On December 19, 2025, the Official Journal of the European Union published Regulation (EU) 2025/2573. The primary content is an update to the testing methods under the Regulation concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), aimed at adapting to technological advancements.
Key Revisions
1. Introduction of New OECD Test Methods This revision introduces the following six new OECD Test Guidelines:
Health-Related (In Vitro Tests):
- 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
Ecotoxicological:
- 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)
2. Update of Existing OECD Test Methods The following seven test methods, revised by the OECD in 2024, have been correspondingly updated in this regulation:
- 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
3. Addition of Dustiness Test Standards (Applicable to Nanomaterials) Four additional test methods related to dustiness endpoints for nanomaterials have been added:
- 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;
4. Deletion of Obsolete Test Methods The full descriptions of the following test methods have been deleted (as they have been superseded by updated versions):
- A.13 (Pyrophoric Solids and Liquids) in Part A
- B.2 (Acute Inhalation Toxicity) in Part B
- B.70 (Estrogen Receptor Binding Assay) in Part B
The regulation enters into force on the twentieth day following its publication (January 8, 2026) and is directly applicable in all EU Member States.
Further Information
