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Commission Regulation (EU) No 545/2011 of 10 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the data requirements for plant protection products (Text with EEA relevance) (repealed)

EU Regulation No 545/2011 · Adopted 10 June 2011 · 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.

Commission Regulation (EU) No 545/2011

of 10 June 2011

implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the data requirements for plant protection products

(Text with EEA relevance) (repealed)

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

Annotations to the whole text

Textual amendments

F1

Repealed by Commission Regulation (EU) No 284/2013 of 1 March 2013 setting out the data requirements for plant protection products, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market Text with EEA relevance, Art. 2 (with savings in relation to procedures for the approval of active substances and the authorisation of plant protection products in Arts. 3, 4); and, in so far still in force, amended: (31.12.2020) by S.I. 2019/556, regs. 1(1), 17 (as amended by S.I. 2020/1376, regs. 1(4), 3(15)); and S.I. 2019/720, reg. 1(2), Sch. 2 para. 59 (as amended by S.I. 2020/1567, reg. 1(2), Sch. 2 para. 19); 2020 c. 1, Sch. 5 para. 1(1); and (27.2.2025) by S.I. 2025/82, reg. 1(2), Sch. 15 para. 94

Contents

  1. 1Article 1 Repealed
  2. 2Article 2 Repealed
  3. Signature
  4. Annex: DATA REQUIREMENTS FOR PLANT PROTECTION PRODUCTS, AS PROVIDED FOR IN ARTICLE 8(1)(c) OF REGULATION (EC) No 1107/2009
  5. INTRODUCTION Repealed
  6. 1Division 1 Repealed
  7. Tests and analyses Repealed
  8. 2.1Division 2.1 Repealed
  9. 2.2Tests and analyses, required under points 6.2 to 6.7 of this Annex, shall be conducted by official or officially recognised testing facilities or organisations which satisfy at least the following requirements: Repealed
  10. 2.3Officially recognised testing facilities and organisations, and, where requested, official facilities and organisations shall: Repealed
  11. 2.4Division 2.4 Repealed
  12. 2.5Division 2.5 Repealed
  13. 2.6Division 2.6 Repealed
  14. 3Division 3 Repealed
  15. 4Division 4 Repealed
  16. Part A: CHEMICAL PREPARATIONS Repealed
  17. 1Identity of the plant protection product Repealed
  18. 1.1Applicant (name and address, etc.) Repealed
  19. 1.2Manufacturer of the preparation and the active substance(s) (names and addresses etc. including location of plants) Repealed
  20. 1.3Trade name or proposed trade name, and manufacturer’s development code number of the preparation if appropriate Repealed
  21. Detailed quantitative and qualitative information on the composition of the preparation (active substance(s), and co-formulants) Repealed
  22. 1.4.1Division 1.4.1 Repealed
  23. 1.4.2Division 1.4.2 Repealed
  24. 1.4.3Division 1.4.3 Repealed
  25. 1.4.4Division 1.4.4 Repealed
  26. Physical state and nature of the preparation (emulsifiable concentrate, wettable powder, solution, etc.) Repealed
  27. 1.5.1Division 1.5.1 Repealed
  28. 1.6Function (herbicide, insecticide, etc.) Repealed
  29. 2Physical, chemical and technical properties of the plant protection product Repealed
  30. 2.1Appearance (colour and odour) Repealed
  31. Explosivity and oxidising properties Repealed
  32. 2.2.1Division 2.2.1 Repealed
  33. 2.2.2Division 2.2.2 Repealed
  34. 2.3Flash point and other indications of flammability or spontaneous ignition Repealed
  35. Acidity/alkalinity and if necessary pH value Repealed
  36. 2.4.1Division 2.4.1 Repealed
  37. 2.4.2Division 2.4.2 Repealed
  38. Viscosity and surface tension Repealed
  39. 2.5.1Division 2.5.1 Repealed
  40. 2.5.2Division 2.5.2 Repealed
  41. 2.5.3Division 2.5.3 Repealed
  42. Relative density and bulk density Repealed
  43. 2.6.1Division 2.6.1 Repealed
  44. 2.6.2Division 2.6.2 Repealed
  45. Storage — stability and shelf-life: Effects of light, temperature and humidity on technical characteristics of the plant protection product Repealed
  46. 2.7.1Division 2.7.1 Repealed
  47. 2.7.2Division 2.7.2 Repealed
  48. 2.7.3Division 2.7.3 Repealed
  49. 2.8Technical characteristics of the plant protection product Repealed
  50. 2.8.1Wettability Repealed
  51. 2.8.2Persistent foaming Repealed
  52. 2.8.3Suspensibility and suspension stability Repealed
  53. 2.8.4Dilution stability Repealed
  54. 2.8.5Dry sieve test and wet sieve test Repealed
  55. Particle size distribution (dustable and wettable powders, granules), content of dust/fines (granules), attrition and friability (granules) Repealed
  56. 2.8.6.1Division 2.8.6.1 Repealed
  57. 2.8.6.2Division 2.8.6.2 Repealed
  58. 2.8.6.3Division 2.8.6.3 Repealed
  59. Emulsifiability, re-emulsifiability, emulsion stability Repealed
  60. 2.8.7.1Division 2.8.7.1 Repealed
  61. 2.8.7.2Division 2.8.7.2 Repealed
  62. Flowability, pourability (rinsability) and dustability Repealed
  63. 2.8.8.1Division 2.8.8.1 Repealed
  64. 2.8.8.2Division 2.8.8.2 Repealed
  65. 2.8.8.3Division 2.8.8.3 Repealed
  66. Physical and chemical compatibility with other products including plant protection products with which its use is to be authorised Repealed
  67. 2.9.1Division 2.9.1 Repealed
  68. 2.9.2Division 2.9.2 Repealed
  69. 2.10Adherence and distribution to seeds Repealed
  70. Summary and evaluation of data presented under points 2.1 to 2.10 Repealed
  71. Data on application Repealed
  72. 3.1Field of use envisaged, e.g. field, protected crops, storage of plant products, home gardening Repealed
  73. 3.2Effects on harmful organisms, e.g. contact, inhalation or stomach poison, fungitoxic or fungistatic, etc. systemic or not in plants Repealed
  74. 3.3Details of intended use, e.g. types of harmful organisms controlled and/or plants or plant products to be protected Repealed
  75. 3.4Application rate Repealed
  76. 3.5Concentration of active substance in material used (e.g. in the diluted spray, baits or treated seed) Repealed
  77. 3.6Method of application Repealed
  78. 3.7Number and timing of applications and duration of protection Repealed
  79. 3.8Necessary waiting periods or other precautions to avoid phytotoxic effects on succeeding crops Repealed
  80. 3.9Proposed instructions for use Repealed
  81. Further information on the plant protection product Repealed
  82. Packaging (type, materials, size, etc.), compatibility of the preparation with proposed packaging materials Repealed
  83. 4.1.1Division 4.1.1 Repealed
  84. 4.1.2Division 4.1.2 Repealed
  85. 4.1.3Division 4.1.3 Repealed
  86. 4.2Procedures for cleaning application equipment Repealed
  87. 4.3Re-entry periods, necessary waiting periods or other precautions to protect man, livestock and the environment Repealed
  88. 4.3.1Division 4.3.1 Repealed
  89. 4.3.2Division 4.3.2 Repealed
  90. 4.4Recommended methods and precautions concerning: handling, storage, transport or fire Repealed
  91. 4.5Emergency measures in the case of an accident Repealed
  92. 4.6Procedures for destruction or decontamination of the plant protection product and its packaging Repealed
  93. 4.6.1Possibility of neutralisation Repealed
  94. 4.6.2Controlled incineration Repealed
  95. 4.6.3Others Repealed
  96. Analytical methods Repealed
  97. Introduction Repealed
  98. Methods for the analysis of the preparation Repealed
  99. 5.1.1Division 5.1.1 Repealed
  100. 5.1.2Division 5.1.2 Repealed
  101. Specificity, linearity, accuracy and repeatability Repealed
  102. 5.1.3.1Division 5.1.3.1 Repealed
  103. 5.1.3.2Division 5.1.3.2 Repealed
  104. 5.1.3.3Division 5.1.3.3 Repealed
  105. 5.1.3.4Division 5.1.3.4 Repealed
  106. 5.2Analytical methods for the determination of residues Repealed
  107. Efficacy data Repealed
  108. General Repealed
  109. 6.1Preliminary tests Repealed
  110. Testing effectiveness Repealed
  111. Aim of the tests Repealed
  112. Test conditions Repealed
  113. Test guideline Repealed
  114. 6.3Information on the occurrence or possible occurrence of the development of resistance Repealed
  115. Effects on the yield of treated plants or plant products in terms of quantity and/or quality Repealed
  116. Effects on the quality of plants or plant products Repealed
  117. Aim of the tests Repealed
  118. Circumstances in which required Repealed
  119. Effects on transformation processes Repealed
  120. Aim of the tests Repealed
  121. Circumstances in which required Repealed
  122. Effects on the yield of treated plants or plant products Repealed
  123. Aim of the tests Repealed
  124. Circumstances in which required Repealed
  125. Phytotoxicity to target plants (including different cultivars), or to target plant products Repealed
  126. Aim of the tests Repealed
  127. Circumstances in which required Repealed
  128. Test guideline Repealed
  129. Observations on undesirable or unintended side-effects, e.g. on beneficial and other non-target organisms, on succeeding crops, other plants or parts of treated plants used for propagating purposes (e.g. seeds, cuttings, runners) Repealed
  130. Impact on succeeding crops Repealed
  131. Aim of the information required Repealed
  132. Circumstances in which required Repealed
  133. Impact on other plants, including adjacent crops Repealed
  134. Aim of the information required Repealed
  135. Circumstances in which required Repealed
  136. Impact on treated plants or plant products to be used for propagation Repealed
  137. Aim of the information required Repealed
  138. Circumstances in which required Repealed
  139. Test guideline Repealed
  140. 6.6.4Effects on beneficial and other non-target organisms Repealed
  141. 6.7Summary and evaluation of data presented under 6.1 to 6.6 Repealed
  142. 7Toxicological studies Repealed
  143. 7.1Acute toxicity Repealed
  144. Oral Repealed
  145. Circumstances in which required Repealed
  146. Test method Repealed
  147. Percutaneous Repealed
  148. Circumstances in which required Repealed
  149. Test method Repealed
  150. Inhalation Repealed
  151. Aim of the test Repealed
  152. Circumstances in which required Repealed
  153. Test method Repealed
  154. Skin irritation Repealed
  155. Aim of the test Repealed
  156. Circumstances in which required Repealed
  157. Test method Repealed
  158. Eye irritation Repealed
  159. Aim of the test Repealed
  160. Circumstances in which required Repealed
  161. Test method Repealed
  162. Skin sensitisation Repealed
  163. Aim of the test Repealed
  164. Circumstances in which required Repealed
  165. Test method Repealed
  166. Supplementary studies for combinations of plant protection products Repealed
  167. Aim of the test Repealed
  168. 7.2Data on exposure Repealed
  169. 7.2.1Operator exposure Repealed
  170. Estimation of operator exposure Repealed
  171. Aim of the estimation Repealed
  172. Circumstances in which required Repealed
  173. Estimation conditions Repealed
  174. Measurement of operator exposure Repealed
  175. Aim of the test Repealed
  176. Circumstances in which required Repealed
  177. Test conditions Repealed
  178. 7.2.2Bystander exposure Repealed
  179. Aim of the estimation Repealed
  180. Circumstances in which required Repealed
  181. Estimation conditions Repealed
  182. 7.2.3Worker exposure Repealed
  183. Estimation of worker exposure Repealed
  184. Aim of the estimation Repealed
  185. Circumstances in which required Repealed
  186. Estimation conditions Repealed
  187. Measurement of worker exposure Repealed
  188. Aim of the test Repealed
  189. Circumstances in which required Repealed
  190. Test conditions Repealed
  191. Dermal absorption Repealed
  192. Aim of the test Repealed
  193. Circumstances in which required Repealed
  194. Test conditions Repealed
  195. Test guideline Repealed
  196. 7.4Available toxicological data relating to non-active substances Repealed
  197. Residues in or on treated products, food and feed Repealed
  198. Introduction Repealed
  199. Metabolism, distribution and expression of residue in plants or livestock Repealed
  200. Aim of the tests Repealed
  201. Circumstances in which required Repealed
  202. Test conditions Repealed
  203. Residue trials Repealed
  204. Aim of the tests Repealed
  205. Circumstances in which required Repealed
  206. Test conditions Repealed
  207. Livestock feeding studies Repealed
  208. Aim of the tests Repealed
  209. Circumstances in which required Repealed
  210. Test conditions Repealed
  211. Effects of industrial processing and/or household preparations Repealed
  212. Aim of the tests Repealed
  213. Circumstances in which required Repealed
  214. Test conditions Repealed
  215. Residues in succeeding crops Repealed
  216. Aim of the test Repealed
  217. Circumstances in which required Repealed
  218. Test conditions Repealed
  219. 8.6Proposed maximum residue levels (MRLs) and residue definition Repealed
  220. 8.7Proposed pre-harvest intervals for envisaged uses, or withholding periods or storage periods, in the case of post-harvest uses. Repealed
  221. 8.8Estimation of the potential and actual exposure through diet and other means Repealed
  222. 8.9Summary and evaluation of residue behaviour Repealed
  223. Fate and behaviour in the environment Repealed
  224. Introduction Repealed
  225. (i)Division (i) Repealed
  226. (ii)In particular, the information provided for the plant protection product, together with other relevant information, and that provided for the active substance, should be sufficient to: Repealed
  227. (iii)Division (iii) Repealed
  228. (iv)Where relevant tests shall be designed and data analysed using appropriate statistical methods. Repealed
  229. (v)Predicted environmental concentrations in soil (PECS), water (PECSW and PECGW) and air (PECA). Repealed
  230. 9.1Fate and behaviour in soil Repealed
  231. Rate of degradation in soil Repealed
  232. Laboratory studies Repealed
  233. Aim of the test Repealed
  234. Circumstances in which required Repealed
  235. Test conditions Repealed
  236. Test guideline Repealed
  237. Field studies Repealed
  238. Soil dissipation studies Repealed
  239. Aim of the test Repealed
  240. Circumstances in which required Repealed
  241. Test conditions and test guideline Repealed
  242. Soil residue studies Repealed
  243. Aim of the test Repealed
  244. Circumstances in which required Repealed
  245. Test conditions Repealed
  246. Test guideline Repealed
  247. Soil accumulation studies Repealed
  248. Aim of the tests Repealed
  249. Circumstances in which required Repealed
  250. Test conditions Repealed
  251. Test guideline Repealed
  252. Mobility in the soil Repealed
  253. Aim of the test Repealed
  254. Laboratory studies Repealed
  255. Circumstances in which required Repealed
  256. Test guideline Repealed
  257. Lysimeter studies or field leaching studies Repealed
  258. Aim of the tests Repealed
  259. Circumstances in which required Repealed
  260. Test conditions Repealed
  261. 9.1.3Estimation of expected concentrations in soil Repealed
  262. Fate and behaviour in water Repealed
  263. 9.2.1Estimation of concentrations in groundwater Repealed
  264. 9.2.2Impact on water treatment procedures Repealed
  265. 9.2.3Estimation of concentrations in surface water Repealed
  266. 9.3Fate and behaviour in air Repealed
  267. Ecotoxicological studies Repealed
  268. Introduction Repealed
  269. (i)Division (i) Repealed
  270. (ii)In particular, the information provided for the plant protection product, together with other relevant information, and that provided for the active substance, shall be sufficient to: Repealed
  271. (iii)Division (iii) Repealed
  272. (iv)In general, much of the data relating to impact on non-target species, required for authorisation of plant protection products, will have been submitted and evaluated for the approval of the active substance. The information on fate and behaviour in the environment, generated and submitted in accordance with points 9.1 to 9.3, and on residue levels in plants generated and submitted in accordance with point 8 is central to the assessment of impact on non-target species, in that it provides information on the nature and extent of potential or actual exposure. The final PEC estimations are to be adapted in accordance with the different groups of organisms taking in particular into consideration the biology of the most sensitive species. Repealed
  273. (v)Division (v) Repealed
  274. (vi)Division (vi) Repealed
  275. (vii)Where exposure data are necessary to decide whether a study has to be performed, the data obtained in accordance with Section 9 of this Annex shall be used. Repealed
  276. (viii)Division (viii) Repealed
  277. (ix)Division (ix) Repealed
  278. 10.1Effects on birds Repealed
  279. Acute oral toxicity Repealed
  280. Aim of the test Repealed
  281. Circumstances in which required Repealed
  282. Test conditions Repealed
  283. Supervised cage or field trials Repealed
  284. Aim of the test Repealed
  285. Circumstances in which required Repealed
  286. Test conditions Repealed
  287. Acceptance of bait, granules or treated seeds by birds Repealed
  288. Aim of the test Repealed
  289. Circumstances in which required Repealed
  290. 10.1.4Effects of secondary poisoning Repealed
  291. 10.2Effects on aquatic organisms Repealed
  292. Acute toxicity to fish, aquatic invertebrates or effects on algal growth Repealed
  293. Circumstances in which required Repealed
  294. Test conditions and test guidelines Repealed
  295. Microcosm or mesocosm study Repealed
  296. Aim of the test Repealed
  297. Circumstances in which required Repealed
  298. Test conditions Repealed
  299. Test guideline Repealed
  300. Residue data in fish Repealed
  301. Aim of the test Repealed
  302. Circumstances in which required Repealed
  303. Test guideline Repealed
  304. 10.2.4Additional studies Repealed
  305. 10.3Effects on terrestrial vertebrates other than birds Repealed
  306. Aim of the test Repealed
  307. Circumstances in which required Repealed
  308. Test conditions Repealed
  309. 10.4Effects on bees Repealed
  310. Acute oral and contact toxicity Repealed
  311. Aim of the test Repealed
  312. Circumstances in which required Repealed
  313. Test guideline Repealed
  314. Residue test Repealed
  315. Aim of the test Repealed
  316. Circumstances in which required Repealed
  317. Test conditions Repealed
  318. Cage tests Repealed
  319. Aim of the test Repealed
  320. Circumstances in which required Repealed
  321. Test conditions Repealed
  322. Test guideline Repealed
  323. Field tests Repealed
  324. Aim of the test Repealed
  325. Circumstances in which required Repealed
  326. Test conditions Repealed
  327. Test guideline Repealed
  328. Tunnel tests Repealed
  329. Aim of the test Repealed
  330. Circumstances in which required Repealed
  331. Test conditions Repealed
  332. Test guideline Repealed
  333. 10.5Effects on arthropods other than bees Repealed
  334. Laboratory, extended laboratory and semi-field tests Repealed
  335. Aim of the test Repealed
  336. Circumstances in which required Repealed
  337. Test conditions Repealed
  338. Test guideline Repealed
  339. Field tests Repealed
  340. Aim of the test Repealed
  341. Circumstances in which required Repealed
  342. Test conditions Repealed
  343. Test guideline Repealed
  344. Effects on earthworms and other soil non-target macro-organisms, believed to be at risk Repealed
  345. 10.6.1Effects on earthworms Repealed
  346. Acute toxicity tests Repealed
  347. Aim of the test Repealed
  348. Circumstances in which required Repealed
  349. Test guideline Repealed
  350. Tests for sublethal effects Repealed
  351. Aim of the test Repealed
  352. Circumstances in which required Repealed
  353. Test conditions Repealed
  354. Field studies Repealed
  355. Aim of the test Repealed
  356. Circumstances in which required Repealed
  357. Test conditions Repealed
  358. Effects on other soil non-target macro-organisms Repealed
  359. Aim of the test Repealed
  360. Circumstances in which required Repealed
  361. Effects on soil non-target micro-organisms Repealed
  362. Laboratory testing Repealed
  363. Aim of the test Repealed
  364. Circumstances in which required Repealed
  365. Test guideline Repealed
  366. Additional testing Repealed
  367. Aim of the test Repealed
  368. Circumstances in which required Repealed
  369. 10.8Available data from biological primary screening in summary form Repealed
  370. 11Summary and evaluation of Sections 9 and 10 Repealed
  371. Further information Repealed
  372. Information on authorisations in other countries Repealed
  373. Information on established maximum residue levels (MRL) in other countries Repealed
  374. 12.3Proposals including justification for the classification and labelling proposed in accordance with Regulation (EC) No 1272/2008 and Directive 1999/45/EC Repealed
  375. 12.4Division 12.4 Repealed
  376. Specimens of proposed packaging Repealed
  377. Part B: PREPARATIONS OF MICRO-ORGANISMS INCLUDING VIRUSES Repealed
  378. Introduction Repealed
  379. (i)This Part provides data requirements for the authorisation of a plant protection product based on preparations of micro-organisms including viruses. Repealed
  380. (ii)Division (ii) Repealed
  381. (iii)Division (iii) Repealed
  382. (iv)Division (iv) Repealed
  383. (v)Division (v) Repealed
  384. (vi)Division (vi) Repealed
  385. 1Identity of the plant protection product Repealed
  386. 1.1Applicant Repealed
  387. 1.2Manufacturer of the preparation and the micro-organism(s) Repealed
  388. 1.3Trade name or proposed trade name, and manufacturer’s development code number of the preparation if appropriate Repealed
  389. Detailed quantitative and qualitative information on the composition of the preparation Repealed
  390. (i)Division (i) Repealed
  391. (ii)For preparations the following information must be reported: Repealed
  392. (iii)Division (iii) Repealed
  393. (iv)For co-formulants the function must be given: Repealed
  394. (v)Identification of contaminating micro-organisms and other components derived from production process. Repealed
  395. 1.5Physical state and nature of the preparation Repealed
  396. 1.6Function Repealed
  397. 2Physical, chemical and technical properties of the plant protection product Repealed
  398. 2.1Appearance (colour and odour) Repealed
  399. Storage stability and shelf-life Repealed
  400. Effects of light, temperature and humidity on technical characteristics of the plant protection product Repealed
  401. (i)Division (i) Repealed
  402. (ii)Division (ii) Repealed
  403. (iii)Division (iii) Repealed
  404. 2.2.2Other factors affecting stability Repealed
  405. 2.3Explosivity and oxidising properties Repealed
  406. 2.4Flash point and other indications of flammability or spontaneous ignition Repealed
  407. 2.5Acidity, alkalinity and if necessary pH value Repealed
  408. 2.6Viscosity and surface tension Repealed
  409. 2.7Technical characteristics of the plant protection product Repealed
  410. 2.7.1Wettability Repealed
  411. 2.7.2Persistent foaming Repealed
  412. 2.7.3Suspensibility and suspension stability Repealed
  413. 2.7.4Dry sieve test and wet sieve test Repealed
  414. Particle size distribution (dustable and wettable powders, granules), content of dust/fines (granules), attrition and friability (granules) Repealed
  415. (i)The size distribution of particles in the case of powders, must be determined and reported in accordance with OECD Method 110. Repealed
  416. (ii)Division (ii) Repealed
  417. (iii)Division (iii) Repealed
  418. Emulsifiability, re-emulsifiability, emulsion stability Repealed
  419. (i)Division (i) Repealed
  420. (ii)Division (ii) Repealed
  421. Flowability, pourability (rinsability) and dustability Repealed
  422. (i)Division (i) Repealed
  423. (ii)Division (ii) Repealed
  424. (iii)Division (iii) Repealed
  425. Physical, chemical and biological compatibility with other products including plant protection products with which its use is to be authorised Repealed
  426. 2.8.1Physical compatibility Repealed
  427. 2.8.2Chemical compatibility Repealed
  428. 2.8.3Biological compatibility Repealed
  429. 2.9Adherence and distribution to seeds Repealed
  430. Summary and evaluation of data presented under points 2.1 to 2.9 Repealed
  431. Data on application Repealed
  432. 3.1Field of use envisaged Repealed
  433. 3.2Mode of action Repealed
  434. 3.3Details of intended use Repealed
  435. 3.4Application rate Repealed
  436. 3.5Content of micro-organism in material used (e.g. in the diluted spray, baits or treated seed) Repealed
  437. 3.6Method of application Repealed
  438. 3.7Number and timing of applications and duration of protection Repealed
  439. 3.8Necessary waiting periods or other precautions to avoid phytopathogenic effects on succeeding crops Repealed
  440. 3.9Proposed instructions for use Repealed
  441. Further information on the plant protection product Repealed
  442. Packaging and compatibility of the preparation with proposed packaging materials Repealed
  443. (i)Division (i) Repealed
  444. (ii)Division (ii) Repealed
  445. (iii)Division (iii) Repealed
  446. 4.2Procedures for cleaning application equipment Repealed
  447. 4.3Re-entry periods, necessary waiting periods or other precautions to protect man, livestock and the environment Repealed
  448. 4.4Recommended methods and precautions concerning: handling, storage, transport or fire Repealed
  449. 4.5Measures in the case of an accident Repealed
  450. 4.6Procedures for destruction or decontamination of the plant protection product and its packaging Repealed
  451. 4.6.1Controlled incineration Repealed
  452. 4.6.2Others Repealed
  453. Analytical methods Repealed
  454. Introduction Repealed
  455. 5.1Methods for the analysis of the preparation Repealed
  456. 5.2Methods to determine and quantify residues Repealed
  457. Efficacy data Repealed
  458. General Repealed
  459. 6.1Preliminary tests Repealed
  460. Testing effectiveness Repealed
  461. Aim of the tests Repealed
  462. Test conditions Repealed
  463. Test guideline Repealed
  464. 6.3Information on the occurrence or possible occurrence of the development of resistance Repealed
  465. Effects on the yield of treated plants or plant products in terms of quantity and/or quality Repealed
  466. Effects on the quality of plants or plant products Repealed
  467. Aim of the tests Repealed
  468. Circumstances in which required Repealed
  469. Effects on transformation processes Repealed
  470. Aim of the tests Repealed
  471. Circumstances in which required Repealed
  472. Effects on the yield of treated plants or plant products Repealed
  473. Aim of the tests Repealed
  474. Circumstances in which required Repealed
  475. Phytotoxicity to target plants (including different cultivars), or to target plant products Repealed
  476. Aim of the tests Repealed
  477. Circumstances in which required Repealed
  478. Test guideline Repealed
  479. Observations on undesirable or unintended side-effects, e.g. on beneficial and other non-target organisms, on succeeding crops, other plants or parts of treated plants used for propagating purposes (e.g. seeds, cuttings, runners) Repealed
  480. Impact on succeeding crops Repealed
  481. Aim of the information required Repealed
  482. Circumstances in which required Repealed
  483. Impact on other plants, including adjacent crops Repealed
  484. Aim of the information required Repealed
  485. Circumstances in which required Repealed
  486. Impact on treated plants or plant products to be used for propagation Repealed
  487. Aim of the information required Repealed
  488. Circumstances in which required Repealed
  489. Test guideline Repealed
  490. 6.6.4Effects on beneficial and other non-target organisms Repealed
  491. 6.7Summary and evaluation of data presented under 6.1 to 6.6 Repealed
  492. 7Effects on human health Repealed
  493. 7.1Basic acute toxicity studies Repealed
  494. Acute oral toxicity Repealed
  495. Circumstances in which required Repealed
  496. Test method Repealed
  497. Acute inhalation toxicity Repealed
  498. Aim of the test Repealed
  499. Circumstances in which required Repealed
  500. Test method Repealed
  501. Acute percutaneous toxicity Repealed
  502. Circumstances in which required Repealed
  503. Test method Repealed
  504. Additional acute toxicity studies Repealed
  505. Skin irritation Repealed
  506. Aim of the test Repealed
  507. Circumstances in which required Repealed
  508. Test method Repealed
  509. Eye irritation Repealed
  510. Aim of the test Repealed
  511. Circumstances in which required Repealed
  512. Test method Repealed
  513. Skin sensitisation Repealed
  514. Aim of the test Repealed
  515. Circumstances in which required Repealed
  516. Test method Repealed
  517. 7.3Data on exposure Repealed
  518. 7.4Available toxicological data relating to non-active substances Repealed
  519. Supplementary studies for combinations of plant protection products Repealed
  520. Aim of the test Repealed
  521. 7.6Summary and evaluation of health effects Repealed
  522. 8Residues in or on treated products, food and feed Repealed
  523. 9Fate and behaviour in the environment Repealed
  524. Effects on non-target organisms Repealed
  525. Introduction Repealed
  526. (i)Division (i) Repealed
  527. (ii)Division (ii) Repealed
  528. (iii)In particular, the information provided for the plant protection product, together with other relevant information, and that provided for the micro-organism, shall be sufficient to: Repealed
  529. (iv)Division (iv) Repealed
  530. (v)Division (v) Repealed
  531. (vi)Where exposure data are necessary to decide whether a study has to be performed, the data obtained in accordance with Section 9 of Part B of this Annex, shall be used. Repealed
  532. (vii)Division (vii) Repealed
  533. 10.1Effects on birds Repealed
  534. 10.2Effects on aquatic organisms Repealed
  535. 10.3Effects on bees Repealed
  536. 10.4Effects on arthropods other than bees Repealed
  537. 10.5Effects on earthworms Repealed
  538. 10.6Effects on soil micro-organisms Repealed
  539. 10.7Additional studies Repealed
  540. 11Summary and evaluation of environmental impact Repealed