EFSA and ECHA to consider the fate and behaviour of trifluoroacetic acid (TFA) in soil and water

The European Commission Directorate-General for Health and Food Safety has requested the European Food Safety Authority (EFSA) and the European Chemicals Agency (ECHA) to consider the fate and behaviour of trifluoroacetic acid (TFA) in soil and water. The request comments that TFA is primarily formed as a transformation/degradation product of a broad range of chemicals, including fluorinated refrigerants and some active substances used in plant protection products (PPPs) and biocidal products (BPs). Industrial processes, in which TFA is either used directly or formed as a by-product, can also contribute to its presence in the environment. In addition, TFA may be found in crops as a residue, following use of certain plant protection products or due to uptake from soil or water. 

The request from the European Commission (958b41c6-b1be-5726-83c9-42f90ba39dc0) comments that “Concerns about the presence of TFA in the environment and human exposure (in particular through drinking water) have increased over the years. This is driven by growing awareness of PFAS-related risks and by emerging evidence on the toxicity of TFA, in particular with regards to its potential effects on reproduction.” The following is a brief overview about TFA potential effects on reproduction provided in the Commission request as a footnote.  

“In January 2021, Bayer CropScience notified the Member States, EFSA and the Commission, under Article 56 of the Regulation (EC) No 1107/2009, following adverse findings in a new rabbit developmental toxicity study on TFA submitted under Regulation (EC) No 1907/2006 as part of a REACH registration dossier for TFA. In view of determining the human relevance of these developmental effects observed in rabbits, several applicants (known as the TFA Task Force) initiated follow-up studies which have been submitted to Member States, the Commission and EFSA in May 2024. Based on the new information, the applicant under REACH has proposed self-classification as Toxic for reproduction category 2, In June 2024, in accordance with Regulation (EC) No 1272/2008 Germany submitted two harmonised classification and labelling (CLH) dossiers for TFA and for TFA salts including a proposal for classification as toxic for reproductive category 1B to ECHA.” The relevant CLP hazard categories for reproductive toxicants are given below. 

Under the mandate, EFSA and ECHA are tasked with evaluating the formation of TFA from biocides and pesticides, reviewing current study guidelines, and exploring alternative methods for predicting TFA concentrations in groundwater and surface water. The scientific findings are expected to be ready by 1 June 2027. 

The World Health Organisation (WHO) has issued a request for data on PFAS.  WHO commissioned a landscape review to identify key ingested PFAS and health effects to support prioritization for further evaluation. The landscape review recommended the prioritization of 18 PFAS and 6 health outcome categories for further review. The 18 PFAS include TFA and the 6 health outcome categories are cardiometabolic, hepatic, immune, developmental, reproductive, and cancer. Further information is available at Request for data on PFAS.  

CLP Relevant hazard categories for reproductive toxicants
Guidance on the Application of the CLP Criteria Part 3 version 5.0 November 2024, Section 3.7.2. Classification of substances for reproductive toxicity 

Category 1B
Presumed human reproductive toxicant The classification of a substance in this Category 1B is largely based on data from animal studies. Such data shall provide clear evidence of an adverse effect on sexual function and fertility or on development in the absence of other toxic effects, or if occurring together with other toxic effects the adverse effect on reproduction is considered not to be a secondary non-specific consequence of other toxic effects. However, when there is mechanistic information that raises doubt about the relevance of the effect for humans, classification in Category 2 may be more appropriate. 

Category 2
Suspected human reproductive toxicant Substances are classified in Category 2 for reproductive toxicity when there is some evidence from humans or experimental animals, possibly supplemented with other information, of an adverse effect on sexual function and fertility, or on development, and where the evidence is not sufficiently convincing to place the substance in Category 1. If deficiencies in the study make the quality of evidence less convincing, Category 2 could be the more appropriate classification. Such effects shall have been observed in the absence of other toxic effects, or if occurring together with other toxic effects the adverse effect on reproduction is considered not to be a secondary non-specific consequence of the other toxic effects.