PLS: Consumer health-based guidance values for trifluoroacetic acid

Published date:

Background

  • Trifluoroacetic acid (TFA) is a chemical that can form from several sources when per- and polyfluoroalkyl (PFAS) substances break down, including some industrial gases and certain active substances in plant protection products.
  • TFA persists in the environment and can be present in soil, water and food, so people may be exposed to it over time.
  • TFA has been assessed in pesticide evaluations (for example, in 2017, 2023 and 2024), and EFSA assessed PFAS in food in 2020, but not TFA specifically.
  • The existing TFA safe levels, set in 2017, were based on a limited dataset. This report addresses these shortcomings by incorporating new data and updated scientific methods.

What was EFSA asked to do?

  • The European Commission asked EFSA to:
    • collect and review all available evidence on TFA;
    • reassess TFA’s toxicological properties;
    • derive or revise safe levels, called health-based guidance values (HBGVs), for consumer exposure to TFA via the diet, specifically its acceptable daily intake (ADI) and acute reference dose (ARfD).

How did EFSA carry out this work?

  • EFSA applied a structured, transparent scientific approach, which comprised:
    • calling for data on new toxicological studies from Member States, industry (e.g. REACH dossiers), ECHA and EFSA;
    • assessing a large body of evidence from 170 studies and position papers. These were mainly gathered in 2024 and included previous EFSA evaluations, new experimental studies, regulatory dossiers and scientific literature. New scientific studies on animals addressed developmental and reproductive effects;
    • using a weight of evidence (WOE) method to assess combined animal studies, mechanistic data and human evidence studies on study quality, relevance and consistency;
    • using benchmark dose (BMD) modelling to derive the HBGVs.

What were the outcomes and their implications?

Outcomes:

  • TFA is unlikely to damage DNA.
  • New scientific (animal) studies identified TFA effects on development, reproduction and thyroid hormones (the most sensitive effect).

Implications:

  • Considering the above, EFSA established new HBGVs:
    • an ADI of 0.014 mg/kg body weight per day, down from the previous value of 0.05;
    • an ARfD of 0.07 mg/kg body weight (an ARfD was not previously established).
  • These new safe levels are more stringent than those from 2017 and provide updated benchmarks for risk assessment. They can also inform EU decision-making on food safety, water monitoring and chemical regulation.

What were the limitations/uncertainties?

  • Two main areas of uncertainty were identified:
    • There were no long-term (carcinogenicity) studies available.
    • There were few data on immune effects during development.
  • When deriving HBGVs for exposure to TFA, EFSA first identified levels where no harmful effects were seen. This level was then reduced by applying a standard uncertainty factor of 100 to account for variability, i.e. differences between animals and humans as well as differences between people (such as children or more sensitive individuals). Given the limitations of the dataset, an additional factor of 5 was applied to address the identified uncertainties.

Glossary

Acceptable daily intake (ADI): An estimate of the amount of a substance in food or drinking water that can be consumed daily over a lifetime without presenting an appreciable risk to health.

Acute reference dose (ARfD): An estimate of the amount of a substance in food that can be ingested in a period of 24 hours or less without an appreciable health risk to the consumer.

Health-based guidance value (HBGV): A science-based recommendation for the maximum (oral) exposure to a substance that is not expected to result in an appreciable health risk, taking into account current safety data, uncertainties in these data, and the likely duration of consumption.

Benchmark dose (BMD): The minimum dose of a substance that produces a clear, low-level health risk, such as a 20% change in specific thyroid hormone levels (as in the present case).

Weight of evidence (WOE): A process in which all of the evidence relating to a decision is evaluated based on its strength and quality.

Reference

Scientific Report on consumer health-based guidance values for trifluoroacetic acid.

DOI: https://doi.org/10.2903/j.efsa.2026.10227https://doi.org/10.2903/j.efsa…

ISSN: 1831-4732

© European Food Safety Authority, 2026

Reproduction is authorised provided the source is acknowledged.