Referência à parte A do anexo ao Regulamento (UE) n.o 284/2013

Métodos de ensaio (2)

Documentos de orientação (3)

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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)

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WHO/FAO. 2010. Manual on development and use of FAO and WHO specifications for pesticides. Second revision of the first edition. Rome, 2010

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Propriedades explosivas:

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.

Propriedades oxidantes:

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)

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Inflamabilidade:

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)

Auto-inflamabilidade:

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)

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CIPAC Method MT 75.3: Determination of pH values (revised method)

Preparações ácidas ou alcalinas:

CIPAC Method MT 31: free acidity or alkalinity

CIPAC Method MT 191: Acidity or alkalinity of formulations

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Fluidos Newtonianos:

OECD Test Guideline 114

Fluidos não-Newtonianos:

CIPAC method MT 192: Viscosity of liquids by rotational viscosimetry or

OECD Test Guideline 114

Tensão superficial:

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

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OECD Test Guideline 115

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Densidade relativa:

Method A.3 Relative density (Annex of Regulation (EC) No 440/2008).

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OECD Test Guideline 109

Densidade aparente:

CIPAC method MT 186: Bulk density

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Estabilidade:

CIPAC MT 46.3: Accelerated storage procedure (combined method)

Efeitos da baixa temperatura nas preparações líquidas:

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.

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CIPAC Method MT 53.3: Evaluation of wettability, wetting of dispersible powders

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CIPAC Method MT 47.2 Determination of the foaming of suspension concentrates

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Suspensibilidade:

CIPAC Method MT 184: Suspensibility of formulations forming suspensions on dilution with water

Espontaneidade de dispersão:

CIPAC Method MT 160: Spontaneity of dispersion of suspension concentrates

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CIPAC Method MT 174: Dispersibility of water dispersible granules

Estabilidade de dispersão:

CIPAC Method MT 180: Suspo-emulsions, dispersion stability

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CIPAC Method MT 41.1: Dilution stability of aqueous solutions

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CIPAC Method MT 179: Water soluble granules, degree of dissolution and solution stability

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CIPAC Method MT: Solution properties of ST formulations (6)

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Produtos dispersíveis em água:

CIPAC Method MT 185: Wet sieve test

Distribuição do tamanho (pós):

CIPAC Method MT 187: Particle size analysis by laser diffraction

Gama do tamanho nominal (grânulos):

CIPAC Method MT 170: Dry sieve analysis of water dispersible granules

CIPAC Method MT 187: Particle size analysis by laser diffraction

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CIPAC Method MT 171: Dustiness of granular products

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Aplicável aos grânulos ou pastilhas:

CIPAC Method MT 178: Attrition resistance of granules

CIPAC Method MT 178.2: Attrition resistance of dispersible granules

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CIPAC Method MT 193: Friability of tablets

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CIPAC Method MT 36.3: Emulsion characteristics of emulsifiable concentrates, emulsion characteristics and re-emulsification properties

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Fluidez:

CIPAC Method MT 172.1: Flowability of granular preparations after accelerated storage under pressure

Capacidade de escoamento:

CIPAC Method MT 148: Pourability of suspension concentrates

CIPAC Method MT 148.1: Pourability of suspension concentrates, revised method

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ASTM E1518 – 05: Standard Practice for Evaluation of Physical Compatibility of Pesticides in Aqueous Tank Mixtures by the Dynamic Shaker Method

Distribuição:

CIPAC Method MT 175: Seed treatment formulations, liquid, determination of seed-seed uniformity of distribution

Aderência:

CIPAC Method MT 194: Adhesion to Treated Seed

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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)

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Métodos de ensaio referidos no anexo I, parte II, do Regulamento (CE) n.o 1272/2008 (8)

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EPPO Standard PP1/239: Dose expression of plant protection products

EPPO Standard PP1/240: Harmonized basic information for databases on plant protection products

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FAO. Guidelines for the packaging and storage of pesticides

Resistência dos materiais de embalagem ao seu conteúdo:

CropLife International Technical Monograph No 17, 2nd Edition

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Materiais técnicos e preparações:

EU guidance document on analytical methods for the analysis of technical material and preparation (SANCO/3030/99 rev. 4)

Resíduos:

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.

EPPO standard series PP1 (9) (Efficacy evaluation of plant protection products)

EPPO standard series PP1 (9) (Efficacy evaluation of plant protection products)

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Seeds harvested from treated plants: ISTA Methods - International Rules for Seed Testing (10)

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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)

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Method B.3 Acute toxicity (dermal) (Annex of Regulation (EC) No 440/2008)

OECD Test Guideline 402: Acute Dermal Toxicity

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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

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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

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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)

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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

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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.

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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.

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Aplicam-se os métodos de ensaio referidos na secção 6 do anexo ao Regulamento (UE) n.o 283/2013 (13).

Aplicam-se os documentos de orientação referidos na secção 6 do anexo ao Regulamento (UE) n.o 283/2013.

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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.

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OECD Test Guideline 307: Aerobic and anaerobic transformation in soil.

FOCUS Ground Water

FOCUS Degradation Kinetics

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Os aspetos técnicos que servem para determinar a taxa de degradação no solo em estudos de campo podem ser consultados em:

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

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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

OECD Guidance Document 22: Guidance Document for the Performance Of Out-door Monolith Lysimeter Studies

FOCUS Ground Water

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FOCUS Ground Water

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Orientações sobre o cálculo das concentrações ambientais previstas:

FOCUS soil persistence models

FOCUS Ground Water (source of crop canopy interception values for different crop growth stages).

Orientações sobre os parâmetros de degradação e o cálculo das concentrações ambientais previstas:

FOCUS Degradation Kinetics

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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

OECD Test Guideline 308: Aerobic and Anaerobic Transformation in Aquatic Sediment Systems

FOCUS Surface Water

FOCUS Degradation Kinetics

OECD Test Guideline 308: Aerobic and Anaerobic Transformation in Aquatic Sediment Systems

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FOCUS Ground Water

FOCUS Degradation Kinetics

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Estimativa das concentrações nas águas superficiais e sedimento:

FOCUS Surface Water

FOCUS Degradation Kinetics

EU Guidance on aquatic ecotoxicology (SANCO/3268/2001 rev.4)

Atenuação dos níveis de exposição e avaliação mais avançada a nível da paisagem:

FOCUS Landscape and Mitigation

FOCUS Air

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FOCUS Air

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

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EFSA (2009) Guidance of EFSA - Risk assessment for birds and mammals. EFSA Journal 2009; 7(12):1438.

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OECD Test Guideline 223: Avian Acute oral toxicity study

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US EPA OCSPP 850.2100: Avian Acute Oral Toxicity Test (15)

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OECD Test Guideline 231: Amphibian Metamorphosis Assay

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EU Guidance Document on Aquatic Ecotoxicology (SANCO/3268/2001 rev.4) (16)

Peixes:

OECD Test Guideline 203: Fish, Acute Toxicity Test

Invertebrados:

OECD Test Guideline 202: Daphnia sp. Acute Immobilisation Test

US EPA OCSPP 850.1035 Mysid Acute Toxicity Test

Algas e macrófitos:

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.

Peixes:

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

Invertebrados:

OECD Test Guideline 211: Daphnia magna Reproduction Test

US EPA OCSPP 850.1350 Mysid Chronic Toxicity Test

Organismos dos sedimentos:

OECD Test Guideline 218: Sediment-Water Chironomid Toxicity Using Spiked Sediment

OECD Test Guideline 219: Sediment-Water Chironomid Toxicity Using Spiked Water

[Em geral, um sistema água enriquecida-sedimento (ver OCDE 219) cobre melhor as vias de exposição características dos produtos fitofarmacêuticos]

Outras recomendações figuram em:

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

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EU Guidance Document on Aquatic Ecotoxicology (SANCO/3268/2001 rev.4)

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EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002 rev 2)

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EPPO Standard PP 3/10 (3) Environmental Risk Assessment Scheme for Plant Protection Products - Chapter 10: honey bees

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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

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

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.

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.

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

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

EPPO Standard PP1/170 (4): Test methods for evaluating the side-effects of plant protection products on honeybees

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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

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.

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.

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.

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.

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EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002 rev 2)

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OECD Test Guideline 222: Earthworm Reproduction Test (Eisenia fetida/Eisenia andrei)

ISO 11268-3:1999: Soil quality – Effects of pollutants on earthworms – Part 3: Guidance on the determination of effects in field situations

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Na Collembola:

OECD Test Guideline 232: Collembolan Reproduction Test in Soil

Nos ácaros predadores:

OECD Test Guideline 226: Predatory mite (Hypoaspis (Geolaelaps) aculeifer) reproduction test in soil

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OECD Test Guideline 216: Soil Microorganisms: Nitrogen Transformation Test

EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002 rev 2)

EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002 rev 2)

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Emergência de plântulas e crescimento de plântulas:

OECD Test Guideline 208: Terrestrial Plant Test: Seedling Emergence and Seedling Growth Test

Ensaio do vigor vegetativo dos vegetais terrestres:

OECD Test Guideline 227: Terrestrial Plant Test: Vegetative Vigour Test

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EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002 rev 2)

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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

ECHA Guidance on the application of the CLP criteria. Guidance to Regulation (EC) No 1272/2008 on classification, labelling and packaging (CLP) of substances and mixtures.