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Документ 52013XC0403(02)
Commission Communication in the framework of the implementation of 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
Communication de la Commission dans le cadre de la mise en œuvre du règlement (UE) n ° 283/2013 de la Commission du 1 er mars 2013 établissant les exigences en matière de données applicables aux substances actives, conformément au règlement (CE) n ° 1107/2009 du Parlement européen et du Conseil concernant la mise sur le marché des produits phytopharmaceutiques Texte présentant de l'intérêt pour l'EEE
Communication de la Commission dans le cadre de la mise en œuvre du règlement (UE) n ° 283/2013 de la Commission du 1 er mars 2013 établissant les exigences en matière de données applicables aux substances actives, conformément au règlement (CE) n ° 1107/2009 du Parlement européen et du Conseil concernant la mise sur le marché des produits phytopharmaceutiques Texte présentant de l'intérêt pour l'EEE
JO C 95 du 3.4.2013г., стр. 1—20
(BG, ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
3.4.2013 |
FR |
Journal officiel de l'Union européenne |
C 95/1 |
Communication de la Commission dans le cadre de la mise en œuvre du règlement (UE) no 283/2013 de la Commission du 1er mars 2013 établissant les exigences en matière de données applicables aux substances actives, conformément au règlement (CE) no 1107/2009 du Parlement européen et du Conseil concernant la mise sur le marché des produits phytopharmaceutiques (1)
(Texte présentant de l'intérêt pour l'EEE)
2013/C 95/01
La présente communication de la Commission satisfait à l'exigence contenue au point 6 de l'introduction de l'annexe du règlement (UE) no 283/2013, qui dispose qu'à des fins d’information et d’harmonisation, la liste des méthodes d’essai et les lignes directrices pertinentes pour l’application du présent règlement sont publiées au Journal officiel de l’Union européenne. Le tableau ci-dessous constitue cette liste et sera régulièrement mis à jour.
Renvoi à la partie A de l'annexe du règlement (UE) no 283/2013 |
Méthodes d’essai (2) |
Documents d'orientation (3) |
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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) |
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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 |
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Method A.4 Vapour pressure (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 104: Vapour Pressure |
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OECD Test Guideline 101: UV-VIS Absorption Spectra |
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Method A.6 Water solubility (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 105: Water Solubility |
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CIPAC Method MT 181: Solubility in organic solvents |
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Method A.8 Partition coefficient (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 107: Partition coefficient, shake-flask method Si un composé est tensio-actif (selon la définition de la tension superficielle de la méthode A.5), la méthode par agitation en flacon décrite dans la méthode A.8 peut être appliquée s'il apparaît clairement dans le rapport quil n'y a aucun problème (par exemple, séparations des phases). La méthode HPLC décrite dans la méthode A.8 n'est pas applicable aux composés tensio-actifs. |
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OECD Test Guideline 112: Dissociation Constants in Water. |
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Inflammabilité: 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) Auto-échauffement: 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) |
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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); |
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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. |
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Method A.5 Surface tension (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 115: Surface tension of aqueous solutions |
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Solides: Method A.17 Oxidising properties (solids) (Annex to Regulation (EC) No 440/2008) Liquides: 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) |
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Méthodes d'essai mentionnées à l'annexe I, partie II, du règlement (CE) no 1272/2008 |
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EPPO standard series PP1: Efficacy evaluation of plant protection products (7) |
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EPPO standard PP 1/213: Resistance risk analysis |
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Matériel technique et préparations: EU guidance document on analytical methods for the analysis of technical material and preparation (SANCO/3030/99 rev. 4) Résidus: 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. |
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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 |
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Method B.36 Toxicokinetics (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 417: Toxicokinetics |
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Method B.36 Toxicokinetics (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 417: Toxicokinetics |
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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) |
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Method B.3 Acute toxicity (dermal) (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 402: Acute Dermal Toxicity |
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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 |
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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)). |
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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) |
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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 |
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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 |
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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 |
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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 |
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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. |
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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. |
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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 |
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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. |
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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. |
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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. |
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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. |
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Method B.43 Neurotoxicity study in rodents (Annex to Regulation (EC) No 440/2008). OECD Test Guideline 424: Neurotoxicity study in rodents. |
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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. |
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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) |
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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 |
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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 |
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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. |
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OECD Test Guideline 506: Stability of pesticide residues in stored commodities |
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OECD Test Guideline 501: Metabolism in crops |
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OECD Test Guideline 503: Metabolism in livestock |
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OECD Test Guideline 503: Metabolism in livestock |
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OECD Test Guideline 503: Metabolism in livestock |
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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) |
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OECD Test Guideline 505: Residues in livestock. |
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OECD Test Guideline 505: Residues in livestock. |
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OECD Test Guideline 505: Residues in livestock. |
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OECD Test Guideline 507: Nature of the pesticide residues in processed commodities – High temperature hydrolysis. |
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OECD Test Guideline 508: Magnitude of the pesticide residues in processed commodities. OECD Test Guideline 509: Crop field trials. |
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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. |
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OECD Test Guideline 502: Metabolism in rotational crops. |
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OECD Test Guideline 504: Residues in rotational crops (limited field studies). OECD Test Guideline 509: Crop field trials. |
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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 |
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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) |
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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) |
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EU guidance document "Calculation of Maximum Residue Levels and Safety Intervals e.g. Pre-harvest Intervals" (SANCO 7039/VI/95, 22/7/1997) |
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EFSA calculation model Pesticide Residue Intake Model "PRIMo" - revision 2 (10) |
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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 |
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OECD Test Guideline 307: Aerobic and anaerobic transformation in soil. |
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OECD Test Guideline 307: Aerobic and anaerobic transformation in soil. |
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SETAC 1995 – Procedures for assessing the environmental fate and ecotoxicity of pesticides |
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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. |
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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. |
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US EPA OCSPP 835.6100: Terrestrial field dissipation |
FOCUS Ground Water FOCUS Degradation Kinetics FOCUS soil persistence models Les aspects techniques servant à déterminer les taux de dégradation dans le sol dans les études au champ peuvent être consultés dans le document suivant: 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) |
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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 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) |
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FOCUS Ground Water |
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OECD Test Guideline 312: Leaching in Soil Columns |
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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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OECD Test Guideline 111: Hydrolysis as a Function of pH |
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OECD Test Guideline 316: Phototransformation of Chemicals in Water - Direct Photolysis |
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Method C.4 Determination of "ready" biodegradability (Annex to Regulation (EC) No 440/2008). OECD Guideline Test 301: Ready Biodegradability (301 A - F) |
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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 |
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OECD Test Guideline 308: Aerobic and Anaerobic Transformation in Aquatic Sediment Systems |
FOCUS Surface Water FOCUS Degradation Kinetics |
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OECD Test Guideline 308: Aerobic and Anaerobic Transformation in Aquatic Sediment Systems |
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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 No 223: Avian acute oral toxicity study ou US EPA OCSPP 850.2100: Avian oral toxicity test |
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OECD Test Guideline 205: Avian Dietary Toxicity Test ou US EPA OCSPP 850.2200: Avian dietary toxicity test. |
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OECD Test Guideline 206: Avian Reproduction Test ou US EPA OCSPP 850.2300: Avian Reproduction Test |
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OECD Test Guideline 231: Amphibian Metamorphosis Assay |
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Workshop report on OECD countries activities regarding testing, assessment and management of endocrine disrupters. Series on testing and assessment No 118. 18 January 2010. |
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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. |
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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 |
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OECD Test Guideline 210: Fish, Early-Life Stage Toxicity Test |
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US EPA protocol OCSPP 850.1500 Fish life cycle toxicity. |
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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. |
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EU Guidance Document on Aquatic Ecotoxicology (SANCO/3268/2001 rev.4) |
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OECD Test Guideline 202: Daphnia sp. Acute Immobilisation Test |
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US EPA OCSPP 850.1035 Mysid Acute Toxicity Test |
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OECD Test Guideline 211: Daphnia magna Reproduction Test |
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US EPA OCSPP 850.1350 Mysid Chronic Toxicity Test |
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OECD Test Guideline 219: Essai de toxicité des chironomes dans un système eau chargée-sédiment [en général, un système eau chargée-sédiment (voir OCDE 219) couvre mieux les voies d'exposition caractéristiques des produits phytopharmaceutiques] |
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OECD Test Guideline 218: Sediment-Water Chironomid Toxicity Using Spiked Sediment |
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OECD Test Guideline 201: Algae growth inhibition test |
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OECD Test Guideline 201: Algae growth inhibition test. |
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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. |
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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: honeybees. |
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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 |
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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 214: Honeybees, Acute Contact Toxicity Test |
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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. |
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Aupinel et al (2007): A new larval in vitro rearing method to test effects of pesticides on honey bee brood. Redia XC: 87-90 |
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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. |
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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. |
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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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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) |
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Chez les collemboles: OECD Test Guideline 232: Collembolan Reproduction Test in Soil Chez les acariens prédateurs: 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) |
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EU Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002 rev 2) |
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Essai d'émergence de plantules et de croissance de plantules: OECD Test Guideline 208: Terrestrial Plant Test: Seedling Emergence and Seedling Growth Test Essai de vigueur végétative de plantes 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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OECD Test Guideline 209: Activated Sludge, Respiration Inhibition Test |
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 |
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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. |
(1) JO L 93 du 3.4.2013, p. 1.
(2) À l'exception des méthodes décrites dans le règlement (CE) no 440/2008 (JO L 142 du 31.5.2008, p. 1), la plupart des méthodes d'essai mentionnées ne sont disponibles qu'en anglais (certaines sont également disponibles en français). Des informations détaillées sur les méthodes d'essai peuvent être consultées sur les sites suivants:
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CIMAP http://www.cipac.org/ |
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ASTM http://www.astm.org/Standard/index.shtml |
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ISO http://www.iso.org/iso/home/store/catalogue_ics.htm |
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OCDE http://www.oecd.org/env/chemicalsafetyandbiosafety/testingofchemicals/ |
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OEPP http://www.eppo.int/STANDARDS/standards.htm |
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US EPA OCSPP http://www.epa.gov/ocspp/pubs/frs/home/testmeth.htm |
(3) La plupart des documents d'orientation cités ne sont disponibles qu'en anglais. Des informations détaillées sur les documents d'orientation peuvent être consultées sur les sites suivants:
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Commission européenne:
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OCDE http://www.oecd.org/env/chemicalsafetyandbiosafety/testingofchemicals/ |
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OEPP:http://www.eppo.int/STANDARDS/standards.htm |
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ECHA: http://echa.europa.eu/support/guidance-on-reach-and-clp-implementation |
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http://www.efsa.europa.eu/en/publications.htm |
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http://focus.jrc.ec.europa.eu/index.html |
(4) http://www.fao.org/fileadmin/templates/agphome/documents/Pests_Pesticides/PestSpecsManual2010.pdf
(5) JO L 309 du 24.11.2009, p. 1.
(6) JO L 353 du 31.12.2008, p. 1.
(7) Les normes de l'OEPP peuvent être consultées sur le site suivant: http://pp1.eppo.int/ - Les normes OEPP de la série PP1 décrivent comment évaluer l'efficacité des produits phytopharmaceutiques. La série contient des normes générales et des normes spécifiques. Les normes spécifiques doivent être utilisées avec les normes générales correspondantes et vice versa.
(8) JO L 220 du 24.8.2009, p. 1.
(9) JO L 324 du 9.12.2010, p. 13.
(10) http://www.efsa.europa.eu/en/mrls/mrlteam.htm
(11) http://www.hc-sc.gc.ca/cps-spc/pubs/pest/_pol-guide/dir2006-01/index-fra.php
(12) http://ec.europa.eu/food/fs/sc/scp/outcome_ppp_en.html
(13) Avant l'adoption de la ligne directrice révisée, il convient, dans toute la mesure du possible, de s'efforcer de réduire le nombre d'animaux dans les limites fixées et de procéder aux principaux essais.