Official Gazette Notification Text
Official TranscriptOfficial Journal EN of the European Union L series 2024/2492 24.9.2024 COMMISSION REGULATION (EU) 2024/2492 of 23 September 2024 amending Regulation (EC) No 440/2008 as regards the test methods, to adapt them to technical progress (Text with EEA relevance) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EC) No 1907/2006 of...
Official Journal EN of the European Union L series 2024/2492 24.9.2024 COMMISSION REGULATION (EU) 2024/2492 of 23 September 2024 amending Regulation (EC) No 440/2008 as regards the test methods, to adapt them to technical progress (Text with EEA relevance) 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(1), and in particular Article 13(2) thereof,
Whereas:
(1) Commission Regulation (EC) No 440/2008(2)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(3), seven test methods should be added to the Annex of Regulation (EC) No 440/2008: one new test method for basic physicochemical properties(4), 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(5), and three updated test methods for the assessment of ecotoxicity(6).
(1) OJ L 396, 30.12.2006, p. 1, ELI: http://data.europa.eu/eli/reg/2006/1907/oj
(2) Commission Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (OJ L 142, 31.5.2008, p. 1, ELI: http://data.europa.eu/eli/reg/2008/440/oj).
(3) Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes (OJ L 276, 20.10.2010, p. 33, ELI: http://data.europa.eu/eli/dir/2010/63/oj).
(4) OECD Test Guideline 126: Determination of the Hydrophobicity Index of Nanomaterials Through an Affinity Measurement (2023),
https://doi.org/10.1787/ae9c0fd1-en.
(5) OECD Test Guideline 444A: In Vitro Immunotoxicity: IL-2 Luc Assay (2023) https://doi.org/10.1787/27b10ba3-en; OECD Test Guideline 442C: In Chemico Skin Sensitisation: Assays addressing the Adverse Outcome Pathway key event on covalent binding to proteins (2023) https://doi.org/10.1787/9789264229709-en; 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), https://doi.org/10.1787/9789264264359-en.
(6) OECD Test Guideline No 240: Medaka Extended One Generation Reproduction Test (MEOGRT) (2023) https://doi.org/10.1787/ 9789264242258-en; OECD Test Guideline 218: Sediment-Water Chironomid Toxicity Using Spiked Sediment (2023) https://doi.org/
10.1787/9789264070264-en; OECD Test Guideline 219: Sediment-Water Chironomid Toxicity Using Spiked Water (2023) https:// doi.org/10.1787/9789264070288-en.
ELI: http://data.europa.eu/eli/reg/2024/2492/oj 1/10EN OJ L, 24.9.2024
(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(7); OECD Test Guideline 316(8); OECD Test Guideline405(9); OECD Test Guideline 437(10); OECD Test Guideline 438(11); OECD Test Guideline 456(12); OECD Test Guideline 458(13); OECD Test Guideline 460(14); OECD Test Guideline 487(15); OECD Test Guideline 491(16);
OECD Test Guideline 492(17); OECD Test Guideline 496(18); OECD Test Guideline 497(19); OECD Test Guideline 498(20). 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(21), 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(22); test method for chemical instability(23); test methods for determining the initial boiling point of flammable liquids(24); test methods for determining the flash point of flammable liquids(25); test method for self- reactive substances(26); test methods for organic peroxides(27); test method for substances corrosive to metals(28), and test methods for desensitised explosives(29).
(7) OECD Test Guideline 125: Nanomaterial Particle Size and Size Distribution of Nanomaterials (2023) https://doi.org/10.1787/ af5f9bda-en.
(8) OECD Test Guideline 316: Phototransformation of Chemicals in Water – Direct Photolysis (2023) https://doi.org/10.1787/ 9789264067585-en.
(9) OECD Test Guideline 405: Acute Eye Irritation/Corrosion (2023 https://doi.org/10.1787/9789264185333-en.
(10) 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), https://doi.org/10.1787/ 9789264203846-en.
(11) 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) https://doi.org/10.1787/9789264203860-en.
(12) OECD Test Guideline 456: H295R Steroidogenesis Assay (2023) https://doi.org/10.1787/9789264122642-en.
(13) OECD Test Guideline 458: Stably Transfected Human Androgen Receptor Transcriptional Activation Assay for Detection of Androgenic Agonist and Antagonist Activity of Chemicals (2023) https://doi.org/10.1787/9789264264366-en.
(14) OECD, Test Guideline 460: Fluorescein Leakage Test Method for Identifying Ocular Corrosives and Severe Irritants (2023) https://doi. org/10.1787/9789264185401-en.
(15) OECD Test Guideline 487: In Vitro Mammalian Cell Micronucleus Test (2023) https://doi.org/10.1787/9789264264861-en.
(16) 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) https://doi.org/10.1787/9789264242432-en.
(17) 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) https://doi.org/10.1787/9789264242548-en.
(18) 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) https://doi.org/10.1787/970e5cd9-en.
(19) OECD Test Guideline 497: Defined Approaches on Skin Sensitisation (2023) https://doi.org/10.1787/b92879a4-en.
(20) OECD Test Guideline 498: In vitro Phototoxicity – Reconstructed Human Epidermis Phototoxicity test method (2023) https://doi.org/
10.1787/7b2f9ea0-en.
(21) Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation
(EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1, ELI: http://data.europa.eu/eli/reg/2008/1272/oj).
(22) Section 2.2.4.2. of Annex I, Part 2, of Regulation (EC) No 1272/2008.
(23) Section 2.2.4.4. of Annex I, Part 2, of Regulation (EC) No 1272/2008.
(24) Table 2.6.4 of Annex I, Part 2 of Regulation (EC) No 1272/2008.
(25) Section 2.6.4.4. of Annex I, Part 2 of Regulation (EC) No 1272/2008.
(26) Section 2.8.4.1. of Annex I, Part 2, of Regulation (EC) No 1272/2008.
(27) Section 2.15.4.1. of Annex I, Part 2, of Regulation (EC) No 1272/2008.
(28) Section 2.16.2.1. of Annex I, Part 2, of Regulation (EC) No 1272/2008.
(29) Section 2.17.2.1., points (b) and (c), and Section 2.17.2.2 of Annex I, Part 2 of Regulation (EC) No 1272/2008 of the European Parliament and of the Council.
2/10 ELI: http://data.europa.eu/eli/reg/2024/2492/ojEN OJ L, 24.9.2024
(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.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 23 September 2024.
For the Commission The President Ursula VON DER LEYEN
ELI: http://data.europa.eu/eli/reg/2024/2492/oj 3/10EN OJ L, 24.9.2024 ANNEX The Annex to Regulation (EC) No 440/2008 is amended as follows:
(1) Part 0 is amended as follows:
(a) Table 1 is replaced by the following: ‘TABLE 1: TEST METHODS FOR PHYSICOCHEMICAL PROPERTIES OF THE SUBSTANCE Basic physicochemical properties Corresponding chapter, containing the full description of the test method, in Part A of this Annex (numbers in brackets indicate that the Endpoint Test method 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 OECD Test Guideline 102: Melting Point/Melting Range A.1.
point (1995) 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 igni tion behaviour of dust accumulations Lower and upper explo Test methods according to section 2.2.4.1. of Annex I, Part 2 sion limit 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 tempera ISO/IEC 80079-20-1:2017 – Explosive atmospheres – Part ture (liquids, gases) 20-1: Material characteristics for gas and vapour classifica tion – Test methods and data Decomposition tempera Calorimetric test methods according to section 20.3.3.3 of ture 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 tem perature (SADT) (with reference to a specific package) 4/10 ELI: http://data.europa.eu/eli/reg/2024/2492/ojEN OJ L, 24.9.2024 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 coefficient OECD Test Guideline 107: Partition Coefficient (n-octanol/ (A.8.) n-octanol/water water): Shake-Flask Method (1995) OECD Test Guideline 123: Partition Coefficient (1-Octanol/ A.23.
Water): Slow-Stirring Method (2022) OECD Test Guideline 117: Partition Coefficient (n-octanol/ A.24. water): HPLC Method (2022) Vapour pressure OECD Test Guideline 104: Vapour Pressure (2006) (A.4) Density/Relative density OECD Test Guideline 109: Density of Liquids and Solids (A.3.)
(2012) DIN 66137-2 – Determination of solid state density – Part 2:
Gas pycnometry ISO 12154 – Determination of density by volumetric dis placement – Skeleton density by gas pycnometry Particle characteristics EU test method A.22. Length Weighted Geometric Mean A.22.
Diameter of Fibres 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 –Charac terization of nanostructured materials Dustiness (for nanoforms EN 17199-1:2019 – Workplace exposure – Measurement of of a substance) 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
ELI: http://data.europa.eu/eli/reg/2024/2492/oj 5/10EN OJ L, 24.9.2024 Surface tension OECD Test Guideline 115: Surface Tension of Aqueous A.5.
Solutions (1995) Dissociation constant OECD Test Guideline 112: Dissociation Constants in Water. A.25.
(1981) Hydrophobicity OECD Test Guideline 126: Determination of the Hydro phobicity Index of Manufactured Nanomaterials Through an Affinity Measurement (2023) Physicochemical hazard properties Explosives 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.14 Flammable 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 1272/2008 Flammable 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 con Test method for substances which in contact with water emit tact with water emit flammable gases according to section 2.12.2.1. of Annex I, flammable gases Part 2 of Regulation (EC) No 1272/2008 6/10 ELI: http://data.europa.eu/eli/reg/2024/2492/ojEN OJ L, 24.9.2024 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 Regula tion (EC) No 1272/2008 Properties of polymers OECD Test Guideline 118: Determination of the Number- A.18.
Average Molecular Weight and the Molecular Weight Distri bution of Polymers using Gel Permeation Chromatography
(1996) OECD Test Guideline 119: Determination of the Low Mole A.19. cular Weight Content of a Polymer Using Gel Permeation Chromatography (1996) OECD Test Guideline 120: Solution/Extraction Behaviour of (A.20.)’ Polymers in Water (2000)
(b) Table 2 is amended as follows:
(i) the entry ‘Serious eye damage/eye irritation’ is replaced by the following: ‘Serious eye damage/eye In vitro: irritation OECD Test Guideline 437: Bovine Corneal Opacity and (B.47.) Permeability Test Method for Identifying i) Chemicals Indu cing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage
(2023) OECD Test Guideline 438: Isolated Chicken Eye Test Method (B.48.) for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irri tation or Serious Eye Damage (2023) OECD Test Guideline 460: Fluorescein Leakage Test Method (B.61.) for Identifying Ocular Corrosives and Severe Irritants
(2023) OECD Test Guideline 491: Short Time Exposure In Vitro Test (B.68.) Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage (2023)
ELI: http://data.europa.eu/eli/reg/2024/2492/oj 7/10EN OJ L, 24.9.2024 OECD Test Guideline 492: Reconstructed human Cornea- (B.69.) like Epithelium (RhCE) Test Method for Identifying Chemi cals Not Requiring Classification and Labelling for Eye Irri tation or Serious Eye Damage (2023) OECD Test Guideline 492B: Reconstructed Human Cornea- like Epithelium (RHCE) Test Method for Eye Hazard Identi fication (2022) OECD Test Guideline 494: Vitrigel-Eye Irritancy Test Method for Identifying Chemicals Not Requiring Classifica tion 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 (B.5.)’;
(2023)
(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 addres (B.59.) sing the Adverse Outcome Pathway key event on covalent binding to proteins (2023) OECD Test Guideline 442D: In Vitro Skin Sensitisation Assays Addressing (B.60.) the AOP Key Event on Keratinocyte Activation (2022) OECD Test Guideline 442E: In Vitro Skin Sensitisation: In Vitro Skin Sen (B.71.)’ sitisation Assays Addressing the Key Event on Activation of Dendritic Cells on the Adverse Outcome Pathway for Skin Sensitisation (2023) 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 B.49.’ Micronucleus Test (2016) 8/10 ELI: http://data.europa.eu/eli/reg/2024/2492/ojEN OJ L, 24.9.2024
is replaced by the following: ‘OECD Test Guideline 487. In vitro Mammalian Cell (B.49.)’;
Micronucleus Test (2023)
(iv) in the entry ‘Endocrine disrupting properties’, the rows: ‘OECD Test Guideline 456: H295R Steroidogenesis B.57.’ Assay (2022) 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 (B.57.)’ Assay (2023) 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)’
ELI: http://data.europa.eu/eli/reg/2024/2492/oj 9/10EN OJ L, 24.9.2024
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 Chirono C.27. mid Toxicity Using Spiked Sediment (2004) OECD Test Guideline 219: Sediment-Water Chirono C.28.’ mid Toxicity Using Spiked Water (2004)
are replaced by the following: ‘OECD Test Guideline 218: Sediment-Water Chirono (C.27.) mid Toxicity Test Using Spiked Sediment (2023) OECD Test Guideline 219: Sediment-Water Chirono (C.28.)’; mid Toxicity Test Using Spiked Water (2023)
(iii) in the entry ‘Endocrine disrupting properties’, the row: ‘OECD Test Guideline 240: Medaka Extended One C.52.’ Generation Reproduction Test (MEOGRT) (2015)
is replaced by the following: ‘OECD Test Guideline 240: Medaka Extended One (C.52.)’ Generation Reproduction Test (MEOGRT) (2023)
(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.’ 10/10 ELI: http://data.europa.eu/eli/reg/2024/2492/oj