Overview

The European Commission has adopted Commission Regulation (EU) 2025/2573, introducing a comprehensive update to EU-recognised chemical test methods under the REACH Regulation. The Regulation amends Regulation (EC) No 440/2008, ensuring that EU chemical safety assessments reflect scientific and technical progress.

The update strengthens alignment with OECD Test Guidelines, expands environmental hazard assessment, and accelerates the shift toward non-animal testing methods, supporting both regulatory efficiency and animal welfare.

Legal Basis

  • Amends: Regulation (EC) No 440/2008
  • Purpose: Defines harmonised reference test methods for determining the physical-chemical, toxicological and ecotoxicological properties of substances under REACH.

Entry into Force

The Regulation applies 20 days after publication in the Official Journal, meaning it will take effect in early January 2026 and apply directly across all EU Member States and the EEA.

Amendments to Test Methods

1. New and Updated In Vitro Human Health Methods

The Regulation introduces three updated OECD Test Guidelines, reinforcing non-animal testing approaches for key health endpoints:

  • Skin Sensitisation (OECD TG 442D):
    In vitro assays addressing keratinocyte activation, a critical step in the skin sensitisation adverse outcome pathway.
  • Serious Eye Damage / Eye Irritation – Integrated Approach (OECD TG 467):
    A defined approach combining multiple data streams to improve eye hazard classification.
  • Ocular Irritation / Serious Eye Damage – Macromolecular Method (OECD TG 496):
    An in vitro method supporting classification and non-classification decisions.

Impact: These updates replace outdated descriptions, improve scientific reliability, and further reduce reliance on animal testing.

2. New Ecotoxicity Test Methods

Three additional OECD methods have been added to strengthen environmental hazard assessment:

  • OECD TG 252 – Rapid Estrogen Activity In Vivo (REACTIV):
    Screens substances for estrogenic activity.
  • OECD TG 253 – Juvenile Hormone Activity in Daphnia (JHASA):
    Evaluates juvenile hormone-related effects using Daphnia magna.
  • OECD TG 321 – Hyalella azteca Bioconcentration Test (HYBIT):
    Assesses bioconcentration potential in aquatic invertebrates.

Significance: These methods enhance detection of endocrine activity and aquatic risks, supporting more robust environmental protection.

3. Updates to Existing Test Methods

Several existing OECD test methods have been aligned with 2024 OECD revisions, including:

  • OECD TG 403 – Acute inhalation toxicity
  • OECD TG 442B, 442C, 442E – Skin sensitisation assays
  • OECD TG 492 / 492B – In vitro skin absorption
  • OECD TG 493 – Acute oral toxicity

This ensures EU reference methods remain consistent with the latest international standards.

4. Dustiness Testing for Nanoforms

To improve exposure assessment for powders and nanoforms, the Regulation adds four EN standards:

  • EN 17199-2: Rotating drum method
  • EN 17199-3: Continuous drop method
  • EN 17199-4: Small rotating drum method
  • EN 17199-5: Vortex shaker method

These validated workplace methods support safer material handling and compliance with nano-specific REACH requirements.

5. Deletions and Simplifications

To reduce regulatory complexity, the Regulation removes:

  • Obsolete full method descriptions where updated OECD references exist
  • Redundant pyrophoric properties methods already covered elsewhere in the Regulation

This streamlining improves clarity and future-proofs the EU testing framework.

Scientific and Regulatory Impact

a. Alignment with Global Science

The amendments ensure full consistency with current OECD Test Guidelines, facilitating international data acceptance.

b. Reduced Animal Testing

Expanded use of new approach methodologies (NAMs) supports REACH’s objective to replace animal testing wherever scientifically possible.

c. Improved Regulatory Efficiency

By referencing OECD methods directly, the EU simplifies future updates and accelerates implementation across Member States.

Stakeholders

  • Manufacturers & Importers:
  • Review updated test requirements for REACH registrations and ongoing dossiers.
  • Downstream Users:
  • Align testing strategies and hazard assessments with revised OECD methods.
  • Test Laboratories:
  • Ensure technical capability and reporting formats comply with newly added and updated methods.

Source: Regulation – EU – 2025/2573 – EN – EUR-Lex

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