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Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC (Text with EEA relevance) (revoked)

EU Decision 2008/768 · Adopted 9 July 2008 · Extends to United Kingdom

Original text. legislation.gov.uk does not revise this item, so later amendments are not shown here. Changes made to it are listed under each provision when known.

Decision No 768/2008/EC of the European Parliament and of the Council

of 9 July 2008

on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC

(Text with EEA relevance) (revoked)

F1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Annotations to the whole text

Textual amendments

F1

Decision revoked (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), Sch. 2 Pt. 2 (with reg. 29(2)) (as amended by S.I. 2020/1376, regs. 1(4), 3(20)); 2020 c. 1, Sch. 5 para. 1(1); and also expressed to be revoked (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), Sch. 37 para. 1(c) (as amended by S.I. 2020/676, regs. 1(1), 3); 2020 c. 1, Sch. 5 para. 1(1)

Contents

  1. 1General principles Repealed
  2. 2Subject matter and scope Repealed
  3. 3Level of protection of public interests Repealed
  4. 4Conformity assessment procedures Repealed
  5. 5EC declaration of conformity Repealed
  6. 6Conformity assessment Repealed
  7. 7Reference provisions Repealed
  8. 8Repeal Repealed
  9. Signature
  10. Annex I: REFERENCE PROVISIONS FOR COMMUNITY HARMONISATION LEGISLATION FOR PRODUCTS Repealed
  11. Chapter R1: Definitions Repealed
  12. R1Definitions Repealed
  13. Chapter R2: Obligations of economic operators Repealed
  14. R2Obligations of manufacturers Repealed
  15. R3Authorised representatives Repealed
  16. R4Obligations of importers Repealed
  17. R5Obligations of distributors Repealed
  18. R6Cases in which obligations of manufacturers apply to importers and distributors Repealed
  19. R7Identification of economic operators Repealed
  20. Chapter R3: Conformity of the product Repealed
  21. R8Presumption of conformity Repealed
  22. R9Formal objection to a harmonised standard Repealed
  23. R10EC declaration of conformity Repealed
  24. R11General principles of the CE marking Repealed
  25. R12Rules and conditions for affixing the CE marking Repealed
  26. Chapter R4: Notification of conformity assessment bodies Repealed
  27. R13Notification Repealed
  28. R14Notifying authorities Repealed
  29. R15Requirements relating to notifying authorities Repealed
  30. R16Information obligation on notifying authorities Repealed
  31. R17Requirements relating to notified bodies Repealed
  32. R18Presumption of conformity Repealed
  33. R19Formal objection to a harmonised standard Repealed
  34. R20Subsidiaries of and subcontracting by notified bodies Repealed
  35. R21Accredited in-house bodies Repealed
  36. R22Application for notification Repealed
  37. R23Notification procedure Repealed
  38. R24Identification numbers and lists of notified bodies Repealed
  39. R25Changes to notifications Repealed
  40. R26Challenge of the competence of notified bodies Repealed
  41. R27Operational obligations of notified bodies Repealed
  42. R28Information obligation on notified bodies Repealed
  43. R29Exchange of experience Repealed
  44. R30Coordination of notified bodies Repealed
  45. Chapter R5: Safeguard procedures Repealed
  46. R31Procedure for dealing with products presenting a risk at national level Repealed
  47. R32Community safeguard procedure Repealed
  48. R33Compliant products which present a risk to health and safety Repealed
  49. R34Formal non-compliance Repealed
  50. Annex II: CONFORMITY ASSESSMENT PROCEDURES Repealed
  51. Internal production control Repealed
  52. 1Division 1 Repealed
  53. 2Technical documentation Repealed
  54. 3Manufacturing Repealed
  55. 4Division 4 Repealed
  56. 4.1Division 4.1 Repealed
  57. 4.2The manufacturer shall draw up a written declaration of conformity for a product model and keep it together with the technical documentation at the disposal of the national authorities for 10 years after the product has been placed on the market. The declaration of conformity shall identify the product for which it has been drawn up. Repealed
  58. 5Authorised representative Repealed
  59. Internal production control plus supervised product testing Repealed
  60. 1Division 1 Repealed
  61. 2Technical documentation Repealed
  62. 3Manufacturing Repealed
  63. 4Product checks Repealed
  64. 5Division 5 Repealed
  65. 5.1Division 5.1 Repealed
  66. 5.2The manufacturer shall draw up a written declaration of conformity for a product model and keep it together with the technical documentation at the disposal of the national authorities for 10 years after the product has been placed on the market. The declaration of conformity shall identify the product for which it has been drawn up. Repealed
  67. 6Authorised representative Repealed
  68. Internal production control plus supervised product checks at random intervals Repealed
  69. 1Division 1 Repealed
  70. 2Technical documentation Repealed
  71. 3Manufacturing Repealed
  72. 4Product checks Repealed
  73. 5Division 5 Repealed
  74. 5.1Division 5.1 Repealed
  75. 5.2The manufacturer shall draw up a written declaration of conformity for a product model and keep it together with the technical documentation at the disposal of the national authorities for 10 years after the product has been placed on the market. The declaration of conformity shall identify the product for which it has been drawn up. Repealed
  76. 6Authorised representative Repealed
  77. EC-type examination Repealed
  78. 1Division 1 Repealed
  79. 2EC-type examination may be carried out in either of the following manners: Repealed
  80. 3The manufacturer shall lodge an application for EC-type examination with a single notified body of his choice. Repealed
  81. 4The notified body shall: Repealed
  82. 4.1examine the technical documentation and supporting evidence to assess the adequacy of the technical design of the product; Repealed
  83. 4.2Division 4.2 Repealed
  84. 4.3Division 4.3 Repealed
  85. 4.4Division 4.4 Repealed
  86. 4.5Division 4.5 Repealed
  87. 5Division 5 Repealed
  88. 6Where the type meets the requirements of the specific legislative instrument that apply to the product concerned, the notified body shall issue an EC-type examination certificate to the manufacturer. The certificate shall contain the name and address of the manufacturer, the conclusions of the examination, the conditions (if any) for its validity and the necessary data for identification of the approved type. The certificate may have one or more annexes attached. Repealed
  89. 7The notified body shall keep itself apprised of any changes in the generally acknowledged state of the art which indicate that the approved type may no longer comply with the applicable requirements of the legislative instrument, and shall determine whether such changes require further investigation. If so, the notified body shall inform the manufacturer accordingly. Repealed
  90. 8Each notified body shall inform its notifying authorities concerning the EC-type examination certificates and/or any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to its notifying authorities the list of certificates and/or any additions thereto refused, suspended or otherwise restricted. Repealed
  91. 9Division 9 Repealed
  92. 10Division 10 Repealed
  93. Conformity to type based on internal production control Repealed
  94. 1Division 1 Repealed
  95. 2Manufacturing Repealed
  96. 3Division 3 Repealed
  97. 3.1Division 3.1 Repealed
  98. 3.2The manufacturer shall draw up a written declaration of conformity for a product model and keep it at the disposal of the national authorities for 10 years after the product has been placed on the market. The declaration of conformity shall identify the product model for which it has been drawn up. Repealed
  99. 4Authorised representative Repealed
  100. Conformity to type based on internal production control plus supervised product testing Repealed
  101. 1Division 1 Repealed
  102. 2Manufacturing Repealed
  103. 3Product checks Repealed
  104. 4Division 4 Repealed
  105. 4.1Division 4.1 Repealed
  106. 4.2The manufacturer shall draw up a written declaration of conformity for a product model and keep it at the disposal of the national authorities for 10 years after the product has been placed on the market. The declaration of conformity shall identify the product model for which it has been drawn up. Repealed
  107. 5Authorised representative Repealed
  108. Conformity to type based on internal production control plus supervised product checks at random intervals Repealed
  109. 1Division 1 Repealed
  110. 2Manufacturing Repealed
  111. 3Product checks Repealed
  112. 4Division 4 Repealed
  113. 4.1Division 4.1 Repealed
  114. 4.2The manufacturer shall draw up a written declaration of conformity for a product model and keep it at the disposal of the national authorities for 10 years after the product has been placed on the market. The declaration of conformity shall identify the product model for which it has been drawn up. Repealed
  115. 5Authorised representative Repealed
  116. Conformity to type based on quality assurance of the production process Repealed
  117. 1Division 1 Repealed
  118. 2Manufacturing Repealed
  119. 3Division 3 Repealed
  120. 3.1The manufacturer shall lodge an application for assessment of his quality system with the notified body of his choice, for the products concerned. Repealed
  121. 3.2The quality system shall ensure that the products are in conformity with the type described in the EC-type examination certificate and comply with the requirements of the legislative instrument that apply to them. Repealed
  122. 3.3The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 3.2. Repealed
  123. 3.4Division 3.4 Repealed
  124. 3.5The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the quality system. Repealed
  125. 4Division 4 Repealed
  126. 4.1Division 4.1 Repealed
  127. 4.2The manufacturer shall, for assessment purposes, allow the notified body access to the manufacture, inspection, testing and storage sites and shall provide it with all necessary information, in particular: Repealed
  128. 4.3Division 4.3 Repealed
  129. 4.4Division 4.4 Repealed
  130. 5Division 5 Repealed
  131. 5.1Division 5.1 Repealed
  132. 5.2The manufacturer shall draw up a written declaration of conformity for each product model and keep it at the disposal of the national authorities for 10 years after the product has been placed on the market. The declaration of conformity shall identify the product model for which it has been drawn up. Repealed
  133. 6The manufacturer shall, for a period ending at least 10 years after the product has been placed on the market, keep at the disposal of the national authorities: Repealed
  134. 7Each notified body shall inform its notifying authorities of quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to its notifying authorities the list of quality system approvals refused, suspended or otherwise restricted. Repealed
  135. 8Authorised representative Repealed
  136. Quality assurance of the production process Repealed
  137. 1Division 1 Repealed
  138. 2Technical documentation Repealed
  139. 3Division 3 Repealed
  140. 4Manufacturing Repealed
  141. 5Division 5 Repealed
  142. 5.1The manufacturer shall lodge an application for assessment of his quality system with the notified body of his choice, for the products concerned. Repealed
  143. 5.2The quality system shall ensure compliance of the products with the requirements of the legislative instrument that apply to them. Repealed
  144. 5.3The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 5.2. Repealed
  145. 5.4Division 5.4 Repealed
  146. 5.5The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the quality system. Repealed
  147. 6Division 6 Repealed
  148. 6.1Division 6.1 Repealed
  149. 6.2The manufacturer shall, for assessment purposes, allow the notified body access to the manufacture, inspection, testing and storage sites and shall provide it with all necessary information, in particular: Repealed
  150. 6.3Division 6.3 Repealed
  151. 6.4Division 6.4 Repealed
  152. 7Division 7 Repealed
  153. 7.1Division 7.1 Repealed
  154. 7.2The manufacturer shall draw up a written declaration of conformity for each product model and keep it at the disposal of the national authorities for 10 years after the product has been placed on the market. The declaration of conformity shall identify the product model for which it has been drawn up. Repealed
  155. 8The manufacturer shall, for a period ending at least 10 years after the product has been placed on the market, keep at the disposal of the national authorities: Repealed
  156. 9Each notified body shall inform its notifying authorities of quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to its notifying authorities the list of quality system approvals refused, suspended or otherwise restricted. Repealed
  157. 10Authorised representative Repealed
  158. Conformity to type based on product quality assurance Repealed
  159. 1Division 1 Repealed
  160. 2Manufacturing Repealed
  161. 3Division 3 Repealed
  162. 3.1The manufacturer shall lodge an application for assessment of his quality system with the notified body of his choice, for the products concerned. Repealed
  163. 3.2The quality system shall ensure compliance of the products with the type described in the EC-type examination certificate and with the applicable requirements of the legislative instrument. Repealed
  164. 3.3The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 3.2. Repealed
  165. 3.4Division 3.4 Repealed
  166. 3.5The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the quality system. Repealed
  167. 4Division 4 Repealed
  168. 4.1Division 4.1 Repealed
  169. 4.2The manufacturer shall, for assessment purposes, allow the notified body access to the manufacture, inspection, testing and storage sites and shall provide it with all necessary information, in particular: Repealed
  170. 4.3Division 4.3 Repealed
  171. 4.4Division 4.4 Repealed
  172. 5Division 5 Repealed
  173. 5.1Division 5.1 Repealed
  174. 5.2The manufacturer shall draw up a written declaration of conformity for each product model and keep it at the disposal of the national authorities for 10 years after the product has been placed on the market. The declaration of conformity shall identify the product model for which it has been drawn up. Repealed
  175. 6The manufacturer shall, for a period ending at least 10 years after the product has been placed on the market, keep at the disposal of the national authorities: Repealed
  176. 7Each notified body shall inform its notifying authorities of quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to its notifying authorities the list of quality system approvals refused, suspended or otherwise restricted. Repealed
  177. 8Authorised representative Repealed
  178. Quality assurance of final product inspection and testing Repealed
  179. 1Division 1 Repealed
  180. 2Technical documentation Repealed
  181. 3Division 3 Repealed
  182. 4Manufacturing Repealed
  183. 5Division 5 Repealed
  184. 5.1The manufacturer shall lodge an application for assessment of his quality system with the notified body of his choice, for the products concerned. Repealed
  185. 5.2The quality system shall ensure compliance of the products with the requirements of the legislative instrument that apply to them. Repealed
  186. 5.3The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 5.2. Repealed
  187. 5.4Division 5.4 Repealed
  188. 5.5The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the quality system. Repealed
  189. 6Division 6 Repealed
  190. 6.1Division 6.1 Repealed
  191. 6.2The manufacturer shall, for assessment purposes, allow the notified body access to the manufacture, inspection, testing and storage sites and shall provide it with all necessary information, in particular: Repealed
  192. 6.3Division 6.3 Repealed
  193. 6.4Division 6.4 Repealed
  194. 7Division 7 Repealed
  195. 7.1Division 7.1 Repealed
  196. 7.2The manufacturer shall draw up a written declaration of conformity for each product model and keep it at the disposal of the national authorities for 10 years after the product has been placed on the market. The declaration of conformity shall identify the product model for which it has been drawn up. Repealed
  197. 8The manufacturer shall, for a period ending at least 10 years after the product has been placed on the market, keep at the disposal of the national authorities: Repealed
  198. 9Each notified body shall inform its notifying authorities of quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to its notifying authorities the list of quality system approvals refused, suspended or otherwise restricted. Repealed
  199. 10Authorised representative Repealed
  200. Conformity to type based on product verification Repealed
  201. 1Division 1 Repealed
  202. 2Manufacturing Repealed
  203. 3Verification Repealed
  204. 4Division 4 Repealed
  205. 4.1Division 4.1 Repealed
  206. 4.2The notified body shall issue a certificate of conformity in respect of the examinations and tests carried out, and shall affix its identification number to each approved product or have it affixed under its responsibility. Repealed
  207. 5Division 5 Repealed
  208. 5.1Division 5.1 Repealed
  209. 5.2Division 5.2 Repealed
  210. 5.3If a lot is accepted, all products of the lot shall be considered approved, except for those products from the sample that have been found not to satisfy the tests. Repealed
  211. 5.4Division 5.4 Repealed
  212. 6Division 6 Repealed
  213. 6.1Division 6.1 Repealed
  214. 6.2The manufacturer shall draw up a written declaration of conformity for each product model and keep it at the disposal of the national authorities, for 10 years after the product has been placed on the market. The declaration of conformity shall identify the product model for which it has been drawn up. Repealed
  215. 7Division 7 Repealed
  216. 8Authorised representative Repealed
  217. Conformity based on product verification Repealed
  218. 1Division 1 Repealed
  219. 2Technical documentation Repealed
  220. 3Manufacturing Repealed
  221. 4Verification Repealed
  222. 5Division 5 Repealed
  223. 5.1Division 5.1 Repealed
  224. 5.2The notified body shall issue a certificate of conformity in respect of the examinations and tests carried out, and shall affix its identification number to each approved product or have it affixed under its responsibility. Repealed
  225. 6Division 6 Repealed
  226. 6.1Division 6.1 Repealed
  227. 6.2Division 6.2 Repealed
  228. 6.3If a lot is accepted, all products of the lot shall be considered approved, except for those products from the sample that have been found not to satisfy the tests. Repealed
  229. 7Division 7 Repealed
  230. 7.1Division 7.1 Repealed
  231. 7.2The manufacturer shall draw up a written declaration of conformity for each product model and keep it at the disposal of the national authorities for 10 years after the product has been placed on the market. The declaration of conformity shall identify the product model for which it has been drawn up. Repealed
  232. 8Division 8 Repealed
  233. 9Authorised representative Repealed
  234. Conformity based on unit verification Repealed
  235. 1Division 1 Repealed
  236. 2Technical documentation Repealed
  237. 3Manufacturing Repealed
  238. 4Verification Repealed
  239. 5Division 5 Repealed
  240. 5.1Division 5.1 Repealed
  241. 5.2The manufacturer shall draw up a written declaration of conformity and keep it at the disposal of the national authorities for 10 years after the product has been placed on the market. The declaration of conformity shall identify the product for which it has been drawn up. Repealed
  242. 6Authorised representative Repealed
  243. Conformity based on full quality assurance Repealed
  244. 1Division 1 Repealed
  245. 2Manufacturing Repealed
  246. 3Division 3 Repealed
  247. 3.1The manufacturer shall lodge an application for assessment of his quality system with the notified body of his choice, for the products concerned. Repealed
  248. 3.2The quality system shall ensure compliance of the products with the requirements of the legislative instrument that apply to them. Repealed
  249. 3.3The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 3.2. Repealed
  250. 3.4Division 3.4 Repealed
  251. 3.5The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the quality system. Repealed
  252. 4Division 4 Repealed
  253. 4.1Division 4.1 Repealed
  254. 4.2The manufacturer shall, for assessment purposes, allow the notified body access to the design, manufacture, inspection, testing and storage sites, and shall provide it with all necessary information, in particular: Repealed
  255. 4.3Division 4.3 Repealed
  256. 4.4Division 4.4 Repealed
  257. 5Division 5 Repealed
  258. 5.1Division 5.1 Repealed
  259. 5.2The manufacturer shall draw up a written declaration of conformity for each product model and keep it at the disposal of the national authorities for 10 years after the product has been placed on the market. The declaration of conformity shall identify the product model for which it has been drawn up. Repealed
  260. 6The manufacturer shall, for a period ending at least 10 years after the product has been placed on the market, keep at the disposal of the national authorities: Repealed
  261. 7Each notified body shall inform its notifying authorities of quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to its notifying authorities the list of quality system approvals refused, suspended or otherwise restricted. Repealed
  262. 8Authorised representative Repealed
  263. Conformity based on full quality assurance plus design examination Repealed
  264. 1Division 1 Repealed
  265. 2Manufacturing Repealed
  266. 3Division 3 Repealed
  267. 3.1The manufacturer shall lodge an application for assessment of his quality system with the notified body of his choice, for the products concerned. Repealed
  268. 3.2The quality system shall ensure compliance of the products with the requirements of the legislative instrument that apply to them. Repealed
  269. 3.3The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 3.2. Repealed
  270. 3.4Division 3.4 Repealed
  271. 3.5The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the quality system. Repealed
  272. 3.6Each notified body shall inform its notifying authorities of quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to its notifying authorities the list of quality system approvals refused, suspended or otherwise restricted. Repealed
  273. 4Division 4 Repealed
  274. 4.1Division 4.1 Repealed
  275. 4.2The application shall make it possible to understand the design, manufacture and operation of the product, and to assess the conformity with the requirements of the legislative instrument that apply to it. It shall include: Repealed
  276. 4.3The notified body shall examine the application, and where the design meets the requirements of the legislative instrument that apply to the product it shall issue an EC design examination certificate to the manufacturer. The certificate shall give the name and address of the manufacturer, the conclusions of the examination, the conditions (if any) for its validity and the data necessary for identification of the approved design. The certificate may have one or more annexes attached. Repealed
  277. 4.4The notified body shall keep itself apprised of any changes in the generally acknowledged state of the art which indicate that the approved design may no longer comply with the applicable requirements of the legislative instrument, and shall determine whether such changes require further investigation. If so, the notified body shall inform the manufacturer accordingly. Repealed
  278. 4.5Each notified body shall inform its notifying authorities of the EC design examination certificates and/or any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to its notifying authorities the list of certificates and/or any additions thereto refused, suspended or otherwise restricted. Repealed
  279. 4.6Division 4.6 Repealed
  280. 5Division 5 Repealed
  281. 5.1Division 5.1 Repealed
  282. 5.2The manufacturer shall, for assessment purposes, allow the notified body access to the design, manufacture, inspection, testing and storage sites, and shall provide it with all necessary information, in particular: Repealed
  283. 5.3Division 5.3 Repealed
  284. 5.4Division 5.4 Repealed
  285. 6Division 6 Repealed
  286. 6.1Division 6.1 Repealed
  287. 6.2The manufacturer shall draw up a written declaration of conformity for each product model and keep it at the disposal of the national authorities for 10 years after the product has been placed on the market. The declaration of conformity shall identify the product model for which it has been drawn up and shall mention the number of the design examination certificate. Repealed
  288. 7The manufacturer shall, for a period ending at least 10 years after the product has been placed on the market, keep at the disposal of the national authorities: Repealed
  289. 8Authorised representative Repealed
  290. TABLE: CONFORMITY ASSESSMENT PROCEDURES IN COMMUNITY LEGISLATION Repealed
  291. Annex IIIEC DECLARATION OF CONFORMITY Repealed
  292. 1Division 1 Repealed
  293. 2Division 2 Repealed
  294. 3Division 3 Repealed
  295. 4Division 4 Repealed
  296. 5Division 5 Repealed
  297. 6Division 6 Repealed
  298. 7Division 7 Repealed
  299. 8Division 8 Repealed