LegalizeCouncil 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) (Text with EEA relevance)
Article 1
The test methods to be applied for the purposes of Regulation 1907/2006/EC are set out in the Annex to this Regulation.
Article 2
The Commission shall review, where appropriate, the test methods contained in this Regulation with a view to replacing, reducing or refining testing on vertebrate animals.
Article 3
All references to Annex V to Directive 67/548/EEC shall be construed as references to this Regulation.
Article 4
This Regulation shall enter into force on the day following its publication in the Official Journal of the European Union.
It shall apply from 1 June 2008.
ANNEX
Note:
Before using any of the following test methods to test a multi-constituent substance (MCS), a substance of unknown or variable composition, complex reaction product or biological material (UVCB), or a mixture and where its applicability for the testing of MCS, UVCB, or mixtures is not indicated in the respective test method, it should be considered whether the method is adequate for the intended regulatory purpose.
If the test method is used for the testing of a MCS, UVCB or mixture, sufficient information on its composition should be made available, as far as possible, e.g. by the chemical identity of its constituents, their quantitative occurrence, and relevant properties of the constituents.
PART 0
TABLE 1: TEST METHODS FOR PHYSICOCHEMICAL PROPERTIES OF THE SUBSTANCE
| Basic physicochemical properties | ||
|---|---|---|
| Endpoint | 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 coefficient n-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 pycnometry | ||
| ISO 12154 – Determination of density by volumetric displacement – Skeleton density by gas pycnometry | ||
| Particle 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 materials | ||
| Dustiness (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 – Part 1: Requirements and choice of test methods | |
| 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 | ||
| EN 15051-1:2013 Workplace exposure – Measurement of the dustiness of bulk materials – Part 1: Requirements and choice of test methods | ||
| EN 15051-2:2016 Workplace exposure – Measurement of the dustiness of bulk materials – Part 2: Rotating drum method | ||
| EN 15051-3:2013 Workplace exposure – Measurement of the dustiness of bulk materials – Part 3: Continuous drop method | ||
| Surface 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 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 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.) |
TABLE 2: TEST METHODS FOR TOXICOLOGICAL PROPERTIES
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