L’annexe du règlement (CE) no 440/2008 est modifiée comme suit:
1) La partie 0 est modifiée comme suit:
a) le tableau 1 est remplacé par le tableau suivant:
«TABLEAU 1: MÉTHODES D’ESSAI POUR LA DÉTERMINATION DES PROPRIÉTÉS PHYSICO-CHIMIQUES DES SUBSTANCES
| Propriétés physicochimiques de base
| Effet mesuré | Méthode d’essai | Chapitre correspondant, contenant la description complète de la méthode d’essai, dans la partie A de la présente annexe (les références entre parenthèses indiquent que la description complète de la méthode d’essai a été supprimée de la partie A; cellule vide: aucune méthode d’essai correspondante ne figure dans la partie A de la présente annexe)
| Point de fusion/point de congélation | 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) |
| Point d’ébullition | 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 |
| Inflammabilité | EN 15188:2020 – Determination of the spontaneous ignition behaviour of dust accumulations |
| Limites inférieure et supérieure d’explosivité | 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) |
| Point d’éclair | Test methods according to table 2.6.3 of Annex I, Part 2 of Regulation (EC) No 1272/2008 |
| Température d’inflammation spontanée (liquides, gaz) | ISO/IEC 80079-20-1:2017 – Explosive atmospheres - Part 20-1: Material characteristics for gas and vapour classification - Test methods and data |
| Température de décomposition | 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) |
| Viscosité cinématique | OECD Test Guideline 114: Viscosity of Liquids (2012) |
| Solubilité dans l’eau | OECD Test Guideline 105: Water Solubility (1995) | A.6
|
Coefficient de partage
n-octanol/eau
| 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
| Pression de vapeur | OECD Test Guideline 104: Vapour Pressure (2006) | (A.4)
| Densité/densité relative | OECD Test Guideline 109: Density of Liquids and Solids (2012) | (A.3)
| 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
| Caractéristiques des particules | 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 materials
| Pouvoir de resuspension (pour les nanoformes d’une 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 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
| Tension superficielle | OECD Test Guideline 115: Surface Tension of Aqueous Solutions (1995) | A.5
| Constante de dissociation | OECD Test Guideline 112: Dissociation Constants in Water. (1981) | A.25
| Hydrophobicité | OECD Test Guideline 126: Determination of the Hydrophobicity Index of Manufactured Nanomaterials Through an Affinity Measurement (2023) |
| Propriétés physicochimiques dangereuses
| Explosibles | 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
| Gaz inflammables | 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 |
| Gaz comburants | Test method for oxidising gases according to section 2.4.4. of Annex I, Part 2 of Regulation (EC) No 1272/2008 |
| Liquides inflammables | 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
| Matières solides inflammables | Test method for flammable solids according to section 2.7.2.3. of Annex I, Part 2 of Regulation (EC) No 1272/2008 |
| Substances autoréactives | Test method for self-reactive substances according to section 2.8.4.1. of Annex I, Part 2 of Regulation (EC) No 1272/2008 |
| Liquides pyrophoriques | Test method for pyrophoric liquids according to section 2.9.2.1. of Annex I, Part 2 of Regulation (EC) No 1272/2008 |
| Matières solides pyrophoriques | Test method for pyrophoric solids according to section 2.10.2.1. of Annex I, Part 2 of Regulation (EC) No 1272/2008, |
| Substances auto-échauffantes | 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 qui, au contact de l’eau, dégagent des gaz inflammables | 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 |
| Liquides comburants | Test method for oxidising liquids according to section 2.13.2.1. of Annex I, Part 2 of Regulation (EC) No 1272/2008 |
| Matières solides comburantes | Test method for oxidising solids according to section 2.14.2.1. of Annex I, Part 2 of Regulation (EC) No 1272/2008 |
| Peroxydes organiques | Test methods according to section 2.15.4.1 of Annex I, Part 2 of Regulation (EC) No 1272/2008 |
| Substances ou mélanges corrosifs pour les métaux | 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 |
| Explosibles désensibilisés | 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 |
| Propriétés des polymères | 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) le tableau 2 est modifié comme suit:
i) la rubrique «Lésions oculaires graves/irritation oculaire» est remplacée par la rubrique suivante:
| «Lésions oculaires graves/irritation oculaire | 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) dans la rubrique «Sensibilisation cutanée», la section «In vitro» est remplacée par la section suivante:
| «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) dans la rubrique «Mutagénicité», la ligne:
| |
| «OECD Test Guideline 487. In vitro Mammalian Cell Micronucleus Test (2016) | B.49»
est remplacée par la ligne suivante:
| |
| «OECD Test Guideline 487. In vitro Mammalian Cell Micronucleus Test (2023) | (B.49.)»
iv) dans la rubrique «Propriétés de perturbation endocrinienne», les lignes:
| |
| «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) |
sont remplacées par les lignes suivantes:
| |
| «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) dans la rubrique «Phototoxicité», la ligne:
| | «OECD Test Guideline 498: In Vitro Phototoxicity Test Method Using the Reconstructed Human Epidermis (RhE) (2021)» |
est remplacée par la ligne suivante:
| | «OECD Test Guideline 498: In Vitro Phototoxicity Reconstructed Human Epidermis Phototoxicity test method (2023)» |
vi) la rubrique suivante est insérée après la section «Phototoxicité»:
| «Immunotoxicité | OECD Test Guideline 444A: In vitro immunotoxicity IL-2 Luc assay (2023)» |
c) le tableau 3 est modifié comme suit:
i) dans la rubrique «Dégradation», la ligne:
| | «OECD Test Guideline 316: Phototransformation of Chemicals in Water – Direct Photolysis (2008)» |
est remplacée par la ligne suivante:
| | «OECD Test Guideline 316: Phototransformation of Chemicals in Water – Direct Photolysis (2023)» |
ii) dans la rubrique «Effets sur les organismes présents dans les sédiments», les lignes:
| | «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»
sont remplacées par les lignes suivantes:
| | «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) dans la rubrique «Propriétés de perturbation endocrinienne», la ligne:
| | «OECD Test Guideline 240: Medaka Extended OneGeneration Reproduction Test (MEOGRT) (2015) | C.52»
est remplacée par la ligne suivante:
| | «OECD Test Guideline 240: Medaka Extended One Generation Reproduction Test (MEOGRT) (2023) | (C.52.)»
2) Dans la partie B, le texte figurant sous le titre de chacun des chapitres B.49 et B.57 est remplacé par le texte suivant: «La description complète de cette méthode d’essai a été supprimée. La méthode d’essai internationale équivalente figure dans le tableau 2 de la partie 0.»;
3) Dans la partie C, le texte figurant sous le titre de chacun des chapitres C.27, C.28 et C.52 est remplacé par le texte suivant: «La description complète de cette méthode d’essai a été supprimée. La méthode d’essai internationale équivalente figure dans le tableau 3 de la partie 0.».