Referenza għal Parti A tal-Anness tar-Regolament (UE) Nru 283/2013 Metodi ta’ ttestjar (2) Dokumenti ta’ gwida (3)

1. IDENTITÀ TAS-SUSTANZA ATTIVA — WHO/FAO. 2002. Pesticide Specifications. Manual on development and use of FAO and WHO specifications for pesticides. Series FAO Plant Production and Protection Papers, Rome, 2002 (4) EU Guidance Document on the assessment of the equivalence of technical materials of substances regulated under Regulation (EC) No. 1107/2009 (5) (SANCO/10597/2003 rev. 10.1)

2. KARATTERISTIĊI FIŻIĊI U KIMIĊI TAS-SUSTANZA ATTIVA —

2.1. Il-punt ta’ tidwib u ta’ togħlija Method A.1 Melting/Freezing temperature (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 102: Melting Point/ Melting Range Method A.2 Boiling temperature (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 103: Boiling point —

2.2. Il-pressjoni tal-fwar, volatilità Method A.4 Vapour pressure (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 104: Vapour Pressure —

2.3. Id-dehra (stat fiżiku, kulur) — —

2.4. L-ispettri (UV/VIS, IR, NMR, MS), estinzjoni molari fil-frekwenzi relevanti, purità ottika OECD Test Guideline 101: UV-VIS Absorption Spectra —

2.5. Is-solubilità fl-ilma Method A.6 Water solubility (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 105: Water Solubility —

2.6. Is-solubilità f’solventi organiċi CIPAC Method MT 181: Solubility in organic solvents —

2.7. Il-koeffiċjent tas-sehem ta’ n-octanol/ilma Method A.8 Partition coefficient (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 107: Partition coefficient, shake-flask method Jekk kompost ikun tensjoattiv (kif iddefinit mill-Metodu A.5 Tensjoni tal-wiċċ) il-metodu tat-tħawwid tal-flask fil-metodu A.8 jista’ jkun applikabbli jekk fir-rapport ikun ċar li ma nħolqu l-ebda problemi (eż. is-separazzjonijiet f'fażijiet). Il-metodu HPLC deskritt fil-Metodu A.8 mhuwiex applikabbli għall-komposti li huma attivi fil-wiċċ. —

2.8. Id-dissaċjazzjoni fl-ilma OECD Test Guideline 112: Dissociation Constants in Water. —

2.9. Il-fjammabbilità u l-awtotisħin Fjammabbiltà: Methods A.10 Flammability (solids), A.11 Flammability (gases), A.12 Flammability (contact with water) (Annex to Regulation (EC) No 440/2008), as appropriate; Test N.1: test method for readily combustible solids (UN RTDG Manual of Tests and Criteria ST/SG/AC.10/11/Rev. 5 – Part III, section 33.2.1.4) Awtotisħin: Methods A.15 Auto-ignition temperature (liquids and gases), A16 Relative self-ignition temperature for solids, (Annex to Regulation (EC) No 440/2008), as appropriate. Test N.4: test method for self-heating substances (UN RTDG Manual of Tests and Criteria ST/SG/AC.10/11/Rev. 5 – Part III, section 33.3.1.6) —

2.10. Il-punt ta’ fjammabbiltà Method A.9 Flash-point (Annex to Regulation (EC) No 440/2008) - only closed cup methods should be used. Test methods according to table 2.6.3 of Annex I, Part 2 of Regulation (EC) No 1272/2008 (6) (liquids); —

2.11. Karatteristiċi splussivi Method A.14 Explosive properties (Annex to Regulation (EC) No 440/2008) United Nations Recommendations on the Transport of Dangerous Goods (UN RTDG) Manual of Tests and Criteria ST/SG/AC.10/11/ Rev. 5 – Part I (Test series), section 11. —

2.12. It-tensjoni tal-wiċċ Method A.5 Surface tension (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 115: Surface tension of aqueous solutions —

2.13. Il-karatteristiċi ossidanti Solidi: Method A.17 Oxidising properties (solids) (Annex to Regulation (EC) No 440/2008) Likwidi: Method A.21 Oxidising properties (liquids) (Annex to Regulation (EC) No 440/2008) United Nations Recommendations on the Transport of Dangerous Goods (UN RTDG) Manual of Tests and Criteria ST/SG/AC.10/11/Rev. 4 – Part I (Test series). Test O.1: Test for oxidizing solids (UN RTDG Manual of Tests and Criteria ST/SG/AC.10/11/Rev. 5 – Part III, section 34.4.1) Test O.2: Test for oxidizing liquids (UN RTDG Manual of Tests and Criteria ST/SG/AC.10/11/Rev. 5 – Part III, section 34.4.2) —

2.14. Studji oħrajn Metodi ta’ ttestjar rrappurtati fl-Anness I, il-Parti II tar-Regolament (KE) Nru 1272/2008 —

3. IKTAR INFORMAZZJONI DWAR IS-SUSTANZA ATTIVA EPPO standard series PP1: Efficacy evaluation of plant protection products (7) —

3.1. L-użu tas-sustanza attiva — —

3.2. Il-funzjoni — —

3.3. L-effetti fuq organiżmi dannużi — —

3.4. Il-firxa tal-użu mbassra — —

3.5. L-organiżmi dannużi kkontrollati u l-għelejjel jew il-prodotti protetti jew ittrattati — —

3.6. Il-modalità tal-azzjoni — —

3.7. Informazzjoni dwar l-okkorrenza jew l-okkorrenza possibbli tal-iżvilupp tar-reżistenza u strateġiji ta’ ġestjoni xierqa EPPO standard PP 1/213: Resistance risk analysis —

3.8. Il-metodi u l-prekawzjonijiet rakkomandati li jikkonċernaw il-manipulazzjoni, il-ħżin, it-trasport jew in-nar — —

3.9. Il-proċeduri għall-qerda jew id-dekontaminazzjoni — —

3.10. Il-miżuri ta’ emerġenza fil-każ ta’ inċident — —

4. METODI ANALITIĊI — Materjal tekniku u preparazzjonijiet: EU guidance document on analytical methods for the analysis of technical material and preparation (SANCO/3030/99 rev. 4) Residwi: EU guidance document on analytical methods for the determination of residues (Post-registration monitoring and control) (SANCO/825/00 rev. 8.1, 2010) EU guidance document for generating and reporting methods of analysis in support of pre-registration data requirements (SANCO/3029/99 rev. 4). OECD (2007). Guidance Document on Pesticide Residue Analytical Methods. Environment, Health and Safety Publications. Series on Testing and Assessment No. 72 and Series on Pesticides No. 39.

5. L-ISTUDJI TOSSIKOLOĠIĊI U TAL-METABOLIŻMU — —

5.1. Studji dwar l-assorbiment, id-distribuzzjoni, il-metaboliżmu u t-tneħħija fil-mammiferi — EU Working Document. Draft Guidance for the Setting and Application of Acceptable Operator Exposure Levels (AOEL’s) (SANCO 7531 rev. 10, 10.07.2006) OECD (2010) Guidance for the Derivation of an Acute Reference Dose” OECD Series on testing and assessment, No. 124, 08-Jun-2010

5.1.1. L-assorbiment, id-distribuzzjoni, il-metaboliżmu u t-tneħħija wara espożizzjoni mir-rotta orali Method B.36 Toxicokinetics (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 417: Toxicokinetics —

5.1.2. L-assorbiment, id-distribuzzjoni, il-metaboliżmu u t-tneħħija wara espożizzjoni minn rotot oħra Method B.36 Toxicokinetics (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 417: Toxicokinetics —

5.2. Tossiċità akuta — —

5.2.1. Orali Method B.1 bis Acute oral toxicity - fixed dose procedure (Annex to Regulation (EC) No 440/2008). Method B.1 tris Acute oral toxicity - Acute toxic class method (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 420: Acute oral toxicity: fixed dose procedure OECD Test Guideline 423: Acute oral toxicity: acute toxic class method OECD Test Guideline 425: Acute oral toxicity: up-and-down procedure OECD Test Guideline No 401: Acute oral toxicity (only acceptable, if performed before December 2002) —

5.2.2. Dermali Method B.3 Acute toxicity (dermal) (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 402: Acute Dermal Toxicity —

5.2.3. Teħid man-nifs Method B.2 Acute toxicity (inhalation) (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 403: Acute Inhalation Toxicity OECD Test Guideline 436: Acute Inhalation Toxicity – Acute Toxic Class Method —

5.2.4. Irritazzjoni tal-ġilda Method B.4 Acute toxicity: dermal irritation/corrosion (Annex to Regulation (EC) No 440/2008). Method B.40 In vitro skin corrosion: transcutaneous electrical resistance test (TER) (Annex to Regulation (EC) No 440/2008). Method B.40 bis In vitro skin corrosion: human skin model test (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 404: Acute Dermal Irritation/Corrosion OECD Test Guideline 431: In vitro Skin Corrosion: Human Skin Model Test OECD Test Guideline 430: In vitro Skin Corrosion: Transcutaneous Electrical Resistance Test OECD Test Guideline 435: In vitro Membrane Barrier Test Method for Skin Corrosion OECD Test Guideline 439: In vitro Skin Irritation: Reconstructed Human Epidermis Test Method Method B.46 In vitro skin irritation: reconstructed human epidermis model test (Annex III of Regulation (EC) No 761/2009 (8)). —

5.2.5. Irritazzjoni tal-għajnejn Method B.5 Acute toxicity: eye irritation/corrosion (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 405: Acute eye irritation/corrosion OECD Test Guideline 437: Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants OECD Test Guideline 438: Isolated Chicken Eye Test Method for Identifying Ocular Corrosives and Severe Irritants Method B.47 Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants (Annex of Regulation (EC) No 1152/2010 (9)) Method B.48 Isolated chicken eye test method for identifying ocular corrosives and severe irritants (Annex of Regulation (EC) No 1152/2010) —

5.2.6. Is-sensitizzazzjoni tal-ġilda Method B.42 Skin sensitisation: Local lymph node assay (Annex to Regulation (EC) No 440/2008). Method B.6 Skin sensitisation (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 429: Skin Sensitisation – Local Lymph Node Assay OECD Test Guideline 406: Skin sensitisation OECD Test Guideline 442A: Skin Sensitisation – Local Lymph Node Assay: DA OECD Test Guideline 442B: Skin Sensitisation – Local Lymph Node Assay: BrdU-ELISA —

5.2.7. Fototossiċità Method B.41 In vitro 3T3 NRU phototoxicity test (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 432: In vitro 3T3 NRU Phototoxicity Test OECD Test Guideline 101: UV-VIS Absorption Spectra —

5.3. It-tossoċità fuq perjodu qasir — —

5.3.1. L-istudju orali ta’ 28 ġurnata Method B.7 Repeated dose (28 days) toxicity (oral) (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 407: Repeated dose 28-day oral toxicity study in rodents —

5.3.2. L-istudju orali ta’ 90 ġurnata Method B.26 Sub-chronic oral toxicity test. Repeated dose 90-day oral toxicity study in rodents (Annex to Regulation (EC) No 440/2008). Method B.27 Sub-chronic oral toxicity test. Repeated dose 90-day oral toxicity study in non-rodents (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 408: Repeated dose 90-day oral toxicity study in rodents OECD Test Guideline 409: Repeated dose 90-day oral toxicity study in non-rodents —

5.3.3. Rotot oħrajn Method B8 Repeated dose (28 days) toxicity (inhalation) (Annex to Regulation (EC) No 440/2008). Method B.9 Repeated dose (28 days) toxicity (dermal) (Annex to Regulation (EC) No 440/2008). Method B.28 Sub-chronic dermal toxicity test: 90-day repeated dermal dose study using rodent species (Annex to Regulation (EC) No 440/2008). Method B.29 Sub-chronic inhalation toxicity study 90-day repeated inhalation dose study using rodent species (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 410: Repeated dose dermal toxicity: 21/28-day study. OECD Test Guideline 411: Subchronic dermal toxicity: 90-day study. OECD Test Guideline 412: Subacute inhalation toxicity: 28-day study. OECD Test Guideline 413: Subchronic inhalation toxicity: 90-day study. —

5.4. Ittestjar tal-ġenotossiċità — —

5.4.1. Studji in vitro Method B.13/14 Mutagenicity - reverse mutation test using bacteria (Annex to Regulation (EC) No 440/2008). Method B.10 Mutagenicity - In vitro mammalian chromosome aberration test (Annex to Regulation (EC) No 440/2008). Method B.17 – Mutagenicity – In vitro mammalian cell gene mutation test (Annex to Regulation (EC) No 440/2008). - For this test mouse lymphoma assay is recommended. OECD Test Guideline 471: Bacterial Reverse Mutation Test OECD Test Guideline 473: In vitro Mammalian Chromosome Aberration Test OECD Test Guideline 476: In vitro Mammalian Cell Gene Mutation Test - For this test mouse lymphoma assay is recommended. OECD Test Guideline 487. In vitro Mammalian Cell Micronucleus Test. In vitro Comet assay could be used when justified. —

5.4.2. Studji in vivo f’ċelloli somatiċi Method B.12 - Mutagenicity - In vivo mammalian erythrocyte micronucleus test (Annex to Regulation (EC) No 440/2008). Method B.11 - Mutagenicity – In vivo mammalian bone-marrow chromosome aberration test (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 474: Mammalian Erythrocyte Micronucleus Test OECD Test Guideline 475: Mammalian Bone Marrow Chromosome Aberration Test OECD Test Guideline 486: Unscheduled DNA synthesis (UDS) - Test with mammalian liver cells in vivo. OECD Test Guideline 488: Transgenic Rodent Somatic and Germ Cell Gene Mutation Assays Method B.39 Unscheduled DNA synthesis (UDS) - Test with mammalian liver cells in vivo (Annex to Regulation (EC) No 440/2008). In vivo Comet assay could be used when justified and considering EFSA (2012). Minimum Criteria for the acceptance of in vivo alkaline Comet Assay Reports. EFSA Journal 2012;10(11):2977

5.4.3. Studji in vivo f’ċelloli ġerminali Method B.23 Mammalian spermatogonial chromosome aberration test (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 483: Mammalian Spermatogonial Chromosome Aberration Test. OECD Test Guideline 488: Transgenic Rodent Somatic and Germ Cell Gene Mutation Assays. —

5.5. It-tossiċità fuq perjodu twil u l-karċinoġeniċità Method B.30 Chronic toxicity test (Annex to Regulation (EC) No 440/2008). Method B.32 Carcinogenicity test (Annex to Regulation (EC) No 440/2008). Method B.33 Combined chronic toxicity/carcinogenicity test (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 451: Carcinogenicity Studies. OECD Test Guideline 452: Chronic Toxicity Studies. OECD Test Guideline 453: Combined Chronic Toxicity/Carcinogenicity Studies. —

5.6. It-tossiċità għar-riproduzzjoni —

5.6.1. Studji fuq ħafna ġenerazzjonijiet Method B.35 Two-generation reproduction toxicity study (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 416: Two-Generation Reproduction Toxicity. OECD Test Guideline 443: Extended One-generation Reproduction Toxicity. —

5.6.2. Studji tal-effett tossiku fuq l-iżvilupp Method B.31 Prenatal developmental toxicity study (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 414: Prenatal developmental toxicity study. OECD Test Guideline 426: Developmental neurotoxicity study. —

5.7. Studji tan-newrotossiċità —

5.7.1. Studji tan-newrotossiċità f’annimali li jgerrmu Method B.43 Neurotoxicity study in rodents (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 424: Neurotoxicity study in rodents. —

5.7.2. Studji tal-polinewropatija ttardjata Method B.37 Delayed neurotoxicity of organophosphorus substances after acute exposure (Annex to Regulation (EC) No 440/2008). Method B.38 Delayed neurotoxicity of organophosphorus substances 28-day repeated dose study (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 418: Delayed Neurotoxicity of Organophosphorus Substances Following Acute Exposure. OECD Test Guideline 419: Delayed Neurotoxicity of Organophosphorus Substances: 28-day Repeated Dose Study. —

5.8. Studji tossikoloġiċi oħrajn — —

5.8.1. Studji tossikoloġiċi tal-metaboliti EU Guidance document on the assessment of the relevance of metabolites in groundwater of substances regulated under Council Directive 91/414/EEC (SANCO/221/2000 – rev.10. final)

5.8.2. Studji addizzjonali dwar is-sustanza attiva — OECD (2010) Guidance for conducting a single exposure toxicity study. IN: OECD (2010) Guidance for the Derivation of an Acute Reference Dose” OECD Series on testing and assessment, No. 124, 08-Jun-2010

5.8.3. Karatteristiċi li jfixklu l-endokrina OECD Test Guideline 456: H295R Steroidogenesis Assay OECD Test Guideline 441: Hershberger Bioassay in Rats, A Short-term Screening Assay for (Anti)Androgenic Properties OECD Test Guideline 455: Stably Transfected Human Estrogen Receptor-alpha Transcriptional Activation Assay for Detection of Estrogenic Agonist-Activity of Chemicals OECD Test Guideline 440: Uterotrophic Bioassay in Rodents A short-term screening test for oestrogenic properties OCSPP Guideline 890.1500: Pubertal Development and Thyroid Function in Intact Juvenile/Peripubertal Male Rats Assay OCSPP Guideline 890.1450: Pubertal Development and Thyroid Function in Intact Juvenile/Peripubertal Female Rats Assay U.S. Environmental Protection Agency (2007): 15-Day Intact Adult Male Rat Assay —

5.9. Dejta medika — —

6. RESIDWI FIL-PRODOTTI, L-IKEL JEW L-GĦALF ITTRATTATI JEW FUQHOM OECD (2009). Guidance Document on Overview of Residue Chemistry Studies (as revised in 2009). Environment, Health and Safety Publications. Series on Testing and Assessment No. 64 and Series on Pesticides No. 32.

6.1 L-istabilità tar-residwi matul il-ħażna OECD Test Guideline 506: Stability of pesticide residues in stored commodities —

6.2 Il-metaboliżmu, id-distribuzzjoni u l-espressjoni tar-residwi — —

6.2.1. Pjanti OECD Test Guideline 501: Metabolism in crops —

6.2.2. Tjur OECD Test Guideline 503: Metabolism in livestock —

6.2.3. Ruminanti li jaħilbu OECD Test Guideline 503: Metabolism in livestock —

6.2.4. Ħnieżer OECD Test Guideline 503: Metabolism in livestock —

6.2.5. Ħut — —

6.3. Il-kobor tal-provi tar-residwi fil-pjanti OECD Test Guideline 509: Crop field trials OECD (2011) Guidance Document on Crop Field Trials (Series on Testing and Assessment No. 164 and Series on Pesticides No. 66)

6.4. Studji dwar l-għalf — —

6.4.1. Tjur OECD Test Guideline 505: Residues in livestock. —

6.4.2. Ruminanti OECD Test Guideline 505: Residues in livestock. —

6.4.3. Ħnieżer OECD Test Guideline 505: Residues in livestock. —

6.4.4. Ħut — —

6.5. L-effetti tal-ipproċessar — —

6.5.1. In-natura tar-residwu OECD Test Guideline 507: Nature of the pesticide residues in processed commodities – High temperature hydrolysis. —

6.5.2. Id-distribuzzjoni tar-residwu fil-qoxra u l-polpa mhux tal-ikel OECD Test Guideline 508: Magnitude of the pesticide residues in processed commodities. OECD Test Guideline 509: Crop field trials. —

6.5.3. Il-kobor tar-residwi fi prodotti pproċessati OECD Test Guideline 508: Magnitude of the pesticide residues in processed commodities. OECD (2008). Guidance document on magnitude of pesticide residues in processed commodities. Environment, Health and Safety Publications. Series on Testing and Assessment No. 96.

6.6. Ir-residwi fl-għelejjel ta’ rotazzjoni — —

6.6.1. Il-metaboliżmu fl-għelejjel ta’ rotazzjoni OECD Test Guideline 502: Metabolism in rotational crops. —

6.6.2. Il-kobor tar-residwi fl-għelejjel ta’ rotazzjoni OECD Test Guideline 504: Residues in rotational crops (limited field studies). OECD Test Guideline 509: Crop field trials. —

6.7. Id-definizzjonijiet proposti ta’ residwu u l-livelli massimi ta’ residwu — —

6.7.1. Id-definizzjonijiet proposti ta’ residwu — OECD (2009). Guidance Document on the Definition of Residues. Environment, Health and Safety Publications. Series on Testing and Assessment No. 63 and Series on Pesticides No. 31

6.7.2. Livelli massimi ta' residwu proposti (MRLs) u ġustifikazzjoni tal-aċċettabilità tal-livelli proposti — EU guidance document "Guidelines on comparability, extrapolation, group tolerances and data requirements for setting MRLs" (SANCO 7525/VI/95 rev. 9, March 2011). OECD MRL calculator (2011)

6.7.3. Livelli massimi ta' residwu proposti (MRLs) u ġustifikazzjoni tal-aċċettabilità tal-livelli proposti għal prodotti importati (tolleranza tal-importazzjoni) — EU guidance document "Guidelines on comparability, extrapolation, group tolerances and data requirements for setting MRLs" (SANCO 7525/VI/95 rev. 9, March 2011). OECD MRL calculator (2011)

6.8. Intervalli proposti tas-sigurtà — EU guidance document "Calculation of Maximum Residue Levels and Safety Intervals e.g. Pre-harvest Intervals" (SANCO 7039/VI/95, 22/7/1997)

6.9. Stima tal-espożizzjoni potenzjali u reali permezz tad-dieta u sorsi oħra — EFSA calculation model Pesticide Residue Intake Model "PRIMo" - revision 2 (10)

6.10. Studji oħrajn — —

6.10.1. Il-livell ta’ residwu fl-għabra tad-dakra u l-prodotti tan-naħal — —

7. DESTIN U MĠIBA FL-AMBJENT — —

7.1. Destin u mġiba fil-ħamrija OECD Test Guideline 307: Aerobic and anaerobic transformation in soil. ISO 10381-6:2009 Soil quality. Sampling. Guidance on the collection, handling and storage of soil under aerobic conditions for the assessment of microbiological processes, biomass and diversity in the laboratory —

7.1.1. Ir-rotta tad-degradazzjoni fil-ħamrija — —

7.1.1.1. Id-degredazzjoni aerobika OECD Test Guideline 307: Aerobic and anaerobic transformation in soil. —

7.1.1.2. Id-degradazzjoni anaerobika OECD Test Guideline 307: Aerobic and anaerobic transformation in soil. —

7.1.1.3. Il-fotoliżi tal-ħamrija — SETAC 1995 – Procedures for assessing the environmental fate and ecotoxicity of pesticides

7.1.2. Ir-rata ta’ degradazzjoni fil-ħamrija — EFSA (2010). EFSA Panel on Plant Protection Products; Guidance for evaluating laboratory and field dissipation studies to obtain DegT50 values of plant protection products in soil. EFSA Journal 2010;8(12):1936.

7.1.2.1. Studji tal-laboratorji OECD Test Guideline 307: Aerobic and anaerobic transformation in soil. FOCUS Ground Water FOCUS Degradation Kinetics EFSA (2007). Scientific Opinion on a request from EFSA related to the default Q10 value used to describe the temperature effect on transformation rates of pesticides in soil. The EFSA Journal (2007) 622, 1-32.

7.1.2.2. Studji fuq il-post US EPA OCSPP 835.6100: Terrestrial field dissipation FOCUS Ground Water FOCUS Degradation Kinetics FOCUS soil persistence models Aspetti tekniċi li jgħinu biex jiddeterminaw ir-rati ta' degradazzjoni fil-ħamrija fl-istudji fuq il-post, jistgħu jiġu kkonsultati fi: Regulatory Directive DIR2006-01: Harmonization of Guidance for Terrestrial Field Studies of Pesticide Dissipation under the North American Free Trade Agreement. Pest Management Regulatory Agency (PMRA). Health Canada (11)

7.1.3. Assorbiment u dissorbiment fil-ħamrija — —

7.1.3.1. Assorbiment u dissorbiment OECD Test Guideline 106: Adsorption - Desorption Using a Batch Equilibrium Method OECD Test Guideline 121: Estimation of the Adsorption Coefficient (Koc ) on Soil and on Sewage Sludge using High Performance Liquid Chromatography (HPLC) OECD Test Guideline 307: Aerobic and anaerobic transformation in soil. FOCUS Ground Water European Commission. Scientific Committee on plants SCP/KOC/002-Final. Opinion of the Scientific Committee on Plants on methods for the determination of the organic carbon adsorption coefficient (K0c) for a plant protection product active substance in the context of Council Directive 91/414/EEC (18 July 2002) (12)

7.1.3.2. Sorbiment li għadda ż-żmien fuqu — FOCUS Ground Water

7.1.4. Mobilità fil-ħamrija — —

7.1.4.1. Studji ta' lissija fuq kolonna OECD Test Guideline 312: Leaching in Soil Columns —

7.1.4.2. Studji lisimetriċi OECD Guidance Document 22: Guidance Document for the Performance Of Out-door Monolith Lysimeter Studies FOCUS Ground Water

7.1.4.3. Studji tal-lissija fil-post — FOCUS Ground Water

7.2. Destin u mġiba fl-ilma u s-sediment — —

7.2.1. Ir-rotta u r-rata ta’ degradazzjoni fis-sistemi akwatiċi (degradazzjoni kimika u fotokimika) — —

7.2.1.1. Id-degradazzjoni idrolitika OECD Test Guideline 111: Hydrolysis as a Function of pH —

7.2.1.2. Id-degradazzjoni fotokimika diretta OECD Test Guideline 316: Phototransformation of Chemicals in Water - Direct Photolysis —

7.2.1.3. Id-degradazzjoni fotokimika indiretta — —

7.2.2. Ir-rotta u r-rata ta’ degradazzjoni bijoloġika fis-sistemi akkwatiċi — —

7.2.2.1. “Bijodegradabilità immedjata” Method C.4 Determination of "ready" biodegradability (Annex to Regulation (EC) No 440/2008). OECD Guideline Test 301: Ready Biodegradability (301 A - F) —

7.2.2.2. Mineralizzazzjoni aerobika fl-ilma tal-wiċċ OECD Test Guideline 309: Aerobic Mineralisation in Surface Water - Simulation Biodegradation Test ECHA Guidance on information requirements and chemical safety assessment Chapter R 11: PBT Assessment

7.2.2.3. Studju tal-ilma/sediment OECD Test Guideline 308: Aerobic and Anaerobic Transformation in Aquatic Sediment Systems FOCUS Surface Water FOCUS Degradation Kinetics

7.2.2.4. Studju tal-ilma/sediment irradjat OECD Test Guideline 308: Aerobic and Anaerobic Transformation in Aquatic Sediment Systems —

7.2.3. Degradazzjoni fiż-żona ta’ saturazzjoni — —

7.3. Destin u mġiba fl-arja FOCUS Air

7.3.1. Ir-rotta u r-rata ta’ degradazzjoni fl-arja — —

7.3.2. Trasport bl-arja — —

7.3.3. Effetti lokali u globali — —

7.4. Definizzjoni tar-residwu — —

7.4.1. Id-definizzjoni tar-residwu għall-valutazzjoni tar-riskju — —

7.4.2. Id-definizzjoni tar-residwu għall-monitoraġġ — —

7.5. Dejta dwar il-monitoraġġ — —

8. STUDJI EKOTOSSIKOLOĠIĊI — OECD series of testing and assessment Number 54. "Current approaches in the statistical analysis of ecotoxicity data: a guidance to application"

8.1. Effetti fuq l-għasafar u vertebrati terrestri oħrajn — EFSA (2009) Guidance of EFSA - Risk assessment for birds and mammals. EFSA Journal 2009; 7(12):1438.

8.1.1. Effetti fuq l-għasafar — —

8.1.1.1. Tossiċità orali akuta għall-għasafar OECD Test Guideline No 223: Avian acute oral toxicity study jew US EPA OCSPP 850.2100: Avian oral toxicity test —

8.1.1.2. Tossiċità dijatetika għall-għasafar fuq perjodu qasir OECD Test Guideline 205: Avian Dietary Toxicity Test jew US EPA OCSPP 850.2200: Avian dietary toxicity test. —

8.1.1.3. Tossiċità subkronika u riproduttiva għall-għasafar OECD Test Guideline 206: Avian Reproduction Test jew US EPA OCSPP 850.2300: Avian Reproduction Test —

8.1.2. Effetti fuq vertebrati terrestri li mhumiex għasafar — —

8.1.2.1. Tossiċità orali akuta għall-mammiferi — —

8.1.2.2. Tossiċità riproduttiva u fit-tul għall-mammiferi — —

8.1.3. Bijokonċentrazzjoni tas-sustanza attiva fil-priża ta’ għasafar u mammiferi — —

8.1.4. Effetti fuq l-annimali vertebrati terrestri (għasafar, mammiferi, rettili u amfibji) OECD Test Guideline 231: Amphibian Metamorphosis Assay —

8.1.5. Karatteristiċi li jfixklu l-endokrina — Workshop report on OECD countries activities regarding testing, assessment and management of endocrine disrupters. Series on testing and assessment No 118. 18 January 2010.

8.2. Effetti fuq organiżmi akkwatiċi — EU Guidance Document on Aquatic Ecotoxicology (SANCO/3268/2001 rev.4) OECD (2000). Guidance document on aquatic toxicity testing of difficult substances and mixtures. OECD series on testing and assessment Number 23.

8.2.1. Tossiċità akuta għall-ħut OECD Test Guideline 203: Fish, Acute Toxicity Test (13) OECD. Series on testing and assessment No 126. Short guidance on the threshold approach for acute fish toxicity. ENV/JM/MONO(2010)17

8.2.2. Tossiċità kronika u fit-tul għall-ħut — —

8.2.2.1. Test tat-tossiċità fi stadju bikri tal-ħajja tal-ħut OECD Test Guideline 210: Fish, Early-Life Stage Toxicity Test —

8.2.2.2. Test taċ-ċiklu sħiħ tal-ħajja tal-ħut US EPA protocol OCSPP 850.1500 Fish life cycle toxicity. —

8.2.2.3. Il-bijokonċentrazzjoni fil-ħut — —

8.2.3. Karatteristiċi li jfixklu l-endokrina OECD Test Guideline 229: Fish Short Term Reproduction Assay OECD Test Guideline 230: 21-day Fish Assay: A Short-Term Screening for Oestrogenic and Androgenic Activity, and Aromatase Inhibition OECD Test Guideline 231: Amphibian Metamorphosis Assay OECD Test Guideline 234 Fish Sexual Development Test Workshop report on OECD countries activities regarding testing, assessment and management of endocrine disrupters. Series on testing and assessment No 118. 18 January 2010.

8.2.4. Tossiċità akuta għall-invertebrati akkwatiċi — EU Guidance Document on Aquatic Ecotoxicology (SANCO/3268/2001 rev.4)

8.2.4.1. Tossiċità akuta għad-Daphnia magna OECD Test Guideline 202: Daphnia sp. Acute Immobilisation Test —

8.2.4.2. Tossiċità akuta għal speċi ta’ invertebrat akkwatiku addizzjonali US EPA OCSPP 850.1035 Mysid Acute Toxicity Test —

8.2.5. Tossiċità kronika u fit-tul għall-invertebrati akkwatiċi — —

8.2.5.1. Effett tossiku fuq ir-riproduzzjoni u l-iżvilupp għad-Daphnia magna OECD Test Guideline 211: Daphnia magna Reproduction Test —

8.2.5.2. Effett tossiku fuq ir-riproduzzjoni u l-iżvilupp għal speċi invertebrata akkwatika addizzjonali US EPA OCSPP 850.1350 Mysid Chronic Toxicity Test —

8.2.5.3. L-iżvilupp u t-tfaċċar fi Chironomus riparius OECD Test Guideline 219: Sediment-Water Chironomid Toxicity Using Spiked Water [B’mod ġenerali, sistema ta' sediment tal-ilma (jiġifieri OECD 219) tkopri aħjar ir-rotot ta’ espożizzjoni li huma tipiċi għall-prodotti ta’ protezzjoni tal-pjanti] —

8.2.5.4. Organiżmi li jgħixu fis-sediment OECD Test Guideline 218: Sediment-Water Chironomid Toxicity Using Spiked Sediment —

8.2.6. Effetti fuq it-tkabbir tal-alga — —

8.2.6.1. Effetti fuq it-tkabbir tal-alga ħadra OECD Test Guideline 201: Algae growth inhibition test —

8.2.6.2. Effetti fuq it-tkabbir ta’ speċi oħrajn ta’ alga OECD Test Guideline 201: Algae growth inhibition test. —

8.2.7. Effetti fuq il-makrofiti akkwatiċi OECD Test Guideline 221: Lemna sp. Growth Inhibition Test ASTM E1913-04: Standard Guide for Conducting Static, Axenic, 14-Day Phytotoxicity Tests in Test Tubes with the Submersed Aquatic Macrophyte, Myriophyllum sibiricum Komarov Development of a proposed test method for the rooted aquatic macrophyte Myriophyllum sp. In: Maltby L, Arnold D, Arts G, et al (2010). Aquatic Macrophyte Risk Assessment for pesticides (AMRAP). SETAC Press & CRC Press, Taylor & -Francis Group, Boca Raton, London, New York, p. 46-56.

8.2.8. Iktar ittestjar fuq organiżmi akkwatiċi — EU Guidance Document on Aquatic Ecotoxicology (SANCO/3268/2001 rev.4)

8.3. Effetti fuq l-artropodi — EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002 rev 2)

8.3.1. Effetti fuq in-naħal — EPPO Standard PP 3/10 (3) Environmental risk assessment scheme for plant protection products. Chapter 10: honeybees.

8.3.1.1. Tossiċità akuta għan-naħal —

8.3.1.1.1. Tossiċità orali akuta EPPO Standard PP1/170 (4): Test methods for evaluating the side-effects of plant protection products on honeybees. OECD Test Guideline 213: Honeybees, Acute Oral Toxicity Test

8.3.1.1.2. Tossiċità akuta minn kuntatt EPPO Standard PP1/170 (4): Test methods for evaluating the side-effects of plant protection products on honeybees. OECD Test Guideline 214: Honeybees, Acute Contact Toxicity Test

8.3.1.2. Tossiċità kronika għan-naħal Aupinel et al (2007): A new larval in vitro rearing method to test effects of pesticides on honey bee brood. Redia XC: 87-90 Oomen PA, de Ruijter A and van der Steen J, 1992. Method for honeybee brood feeding tests with insect growth - regulating insecticides. Bulletin OEPP/EPPO Bulletin 22, 613-616.

8.3.1.3. Effetti fuq l-iżvilupp tan-naħal tal-għasel u stadji tal-ħajja oħrajn tan-naħal tal-għasel Aupinel et al (2007): A new larval in vitro rearing method to test effects of pesticides on honey bee brood. Redia XC: 87-90

8.3.1.4. Effetti subletali Oomen PA, de Ruijter A and van der Steen J, 1992. Method for honeybee brood feeding tests with insect growth - regulating insecticides. Bulletin OEPP/EPPO Bulletin 22, 613-616.

8.3.2. Effetti fuq antropodi mhux fil-mira għajr in-naħal Candolfi et al (2001). Guidance Document on Regulatory Testing and Risk Assessment Procedures for Plant Protection Products With Non-Target Arthropods: From the Escort 2 Workshop (European Standard Characteristics of Non-Target Arthropod Regulatory Testing). SETAC press, pp 46. ISBN 1-880611-52-x.

8.3.2.1. Effetti fuq Aphidius rhopalosiphi M.P. Candolfi, S. Blümel, R. Forster et al. (2000): Guidelines to evaluate side-effects of plant protection products to non-target arthropods. IOBC, BART and EPPO Joint Initiative. ISBN: 92-9067-129-7.

8.3.2.2. Effetti fuq Typhlodromus pyri M.P. Candolfi, S. Blümel, R. Forster et al. (2000): Guidelines to evaluate side-effects of plant protection products to non-target arthropods. IOBC, BART and EPPO Joint Initiative. ISBN: 92-9067-129-7

8.4. Effetti fuq mesofawna u makrofawna tal-ħamrija li mhumiex fil-mira — EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002 rev 2)

8.4.1. Il-ħanex – l-effetti subletali OECD Test Guideline 222: Earthworm Reproduction Test (Eisenia fetida/Eisenia andrei)

8.4.2. Effetti fuq mesofawna u makrofawna tal-ħamrija li mhumiex fil-mira (minbarra l-ħniex) —

8.4.2.1. Ittestjar tal-livell tal-ispeċi Għall-Collembola: OECD Test Guideline 232: Collembolan Reproduction Test in Soil Għad-dud predatorju: OECD Test Guideline 226: Predatory mite (Hypoaspis (Geolaelaps) aculeifer) reproduction test in soil

8.5. Effetti fuq it-trasformazzjoni tan-nitroġenu tal-ħamrija OECD Test Guideline 216: Soil Microorganisms: Nitrogen Transformation Test EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002 rev 2)

8.6. Effetti fuq pjanti terrestri ogħla li mhumiex fil-mira — EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002 rev 2)

8.6.1. Sommarju tad-dejta ta’ tgħarbil — —

8.6.2. Ittestjar fuq pjanti mhux fil-mira Bidu u tkabbir ta' nebbieta: OECD Test Guideline 208: Terrestrial Plant Test: Seedling Emergence and Seedling Growth Test Ittestjar tal-vitalità veġetattiva tal-pjanti terrestri OECD Test Guideline 227: Terrestrial Plant Test: Vegetative Vigour Test —

8.7. Effetti fuq organiżmi terrestri oħra (flora u fawna) — EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002 rev 2)

8.8. Effetti fuq metodi bijoloġiċi għat-trattament tad-drenaġġ OECD Test Guideline 209: Activated Sludge, Respiration Inhibition Test EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002 rev 2)

9. DEJTA MIL-LETTERATURA EFSA (2011). Guidance of EFSA - Submission of scientific peer-reviewed open literature for the approval of pesticide active substances under Regulation (EC) No 1107/2009. EFSA Journal 2011; 9(2):209