Regulation (EC) No. 440/2008

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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 .

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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

  1. 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
  2. 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)
  3. 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
  4. 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
  5. 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
  6. 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
  7. 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)
  8. 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)