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Commission Regulation (EC) No 761/2009 of 23 July 2009 amending, for the purpose of its adaptation to technical progress, Regulation (EC) No 440/2008 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)

EU Regulation No 761/2009 · Adopted 23 July 2009 · Extends to United Kingdom

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Commission Regulation (EC) No 761/2009

of 23 July 2009

amending, for the purpose of its adaptation to technical progress, Regulation (EC) No 440/2008 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)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Regulation (EC) No 1907/2006 of 18 December 2006 of the European Parliament and of the Council 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/ECf1, and in particular Article 13(3) thereof,

Whereas:

(1)

Commission Regulation (EC) No 440/2008f2 contains the test methods for the purposes of the determination of the physico-chemical properties, toxicity and eco-toxicity of substances to be applied for the purposes of Regulation (EC) No 1907/2006.

(2)

It is necessary to update Regulation (EC) No 440/2008 to include changes to certain test methods and to include several new test methods adopted by the OECD. Stakeholders have been consulted on this proposal. Those amendments adapt the methods in question to scientific and technical progress.

(3)

The provisions concerning vapour pressure to include the new effusion method should be revised.

(4)

It is necessary to add a new method to measure length weighted geometric mean diameter of fibres.

(5)

It is appropriate to update Regulation (EC) No 440/2008 to include with priority a new in vitro test method for skin irritation, in order to obtain a reduction of the number of animals to be used for experimental purposes, in accordance with Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposesf3. Although a draft in vitro test method for skin irritation is still under discussion within the OECD, it is appropriate in this exceptional case to include method B 46 in this Regulation. Method B 46 should be updated as soon as possible once an agreement has been reached within the OECD or if further information justifying such a revision becomes available.

(6)

The provisions concerning the algal inhibition test need to be revised to include additional species and to meet the requirements for hazard assessment and classification of chemicals.

(7)

It is necessary to add a new method to measure aerobic mineralisation in surface water, by virtue of a simulation biodegradation test and a new method to assess toxicity to the genus Lemna, by virtue of a growth inhibition test.

(8)

Regulation (EC) No 440/2008 should therefore be amended accordingly.

(9)

The measures provided for in this Regulation are in accordance with the opinion of the Committee established under Article 133 of Regulation (EC) No 1907/2006,

HAS ADOPTED THIS REGULATION:

Annotations to the whole text

Footnotes

f1

OJ L 396, 30.12.2006, p. 1.

f2

OJ L 142, 31.5.2008, p. 1.

f3

OJ L 358, 18.12.1986, p. 1.

Contents

  1. 1Article 1
  2. 2Article 2
  3. Signature
  4. Annex I: A.4. VAPOUR PRESSURE
  5. METHOD
  6. Division
  7. 1.1INTRODUCTION
  8. 1.2DEFINITIONS AND UNITS
  9. 1.3PRINCIPLE OF THE TEST
  10. 1.4REFERENCE SUBSTANCES
  11. DESCRIPTION OF THE METHOD
  12. Dynamic method (Cottrell’s method)
  13. Principle
  14. Division
  15. A:Division A:
  16. B:Division B:
  17. C:Division C:
  18. D:Division D:
  19. E:Division E:
  20. F:Division F:
  21. 1.5.1.2Apparatus
  22. 1.5.1.3Procedure
  23. Static method
  24. 1.5.2.1Principle
  25. 1.5.2.2Apparatus
  26. Procedure
  27. Division
  28. Division
  29. Isoteniscope Method
  30. 1.5.3.1Principle
  31. 1.5.3.2Apparatus
  32. 1.5.3.3Procedure
  33. Division
  34. Division
  35. Effusion method: vapour pressure balance (7)
  36. 1.5.4.1Principle
  37. 1.5.4.2Apparatus
  38. Division
  39. Effusion method: Knudsen cell
  40. 1.5.5.1Principle
  41. 1.5.5.2Apparatus
  42. Division
  43. Effusion method: isothermal thermogravimetry
  44. 1.5.6.1Principle
  45. 1.5.6.2Apparatus
  46. Division
  47. Division
  48. 1.5.6.3Procedure
  49. Gas saturation method (23)
  50. 1.5.7.1Principle
  51. 1.5.7.2Apparatus
  52. Division
  53. Division
  54. 1.5.7.3Procedure
  55. Spinning rotor
  56. 1.5.8.1Principle
  57. 1.5.8.2Apparatus
  58. Division
  59. DATA AND REPORTING
  60. 2.1DATA
  61. 2.2TEST REPORT
  62. 3LITERATURE
  63. Estimation method
  64. Annex II: A.22. LENGTH WEIGHTED GEOMETRIC MEAN DIAMETER OF FIBRES
  65. METHOD
  66. 1.1INTRODUCTION
  67. 1.2DEFINITIONS
  68. 1.3SCOPE AND LIMITATIONS
  69. 1.4PRINCIPLE OF THE TEST METHOD
  70. DESCRIPTION OF THE TEST METHOD
  71. 1.5.1Safety/precautions
  72. 1.5.2Apparatus/equipment
  73. Test Procedure
  74. 1.5.3.1Sampling
  75. 1.5.3.2Sample Preparation
  76. SEM calibration and operation
  77. 1.5.3.3.1Calibration
  78. 1.5.3.3.2Operation
  79. Sizing
  80. 1.5.3.4.1Low magnification examination to assess the sample
  81. 1.5.3.4.2Length weighting of the fibre diameters
  82. 1.5.3.4.3Fibre sizing
  83. DATA
  84. 2.1TREATMENT OF RESULTS
  85. REPORTING
  86. TEST REPORT
  87. 4REFERENCES
  88. Annex III: B.46. IN VITRO SKIN IRRITATION: RECONSTRUCTED HUMAN EPIDERMIS MODEL TEST
  89. METHOD
  90. 1.1INTRODUCTION
  91. 1.2DEFINITIONS
  92. 1.3SCOPE AND LIMITATIONS
  93. 1.4PRINCIPLE OF THE TEST
  94. 1.5DEMONSTRATION OF PROFICIENCY
  95. DESCRIPTION OF THE METHOD
  96. Division
  97. Reconstructed Human Epidermis Model Components
  98. 1.6.1.1General model conditions
  99. Functional model conditions
  100. 1.6.1.2.1Viability
  101. 1.6.1.2.2Barrier function
  102. 1.6.1.2.3Morphology
  103. 1.6.1.2.4Reproducibility
  104. 1.6.1.2.5Quality controls (QC) of the model
  105. 1.6.1.3Application of the Test and Control Substances
  106. 1.6.1.4Cell Viability Measurements
  107. 1.6.1.5Assay Acceptability Criteria
  108. DATA
  109. 2.1DATA
  110. 2.2INTERPRETATION OF RESULTS
  111. (i)Division (i)
  112. (ii)Division (ii)
  113. REPORTING
  114. 3.1TEST REPORT
  115. 4REFERENCES
  116. Assessment of the performance characteristics of proposed in vitro reconstructed human epidermis models for skin irritation
  117. Annex IV: C.3. FRESHWATER ALGAE AND CYANOBACTERIA, GROWTH INHIBITION TEST
  118. METHOD
  119. Division
  120. 1.1INTRODUCTION
  121. 1.2DEFINITIONS
  122. 1.3APPLICABILITY OF THE TEST
  123. 1.4PRINCIPLE OF THE TEST
  124. 1.5INFORMATION ON THE TEST SUBSTANCE
  125. 1.6REFERENCE SUBSTANCE
  126. 1.7VALIDITY OF THE TEST
  127. DESCRIPTION OF THE METHOD
  128. 1.8.1Apparatus
  129. 1.8.2Test organisms
  130. 1.8.3Growth medium
  131. 1.8.4Initial biomass concentration
  132. 1.8.5Concentrations of test substance
  133. 1.8.6Replicates and controls
  134. 1.8.7Preparation of inoculum culture
  135. 1.8.8Preparation of test solutions
  136. 1.8.9Incubation
  137. 1.8.10Test duration
  138. 1.8.11Measurements and analytical determinations
  139. 1.8.12Other observations
  140. 1.8.13Limit test
  141. 1.8.14Modification for strongly coloured substances
  142. DATA
  143. 2.1PLOTTING GROWTH CURVES
  144. RESPONSE VARIABLES
  145. Division
  146. 2.2.1Average growth rate
  147. 2.2.2Yield
  148. 2.3PLOTTING CONCENTRATION RESPONSE CURVE
  149. 2.4STATISTICAL PROCEDURES
  150. 2.5GROWTH STIMULATION
  151. 2.6NON-TOXIC GROWTH INHIBITION
  152. REPORTING
  153. 3.1TEST REPORT
  154. 4LITERATURE
  155. 1Strains shown to be suitable for the test
  156. 2Growth media
  157. 3Example of a procedure for the culturing of algae
  158. 4Data analysis by nonlinear regression
  159. Annex V: C.25. AEROBIC MINERALISATION IN SURFACE WATER — SIMULATION BIODEGRADATION TEST
  160. METHOD
  161. Division
  162. 1.1INTRODUCTION
  163. 1.2DEFINITIONS
  164. 1.3APPLICABILITY OF THE TEST
  165. 1.4PRINCIPLE OF THE TEST
  166. 1.5INFORMATION ON THE TEST SUBSTANCE
  167. 1.6REFERENCE SUBSTANCE
  168. QUALITY CRITERIA
  169. 1.7.1Recovery
  170. 1.7.2Repeatability and sensitivity of analytical method
  171. DESCRIPTION OF THE TEST METHOD
  172. 1.8.1Equipment
  173. 1.8.2Stock solutions of test substance
  174. 1.8.3Collection and transport of surface water
  175. 1.8.4Storage and preparation of surface water
  176. 1.8.5Preparation of water amended with sediment (optional)
  177. 1.8.6Semi-continuous procedure (optional)
  178. 1.8.7Addition of the test (or reference) substance
  179. Test conditions
  180. 1.8.8.1Test temperature
  181. 1.8.8.2Agitation
  182. 1.8.8.3Test duration
  183. Procedure
  184. 1.8.9.1Preparation of flasks for pelagic test
  185. 1.8.9.2Number of flasks and samples
  186. 1.8.9.3Preparation of flasks for suspended sediment test [optional]
  187. 1.8.9.4Radiochemical determinations
  188. 1.8.9.5Specific chemical analysis
  189. DATA AND REPORTING
  190. TREATMENT OF RESULTS
  191. 2.1.1Plot of data
  192. 2.1.2Residual activity
  193. 2.2INTERPRETATION OF RESULTS
  194. 2.3VALIDITY OF THE TEST
  195. 3TEST REPORT
  196. 4LITERATURE
  197. 1Phase distribution of 14C
  198. 2Semi-continuous procedure
  199. 3Determination of 14CO2
  200. Annex VI: C.26. LEMNA SP. GROWTH INHIBITION TEST
  201. METHOD
  202. Division
  203. 1.1INTRODUCTION
  204. 1.2DEFINITIONS
  205. 1.3PRINCIPLE OF THE TEST
  206. 1.4INFORMATION ON THE TEST SUBSTANCE
  207. 1.5REFERENCE SUBSTANCE
  208. 1.6VALIDITY OF THE TEST
  209. DESCRIPTION OF THE METHOD
  210. 1.7.1Apparatus
  211. 1.7.2Test organism
  212. 1.7.3Cultivation
  213. 1.7.4Test medium
  214. 1.7.5Test solutions
  215. 1.7.6Test and control groups
  216. 1.7.7Exposure
  217. 1.7.8Incubation conditions
  218. 1.7.9Duration
  219. Measurements and analytical determinations
  220. Division
  221. 1.7.10.1Frequency of measurements and analytical determinations
  222. 1.7.11Limit test
  223. DATA AND REPORTING
  224. 2.1DOUBLING TIME
  225. RESPONSE VARIABLES
  226. Division
  227. 2.2.1Average specific growth rate
  228. 2.2.2Yield
  229. 2.2.3Plotting concentration-response curves
  230. 2.2.4ECx estimation
  231. 2.3STATISTICAL PROCEDURES
  232. REPORTING
  233. 3.1TEST REPORT
  234. 4LITERATURE
  235. 1Description of lemna spp.
  236. 2Maintenance of stock culture
  237. 3Media