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EU Proposes Stricter Classification for Trifluoroacetic Acid under CLP Regulation

CLP
20
June 2025
•
450
Dr Steven Brennan
EU proposes new classification for Trifluoroacetic Acid under CLP—affecting hazard labelling, compliance, and chemical safety strategies.
Medicine on shelf
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Summarise this article

Germany’s proposal to reclassify Trifluoroacetic Acid under the CLP Regulation signals a regulatory shift with wide-reaching implications. Stakeholders must evaluate the operational and compliance impacts of new hazard designations for reproductive toxicity and environmental persistence.

What does the proposed CLP classification mean for TFA users?

Users of TFA may need to update hazard communication tools, safety data sheets, and compliance procedures if the classification becomes legally binding. This includes addressing newly identified reproductive and environmental risks.

Why is Trifluoroacetic Acid being classified as PMT and vPvM?

Scientific data show that TFA is persistent, mobile in aquatic environments, and toxic. These properties qualify it for PMT and vPvM classification, reflecting its potential for long-range environmental transport and long-term exposure hazards.

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Germany has formally proposed an update to the harmonised classification and labelling (CLH) of Trifluoroacetic Acid (TFA) under the EU's Classification, Labelling and Packaging (CLP) Regulation. Submitted to the European Chemicals Agency (ECHA), the proposal recommends classifying TFA as a reproductive toxicant and recognising its environmental persistence and mobility. The public consultation opened on 26 May 2025 and will close on 25 July 2025, inviting stakeholders to comment on the potential impacts across the chemical and manufacturing sectors.

Key Revisions in the CLP Proposal

The proposed classification introduces several changes:

  • Upgrading TFA’s acute inhalation toxicity to Category 3 (H331), reflecting its harmful effects at lower concentrations.
  • Adding reproductive toxicity (Category 1B, H360fD), based on developmental toxicity data from animal studies.
  • Designating TFA as both PMT (Persistent, Mobile, Toxic) and vPvM (very Persistent, very Mobile), signalling long-term environmental risk.
  • Introducing supplemental hazard statements: EUH450, EUH451 (indicating PMT/vPvM properties), and EUH071 for respiratory tract corrosion.

These updates align with the EU’s Chemicals Strategy for Sustainability and its objectives to regulate substances of very high concern more stringently.

Industry-Wide Implications

TFA is commonly used in the production of fluorinated pharmaceuticals, pesticides, and other fine chemicals. The proposed reclassification will impact multiple points in the value chain—from raw material sourcing to occupational safety, environmental reporting, and end-user disclosures.

Companies handling TFA may need to update safety data sheets, reassess product labels, and prepare for stricter inventory and transport requirements. Downstream users should also examine whether the proposed classification affects authorisation duties under REACH, particularly where TFA is used as a process chemical or intermediate.

This development is particularly significant for sectors such as pharmaceuticals, chemicals, agriculture, and environmental services, where product compliance and sustainability targets intersect.

Engage with the Consultation Process

Stakeholders have until 25 July 2025 to submit scientific evidence, risk assessments, or operational feedback. ECHA’s Committee for Risk Assessment (RAC) will review the input and may modify the proposal before making final recommendations to the European Commission.

For professionals tracking regulatory trends, this consultation offers a critical opportunity to influence future compliance landscapes and risk management priorities.

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