Regulation (EC) No. 440/2008
 Regulation (EC) No. 440/2008 |
|
|---|---|
| Title: | Regulation (EC) No. 440/2008 of the Commission of 30 May 2008 laying down test methods in accordance with Regulation (EC) No. 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) |
| Scope: | EEA |
| Legal matter: | Chemicals law |
| Basis: |
EGV Regulation (EG) No. 1907/2006 in particular Article 13 Paragraph 3 |
| Date of issue: | May 30, 2008 |
| Release date: | May 31, 2008 |
| Come into effect: | June 1, 2008 |
| To be used from: | June 1, 2008 |
| Reference: | OJ L 142 of May 31, 2008, pp. 1-739 |
| Full text |
Consolidated version (not official) basic version |
| Regulation has entered into force and is applicable. | |
| Please note the information on the current version of legal acts of the European Union ! | |
The European Regulation (EC) No. 440/2008 defines test procedures according to Regulation (EC) No. 1907/2006 for REACH . This regulation was replaced by regulations (EC) No. 761/2009, (EU) No. 1152/2010, (EC) No. 640/2012, (EU) No. 260/2014, (EU) No. 900/2014 , (EU) No. 2016/266, (EU) No. 2017/735 and (EU) No. 2019/1390 changed and thus adapted to technical progress.
The measurement procedures and methods are described in the annex to the ordinance. Part A contains the possible test procedures, reference substances and the quality criteria for physico-chemical properties. Part B covers tests for measuring the effects on health ( human toxicology ), while Part C deals with the measurement methods for ecotoxicology .
attachment
Part A: Methods for determining the physicochemical properties
| number | method |
|---|---|
| A.1 | Melting / freezing temperature |
| A.2 | Boiling temperature |
| A.3 | relativ density |
| A.4 | Vapor pressure |
| A.5 | Surface tension |
| A.6 | Water solubility |
| A.8 | Partition coefficient |
| A.23 | Partition coefficient ( 1-octanol / water ): method for testing with slow stirring |
| A.24 | Partition coefficient (1-octanol / water): high-performance liquid chromatography (HPLC method) |
| A.9 | Flash point |
| A.10 | Flammability (solids) |
| A.11 | Flammability (gases) |
| A.12 | Flammability (contact with water) |
| A.13 | Pyrophoric properties of solid and liquid substances |
| A.14 | Risk of explosion |
| A.15 | Ignition temperature (liquids and gases) |
| A.16 | Relative auto-ignition temperature for solids |
| A.17 | Oxidising properties (solids) |
| A.21 | Oxidizing properties (liquid substances) |
| A.18 | Polymers : number average molasses and molar mass distribution |
| A.19 | Polymers: low molecular weight fraction |
| A.20 | Polymers: dissolution / extraction behavior in water |
| A.22 | Geometric diameter (length weighted, mean) of fibers |
| A.25 | Dissociation constant in water ( titration - spectrophotometric method - conductometric method ) |
Part B: Methods for determining toxicity and other health effects
| number | method |
|---|---|
| B.1 to | Acute toxicity (oral) - fixed dose method |
| B.1 tris | Acute toxicity (oral) - acute toxic class method |
| B.2 | Acute toxicity (inhalation) |
| B.52 | Acute toxicity (inhalation) - acute toxic class method |
| B.3 | Acute toxicity (dermal) |
| B.4 | Acute skin irritation / corrosion |
| B.5 | Acute eye irritation / corrosion |
| B.7 | Subacute toxicity: 28-day repeated oral toxicity study in rodents |
| B.8 | Subacute Toxicity: Subacute Inhalation Toxicity Study - 28 Day Test |
| B.9 | Subacute toxicity: toxicity after 28 days of administration (dermal) |
| B.26 | Sub-Chronic Oral Toxicity Study - 90 day repeated oral toxicity study in rodents |
| B.27 | Sub-Chronic Oral Toxicity Study - 90-day repeated oral toxicity study in non-rodents |
| B.28 | Test for sub-chronic toxicity after dermal application - 90-day test with rodents |
| B.29 | Sub-Chronic Inhalation Toxicity Test - 90 Day Test |
| B.30 | Chronic Toxicity: Chronic Toxicity Tests |
| B.33 | Chronic toxicity: combined studies to test for chronic toxicity and carcinogenicity |
| B.6 | Skin sensitization : Skin sensitization |
| B.42 | Skin sensitization: local lymph node test |
| B.50 | Skin sensitization: local lymph node test: DA |
| B.51 | Skin sensitization: local lymph node test: BrdU - ELISA |
| B.59 | Skin sensitization: in-chemico skin sensitization: direct peptide reactivity test (DPRA) |
| B.60 | Skin sensitization: in vitro skin sensitization: ARE-Nrf2 - luciferase test method |
| B.71 | Skin sensitization: in vitro tests for the key process of activating dendritic cells on the Adverse Outcome Pathway (AOP) |
| B.10 | Mutagenicity: in vitro test for chromosomal aberrations in mammalian cells |
| B.11 | Mutagenicity: Test for chromosomal aberrations in mammalian bone marrow cells |
| B.12 | Mutagenicity: Erythrocyte micronucleus test in mammals |
| B. 13/14 | Mutagenicity: reverse mutation test using bacteria |
| B.58 | Mutagenicity: Gene mutation assay on somatic cells and germ cells of transgenic rodents |
| B.17 | Mutagenicity: in vitro gene mutation testing on mammalian cells using the hprt and xprt genes |
| B.67 | Mutagenicity: in vitro gene mutation testing on mammalian cells using the thymidine kinase gene |
| B.21 | Cell transformation : in vitro cell transformation test |
| B.49 | Cell transformation: in vitro micronucleus test on mammalian cells |
| B.22 | Dominant lethal test on rodents |
| B.23 | Spermatogenesis testing for chromosomal aberrations in mammals |
| B.25 | In vivo mammalian translocation test |
| B.31 | Study to test for prenatal developmental toxicity |
| B.32 | Carcinogenicity tests |
| B.33 | Combined studies to test for chronic toxicity and carcinogenicity |
| B.34 | Reproductive toxicity : one-generation study |
| B.35 | Reproductive toxicity: two-generation study for review |
| B.56 | Reproductive toxicity: extended one-generation study |
| B.62 | Reproductive toxicity: alkaline in-vivo - comet assay in mammalian cells |
| B.63 | Reproductive toxicity: screening test to assess reproductive / developmental toxicity |
| B.64 | Reproductive toxicity: combined repeated dose screening test to assess reproductive / developmental toxicity |
| B.36 | Toxicokinetics |
| B.37 | Neurotoxicity : Delayed neurotoxicity of organophosphorus substances after acute exposure |
| B.38 | Neurotoxicity: Delayed neurotoxicity of organophosphorus substances after repeated administration over 28 days |
| B.43 | Neurotoxicity: Test for neurotoxicity in rodents |
| B.53 | Neurotoxicity: Developmental neurotoxicity test |
| B.39 | In vivo test for unscheduled DNA synthesis (UDS) in mammalian liver cells |
| B.40 | Skin corrosion in vitro - TER test method |
| B.40 to | Skin corrosion in vitro test method with reconstructed human epidermis (RhE) |
| B.65 | Skin corrosion : in vitro test method for examining the membrane barrier |
| B.41 | Photo toxicity : in-vitro -3t3- NRU test |
| B.44 | Skin absorption : in vivo method |
| B.45 | Skin absorption: in vitro method |
| B.46 | Skin irritation: in vitro test method with reconstructed human epidermis |
| B.47 | Eye Irritation / Damage: Bovine cornea opacity and permeability test to identify i) chemicals that cause serious eye damage and ii) chemicals that do not require classification as eye irritant or seriously damaging |
| B.48 | Eye irritation / damage: Isolated corn test to identify i) chemicals that cause serious eye damage and ii) chemicals that do not require classification as eye irritant or serious eye damage |
| B.61 | Eye irritation / damage: Fluorescein leakage test method to identify substances that are corrosive and strongly irritating to the eyes |
| B.68 | Eye Irritation / Damage: In vitro short-term exposure test method to identify i) chemicals that cause serious eye damage and ii) chemicals that do not require classification as eye irritant or seriously damaging |
| B.69 | Eye irritation / damage: Test method using reconstructed human corneal epithelium (RhCE) to identify chemicals that do not need to be classified and labeled as irritating or seriously damaging to the eyes |
| B.54 | Uterotrophic biomass with rodents: short-term screening test for estrogenic properties |
| B.55 | Hershberger bioassay with rats: short-term screening test for (anti) androgenic properties |
| B.57 | H295R Steroid Genesis Assay |
| B.66 | STTA - in vitro assays for the detection of estrogen receptor agonists and antagonists |
| B.70 | In vitro assays with a human recombinant estrogen receptor (hrER) to determine chemicals with ER binding affinity |
Part C: Methods for determining ecotoxicity
| number | method |
|---|---|
| C.1 | Toxicity , acute to fish |
| C.8 | Toxicity to earthworms |
| C.15 | Toxicity test, short-term - on embryos and young fish with yolk sac |
| C.16 | Acute oral toxicity test - honeybees |
| C.17 | Toxicity test, acute contact toxicity test - honey bees |
| C.27 | Toxicity test in sediment-water systems with spiked sediment - chironomids |
| C.28 | Toxicity test in sediment-water systems with spiked water - chironomids |
| C.40 | Toxicity tests (life cycle) in sediment-water systems with spiked sediment - chironomids |
| C.47 | Toxicity testing on fish at an early stage of development |
| C.49 | Acute toxicity - test on fish embryos (fet) |
| C.50 | Toxicity test, sediment-free - Myriophyllum spicatum |
| C.51 | Toxicity test in water sediment - Myriophyllum spicatum |
| C.35 | Toxicity study with spiked sediment on the lumbriculus |
| C.3 | Growth inhibition test: freshwater algae and cyanobacteria |
| C.14 | Growth test on young fish |
| C.26 | Growth Inhibition Test - Lemna sp. |
| C.31 | Land plant growth test: investigation of seedling emergence and growth |
| C.53 | Growth of amphibians : The Larval Amphibian Growth and Development assay (Lagda) |
| C.34 | Determination of the inhibition of anaerobic bacteria - reduction of the gas production of anaerobic digested sludge |
| C.2 | Daphnia sp . Test for acute inability to swim |
| C.4 | Biodegradation work - Determination of the "easy" biodegradation work ( DOC die away test , modified OECD screening test , CO 2 development test , manometric respiration test , closed bottle test , MITI test ) |
| C.9 | Biodegradation work - Zahn-Wellens test |
| C.12 | Biodegradation Work - Modified SCAS Test |
| C.29 | Biodegradation work, easy - determination of CO 2 in closed bottles ( headspace test ) |
| C.42 | Biodegradation work in sea water |
| C.43 | Biodegradation work (anaerobic) organic substances in digested sludge: Determination by measuring the gas production |
| C.25 | Biodegradation work (aerobic mineralization in surface water ) - simulation test |
| C.5 | Degradation work - biochemical oxygen demand |
| C.6 | Decomposition work - chemical oxygen demand |
| C.7 | Degradation work - abiotic degradation: hydrolysis depending on the pH value |
| C.10 | Simulation of aerobic wastewater treatment: a) activated sludge c) biofilms |
| C.11 | Activated sludge, testing of respiratory inhibition (carbon and ammonium oxidation) |
| C.18 | Adsorption / desorption by a shaking method |
| C.19 | Adsorption coefficients (K oc ) in the soil and in sewage sludge - estimate using high pressure liquid chromatography (HPLC) |
| C.13 | Bioaccumulation test on fish with aquatic exposure and exposure via the feed |
| C.30 | Bioaccumulation in terrestrial oligochaetes |
| C.46 | Bioaccumulation in sediment- dwelling benthic oligochaetes |
| C.20 | Reproduction test: Daphnia magna |
| C.32 | Reproduction test: enchytrae |
| C.33 | Reproduction test with earthworms ( Eisenia fetida / Eisenia andrei ) |
| C.36 | Reproduction test with predatory mites ( Hypoaspis (geolaelaps) aculeifer ) in soil samples |
| C.39 | Reproduction test: collembola in soils |
| C.48 | Reproduction test: short-term reproduction test on fish |
| C.52 | Reproduction test: Medaka extended 1 generations (MEOGRT) |
| C.21 | Soil microorganisms: nitrogen transformation test |
| C.22 | Soil microorganisms: carbon transformation test |
| C.23 | Aerobic and anaerobic transformation in the soil |
| C.24 | Aerobic and anaerobic transformation in water-sediment systems |
| C.37 | Endocrine properties: 21-day fish screening assay: a short-term test to determine estrogenic and androgenic activity and aromatase inhibition |
| C.38 | Endocrine Features: The amphibians - Metamorphosis Assay (AMA) |
| C.41 | Endocrine properties: Fish sexual development test (test for sex development in fish) |
| C.44 | Infiltration in soil columns |
| C.45 | Estimation of the emissions of wood treated with wood preservatives into the environment: laboratory method for uncoated wood products that come into contact with fresh water or sea water |
See also
Individual evidence
- ↑ Regulation (EC) No. 761/2009 of the Commission of July 23, 2009 amending Regulation (EC) No. 440/2008 laying down test methods in accordance with Regulation (EC) No. 1907/2006 of the European Parliament and of the Council for the registration, evaluation, authorization and restriction of chemical substances (REACH) in order to adapt to technical progress
- ↑ Regulation (EU) No. 1152/2010 of the Commission of December 8, 2010 amending - for the purpose of adapting to technical progress - Regulation (EC) No. 440/2008 laying down test methods according to Regulation (EC) No. 1907 / 2006 of the European Parliament and the Council for the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH)
- ↑ Regulation (EU) No. 640/2012 of the Commission of 6 July 2012 amending Regulation (EC) No. 440/2008 on the definition of test methods in accordance with Regulation (EC) No. 1907/2006 of the European Parliament and of the Council for the registration, evaluation, authorization and restriction of chemical substances (REACH) in order to adapt to technical progress
- ↑ Regulation (EU) No. 260/2014 of the Commission of January 24, 2014 amending Regulation (EC) No. 440/2008 on the definition of test methods in accordance with Regulation (EC) No. 1907/2006 of the European Parliament and of the Council for the registration, evaluation, authorization and restriction of chemical substances (REACH) in order to adapt to technical progress
- ↑ Regulation (EU) No. 900/2014 of the Commission of July 15, 2014 amending Regulation (EC) No. 440/2008 laying down test methods in accordance with Regulation (EC) No. 1907/2006 of the European Parliament and of the Council for the registration, evaluation, authorization and restriction of chemical substances (REACH) in order to adapt to technical progress
- ↑ Regulation (EU) 2016/266 of the Commission of December 7th, 2015 amending Regulation (EC) No. 440/2008 on the definition of test methods according to Regulation (EC) No. 1907/2006 of the European Parliament and of the Council on registration , Evaluation, Authorization and Restriction of Chemicals (REACH) in order to adapt to technical progress
- ↑ Regulation (EU) 2017/735 of the Commission of February 14, 2017 amending - in order to adapt to technical progress - the annex to Regulation (EC) No. 440/2008 laying down test methods in accordance with Regulation (EC) No. 1907 / 2006 of the European Parliament and the Council for the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH)
- ↑ Regulation (EU) 2019/1390 of the Commission of July 31, 2019 amending - for the purpose of adapting to technical progress - the annex to Regulation (EC) No. 440/2008 laying down test methods in accordance with Regulation (EC) No. 1907 / 2006 of the European Parliament and the Council for the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH)