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Fourth Commission Directive of 11 October 1985 on the approximation of the laws of the Member States relating to methods of analysis necessary for checking the composition of cosmetic products (85/490/EEC)

EU Directive 1985/490 · Adopted 11 October 1985 · Extends to United Kingdom

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Fourth Commission Directive

of 11 October 1985

on the approximation of the laws of the Member States relating to methods of analysis necessary for checking the composition of cosmetic products

(85/490/EEC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Economic Community,

Having regard to Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic productsf1, as last amended by Directive 85/391/EECf2, and in particular Article 8 (1) thereof,

Whereas Directive 76/768/EEC provides for the official testing of cosmetic products with the aim of ensuring that the conditions laid down by Community provisions concerning the composition of cosmetic products are satisfied;

Whereas all the necessary methods of analysis should be laid down as quickly as possible; whereas three steps towards the attainment of this objective having already been taken through the definition of certain methods in Commission Directive 80/1335/EECf3, 82/434/EECf4 and 83/514/EECf5, the fourth step is to consist in the definition of methods for the identification and determination of glycerol 1-(4-aminobenzoate), the determination of chlorobutanol, the identification and determination of quinine, the identification and determination of inorganic sulphites and hydrogen sulphites, the identification and determination of chlorates of the alkali metals and the identification and determination of sodium iodate;

Whereas the measures provided for in this Directive are in accordance with the opinion of the Committee on the Adaptation of Directive 76/768/EEC to Technical Progress,

HAS ADOPTED THIS DIRECTIVE:

Annotations to the whole text

Footnotes

f1

OJ No L 262, 27. 9. 1976, p. 169.

f2

OJ No L 224, 22. 8. 1985, p. 40.

f3

OJ No L 383, 31. 12. 1980, p. 27.

f4

OJ No L 185, 30. 6. 1982, p. 1.

f5

OJ No L 291, 24. 10. 1983, p. 9.

Contents

  1. 1Article 1
  2. 2Article 2
  3. 3Article 3
  4. Signature
  5. Annex
  6. IDENTIFICATION AND DETERMINATION OF GLYCEROL l-(4-AMINOBENZOATE)
  7. IDENTIFICATION
  8. 1SCOPE AND FIELD OF APPLICATION
  9. 2PRINCIPLE
  10. 3REAGENTS
  11. 3.1Division 3.1
  12. 3.2Division 3.2
  13. 3.3Division 3.3
  14. 3.4Standard solutions:
  15. 3.5Division 3.5
  16. APPARATUS
  17. 4.1Division 4.1
  18. 4.2Division 4.2
  19. 4.3Division 4.3
  20. PROCEDURE
  21. 5.1Sample preparation
  22. 5.2Thin layer chromatography
  23. Development
  24. 5.3.1Division 5.3.1
  25. 5.3.2Spray the completely dried plate with the solution 3.3 (a).
  26. DETERMINATION
  27. 1SCOPE AND FIELD OF APPLICATION
  28. 2DEFINITION
  29. 3PRINCIPLE
  30. 4REAGENTS
  31. 4.1Division 4.1
  32. 4.2Division 4.2
  33. 4.3Division 4.3
  34. 4.4Division 4.4
  35. 4.5Division 4.5
  36. 4.6Division 4.6
  37. 4.7Division 4.7
  38. 4.8Division 4.8
  39. 4.9Division 4.9
  40. 4.10Eluant: phosphate buffer solution (4.9)/methanol (4.1) 61/39(v/v)
  41. 4.11Division 4.11
  42. 4.12Division 4.12
  43. 4.13Division 4.13
  44. 4.14Standard solutions: prepare four standard solutions by dissolving in 100 ml eluant (4.10) according to the following table:
  45. 4.15Division 4.15
  46. 4.16Division 4.16
  47. 4.17Division 4.17
  48. APPARATUS
  49. 5.1Division 5.1
  50. 5.2Division 5.2
  51. 5.3Division 5.3
  52. 5.4Division 5.4
  53. PROCEDURE
  54. Sample preparation
  55. 6.1.1Division 6.1.1
  56. 6.1.2Place the beaker in the ultrasonic bath (5.4) for 20 minutes to produce a suspension. Transfer the suspension thus obtained quantitatively into a 100 ml standard flask with not more than 75 ml of eluant (4.10).
  57. 6.1.3Division 6.1.3
  58. Chromatography
  59. 6.2.1Division 6.2.1
  60. 6.2.2Division 6.2.2
  61. 6.2.3Division 6.2.3
  62. Calibration curve
  63. 6.3.1Division 6.3.1
  64. 6.3.2Division 6.3.2
  65. 6.3.3Division 6.3.3
  66. CALCULATION
  67. 7.1From the calibration curve obtained in 6.3 read off the mass ratios (RP1, RP2) corresponding to the ratios between the areas of the peaks calculated in 6.2.3 where
  68. 7.2From the mass ratios obtained in this way calculate the alpha-monoglyceryl 4-aminobenzoate and ethyl 4-aminobenzoate contents, as mass percentages (% m/m) with the formulae:
  69. REPEATABILITY
  70. 8.1Division 8.1
  71. 8.2Division 8.2
  72. NOTES
  73. 9.1Division 9.1
  74. 9.2Division 9.2
  75. DETERMINATION OF CHLOROBUTANOL
  77. 1SCOPE AND FIELD OF APPLICATION
  78. 2DEFINITION
  79. 3PRINCIPLE
  80. 4REAGENTS
  81. 4.1Division 4.1
  82. 4.2Division 4.2
  83. 4.3Division 4.3
  84. 4.4Division 4.4
  85. 4.5Division 4.5
  86. APPARATUS
  87. 5.1Division 5.1
  88. 5.2Division 5.2
  89. PROCEDURE
  90. 6.1Preparation of sample
  91. Gas chromatography conditions
  92. 6.2.1The operating conditions must yield a resolution factor R ≥ 1,5.
  93. 6.2.2As examples, the following operating conditions provide the required resolution:
  94. 6.3Standard curve
  95. 6.4Division 6.4
  96. CALCULATION
  97. 7.1Division 7.1
  98. 7.2The content of chlorobutanol in the sample is calculated according to the formula:
  99. 8REPEATABILITY
  100. Note
  101. IDENTIFICATION AND DETERMINATION OF QUININE
  102. IDENTIFICATION
  103. 1SCOPE AND FIELD OF APPLICATION
  104. 2PRINCIPLE
  105. 3REAGENTS
  106. 3.1Division 3.1
  107. 3.2Division 3.2
  108. 3.3Division 3.3
  109. 3.4Division 3.4
  110. 3.5Division 3.5
  111. 3.6Division 3.6
  112. 3.7Division 3.7
  113. 3.8Division 3.8
  114. 3.9Division 3.9
  115. 3.10Division 3.10
  116. APPARATUS
  117. 4.1Division 4.1
  118. 4.2Division 4.2
  119. 4.3Division 4.3
  120. PROCEDURE
  121. 5.1Preparation of the sample
  122. 5.2Thin layer chromatography
  123. Development
  124. 5.3.1Division 5.3.1
  125. 5.3.21Division 5.3.21
  126. 5.3.3Division 5.3.3
  127. 5.3.4Observe under the light from a UV lamp adjusted to a wavelength of 360 nm. Quinine appears as a fluorescent intense blue spot.
  128. 5.3.5For further confirmation that quinine is present, the plate is exposed for approximately one hour to bromine vapour (3.7). The fluorescence disappears. When the same plate is exposed to ammonia vapour (3.8), the spots reappear with a brown colour, and when the plate is again examined under UV light at 360 nm a yellowish fluorescence can be observed.
  129. DETERMINATION
  130. 1SCOPE AND FIELD OF APPLICATION
  131. 2DEFINITION
  132. 3PRINCIPLE
  133. 4REAGENTS
  134. 4.1Division 4.1
  135. 4.2Division 4.2
  136. 4.3Division 4.3
  137. 4.4Division 4.4
  138. 4.5Division 4.5
  139. 4.6Division 4.6
  140. 4.7Division 4.7
  141. 4.8Division 4.8
  142. 4.9Division 4.9
  143. 4.10Eluant: orthophosphoric acid (4.7) /potassium dihydrogenorthophosphate (4.8) /tetramethylammonium bromide (4.9)/water/acetonitrile (4.1) 10/50/100/340/90 (v/v/v/v/v).
  144. 4.11Division 4.11
  145. 4.12Division 4.12
  146. APPARATUS
  147. 5.1Division 5.1
  148. 5.2Division 5.2
  149. 5.3Division 5.3
  150. 5.4Division 5.4
  151. 5.5Division 5.5
  152. PROCEDURE
  153. 6.1Sample preparation
  154. 6.2Chromatography
  155. 6.3Calibration curve
  156. CALCULATION
  157. 7.1Division 7.1
  158. 7.2The concentration of anhydrous quinine in the sample, as a percentage by mass (% m/m), is obtained by the following formula:
  159. 8REPEATABILITY
  160. IDENTIFICATION AND DETERMINATION OF INORGANIC SULPSCOPE AND FIELD OF APPLICATION
  161. IDENTIFICATION
  162. 1PRINCIPLE
  163. 2REAGENTS
  164. 2.1Division 2.1
  165. 2.2Division 2.2
  166. APPARATUS
  167. 3.1Division 3.1
  168. 3.2Division 3.2
  169. PROCEDURE
  170. 4.1Division 4.1
  171. 4.2Division 4.2
  172. 4.3Division 4.3
  173. DETERMINATION
  174. 1DEFINITION
  175. 2PRINCIPLE
  176. 3REAGENTS
  177. 3.1Division 3.1
  178. 3.2Division 3.2
  179. 3.3Division 3.3
  180. 3.4Division 3.4
  181. 3.5Division 3.5
  182. 3.6Division 3.6
  183. APPARATUS
  184. 4.1Division 4.1
  185. 4.2Division 4.2
  186. PROCEDURE
  187. 5.1Division 5.1
  188. 5.2Division 5.2
  189. 5.3Division 5.3
  190. 5.4Division 5.4
  191. 5.5Division 5.5
  192. 5.6Division 5.6
  193. 5.7Division 5.7
  194. 5.8Division 5.8
  195. 6CALCULATION
  196. 7REPEATABILITY
  197. Sulphurdioxide distillation apparatus according toAll dimensions in mm