With Commission Regulation (EU) 2025/2573 dated 18 December 2025, the test methods applicable under the REACH Regulation have been updated.

Under this amendment:

  • The primary objective of the Regulation is to integrate new and revised test guidelines developed by the OECD into EU legislation.
  • The use of the most up-to-date methods for determining the physicochemical, toxicological, and ecotoxicological properties of chemicals is promoted.
  • The reduction of the number of animals used in testing is encouraged.

Human Health, Ecotoxicity, and Nanoforms

  • Within the scope of human health testing, three updated in vitro methods for serious eye damage and skin sensitisation have been introduced.
  • Three new test methods have been added for ecotoxicity assessment.
  • Certain existing methods, such as acute inhalation toxicity, have been updated.
  • New standards for measuring dustiness, which is of critical importance for nanoforms, have been incorporated into the Regulation.
  • New in vivo screening tests aimed at assessing the endocrine-related effects of substances have been included.

Structural and Technical Amendments

To improve efficiency, additional explanatory notes for certain test methods have been removed. Instead, the updated tables in Part 0 and references to international standards have been adopted as the basis.

Updates and Additions

Six new OECD test guidelines have been introduced, as listed below:

  • OECD TG 442D: In Vitro Skin Sensitisation (Activation of Keratinocytes)
  • OECD TG 467: Integrated Approach for Testing and Assessment of Serious Eye Damage and Eye Irritation
  • OECD TG 496: In Vitro Macromolecular Test Method for Identifying Ocular Irritants
  • OECD TG 252: Rapid Androgenised Chickens Test for In Vivo Estrogenic Activity (REACTIV)
  • OECD TG 253: Juvenile Hormone Activity Screening Assay in Daphnia (JHASA)
  • OECD TG 321: Bioaccumulation Test in Hyalella azteca (HYBIT)

The following test guidelines have been updated:

  • OECD TG 403: Acute Inhalation Toxicity Study
  • OECD TG 442B: Skin Sensitisation (Local Lymph Node Assay: BrdU-ELISA or FCM)
  • OECD TG 442C: In Chemico Skin Sensitisation (Assay addressing the Adverse Outcome Pathway key event on covalent binding to proteins)
  • OECD TG 442E: In Vitro Skin Sensitisation (Human Cell Line Activation Test – h-CLAT)
  • OECD TG 492/492B: Reconstructed human Cornea-like Epithelium (RhCE) test method for eye irritation
  • OECD TG 493: In Vitro Estrogen Receptor Binding Assays

In addition, Commission Regulation (EU) 2025/2573 introduces four new test methods related to the dustiness endpoint (for nanoforms of a substance):

  • EN 17199-2:2019 Workplace exposure – Measurement of dustiness of bulk materials containing or releasing nano-objects and their aggregates and agglomerates (NOAA) and other inhalable particles – Part 2: Rotating drum method
  • EN 17199-3:2019 Workplace exposure – Measurement of dustiness of bulk materials containing or releasing nano-objects and their aggregates and agglomerates (NOAA) and other inhalable particles – Part 3: Continuous drop method
  • EN 17199-4:2019 Workplace exposure – Measurement of dustiness of bulk materials containing or releasing nano-objects and their aggregates and agglomerates (NOAA) and other inhalable particles – Part 4: Small rotating drum method
  • EN 17199-5:2019 Workplace exposure – Measurement of dustiness of bulk materials containing or releasing nano-objects and their aggregates and agglomerates (NOAA) and other inhalable particles – Part 5: Vortex shaker method

Furthermore, A.13 (Pyrophoric Solids and Liquids) in Part A, B.2 (Acute Inhalation Toxicity) in Part B, and B.70 (Estrogen Receptor Binding Assay) in Part B have been deleted.

Date of Entry into Force

The Regulation will enter into force in all EU Member States on 8 January 2026.

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