German TFA proposal are currently underway. Until July 25, stakeholders can comment on the TFA assessment here and the TFA salts assessment here. Summaries of the proposed changes are available here and here, with the dossiers available here and here.
“With our proposal, we are creating an important foundation for reducing the release of this persistent and hazardous chemical into the environment and the associated risks.”
Dr. Kerstin Heesche-Wagner, Head of Germany’s Federal Office for Chemicals
ECHA’s Scientific Committee for Risk Assessment (RAC) will then discuss the dossiers and the comments received. Within 18 months, the RAC’s opinion will be submitted to the EU Commission, which will then propose a corresponding draft regulation to update the CLP Regulation. ECHA is also evaluating regulations for TFA and f-gases as PFAS under a proposed universal PFAS regulation. The EU is not expected to finalize its universal PFAS and CLP regulations for several years.
“With our proposal, we are creating an important foundation for reducing the release of this persistent and hazardous chemical into the environment and the associated risks,” said Dr. Kerstin Heesche-Wagner, Head of the BfC. “The harmonized classification is an important tool in hazard communication and a basis for risk management.”
In Germany, TFA was detected in the drinking water of the Neckar region in 2016 and has been found in German waters for years, said the agencies, adding that “the trend is increasing.” Moreover, they said, drinking water treatment can only remove such substances with considerable technical effort.
”The number and quantities of chemicals that degrade to TFA are constantly increasing,” said UBA President Dirk Messner. “Environmental discharges must be reduced as quickly as possible to ensure sustainable protection of the environment and drinking water resources.”
TFA emissions from refrigerants could be reduced quickly, as market-ready alternatives such as hydrocarbons, carbon dioxide, ammonia or air are already available, the agencies said. TFA emissions from agriculture could be significantly reduced if approvals of TFA-forming pesticides are removed.
Based on animal models
In particular, the German authorities, based on TFA’s potential to cause adverse effects in animal models (particularly rabbits), are proposing to classify TFA and its salts as toxic to reproduction, Category 1B with the hazard statements H360Df: May harm the unborn child. Suspected of damaging fertility. Germany is the first country to connect TFA with reproductive toxicity in humans.
But the agencies stressed that this hazard classification “does not initially indicate any actual health risks, as the amount of the substance ingested is also crucial for this.”
Added BfR President Andreas Hensel, “The toxicological effect was only demonstrated in animal models at TFA concentrations significantly higher than those found in the environment. Therefore, health impairments are currently not expected from consuming water or food contaminated with TFA.”
However, “the new classification is an important step in preparing further measures to ensure this remains the case in the future,” Hensel said.
In addition, the German proposal categorizes TFA and its inorganic salts under hazard classes PMT (persistent, mobile and toxic) and vPvM (very persistent, very mobile). TFA and its salts are tied to PMT EUH450 (can cause long-lasting and diffuse contamination of water resources) and vPvM EUH451 (can cause very long-lasting and diffuse contamination of water resources).
It would also change TFA’s current classification of Acute Toxicity 4 H332 (harmful if inhaled) to Acute Toxicity 3 H331 (toxic if inhaled), adding proposed specific concentration limits of 5mg/L (vapor) for inhalation ATE (acute toxicity estimate).
Under the proposal, TFA continues to be classified as Aquatic Chronic 3, H412 (.harmful to aquatic life) with long-lasting effects) and Skin Corrosion 1A, H314 (causes severe skin burns and eye damage).
According to the UN’s Globally Harmonized System (GHS) of Classification and Labelling of Chemicals, followed by the EU, reproductive toxicity refers to “adverse effects of a chemical substance/mixture on sexual function and fertility in adult males and females, as well as developmental toxicity in the offspring.” Developmental toxicity pertains to adverse toxic effects in developing embryos or fetuses. Under GHS, Category 1B refers to presumed human reproductive toxicants, largely based on animal studies. (Category 1A refers to known human reproductive toxicants based on evidence from humans.)
The GHS also lists the minimum concentration for a hazardous substance to trigger the classification of a mixture containing it. For the reproductive toxicity classification 1B, the minimum concentration is 0.1% in the U.S. and Canada and 0.3% in the EU, Japan, Australia and other countries.
The GHS says that if a reproductive toxicant is present in a mixture as an ingredient at a concentration between 0.1 and 0.3%, every regulatory authority would require information on the safety data sheet (SDS) for that ingredient; a label would be optional. However, if the concentration is equal to or greater than 0.3%, both SDS information and a label would generally be expected.
An invisible threat
NGOs welcomed news of Germany’s public TFA assessment.
“The perennial chemical TFA is an invisible threat to our health,” said Jürgen Resch, Federal Director of the German Environmental Aid (DUH). “It is irresponsible that TFA precursor substances such as pesticides and refrigerants, for example, in car air conditioning systems, are still widely used – especially since more environmentally friendly alternatives have long been available. We call on the federal government to strictly restrict fluorinated refrigerants and TFA-forming pesticides.”
“We hope this is the first step towards a ban on TFA and all PFAS,” said Hanna Holmquist, Toxicologist at ChemSec, in a LinkedIn statement.
The UBA has already set a human health-based guideline value of 60μg/L for TFA in drinking water and a “precautionary measure” of 10μg/L. This guideline value is based “a dose-dependent activation of the enzyme ALT [alanin-amino-transferase], which is an indicator of possible liver toxicity,” said Dr. Alexander Eckhardt, Researcher for UBA’s Department of Toxicology of Drinking Water and Swimming Pool Water. In 2020, UBA published a study showing the link between TFA and ALT in rats.
Other state and local governments are beginning to take action in regard to TFA. The Belgian village of Villers-le-Gambon announced on February 13 that it temporarily closing a spring that provides mineral water due to a high level of TFA. In April, the state of Minnesota’s Department of Health (MDH) initiated a toxicity review of trifluoroacetate.
There have been competing contentions about the potential toxicity of TFA made by the fluorochemical industry, which refers to a 2020 Assessment Report by the UN Environment Programme that says TFA is unlikely to cause adverse effects in terrestrial and aquatic organisms. In response to a query about the German agencies’ TFA announcement, Angelica Candido, Sector Manager for the European Chemical Industry Council (CEFTIC), said, “EFCTC [European Fluorocarbons Technical Committee] and/or CEFIC are not planning to respond to any press release. The process is still ongoing.”
