Commission Regulation (EU) 2024/2492

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 Cooperation 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, seven test methods should be added to the Annex of Regulation (EC) No 440/2008: one new test method for basic physicochemical properties^note, one new and two updated test methods for the determination of effects on human health, relating to in vitro tests for immunotoxicity and skin sensitisation^note, and three updated test methods for the assessment of ecotoxicity^note.

(4)In addition, OECD has issued in 2023 new, corrected versions of the following test methods, which were included in Regulation (EC) No 440/2008: OECD Test Guideline 125^note; OECD Test Guideline 316^note; OECD Test Guideline405^note; OECD Test Guideline 437^note; OECD Test Guideline 438^note; OECD Test Guideline 456^note; OECD Test Guideline 458^note; OECD Test Guideline 460^note; OECD Test Guideline 487^note; OECD Test Guideline 491^note; OECD Test Guideline 492^note; OECD Test Guideline 496^note; OECD Test Guideline 497^note; OECD Test Guideline 498^note. It is therefore appropriate to delete the outdated versions of the full descriptions for those test methods from Parts B and C of the Annex to Regulation (EC) No 440/2008.

(5)In order to achieve better alignment with related legislation, in particular Regulation (EC) No 1272/2008 of the European Parliament and of the Council^note, the listing of the test methods for physicochemical properties in Part 0, Table 1 of the Annex to Regulation (EC) No 440/2008 should be restructured and relevant test methods should be added: ASTM D4359-90: Standard Test Method for Determining whether a Material Is a Liquid or a Solid; Test for determining fluidity according to section 2.3.4 of Annex A of the Agreement concerning the International Carriage of Dangerous Goods by Road (ADR); Calorimetric test methods according to section 20.3.3.3 of Part II of the UN Manual of Tests and Criteria; DIN 66137-2 – Determination of solid state density – Part 2: Gas pycnometry; ISO 12154- Determination of density by volumetric displacement – Skeleton density by gas pycnometry; ISO/TR 14187:2020 – Surface chemical analysis -Characterization of nanostructured materials; EN 17199-1:2019 – Workplace exposure – Measurement of dustiness of bulk materials that contain or release respirable NOAA and other respirable particles; EN 15051-1: Workplace exposure – Measurement of the dustiness of bulk materials – Part 1: Requirements and choice of test methods; EN 15051-2: Workplace exposure – Measurement of the dustiness of bulk materials – Part 2: Rotating drum method; EN 15051-3: Workplace exposure – Measurement of the dustiness of bulk materials – Part 3: Continuous drop method; the following tests methods, as provided for in Annex I, Part 2, of Regulation (EC) No 1272/2008 of the European Parliament and of the Council: test method for pyrophoric gases^note; test method for chemical instability^note; test methods for determining the initial boiling point of flammable liquids^note; test methods for determining the flash point of flammable liquids^note; test method for self-reactive substances^note; test methods for organic peroxides^note; test method for substances corrosive to metals^note, and test methods for desensitised explosives^note.

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

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

(8)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: