Council Directive of 15 July 1991 concerning the placing of plant protection products on the market (91/414/EEC) (repealed)
EU Directive 1991/414 · Adopted 15 July 1991 · Extends to United Kingdom
Council Directive
of 15 July 1991
concerning the placing of plant protection products on the market
(91/414/EEC) (repealed)
F1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Annotations to the whole text
Textual amendments
Contents
- Scope Repealed
- 1Article 1 Repealed
- Definitions Repealed
- 2Article 2 Repealed
- General provisions Repealed
- 3Article 3 Repealed
- Granting, review and withdrawal of authorizations of plant protection products Repealed
- 4Article 4 Repealed
- Inclusion of active substances in Annex I Repealed
- 5Article 5 Repealed
- 6Article 6 Repealed
- Information on potentially harmful effects Repealed
- 7Article 7 Repealed
- Transitional measures and derogations Repealed
- 8Article 8 Repealed
- Application for authorization Repealed
- 9Article 9 Repealed
- Mutual recognition of authorizations Repealed
- 10Article 10 Repealed
- 11Article 11 Repealed
- Exchange of information Repealed
- 12Article 12 Repealed
- Data requirements, data protection and confidentiality Repealed
- 13Article 13 Repealed
- 14Article 14 Repealed
- Packaging and labelling of plant protection products Repealed
- 15Article 15 Repealed
- 16Article 16 Repealed
- Control measures Repealed
- 17Article 17 Repealed
- Administrative provisions Repealed
- 18Article 18 Repealed
- 19Article 19 Repealed
- 20Article 20 Repealed
- 21Article 21 Repealed
- Research and development Repealed
- 22Article 22 Repealed
- Implementation of the Directive Repealed
- 23Article 23 Repealed
- 24Article 24 Repealed
- Annex IAnnex I Repealed
- Annex II: REQUIREMENTS FOR THE DOSSIER TO BE SUBMITTED FOR THE INCLUSION OF AN ACTIVE SUBSTANCE IN ANNEX I Repealed
- INTRODUCTION Repealed
- 1.1Division 1.1 Repealed
- 1.2Division 1.2 Repealed
- 1.3Division 1.3 Repealed
- 1.4Division 1.4 Repealed
- 1.5Division 1.5 Repealed
- 1.6Division 1.6 Repealed
- 2.1Division 2.1 Repealed
- 2.2Division 2.2 Repealed
- 2.3Division 2.3 Repealed
- 2.4Division 2.4 Repealed
- Part A: Chemical substances Repealed
- 1Identity of the active substance Repealed
- 1.1Applicant (name, address, etc.) Repealed
- 1.2Manufacturer (name, address, including location of plant) Repealed
- 1.3Common name proposed or ISO-accepted, and synonyms Repealed
- 1.4Chemical name (IUPAC and CA nomenclature) Repealed
- 1.5Manufacturer's development code number(s) Repealed
- 1.6CAS, EEC and CIPAC numbers (if available) Repealed
- 1.7Molecular and structural formula, molecular mass Repealed
- 1.8Method of manufacture (synthesis pathway) of the active substance Repealed
- 1.9Specification of purity of the active substance in g/kg Repealed
- 1.10Identity of isomers, impurities and additives (e.g. stabilizers), together with the structural formula and the content expressed as g/kg Repealed
- 1.11Analytical profile of batches Repealed
- 2Physical and chemical properties of the active substance Repealed
- Melting point and boiling point Repealed
- 2.1.1Division 2.1.1 Repealed
- 2.1.2Division 2.1.2 Repealed
- 2.1.3Division 2.1.3 Repealed
- 2.2Relative density Repealed
- Vapour pressure (in Pa), volatility (e.g. Henry's law constant) Repealed
- 2.3.1Division 2.3.1 Repealed
- 2.3.2Division 2.3.2 Repealed
- Appearance (physical state, colour and odour; if known) Repealed
- 2.4.1Division 2.4.1 Repealed
- 2.4.2Division 2.4.2 Repealed
- Spectra (UV/VIS, IR, NMR, MS), molecular extinction at relevant wavelengths Repealed
- 2.5.1Division 2.5.1 Repealed
- 2.5.2Division 2.5.2 Repealed
- 2.6Solubility in water including effect of pH (4 to 10) on solubility Repealed
- 2.7Solubility in organic solvents Repealed
- 2.8Partition coefficient n-octanol/water including effect of pH (4 to 10) Repealed
- Stability in water, hydrolysis rate, photochemical degradation, quantum yield and identity of breakdown product(s), dissociation constant including effect of pH (4 to 9) Repealed
- 2.9.1Division 2.9.1 Repealed
- 2.9.2Division 2.9.2 Repealed
- 2.9.3Division 2.9.3 Repealed
- 2.9.4Division 2.9.4 Repealed
- 2.10Stability in air, photochemical degradation, identity of breakdown product(s) Repealed
- Flammability including auto-flammability Repealed
- 2.11.1Division 2.11.1 Repealed
- 2.11.2Division 2.11.2 Repealed
- 2.12Flash point Repealed
- 2.13Explosive properties Repealed
- 2.14Surface tension Repealed
- 2.15Oxidizing properties Repealed
- 3Further information on the active substance Repealed
- 3.1Function, e.g. fungicide, herbicide, insecticide, repellant, growth regulator Repealed
- Effects on harmful organisms, e.g. contact poison, inhalation poison, stomach poison, fungitoxic, etc. systematic or not in plants Repealed
- 3.2.1Division 3.2.1 Repealed
- 3.2.2Division 3.2.2 Repealed
- 3.3Field of use envisaged, e.g. field, protected crops, storage of plant products, home gardening Repealed
- Harmful organisms controlled and crops or products protected or treated Repealed
- 3.4.1Division 3.4.1 Repealed
- 3.4.2Division 3.4.2 Repealed
- 3.4.3Division 3.4.3 Repealed
- Mode of action Repealed
- 3.5.1Division 3.5.1 Repealed
- 3.5.2Division 3.5.2 Repealed
- 3.5.3Division 3.5.3 Repealed
- 3.6Information on the occurrence or possible occurrence of the development of resistance and appropriate management strategies Repealed
- 3.7Recommended methods and precautions concerning handling, storage, transport or fire Repealed
- Procedures for destruction or decontamination Repealed
- 3.8.1Controlled incineration Repealed
- 3.8.2Others Repealed
- 3.9Emergency measures in case of an accident Repealed
- Analytical methods Repealed
- Introduction Repealed
- 4.1Methods for the analysis of the active substance as manufactured Repealed
- 4.1.1Division 4.1.1 Repealed
- 4.1.2Division 4.1.2 Repealed
- 4.1.3Division 4.1.3 Repealed
- 4.1.3.1Division 4.1.3.1 Repealed
- 4.1.3.2Division 4.1.3.2 Repealed
- 4.1.3.3Division 4.1.3.3 Repealed
- 4.1.3.4Division 4.1.3.4 Repealed
- 4.2Methods for the determination of residues Repealed
- 4.2.1Division 4.2.1 Repealed
- 4.2.2Division 4.2.2 Repealed
- 4.2.3Division 4.2.3 Repealed
- 4.2.4Division 4.2.4 Repealed
- 4.2.5Division 4.2.5 Repealed
- Toxicological and metabolism studies Repealed
- Introduction Repealed
- 5.1Studies on absorption, distribution, excretion and metabolism in mammals Repealed
- Aim of the test: Repealed
- Circumstances in which required Repealed
- Test guideline Repealed
- 5.2Acute toxicity Repealed
- Oral Repealed
- Circumtances in which required Repealed
- Test guideline Repealed
- Percutaneous Repealed
- Circumstances in which required Repealed
- Test guideline Repealed
- Inhalation Repealed
- Circumstances in which required Repealed
- Test guideline Repealed
- Skin irritation Repealed
- Aim of the test Repealed
- Circumstances in which required Repealed
- Test guideline Repealed
- Eye irritation Repealed
- Aim of test Repealed
- Circumstances in which required Repealed
- Test guidelines Repealed
- Skin sensitization Repealed
- Aim of test Repealed
- Circumstances in which required Repealed
- Test guideline Repealed
- 5.3Short-term toxicity Repealed
- Oral 28-day study Repealed
- Circumstances in which required Repealed
- Test guideline Repealed
- Oral 90-day study Repealed
- Circumstances in which required Repealed
- Test guidelines Repealed
- Other routes Repealed
- Circumstances in which required Repealed
- Test guidelines Repealed
- Genotoxicity testing Repealed
- Aim of the test Repealed
- In vitro studies Repealed
- Circumstances in which required Repealed
- Test guidelines Repealed
- In vivo studies in somatic cells Repealed
- Circumstances in which required Repealed
- Test guidelines Repealed
- In vivo studies in germ cells Repealed
- Circumstances in which required Repealed
- Long term toxicity and carcinogenicity Repealed
- Aim of the test Repealed
- Circumstances in which required Repealed
- Test conditions Repealed
- Test guideline Repealed
- 5.6Reproductive toxicity Repealed
- Multi-generation studies Repealed
- Aim of the test Repealed
- Circumstances in which required Repealed
- Test guideline Repealed
- Supplementary studies Repealed
- Developmental toxicity studies Repealed
- Aim of the test Repealed
- Circumstances in which required Repealed
- Test conditions Repealed
- Test guideline Repealed
- Delayed neurotoxicity studies Repealed
- Aim of the test Repealed
- Circumstances in which required Repealed
- Test guidelines Repealed
- Other toxicological studies Repealed
- 5.8.1Toxicity studies of metabolites as referred to in the introduction point (vii) Repealed
- 5.8.2Supplementary studies on the active substance Repealed
- 5.9Medical data Repealed
- 5.9.1Medicinal surveillance on manufacturing plant personnel Repealed
- 5.9.2Direct observation, e.g.: clinical cases and poisoning incidents Repealed
- 5.9.3Observations on exposure of the general population and epidemiological studies if appropriate Repealed
- 5.9.4Diagnosis of poisoning (determination of active substance, metabolites), specific signs of poisoning, clinical tests Repealed
- 5.9.5Proposed treatment: first aid measures, antidotes, medical treatment Repealed
- 5.9.6Expected effects of poisoning Repealed
- 5.10Summary of mammalian toxicity and overall evaluation Repealed
- Residues in or on treated products, food and feed Repealed
- Introduction Repealed
- Metabolism, distribution and expression of residue in plants Repealed
- Aim of the tests Repealed
- Circumstances in which required Repealed
- Test conditions Repealed
- Metabolism, distribution and expression of residue in livestock Repealed
- Aim of tests Repealed
- Circumstances in which required Repealed
- Residue trials Repealed
- Aim of the tests Repealed
- Circumstances in which required Repealed
- Test conditions Repealed
- Livestock feeding studies Repealed
- Aim of the tests Repealed
- Circumstances in which required Repealed
- Test conditions Repealed
- Effects of industrial processing and/or household preparations Repealed
- Circumstances in which required Repealed
- Effects on the nature of the residue Repealed
- Aim of the tests Repealed
- Test conditions Repealed
- Effects on the residue levels Repealed
- Aim of the tests Repealed
- Test conditions Repealed
- Residues in succeeding crops Repealed
- Aim of the test Repealed
- Circumstances in which required Repealed
- Test conditions Repealed
- 6.7Proposed maximum residue levels (MRLs) and residue definiton Repealed
- 6.8Proposed pre-harvest intervals for envisaged uses, or withholding periods or storage periods, in the case of post-harvest uses Repealed
- 6.9Estimation of the potential and actual exposure through diet and other means Repealed
- 6.10Summary and evaluation of residue behaviour Repealed
- Fate and behaviour in the environment Repealed
- Introduction Repealed
- 7.1Fate and behaviour in soil Repealed
- Route and rate of degradation Repealed
- 7.1.1.1Division 7.1.1.1 Repealed
- 7.1.1.1.1Division 7.1.1.1.1 Repealed
- 7.1.1.1.2Division 7.1.1.1.2 Repealed
- 7.1.1.2Division 7.1.1.2 Repealed
- 7.1.1.2.1Division 7.1.1.2.1 Repealed
- 7.1.1.2.2Division 7.1.1.2.2 Repealed
- 7.1.2Adsorption and desorption Repealed
- Mobility in the soil Repealed
- 7.1.3.1Division 7.1.3.1 Repealed
- 7.1.3.2Division 7.1.3.2 Repealed
- 7.1.3.3Division 7.1.3.3 Repealed
- 7.2Fate and behaviour in water and air Repealed
- 7.2.1Route and rate of degradation in aquatic systemes (as far as not covered by point 2.9) Repealed
- 7.2.1.1Division 7.2.1.1 Repealed
- 7.2.1.2Division 7.2.1.2 Repealed
- Biological degradation Repealed
- 7.2.1.3.1Division 7.2.1.3.1 Repealed
- 7.2.1.3.2Division 7.2.1.3.2 Repealed
- 7.2.1.4Division 7.2.1.4 Repealed
- 7.2.2Route and rate of degradation in air (as far as not covered by point 2.10) Repealed
- 7.3Definition of the residue Repealed
- 7.4Monitoring data Repealed
- Ecotoxicological studies Repealed
- Introduction Repealed
- Test substance Repealed
- Test organisms Repealed
- Effects on birds Repealed
- 8.1.1Division 8.1.1 Repealed
- Aim of the test Repealed
- Circumstances in which required Repealed
- Test conditions Repealed
- Test guideline Repealed
- 8.1.2Division 8.1.2 Repealed
- Aim of the test Repealed
- Circumstances in which required Repealed
- Test conditions Repealed
- Test guideline Repealed
- 8.1.3Division 8.1.3 Repealed
- Aim of the test Repealed
- Circumstances in which required Repealed
- Test guideline Repealed
- 8.2Effects on aquatic organisms Repealed
- 8.2.1Division 8.2.1 Repealed
- Aim of the test Repealed
- Circumstances in which required Repealed
- Test conditions Repealed
- Test guideline Repealed
- 8.2.2Division 8.2.2 Repealed
- Circumstances in which required Repealed
- 8.2.2.1Division 8.2.2.1 Repealed
- Aim of the test Repealed
- Test conditions Repealed
- 8.2.2.2Division 8.2.2.2 Repealed
- Aim of the test Repealed
- Test guideline Repealed
- 8.2.2.3Division 8.2.2.3 Repealed
- Aim of the test Repealed
- Test conditions Repealed
- 8.2.3Division 8.2.3 Repealed
- Aim of the test Repealed
- Circumstances in which required Repealed
- Test guideline Repealed
- 8.2.4Division 8.2.4 Repealed
- Aim of the test Repealed
- Circumstances in which required Repealed
- Test guideline Repealed
- 8.2.5Division 8.2.5 Repealed
- Aim of the test Repealed
- Circumstances in which required Repealed
- Test conditions Repealed
- Test guideline Repealed
- 8.2.6Division 8.2.6 Repealed
- Aim of the test Repealed
- Circumstances in which required Repealed
- Test guideline Repealed
- 8.2.7Division 8.2.7 Repealed
- Aim of test Repealed
- Circumstances in which required Repealed
- Test conditions Repealed
- 8.2.8Division 8.2.8 Repealed
- Effect on arthropods Repealed
- 8.3.1Division 8.3.1 Repealed
- 8.3.1.1Division 8.3.1.1 Repealed
- Aim of the test Repealed
- Circumstances in which required Repealed
- Test guideline Repealed
- 8.3.1.2Division 8.3.1.2 Repealed
- Aim of the test Repealed
- Circumstances in which required Repealed
- Test guideline Repealed
- 8.3.2Division 8.3.2 Repealed
- Aim of the test Repealed
- Circumstances in which required Repealed
- Test conditions Repealed
- Test guideline Repealed
- Effects on earthworms Repealed
- 8.4.1Division 8.4.1 Repealed
- Aim of the test Repealed
- Circumstances in which required Repealed
- Test guideline Repealed
- 8.4.2Division 8.4.2 Repealed
- Aim of the test Repealed
- Circumstances in which required Repealed
- Test conditions Repealed
- Effects on soil non-target micro-organisms Repealed
- Aim of the test Repealed
- Circumstances in which required Repealed
- Test conditions Repealed
- Test guideline Repealed
- 8.6Effects on other non-target organisms (flora and fauna) believed to be at risk Repealed
- 8.7Effects on biological methods for sewage treatment Repealed
- Summary and evaluation of points 7 and 8 Repealed
- 10Proposals including justification for the proposals for the classification and labelling of the active substance according to Council Directive 67/548/EEC Repealed
- A dossier as referred to in Annex III, part A, for a representative plant protection product Repealed
- Part B Repealed
- Introduction Repealed
- 1Identity of the micro-organism Repealed
- 1.1Applicant Repealed
- 1.2Producer Repealed
- 1.3Name and species description, strain characterisation Repealed
- Specification of the material used for manufacturing of formulated products Repealed
- 1.4.1Content of the micro-organism Repealed
- 1.4.2Identity and content of impurities, additives, contaminating micro-organisms Repealed
- 1.4.3Analytical profile of batches Repealed
- Biological properties of the micro-organism Repealed
- 2.1History of the micro-organism and its uses. Natural occurrence and geographical distribution Repealed
- 2.1.1Historical background Repealed
- 2.1.2Origin and natural occurrence Repealed
- Information on target organism(s) Repealed
- 2.2.1Description of the target organism(s) Repealed
- 2.2.2Mode of action Repealed
- 2.3Host specificity range and effects on species other than the target harmful organism Repealed
- 2.4Development stages/life cycle of the micro-organism Repealed
- 2.5Infectiveness, dispersal and colonisation ability Repealed
- 2.6Relationships to known plant or animal or human pathogens Repealed
- 2.7Genetic stability and factors affecting it Repealed
- 2.8Information on the production of metabolites (especially toxins) Repealed
- 2.9Antibiotics and other anti-microbial agents Repealed
- Further information on the micro-organism Repealed
- Introduction Repealed
- 3.1Function Repealed
- 3.2Field of use envisaged Repealed
- 3.3Crops or products protected or treated Repealed
- 3.4Method of production and quality control Repealed
- 3.5Information on the occurrence or possible occurrence of the development of resistance of the target organism(s) Repealed
- 3.6Methods to prevent loss of virulence of seed stock of the micro-organism Repealed
- 3.7Recommended methods and precautions concerning handling, storage, transport or fire Repealed
- 3.8Procedures for destruction or decontamination Repealed
- 3.9Measures in case of an accident Repealed
- Analytical methods Repealed
- Introduction Repealed
- 4.1Methods for the analysis of the micro-organism as manufactured Repealed
- 4.2Methods to determine and quantify residues (viable or non-viable) Repealed
- Effects on human health Repealed
- Introduction Repealed
- TIER I Repealed
- 5.1Basic information Repealed
- 5.1.1Medical data Repealed
- 5.1.2Medical surveillance on manufacturing plant personnel Repealed
- 5.1.3Sensitisation/allergenicity observations, if appropriate Repealed
- 5.1.4Direct observation, e.g. clinical cases Repealed
- 5.2Basic studies Repealed
- Sensitisation Repealed
- Aim of the test Repealed
- Circumstances in which required Repealed
- 5.2.2Acute toxicity, pathogenicity and infectiveness Repealed
- Acute oral toxicity, pathogenicity and infectiveness Repealed
- Circumstances in which required Repealed
- Acute inhalation toxicity, pathogenicity and infectiveness Repealed
- Circumstances in which required Repealed
- 5.2.2.3Intraperitoneal/subcutaneous single dose Repealed
- Circumstances in which required Repealed
- Genotoxicity testing Repealed
- Circumstances in which required Repealed
- Aim of the test Repealed
- Test conditions Repealed
- In vitro studies Repealed
- Circumstances in which required Repealed
- 5.2.4Cell culture study Repealed
- Information on short-term toxicity and pathogenicity Repealed
- Aim of the test Repealed
- Circumstances in which required Repealed
- 5.2.5.1Health effects after repeated inhalatory exposure Repealed
- Circumstances in which required Repealed
- 5.2.6Proposed treatment: first aid measures, medical treatment Repealed
- TIER II Repealed
- 5.3Specific toxicity, pathogenicity and infectiveness studies Repealed
- In vivo studies in somatic cells Repealed
- Circumstances in which required Repealed
- Genotoxicity — In vivo studies in germ cells Repealed
- Aim of the test and test conditions Repealed
- Circumstances in which required Repealed
- 5.6Summary of mammalian toxicity, pathogenicity and infectiveness and overall evaluation Repealed
- Residues in or on treated products, food and feed Repealed
- Introduction Repealed
- 6.1Persistance and likelihood of multiplication in or on crops, feedingstuffs or foodstuffs Repealed
- 6.2Further information required Repealed
- 6.2.1Non-viable residues Repealed
- 6.2.2Viable residues Repealed
- Summary and evaluation of residue behaviour resulting from data submitted under points 6.1 and 6.2 Repealed
- Fate and behaviour in the environment Repealed
- Introduction Repealed
- 7.1Persistence and multiplication Repealed
- 7.1.1Soil Repealed
- 7.1.2Water Repealed
- 7.1.3Air Repealed
- 7.2Mobility Repealed
- Effects on non-target organisms Repealed
- Introduction Repealed
- Effects on birds Repealed
- Aim of the test Repealed
- Effects on aquatic organisms Repealed
- Aim of the test Repealed
- Effects on fish Repealed
- Aim of the test Repealed
- Effects on freshwater invertebrates Repealed
- Aim of the test Repealed
- Effects on algae growth Repealed
- Aim of the test Repealed
- Effects on plants other than algae Repealed
- Aim of the test Repealed
- Effects on bees Repealed
- Aim of the test Repealed
- Effects on arthropods other than bees Repealed
- Aim of the test Repealed
- Effects on earthworms Repealed
- Aim of the test Repealed
- 8.6Effects on non-target soil micro-organisms Repealed
- 8.7Additional studies Repealed
- 9Summary and evaluation of environmental impact Repealed
- Annex III: REQUIREMENTS FOR THE DOSSIER TO BE SUBMITTED FOR THE AUTHORIZATION OF A PLANT PROTECTION PRODUCT Repealed
- INTRODUCTION Repealed
- 1.1Division 1.1 Repealed
- 1.2Division 1.2 Repealed
- 1.3Division 1.3 Repealed
- 1.4Division 1.4 Repealed
- 1.5Division 1.5 Repealed
- 1.6Division 1.6 Repealed
- 2.1Division 2.1 Repealed
- 2.2Division 2.2 Repealed
- 2.3Division 2.3 Repealed
- 2.4Division 2.4 Repealed
- 2.5Division 2.5 Repealed
- 2.6Division 2.6 Repealed
- 3Division 3 Repealed
- 4Division 4 Repealed
- Part A: Chemical preparations Repealed
- 1Identity of the plant protection product Repealed
- 1.1Applicant (name and address, etc.) Repealed
- 1.2Manufacturer of the preparation and the active substance(s) (names and addresses etc. including location of plants) Repealed
- 1.3Trade name or proposed trade name, and manufacturer's development code number of the preparation if appropriate Repealed
- Detailed quantitative and qualitative information on the composition of the preparation (active substance(s), and formulants) Repealed
- 1.4.1Division 1.4.1 Repealed
- 1.4.2Division 1.4.2 Repealed
- 1.4.3Division 1.4.3 Repealed
- 1.4.4Division 1.4.4 Repealed
- Physical state and nature of the preparation (emulsifiable concentrate, wettable powder, solution etc). Repealed
- 1.5.1Division 1.5.1 Repealed
- 1.6Function (herbicide, insecticide, etc.) Repealed
- 2Physical, chemical and technical properties of the plant protection product Repealed
- 2.1Appearance (colour and odour) Repealed
- Explosivity and oxidizing properties Repealed
- 2.2.1Division 2.2.1 Repealed
- 2.2.2Division 2.2.2 Repealed
- 2.3Flash point and other indications of flammability or spontaneous ignition Repealed
- Acidity/alkalinity and if necessary pH value Repealed
- 2.4.1Division 2.4.1 Repealed
- 2.4.2Division 2.4.2 Repealed
- Viscosity and surface tension Repealed
- 2.5.1Division 2.5.1 Repealed
- 2.5.2Division 2.5.2 Repealed
- 2.5.3Division 2.5.3 Repealed
- Relative density and bulk density Repealed
- 2.6.1Division 2.6.1 Repealed
- 2.6.2Division 2.6.2 Repealed
- Storage — stability and shelf-life: Effects of light, temperature and humidity on technical characteristics of the plant protection product Repealed
- 2.7.1Division 2.7.1 Repealed
- 2.7.2Division 2.7.2 Repealed
- 2.7.3Division 2.7.3 Repealed
- 2.8Technical characteristics of the plant protection product Repealed
- 2.8.1Wettability Repealed
- 2.8.2Persistent foaming Repealed
- 2.8.3Suspensibility and suspension stability Repealed
- 2.8.4Dilution stability Repealed
- 2.8.5Dry sieve test and wet sieve test Repealed
- Particle size distribution (dustable and wettable powders, granules), content of dust/fines (granules), attrition and friability (granules) Repealed
- 2.8.6.1Division 2.8.6.1 Repealed
- 2.8.6.2Division 2.8.6.2 Repealed
- 2.8.6.3Division 2.8.6.3 Repealed
- Emulsifiability, Re-emulsifiability, emulsion stability Repealed
- 2.8.7.1Division 2.8.7.1 Repealed
- 2.8.7.2Division 2.8.7.2 Repealed
- Flowability, pourability (rinsability) and dustability Repealed
- 2.8.8.1Division 2.8.8.1 Repealed
- 2.8.8.2Division 2.8.8.2 Repealed
- 2.8.8.3Division 2.8.8.3 Repealed
- Physical and chemical compatibility with other products including plant protection products with which its use is to be authorized Repealed
- 2.9.1Division 2.9.1 Repealed
- 2.9.2Division 2.9.2 Repealed
- 2.10Adherence and distribution to seeds Repealed
- Summary and evaluation of data presented under points 2.1. to 2.10 Repealed
- Data on application Repealed
- 3.1Field of use envisaged, e.g. field, protected crops, storage of plant products, home gardening Repealed
- 3.2Effects on harmful organisms, e.g. contact, inhalation or stomach poison, fungitoxic or fungistatic, etc., systemic or not in plants Repealed
- 3.3Details of intended use e.g. types of harmful organisms controlled and/or plants or plant products to be protected Repealed
- 3.4Application rate Repealed
- 3.5Concentration of active substance in material used (e.g. in the diluted spray, baits or treated seed) Repealed
- 3.6Method of application Repealed
- 3.7Number and timing of applications and duration of protection Repealed
- 3.8Necessary waiting periods or other precautions to avoid phytotoxic effects on succeeding crops Repealed
- 3.9Proposed instructions for use Repealed
- Further information on the plant protection product Repealed
- Packaging (type, materials, size etc.), compatibility of the preparation with proposed packaging materials Repealed
- 4.1.1Division 4.1.1 Repealed
- 4.1.2Division 4.1.2 Repealed
- 4.1.3Division 4.1.3 Repealed
- 4.2Procedures for cleaning application equipment Repealed
- 4.3Re-entry periods, necessary waiting periods or other precautions to protect man, livestock and the environment Repealed
- 4.3.1Division 4.3.1 Repealed
- 4.3.2Division 4.3.2 Repealed
- 4.4Recommended methods and precautions concerning: handling, storage, transport or fire Repealed
- 4.5Emergency measures in the case of an accident Repealed
- 4.6Procedures for destruction or decontamination of the plant protection product and its packaging Repealed
- 4.6.1Possibility of neutralization Repealed
- 4.6.2Controlled incineration Repealed
- 4.6.3Others Repealed
- Analytical methods Repealed
- Introduction Repealed
- Methods for the analysis of the preparation Repealed
- 5.1.1Division 5.1.1 Repealed
- 5.1.2Division 5.1.2 Repealed
- 5.1.3Division 5.1.3 Repealed
- 5.1.3.1Division 5.1.3.1 Repealed
- 5.1.3.2Division 5.1.3.2 Repealed
- 5.1.3.3Division 5.1.3.3 Repealed
- 5.1.3.4Division 5.1.3.4 Repealed
- 5.2Analytical methods for the determination of residues Repealed
- Efficacy data Repealed
- General Repealed
- 6.1Preliminary tests Repealed
- Testing effectiveness Repealed
- Aim of the tests Repealed
- Test conditions Repealed
- Test guideline Repealed
- 6.3Information on the occurrence or possible occurrence of the development of resistance Repealed
- Effects on the yield of treated plants or plant products in terms of quantity and/or quality Repealed
- Effects on the quality of plants or plant product Repealed
- Aim of the tests Repealed
- Circumstances in which required Repealed
- Effects on transformation processes Repealed
- Aim of the tests Repealed
- Circumstances in which required Repealed
- Effects on the yield of treated plants or plant products Repealed
- Aim of the tests Repealed
- Circumstances in which required Repealed
- Phytotoxicity to target plants (including different cultivars), or to target plant products Repealed
- Aim of the tests Repealed
- Circumstances in which required Repealed
- Test guideline Repealed
- Observations on undesirable or unintended side-effects, e. g. on beneficial and other non-target organisms, on succeeding crops, other plants or parts of treated plants used for propagating purposes (e. g. seeds, cuttings, runners) Repealed
- Impact on succeeding crops Repealed
- Aim of the information required Repealed
- Circumstances in which required Repealed
- Impact on other plants, including adjacent crops Repealed
- Aim of the information required Repealed
- Circumstances in which required Repealed
- Impact on treated plants or plant products to be used for propagation Repealed
- Aim of the information required Repealed
- Circumstances in which required Repealed
- Test guideline Repealed
- 6.6.4Effects on beneficial and other non-target organisms Repealed
- 6.7Summary and evaluation of data presented under 6.1 to 6.6 Repealed
- 7Toxicological studies Repealed
- 7.1Acute toxicity Repealed
- Oral Repealed
- Circumstances in which required Repealed
- Test guidelines Repealed
- Percutaneous Repealed
- Circumstances in which required Repealed
- Test guideline Repealed
- Inhalation Repealed
- Aim of the test Repealed
- Circumstances in which required Repealed
- Test guideline Repealed
- Skin irritation Repealed
- Aim of the test Repealed
- Circumstances in which required Repealed
- Test guideline Repealed
- Eye irritation Repealed
- Aim of the test Repealed
- Circumstances in which required Repealed
- Test guideline Repealed
- Skin sensitization Repealed
- Aim of the test Repealed
- Circumstances in which required Repealed
- Test guideline Repealed
- Supplementary studies for combinations of plant protection products Repealed
- Aim of the test Repealed
- 7.2Data on exposure Repealed
- 7.2.1Operator exposure Repealed
- Estimation of operator exposure Repealed
- Aim of the estimation Repealed
- Circumstances in which required Repealed
- Estimation conditions Repealed
- Measurement of operator exposure Repealed
- Aim of the test Repealed
- Circumstances in which required Repealed
- Test conditions Repealed
- 7.2.2Bystander exposure Repealed
- Aim of the estimation Repealed
- Circumstances in which required Repealed
- Estimation conditions Repealed
- 7.2.3Worker exposure Repealed
- Estimation of worker exposure Repealed
- Aim of the estimation Repealed
- Circumstances in which required Repealed
- Estimation conditions Repealed
- Measurement of worker exposure Repealed
- Aim of the test Repealed
- Circumstances in which required Repealed
- Test conditions Repealed
- Dermal absorption Repealed
- Aim of the test Repealed
- Circumstances in which required Repealed
- Test conditions Repealed
- Test guideline Repealed
- 7.4Available toxicological data relating to non-active substances Repealed
- Residues in or on treated products, food and feed Repealed
- Introduction Repealed
- Metabolism, distribution and expression of residue in plants or livestock Repealed
- Aim of the tests Repealed
- Circumstances in which required Repealed
- Test conditions Repealed
- Residue trials Repealed
- Aim of the tests Repealed
- Circumstances in which required Repealed
- Test conditions Repealed
- Livestock feeding studies Repealed
- Aim of the tests Repealed
- Circumstances in which required Repealed
- Test conditions Repealed
- Effects of industrial processing and/or household preparations Repealed
- Aim of the tests Repealed
- Circumstances in which required Repealed
- Test conditions Repealed
- Residues in succeeding crops Repealed
- Aim of the test Repealed
- Circumstances in which required Repealed
- Test conditions Repealed
- 8.6Proposed maximum residue levels (MRLs) and residue definition Repealed
- 8.7Proposed pre-harvest intervals for envisaged uses, or withholding periods or storage periods, in the case of post-harvest uses. Repealed
- 8.8Estimation of the potential and actual exposure through diet and other means Repealed
- 8.9Summary and evaluation of residue behaviour Repealed
- Fate and behaviour in the environment Repealed
- Introduction Repealed
- 9.1Fate and behaviour in soil Repealed
- Rate of degradation in soil Repealed
- 9.1.1.1Division 9.1.1.1 Repealed
- 9.1.1.2Division 9.1.1.2 Repealed
- 9.1.2Mobility in the soil Repealed
- 9.1.2.1Division 9.1.2.1 Repealed
- 9.1.2.2Division 9.1.2.2 Repealed
- 9.1.3Estimation of expected concentrations in soil Repealed
- Fate and behaviour in water Repealed
- 9.2.1Estimation of concentrations in groundwater Repealed
- 9.2.2Impact on water treatment procedures Repealed
- 9.2.3Estimation of concentrations in surface water Repealed
- 9.3Fate and behaviour in air Repealed
- Ecotoxicological studies Repealed
- Introduction Repealed
- 10.1Effects on birds Repealed
- 10.1.1Division 10.1.1 Repealed
- Aim of the test Repealed
- Circumstances in which required Repealed
- Test conditions Repealed
- 10.1.2Division 10.1.2 Repealed
- Aim of the test Repealed
- Circumstances in which required Repealed
- Test conditions Repealed
- 10.1.3Division 10.1.3 Repealed
- Aim of the test Repealed
- Circumstances in which required Repealed
- 10.1.4Division 10.1.4 Repealed
- 10.2Effects on aquatic organisms Repealed
- 10.2.1Division 10.2.1 Repealed
- Circumstances in which required Repealed
- Test conditions and test guidelines Repealed
- 10.2.2Division 10.2.2 Repealed
- Aim of the test Repealed
- Circumstances in which required Repealed
- Test conditions Repealed
- Test guideline Repealed
- 10.2.3Division 10.2.3 Repealed
- Aim of the test Repealed
- Circumstances in which required Repealed
- Test guideline Repealed
- 10.2.4Division 10.2.4 Repealed
- 10.3Effects on terrestrial vertebrates other than birds Repealed
- Aim of the test Repealed
- Circumstances in which required Repealed
- Test conditions Repealed
- 10.4Effects on bees Repealed
- 10.4.1Division 10.4.1 Repealed
- Aim of the test Repealed
- Circumstances in which required Repealed
- Test guideline Repealed
- 10.4.2Division 10.4.2 Repealed
- Aim of the test Repealed
- Circumstances in which required Repealed
- Test conditions Repealed
- 10.4.3Division 10.4.3 Repealed
- Aim of the test Repealed
- Circumstances in which required Repealed
- Test conditions Repealed
- Test guideline Repealed
- 10.4.4Division 10.4.4 Repealed
- Aim of the test Repealed
- Circumstances in which required Repealed
- Test conditions Repealed
- Test guideline Repealed
- 10.4.5Division 10.4.5 Repealed
- Aim of the test Repealed
- Circumstances in which required Repealed
- Test conditions Repealed
- Test guideline Repealed
- 10.5Effects on arthropods other than bees Repealed
- 10.5.1Division 10.5.1 Repealed
- Aim of the test Repealed
- Circumstances in which required Repealed
- Test conditions Repealed
- Test guideline Repealed
- 10.5.2Division 10.5.2 Repealed
- Aim of the test Repealed
- Circumstances in which required Repealed
- Test conditions Repealed
- Test guideline Repealed
- Effects on earthworms and other soil non-target macro-organisms, believed to be at risk Repealed
- 10.6.1Division 10.6.1 Repealed
- 10.6.1.1Division 10.6.1.1 Repealed
- Aim of the test Repealed
- Circumstances in which required Repealed
- Test guideline Repealed
- 10.6.1.2Division 10.6.1.2 Repealed
- Aim of the test Repealed
- Circumstances in which required Repealed
- Test conditions Repealed
- 10.6.1.3Division 10.6.1.3 Repealed
- Aim of the test Repealed
- Circumstances in which required Repealed
- Test conditions Repealed
- 10.6.2Division 10.6.2 Repealed
- Aim of the test Repealed
- Circumstances in which required Repealed
- Effects on soil non-target micro-organisms Repealed
- 10.7.1Division 10.7.1 Repealed
- Aim of the test Repealed
- Circumstances in which required Repealed
- Test guideline Repealed
- 10.7.2Division 10.7.2 Repealed
- Aim of the test Repealed
- Circumstances in which required Repealed
- 10.8Available data from biological primary screening in summary form Repealed
- 11Summary and evaluation of points 9 and 10 Repealed
- Further information Repealed
- 12.1Division 12.1 Repealed
- 12.2Division 12.2 Repealed
- 12.3Division 12.3 Repealed
- 12.4Division 12.4 Repealed
- 12.5Division 12.5 Repealed
- Part B Repealed
- Introduction Repealed
- 1IDENTITY OF THE PLANT PROTECTION PRODUCT Repealed
- 1.1Applicant Repealed
- 1.2Manufacturer of the preparation and the micro-organism(s) Repealed
- 1.3Trade name or proposed trade name, and manufacturer's development code number of the preparation if appropriate Repealed
- 1.4Detailed quantitative and qualitative information on the composition of the preparation Repealed
- 1.5Physical state and nature of the preparation Repealed
- 1.6Function Repealed
- 2PHYSICAL, CHEMICAL AND TECHNICAL PROPERTIES OF THE PLANT PROTECTION PRODUCT Repealed
- 2.1Appearance (colour and odour) Repealed
- Storage stability and shelf-life Repealed
- 2.2.1Effects of light, temperature and humidity on technical characteristics of the plant protection product Repealed
- 2.2.2Other factors affecting stability Repealed
- 2.3Explosivity and oxidising properties Repealed
- 2.4Flash point and other indications of flammability or spontaneous ignition Repealed
- 2.5Acidity, alkalinity and if necessary pH value Repealed
- 2.6Viscosity and surface tension Repealed
- 2.7Technical characteristics of the plant protection product Repealed
- 2.7.1Wettability Repealed
- 2.7.2Persistent foaming Repealed
- 2.7.3Suspensibility and suspension stability Repealed
- 2.7.4Dry sieve test and wet sieve test Repealed
- 2.7.5Particle size distribution (dustable and wettable powders, granules), content of dust/fines (granules), attrition and friability (granules) Repealed
- 2.7.6Emulsifiability, re-emulsifiability, emulsion stability Repealed
- 2.7.7Flowability, pourability (rinsability) and dustability Repealed
- Physical, chemical and biological compatibility with other products including plant protection products with which its use is to be authorised Repealed
- 2.8.1Physical compatibility Repealed
- 2.8.2Chemical compatibility Repealed
- 2.8.3Biological compatibility Repealed
- 2.9Adherence and distribution to seeds Repealed
- Summary and evaluation of data presented under points 2.1 to 2.9 Repealed
- DATA ON APPLICATION Repealed
- 3.1Field of use envisaged Repealed
- 3.2Mode of action Repealed
- 3.3Details of intended use Repealed
- 3.4Application rate Repealed
- 3.5Content of micro-organism in material used (e.g. in the diluted spray, baits or treated seed) Repealed
- 3.6Method of application Repealed
- 3.7Number and timing of applications and duration of protection Repealed
- 3.8Necessary waiting periods or other precautions to avoid phytopathogenic effects on succeeding crops Repealed
- 3.9Proposed instructions for use Repealed
- FURTHER INFORMATION ON THE PLANT PROTECTION PRODUCT Repealed
- 4.1Packaging and compatibility of the preparation with proposed packaging materials Repealed
- 4.2Procedures for cleaning application equipment Repealed
- 4.3Re-entry periods, necessary waiting periods or other precautions to protect man, livestock and the environment Repealed
- 4.4Recommended methods and precautions concerning: handling, storage, transport or fire Repealed
- 4.5Measures in the case of an accident Repealed
- 4.6Procedures for destruction or decontamination of the plant protection product and its packaging Repealed
- 4.6.1Controlled incineration Repealed
- 4.6.2Others Repealed
- ANALYTICAL METHODS Repealed
- Introduction Repealed
- 5.1Methods for the analysis of the preparation Repealed
- 5.2Methods to determine and quantify residues Repealed
- 6EFFICACY DATA Repealed
- 7EFFECTS ON HUMAN HEALTH Repealed
- 7.1Basic acute toxicity studies Repealed
- Acute oral toxicity Repealed
- Circumstances in which required Repealed
- Test guideline Repealed
- Acute inhalation toxicity Repealed
- Aim of the test Repealed
- Circumstances in which required Repealed
- Test guideline Repealed
- Acute percutaneous toxicity Repealed
- Circumstances in which required Repealed
- Test guideline Repealed
- Additional acute toxicity studies Repealed
- Skin irritation Repealed
- Aim of the test Repealed
- Circumstances in which required Repealed
- Test guideline Repealed
- Eye irritation Repealed
- Aim of the test Repealed
- Circumstances in which required Repealed
- Test guideline Repealed
- Skin sensitisation Repealed
- Aim of the test Repealed
- Circumstances in which required Repealed
- Test guideline Repealed
- 7.3Data on exposure Repealed
- 7.4Available toxicological data relating to non-active substances Repealed
- Supplementary studies for combinations of plant protection products Repealed
- Aim of the test Repealed
- 7.6Summary and evaluation of health effects Repealed
- 8RESIDUES IN OR ON TREATED PRODUCTS, FOOD AND FEED Repealed
- 9FATE AND BEHAVIOUR IN THE ENVIRONMENT Repealed
- EFFECTS ON NON-TARGET ORGANISMS Repealed
- Introduction Repealed
- 10.1Effects on birds Repealed
- 10.2Effects on aquatic organisms Repealed
- 10.3Effects on bees Repealed
- 10.4Effects on arthropods other than bees Repealed
- 10.5Effects on earthworms Repealed
- 10.6Effects on soil micro-organisms Repealed
- 10.7Additional studies Repealed
- 11SUMMARY AND EVALUATION OF ENVIRONMENTAL IMPACT Repealed
- Annex IV: STANDARD PHRASES FOR SPECIAL RISKS FOR HUMANS OR THE ENVIRONMENT AS REFERRED TO IN ARTICLE 16 Repealed
- INTRODUCTION Repealed
- Standard phrases for special risks Repealed
- Special risks related to humans (RSh) Repealed
- RSh 1 Repealed
- RSh 2 Repealed
- RSh 3 Repealed
- 1.2Special risks related to the environment (RSe) Repealed
- Attribution criteria for standard phrases for special risks Repealed
- Attribution criteria for standard phrases related to humans Repealed
- RSh 1Toxic by eye contact. Repealed
- 2.2Attribution criteria for standard phrases related to the environment Repealed
- Annex V: STANDARD PHRASES FOR SAFETY PRECAUTIONS FOR THE PROTECTION OF HUMANS OR THE ENVIRONMENT AS REFERRED TO IN ARTICLE 16 Repealed
- INTRODUCTION Repealed
- 1General provisions Repealed
- SP 1 Repealed
- Specific safety precautions Repealed
- Safety precautions for operators (SPo) Repealed
- General provisions Repealed
- 1Division 1 Repealed
- 2Division 2 Repealed
- 3Member States may add specifications of engineering controls, such as: Repealed
- Specific provisions Repealed
- SPo 1 Repealed
- SPo 2 Repealed
- SPo 3 Repealed
- SPo 4 Repealed
- SPo 5 Repealed
- Safety precautions related to the environment (SPe) Repealed
- SPe 1 Repealed
- SPe 2 Repealed
- SPe 3 Repealed
- SPe 4 Repealed
- SPe 5 Repealed
- SPe 6 Repealed
- SPe 7 Repealed
- SPe 8 Repealed
- Safety precautions related to good agricultural practice Repealed
- SPa 1 Repealed
- Specific safety precautions for rodenticides (SPr) Repealed
- SPr 1 Repealed
- SPr 2 Repealed
- SPr 3 Repealed
- Attribution criteria for standard phrases for specific safety precautions Repealed
- 3.1INTRODUCTION Repealed
- Attribution criteria for standard phrases for safety precautions for operators Repealed
- SPo 1 Repealed
- SPo 2 Repealed
- SPo 3 Repealed
- SPo 4 Repealed
- SPo 5 Repealed
- Attribution criteria for standard phrases for safety precautions for the environment Repealed
- SPe 1 Repealed
- SPe 2 Repealed
- SPe 3 Repealed
- SPe 4 Repealed
- SPe 5 Repealed
- SPe 6 Repealed
- SPe 7 Repealed
- SPe 8 Repealed
- Attribution criteria for standard phrases for safety precautions for good agricultural practice Repealed
- SPa 1 Repealed
- Attribution criteria for standard phrases for specific safety precautions for rodenticides Repealed
- SPr 1 Repealed
- SPr 2 Repealed
- SPr 3 Repealed
- Annex VI Repealed
- Part I: UNIFORM PRINCIPLES FOR EVALUATION AND AUTHORISATION OF CHEMICAL PLANT PROTECTION PRODUCTS Repealed
- CONTENTS Repealed
- INTRODUCTION Repealed
- EVALUATION Repealed
- General principles Repealed
- Specific principles Repealed
- 2.1Division 2.1 Repealed
- 2.2Division 2.2 Repealed
- 2.3Division 2.3 Repealed
- 2.4Division 2.4 Repealed
- 2.4.1Division 2.4.1 Repealed
- 2.4.2Division 2.4.2 Repealed
- 2.5Division 2.5 Repealed
- 2.5.1Division 2.5.1 Repealed
- 2.5.2Division 2.5.2 Repealed
- 2.6Division 2.6 Repealed
- 2.7Division 2.7 Repealed
- DECISION-MAKING Repealed
- General principles Repealed
- Specific principles Repealed
- 2.1Division 2.1 Repealed
- 2.2Division 2.2 Repealed
- 2.3Division 2.3 Repealed
- 2.4Division 2.4 Repealed
- 2.4.1Division 2.4.1 Repealed
- 2.4.2Division 2.4.2 Repealed
- 2.5Division 2.5 Repealed
- 2.5.1Division 2.5.1 Repealed
- 2.5.2Division 2.5.2 Repealed
- 2.6Division 2.6 Repealed
- 2.7Division 2.7 Repealed
- INTRODUCTION Repealed
- 1Division 1 Repealed
- 2Division 2 Repealed
- 3Division 3 Repealed
- 4Division 4 Repealed
- 5Division 5 Repealed
- 6Division 6 Repealed
- EVALUATION Repealed
- General principles Repealed
- 1Division 1 Repealed
- 2Division 2 Repealed
- 3Division 3 Repealed
- 4Division 4 Repealed
- 5Division 5 Repealed
- 6Division 6 Repealed
- 2Specific priciples Repealed
- Efficacy Repealed
- 2.1.1Division 2.1.1 Repealed
- 2.1.2Division 2.1.2 Repealed
- 2.1.3Division 2.1.3 Repealed
- 2.1.4Division 2.1.4 Repealed
- 2.1.5Division 2.1.5 Repealed
- Absence of unacceptable effects on plants or plant products Repealed
- 2.2.1Division 2.2.1 Repealed
- 2.2.2Division 2.2.2 Repealed
- 2.2.3Division 2.2.3 Repealed
- 2.3Impact on vertebrates to be controlled Repealed
- Impact on human or animal health Repealed
- arising from the plant protection product Repealed
- 2.4.1.1Division 2.4.1.1 Repealed
- 2.4.1.2Division 2.4.1.2 Repealed
- 2.4.1.3Division 2.4.1.3 Repealed
- 2.4.1.4Division 2.4.1.4 Repealed
- Arising from residues Repealed
- 2.4.2.1Division 2.4.2.1 Repealed
- 2.4.2.2Division 2.4.2.2 Repealed
- 2.4.2.3Division 2.4.2.3 Repealed
- 2.4.2.4Division 2.4.2.4 Repealed
- 2.4.2.5Division 2.4.2.5 Repealed
- 2.4.2.6Division 2.4.2.6 Repealed
- Influence on the environment Repealed
- 2.5.1Fate and distribution in the environment Repealed
- 2.5.1.1Division 2.5.1.1 Repealed
- 2.5.1.2Division 2.5.1.2 Repealed
- 2.5.1.3Division 2.5.1.3 Repealed
- 2.5.1.4Division 2.5.1.4 Repealed
- 2.5.1.5Division 2.5.1.5 Repealed
- 2.5.2Impact on non-target species Repealed
- 2.5.2.1Division 2.5.2.1 Repealed
- 2.5.2.2Division 2.5.2.2 Repealed
- 2.5.2.3Division 2.5.2.3 Repealed
- 2.5.2.4Division 2.5.2.4 Repealed
- 2.5.2.5Division 2.5.2.5 Repealed
- 2.5.2.6Division 2.5.2.6 Repealed
- 2.6Analytical methods Repealed
- 2.6.1for formulation analysis: Repealed
- 2.6.2for residue analysis: Repealed
- Physical and chemical properties Repealed
- 2.7.1Division 2.7.1 Repealed
- 2.7.2Division 2.7.2 Repealed
- 2.7.3Division 2.7.3 Repealed
- DECISION-MAKING Repealed
- General principles Repealed
- 1Division 1 Repealed
- 2Division 2 Repealed
- 3Division 3 Repealed
- 4Division 4 Repealed
- 5Division 5 Repealed
- 6Division 6 Repealed
- 7Division 7 Repealed
- 8Division 8 Repealed
- 9Division 9 Repealed
- 2Specific principles Repealed
- Efficacy Repealed
- 2.1.1Division 2.1.1 Repealed
- 2.1.2Division 2.1.2 Repealed
- 2.1.3Division 2.1.3 Repealed
- 2.1.4Division 2.1.4 Repealed
- 2.1.5Division 2.1.5 Repealed
- Absence of unacceptable effects on plants or plant products Repealed
- 2.2.1Division 2.2.1 Repealed
- 2.2.2Division 2.2.2 Repealed
- 2.2.3Division 2.2.3 Repealed
- 2.2.4Division 2.2.4 Repealed
- 2.2.5Division 2.2.5 Repealed
- 2.2.6Division 2.2.6 Repealed
- 2.2.7Division 2.2.7 Repealed
- 2.2.8Division 2.2.8 Repealed
- 2.3Impact on vertebrates to be controlled Repealed
- Impact on human or animal health Repealed
- arising from the plant protection product Repealed
- 2.4.1.1Division 2.4.1.1 Repealed
- 2.4.1.2Division 2.4.1.2 Repealed
- 2.4.1.3Division 2.4.1.3 Repealed
- 2.4.1.4Division 2.4.1.4 Repealed
- 2.4.1.5Division 2.4.1.5 Repealed
- 2.4.1.6Division 2.4.1.6 Repealed
- arising from residues Repealed
- 2.4.2.1Division 2.4.2.1 Repealed
- 2.4.2.2Division 2.4.2.2 Repealed
- 2.4.2.3Division 2.4.2.3 Repealed
- 2.4.2.4Division 2.4.2.4 Repealed
- 2.4.2.5Division 2.4.2.5 Repealed
- 2.4.2.6Division 2.4.2.6 Repealed
- 2.4.2.7Division 2.4.2.7 Repealed
- Influence on the environment Repealed
- Fate and distribution in the environment Repealed
- 2.5.1.1Division 2.5.1.1 Repealed
- 2.5.1.2Division 2.5.1.2 Repealed
- 2.5.1.3Division 2.5.1.3 Repealed
- 2.5.1.4Division 2.5.1.4 Repealed
- Impact on non-target species Repealed
- 2.5.2.1Division 2.5.2.1 Repealed
- 2.5.2.2Division 2.5.2.2 Repealed
- 2.5.2.3Division 2.5.2.3 Repealed
- 2.5.2.4Division 2.5.2.4 Repealed
- 2.5.2.5Division 2.5.2.5 Repealed
- 2.5.2.6Division 2.5.2.6 Repealed
- 2.6Analytical methods Repealed
- 2.6.1for formulation analysis: Repealed
- 2.6.2for residue analysis: Repealed
- Physical and chemical properties Repealed
- 2.7.1Division 2.7.1 Repealed
- 2.7.2Division 2.7.2 Repealed
- 2.7.3Division 2.7.3 Repealed
- Part II: UNIFORM PRINCIPLES FOR EVALUATION AND AUTHORISATION OF PLANT PROTECTION PRODUCTS CONTAINING MICRO-ORGANISMS Repealed
- Repealed
- INTRODUCTION Repealed
- 1Division 1 Repealed
- 2In evaluating applications for granting authorisations Member States shall: Repealed
- 3Division 3 Repealed
- 4Where the data and information provided are sufficient to permit completion of the evaluation for one of the proposed uses, applications must be evaluated and a decision made for the proposed use. Repealed
- 5During the process of evaluation and decision-making, the Member State shall cooperate with the applicants in order to resolve any questions on the dossier quickly or to identify at an early stage any additional studies necessary for a proper evaluation of the dossier, or to amend any proposed conditions for the use of the plant protection product or to modify its nature or its composition in order to ensure full satisfaction of the requirements of this Annex or of this Directive. Repealed
- 6Division 6 Repealed
- 7Division 7 Repealed
- 8Division 8 Repealed
- 9Division 9 Repealed
- 10Definitions and explanations of microbiological terms Repealed
- BEVALUATION Repealed
- General principles Repealed
- 1.1Having regard to current scientific and technical knowledge, Member States shall evaluate the information provided in accordance with the requirements of Annex IIB and IIIB and in particular: Repealed
- 1.2The quality/methodology of tests, where there are no standardised test methods, must be evaluated and the following characteristics, when available, of the methods described must be assessed: Repealed
- 1.3In interpreting the results of evaluations, Member States shall take into consideration possible elements of uncertainty in the information obtained during the evaluation, in order to ensure that the chances of failing to detect adverse effects or of underestimating their importance are reduced to a minimum. The decision-making process shall be examined to identify critical decision points or items of data for which uncertainties could lead to a false classification of risk. Repealed
- 1.4Division 1.4 Repealed
- 1.5Division 1.5 Repealed
- 1.6Division 1.6 Repealed
- 1.7Where specific principles in Section 2 provide for the use of calculation models in the evaluation of a plant protection product, those models shall: Repealed
- 1.8Division 1.8 Repealed
- 2Specific principles Repealed
- Identity Repealed
- 2.1.1Identity of the micro-organism in the plant protection product Repealed
- 2.1.2Identity of the plant protection product Repealed
- Biological, physical, chemical, and technical properties Repealed
- Biological properties of the micro-organism in the plant protection product Repealed
- 2.2.1.1Division 2.2.1.1 Repealed
- 2.2.1.2The ability of micro-organisms to adapt to the environment must be evaluated. In particular, Member States must take account of the following principles: Repealed
- 2.2.1.3The mode of action of the micro-organism should be evaluated in as much detail as appropriate. The possible role of metabolites/toxins for the mode of action should be evaluated and when identified, the minimal effective concentration for each active metabolite/toxin should be established. Information on mode of action can be a very valuable tool in identifying potential risks. Aspects to be considered in the evaluation, are: Repealed
- 2.2.1.4In order to evaluate possible effects on non-target organisms, information on the micro-organism's host specificity must be evaluated, taking into account the characteristics and properties described in (a) and (b). Repealed
- 2.2.1.5Division 2.2.1.5 Repealed
- Physical, chemical and technical properties of the plant protection product Repealed
- 2.2.2.1Division 2.2.2.1 Repealed
- 2.2.2.2Division 2.2.2.2 Repealed
- 2.2.2.3Member States shall evaluate the physical and chemical properties of the plant protection product and the retention of these characteristics after storage and take into consideration: Repealed
- 2.2.2.4Division 2.2.2.4 Repealed
- Further information Repealed
- 2.3.1Quality control of the production of the micro-organism in the plant protection product Repealed
- 2.3.2Quality control of the plant protection product Repealed
- Efficacy Repealed
- 2.4.1Division 2.4.1 Repealed
- 2.4.2Division 2.4.2 Repealed
- 2.4.3Member States shall evaluate the efficacy data provided for in Annex IIIB on the plant protection product having regard to the degree of control or the extent of the effect desired and having regard to relevant experimental conditions such as: Repealed
- 2.4.4Member States shall evaluate the performance of the plant protection product under the range of agricultural, plant health and environmental (including climatic) conditions likely to be encountered in practice in the area of proposed use. The effect on integrated control must be included in the evaluation. In particular, consideration should be paid to: Repealed
- 2.4.5Member States shall evaluate the degree of adverse effects on the treated crop after use of the plant protection product according to the proposed conditions of use in comparison, where relevant, with a suitable reference product or products, where they exist, and/or an untreated control. Repealed
- 2.4.6Where the plant protection product label includes requirements for use of the plant protection product with other plant protection products and/or with adjuvants as a tank mix, Member States shall make the evaluations referred to in points 2.4.3 to 2.4.5 in relation to the information supplied for the tank mix. Repealed
- 2.4.7Division 2.4.7 Repealed
- 2.4.8Where the proposed use of a plant protection product is intended to have an effect on vertebrates, Member States shall evaluate the mechanism by which this effect is obtained and the observed effects on the behaviour and health of the target animals. When the intended effect is to kill the target animal they shall evaluate the time necessary to obtain the death of the animal and the conditions under which death occurs. Repealed
- 2.5Identification/detection and quantification methods Repealed
- Analytical methods for the plant protection product Repealed
- 2.5.1.1Non-viable components Repealed
- 2.5.1.2Viable components Repealed
- Analytical methods for the determination of residues Repealed
- 2.5.2.1Non-viable residues Repealed
- 2.5.2.2Viable residues Repealed
- 2.6Impact on human or animal health Repealed
- Effects on human or animal health arising from the plant protection product Repealed
- 2.6.1.1Member States shall evaluate operator exposure to the micro-organism, and/or to toxicologically relevant compounds in the plant protection product (e.g. their metabolites/toxins, residual growth medium, contaminants and co-formulants), likely to occur under the proposed conditions of use (including in particular dose, application method and climatic conditions). Realistic data on exposure levels must be used and, if such data are not available, a suitable, validated calculation model. When available, a European harmonised generic exposure database for plant protection products should be used. Repealed
- 2.6.1.2Member States shall examine information relating to the nature and characteristics of the packaging proposed with particular reference to the following aspects: Repealed
- 2.6.1.3Member States shall examine the nature and characteristics of the protective clothing and equipment proposed with particular reference to the following aspects: Repealed
- 2.6.1.4Member States shall evaluate the possibility of exposure of other humans (workers exposed after the application of the plant protection product, such as re-entering workers, or bystanders) or animals to the micro-organism and/or to other toxicologically relevant compounds in the plant protection product under the proposed conditions of use. This evaluation will take into consideration the following information: Repealed
- 2.6.2Effects on human or animal health arising from residues Repealed
- 2.6.2.1Non-viable residues Repealed
- 2.6.2.2Viable residues Repealed
- 2.7Fate and behaviour in the environment Repealed
- 2.7.1Member States shall evaluate the possibility of contamination of ground water, surface water and drinking water under the proposed conditions of use of the plant protection product. Repealed
- 2.7.2Member States shall evaluate the risk for the aquatic compartment where the possibility of the exposure of aquatic organisms has been established. A micro-organism may give rise to risks because of its potential through multiplication to establish itself in the environment and can therefore have a long-lasting or permanent impact on microbial communities or their predators. Repealed
- 2.7.3Division 2.7.3 Repealed
- 2.7.4Member States shall evaluate the possibility of exposure of organisms in the terrestrial compartment to the plant protection product under the proposed conditions of use; if this possibility exists they shall evaluate the risks arising for the terrestrial compartment. A micro-organism may give rise to risks because of its potential through multiplication to establish itself in the environment and can therefore have a long-lasting or permanent impact on microbial communities or their predators. Repealed
- 2.8Effects on and exposure of non-target organisms Repealed
- Member States shall evaluate the possibility of exposure of and effects on terrestrial wildlife (non-domestic birds, mammals and other terrestrial vertebrates). Repealed
- 2.8.1.1A micro-organism may give rise to risks because of its potential to infect and multiply in avian and mammalian host systems. Whether or not identified risks could be changed due to the formulation of the plant protection product shall be assessed, taking into account the following information on the micro-organism: Repealed
- 2.8.1.2A plant protection product may give rise to toxic effects due to the action of toxins or co-formulants. For the assessment of such effects, the following information should be taken into consideration: Repealed
- Member States shall evaluate the possibility of exposure of and effects on aquatic organisms. Repealed
- 2.8.2.1A micro-organism may give rise to risks because of its potential to infect and multiply in aquatic organisms. Whether or not identified risks could be changed due to the formulation of the plant protection product shall be assessed, taking into account the following information on the micro-organism: Repealed
- 2.8.2.2A plant protection product may give rise to toxic effects due to the action of toxins or co-formulants. For the assessment of such effects the following information should be taken into consideration: Repealed
- Member States shall evaluate the possibility of exposure of and effects on bees. Repealed
- 2.8.3.1A micro-organism may give rise to risks because of its potential to infect and multiply in bees. Whether or not identified risks could be changed due to the formulation of the plant protection product shall be assessed, taking into account the following information on the micro-organism: Repealed
- 2.8.3.2A plant protection product may give rise to toxic effects due to the action of toxins or co-formulants. For the assessment of such effects the following information should be taken into consideration: Repealed
- Member States shall evaluate the possibility of exposure of and effects on arthropods other than bees. Repealed
- 2.8.4.1A micro-organism may give rise to risks because of its potential to infect and multiply in arthropods other than bees. Whether or not identified risks could be changed due to the formulation of the plant protection product shall be assessed, taking into account the following information on the micro-organism: Repealed
- 2.8.4.2A plant protection product may give rise to toxic effects due to the action of toxins or co-formulants. For the assessment of such effects the following information should be taken into consideration: Repealed
- Member States shall evaluate the possibility of exposure of and effects on earthworms. Repealed
- 2.8.5.1A micro-organism may give rise to risks because of its potential to infect and multiply in earthworms. Whether or not identified risks could be changed due to the formulation of the plant protection product shall be assessed, taking into account the following information on the micro-organism: Repealed
- 2.8.5.2A plant protection product may give rise to toxic effects due to the action of toxins or co-formulants. For the assessment of such effects the following information should be taken into consideration: Repealed
- Member States shall evaluate the possibility of exposure of and effects on soil micro-organisms. Repealed
- 2.8.6.1A micro-organism may give rise to risks because of its potential to interfere with nitrogen and carbon mineralisation in the soil. Whether or not identified risks could be changed due to the formulation of the plant protection product shall be assessed, taking into account the following information on the micro-organism: Repealed
- 2.8.6.2Division 2.8.6.2 Repealed
- 2.8.6.3A plant protection product may give rise to toxic effects due to the action of toxins or co-formulants. For the assessment of such effects the following information should be taken into consideration: Repealed
- 2.9Conclusions and proposals Repealed
- DECISION-MAKING Repealed
- General principles Repealed
- 1.1Division 1.1 Repealed
- 1.2Division 1.2 Repealed
- 1.3Division 1.3 Repealed
- 1.4Division 1.4 Repealed
- 1.5Division 1.5 Repealed
- 1.6Before issuing an authorisation, Member States shall ensure that the label of the plant protection product: Repealed
- 1.7Before issuing authorisations, Member States shall: Repealed
- 1.8No authorisation shall be granted unless all the requirements referred to in point 2 are satisfied. However, when one or more of the specific decision-making requirements referred to in point 2.4 are not fully satisfied, authorisations shall be granted only where the advantages of the use of the plant protection product under the proposed conditions of use outweigh the possible adverse effects of its use. Any restrictions on use of the plant protection product relating to non-compliance with some of the requirements referred to in point 2.4 must be mentioned on the label. These advantages can be in terms of: Repealed
- 1.9Where an authorisation has been granted according to the requirements provided for in this Annex, Member States may, by virtue of Article 4(6): Repealed
- 1.10Division 1.10 Repealed
- 1.11Division 1.11 Repealed
- 1.12Division 1.12 Repealed
- 1.13Division 1.13 Repealed
- 1.14Division 1.14 Repealed
- 2Specific principles Repealed
- 2.1Identity Repealed
- Biological and technical properties Repealed
- 2.2.1Division 2.2.1 Repealed
- 2.2.2Division 2.2.2 Repealed
- 2.3Further information Repealed
- Efficacy Repealed
- Performance Repealed
- 2.4.1.1Division 2.4.1.1 Repealed
- 2.4.1.2Division 2.4.1.2 Repealed
- 2.4.1.3Division 2.4.1.3 Repealed
- 2.4.1.4Division 2.4.1.4 Repealed
- 2.4.1.5Where proposed label claims include requirements for use of the preparation with other specified plant protection products or adjuvants as a tank mix, the mixture must achieve the desired effect and comply with the principles referred to in points 2.4.1.1 to 2.4.1.4. Repealed
- 2.4.1.6Division 2.4.1.6 Repealed
- 2.4.1.7Division 2.4.1.7 Repealed
- Absence of unacceptable effects on plants and plant products Repealed
- 2.4.2.1Division 2.4.2.1 Repealed
- 2.4.2.2Division 2.4.2.2 Repealed
- 2.4.2.3Division 2.4.2.3 Repealed
- 2.4.2.4Division 2.4.2.4 Repealed
- 2.4.2.5Division 2.4.2.5 Repealed
- 2.4.2.6Division 2.4.2.6 Repealed
- 2.4.2.7Division 2.4.2.7 Repealed
- 2.4.2.8Division 2.4.2.8 Repealed
- 2.5Identification/detection and quantification methods Repealed
- 2.5.1Division 2.5.1 Repealed
- 2.5.2No authorisation shall be granted unless there are adequate methods for post-registration control and monitoring of viable and/or non-viable residues. Methods must be available for analysis of: Repealed
- Impact on human and animal health Repealed
- Effects on human and animal health arising from the plant protection product Repealed
- 2.6.1.1Division 2.6.1.1 Repealed
- 2.6.1.2No authorisation shall be granted if the micro-organism and/or the plant protection product containing the micro-organism might, under the recommended conditions of use, including a realistic worst case scenario, colonise or cause adverse effects in humans or animals. Repealed
- 2.6.1.3All micro-organisms should be regarded as potential sensitisers, unless it is established by means of relevant information that there is no risk of sensitisation, taking into account immuno-compromised and other sensitive individuals. Authorisations granted shall therefore specify that protective clothing and suitable gloves be worn and that the plant protection product containing the micro-organism should not be inhaled. Moreover, the proposed conditions of use may require use of additional items of protective clothing and equipment. Repealed
- 2.6.1.4Division 2.6.1.4 Repealed
- 2.6.1.5Division 2.6.1.5 Repealed
- 2.6.1.6Division 2.6.1.6 Repealed
- 2.6.1.7Division 2.6.1.7 Repealed
- 2.6.1.8Division 2.6.1.8 Repealed
- 2.6.1.9Division 2.6.1.9 Repealed
- Effects on human and animal health arising from residues Repealed
- 2.6.2.1Division 2.6.2.1 Repealed
- 2.6.2.2Division 2.6.2.2 Repealed
- Fate and behaviour in the environment Repealed
- 2.7.1Division 2.7.1 Repealed
- 2.7.2Division 2.7.2 Repealed
- 2.7.3No authorisation shall be granted if the contamination of groundwater expected as a result of the use of a plant protection product under the proposed conditions of use contravenes or exceeds whichever of the following is the lower: Repealed
- 2.7.4No authorisation shall be granted if the contamination of surface water expected as a result of the use of a plant protection product under the proposed conditions of use: Repealed
- 2.7.5Division 2.7.5 Repealed
- 2.7.6Division 2.7.6 Repealed
- 2.7.7Division 2.7.7 Repealed
- 2.8Effects on non-target organisms Repealed
- 2.8.1Where there is a possibility of birds and other non-target terrestrial vertebrates being exposed, no authorisation shall be granted if: Repealed
- 2.8.2Where there is a possibility of aquatic organisms being exposed, no authorisation shall be granted if: Repealed
- 2.8.3Where there is a possibility of bees being exposed, no authorisation shall be granted: Repealed
- 2.8.4Where there is a possibility of arthropods other than bees being exposed, no authorisation shall be granted if: Repealed
- 2.8.5Division 2.8.5 Repealed
- 2.8.6Division 2.8.6 Repealed