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Commission Regulation (EU) No 546/2011 of 10 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards uniform principles for evaluation and authorisation of plant protection products (Text with EEA relevance)

EU Regulation No 546/2011 · Adopted 10 June 2011 · Extends to United Kingdom

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Commission Regulation (EU) No 546/2011

of 10 June 2011

implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards uniform principles for evaluation and authorisation of plant protection products

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EECf1, and in particular Article 29(6) and Article 84 thereof,

After consulting the Standing Committee on the Food Chain and Animal Health,

Whereas:

(1)

In accordance with Regulation (EC) No 1107/2009 the uniform principles for evaluation and authorisation of plant protection products are to contain the requirements set out in Annex VI to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the marketf2.

(2)

It is therefore necessary for the implementation of Regulation (EC) No 1107/2009 to adopt a regulation containing the requirements, as set out in Annex VI to Directive 91/414/EEC. Such a regulation is not to include any substantial modification,

HAS ADOPTED THIS REGULATION:

Annotations to the whole text

Footnotes

f1

OJ L 309, 24.11.2009, p. 11.

f2

OJ L 230, 19.8.1991, p. 1.

Contents

  1. A1Interpretation
  2. 1Article 1
  3. 2Article 2 Repealed
  4. Signature
  5. Annex: UNIFORM PRINCIPLES FOR EVALUATION AND AUTHORISATION OF PLANT PROTECTION PRODUCTS, AS PROVIDED FOR IN ARTICLE 29(6)(a) OF REGULATION (EC) No 1107/2009
  6. Uniform principles for evaluation and authorisation of chemical plant protection products
  7. INTRODUCTION
  8. 1Division 1
  9. 2Division 2
  10. 3Division 3
  11. 4Division 4
  12. 5Division 5
  13. 6Division 6
  14. EVALUATION
  15. General principles
  16. 1.1Division 1.1
  17. 1.2Division 1.2
  18. 1.3Division 1.3
  19. 1.4Division 1.4
  20. 1.5Division 1.5
  21. 1.6Division 1.6
  22. 2Specific principles
  23. Efficacy
  24. 2.1.1Division 2.1.1
  25. 2.1.2Division 2.1.2
  26. 2.1.3Division 2.1.3
  27. 2.1.4Division 2.1.4
  28. 2.1.5Division 2.1.5
  29. Absence of unacceptable effects on plants or plant products
  30. 2.2.1Division 2.2.1
  31. 2.2.2Division 2.2.2
  32. 2.2.3Division 2.2.3
  33. 2.3Impact on vertebrates to be controlled
  34. Impact on human or animal health
  35. Impact on human or animal health arising from the plant protection product
  36. 2.4.1.1Division 2.4.1.1
  37. 2.4.1.2Division 2.4.1.2
  38. 2.4.1.3Division 2.4.1.3
  39. 2.4.1.4Division 2.4.1.4
  40. Impact on human or animal health arising from residues
  41. 2.4.2.1Division 2.4.2.1
  42. 2.4.2.2Division 2.4.2.2
  43. 2.4.2.3Division 2.4.2.3
  44. 2.4.2.4Division 2.4.2.4
  45. 2.4.2.5Division 2.4.2.5
  46. 2.4.2.6Division 2.4.2.6
  47. Influence on the environment
  48. 2.5.1Fate and distribution in the environment
  49. 2.5.2Impact on non-target species
  50. 2.5.2.1Division 2.5.2.1
  51. 2.5.2.2Division 2.5.2.2
  52. 2.5.2.3Division 2.5.2.3
  53. 2.5.2.4Division 2.5.2.4
  54. 2.5.2.5Division 2.5.2.5
  55. 2.5.2.6Division 2.5.2.6
  56. 2.6Analytical methods
  57. Physical and chemical properties
  58. 2.7.1Division 2.7.1
  59. 2.7.2Division 2.7.2
  60. 2.7.3Division 2.7.3
  61. DECISION-MAKING
  62. General principles
  63. 1.1Division 1.1
  64. 1.2Division 1.2
  65. 1.3Division 1.3
  66. 1.4Division 1.4
  67. 1.5Division 1.5
  68. 1.6Division 1.6
  69. 1.7Division 1.7
  70. 1.8Division 1.8
  71. 1.9Division 1.9
  72. 2Specific principles
  73. Efficacy
  74. 2.1.1Division 2.1.1
  75. 2.1.2Division 2.1.2
  76. 2.1.3Division 2.1.3
  77. 2.1.4Division 2.1.4
  78. 2.1.5Division 2.1.5
  79. Absence of unacceptable effects on plants or plant products
  80. 2.2.1Division 2.2.1
  81. 2.2.2Division 2.2.2
  82. 2.2.3Division 2.2.3
  83. 2.2.4Division 2.2.4
  84. 2.2.5Division 2.2.5
  85. 2.2.6Division 2.2.6
  86. 2.2.7Division 2.2.7
  87. 2.2.8Division 2.2.8
  88. 2.3Impact on vertebrates to be controlled
  89. Impact on human or animal health
  90. Impact on human or animal health arising from the plant protection product
  91. 2.4.1.1Division 2.4.1.1
  92. 2.4.1.2Division 2.4.1.2
  93. 2.4.1.3Division 2.4.1.3
  94. 2.4.1.4Division 2.4.1.4
  95. 2.4.1.5Division 2.4.1.5
  96. 2.4.1.6Division 2.4.1.6
  97. Impact on human or animal health arising from residues
  98. 2.4.2.1Division 2.4.2.1
  99. 2.4.2.2Division 2.4.2.2
  100. 2.4.2.3Division 2.4.2.3
  101. 2.4.2.4Division 2.4.2.4
  102. 2.4.2.5Division 2.4.2.5
  103. 2.4.2.6Division 2.4.2.6
  104. Influence on the environment
  105. Fate and distribution in the environment
  106. 2.5.1.1Division 2.5.1.1
  107. 2.5.1.2Division 2.5.1.2
  108. 2.5.1.3Division 2.5.1.3
  109. 2.5.1.4Division 2.5.1.4
  110. Impact on non-target species
  111. 2.5.2.1Division 2.5.2.1
  112. 2.5.2.2Division 2.5.2.2
  113. 2.5.2.3Division 2.5.2.3
  114. 2.5.2.4Division 2.5.2.4
  115. 2.5.2.5Division 2.5.2.5
  116. 2.5.2.6Division 2.5.2.6
  117. 2.6Analytical methods
  118. Physical and chemical properties
  119. 2.7.1Division 2.7.1
  120. 2.7.2Division 2.7.2
  121. 2.7.3Division 2.7.3
  122. Uniform principles for evaluation and authorisation of plant protection products containing micro-organisms
  123. INTRODUCTION
  124. 1Division 1
  125. 2Division 2
  126. 3Division 3
  127. 4Division 4
  128. 5Division 5
  129. 6Division 6
  130. 7Division 7
  131. 8Division 8
  132. 9Division 9
  133. 10Definitions and explanations of microbiological terms
  134. BEVALUATION
  135. General principles
  136. 1.1Division 1.1
  137. 1.2Division 1.2
  138. 1.3Division 1.3
  139. 1.4Division 1.4
  140. 1.5Division 1.5
  141. 1.6Division 1.6
  142. 1.7Division 1.7
  143. 1.8Division 1.8
  144. 2Specific principles
  145. Identity
  146. 2.1.1Identity of the micro-organism in the plant protection product
  147. 2.1.2Identity of the plant protection product
  148. Biological, physical, chemical, and technical properties
  149. Biological properties of the micro-organism in the plant protection product
  150. 2.2.1.1Division 2.2.1.1
  151. 2.2.1.2Division 2.2.1.2
  152. 2.2.1.3Division 2.2.1.3
  153. 2.2.1.4Division 2.2.1.4
  154. 2.2.1.5Division 2.2.1.5
  155. Physical, chemical and technical properties of the plant protection product
  156. 2.2.2.1Division 2.2.2.1
  157. 2.2.2.2Division 2.2.2.2
  158. 2.2.2.3Division 2.2.2.3
  159. 2.2.2.4Division 2.2.2.4
  160. Further information
  161. 2.3.1Quality control of the production of the micro-organism in the plant protection product
  162. 2.3.2Quality control of the plant protection product
  163. Efficacy
  164. 2.4.1Division 2.4.1
  165. 2.4.2Division 2.4.2
  166. 2.4.3Division 2.4.3
  167. 2.4.4Division 2.4.4
  168. 2.4.5Division 2.4.5
  169. 2.4.6Division 2.4.6
  170. 2.4.7Division 2.4.7
  171. 2.4.8Division 2.4.8
  172. 2.5Identification/detection and quantification methods
  173. Analytical methods for the plant protection product
  174. 2.5.1.1Non-viable components
  175. 2.5.1.2Viable components
  176. Analytical methods for the determination of residues
  177. 2.5.2.1Non-viable residues
  178. 2.5.2.2Viable residues
  179. 2.6Impact on human or animal health
  180. Effects on human or animal health arising from the plant protection product
  181. 2.6.1.1Division 2.6.1.1
  182. 2.6.1.2Division 2.6.1.2
  183. 2.6.1.3Division 2.6.1.3
  184. 2.6.1.4Division 2.6.1.4
  185. 2.6.2Effects on human or animal health arising from residues
  186. Non-viable residues
  187. (a)Competent authorities shall evaluate the possibility of exposure of humans or animals to non-viable residues and their degradation products via the food chain due to the possible occurrence of such residues in or on edible parts of treated crops. In particular, the following information should be taken into account:
  188. (b)Division (b)
  189. (c)Where non-viable residues or their degradation products are considered toxicologically relevant for humans and/or animals and when exposure is not considered negligible, the actual levels in or on the edible parts of treated crops shall be determined, taking into consideration:
  190. Viable residues
  191. (a)Competent authorities shall evaluate the possibility of exposure of humans or animals to viable residues via the food chain due to the possible occurrence of such residues in or on edible parts of treated crops. In particular, the following information should be taken into account:
  192. (b)Competent authorities shall evaluate the specific information concerning the ability of viable residues to persist or grow in the host and the ability of such residues to cause effects/reactions in the host. In particular, the following information shall be taken into account:
  193. (c)In the event that viable residues are considered to be toxicologically relevant for humans and/or animals and if exposure is not considered negligible, the actual levels in or on the edible parts of treated crops shall be determined, taking into consideration:
  194. 2.7Fate and behaviour in the environment
  195. 2.7.1Division 2.7.1
  196. 2.7.2Division 2.7.2
  197. 2.7.3Division 2.7.3
  198. 2.7.4Division 2.7.4
  199. 2.8Effects on and exposure of non-target organisms
  200. 2.8.1Division 2.8.1
  201. 2.8.1.1Division 2.8.1.1
  202. 2.8.1.2Division 2.8.1.2
  203. 2.8.2Division 2.8.2
  204. 2.8.2.1Division 2.8.2.1
  205. 2.8.2.2Division 2.8.2.2
  206. 2.8.3Division 2.8.3
  207. 2.8.3.1Division 2.8.3.1
  208. 2.8.3.2Division 2.8.3.2
  209. 2.8.4Division 2.8.4
  210. 2.8.4.1Division 2.8.4.1
  211. 2.8.4.2Division 2.8.4.2
  212. 2.8.5Division 2.8.5
  213. 2.8.5.1Division 2.8.5.1
  214. 2.8.5.2Division 2.8.5.2
  215. 2.8.6Division 2.8.6
  216. 2.8.6.1Division 2.8.6.1
  217. 2.8.6.2Division 2.8.6.2
  218. 2.8.6.3Division 2.8.6.3
  219. 2.9Conclusions and proposals
  220. DECISION-MAKING
  221. General principles
  222. 1.1Division 1.1
  223. 1.2Division 1.2
  224. 1.3Division 1.3
  225. 1.4Division 1.4
  226. 1.5Division 1.5
  227. 1.6Division 1.6
  228. 1.7Division 1.7
  229. 1.8Division 1.8
  230. 1.9Division 1.9
  231. 1.10Division 1.10
  232. 1.11Division 1.11
  233. 1.12Division 1.12
  234. 1.13Division 1.13
  235. 1.14Division 1.14
  236. 2Specific principles
  237. 2.1Identity
  238. Biological and technical properties
  239. 2.2.1Division 2.2.1
  240. 2.2.2Division 2.2.2
  241. 2.3Further information
  242. Efficacy
  243. Performance
  244. 2.4.1.1Division 2.4.1.1
  245. 2.4.1.2Division 2.4.1.2
  246. 2.4.1.3Division 2.4.1.3
  247. 2.4.1.4Division 2.4.1.4
  248. 2.4.1.5Division 2.4.1.5
  249. 2.4.1.6Division 2.4.1.6
  250. 2.4.1.7Division 2.4.1.7
  251. Absence of unacceptable effects on plants and plant products
  252. 2.4.2.1Division 2.4.2.1
  253. 2.4.2.2Division 2.4.2.2
  254. 2.4.2.3Division 2.4.2.3
  255. 2.4.2.4Division 2.4.2.4
  256. 2.4.2.5Division 2.4.2.5
  257. 2.4.2.6Division 2.4.2.6
  258. 2.4.2.7Division 2.4.2.7
  259. 2.4.2.8Division 2.4.2.8
  260. 2.5Identification/detection and quantification methods
  261. 2.5.1Division 2.5.1
  262. 2.5.2Division 2.5.2
  263. Impact on human and animal health
  264. Effects on human and animal health arising from the plant protection product
  265. 2.6.1.1Division 2.6.1.1
  266. 2.6.1.2Division 2.6.1.2
  267. 2.6.1.3Division 2.6.1.3
  268. 2.6.1.4Division 2.6.1.4
  269. 2.6.1.5Division 2.6.1.5
  270. 2.6.1.6Division 2.6.1.6
  271. 2.6.1.7Division 2.6.1.7
  272. 2.6.1.8Division 2.6.1.8
  273. 2.6.1.9Division 2.6.1.9
  274. Effects on human and animal health arising from residues
  275. 2.6.2.1Division 2.6.2.1
  276. 2.6.2.2Division 2.6.2.2
  277. Fate and behaviour in the environment
  278. 2.7.1Division 2.7.1
  279. 2.7.2Division 2.7.2
  280. 2.7.3Division 2.7.3
  281. 2.7.4Division 2.7.4
  282. 2.7.5Division 2.7.5
  283. 2.7.6Division 2.7.6
  284. 2.7.7Division 2.7.7
  285. 2.8Effects on non-target organisms
  286. 2.8.1Division 2.8.1
  287. 2.8.2Division 2.8.2
  288. 2.8.3Division 2.8.3
  289. 2.8.4Division 2.8.4
  290. 2.8.5Division 2.8.5
  291. 2.8.6Division 2.8.6