Referenza għal Parti A tal-Anness tar-Regolament (UE) Nru 284/2013 Metodi ta’ ttestjar (2) Dokumenti ta’ gwida (3)

1. IDENTITÀ TAL-PRODOTT GĦALL-PROTEZZJONI TAL-PJANTI — WHO/FAO. 2010. Manual on development and use of FAO and WHO specifications for pesticides. Second revision of the first edition. Rome, 2010 (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. IL-KARATTERISTIĊI FIŻIĊI, KIMIĊI U TEKNIĊI TAL-PRODOTT GĦALL-PROTEZZJONI TAL-PJANTI — WHO/FAO. 2010. Manual on development and use of FAO and WHO specifications for pesticides. Second revision of the first edition. Rome, 2010

2.1. Dehra — —

2.2. Karatteristiċi esplożivi u ossidanti Karatteristiċi esplożivi: Method A.14 Explosive properties (Annex of 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. Karatteristiċi ossidanti: Solids: Method A.17 Oxidising properties (solids) (Annex of Regulation (EC) No 440/2008) Liquids: Method A.21 Oxidising properties (liquids) (Annex of Regulation (EC) No 440/2008) 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) —

2.3. Fjammabbiltà u tisħin spontanju Fjammabbiltà: Method A.9 Flash-point (liquids) (Annex of Regulation (EC) No 440/2008) Methods A.10 Flammability (solids), A.11 Flammability (gases), A.12 Flammability (contact with water) (Annex of 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) Tisħin spontanju: Methods A.15 Auto-ignition temperature (liquids and gases) and A.16 Relative self-ignition temperature for solids (Annex of Regulation (EC) No 440/2008) 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) —

2.4. Aċidità/alkalinità u l-valur pH CIPAC Method MT 75.3: Determination of pH values (revised method) Preparazzjonijiet aċidużi jew alkalini: CIPAC Method MT 31: free acidity or alkalinity CIPAC Method MT 191: Acidity or alkalinity of formulations —

2.5. Viskożità u tensjoni tal-wiċċ Likwidi Newtonjani: OECD Test Guideline 114 Likwidi Mhux Newtonjani: CIPAC method MT 192: Viscosity of liquids by rotational viscosimetry or OECD Test Guideline 114 Tensjoni tal-wiċċ: Method A.5 Surface tension (Annex of Regulation (EC) No 440/2008) Method A.5 is written only for solutions in water however the principles contained in it can be used for other formulation types e.g. EC jew OECD Test Guideline 115 —

2.6. Densità relattiva u densità tal-massa Densità relattiva: Method A.3 Relative density (Annex of Regulation (EC) No 440/2008). jew OECD Test Guideline 109 Densità tal-massa: CIPAC method MT 186: Bulk density —

2.7. L-istabbiltà fil-ħażna u l-perjodu ta’ konservazzjoni l-effetti tat-temperatura fuq il-karetteristiċi tekniċi tal-prodott għall-protezzjoni tal-pjanti Stabbiltà: CIPAC MT 46.3: Accelerated storage procedure (combined method) Effett ta’ temperaturi baxxi fuq preparazzjonijiet likwidi: CIPAC Method MT 39.3: Low temperature stability of liquid formulations CropLife International, 2009. Technical Monograph No 17. Guidelines for Specifying the Shelf Life of Plant Protection Products.

2.8 Karatteristiċi tekniċi tal-prodott għall-protezzjoni tal-pjanti — —

2.8.1. Kemm jista’ jixxarrab CIPAC Method MT 53.3: Evaluation of wettability, wetting of dispersible powders —

2.8.2. Kemm jagħmel ragħwa b’mod persistenti CIPAC Method MT 47.2 Determination of the foaming of suspension concentrates —

2.8.3. Kapaċità ta’ sospensjoni, spontanjetà tad-dispersjoni u stabbiltà fid-dispersjoni Kapaċità ta’ sospensjoni: CIPAC Method MT 184: Suspensibility of formulations forming suspensions on dilution with water Spontanjetà tad-dispersjoni: CIPAC Method MT 160: Spontaneity of dispersion of suspension concentrates jew CIPAC Method MT 174: Dispersibility of water dispersible granules Stabbiltà fid-dispersjoni: CIPAC Method MT 180: Suspo-emulsions, dispersion stability —

2.8.4. Grad ta’ dissoluzzjoni tad-dilwizzjoni CIPAC Method MT 41.1: Dilution stability of aqueous solutions jew CIPAC Method MT 179: Water soluble granules, degree of dissolution and solution stability jew CIPAC Method MT: Solution properties of ST formulations (6) —

2.8.5. Distribuzzjoni tad-daqs tal-partikoli, kontenut ta’ trab, attrizzjoni u stabbiltà mekkanika — —

2.8.5.1. Distribuzzjoni tad-daqs tal-partikoli Prodotti idrodispersibbli: CIPAC Method MT 185: Wet sieve test Distribuzzjoni tad-daqs (trab): CIPAC Method MT 187: Particle size analysis by laser diffraction Firxa nominali tad-daqs (granuli): CIPAC Method MT 170: Dry sieve analysis of water dispersible granules CIPAC Method MT 187: Particle size analysis by laser diffraction —

2.8.5.2. Kontenut ta’ trab CIPAC Method MT 171: Dustiness of granular products —

2.8.5.3. Attrizzjoni Applikabbli għal granuli jew pilloli: CIPAC Method MT 178: Attrition resistance of granules CIPAC Method MT 178.2: Attrition resistance of dispersible granules —

2.8.5.4. Ebusija u integrità CIPAC Method MT 193: Friability of tablets —

2.8.6. L-emulsjonabbiltà, ir-riemulsjonabbiltà, l-istabbiltà tal-emulsjoni CIPAC Method MT 36.3: Emulsion characteristics of emulsifiable concentrates, emulsion characteristics and re-emulsification properties —

2.8.7. Fluwidità, kemm jista’ jitferra’ u kemm jista’ jitfarfar Fluwidità: CIPAC Method MT 172.1: Flowability of granular preparations after accelerated storage under pressure Kemm jista’ jitferra’: CIPAC Method MT 148: Pourability of suspension concentrates CIPAC Method MT 148.1: Pourability of suspension concentrates, revised method —

2.9. Kompatibilità fiżika u kimika ma’ prodotti oħra inklużi l-prodotti għall-protezzjoni tal-pjanti li magħhom irid jiġi awtorizzat l-użu tiegħu ASTM E1518 – 05: Standard Practice for Evaluation of Physical Compatibility of Pesticides in Aqueous Tank Mixtures by the Dynamic Shaker Method

2.10. Aderenza u distribuzzjoni maż-żrieragħ Distribuzzjoni: CIPAC Method MT 175: Seed treatment formulations, liquid, determination of seed-seed uniformity of distribution Adeżjoni: CIPAC Method MT 194: Adhesion to Treated Seed jew European Seed Association, 2011. Assessment of free floating dust and abrasion particles of treated seeds as a parameter of the quality of treated seeds: Heubach test. ESA STAT Dust Working Group (7). —

2.11. Studji oħrajn Metodi ta’ ttestjar rrappurtati fl-Anness I, il-Parti II tar-Regolament (KE) Nru 1272/2008 (8) —

3. INFORMAZZJONI DWAR L-APPLIKAZZJONI EPPO Standard PP1/239: Dose expression of plant protection products EPPO Standard PP1/240: Harmonized basic information for databases on plant protection products —

4. AKTAR TAGĦRIF DWAR IL-PRODOTT GĦALL-PROTEZZJONI TAL-PJANTI — FAO. Guidelines for the packaging and storage of pesticides Reżistenza tal-materjal ta’ ppakkjar mal-kontenut tiegħu: CropLife International Technical Monograph No 17, 2nd Edition

5. 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.

6. TAGĦRIF DWAR L-EFFIKAĊJA EPPO standard series PP1 (9) (Efficacy evaluation of plant protection products) EPPO standard series PP1 (9) (Efficacy evaluation of plant protection products)

6.1. Testijiet preliminari — —

6.2. L-effikaċja tat-testijiet — —

6.3. Informazzjoni dwar l-okkorrenza jew l-okkorrenza possibbli tal-iżvilupp tar-reżistenza — —

6.4. L-effetti avversi fuq il-pjanti ttrattati — —

6.4.1. Il-fitotossiċità għall-pjanti fil-mira (inklużi l-kultivars), jew għall-prodotti mill-pjanti fil-mira — —

6.4.2. L-effetti fuq il-produzzjoni tal-pjanti jew fuq il-prodotti mill-pjanti ttrattati — —

6.4.3. L-effetti fuq il-kwalità tal-pjanti jew tal-prodotti mill-pjanti — —

6.4.4. L-effetti fuq il-proċessi ta’ trasformazzjoni — —

6.4.5. L-impatt fuq il-pjanti ttrattati jew fuq il-prodotti mill-pjanti li jridu jintużaw għat-tkattir Seeds harvested from treated plants: ISTA Methods - International Rules for Seed Testing (10) —

6.5. Osservazzjonijiet dwar l-effetti sekondarji mhux mixtieqa jew mhux intenzjonati — —

6.5.1. L-impatt fuq l-uċuħ tar-raba’ sussegwenti — —

6.5.2. L-impatt fuq pjanti oħra, inklużi l-uċuħ tar-raba’ li jmissu magħhom — —

6.5.3. L-effetti fuq l-organiżmi ta’ benefiċċju u organiżmi oħra mhux fil-mira — —

7. STUDJI TOSSIKOLOĠIĊI — —

7.1. Tossiċità akuta — —

7.1.1. Tossiċità orali Method B.1 bis Acute oral toxicity - fixed dose procedure (Annex of Regulation (EC) No 440/2008). Method B.1 tris Acute oral toxicity - Acute toxic class method (Annex of 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 401: Acute oral toxicity (only acceptable, if performed before December 2002) —

7.1.2. Tossiċità dermali Method B.3 Acute toxicity (dermal) (Annex of Regulation (EC) No 440/2008) OECD Test Guideline 402: Acute Dermal Toxicity —

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

7.1.4. Irritazzjoni tal-ġilda Method B.4 Acute toxicity: dermal irritation/corrosion (Annex of Regulation (EC) No 440/2008). Method B.40 In vitro skin corrosion: transcutaneous electrical resistance test (TER) (Annex of Regulation (EC) No 440/2008). Method B.40 bis In vitro skin corrosion: human skin model test (Annex of 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 Method B.46 In vitro skin irritation: reconstructed human epidermis model test (Annex of Regulation (EC) No 440/2008). OECD Test Guideline 439: In vitro Skin Irritation: Reconstructed Human Epidermis Test Method —

7.1.5. Irritazzjoni tal-għajnejn Method B.5 Acute toxicity: eye irritation/corrosion (Annex of 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 (11)) Method B.48 Isolated chicken eye test method for identifying ocular corrosives and severe irritants (Annex of Regulation (EC) No 1152/2010) —

7.1.6. Sensitizzazzjoni tal-ġilda Method B.42 Skin sensitisation: Local lymph node assay (Annex of Regulation (EC) No 440/2008). Method B.6 Skin sensitisation (Annex of 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 —

7.1.7. Studji supplimentari dwar il-prodott għall-protezzjoni tal-pjanti — —

7.1.8. Studji supplimentari għal taħlitiet ta’ prodotti għall-protezzjoni tal-pjanti — —

7.2 Dejta dwar l-espożizzjoni —

7.2.1. L-espożizzjoni tal-operatur — OECD Guidance Document for the Conduct of Studies of Occupational Exposure to Pesticides During Agricultural Application, Series on Testing and Assessment No. 9, ECDE/GD(97)148.

7.2.1.1. Stima tal-espożizzjoni tal-operatur — —

7.2.1.2. Kejl tal-espożizzjoni tal-operatur — —

7.2.2. L-espożizzjoni ta’ min ikun fil-qrib u tar-residenti — —

7.2.2.1. Stima tal-espożizzjoni ta’ min ikun fil-qrib u tar-residenti — —

7.2.2.2 Kejl tal-espożizzjoni ta’ min ikun fil-qrib u tar-residenti — —

7.2.3. L-espożizzjoni tal-ħaddiema — —

7.2.3.1. Stima tal-espożizzjoni tal-ħaddiema — —

7.2.3.2. Kejl tal-espożizzjoni tal-ħaddiema — —

7.3. L-assorbiment mill-ġilda OECD Test Guideline 428: Skin absorption: in vitro method OECD Test Guideline 427: Skin absorption: in vivo method Method B.44 Skin absorption: in vivo method. (Annex of Regulation (EC) No 440/2008). Method B.45 Skin absorption: in vitro method. (Annex of Regulation (EC) No 440/2008). OECD Guidance notes on dermal absorption, Series on Testing and Assessment No. 156, ENV/JM/MONO (2011)36. WHO, 2006. Environmental Health Criteria, 235. Dermal Absorption (12). EFSA Scientific Opinion of PPR Panel - Guidance on Dermal Absorption EFSA Journal 2012; 10 (4):2665.

7.4. Dejta tossikoloġika disponibbli dwar il-koformulanti — —

8. RESIDWI FIL-PRODOTTI, L-IKEL JEW L-GĦALF ITTRATTATI, JEW FUQHOM Metodi ta’ ttestjar rrappurtati fit-Taqsima 6 tal-Anness tar-Regolament (UE) Nru 283/2013 (13) japplikaw. Dokumenti ta’ gwida rrappurtati fit-Taqsima 6 tal-Anness tar-Regolament (UE) Nru 283/2013 japplikaw.

9. DESTIN U MĠIBA FL-AMBJENT — —

9.1. 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 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.

9.1.1. Ir-rata ta’ degradazzjoni fil-ħamrija — —

9.1.1.1. Studji fil-laboratorju OECD Test Guideline 307: Aerobic and anaerobic transformation in soil. FOCUS Ground Water FOCUS Degradation Kinetics

9.1.1.1.2. Studji fuq il-post — Aspetti tekniċi li jgħinu biex jiddeterminaw ir-rati ta' degradazzjoni fil-ħamrija fl-istudji fuq il-post, jistgħu jiġu kkonsultati fi: EPA Fate, Transport and Transformation Test Guideline OCSPP 835.6100 Terrestrial Field Dissipation. 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 (14) FOCUS Ground Water FOCUS Degradation Kinetics

9.1.2. Il-mobilità fil-ħamrija — —

9.1.2.1. Studji fil-laboratorju 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 312: Leaching in Soil Columns OECD Test Guideline 307: Aerobic and anaerobic transformation in soil. FOCUS Ground Water

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

9.1.2.3. Studji tal-lissija fuq il-post — FOCUS Ground Water

9.1.3. Stima tal-konċentrazzjonijiet fil-ħamrija — Gwida dwar il-kalkolu PEC: FOCUS soil persistence models FOCUS Ground Water (source of crop canopy interception values for different crop growth stages). Gwida dwar il-parametri ta’ degradazzjoni u l-kalkolu PEC: FOCUS Degradation Kinetics

9.2. Destin u mġiba fl-ilma u fis-sediment — —

9.2.1. 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

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

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

9.2.4. Stima tal-konċentrazzjonijiet fl-ilma ta’ taħt l-art — FOCUS Ground Water FOCUS Degradation Kinetics

9.2.4.1. Kalkolu tal-konċentrazzjonijiet fl-ilma ta’ taħt l-art — —

9.2.4.2. Testijiet addizzjonali fuq il-post — —

9.2.5. Stima tal-konċentrazzjonijiet fl-ilma tal-wiċċ u s-sediment — Stima tal-konċentrazzjonijiet fl-ilma tal-wiċċ u s-sediment: FOCUS Surface Water FOCUS Degradation Kinetics EU Guidance on aquatic ecotoxicology (SANCO/3268/2001 rev.4) Mitigazzjoni tal-livelli ta’ espożizzjoni u valutazzjoni tal-ogħla livell fuq il-livell ta’ pajsaġġ: FOCUS Landscape and Mitigation FOCUS Air

9.3. Destin u mġiba fl-arja — —

9.3.1. Ir-rotta u r-rata ta' degradazzjoni fl-arja u l-ġarr permezz tal-arja — FOCUS Air

9.4. Stima tal-konċentrazzjonijiet għal rotot oħrajn ta’ espożizzjoni — —

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

10.1 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.

10.1.1. Effetti fuq l-għasafar — —

10.1.1.1. Tossiċità orali akuta OECD Test Guideline 223: Avian Acute oral toxicity study jew US EPA OCSPP 850.2100: Avian Acute Oral Toxicity Test (15) —

10.1.1.2. Tagħrif ta’ livell ogħla fuq l-għasafar — —

10.1.2. Effetti fuq vertebrati terrestri minbarra l-għasafar — —

10.1.2.1. Tossiċità orali akuta għall-mammiferi — —

10.1.2.2. Tagħrif ta’ livell ogħla fuq il-mammiferi — —

10.1.3. Effetti fuq annimali vertebrati terrestri oħrajn (rettili u amfibji) OECD Test Guideline 231: Amphibian Metamorphosis Assay —

10.2. Effetti fuq l-organiżmi akkwatiċi — EU Guidance Document on Aquatic Ecotoxicology (SANCO/3268/2001 rev.4) (16)

10.2.1. Tossiċità akuta għall-ħut, għall-invertebrati akkwatiċi jew effetti fuq l-algi u l-makrofiti akkwatiċi Ħut: OECD Test Guideline 203: Fish, Acute Toxicity Test Invertebrati: OECD Test Guideline 202: Daphnia sp. Acute Immobilisation Test US EPA OCSPP 850.1035 Mysid Acute Toxicity Test Algi u makrofiti: OECD Test Guideline 201: Freshwater Alga and Cyanobacteria, Growth Inhibition Test 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 OECD. Series on testing and assessment No 126. Short guidance on the threshold approach for acute fish toxicity. ENV/JM/MONO(2010)17.

10.2.2. Studji addizzjonali fit-tul dwar it-tossiċità kronika fuq il-ħut, l-invertebrati akkwatiċi u l-organiżmi li jgħixu fis-sediment Ħut: 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 210: Fish, Early-Life Stage Toxicity Test OECD Test Guideline 234: Fish Sexual Development Test US EPA protocol OCSPP 850.1500 Fish life cycle toxicity Invertebrati: OECD Test Guideline 211: Daphnia magna Reproduction Test US EPA OCSPP 850.1350 Mysid Chronic Toxicity Test Organiżmi li jgħixu fis-sediment: OECD Test Guideline 218: Sediment-Water Chironomid Toxicity Using Spiked Sediment 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] Rakkomandazzjoni ulterjuri hija disponibbli fuq: Brock TCM, Alix A, Brown CD, et al (2009). Linking Aquatic Exposure and Effects: Risk Assessment of Pesticides (E-LINK). SETAC Press 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

10.2.3. Testijiet ulterjuri fuq l-organiżmu akkwatiċi — EU Guidance Document on Aquatic Ecotoxicology (SANCO/3268/2001 rev.4)

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

10.3.1. Effetti fuq in-naħal — EPPO Standard PP 3/10 (3) Environmental Risk Assessment Scheme for Plant Protection Products - Chapter 10: honey bees

10.3.1.1. Tossiċità akuta għan-naħal —

10.3.1.1.1. Tossiċità orali akuta għan-naħal 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

10.3.1.1.2. Tossiċità akuta permezz tal-kuntatt għan-naħal 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

10.3.1.2. 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.

10.3.1.3. Effetti fuq l-iżvilupp tan-naħal tal-għasel u stadji oħrajn tal-ħajja tan-naħal tal-għasel Aupinel P et al. (2007): A new larval in vitro rearing method to test effects of pesticides on honey bee brood. Redia XC: 87-90 EPPO Standard PP 3/10 (3) Environmental Risk Assessment Scheme for Plant Protection Products - Chapter 10: honey bees.

10.3.1.4. 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. OECD Guidance Document 75 on the honeybee (Apis mellifera L) brood test under semi-field conditions

10.3.1.5. Testijiet fil-gaġġa u fil-mira EPPO Standard PP1/170 (4): Test methods for evaluating the side-effects of plant protection products on honeybees.

10.3.1.6. Testijiet fuq il-post bin-naħal tal-għasel EPPO Standard PP1/170 (4): Test methods for evaluating the side-effects of plant protection products on honeybees —

10.3.2. L-effetti fuq artropodi mhux fil-mira minbarra n-naħal EU guidance document on terrestrial ecotoxicology (SANCO/10329/2002 rev 2). 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

10.3.2.1. Ittestjar standard fil-laboratorju għall-artropodi mhux fil-mira 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.

10.3.2.2. Ittestjar estiż fil-laboratorju, studji dwar residwi qodma b’artropodi mhux fil-mira 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. Mead-Briggs, M.A., Moll, M., Grimm, et al (2010). An extended laboratory test for evaluating the effects of plant protection products on the parasitic wasp, Aphidius rhopalosiphi (Hymenoptera, Braconidae). BioControl 55:329-338.

10.3.2.3. Studji semiprattiċi b’artropodi mhux fil-mira 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.

10.3.2.4. Studji fuq il-post b’artropodi mhux fil-mira 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.

10.3.2.5. Rotot oħrajn ta’ espożizzjoni għall-artropodi mhux fil-mira —

10.4. L-effetti fuq meżo- u makrofawna fil-ħamrija mhux fil-mira — EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002 rev 2)

10.4.1. Ħniex —

10.4.1.1. Ħniex - effetti subletali OECD Test Guideline 222: Earthworm Reproduction Test (Eisenia fetida/Eisenia andrei)

10.4.1.2 Ħniex - studji fuq il-post ISO 11268-3:1999: Soil quality – Effects of pollutants on earthworms – Part 3: Guidance on the determination of effects in field situations

10.4.2. L-effetti fuq meżo- u makrofawna fil-ħamrija mhux fil-mira (minbarra ħniex) —

10.4.2.1. Ittestjar fil-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

10.4.2.2. Ittestjar ta’ livell ogħla —

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

10.6. L-effetti fuq pjanti terrestri ogħla mhux fil-mira EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002 rev 2)

10.6.1. Sommarju tad-dejta dwar l-iskrining — —

10.6.2. L-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 —

10.6.3. Studji estiżi fil-laboratorju fuq pjanti mhux fil-mira — —

10.6.4. Testijiet semiprattiċi u fuq il-post fuq pjanti mhux fil-mira — —

10.7. L-effetti fuq organiżmi terrestri oħrajn (flora u fawna) — EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002 rev 2)

10.8. Dejta ta’ monitoraġġ — —

11. 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