-- particular data and information which would not be necessary owing to the nature of the product or its proposed uses, are not provided, or

-- it is not scientifically necessary, or technically possible to supply information and data;

-- chemical name according to IUPAC and CA nomenclature;

-- ISO common name or proposed common name if available;

-- CAS number, EEC (EINECS or ELINCS) number, and CIPAC number if available;

-- molecular and structural formula;

-- molecular mass; and

-- maximum content in g/kg.

( i ) The information provided, must describe the physical and chemical properties of active substances and together with other relevant information, must serve to characterize them. In particular, the information provided must permit--

-- specify the hazard symbols, the indications of danger, and the risk and safety phrases for the protection of man, animals and the environment to be included on packaging (containers),

-- identify relevant first aid measures as well as appropriate diagnostic and therapeutic measures to be followed in the event of poisoning in man, and

-- permit an evaluation to be made as to the nature and extent of the risks for man, animals (species normally fed and kept or consumed by man) and of the risks for other non-target vertebrate species.

(ii) There is no need to investigate and report all potentially adverse effects found during routine toxicological investigations (including effects on organs and special systems such as immunotoxicity and neurotoxicity) and to undertake and report such additional studies which may be necessary to investigate the probable mechanism involved, to establish NOAELs (no observed adverse effect levels), and to assess the significance of these effects. All available biological data and information which is relevant to the assessment of the toxicological profile of the substance tested, must be provided.

(iii) In the context of the influence that impurities can have on toxicological behaviour, it is essential that for each study submitted, a detailed description (specification) of the material used, as mentioned under section 1 point 11, be provided. Tests should be conducted using active substance of that specification to be used in the manufacture of preparations to be authorized, except where radio labelled material is required or permitted.

(iv) Where studies are conducted using an active substance produced in the laboratory or in a pilot plant production system, the studies must be repeated using the active substance as manufactured, unless it can be justified that the test material used is essentially the same, for the purposes of toxicological testing and assessment. In cases of uncertainty, appropriate bridging studies must be submitted to serve as a basis for a decision as to the possible need for repetition of studies.

(v) In the case of studies in which dosing extends over a period, dosing should preferably be done using a single batch of active substance if stability permits.

(vi) For all studies actual achieved dose in mg/kg body weight, as well as in other convenient units, must be reported. Where dosing via the diet is utilized the test compound must be distributed uniformly in the diet.

(vii) Where, as a result of metabolism or other processes in or on treated plants, or as a result of processing of treated products, the terminal residue (to which consumers or workers as defined in Annex III, point 7.2.3 will be exposed) contains a substance which is not the active substance itself and is not identified as a metabolite in mammals, it will be necessary to carry out toxicity studies on those components of the terminal residue unless it can be demonstrated that consumer or worker exposure to these substances does not constitute a relevant risk to health. Toxicokinetic and metabolism studies relating to metabolites and degradation products should only be conducted if toxicity findings of the metabolite cannot be evaluated by the available results relating to the active substance.

(viii) The route of administration of the test substance depends on the main exposure routes. In cases where exposure is mainly to the gas phase, it can be more appropriate to perform inhalation studies instead of oral studies.

-- an evaluation of the rate and extent of absorption,

-- the tissue distribution and the rate and extent of excretion of the test substance and of relevant metabolites,

-- the identification of metabolites and the metabolic pathway.

-- the toxicity of the active substance,

-- the time course and characteristics of the effects with full details of behavioural changes and possible gross pathological changes at postmortem,

-- where possible mode of toxic action, and

-- the relative hazard associated with the different routes of exposure.

-- a gas or a liquified gas,

-- to be used as a fumigant,

-- to be included in a smoke generating, aerosol or vapour releasing, preparation,

-- to be used with fogging equipment,

-- has a vapour pressure> 1 x 10^-2 Pa and is to be included in preparations to be used in enclosed spaces such as warehouses or glasshouses,

-- to be included in preparations which are powders containing a significant proportion of particles of diameter 1% on a weight basis), or

-- to be included in preparations to be applied in a manner which generates a significant proportion of particles or droplets of diameter 1% on a weight basis).

-- the relationship between dose and adverse effects,

-- the toxicity of the active substance including where possible the NOAEL,

-- the target organs, where relevant,

-- the time course and characteristics of poisoning with full details of behavioural changes and possible pathological findings at post-mortem,

-- specific toxic effects and pathological changes produced,

-- where relevant the persistence and reversibility of certain toxic effects observed, following discontinuation of dosing,

-- where possible, the mode of toxic action, and

-- the relative hazard associated with different routes of exposure.

-- 28-day dermal: EEC Method B 9,

-- 90-day dermal: Commission Directive 88/302/EEC¹⁰, Part B, sub-chronic dermal toxicity study,

-- 28-day inhalation: EEC Method B 8,

-- 90-day inhalation; Commission Directive 88/3O2/EEC¹⁰, Part B, sub-chronic inhalation toxicity study.

-- the prediction of genotoxic potential,

-- the early identification of genotoxic carcinogens, and

-- the elucidation of the mechanism of action of some carcinogens.

-- identify adverse effects resulting from exposure to the active substance,

-- identify target organs, where relevant,

-- establish the dose-response relationship,

-- identify changes in toxic signs and manifestations observed, and

-- establish the NOAEL.

-- to identify carcinogenic effects resulting from exposure to the active substance,

-- to establish the species and organ specificity of tumours induced,

-- to establish the dose-response relationship, and

-- for non-genotoxic carcinogens, to identify the maximum dose eliciting no adverse effect (threshold dose).

-- the identification of species and strain, the name of the supplier and the specific colony identification, if the supplier has more than one geographical location,

-- the name of the laboratory and the dates when the study was performed,

-- a description of the general conditions under which animals were maintained, including the type or brand of diet and, where possible, the amount consumed,

-- the approximate age, in days, of the control animals at the beginning of the study and at the time of killing or death,

-- a description of the control group mortality pattern observed during or at the end of the study, and other pertinent observations (e.g. diseases, infections),

-- the names of the laboratory and of the examining scientists responsible for gathering and interpreting pathological data from the study, and

-- a statement of the nature of the tumours that may have been combined to produce any of the incidence data.

-- impairment of male or female fertility, and

-- effects on the normal development of progeny (developmental toxicity).

-- the identification of species and strain, the name of the supplier and the specific colony identification, if the supplier has more than one geographical location,

-- the name of the laboratory and the dates when the study was performed,

-- a description of the general conditions under which animals were maintained, including the type of brand of diet and, where possible, the amount consumed,

-- the approximate age, in days, of the control animals at the beginning of the study and at the time of killing or death,

-- a description of the control group mortality pattern observed during or at the end of the study, and other pertinent observations (e.g. diseases, infections), and

-- the names and the laboratory and of the examining scientists responsible for gathering and interpreting pathological data from the study.

-- to identify direct and indirect effects on reproduction resulting from exposure to the active substance,

-- to identify any enhancement of general toxic effects (noted during short-term and chronic testing),

-- to establish the dose-response relationship, to identify changes in toxic signs and manifestations observed, and

-- to establish the NOAEL.

-- separate male and female studies,

-- three segment design studies,

-- dominant lethal assay for male fertility,

-- cross matings of treated males with untreated females and vice versa,

-- effects on spermatogenesis,

-- effects on oogenesis,

-- sperm motility, mobility and morphology, and

-- investigation of hormonal activity.

-- to identify direct and indirect effects on embryonic and foetal development resulting from exposure to the active substance,

-- to identify any maternal toxicity,

-- to establish the relationship between observed responses and dose in both dam and offspring,

-- to identify changes in toxic signs and manifestations observed, and

-- to establish the NOAEL.

-- studies on absorption, distribution, excretion and metabolism,

-- studies on neurotoxic potential,

-- studies on immunotoxicological potential,

-- studies using other routes of administration.

-- the type, level and duration of exposure, or ingestion, and

-- varying time periods between exposure, or ingestion, and commencement of treatment.

(i) The introduction provided, taken together with that for one or more preparations containing the active substance, must be sufficient to permit an assessment of the fate and behaviour of the active substance in the environment, and of the non-target species likely to be at risk from exposure to the active substance, its metabolites, degradation and reaction products, where they are of toxicological or environmental significance.

(ii) In particular, the information provided for the active substance, together with other relevant information, and that provided for one or more preparations containing it, should be sufficient to--

-- decide whether, or not, the active substance can be included in Annex I;

-- specify appropriate conditions or restrictions to be associated with any inclusion in Annex I;

-- classify the active substance as to hazard;

-- specify the hazard symbols,, the indications of danger, and relevant risk and safety phrases for the protection of the environment, which are to be included on packaging (containers);

-- predict the distribution, fate, and behaviour in the environment of the active substance and relevant metabolites, degradation and reaction products as well as the time courses involved:

-- identify non-target species and populations for which hazards arise because of potential exposure; and

-- identify measures necessary to minimize contamination of the environment and impact on non-target species.

(iii) A detailed description (specification) of the material used, as provided for under section 1 point 11 must be provided. Where testing is done using active substance the material used should be of that specification that will be used in the manufacture of preparations to be authorized except where radiolabelled material is used.

Where studies are conducted using active substance produced in the laboratory or in a pilot plant production system, the studies must be repeated using active substance as manufactured, unless it can be justified that the test material used is essentially the same for the purposes of environmental testing and assessment.

(iv) Where radiolabelled test material is used, radiolabels should be positioned at sites (one or more as necessary), to facilitate elucidation of metabolic and degradative pathways and to facilitate investigation of the distribution of the active substance and of its metabolites, reaction and degradation products in the environment.

(v) It may be necessary to conduct separate studies for metabolites, degradation or reaction products, where these products can constitute a relevant risk to non-target organisms or to the quality of water, soil and air and where their effects cannot be evaluated by the available results relating to the active substance. Before such studies are performed the information from the sections 5 and 6 must be taken into account.

(vi) Where relevant, tests should be designed and data analyzed using appropriate statistical methods.

Full details of the statistical analysis should be reported (e.g. all point estimates should be given with confidence intervals, exact p-values should be given rather than stating significant/non significant).

-- they cover a range of organic carbon content, particle size distribution and pH values, and

-- where on the basis of other information, degradation or mobility are expected to be pH dependent (e.g. solubility and hydrolysis rate -- paragraphs 2.7 and 2.8), they cover the following pH ranges--

4.5 to 5.5,

6 to 7, and 8 (approximately).

-- indentify, where feasible, the relative importance of the types of process involved (balance between chemical and biological degradation),

-- identify the individual components present which at any time account for more than 10% of the amount of active substance added, including, where feasible, non-extractable residues,

^-- identify, where possible, individual components present which account for less than 10% of the amount of active substance added,

-- establish the relative proportions of the components present (mass balance), and

-- permit the soil residue of concern and to which non-target species are or may be exposed, to be defined.

-- active substance,

-- CO2,

-- volatile compounds other than CO2,

-- individual identified transformation products,

-- extractable substances not identified, and

-- non-extractable residues in soil.

-- where the nature and manner of use of preparations containing the active substance, preclude soil contamination, such as uses on stored products or wound healing treatments for trees, or

-- where a separate study for the metabolite, degradation or reaction product in accordance with point 7.1.2 or 7.1.3.1 was performed.

-- mobility in soil,

-- potential for leaching to ground water,

-- the potential distribution in soil.

-- persistence in water systems (bottom sediment and water, including suspended particles),

-- the extent to which water, sediment organisms and air are at risk, and

-- potential for contamination of surface water and groundwater.

-- identify the relative importance of the types of processes involved (balance between chemical and biological degradation),

-- where possible, identify the individual components present,

-- establish the relative proportions of the components present and their distribution as between water, including suspended particles, and sediment, and

-- permit the residue of concern and to which non-target species are or may be exposed, to be defined.

-- Hazard symbol(s)

-- Indications of danger

-- Risk phrases

-- Safety phrases

-- particular data and information which would not be necessary owing to the nature of the product or its proposed uses, are not provided, or

-- it is not scientifically necessary, or technically possible to supply information and data.

-- the use of the formulant is permitted in food, animal feeding stuffs, medicines or cosmetics in accordance with Community legislation; or

-- a safety data sheet has been submitted for the formulant in accordance with Council Directive 67/548/EEC of 27 June 1967, on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances.

-- the content of both technical active substance(s) and pure active substance(s); and

-- the content of formulants.

-- Agriculture

-- Horticulture

-- Forestry

-- Viticulture

-- pre-harvest interval (in days) for each relevant crop;

-- re-entry period (in days) for livestock, to areas to be grazed;

-- re-entry period (in hours or days) for man to crops, buildings or spaces treated;

-- withholding period (in days) for animal feedingstuffs;

-- waiting period (in days), between application and handling treated products; or

-- waiting period (in days), between last application and sowing or planting succeeding crops.

-- containment of spillages;

-- decontamination of areas, vehicles and buildings;

-- disposal of damaged packaging, adsorbents and other materials;

-- protection of emergency workers and bystanders; and

-- first aid measures.

-- the nature of the product or its use is such that a risk of occurrence of taint or odour might be expected, or

-- other products based on the same or a closely similar active substance have been shown to present a risk of occurrence of taint or odour.

-- the nature of the plant protection product or its use could have an adverse influence on other quality aspects (for example in the case of use of plant growth regulators close to harvest), or

-- other products based on the same or a closely similar active substance have been shown to have an adverse influence on the quality.

-- there are indications that the use of the plant protection product could have an influence on the processes involved (for example in the case of use of plant growth regulators or fungicides close to harvest), or

-- other products based on the same or a closely similar active substance have been shown to have an adverse influence on these processes or its products.

(i) For seeds -- viability, germination and vigour

(ii) Cuttings -- rooting and growth rates

(iii) Runners -- establishment and growth rates

(iv) Tubers -- sprouting and normal growth

-- the toxicity of the plant protection product,

-- the toxicity of the plant protection product relative to that of the active substance,

-- the time course and characteristics of the effects with full details of behavioural changes and possible gross pathological changes at postmortem,

-- where possible mode of toxic action, and

-- the relative hazard associated with the different routes of exposure.

-- is a gas or liquified gas,

-- is a smoke generating formulation or a fumigant,

-- is used with fogging equipment,

-- is a vapour releasing preparation,

-- is an aerosol,

-- is a powder containing a significant proportion of particles of diameter 1% on a weight basis),

-- is to be applied from aircraft in cases where inhalation exposure is relevant,

-- contains an active substance with a vapour pressure> 1 x 10-2 Pa and is to be used in enclosed spaces such as warehouses or glasshouses,

-- is to be applied in a manner which generates a significant proportion of particles or droplets of diameter 1% on a weight basis).

-- the Acceptable Operator Exposure Level(s) (AOEL) established in the context of the inclusion of the active substance(s) in Annex 1, and/or

-- the Limit Values established for the active substance(s) and/or toxicologically relevant compound(s) contained in the plant protection product, in accordance with Council Directive 80/1107/EEC¹² and Council Directive 90/394/EEC¹⁵, on the protection of workers from the risks related to exposure to carcinogens at work,

-- the AOELs established in the context of the inclusion of the active substance(s) in Annex 1, and/or

-- the Limit Values established for the active substance(s) and/or toxicologically relevant compound(s) contained in the plant protection product, in accordance with Council Directive 80/1107/EEC¹² and Council Directive 90/394/EEC¹⁵,

-- the AOELs established in the context of the inclusion of the active substance(s) in Annex I, and/or

-- the Limit Values established for the active substance(s) and/or toxicologically relevant compound(s) contained in the plant protection product, in accordance with Council Directive 80/1107/EEC¹² and Council Directive 90/394/EEC¹⁵,

(i) The information provided, taken together with that for the active substance as provided for in Annex II, must be sufficient to permit an assessment of the fate and behaviour of the plant protection product in the environment, and of the non-target species likely to be at risk from exposure to it.

(ii) In particular, the information provided for the plant protection product, together with other relevant information, and that provided for the active substance, should be sufficient to--

-- specify the hazard symbols, the indications of danger, and relevant risk and safety phrases for the protection of the environment, which are to be included on packaging (containers);

-- predict distribution, fate, and behaviour in the environment as well as the time courses involved;

-- identify non-target species and populations for which hazards arise because of potential exposure; and

-- identify measures necessary to minimize contamination of the environment and impact on non-target species.

(iii) Where radiolabelled test material is used, radio labels should be positioned at sites (one or more as necessary), to facilitate elucidation of metabolic and degradative pathways and to facilitate investigation of the distribution of the active substance and of its metabolites, reaction and degradation products in the environment.

(iv) Where relevant, tests should be designed and data analyzed using appropriate statistical methods.

"Predicted environmental concentration in soil (PEC_s)"

the level of residues in the top layer of the soil and to which non-target soil organisms may be exposed (acute and chronic exposure)

"Predicted environmental concentration in surface water (PEC_sw)"

the level of residues in surface water to which non-target aquatic organisms may be exposed (acute and chronic exposure)

"Predicted environmental concentration in groundwater (PEC_GW)"

the level of residues in groundwater

"Predicted environmental concentration in air (PEC_A)"

the level of residues in air, to which man, animals and other non-target organisms may be exposed (acute and chronic exposure)

-- provide a best possible estimation of all relevant processes involved taking into account realistic parameters and assumptions,

-- where possible be reliably validated with measurements carried out under circumstances relevant for the use of the model, and

-- be relevant to conditions in the area of use of proposed use for the plant protection product.

-- the mobility of the plant protection product in soil,

-- the potential for leaching to ground water,

-- the potential distribution in soil.

--

Hazard symbol(s)

--

Indication of danger

--

Risk phrases

--

Safety phrases

A

INTRODUCTION

( a ) -- without prejudice to the provisions of subparagraph (3) (a) of Regulation 8 and paragraph (3) of Regulation 10 of the principal Regulations, ensure that the dossier supplied is in accordance with the requirements of Annex III, at the latest at the time of finalization of the evaluation for the purposes of decision-making,

-- ensure that the data submitted are acceptable in terms of quantity, quality, consistency and reliability and are sufficient to permit a proper evaluation of the dossier,

-- evaluate, where relevant, justifications submitted by the applicant for not supplying certain data;

( b ) without prejudice, where relevant, to the provisions of subparagraphs (3) (b) and (5) (a) of Regulation 8, paragraphs (1) and (2) of Regulation 10 of the principal Regulations, take into account the Annex II data concerning the active substance in the plant protection product, submitted for the purpose of inclusion of the active substance concerned in Annex I, and the results of th^e evaluation of those data; and

( c ) take into consideration other relevant technical or scientific information that it possesses with regard to the performance of the plant protection product or to the potentially adverse effects of the plant protection product, its components or its residues.

( a ) assess the performance in terms of efficacy and phytotoxicity of the plant protection product for each use for which authorization is sought, and

( b ) identify the hazards arising, assess their significance and make a judgement as to the likely risks to humans, animals or the environment.

-- make a best possible estimation of all relevant processes involved taking into account realistic parameters and assumptions,

-- be submitted to an analysis as referred to in B, point 1.4,

-- be reliably validated with measurements carried out under circumstances relevant for the use of the model, and

-- be relevant to the conditions in the area of use.

-- the choice of the crop or cultivar,

-- the agricultural and environmental (including climatic) conditions,

-- the presence and density of the harmful organism,

-- the development stage of crop and organism,

-- the amount of the plant protection product used,

-- if required on the label, the amount of adjuvant added,

-- the frequency and timing of the applications, and

-- the type of application equipment.

(i) the level, consistency and duration of the effect sought in relation to the dose in comparison with a suitable reference product or products and an untreated control; and

(ii) where relevant, effect on yield or reduction of loss in storage, in terms of quantity and/or quality, in comparison with a suitable reference product or products and an untreated control.

( a ) This evaluation will take into consideration the following information:

(i) the efficacy data provided for in Annex III;

(ii) other relevant information on the plant protection product such as nature of the preparation, dose, method of application, number and timing of applications; and

(iii) all relevant information on the active substance as provided for in Annex II, including mode of action, vapour pressure, volatility and water solubility.

( b ) This evaluation will include:

(i) the nature, frequency, level and duration of observed phytotoxic effects and the agricultural, plant health and environmental (including climatic) conditions that affect these;

(ii) the differences between main cultivars with regard to their sensitivity to phytotoxic effects;

(iii) the part of the treated crop or plant products where phytotoxic effects are observed;

(iv) the adverse impact on the yield of the treated crop or plant products in terms of quantity and/or quality;

(v) the adverse impact on treated plants or plant products to be used for propagation, in terms of viability, germination, sprouting, rooting and establishment; and

(vi) where volatile products are concerned, the adverse impact on adjacent crops.

(i) all relevant information as provided for in Annex II and the results of the evaluation thereof, including the toxicological and metabolism studies; and

(ii) all relevant information on the plant protection product as provided for in Annex III, including toxicological studies and efficacy data.

( a ) This evaluation shall take into consideration the following information:

(i) the toxicological and metabolism studies as provided for in Annex II and the results of the evaluation thereof including the acceptable operator exposure level (AOEL). The acceptable operator exposure level is the maximum amount of active substance to which the operator may be exposed without any adverse health effects. The AOEL is expressed as milligrams of the chemical per kilogram body weight of the operator. The AOEL is based on the highest level at which no adverse effect is observed in tests in the most sensitive relevant animal species or, if appropriate data are available, in humans;

(ii) other relevant information on the active substances such as physical and chemical properties;

(iii) the toxicological studies provided for in Annex III, including where appropriate dermal absorption studies; and

(iv) other relevant information as provided for in Annex III such as--

-- composition of the preparation,

-- nature of the preparation,

-- size, design and type of packaging,

-- field of use and nature of crop or target,

-- method of application including handling, loading and mixing of product,

-- exposure reduction measures recommended,

-- protective clothing recommendations,

-- maximum application rate,

-- minimum spray application volume stated on the label,

-- number and timing of applications.

(b) This evaluation shall be made for each type of application method and application equipment proposed for use of the plant protection product as well as for the different types and sizes of containers to be used, taking account of mixing, loading operations, application of the plant protection product and cleaning and routine maintenance of application equipment.

-- the type of packaging,

-- its dimensions and capacity,

-- the size of the opening,

-- the type of closure,

-- its strength, leakproofness and resistance to normal transport and handling, and

-- its resistance to and compatibility with the contents.

-- obtainability and suitability, and

-- ease of wearing taking into account physical stress and climatic conditions.

(i) the toxicological and metabolism studies on the active substance as provided for in Annex II and the results of the evaluation thereof, including the acceptable operator exposure level;

(ii) the toxicological studies provided for in Annex III, including where appropriate dermal absorption studies; and

(iii) other relevant information on the plant protection product as provided for in Annex III such as--

-- re-entry periods, necessary waiting periods or other precautions to protect humans and animals,

-- method of application, in particular spraying,

-- maximum application rate,

-- maximum spray application volume,

-- composition of the preparation,

-- excess remaining on plants and plant products after treatment, and

-- further activities whereby workers are exposed.

-- the determination of an acceptable daily intake (ADI),

-- the identification of metabolites, degradation and reaction products in treated plants or plant products, and

-- behaviour of residues of the active substance and its metabolites from the time of application until harvest, or in the case of post-harvest uses, until outloading of stored plant products.

-- data on the proposed good agricultural practice, including data on application as provided for in Annex III and proposed pre-harvest intervals for envisaged uses, or withholding periods or storage periods, in the case of post-harvest uses,

-- nature of the preparation, and

-- analytical methods and the residue definition.

(i) the proposed conditions of use of the plant protection product;

(ii) the specific information on residues in or on treated plants, plant products, food and feed as provided for in Annex III and the distribution of residues between edible and non-edible parts;

(iii) the specific information on residues in or on treated plants, plant products, food and feed as provided for in Annex II and the result of the evaluation thereof; and

(iv) realistic possibilities of extrapolating data from one crop to another.

(i) the specific information on fate and behaviour in soil as provided for in Annex II and the results of the evaluation thereof;

(ii) other relevant information on the active substance such as--

-- molecular weight,

-- solubility in water,

-- octanol/water partition coefficient;

-- vapour pressure,

-- volatilization rate,

-- dissociation constant,

-- photodegradation rate and identity of breakdown products,

-- hydrolysis rate in relation to pH and identity of breakdown products;

(iii) all information on the plant protection product as provided for in Annex III, including the information on distribution and dissipation in soil; and

(iv) where relevant, other authorized uses of plant protection products in the area of proposed use containing the same active substance or which give rise to the same residues.

(i) the specific information on fate and behaviour in soil and water as provided for in Annex II and the results of the evaluation thereof;

(ii) other relevant information on the active substance such as--

-- molecular weight,

-- solubility in water,

-- octanol/water partition coefficient,

-- vapour pressure,

-- volatilization rate,

-- hydrolysis rate in relation to pH and identity of breakdown products,

-- dissociation constant;

(iii) all information on the plant protection product as provided for in Annex III, including the information on distribution and dissipation in soil and water;

(iv) where relevant, other authorized uses of plant protection products in the area of envisaged use containing the same active substance or which give rise to the same residues;

(v) where relevant, data on dissipation including transformation and sorption in the saturated zone;

(vi) where relevant, data on the procedures for drinking water abstraction and treatment in the area of envisaged use;

(vii) where relevant, monitoring data on the presence or absence of the active substance in groundwater as a result of previous use of plant protection products containing the same active substance or which give rise to the same residues.

(i) the specific information on fate and behaviour in soil and water as provided for in Annex II and the results of the evaluation thereof;

(ii) other relevant information on the active substance such as--

-- molecular weight,

-- solubility in water,

-- octanol/water partition coefficient,

-- vapour pressure,

-- volatilization rate,

-- hydrolysis rate in relation to pH and identity of breakdown products,

-- dissociation constant;

(iii) all relevant information on the plant protection product as provided for in Annex III, including the information on distribution and dissipation in soil and water;

(iv) possible routes of exposure--

-- drift,

-- run-off,

-- overspray,

-- discharge via drains,

-- leaching,

-- deposit via the atmosphere;

(v) where relevant, other authorized uses of plant protection products in the area of envisaged use containing the same active substance or which give rise to the same residues; and

(vi) where relevant, data on the procedures for drinking water abstraction and treatment in the area of envisaged use.

2.5.1.4

The competent authority shall evaluate the possibility that the plant protection product may be dissipated in the air under the proposed conditions of use; if this possibility exists it shall make the best possible estimation, using where appropriate a suitable, validated calculation model, of the concentration of the active substance and of relevant metabolites, degradation and reaction products that could be expected in the air after use of the plant protection product according to the proposed conditions of use.

(i) the specific information on fate and behaviour in soil, water and air as provided for in Annex II and the results of the evaluation thereof;

(ii) other relevant information on the active substance suc_h as--

-- vapour pressure,

-- solubility in water,

-- hydrolysis rate in relation to pH and identity of breakdown products,

-- photochemical degradation in water and air and identity _of breakdown products,

-- octanol/water partition coefficient;

(iii) all relevant information on the plant protec_tion product as provided for in Annex III, including the information on distribution and dissipation in air.

( a ) This evaluation shall take into consideration the following information:

(i) the specific information relating to toxicological studies on mammals and to the effects on birds and other non-target terrestrial vertebrates, including effects on reproduction, and other relevant information concerning the active substance as provided for in Annex II and the results of the evaluation thereof;

(ii) all relevant information on the plant protection product as provided for in Annex III, including the information on effects on birds and other non-target terrestrial vertebrates; and

(iii) where relevant, other authorized uses of plant protection products in the area of envisaged use containing the same active substance or which give rise to the same residues.

( b ) This evaluation shall include:

(i) the fate and distribution, including persistence and bioconcentration, of the active substance and of relevant metabolites, breakdown and reaction products in the various parts of the environment after application of the plant protection product;

(ii) the estimated exposure of the species likely to be exposed at the time of application or during the period that residues are present, taking into account all relevant routes of exposure such as ingestion of the formulated product or treated food, predation on invertebrates, feeding on vertebrate prey, contact by overspraying or with treated vegetation;

(iii) a calculation of the acute, short-term and, where necessary, long-term toxicity/exposure ratios. The toxicity/exposure ratios are defined as, respectively, the quotient of LD50, LC50 or NOEC expressed on an active substance basis and the estimated exposure expressed on mg/kg body weight.

( a ) This evaluation shall take into consideration the following information:

(i) the specific information relating to the effects on aquatic organisms as provided for in Annex II and the results _of the evaluation thereof;

(ii) other relevant information on the active substance such as--

-- solubility in water,

-- octanol/water partition coefficient,

-- vapour pressure,

-- volatilization rate,

-- KOC,

-- biodegradation in aquatic systems and in particular the ready biodegradability,

-- photodegradation rate and identity of breakdown products,

-- hydrolysis rate in relation to pH and identity of breakdown products;

(iii) all relevant information on the plant protection product as provided for in Annex III and in particular the effects on aquatic organisms;

(iv) where relevant, other authorized uses of plant protection products in the area of envisaged use, containing the same active substance or which give rise to the same residues.

( b ) This evaluation shall include:

(i) the fate and distribution of residues of the active substance and of relevant metabolites, breakdown and reaction products in water, sediment or fish;

(ii) a calculation of the acute toxicity/exposure ratios for fish and Daphnia. These ratios are defined as the quotient of respective acute LC50 or EC50 and the predicted short-term environmental concentration;

(iii) a calculation of the algal growth inhibition/exposure ratio for algae. This ratio is defined as the quotient of the EC50 and the predicted short-term environmental concentration;

(iv) a calculation of the long-term toxicity/exposure ratios for fish and Daphnia. The long-term toxicity/exposure ratios are defined as the quotient of the NOEC and the predicted long-term environmental concentration;

(v) where relevant, bioconcentration in fish and possible exposure of predators of fish, including humans; and

(vi) if the plant protection product is to be applied directly to surface water, effects on surface water quality, such as pH or dissolved oxygen content.

The competent authority shall evaluate the possibility that exposure of honeybees may occur to the plant protection product under the proposed conditions of use; if this possibility exists it shall evaluate the short-term and long-term risks to be expected for honeybees after use of the plant protection product according to the proposed conditions of use.

( a ) This evaluation shall take into consideration the following information:

(i) the specific information on toxicity to honeybees as provided for in Annex II and the results of the evaluation thereof;

(ii) other relevant information on the active substance such as--

-- solubility in water,

-- octanol/water partition coefficient,

-- vapour pressure,

-- photodegradation rate and identity of breakdown products,

-- mode of action (e.g. insect growth regulating activity);

(iii) all relevant information on the plant protection product as provided for in Annex III, including the toxicity to honeybees; and

(iv) where relevant, other authorized uses of plant protection products in the area of envisaged use, containing the same active substance or which give rise to the same residues.

( b ) This evaluation shall include:

(i) the ratios between the maximum application rate expressed in grammes of active substance per hectare and the contact and oral LD50 expressed in µg of active substance per bee (hazard quotients) and where necessary the persistence of residues on or, where relevant, in the treated plants; and

(ii) where relevant, effects on honeybee larvae, honeybee behaviour, colony survival and development after use of the plant protection product according to the proposed conditions of use.

(i) the specific information on toxicity to honeybees and other beneficial arthropods as provided for in Annex II and the results of the evaluation thereof;

(ii) other relevant information on the active substance such as--

-- solubility in water,

-- octanol/water partition coefficient,

-- vapour pressure,

-- photodegradation rate and identity of breakdown products,

-- mode of action (e.g. insect growth regulating activity);

(iii) all relevant information on the plant protection product as provided for in Annex III such as--

-- effects on beneficial arthropods other than bees,

-- toxicity to honeybees,

-- available data from biological primary screening,

-- maximum application rate,

-- maximum number and timetable of applications;

(iv) where relevant, other authorized uses of plant protection products in the area of envisaged use, containing the same active substance or which give rise to the same residues.

( a ) This evaluation shall take into consideration the following information:

(i) the specific information relating to the toxicity of the active substance to earthworms and to other non-target soil macro-organisms as provided for in Annex II and the results of the evaluation thereof;

(ii) other relevant information on the active substance such as--

-- solubility in water,

-- octanol/water partition coefficient,

-- Kd for absorption,

-- vapour pressure,

-- hydrolysis rate in relation to pH and identity of breakdown products;

-- photodegradation rate and identity of breakdown products, DT50 and DT90 for degradation in the soil;

(iii) all relevant information on the plant protection product as provided for in Annex III, including the effects on earthworms and other non-target soil macro-organisms; and

(iv) where relevant, other authorized uses of plant protection products in the area of envisaged use, containing the same active substance or which give rise to the same residues.

( b ) This evaluation shall include:

(i) lethal and sublethal effects;

(ii) predicted initial and long-term environmental concentration:

(iii) a calculation of the acute toxicity/exposure ratio (defined as the quotient of LC50 and predicted initial environmental concentration) and of the long-term toxicity/exposure ratio (defined as the quotient of the NOEC and predicted long-term environmental concentration); and

(iv) where relevant, bioconcentration and the persistence of residues in earthworms.

( a ) This evaluation shall take into consideration the following information:

(i) all relevant information on the active substance, including the specific information relating to the effects on non-target soil micro-organisms as provided in Annex II and the results of the evaluation thereof;

(ii) all relevant information on the plant protection product as provided for in Annex III, including the effects on non-target soil micro-organisms;

(iii) where relevant, other authorized uses of plant protection products in the area of envisaged use, containing the same active substance or which give rise to the same residues; and

(iv) all available information from biological primary screening.

(i) data on analytical methods as provided for in Annex II and the results of the evaluation thereof;

(ii) data on analytical methods as provided for in Annex III, in particular--

-- the specificity and linearity of the proposed methods,

-- the importance of interferences

-- the precision of the proposed methods (intra-laboratory repeatability and inter-la_boratory reproducibility); and

(iii) the limit of detection and determination of the proposed methods for impurities.

(i) data on analytical methods as provided for in Annex II and the results of the evaluation thereof;

(ii) data on analytical methods as provided for in Annex III, in particular--

-- the specificity of the proposed methods,

-- the precision of the proposed methods (intra-laboratory repeatability and inter-laboratory reproducibility)

-- the recovery rate of the proposed methods at appropriate concentrations;

(iii) the limit of detection of the proposed methods; and

(iv) the limit of determination of the proposed methods.

-- where a suitable FAO specification exists, the physical and chemical properties addressed in that specification,

-- where no suitable FAO specification exists, all the relevant physical and chemical propertie_s for the formulation as referred to in the "Manual on the development and use of FAO specifications for plant protec_tion products".

(i) data on the physical and chemical properties of the active substance as provided for in Annex II and the results of the evaluation thereof; and