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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)

EU Regulation No 284/2013 · Adopted 1 March 2013 · 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 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)

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 78(1)(b) thereof,

Whereas:

(1)

In accordance with Article 8(4) of Regulation (EC) No 1107/2009, 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 productsf2 was adopted. It contains the data requirements for the authorisation of plant protection products, as set out in Annex III to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant products on the marketf3.

(2)

It is necessary to modify the data requirements concerning chemical preparations in order to take into account current scientific and technical knowledge.

(3)

More detailed information for the implementation of the data requirements is laid down in relevant guidance documents.

(4)

Regulation (EU) No 545/2011 should therefore be repealed.

(5)

A reasonable period should be allowed to elapse before the modified data requirements become applicable in order to permit applicants to prepare themselves to meet those requirements.

(6)

In order to permit Member States and the interested parties to prepare themselves to meet the new requirements, it is appropriate to lay down transitional measures concerning data submitted for applications for the approval, renewal of approval and amendment to the conditions of approval of active substances and for applications for authorisation, renewal of authorisation and amendment to authorisation of plant protection products.

(7)

These transitional measures are without prejudice to Article 80 of Regulation (EC) No 1107/2009.

(8)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health and neither the European Parliament nor the Council has opposed them,

HAS ADOPTED THIS REGULATION:

Annotations to the whole text

Footnotes

f1

OJ L 309, 24.11.2009, p. 1.

f2

OJ L 155, 11.6.2011, p. 67.

f3

OJ L 230, 19.8.1991, p. 1.

Contents

  1. 1Data requirements for plant protection products
  2. 2Repeal Repealed
  3. 3Transitional measures as regards procedures concerning active substances Repealed
  4. 4Transitional measures as regards procedures concerning plant protection products Repealed
  5. 5Entry into force and date of application Repealed
  6. Signature
  7. Annex
  8. Information to be submitted, its generation and its presentation
  9. 1Division 1
  10. 1.1Division 1.1
  11. 1.2Division 1.2
  12. 1.3Division 1.3
  13. 1.4Division 1.4
  14. 1.5The information shall include a full and unbiased report of the studies conducted as well as a full description of them. Such information shall not be required, where one of the following conditions is fulfilled:
  15. 1.6Division 1.6
  16. 1.7Division 1.7
  17. 1.8Division 1.8
  18. 1.9Division 1.9
  19. 1.10Division 1.10
  20. 1.11Division 1.11
  21. 1.12The information provided for the plant protection product and that provided for the active substance, shall be sufficient to:
  22. 1.13Division 1.13
  23. 1.14Division 1.14
  24. 2Division 2
  25. Good laboratory practice (GLP)
  26. 3.1Division 3.1
  27. 3.2By way of derogation from point 3.1, tests and analyses, required under the provisions of Sections 6 of Parts A and B, may be conducted by official or officially recognised testing facilities or organisations which satisfy at least the following requirements:
  28. 3.3Officially recognised testing facilities and organisations, and, where requested by the competent authorities, official facilities and organisations shall:
  29. 3.4By way of derogation from point 3.1:
  30. Test material
  31. 4.1Division 4.1
  32. 4.2Division 4.2
  33. Tests on vertebrate animals
  34. 5.1Tests on vertebrate animals shall be undertaken only where no other validated methods are available.
  35. 5.2Division 5.2
  36. 5.3Division 5.3
  37. 5.4Division 5.4
  38. 6Division 6
  39. Part A: CHEMICAL PLANT PROTECTION PRODUCTS
  40. 1Identity of the plant protection product
  41. 1.1Applicant
  42. 1.2Producer of the plant protection product and of the active substances
  43. 1.3Trade name or proposed trade name and producer’s development code number of the plant protection product if appropriate
  44. Detailed quantitative and qualitative information on the composition of the plant protection product
  45. 1.4.1Composition of the plant protection product
  46. 1.4.2Information on the active substances
  47. 1.4.3Information on safeners, synergists and co-formulants
  48. 1.4.3.1Division 1.4.3.1
  49. 1.5Type and code of the plant protection product
  50. 1.6Function
  51. 2Physical, chemical and technical properties of the plant protection product
  52. 2.1Appearance
  53. 2.2Explosive and oxidising properties
  54. 2.3Flammability and self-heating
  55. 2.4Acidity/alkalinity and pH value
  56. 2.5Viscosity and surface tension
  57. 2.6Relative density and bulk density
  58. 2.7Storage stability and shelf-life: effects of temperature on technical characteristics of the plant protection product
  59. 2.8Technical characteristics of the plant protection product
  60. 2.8.1Wettability
  61. 2.8.2Persistent foaming
  62. 2.8.3Suspensibility, spontaneity of dispersion and dispersion stability
  63. 2.8.4Degree of dissolution and dilution stability
  64. Particle size distribution, dust content, attrition and mechanical stability
  65. 2.8.5.1Particle size distribution
  66. 2.8.5.2Dust content
  67. 2.8.5.3Attrition
  68. 2.8.5.4Hardness and integrity
  69. 2.8.6Emulsifiability, re-emulsifiability, emulsion stability
  70. 2.8.7Flowability, pourability and dustability
  71. 2.9Physical and chemical compatibility with other products including plant protection products with which its use is to be authorised
  72. 2.10Adherence and distribution to seeds
  73. 2.11Other studies
  74. 3Data on application
  75. 3.1Field of use envisaged
  76. 3.2Effects on harmful organisms
  77. 3.3Details of intended use
  78. 3.4Application rate and concentration of the active substance
  79. 3.5Method of application
  80. 3.6Number and timing of applications and duration of protection
  81. 3.7Necessary waiting periods or other precautions to avoid phytotoxic effects on succeeding crops
  82. 3.8Proposed instructions for use
  83. Further information on the plant protection product
  84. 4.1Safety intervals and other precautions to protect humans, animals and the environment
  85. 4.2Recommended methods and precautions
  86. 4.3Emergency measures in the case of an accident
  87. 4.4Packaging, compatibility of the plant protection product with proposed packaging materials
  88. 4.5Procedures for destruction or decontamination of the plant protection product and its packaging
  89. 4.5.1Neutralisation procedures
  90. 4.5.2Controlled incineration
  91. Analytical methods
  92. Introduction
  93. Methods used for the generation of pre-authorisation data
  94. 5.1.1Methods for the analysis of the plant protection product
  95. 5.1.2Methods for the determination of residues
  96. 5.2Methods for post-authorisation control and monitoring purposes
  97. Efficacy data
  98. Introduction
  99. 1Division 1
  100. 2Division 2
  101. 3Division 3
  102. 4Division 4
  103. 5Division 5
  104. 6.1Preliminary tests
  105. 6.2Testing effectiveness
  106. Test conditions
  107. 6.3Information on the occurrence or possible occurrence of the development of resistance
  108. Adverse effects on treated crops
  109. 6.4.1Phytotoxicity to target plants (including different cultivars), or to target plant products
  110. Test conditions
  111. 6.4.2Effects on the yield of treated plants or plant products
  112. Circumstances in which required
  113. 6.4.3Effects on the quality of plants or plant product
  114. 6.4.4Effects on transformation processes
  115. 6.4.5Impact on treated plants or plant products to be used for propagation
  116. Circumstances in which required
  117. Observations on other undesirable or unintended side-effects
  118. 6.5.1Impact on succeeding crops
  119. Circumstances in which required
  120. 6.5.2Impact on other plants, including adjacent crops
  121. Circumstances in which required
  122. 6.5.3Effects on beneficial and other non-target organisms
  123. Toxicological studies
  124. Introduction
  125. 1Division 1
  126. 2Division 2
  127. 7.1Acute toxicity
  128. Oral toxicity
  129. Circumstances in which required
  130. Dermal toxicity
  131. Circumstances in which required
  132. 7.1.3Inhalation toxicity
  133. Circumstances in which required
  134. 7.1.4Skin irritation
  135. Circumstances in which required
  136. 7.1.5Eye irritation
  137. Circumstances in which required
  138. 7.1.6Skin sensitisation
  139. Circumstances in which required
  140. 7.1.7Supplementary studies on the plant protection product
  141. 7.1.8Supplementary studies for combinations of plant protection products
  142. 7.2Data on exposure
  143. 7.2.1Operator exposure
  144. 7.2.1.1Estimation of operator exposure
  145. Circumstances in which required
  146. Estimation conditions
  147. 7.2.1.2Measurement of operator exposure
  148. Circumstances in which required
  149. 7.2.2Bystander and resident exposure
  150. 7.2.2.1Estimation of bystander and resident exposure
  151. Circumstances in which required
  152. Estimation conditions
  153. 7.2.2.2Measurement of bystander and resident exposure
  154. Circumstances in which required
  155. 7.2.3Worker exposure
  156. 7.2.3.1Estimation of worker exposure
  157. Circumstances in which required
  158. Estimation conditions
  159. 7.2.3.2Measurement of worker exposure
  160. Circumstances in which required
  161. 7.3Dermal absorption
  162. Circumstances in which required
  163. Test conditions
  164. 7.4Available toxicological data relating to co-formulants
  165. 8Residues in or on treated products, food and feed
  166. Fate and behaviour in the environment
  167. Introduction
  168. 1Division 1
  169. 1.1A realistic worst-case estimation shall be made of the expected concentrations of the active substance and metabolites, breakdown and reaction products:
  170. 1.2For the purposes of the estimation of such concentrations the following definitions apply:
  171. 1.3Division 1.3
  172. 1.4When models are used for estimation of predicted environmental concentrations they shall:
  173. 1.5Division 1.5
  174. 2Division 2
  175. Fate and behaviour in soil
  176. Rate of degradation in soil
  177. 9.1.1.1Laboratory studies
  178. Circumstances in which required
  179. Test conditions
  180. Field studies
  181. 9.1.1.2.1Soil dissipation studies
  182. Circumstances in which required
  183. Test conditions
  184. 9.1.1.2.2Soil accumulation studies
  185. Circumstances in which required
  186. Test conditions
  187. 9.1.2Mobility in soil
  188. Laboratory studies
  189. Circumstances in which required
  190. Test conditions
  191. 9.1.2.2Lysimeter studies
  192. Circumstances in which required
  193. Test conditions
  194. 9.1.2.3Field leaching studies
  195. Circumstances in which required
  196. Test conditions
  197. 9.1.3Estimation of concentrations in soil
  198. Fate and behaviour in water and sediment
  199. Aerobic mineralisation in surface water
  200. Circumstances in which required
  201. Test conditions
  202. Water/sediment study
  203. Circumstances in which required
  204. Test conditions
  205. 9.2.3Irradiated water/sediment study
  206. Test conditions
  207. 9.2.4Estimation of concentrations in groundwater
  208. 9.2.4.1Calculation of concentrations in groundwater
  209. 9.2.4.2Additional field tests
  210. 9.2.5Estimation of concentrations in surface water and sediment
  211. Fate and behaviour in air
  212. 9.3.1Route and rate of degradation in air and transport via air
  213. 9.4Estimation of concentrations for other routes of exposure
  214. Ecotoxicological studies
  215. Introduction
  216. 1Testing of the plant protection product shall be necessary where its toxicity cannot be predicted on the basis of data on the active substance. Where testing is necessary, the aim shall be to demonstrate whether the plant protection product, taking account of content of active substance, is more toxic than the active substance. Thus bridging studies or a limit test may be sufficient. However, where a plant protection product is more toxic than the active substance (expressed in comparable units), definitive testing shall be required. Possible effects on organisms/ecosystems shall be investigated, unless the applicant shows that exposure of the organisms or ecosystems does not occur.
  217. 2Division 2
  218. 3Division 3
  219. 4Where exposure data are necessary to decide whether a study has to be performed, the data obtained in accordance with Section 9 shall be used.
  220. 5Division 5
  221. 6Division 6
  222. 7Division 7
  223. 8Division 8
  224. 9For those guidelines which allow for study to be designed to determine an effective concentration (ECx), the study shall be conducted to determine an EC10 and EC20 along with corresponding 95 % confidence intervals. If an ECx approach is used, a NOEC shall still be determined.
  225. 10Division 10
  226. 11Division 11
  227. 12Division 12
  228. Effects on birds and other terrestrial vertebrates
  229. 10.1.1Effects on birds
  230. Acute oral toxicity to birds
  231. Circumstances in which required
  232. Test conditions
  233. 10.1.1.2Higher tier data on birds
  234. 10.1.2Effects on terrestrial vertebrates other than birds
  235. Acute oral toxicity to mammals
  236. Circumstances in which required
  237. 10.1.2.2Higher tier data on mammals
  238. 10.1.3Effects on other terrestrial vertebrate wildlife (reptiles and amphibians)
  239. 10.2Effects on aquatic organisms
  240. Acute toxicity to fish, aquatic invertebrates, or effects on aquatic algae and macrophytes.
  241. Circumstances in which required
  242. Test conditions
  243. 10.2.2Additional long-term and chronic toxicity studies on fish, aquatic invertebrates and sediment dwelling organisms
  244. 10.2.3Further testing on aquatic organisms
  245. Effects on arthropods
  246. 10.3.1Effects on bees
  247. 10.3.1.1Acute toxicity to bees
  248. 10.3.1.1.1Acute oral toxicity
  249. Test conditions
  250. 10.3.1.1.2Acute contact toxicity
  251. Test conditions
  252. 10.3.1.2Chronic toxicity to bees
  253. Circumstances in which required
  254. Test conditions
  255. 10.3.1.3Effects on honey bee development and other honey bee life stages
  256. 10.3.1.4Sub-lethal effects
  257. 10.3.1.5Cage and tunnel tests
  258. Circumstances in which required
  259. Test conditions
  260. 10.3.1.6Field tests with honeybees
  261. Circumstances in which required
  262. Test conditions
  263. Test guideline
  264. Effects on non-target arthropods other than bees
  265. Circumstances in which required
  266. 10.3.2.1Standard laboratory testing for non-target arthropods
  267. 10.3.2.2Extended laboratory testing, aged residue studies with non-target arthropods
  268. Circumstances in which required
  269. Test conditions
  270. (a)Extended laboratory studies
  271. (b)Aged residue studies
  272. 10.3.2.3Semi-field studies with non-target arthropods
  273. Circumstances in which required
  274. Test conditions
  275. 10.3.2.4Field studies with non-target arthropods
  276. Circumstances in which required
  277. Test conditions
  278. 10.3.2.5Other routes of exposure for non-target arthropods
  279. Effects on non-target soil meso- and macrofauna
  280. 10.4.1Earthworms
  281. 10.4.1.1Earthworms — sub-lethal effects
  282. Circumstances in which required
  283. Test conditions
  284. 10.4.1.2Earthworms — field studies
  285. Circumstances in which required
  286. Test conditions
  287. Effects on non-target soil meso- and macrofauna (other than earthworms)
  288. Circumstances in which required
  289. 10.4.2.1Species level testing
  290. Test conditions
  291. 10.4.2.2Higher tier testing
  292. Circumstances in which required
  293. Test conditions
  294. 10.5Effects on soil nitrogen transformation
  295. Circumstances in which required
  296. Effects on terrestrial non-target higher plants
  297. 10.6.1Summary of screening data
  298. Circumstances in which required
  299. Test conditions
  300. 10.6.2Testing on non-target plants
  301. Circumstances in which required
  302. Test conditions
  303. 10.6.3Extended laboratory studies on non-target plants
  304. 10.6.4Semi-field and field tests on non-target plants
  305. 10.7Effects on other terrestrial organisms (flora and fauna)
  306. 10.8Monitoring data
  307. 11Literature data
  308. 12Classification and labelling
  309. Part B: PREPARATIONS OF MICRO-ORGANISMS INCLUDING VIRUSES
  310. INTRODUCTION
  311. (i)This Part provides data requirements for the authorisation of a plant protection product based on preparations of micro-organisms including viruses.
  312. (ii)Division (ii)
  313. (iii)Division (iii)
  314. (iv)Division (iv)
  315. (v)Division (v)
  316. (vi)Division (vi)
  317. 1IDENTITY OF THE PLANT PROTECTION PRODUCT
  318. 1.1Applicant
  319. 1.2Manufacturer of the preparation and the micro-organism(s)
  320. 1.3Trade name or proposed trade name, and manufacturer's development code number of the preparation if appropriate
  321. Detailed quantitative and qualitative information on the composition of the preparation
  322. (i)Division (i)
  323. (ii)For preparations the following information must be reported:
  324. (iii)Division (iii)
  325. (iv)For co-formulants the function must be given:
  326. (v)Identification of contaminating micro-organisms and other components derived from production process.
  327. 1.4.1Division 1.4.1
  328. 1.5Physical state and nature of the preparation
  329. 1.6Function
  330. 2PHYSICAL, CHEMICAL AND TECHNICAL PROPERTIES OF THE PLANT PROTECTION PRODUCT
  331. 2.1Appearance (colour and odour)
  332. Storage stability and shelf-life
  333. Effects of light, temperature and humidity on technical characteristics of the plant protection product
  334. (i)Division (i)
  335. (ii)Division (ii)
  336. (iii)Division (iii)
  337. 2.2.2Other factors affecting stability
  338. 2.3Explosivity and oxidising properties
  339. 2.4Flash point and other indications of flammability or spontaneous ignition
  340. 2.5Acidity, alkalinity and if necessary pH value
  341. 2.6Viscosity and surface tension
  342. 2.7Technical characteristics of the plant protection product
  343. 2.7.1Wettability
  344. 2.7.2Persistent foaming
  345. 2.7.3Suspensibility and suspension stability
  346. 2.7.4Dry sieve test and wet sieve test
  347. Particle size distribution (dustable and wettable powders, granules), content of dust/fines (granules), attrition and friability (granules)
  348. (i)The size distribution of particles in the case of powders, must be determined and reported in accordance with OECD Method 110.
  349. (ii)Division (ii)
  350. (iii)Division (iii)
  351. Emulsifiability, re-emulsifiability, emulsion stability
  352. (i)Division (i)
  353. (ii)Division (ii)
  354. Flowability, pourability (rinsability) and dustability
  355. (i)Division (i)
  356. (ii)Division (ii)
  357. (iii)Division (iii)
  358. Physical, chemical and biological compatibility with other products including plant protection products with which its use is to be authorised
  359. 2.8.1Physical compatibility
  360. 2.8.2Chemical compatibility
  361. 2.8.3Biological compatibility
  362. 2.9Adherence and distribution to seeds
  363. Summary and evaluation of data presented under points 2.1 to 2.9
  364. DATA ON APPLICATION
  365. 3.1Field of use envisaged
  366. 3.2Mode of action
  367. 3.3Details of intended use
  368. 3.4Application rate
  369. 3.5Content of micro-organism in material used (e.g. in the diluted spray, baits or treated seed)
  370. 3.6Method of application
  371. 3.7Number and timing of applications and duration of protection
  372. 3.8Necessary waiting periods or other precautions to avoid phytopathogenic effects on succeeding crops
  373. 3.9Proposed instructions for use
  374. FURTHER INFORMATION ON THE PLANT PROTECTION PRODUCT
  375. Packaging and compatibility of the preparation with proposed packaging materials
  376. (i)Division (i)
  377. (ii)Division (ii)
  378. (iii)Division (iii)
  379. 4.2Procedures for cleaning application equipment
  380. 4.3Re-entry periods, necessary waiting periods or other precautions to protect man, livestock and the environment
  381. (i)Where relevant pre-harvest intervals, re-entry periods or withholding periods necessary to minimise the presence of residues in or on crops, plants and plant products, or in treated areas or spaces, with a view to protecting man or livestock, must be specified e.g.:
  382. (ii)Division (ii)
  383. 4.4Recommended methods and precautions concerning: handling, storage, transport or fire
  384. 4.5Measures in the case of an accident
  385. 4.6Procedures for destruction or decontamination of the plant protection product and its packaging
  386. 4.6.1Controlled incineration
  387. 4.6.2Others
  388. ANALYTICAL METHODS
  389. Introduction
  390. 5.1Methods for the analysis of the preparation
  391. 5.2Methods to determine and quantify residues
  392. EFFICACY DATA
  393. General
  394. 6.1Preliminary tests
  395. Testing effectiveness
  396. Aim of the tests
  397. Test conditions
  398. Test guideline
  399. 6.3Information on the occurrence or possible occurrence of the development of resistance
  400. Effects on the yield of treated plants or plant products in terms of quantity and/or quality
  401. Effects on the quality of plants or plant products
  402. Aim of the tests
  403. Circumstances in which required
  404. Effects on transformation processes
  405. Aim of the tests
  406. Circumstances in which required
  407. Effects on the yield of treated plants or plant products
  408. Aim of the tests
  409. Circumstances in which required
  410. Phytotoxicity to target plants (including different cultivars), or to target plant products
  411. Aim of the tests
  412. Circumstances in which required
  413. Test guideline
  414. 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)
  415. Impact on succeeding crops
  416. Aim of the information required
  417. Circumstances in which required
  418. Impact on other plants, including adjacent crops
  419. Aim of the information required
  420. Circumstances in which required
  421. Impact on treated plants or plant products to be used for propagation
  422. Aim of the information required
  423. Circumstances in which required
  424. Test guideline
  425. 6.6.4Effects on beneficial and other non-target organisms
  426. 6.7Summary and evaluation of data presented under 6.1 to 6.6
  427. 7EFFECTS ON HUMAN HEALTH
  428. 7.1Basic acute toxicity studies
  429. Acute oral toxicity
  430. Circumstances in which required
  431. Test method
  432. Acute inhalation toxicity
  433. Aim of the test
  434. Circumstances in which required
  435. Test method
  436. Acute percutaneous toxicity
  437. Circumstances in which required
  438. Test method
  439. Additional acute toxicity studies
  440. Skin irritation
  441. Aim of the test
  442. Circumstances in which required
  443. Test method
  444. Eye irritation
  445. Aim of the test
  446. Circumstances in which required
  447. Test method
  448. Skin sensitisation
  449. Aim of the test
  450. Circumstances in which required
  451. Test method
  452. 7.3Data on exposure
  453. 7.4Available toxicological data relating to non-active substances
  454. Supplementary studies for combinations of plant protection products
  455. Aim of the test
  456. 7.6Summary and evaluation of health effects
  457. 8RESIDUES IN OR ON TREATED PRODUCTS, FOOD AND FEED
  458. 9FATE AND BEHAVIOUR IN THE ENVIRONMENT
  459. EFFECTS ON NON-TARGET ORGANISMS
  460. Introduction
  461. (i)Division (i)
  462. (ii)Division (ii)
  463. (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:
  464. (iv)Division (iv)
  465. (v)Division (v)
  466. (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.
  467. (vii)Division (vii)
  468. 10.1Effects on birds
  469. 10.2Effects on aquatic organisms
  470. 10.3Effects on bees
  471. 10.4Effects on arthropods other than bees
  472. 10.5Effects on earthworms
  473. 10.6Effects on soil micro-organisms
  474. 10.7Additional studies
  475. 11SUMMARY AND EVALUATION OF ENVIRONMENTAL IMPACT