Commission Regulation (EU) 2025/2573

Contents

THE EUROPEAN COMMISSION,Having regard to the Treaty on the Functioning of the European Union,Having regard to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC^note, and in particular Article 13(2) thereof,Whereas:

(1)Commission Regulation (EC) No 440/2008^note contains, in its Annex, test methods recognised as being appropriate for generating information on the physicochemical, toxicological and ecotoxicological properties of substances for the purposes of Regulation (EC) No 1907/2006.

(2)The Organisation for Economic Co-operation and Development (OECD) develops harmonised and internationally agreed test guidelines for the testing of chemicals for regulatory purposes. The OECD regularly issues new and revised test guidelines, taking account of scientific progress in this area.

(3)In order to keep Regulation (EC) No 440/2008 up to date with technical progress and to reduce the number of animals used for experimental purposes, also in accordance with Directive 2010/63/EU of the European Parliament and of the Council^note, the Annex of Regulation (EC) No 440/2008 should be reviewed with three updated test methods for the determination of effects on human health, relating to in vitro tests for serious eye damage/eye irritation and skin sensitisation^note, and by adding three new test methods for the assessment of ecotoxicity^note.

(4)In addition, the following test methods, which were included in Regulation (EC) No 440/2008 – OECD Test Guideline 403^note, OECD Test Guideline 442B^note, OECD Test Guideline 442C^note, OECD Test Guideline 442E^note, OECD Test Guideline 492^note, OECD Test Guideline 492B^note, OECD Test Guideline 493^note – have been corrected by the OECD in 2024. It is therefore appropriate to update these methods in the Annex to Regulation (EC) No 440/2008 and to delete the outdated versions of the full descriptions for the two test methods that are laid down in Part B (OECD Test Guideline 403 and OECD Test Guideline 493) of the Annex to Regulation (EC) No 440/2008. Furthermore, other test methods, relevant for the endpoint of dustiness (for nanoforms of a substance) should be added: EN 17199-2:2019 Workplace exposure – Measurement of dustiness of bulk materials that contain or release respirable NOAA and other respirable particles – Part 2: Rotating drum method; EN 17199-3:2019 Workplace exposure – Measurement of dustiness of bulk materials that contain or release respirable NOAA and other respirable particles – Part 3: Continuous drop method; EN 17199-4:2019 Workplace exposure – Measurement of dustiness of bulk materials that contain or release respirable NOAA and other respirable particles – Part 4: Small rotating drum method; EN 17199-5:2019 Workplace exposure – Measurement of dustiness of bulk materials that contain or release respirable NOAA and other respirable particles – Part 5: Vortex shaker method. It is also appropriate to delete the full description for the test method that is laid down in Part A (Pyrophoric properties of solids and liquids) of the Annex to Regulation (EC) No 440/2008 because Part 0 already includes up to date versions of test methods relevant for those endpoints.

(5)Regulation (EC) No 440/2008 should therefore be amended accordingly.

(6)The relevant stakeholders have been consulted on the proposed amendment.

(7)The measures provided for in this Regulation are in accordance with the opinion of the Committee established under Article 133(1) of Regulation (EC) No 1907/2006,

HAS ADOPTED THIS REGULATION: