EU Commission Proposes Amendments to Regulation 440/2008 for Updated Test Methods

On April 3, 2025, the European Commission released a proposal to amend Regulation (EC) No 440/2008 to update the test methods used for the safety evaluation of chemicals under the EU’s REACH regulation. This amendment aims to incorporate new and revised testing methods in line with technical progress and to reduce animal testing, particularly for human health and environmental effects. The feedback period for this proposed amendment is open until May 1, 2025 (midnight, Brussels time).

Key points of the proposal include:
Amendment to the Annex of Regulation (EC) No 440/2008:
Part 0 – Table 1:
The entry ""Dustiness (for nanoforms of a substance)"" is replaced by :
some amendment  from table 1 are as follows: 
EN 17199-1:2019 – Workplace exposure – Measurement of dustiness of bulk materials that contain or release respirable NOAA and other respirable particles.
EN 17199-2:2019 – Rotating drum method.
EN 17199-5:2019 – Vortex shaker method.

Part 0 – Table 2:
1.The ""In vitro"" section is replaced with:
""OECD Test Guideline 437: Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage (2023).
""OECD Test Guideline 460: Fluorescein Leakage Test Method for Identifying Ocular Corrosives and Severe Irritants (2023)"".
2.Skin Sensitisation:
The ""In vitro"" section is replaced with:
OECD Test Guideline 442C: In Chemico Skin Sensitisation: Assays addressing the Adverse Outcome Pathway Key event on covalent binding to proteins (2024)"".
OECD Test Guideline 497: Defined Approaches on Skin Sensitisation (2023).
3.In the ""In vivo"" section, the row corresponding to the OECD Test Guideline 442B is replaced with:
OECD Test Guideline 442B: Skin Sensitisation – Local Lymph Node Assay: BrdU-ELISA or –FCM (2024).
4. Acute Toxicity – Inhalation:
The row corresponding to the OECD Test Guideline 403 is replaced with:
OECD Test Guideline 403: Acute Inhalation Toxicity (2024).
5.Endocrine Disrupting Properties:
The row corresponding to the OECD Test Guideline 493 is replaced with:
OECD Test Guideline 493: Performance-Based Test Guideline for Human Recombinant Estrogen Receptor (hrER) In Vitro Assays to Detect Chemicals with ER Binding Affinity (2024).
6.Fate and Behaviour in the Environment:
A new row is inserted for: OECD Test Guideline 321: Hyalella azteca Bioconcentration Test (HYBIT) (2024)

Part B Changes:
Chapter B.2: The full description of this test method is deleted. The equivalent international test method appears in Part 0, Table 2.
Chapter B.70: The full description of this test method is deleted. The equivalent international test method appears in Part 0, Table 2.