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Commission Regulation (EU) No 283/2013 of 1 March 2013 setting out the data requirements for active substances, 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 283/2013 · 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 283/2013

of 1 March 2013

setting out the data requirements for active substances, 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 544/2011 of 10 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the data requirements for active substancesf2 was adopted. It contains the requirements for the dossiers to be submitted for the approval of active substances, as set out in Annex II to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the marketf3.

(2)

It is necessary to modify the data requirements concerning chemical substances 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Regulation (EU) No 544/2011 should therefore be repealed.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 or amendment to the conditions of approval of active substances and data submitted for applications for authorisation, renewal of authorisation and amendment to the 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. 1.

f3

OJ L 230, 19.8.1991, p. 1.

Contents

  1. 1Data requirements for active substances
  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. 1.6The simultaneous use of the active substance as a biocide or in veterinary medicine shall be reported.
  16. 1.7Division 1.7
  17. 1.8Division 1.8
  18. 1.9Division 1.9
  19. 1.10Division 1.10
  20. 1.11The information on the active substance, taken together with the information concerning one or more plant protection products containing the active substance and together, if appropriate, with the information concerning safeners and synergists and other components of the plant protection product, shall be sufficient to:
  21. 1.12Division 1.12
  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:
  28. Test material
  29. 4.1Division 4.1
  30. 4.2Division 4.2
  31. 4.3Division 4.3
  32. 4.4Division 4.4
  33. 4.5Division 4.5
  34. 4.6Division 4.6
  35. Tests on vertebrate animals
  36. 5.1Division 5.1
  37. 5.2Division 5.2
  38. 5.3Division 5.3
  39. 5.4Division 5.4
  40. 6Division 6
  41. Part A: CHEMICAL ACTIVE SUBSTANCES
  42. 1Identity of the active substance
  43. 1.1Applicant
  44. 1.2Producer
  45. 1.3Common name proposed or ISO-accepted, and synonyms
  46. 1.4Chemical name (IUPAC and CA nomenclature)
  47. 1.4.1Division 1.4.1
  48. 1.5Producer's development code numbers
  49. 1.6CAS, EC and CIPAC numbers
  50. 1.7Molecular and structural formula, molar mass
  51. 1.8Method of manufacture (synthesis pathway) of the active substance
  52. 1.9Specification of purity of the active substance in g/kg
  53. 1.10Identity and content of additives (such as stabilisers) and impurities
  54. 1.10.1Additives
  55. 1.10.2Significant impurities
  56. 1.10.3Relevant impurities
  57. 1.11Analytical profile of batches
  58. Physical and chemical properties of the active substance
  59. 2.1Melting point and boiling point
  60. 2.2Vapour pressure, volatility
  61. 2.3Appearance (physical state, colour)
  62. 2.4Spectra (UV/VIS, IR, NMR, MS), molar extinction at relevant wavelengths, optical purity
  63. 2.5Solubility in water
  64. 2.6Solubility in organic solvents
  65. 2.7Partition coefficient n-octanol/water
  66. 2.8Dissociation in water
  67. 2.9Flammability and self-heating
  68. 2.10Flash point
  69. 2.11Explosive properties
  70. 2.12Surface tension
  71. 2.13Oxidising properties
  72. 2.14Other studies
  73. Further information on the active substance
  74. 3.1Use of the active substance
  75. 3.2Function
  76. 3.3Effects on harmful organisms
  77. 3.4Field of use envisaged
  78. 3.5Harmful organisms controlled and crops or products protected or treated
  79. 3.6Mode of action
  80. 3.7Information on the occurrence or possible occurrence of the development of resistance and appropriate management strategies
  81. 3.8Methods and precautions concerning handling, storage, transport or fire
  82. 3.9Procedures for destruction or decontamination
  83. 3.10Emergency measures in case of an accident
  84. Analytical methods
  85. Introduction
  86. Methods used for the generation of pre-approval data
  87. 4.1.1Methods for the analysis of the active substance as manufactured
  88. 4.1.2Methods for risk assessment
  89. 4.2Methods for post-approval control and monitoring purposes
  90. Toxicological and metabolism studies
  91. Introduction
  92. 1Division 1
  93. 2All potentially adverse effects found during toxicological investigations (including effects on organs/systems such as the immune system, the nervous system, or the endocrine system) shall be reported. Additional studies may be necessary to investigate the mechanisms underlying effects that could be critical to hazard identification or risk assessment.
  94. 3Division 3
  95. 4Division 4
  96. 5Division 5
  97. 6Division 6
  98. 7Where, as a result of metabolism or other processes in or on treated plants, in livestock, in soil, in ground water, open air, or as a result of processing of treated products, the terminal residue to which humans will be exposed contains a substance which is not the active substance itself and is not identified as a significant metabolite in mammals, toxicity studies shall, where technically possible, be carried out on that substance unless it can be demonstrated that human exposure to that substance does not constitute a relevant risk to health.
  99. 8Division 8
  100. 9Division 9
  101. 5.1Studies on absorption, distribution, metabolism and excretion in mammals
  102. 5.1.1Absorption, distribution, metabolism and excretion after exposure by oral route
  103. 5.1.2Absorption, distribution, metabolism and excretion after exposure by other routes
  104. 5.2Acute toxicity
  105. Oral
  106. Circumstances in which required
  107. Dermal
  108. Circumstances in which required
  109. Inhalation
  110. Circumstances in which required
  111. 5.2.4Skin irritation
  112. Circumstances in which required
  113. 5.2.5Eye irritation
  114. Circumstances in which required
  115. 5.2.6Skin sensitisation
  116. Circumstances in which required
  117. 5.2.7Phototoxicity
  118. Circumstances in which required
  119. 5.3Short-term toxicity
  120. Oral 28-day study
  121. Circumstances in which required
  122. Oral 90-day study
  123. Circumstances in which required
  124. Other routes
  125. Circumstances in which required
  126. 5.4Genotoxicity testing
  127. In vitro studies
  128. Circumstances in which required
  129. In vivo studies in somatic cells
  130. Circumstances in which required
  131. In vivo studies in germ cells
  132. Circumstances in which required
  133. 5.5Long-term toxicity and carcinogenicity
  134. Circumstances in which required
  135. Test conditions
  136. 5.6Reproductive toxicity
  137. 5.6.1Generational studies
  138. Circumstances in which required
  139. 5.6.2Developmental toxicity studies
  140. Circumstances in which required
  141. Test conditions
  142. Neurotoxicity studies
  143. 5.7.1Neurotoxicity studies in rodents
  144. Circumstances in which required
  145. 5.7.2Delayed polyneuropathy studies
  146. Circumstances in which required
  147. Other toxicological studies
  148. 5.8.1Toxicity studies of metabolites
  149. 5.8.2Supplementary studies on the active substance
  150. 5.8.3Endocrine disrupting properties
  151. 5.9Medical data
  152. 5.9.1Medical surveillance on manufacturing plant personnel and monitoring studies
  153. 5.9.2Data collected on humans
  154. 5.9.3Direct observations
  155. 5.9.4Epidemiological studies
  156. 5.9.5Diagnosis of poisoning (determination of active substance, metabolites), specific signs of poisoning, clinical tests
  157. 5.9.6Proposed treatment: first aid measures, antidotes, medical treatment
  158. 5.9.7Expected effects of poisoning
  159. Residues in or on treated products, food and feed
  160. 6.1Storage stability of residues
  161. Circumstances in which required
  162. Test conditions
  163. 6.2Metabolism, distribution and expression of residues
  164. Plants
  165. Circumstances in which required
  166. Test conditions
  167. Poultry
  168. Circumstances in which required
  169. Test conditions
  170. Lactating ruminants
  171. Circumstances in which required
  172. Test conditions
  173. Pigs
  174. Circumstances in which required
  175. Test conditions
  176. Fish
  177. Circumstances in which required
  178. 6.3Magnitude of residue trials in plants
  179. Circumstances in which required
  180. Test conditions
  181. 6.4Feeding studies
  182. Circumstances in which required
  183. 6.4.1Poultry
  184. 6.4.2Ruminants
  185. 6.4.3Pigs
  186. 6.4.4Fish
  187. Effects of processing
  188. 6.5.1Nature of the residue
  189. Circumstances in which required
  190. Test conditions
  191. 6.5.2Distribution of the residue in inedible peel and pulp
  192. Circumstances in which required
  193. Test conditions
  194. 6.5.3Magnitude of residues in processed commodities
  195. Circumstances in which required
  196. Industrial processing
  197. Domestic processing
  198. Test conditions
  199. 6.6Residues in rotational crops
  200. 6.6.1Metabolism in rotational crops
  201. Circumstances in which required
  202. Test conditions
  203. 6.6.2Magnitude of residues in rotational crops
  204. Circumstances in which required
  205. Test conditions
  206. Proposed residue definitions and maximum residue levels
  207. 6.7.1Proposed residue definitions
  208. 6.7.2Proposed maximum residue levels (MRLs) and justification of the acceptability of the levels proposed
  209. 6.7.3Proposed maximum residue levels (MRLs) and justification of the acceptability of the levels proposed for imported products (import tolerance)
  210. 6.8Proposed safety intervals
  211. 6.9Estimation of the potential and actual exposure through diet and other sources
  212. Other studies
  213. 6.10.1Residue level in pollen and bee products
  214. Fate and behaviour in the environment
  215. 7.1Fate and behaviour in soil
  216. 7.1.1Route of degradation in soil
  217. Aerobic degradation
  218. Circumstances in which required
  219. Test conditions
  220. Anaerobic degradation
  221. Circumstances in which required
  222. Test conditions
  223. Soil photolysis
  224. Circumstances in which required
  225. Rate of degradation in soil
  226. 7.1.2.1Laboratory studies
  227. Aerobic degradation of the active substance
  228. Circumstances in which required
  229. Test conditions
  230. Aerobic degradation of metabolites, breakdown and reaction products
  231. Circumstances in which required
  232. Test conditions
  233. Anaerobic degradation of the active substance
  234. Circumstances in which required
  235. Test conditions
  236. Anaerobic degradation of metabolites, breakdown and reaction products
  237. Circumstances in which required
  238. Test conditions
  239. Field studies
  240. 7.1.2.2.1Soil dissipation studies
  241. Circumstances in which required
  242. Test conditions
  243. 7.1.2.2.2Soil accumulation studies
  244. Circumstances in which required
  245. Test conditions
  246. Adsorption and desorption in soil
  247. 7.1.3.1Adsorption and desorption
  248. Adsorption and desorption of the active substance
  249. Circumstances in which required
  250. Test conditions
  251. Adsorption and desorption of metabolites, breakdown and reaction products
  252. Circumstances in which required
  253. Test conditions
  254. 7.1.3.2Aged sorption
  255. Circumstances in which required
  256. Test conditions
  257. Mobility in soil
  258. Column leaching studies
  259. 7.1.4.1.1Column leaching of the active substance
  260. Circumstances in which required
  261. 7.1.4.1.2Column leaching of metabolites, breakdown and reaction products
  262. Circumstances in which required
  263. 7.1.4.2Lysimeter studies
  264. Circumstances in which required
  265. Test conditions
  266. 7.1.4.3Field leaching studies
  267. Circumstances in which required
  268. Test conditions
  269. 7.2Fate and behaviour in water and sediment
  270. 7.2.1Route and rate of degradation in aquatic systems (chemical and photochemical degradation)
  271. Hydrolytic degradation
  272. Circumstances in which required
  273. Test conditions
  274. Direct photochemical degradation
  275. Circumstances in which required
  276. Test conditions
  277. Indirect photochemical degradation
  278. Circumstances in which required
  279. Test conditions
  280. Route and rate of biological degradation in aquatic systems
  281. ‘Ready biodegradability’
  282. Circumstances in which required
  283. 7.2.2.2Aerobic mineralisation in surface water
  284. Circumstances in which required
  285. Test conditions
  286. 7.2.2.3Water/sediment study
  287. Circumstances in which required
  288. Test conditions
  289. 7.2.2.4Irradiated water/sediment study
  290. Circumstances in which required
  291. Test conditions
  292. 7.2.3Degradation in the saturated zone
  293. Fate and behaviour in air
  294. 7.3.1Route and rate of degradation in air
  295. 7.3.2Transport via air
  296. Circumstances in which required
  297. 7.3.3Local and global effects
  298. Definition of the residue
  299. 7.4.1Definition of the residue for risk assessment
  300. 7.4.2Definition of the residue for monitoring
  301. 7.5Monitoring data
  302. Ecotoxicological studies
  303. Introduction
  304. 1Division 1
  305. 2Division 2
  306. 3It may be necessary to conduct separate studies for metabolites, breakdown or reaction products derived from the active substance where non-target organisms may be exposed and where their effects cannot be evaluated by the available results relating to the active substance. Before such studies are performed, the applicant shall take into account the information from Sections 5, 6 and 7.
  307. 4Division 4
  308. 5Division 5
  309. 6For those guidelines which allow for the study to be designed to determine an effective concentration (ECx), the study shall be conducted to determine an EC10, EC20 and EC50, when required, along with corresponding 95 % confidence intervals. If an ECx approach is used, a no observed effect concentration (NOEC) shall still be determined.
  310. 7Division 7
  311. 8Division 8
  312. 9Division 9
  313. 10Division 10
  314. 8.1Effects on birds and other terrestrial vertebrates
  315. Effects on birds
  316. 8.1.1.1Acute oral toxicity to birds
  317. Circumstances in which required
  318. Test conditions
  319. 8.1.1.2Short-term dietary toxicity to birds
  320. Circumstances in which required
  321. Test conditions
  322. 8.1.1.3Sub-chronic and reproductive toxicity to birds
  323. Circumstances in which required
  324. Test conditions
  325. 8.1.2Effects on terrestrial vertebrates other than birds
  326. 8.1.2.1Acute oral toxicity to mammals
  327. Circumstances in which required
  328. Long-term and reproductive toxicity to mammals
  329. Circumstances in which required
  330. 8.1.3Active substance bioconcentration in prey of birds and mammals
  331. 8.1.4Effects on terrestrial vertebrate wildlife (birds, mammals, reptiles and amphibians)
  332. 8.1.5Endocrine disrupting properties
  333. 8.2Effects on aquatic organisms
  334. 8.2.1Acute toxicity to fish
  335. Circumstances in which required
  336. Test conditions
  337. Long-term and chronic toxicity to fish
  338. Circumstances in which required
  339. 8.2.2.1Fish early life stage toxicity test
  340. 8.2.2.2Fish full life cycle test
  341. Test conditions
  342. 8.2.2.3Bioconcentration in fish
  343. Circumstances in which required
  344. 8.2.3Endocrine disrupting properties
  345. Acute toxicity to aquatic invertebrates
  346. Circumstances in which required
  347. 8.2.4.1Acute toxicity to Daphnia magna
  348. Test conditions
  349. 8.2.4.2Acute toxicity to an additional aquatic invertebrate species
  350. Test conditions
  351. Long-term and chronic toxicity to aquatic invertebrates
  352. Circumstances in which required
  353. 8.2.5.1Reproductive and development toxicity to Daphnia magna
  354. 8.2.5.2Reproductive and development toxicity to an additional aquatic invertebrate species
  355. 8.2.5.3Development and emergence in Chironomus riparius
  356. Test conditions
  357. 8.2.5.4Sediment dwelling organisms
  358. Test conditions
  359. Effects on algal growth
  360. Circumstances in which required
  361. 8.2.6.1Effects on growth of green algae
  362. Test conditions
  363. 8.2.6.2Effects on growth of an additional algal species
  364. Test conditions
  365. 8.2.7Effects on aquatic macrophytes
  366. Circumstances in which required
  367. Test conditions
  368. 8.2.8Further testing on aquatic organisms
  369. Circumstances in which required
  370. Test conditions
  371. Effect on arthropods
  372. 8.3.1Effects on bees
  373. 8.3.1.1Acute toxicity to bees
  374. 8.3.1.1.1Acute oral toxicity
  375. Test conditions
  376. 8.3.1.1.2Acute contact toxicity
  377. Test conditions
  378. 8.3.1.2Chronic toxicity to bees
  379. Circumstances in which required
  380. Test conditions
  381. 8.3.1.3Effects on honeybee development and other honeybee life stages
  382. Circumstances in which required
  383. 8.3.1.4Sub-lethal effects
  384. Effects on non-target arthropods other than bees
  385. Circumstances in which required
  386. 8.3.2.1Effects on Aphidius rhopalosiphi
  387. Test conditions
  388. 8.3.2.2Effects on Typhlodromus pyri
  389. Test conditions
  390. Effects on non-target soil meso- and macrofauna
  391. 8.4.1Earthworm — sub-lethal effects
  392. Circumstances in which required
  393. Test conditions
  394. Effects on non-target soil meso- and macrofauna (other than earthworms)
  395. Circumstances in which required
  396. 8.4.2.1Species level testing
  397. Test conditions
  398. 8.5Effects on soil nitrogen transformation
  399. Circumstances in which required
  400. Test conditions
  401. Effects on terrestrial non-target higher plants
  402. 8.6.1Summary of screening data
  403. Circumstances in which required
  404. Test conditions
  405. 8.6.2Testing on non-target plants
  406. Circumstances in which required
  407. Test conditions
  408. 8.7Effects on other terrestrial organisms (flora and fauna)
  409. 8.8Effects on biological methods for sewage treatment
  410. Circumstances in which required
  411. 8.9Monitoring data
  412. 9Literature data
  413. 10Classification and labelling
  414. Part B: MICRO-ORGANISMS INCLUDING VIRUSES
  415. Introduction
  416. (i)Active substances are defined in Article 2(2) of Regulation (EC) No 1107/2009 and include chemical substances and micro-organisms including viruses.
  417. (ii)For all micro-organisms that are subject to application all available relevant knowledge and information in literature should be provided.
  418. (iii)Division (iii)
  419. (iv)Where testing is done, a detailed description (specification) of the material used and its impurities, in accordance with point 1.4, must be provided. The material used shall be of that specification that will be used in the manufacture of preparations to be authorised.
  420. (v)Division (v)
  421. (vi)Division (vi)
  422. (vii)In the case of studies in which dosing extends over a period, dosing shall preferably be done using a single batch of the micro-organism, if stability permits.
  423. (viii)Division (viii)
  424. 1IDENTITY OF THE MICRO-ORGANISM
  425. 1.1Applicant
  426. 1.2Producer
  427. Name and species description, strain characterisation
  428. (i)Division (i)
  429. (ii)Each micro-organism that is subject to the application shall be identified and named at the species level. The scientific name and taxonomic grouping, i.e. family, genus, species, strain, serotype, pathovar or any other denomination relevant to the micro-organism, must be stated.
  430. (iii)Division (iii)
  431. (iv)Division (iv)
  432. (v)Division (v)
  433. Specification of the material used for manufacturing of formulated products
  434. 1.4.1Content of the micro-organism
  435. 1.4.2Identity and content of impurities, additives, contaminating micro-organisms
  436. 1.4.3Analytical profile of batches
  437. BIOLOGICAL PROPERTIES OF THE MICRO-ORGANISM
  438. 2.1History of the micro-organism and its uses. Natural occurrence and geographical distribution
  439. 2.1.1Historical background
  440. 2.1.2Origin and natural occurrence
  441. Information on target organism(s)
  442. 2.2.1Description of the target organism(s)
  443. 2.2.2Mode of action
  444. 2.3Host specificity range and effects on species other than the target harmful organism
  445. 2.4Development stages/life cycle of the micro-organism
  446. 2.5Infectiveness, dispersal and colonisation ability
  447. 2.6Relationships to known plant or animal or human pathogens
  448. 2.7Genetic stability and factors affecting it
  449. 2.8Information on the production of metabolites (especially toxins)
  450. 2.9Antibiotics and other anti-microbial agents
  451. FURTHER INFORMATION ON THE MICRO-ORGANISM
  452. Introduction
  453. (i)Division (i)
  454. (ii)Division (ii)
  455. (iii)Division (iii)
  456. (iv)Division (iv)
  457. 3.1Function
  458. 3.2Field of use envisaged
  459. 3.3Crops or products protected or treated
  460. 3.4Method of production and quality control
  461. 3.5Information on the occurrence or possible occurrence of the development of resistance of the target organism(s)
  462. 3.6Methods to prevent loss of virulence of seed stock of the micro-organism
  463. 3.7Recommended methods and precautions concerning handling, storage, transport or fire
  464. 3.8Procedures for destruction or decontamination
  465. 3.9Measures in case of an accident
  466. ANALYTICAL METHODS
  467. Introduction
  468. 4.1Methods for the analysis of the micro-organism as manufactured
  469. 4.2Methods to determine and quantify residues (viable or non-viable)
  470. EFFECTS ON HUMAN HEALTH
  471. Introduction
  472. (i)Division (i)
  473. (ii)The information provided, taken together with that provided for one or more preparations containing the micro-organism, must be sufficient to permit an evaluation to be made as to the risks for man, directly and/or indirectly associated with the handling and use of plant protection products containing the micro-organism, and the risk for man handling treated products, and the risk for man arising from residual traces or contaminants remaining in food and water. In addition, the information provided must be sufficient to:
  474. (iii)Division (iii)
  475. (iv)Division (iv)
  476. (v)Division (v)
  477. TIER I
  478. 5.1Basic information
  479. 5.1.1Medical data
  480. 5.1.2Medical surveillance on manufacturing plant personnel
  481. 5.1.3Sensitisation/allergenicity observations, if appropriate
  482. 5.1.4Direct observation, e.g. clinical cases
  483. 5.2Basic studies
  484. Sensitisation
  485. Aim of the test
  486. Circumstances in which required
  487. 5.2.2Acute toxicity, pathogenicity and infectiveness
  488. Acute oral toxicity, pathogenicity and infectiveness
  489. Circumstances in which required
  490. Acute inhalation toxicity, pathogenicity and infectiveness
  491. Circumstances in which required
  492. 5.2.2.3Intraperitoneal/subcutaneous single dose
  493. Circumstances in which required
  494. Genotoxicity testing
  495. Circumstances in which required
  496. Aim of the test
  497. Test conditions
  498. In vitro studies
  499. Circumstances in which required
  500. 5.2.4Cell culture study
  501. Information on short-term toxicity and pathogenicity
  502. Aim of the test
  503. Circumstances in which required
  504. 5.2.5.1Health effects after repeated inhalatory exposure
  505. Circumstances in which required
  506. 5.2.6Proposed treatment: first aid measures, medical treatment
  507. TIER II
  508. 5.3Specific toxicity, pathogenicity and infectiveness studies
  509. In vivo studies in somatic cells
  510. Circumstances in which required
  511. Genotoxicity — In vivo studies in germ cells
  512. Aim of the test and test conditions
  513. Circumstances in which required
  514. 5.6Summary of mammalian toxicity, pathogenicity and infectiveness and overall evaluation
  515. RESIDUES IN OR ON TREATED PRODUCTS, FOOD AND FEED
  516. Introduction
  517. (i)Division (i)
  518. (ii)In addition, the information provided must be sufficient to:
  519. (iii)Division (iii)
  520. 6.1Persistence and likelihood of multiplication in or on crops, feedingstuffs or foodstuffs
  521. 6.2Further information required
  522. 6.2.1Non-viable residues
  523. 6.2.2Viable residues
  524. Summary and evaluation of residue behaviour resulting from data submitted under points 6.1 and 6.2
  525. FATE AND BEHAVIOUR IN THE ENVIRONMENT
  526. Introduction
  527. (i)Information on the origin, the properties, and the survival of the micro-organism and its residual metabolites as well as its intended use form the basis for an assessment of environmental fate and behaviour.
  528. (ii)Division (ii)
  529. (iii)In particular, the information provided shall be sufficient to:
  530. (iv)Any relevant metabolites (i.e. of concern for human health and/or the environment) formed by the test organism under any relevant environmental conditions shall be characterised. If relevant metabolites are present in or produced by the micro-organism, data as outlined under Section 7 of Part A of this Annex may be required, if all of the following conditions are met:
  531. (v)Division (v)
  532. (vi)Division (vi)
  533. 7.1Persistence and multiplication
  534. 7.1.1Soil
  535. 7.1.2Water
  536. 7.1.3Air
  537. 7.2Mobility
  538. EFFECTS ON NON-TARGET ORGANISMS
  539. Introduction
  540. (i)The information on identity, biological properties and further information in Sections 1, 2, 3 and 7 is central to the assessment of impact on non-target species. Additional useful information may be found on fate and behaviour in the environment in Section 7 and on residue levels in plants in Section 6 which, together with information on the nature of the preparation and its manner of use, defines the nature and extent of potential exposure. The information submitted in accordance with Section 5 will provide essential information as to effects to mammals and the mechanisms involved.
  541. (ii)Division (ii)
  542. (iii)Division (iii)
  543. (iv)In particular, the information provided for the micro-organism, together with other relevant information, and that provided for one or more preparations containing it, shall be sufficient to:
  544. (v)Division (v)
  545. (vi)Division (vi)
  546. (vii)Division (vii)
  547. (viii)Division (viii)
  548. (ix)Division (ix)
  549. Effects on birds
  550. Aim of the test
  551. Effects on aquatic organisms
  552. Aim of the test
  553. Effects on fish
  554. Aim of the test
  555. Effects on freshwater invertebrates
  556. Aim of the test
  557. Effects on algae growth
  558. Aim of the test
  559. Effects on plants other than algae
  560. Aim of the test
  561. Effects on bees
  562. Aim of the test
  563. Effects on arthropods other than bees
  564. Aim of the test
  565. Effects on earthworms
  566. Aim of the test
  567. 8.6Effects on non-target soil micro-organisms
  568. 8.7Additional studies
  569. 9SUMMARY AND EVALUATION OF ENVIRONMENTAL IMPACT