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 It is therefore appropriate to delete the outdated versions of the full descriptions for those test methods from Parts B and C of the Annex to Regulation (EC) No 440/2008.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:

Article 1 #

The Annex to Regulation (EC) No 440/2008 is amended in accordance with the Annex to this Regulation.

Article 2 #

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

(1)Part 0 is amended as follows:

(a)Table 1 is replaced by the following:TABLE 1: TEST METHODS FOR PHYSICOCHEMICAL PROPERTIES OF THE SUBSTANCEBasic physicochemical propertiesEndpoint | Test method | Corresponding chapter, containing the full description of the test method, in Part A of this Annex (numbers in brackets indicate that the full description of the test method has been deleted from Part A; empty cell: no corresponding test method in Part A of this Annex)Melting point/freezing point | OECD Test Guideline 102: Melting Point/Melting Range (1995) | A.1.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) |Boiling point | OECD Test Guideline 103: Boiling point (1995) | A.2.Test methods according to Table 2.6.4 of Annex I, Part 2 of Regulation (EC) No 1272/2008 |Flammability | EN 15188:2020 – Determination of the spontaneous ignition behaviour of dust accumulations |Lower and upper explosion limit | Test methods according to section 2.2.4.1. of Annex I, Part 2 of Regulation (EC) No 1272/2008 (ISO 10156 and EN 1839) |Flash point | Test methods according to table 2.6.3 of Annex I, Part 2 of Regulation (EC) No 1272/2008 |Auto-ignition temperature (liquids, gases) | ISO/IEC 80079-20-1:2017 – Explosive atmospheres – Part 20-1: Material characteristics for gas and vapour classification – Test methods and data |Decomposition temperature | Calorimetric test methods according to section 20.3.3.3 of Part II of the UN Manual of Tests and Criteria |Test Series H, part II, section 28, of the UN Manual of Tests and Criteria for the self-accelerating decomposition temperature (SADT) (with reference to a specific package) |pH | OECD Test Guideline 122: Determination of pH, Acidity and Alkalinity (2013) |Kinematic Viscosity | OECD Test Guideline 114: Viscosity of Liquids (2012) |Water solubility | OECD Test Guideline 105: Water Solubility (1995) | A.6.Partition coefficientn-octanol/water | OECD Test Guideline 107: Partition Coefficient (n-octanol/water): Shake-Flask Method (1995) | (A.8.)OECD Test Guideline 123: Partition Coefficient (1-Octanol/Water): Slow-Stirring Method (2022) | A.23.OECD Test Guideline 117: Partition Coefficient (n-octanol/water): HPLC Method (2022) | A.24.Vapour pressure | OECD Test Guideline 104: Vapour Pressure (2006) | (A.4)Density/Relative density | OECD Test Guideline 109: Density of Liquids and Solids (2012) | (A.3.)DIN 66137-2 – Determination of solid state density – Part 2: Gas pycnometryISO 12154 – Determination of density by volumetric displacement – Skeleton density by gas pycnometryParticle characteristics | EU test method A.22. Length Weighted Geometric Mean Diameter of Fibres | A.22.ISO 21501 – Determination of Particle Size Distribution – Single Particle Light Interaction Methods |OECD Test Guideline 124: Determination of the Volume Specific Surface Area of Manufactured Nanomaterials (2022) |OECD Test Guideline 125: Particle Size and Particle Size Distribution of Nanomaterials (2023) |ISO/TR 14187:2020 – Surface chemical analysis –Characterization of nanostructured materialsDustiness (for nanoforms of a substance) | 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 methodsEN 15051-2: Workplace exposure – Measurement of the dustiness of bulk materials – Part 2: Rotating drum methodEN 15051-3: Workplace exposure – Measurement of the dustiness of bulk materials – Part 3: Continuous drop methodSurface tension | OECD Test Guideline 115: Surface Tension of Aqueous Solutions (1995) | A.5.Dissociation constant | OECD Test Guideline 112: Dissociation Constants in Water. (1981) | A.25.Hydrophobicity | OECD Test Guideline 126: Determination of the Hydrophobicity Index of Manufactured Nanomaterials Through an Affinity Measurement (2023) |Physicochemical hazard propertiesExplosives | Test methods for explosives according to section 2.1.2.1. and 2.1.2.3. of Annex I, Part 2 of Regulation (EC) No 1272/2008 |EU Test method A.14 Explosive Properties | A.14Flammable gases | Test method for the fundamental burning velocity according to section 2.2.4.1. of Annex I, Part 2 of Regulation (EC) No 1272/2008 |Test method for pyrophoric gases according to section 2.2.4.2. of Annex I, Part 2 of Regulation (EC) No 1272/2008 |Test method for the chemical instability according to section 2.2.4.4. of Annex I, Part 2 of Regulation (EC) No 1272/2008 |Oxidising gases | Test method for oxidising gases according to section 2.4.4. of Annex I, Part 2 of Regulation (EC) No 1272/2008 |Flammable liquids | Test method for the sustained combustibility according to section 2.6.4.5. of Annex I, Part 2 of Regulation (EC) No 1272/2008 |Test methods for determining the flash point of flammable liquids according to section 2.6.4.4. of Annex I, Part 2 of Regulation (EC) No 1272/2008Flammable solids | Test method for flammable solids according to section 2.7.2.3. of Annex I, Part 2 of Regulation (EC) No 1272/2008 |Self-reactive substances | Test method for self-reactive substances according to section 2.8.4.1. of Annex I, Part 2 of Regulation (EC) No 1272/2008 |Pyrophoric liquids | Test method for pyrophoric liquids according to section 2.9.2.1. of Annex I, Part 2 of Regulation (EC) No 1272/2008 |Pyrophoric solids | Test method for pyrophoric solids according to section 2.10.2.1. of Annex I, Part 2 of Regulation (EC) No 1272/2008, |Self-heating substances | Test method for self-heating substances according to section 2.11.2.2 of Annex I, Part 2 of Regulation (EC) No 1272/2008 |Substances which in contact with water emit flammable gases | Test method for substances which in contact with water emit flammable gases according to section 2.12.2.1. of Annex I, Part 2 of Regulation (EC) No 1272/2008 |Oxidising liquids | Test method for oxidising liquids according to section 2.13.2.1. of Annex I, Part 2 of Regulation (EC) No 1272/2008 |Oxidising solids | Test method for oxidising solids according to section 2.14.2.1. of Annex I, Part 2 of Regulation (EC) No 1272/2008 |Organic peroxides | Test methods according to section 2.15.4.1 of Annex I, Part 2 of Regulation (EC) No 1272/2008 |Corrosive to metals | Test method for substances corrosive to metals according to section 2.16.2.1. of Annex I, Part 2 of Regulation (EC) No 1272/2008 |Desensitised explosives | Test methods according to section 2.17.2.1 (b) and (c) and according to section 2.17.2.2 of Annex I, Part 2 of Regulation (EC) No 1272/2008 |Properties of polymers | OECD Test Guideline 118: Determination of the Number-Average Molecular Weight and the Molecular Weight Distribution of Polymers using Gel Permeation Chromatography (1996) | A.18.OECD Test Guideline 119: Determination of the Low Molecular Weight Content of a Polymer Using Gel Permeation Chromatography (1996) | A.19.OECD Test Guideline 120: Solution/Extraction Behaviour of Polymers in Water (2000) | (A.20.)

(b)Table 2 is amended as follows:

(i)the entry ‘Serious eye damage/eye irritation’ is replaced by the following:Serious eye damage/eye irritation | In vitro: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) | (B.47.)OECD Test Guideline 438: Isolated Chicken Eye Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage (2023) | (B.48.)OECD Test Guideline 460: Fluorescein Leakage Test Method for Identifying Ocular Corrosives and Severe Irritants (2023) | (B.61.)OECD Test Guideline 491: Short Time Exposure In Vitro Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage (2023) | (B.68.)OECD Test Guideline 492: Reconstructed human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage (2023) | (B.69.)OECD Test Guideline 492B: Reconstructed Human Cornea-like Epithelium (RHCE) Test Method for Eye Hazard Identification (2022) |OECD Test Guideline 494: Vitrigel-Eye Irritancy Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage (2021) |OECD Test Guideline 496: In vitro Macromolecular Test Method for Identifying Chemicals Inducing Serious Eye Damage and Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage (2023) |OECD Test Guideline 467: Defined Approaches for Serious Eye Damage and Eye Irritation (2022) |In vivo:OECD Test Guideline 405: Acute Eye Irritation/Corrosion (2023) | (B.5.);

(ii)in the entry ‘Skin sensitisation’, the ‘In vitro’ section is replaced by the following:In vitro:OECD Test Guideline 442C: In Chemico Skin Sensitisation Assays addressing the Adverse Outcome Pathway key event on covalent binding to proteins (2023) | (B.59.)OECD Test Guideline 442D: In Vitro Skin Sensitisation Assays Addressing the AOP Key Event on Keratinocyte Activation (2022) | (B.60.)OECD Test Guideline 442E: In Vitro Skin Sensitisation: In Vitro Skin Sensitisation Assays Addressing the Key Event on Activation of Dendritic Cells on the Adverse Outcome Pathway for Skin Sensitisation (2023) | (B.71.)OECD Test Guideline 497: Defined Approaches on Skin Sensitisation (2023); |

(iii)in the entry ‘Mutagenicity’, the row:|OECD Test Guideline 487. In vitro Mammalian Cell Micronucleus Test (2016) | B.49.is replaced by the following:|OECD Test Guideline 487. In vitro Mammalian Cell Micronucleus Test (2023) | (B.49.);

(iv)in the entry ‘Endocrine disrupting properties’, the rows:|OECD Test Guideline 456: H295R Steroidogenesis Assay (2022) | B.57.OECD Test Guideline 458: Stably Transfected Human Androgen Receptor Transcriptional Activation Assay for Detection of Androgenic Agonist and Antagonist Activity of Chemicals (2020) |are replaced by the following:|OECD Test Guideline 456: H295R Steroidogenesis Assay (2023) | (B.57.)OECD Test Guideline 458: Stably Transfected Human Androgen Receptor Transcriptional Activation Assay for Detection of Androgenic Agonist and Antagonist Activity of Chemicals (2023) |

(v)in the entry ‘Phototoxicity’, the row:| OECD Test Guideline 498: In Vitro Phototoxicity Test Method Using the Reconstructed Human Epidermis (RhE) (2021) |is replaced by the following:| OECD Test Guideline 498: In Vitro Phototoxicity Reconstructed Human Epidermis Phototoxicity test method (2023) |

(vi)the following entry is inserted after the section ‘Phototoxicity’,:Immunotoxicity | OECD Test Guideline 444A: In vitro immunotoxicity IL-2 Luc assay (2023) |

(c)Table 3 is amended as follows:

(i)in the entry ‘Degradation’, the row:| OECD Test Guideline 316: Phototransformation of Chemicals in Water – Direct Photolysis (2008) |is replaced by the following:| OECD Test Guideline 316: Phototransformation of Chemicals in Water – Direct Photolysis (2023) |

(ii)in the entry ‘Effects on sediment organisms’, the rows:| OECD Test Guideline 218: Sediment-Water Chironomid Toxicity Using Spiked Sediment (2004) | C.27.OECD Test Guideline 219: Sediment-Water Chironomid Toxicity Using Spiked Water (2004) | C.28.are replaced by the following:| OECD Test Guideline 218: Sediment-Water Chironomid Toxicity Test Using Spiked Sediment (2023) | (C.27.)OECD Test Guideline 219: Sediment-Water Chironomid Toxicity Test Using Spiked Water (2023) | (C.28.);

(iii)in the entry ‘Endocrine disrupting properties’, the row:| OECD Test Guideline 240: Medaka Extended OneGeneration Reproduction Test (MEOGRT) (2015) | C.52.is replaced by the following:| OECD Test Guideline 240: Medaka Extended One Generation Reproduction Test (MEOGRT) (2023) | (C.52.)

(2)in part B, the text below the headings of each of the Chapters B.49. and B.57. is replaced by the following: ‘The full description of this test method has been deleted. The equivalent international test method appears in Part 0, Table 2.’;

(3)in part C, the text below the headings of each of the Chapters C.27., C.28. and C.52. is replaced by the following: ‘The full description of this test method has been deleted. The equivalent international test method appears in Part 0, Table 3.’

The Annex to Regulation (EC) No 440/2008 is amended as follows:

Article 1#

Article 2#

Article 1 #

Article 2 #