S.I. No. 139/1994 - European Communities (Authorization, Placing on The Market, Use and Control of Plant Protection Products) Regulations, 1994.

1.1

Include a technical dossier supplying the information necessary for evaluating the foreseeable risks, whether immediate or delayed, which the substance may entail for humans, animals and the environment and containing at least the information and results of the studies referred to below;

1.2

where relevant, be generated using test guidelines referred to or described in this Annex, in the case of studies initiated before the adoption of the modification of this Annex, the information shall be generated using suitable internationally or nationally validated test guidelines or, in the absence thereof, test guidelines accepted by the competent authority;

1.3

in the event of a test guideline being inappropriate or not described, or where another one than those referred to in this annex has been used, include a justification, which is acceptable to the competent authority for the guideline used;

1.4

include, when required by the competent authority, a full description of test guidelines used, except if they are referred to or described in this Annex, and a full description of any deviations from them including a justification, which is acceptable to the competent authority, for these deviations;

1.5

include a full and unbiased report of the studies conducted as well as a full description of them or a justification, which is acceptable to the competent authority where:

— 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;

1.6

where relevant, have been generated in accordance with the requirements of Directive 86/609/EEC23, of 24 November 1986, on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes.

2.1

Tests and analyses must be conducted in accordance with the principles laid down in Directive 87/18/EEC24 of 18 December 1986, on the harmonization of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their application for tests on chemical substances, where testing is done to obtain data on the properties and/or safety with respect of human or animal health or the environment.

2.2

Notwithstanding the provisions of 2.1, during the period to 31 December 1999, tests and analyses done to obtain data on the properties and/or safety with respect to honeybees and beneficial arthropods other than bees may have been conducted by officially recognized testing facilities or organisations, in accordance with the principles laid down in the Sixth Schedule, or in compliance with Irish/European Standard IS/EN 45001, where they are conducted within the territory of the state, and in accordance with the requirements of points 2.2 and 2.3 of the introduction to Annex III to Directive 93/71/EEC, where they are conducted outside the territory of the state.

1

Identity of the active substance

The information provided must be sufficient to identify with precision each active substance, to define it in terms of its specification and to characterize it as to its nature. The information and data referred to, unless otherwise specified, are required for all active substances.

1.1

Applicant (name, address, etc.)

The name and address of the applicant (permanent community address) must be provided as must the name, position, telephone and telefax number of the appropriate person to contact.

Where, in addition, the applicant has an office, agent or representative in the territory of the State, the name and address of the local office, agent or representative must be provided, as must the name, position, telephone and telefax number of the appropriate person to contact.

1.2

Manufacturer (name, address, including location of plant)

The name and address of the manufacturer or manufacturers of the active substance must be provided as must the name and address of each manufacturing plant in which the active substance is manufactured. A contact point (preferably a central contact point, to include name, telephone and telefax number) must be provided, with a view to providing updating information and responding to queries arising, regarding manufacturing technology, processes and the quality of product (including where relevant, individual batches). Where following inclusion of the active substance in Annex I, there are changes in the location or number of manufacturers, the information required must again be notified to the Commission and the Member States.

1.3

Common name proposed or ISO-accepted, and synonyms

The ISO common name, or proposed ISO common name and where relevant, other proposed or accepted common names (synonyms), including the name (title) of the nomenclature authority concerned, must be provided.

1.4

Chemical name (IUPAC and CA) nomenclature

The chemical name as given in Annex I to the Directive of 1967, or, if not included in that Directive, in accordance with both IUPAC and CA nomenclature, must be provided.

1.5

Manufacturer's development code number(s)

Code numbers used to identify the active substance and, where available, formulations containing the active substance, during development work, must be reported. For each code number reported, the material to which it relates, the period for which it was used, and the Member States or other countries in which it was used and is being used, must be stated.

1.6

CAS, EEC and CIPAC numbers (if available)

Chemical Abstracts, EEC (EINECS or ELINCS), and CIPAC numbers, where they exist, must be reported.

1.7

Molecular and structural formula, molecular mass

The molecular formula, molecular mass and structural formula of the active substance, and where relevant, the structural formula of each stereo and optical isomer present in the active substance, must be provided.

1.8

Method of manufacture (synthesis pathway) of the active substances

The method of manufacturer, in terms of the identity of the starting materials, the chemical pathways involved, and the identity of by-products and impurities present in the final product, must be provided, for each manufacturing plant. Generally process engineering information is not required.

Where the information provided relates to a pilot plant production system, the information required must again be provided once industrial scale production methods and procedures have stabilized.

1.9

Specification of purity of the active substance in g/kg

The minimum content in g/kg of pure active substance (excluding inactive isomers) in the manufactured material used for production of formulated products, must be reported.

Where the information provided relates to a pilot plant production system, the information required must again be provided to the Commission and the Member States once industrial scale production methods and procedures have stabilized, if production changes result in a changed specification of purity.

1.10

Identity of isomers, impurities and additives (e.g. stabilizers), together with the structural formula and the content expressed as g/kg

The maximum content in g/kg of inactive isomers as well as the ratio of the content of isomers/diastereoisomers, where relevant, must be provided. In addition, the maximum content in g/kg of each further component other than additives, including by-products, and impurities, must be provided. In the case of additives the content in g/kg must be provided.

For each component, present in quantities of 1 g/kg or more, the following information, where relevant, must be provided—

— 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.

Where the manufacturing process is such that impurities and by-products which are particularly undesirable because of their toxicological, ecotoxicological or environmental properties could be present in the active substance, the content of each such compound must be determined and reported. In such cases, the analytical methods used and the limits of determination, which must be sufficiently low, for each compound of concern, must be reported. Additionally the following information, where relevant, must be provided—

— 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.

Where the information provided relates to a pilot plant production system, the information required must again be provided once industrial scale production methods and procedures have stabilised, if the production changes result in a changed specification of purity.

Where the information provided does not fully identify a component viz. condensates, detailed information on the composition must be provided for each such component. The trade name of components added to the active substance, prior to manufacture of formulated product, to preserve stability and facilitate ease of handling, where they are used, must also be provided. Additionally the following information, where relevant, must be provided for such additives—

— 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.

For added components, other than active substances and other than impurities resulting from the manufacturing process, the function of the component (additive) must be given—

antifoaming agent

buffer

antifreeze

dispersing agent

binder

stabiliser

other (specify)

1.11

Analytical profile of batches

Representative samples of the active substance must be analyzed for content of pure active substance, inactive isomers, impurities and additives, as appropriate. The analytical results reported must include quantitative data, in terms of g/kg content, for all components present in quantities of more than 1 g/kg and typically should account for at least 98% of the material analyzed. The actual content of components which are particularly undesirable because of their toxicological, ecotoxicological or environmental properties, must be determined and reported. Data reported must include the results of the analysis of individual samples and a summary of that data, to show the minimum or maximum and typical content of each relevant component, as appropriate.

Where an active substance is produced in different plants this information must be provided for each of the plants separately.

In addition, where available and relevant, samples of the active substance produced in laboratory scale or pilot production systems, must be analyzed, if such material was used in generating toxicological or ecotoxicological data.

2

Physical and chemical properties of the active substance

(i) The information provided, must describe they 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—

— physical, chemical, and technical hazards associated with active substances, to be identified;

— classification of active substance as to hazard;

— appropriate restrictions and conditions to be associated with inclusions in Annex I to be selected; and

— appropriate risk and safety phrases to be specified.

The information and data referred to are required for all active substances, except where otherwise specified.

(ii) The information provided, taken together with that provided for relevant preparations, must permit the physical, chemical and technical hazards associated with preparations, to be identified, permit preparations to be classified, and demonstrate that preparations can be used without unnecessary difficulty, and be such that exposure of man, animals, and the environment is minimized, taking account of manner of use.

(iii) The extent to which active substances for which inclusion in Annex I is sought, comply with relevant FAO specifications, must be stated. Divergences from FAO specifications must be described in detail, and justified.

(iv) In certain specified instances, tests must be conducted using purified active substance of stated specification. In such cases the principles of the method(s) of purification used must be reported. The purity of such test material, which must be as high as can be achieved using the best available technology, must be reported. A reasoned justification must be provided in cases where the degree of purity achieved is less than 980 g/kg. Such justification must demonstrate that all technically feasible and reasonable possibilities for the production of the pure active substance have been exhausted.

2.1

Melting point and boiling point

2.1.1

The melting point or where appropriate the freezing or solidification point of purified active substance must be determined in accordance with EEC Method A 1 and be reported. Measurements should be taken up to 360°C.

2.1.2

Where appropriate, the boiling point of purified active substances must be determined in accordance with EEC Method A 2 and be reported. Measurements should be taken up to 360°C.

2.1.3

Where melting point and/or boiling point cannot be determined because of decomposition or sublimation, the temperature at which decomposition or sublimation occurs, must be reported.

2.2

Relative density

In the case of active substances which are liquids or solids, the relative density of the purified active substance must be determined in accordance with EEC Method A3 and be reported.

2.3

Vapour pressure (In Pa), volatility (e.g. Henry's law constant)

2.3.1

The vapour pressure of purified activie substance must be determined in accordance with EEC Method A4 and be reported. Where vapour pressure is less than 10^-5 Pa, the vapour pressure at 20 or 25°C may be estimated using a vapour pressure curve.

2.3.2

In the case of activie substnaces which are solids or liquids, volatility (Henry's law constant) of purified active substance must be determined or calculated from its water solubility and vapour pressure and be reported (in PA x m³ x mol^-1).

2.4

Appearances (physical state, colour and odour; if known)

2.4.1

A description of both the colour, if any, and the physical state of both the active substance as manufactured and the purified active substance, must be provided.

2.4.2

A description of any odour associated with the active substance as manufactured and with the purified active substance, noted when handling the materials in laboratories or production plants, must be reported.

2.5

Spectra (UV/VIS, IR, NMR, MS), molecular extinction at relevant wavelengths

2.5.1

The following spectra including a table of signal characteristics needed for interpretation must be determined and reported: Ultraviolet/Visible (UV/VIS), infrared (IR), nuclear magnetic resonance (NMR), and mass spectra (MS) of purified active substance. Molecular extinction at relevant wavelengths, must be determined and reported. The wavelengths at which UV/visible molecular extinction occurs are to be determined and reported and must include, where appropriate, a wavelength at the highest absorption value above 290 nm.

In the case of active substances which are resolved optical isomers their optical purity must be measured and reported.

2.5.2

The UV/visible absorption spectra, IR, NMR and MS spectra, where necessary for the identification of impurities considered to be of toxicological, ecotoxicological or environmental significance, must be determined and reported.

2.6

Solubility in water including effect of pH (4 to 10) on solubility

The water solubility of purified active substances under atmospheric pressure must be determined in accordance with EEC Method A 6 and be reported. These water solubility determinations must be made in the neutral range (i.e. in distilled water in equilibrium with atmospheric carbon dioxide). Where the active substance is capable of forming ions, determinations must also be made in the acidic range (pH 4 to 6) and in the alkaline range (pH 8 to 10), and be reported. Where the stability of the active substances in aqueous media is such that water solubility cannot be determined, a justification based on test data must be provided.

2.7

Solubility in organic solvents

The solubility of active substances, as manufactured, in the following organic solvents at 15 to 25°C must be determined and reported if less than 250 g/kg; the temperature applied must be specified:

Aliphatic hydrocarbon

—preferably n-heptane

Aromatic hydrocarbon

—preferably xylene

Halogenated hydrocarbon

—preferably 1, 2-dichlorethane

Alcohol

—preferably methanol or isopropyl acetone

Ketone

—preferably acetone

Ester

—preferably ethyl acetate

If for a particular active substance, one or more of these solvents is unsuitable (e.g. reacts with test material), alternative solvents can be used instead. In such cases, choices made must be justified in terms of their structure and polarity.

2.8

Partition co-efficient n-octanol/ water including effect of pH (4 to 10)

The n-octanol/water partition coefficient of purified active substance must be determined in accordance with EEC Method A 8 and be reported. The effect of pH (4 to 10) must be investigated when the substance is acidic or basic as defined by its pka value ( 2 for bases).

2.9

Stability in water, hydrolysis rate, photochemical degradation, quantum yield and identity of breakdown product(s), dissociation constant including effect of pH (4 to 9)

2.9.1

The hydrolysis rate of purified active substances (usually radiolabelled active substance,> 95% purity), for each of the pH values 4, 7 and 9, under sterile conditions, in the absence of light, must be determined in accordance with EEC Method C 7 and be reported. For substances with a low rate of hydrolysis, the rate can be determined at 50°C, or another appropriate temperature. If degradation is observed at 50°C, degradation rate at another temperature must be determined, and an Arrhenius plot must be constructed to permit an estimate to be made of hydrolysis products formed and the rate constant observed, must be reported. The estimated DT₅₀ value must also be reported.

2.9.2

For compounds with a molar (decadic) absorption coefficient (ε) > 10 (1 x x mol^{-1 x} xcm^-1) at a wavelength λ > 290 nm, direct phototransformation in purified (e.g. distilled) water at 20 to 25°C, of purified active substance usually radio labelled using artificial light under sterile conditions, if necessary using a solubilizer, must be determined and reported. Sensitizers such as acetone must not be used as a co-solvent or solubilizer. The light source must simulate sunlight and be equipped with filters to exclude radiation at wavelengths λ > 10% of the active substance added, a mass balance to account for at least 90% of the applied radioactivity, as well as photochemical halflife must be reported.

2.9.3

Where necessary to investigate direct phototransformation, the quantum yield of direct photodegradation in water must be determined and reported, together with calculations to estimate theoretical lifetime of the active substance in the top layer of aqueous systems and the real lifetime of the substance. The method to be used is described in the Annex to the FAO Revised Guidelines on Environmental Criteria for the Registration of Pesticides.

2.9.4

Where dissociation in water occurs, the dissociation constants(s) (pKa values) of purified active substances must be determined in accordance with OECD Test Guideline 112 and be reported. The identity of the dissociated species formed, based on theoretical considerations, must be reported. If the active substance is a salt, the pKa value of the active principle must be given.

2.10

Stability in air, photochemical degradation, identity of breakdown product(s)

An estimation of the photochemical oxidative degradation (indirect phototransformation) of the active substance(s), must be submitted.

2.11

Flammability including auto-flammability

2.11.1

The flammability of active substances as manufactured, which are solids, gases, or are substances which evolve highly flammable gases, must be determined in accordance with EEC Methods A 10, A 11 or A 12, as appropriate, and be reported.

2.11.2

The auto-flammability of active substances as manufactured must be determined in accordance with EEC Method A 15 or A 16, as appropriate, and/or, where necessary, according to the UN-Bowes-Cameron-Cage-Test (UN-Recommendations on the Transport of Dangerous Goods, Chapter 14, Nr. 14.3.4), and be reported.

2.12

Flash point

The flash point of active substances as manufactured with a melting point below 40°C, must be determined in accordance with EEC Method A 9 and be reported; only closed cup methods should be used.

2.13

Explosive properties

The explosive properties of active substances as manufactured, must be determined in accordance with EEC Method A 14, where appropriate, and be reported.

2.14

Surface tension

The surface tension of active substances must be determined in accordance EEC Method A 5 and be reported.

2.15

Oxidizing properties

The oxidizing properties of active substances as manufactured, must be determined in accordance with EEC Method A 17 and be reported, except where examination of their structural formulae, establish beyond reasonable doubt that the active substance concerned is incapable of reacting exothermically with a combustible material. In such cases, it is sufficient to provide that information as justification for not determining the oxidizing properties of the substance.

3

Further information on the active substance

(i) The information provided must describe the intended purposes for which preparations containing the active substance are used, or are to be used and the dose and manner of their use or proposed use.

(ii) The information provided must specify the normal methods and precautions to be followed, in the handling, storage and transport of the active substance.

(iii) The studies, data and information submitted, together with other relevant studies, data and information, must both specify and justify the methods and precautions to be followed in the event of fire. The possible products of combustion in the event of fire should be estimated, based on the chemical structure and the chemical and physical properties of the active substance.

(iv) The studies, data and information submitted, together with other relevant studies, data and information, must demonstrate the suitability of measures proposed for use in emergency situations.

(v) The information and data referred to are required for all active substances, except where otherwise specified.

3.1

Function, e.g. fungicide, herbicide, insecticide, repellant, growth regulator

The function must be specified from among the following:

acaricide

plant growth regulator

bactericide

repellant

fungicide

rodenticide

herbicide

semio-chemicals

insecticide

talpicide

molluscicide

viricide

nematicide

other (must be specified)

3.2

Effects on harmful organisms, e.g. contact poison, inhalation poison, stomach poison, fungitoxic or fungistatic, etc. systemic or not in plants

3.2.1

The nature of the effects on harmful organisms must be stated:

contact action

stomach action

inhalation action

fungitoxic action

fungistatic action

desiccant

reproduction inhibitor

other (must be specified)

3.2.2

It must be stated whether or not the active substance is translocated in plants and where relevant whether such translocation is apoplastic, symplastic or both.

3.3

Field of use envisaged, e.g. field, protected crops, storage of plant products, home gardening

The field(s) of use, existing and proposed, for preparations containing the active substance must be specified from among the following:

Field use

— Agriculture

— Horticulture

— Forestry

— Viticulture

Protected crops

Amenity

Weed control on non-cultivated areas

Home gardening

House plants

Plant products storage practice

Other (specify)

3.4

Harmful organisms controlled and crops or products protected or treated

3.4.1

Details of existing and the intended use in terms of crops, groups of crops, plants, or plant products treated and where relevant protected, must be provided.

3.4.2

Where relevant, details of harmful organisms against which protection is afforded, must be provided.

3.4.3

Where relevant, effects achieved e.g. sprout suppression, retardation of ripening, reduction in stem length, enhanced fertilization etc., must be reported.

3.5

Mode of action

3.5.1

To the extent that it has been elucidated, a statement must be provided as to the mode of action of the active substance in terms, where relevant, of the biochemical and physiological mechanism(s) and biochemical pathway(s) involved. Where available, the results of relevant experimental studies must be reported.

3.5.2

Where it is known that to exert its intended effect, the active substance must be converted to a metabolite or degradation product following application or use of preparations containing it, the following information, cross referenced to and drawing on information provided in the context of paragraphs 5.6, 5.11, 6.1, 6.2, 6.8, 7.1, 7.2 and 9, where relevant, must be provided for the active metabolite or degradation product—

— chemical name according to IUPAC and CA nomenclature;

— ISO common name or proposed common name;

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

— empirical and structural formula; and

— molecular mass.

3.5.3

Available information relating to the formation of active metabolites and degradation products, must be provided, to include —

— the processes, mechanisms and reactions involved;

— kinetic and other data concerning the rate of conversion and if known the rate limiting step; and

— environmental and other factors effecting the rate and extent of conversion.

3.6

Information on the occurrence or possible occurrence of the development of resistance and appropriate management strategies

Where available information on possible occurrence of the development of resistance or cross-resistance must be provided.

3.7

Recommended methods and precautions concerning handling, storage, transport or fire

A Safety Data Sheet in accordance with Article 27 of the Directive of 1967 must be provided for all active substances.

3.8

Procedures for destruction or decontamination

3.8.1

Controlled incineration

In many cases the preferred or sole means to safely dispose of active substances, contaminated materials, or contaminated packaging, is through controlled incineration in a licensed incinerator. Where the content of halogens of the active substance is greater than 60%, the pyrolytic behaviour of the active substance under controlled conditions (including, where relevant, supply of oxygen and residence time), at 800°C and the content of polyhalogenated dibenzo-p-dioxins and dibenzo-furans in the products of pyrolysis must be reported. The applicant must provide detailed instructions for safe disposal.

3.8.2

Others

Other methods to dispose of the active substance, contaminated packaging and contaminated materials, where proposed, must be fully described. Data must be provided for such methods, to establish their effectiveness and safety.

3.9

Emergence measures in case of an accident

Procedures for the decontamination of water in case of an accident must be provided.

4

Analytical methods

4.1

Analytical methods for the determination of pure active substance and, where appropriate, for relevant breakdown products, isomers and impurities of the active substance and additives (e.g. stabilizers)

4.2

Analytical methods including recovery rates and the limits of determination for residues in, and where relevant on, the following:

4.2.1

Treated plants, plant products, foodstuffs, feeding stuffs

4.2.2

Soil

4.2.3

Water (including drinking water)

4.2.4

Air

4.2.5

Animal and human body fluids and tissues

5

Toxicological and metabolism studies on the active substance

5.1

Acute toxicity

5.1.1

Oral

5.1.2

Percutaneous

5.1.3

Inhalation

5.1.4

Intraperitoneal

5.1.5

Skin and where appropriate eye irritation

5.1.6

Skin sensitization

5.2

Short-term toxicity

5.2.1

Oral cumulative toxicity (28-day study)

5.2.2

Oral administration — two species, one rodent (preferably rat) and one non-rodent, usually 90-day study

5.2.3

Other routes (inhalation, percutaneous as appropriate)

5.3

Chronic toxicity

5.3.1

Oral long-term toxicity and carcinogenicity (rat and other mammalian species) — other routes as appropriate

5.4

Mutagenicity — test battery to assess gene mutations, chromosomal aberrations and DNA perturbations

5.5

Reproductive toxicity

5.5.1

Teratogenicity studies — rabbit and one rodent species, oral and when appropriate percutaneous

5.5.2

Multi-generation studies in mammals (at least two generations)

5.6

Metabolism studies in mammals

5.6.1

Absorption, distribution and excretion studies — following both oral and percutaneous administration

5.6.2

Elucidation of metabolic pathways

5.7

Neurotoxicity studies — including where appropriate delayed neurotoxicity tests in adult hens

5.8

Supplementary studies

5.8.1

Toxic effects of metabolites from treated plants in cases where different from those identified in animal studies

5.8.2

Any mechanistic studies needed to clarify effects reported in toxicity studies

5.9

Toxic effects on livestock and pets

5.10

Medical data

5.10.1

Medical surveillance on manufacturing plant personnel

5.10.2

Direct observation, e.g. clinical cases and poisoning incidents

5.10.3

Health records, both from industry and agriculture

5.10.4

Observations on exposure of the general population and epidemiological studies if appropriate

5.10.5

Diagnosis of poisoning (determination of active substance, metabolites), specific signs of poisoning, clinical tests

5.10.6

Sensitization/allergenicity observations

5.10.7

Proposed treatment: first aid measures, antidotes, medical treatment

5.10.8

Prognosis of expected effects of poisoning

5.11

Summary of mammalian toxicology and conclusion (including no observable adverse effect level (NOAEL), no observable effect level (NOEL), acceptable daily intake (ADI). Overall evaluation with regard to all toxicological data, and other information concerning the active substance

6

Residues in or on treated products, food and feed

6.1

Identification of breakdown and reaction products and of metabolites in treated plants or products

6.2

Behaviour of residue of the active substance and its metabolites from the time of application until harvest or out-loading of stored products — uptake and distribution in, and where relevant on, plants, kinetics of disappearance, binding to plant constituents, etc.

6.3

Overall material balance for the active substance. Sufficient residue data from supervised trials to demonstrate that residues likely to arise from the proposed treatments would not be or concern for human and animal health

6.4

Estimation of the potential and actual exposure through diet and other means, such as residue monitoring data for products in the distribution chain, or such as data concerning exposure via air, water, etc.

6.5

Feeding and metabolism studies in livestock (if residues remain in or on crops or parts of crops used for feed) to permit evaluation of residues in foodstuffs of animal origin

6.6

Effects of industrial processing and/or household preparation on the nature and magnitude of residues

6.7

Summary and evaluation of residue behaviour resulting from data submitted pursuant to points 6.1 to 6.6

7

Fate and behaviour in the environment

7.1

Fate and behaviour in soil

7.1.1

Rate and route of degradation (to 90 per cent degradation) including identification of the processes involved and identification of metabolites and breakdown products in at least three soil types under appropriate conditions

7.1.2

Adsorption and desorption in at least three soil types and where relevant adsorption and desorption of metabolites and breakdown products

7.1.3

Mobility in at least three soil types and where relevant mobility of metabolites and breakdown products

7.1.4

Extent and nature of bound residues

7.2

Fate and behaviour in water and air

7.2.1

Rate and route of degradation in aquatic systems — biodegradation, hydrolysis, photolysis (as far as not covered by point 2.8), including identification of metabolites and breakdown products

7.2.2

Adsorption and desorption in water (sedimentation) and where relevant adsorption and desorption of metabolites and breakdown products

7.2.3

Rate and route of degradation in air (for fumigants and other volatile active substances) (as far as not covered by point 2.9)

8

Ecotoxicological studies on the active substance

8.1

Effects on birds

8.1.1

Acute oral toxicity

8.1.2

Short-term toxicity — eight-day dietary study in at least one species (other than chicken)

8.1.3

Effects on reproduction

8.2

Effects on aquatic organisms

8.2.1

Acute toxicity to fish

8.2.2

Chronic toxicity to fish

8.2.3

Effects on fish reproduction and growth rate

8.2.4

Bioaccumulation in fish

8.2.5

Acute toxicity for Daphnia magna

8.2.6

Daphnia magna reproduction and growth rate

8.2.7

Effects on algal growth

8.3

Effects on other non-target organisms

8.3.1

Acute toxicity to honeybees and other beneficial arthropods (e.g. predators)

8.3.2

Toxicity to earthworms and to other soil non-target macro-organisms

8.3.3

Effects on soil non-target micro organisms

8.3.4

Effects on other non-target organisms (flora and fauna) believed to be at risk

8.3.5

Effects on biological methods for sewage treatment

9

Summary and evaluation of points 7 and 8

10

Proposals including justification for the proposals for the classification and labelling of the active substance according to Council Directive 67/548/EEC

— Hazard symbol(s)

— Indications of danger

— Risk phrases

— Safety phrases

11

A dossier as referred to in Annex III, part A, for a representative plant protection product

1

Identity of the organism

1.1

Applicant (name, address, etc.)

1.2

Manufacturer (name, address, including location of plant)

1.3

Common name or alternative and superseded names

1.4

Taxonomic name and strain for bacteria, protozoa and fungi, indication whether it is a stock variant or a mutant strain; for viruses the taxonomic designation of the agent, serotype, strain or mutant

1.5

Collection and culture reference number where the culture is deposited

1.6

The appropriate test procedures and criteria used for identification (e.g. morphology, biochemistry, serology)

1.7

Composition — microbiological purity, nature, identity, properties, content of any impurities and extraneous organisms

2

Biological properties of the organism

2.1

Target organism. Pathogenicity or kind of antagonism to host, infective dose, transmissibility and information on mode of action

2.2

History of the organism and its uses. Natural occurrence and geographical distribution

2.3

Host specificity range and effects on species other than the target harmful organism including species most closely related to the target species — to include infectivity, pathogenicity and transmissibility

2.4

Infectivity and physical stability when used according to the proposed method. Effect of temperature, exposure to air radiation, etc. Persistence under the likely environmental conditions of use

2.5

Whether the organism is closely related to a plant pathogen or to a pathogen of a vertebrate species or a non-target invertebrate species

2.6

Laboratory evidence of genetic stability (i.e. mutation rate) under environmental conditions of proposed use

2.7

Presence, absence or production of toxins as well as their nature, identity, chemical structure (if appropriate) and stability

3

Further information on the organism

3.1

Function, e.g. fungicide, herbicide, insecticide, repellant, growth regulator

3.2

Effects on harmful organisms, e.g. contact poison, inhalation poison, stomach poison, fungitoxic or fungistatic, etc. systemic or not in plants

3.3

Field of use envisaged, e.g. field, glasshouse, food or feed storage, home garden

3.4

Where necessary, in the light of the test results, any specific agricultural, plant health or environmental conditions under which the active substance may or may not be used

3.5

Harmful organisms controlled and crops or products protected or treated

3.6

Method of production with descriptions of the techniques used to ensure a uniform product and of assay methods for its standardization. In the case of a mutant, detailed information should be provided on its production and isolation, together with all known differences between the mutant and the parent wild strains.

3.7

Methods to prevent loss of virulence of seed stock

3.8

Recommended methods and precautions concerning handling, storage, transport or fire

3.9

Possibility of rendering the organism uninfective

4

Analytical methods

4.1

Methods for establishing the identity and purity of seed stock from which batches are produced and results obtained, including information on variability

4.2

Methods to show microbiological purity of the final product and showing that contaminants have been controlled to an acceptable level, results obtained and information on variability

4.3

Methods used to show that there are no human or other mammalian pathogens as contaminants in the active agent, including in the case of protozoa and fungi, the effects of temperature (35°C and other relevant temperatures)

4.4

Methods to determine viable and non-viable (e.g. toxins) residues in or on treated products, foodstuffs, feeding stuffs, animal and human body fluids and tissues, soil, water and air, where relevant

5

Toxicological, pathogenicity and infectivity studies

5.1

Bacteria, fungi, protozoa and mycoplasma

5.1.1

Toxicity and/or pathogenicity and infectivity

5.1.1.1

Oral single dose

5.1.1.2

In cases where a single dose is not appropriate to assess pathogenicity, a set of range-finding texts must be carried out to reveal highly toxic agents and infectivity

5.1.1.3

Percutaneous single dose

5.1.1.4

Inhalation single dose

5.1.1.5

Intraperitoneal single dose

5.1.1.6

Skin and, where necessary, eye irritation

5.1.1.7

Skin sensitization

5.1.2

Short-term toxicity (90 days exposure)

5.1.2.1

Oral administration

5.1.2.2

Other routes (inhalation, percutaneous as appropriate)

5.1.3

Supplementary toxicological and/or pathogenicity and infectivity studies

5.1.3.1

Oral long-term toxicity and carcinogenicity

5.1.3.2

Mutagenicity — (tests as referred to under point 5.4 of part A)

5.1.3.3

Teratogenicity studies

5.1.3.4

Multi-generation study in mammals (at least two generations)

5.1.3.5

Metabolic studies — absorption, distribution and excretion in mammals including elucidation of metabolic pathways

5.1.3.6

Neurotoxicity studies, including where appropriate delayed neurotoxicity tests in adult hens

5.1.3.7

Immunotoxicity, e.g. allergenicity

5.1.3.8

Pathogenicity and infectivity under immunosuppression

5.2

Viruses, viroids

5.2.1

Acute toxicity and/or pathogenicity and infectivity

Data as outlined under point 5.1.1 and cell culture studies using purified infective virus and primary cell cultures of mammalian, avian and fish cells

5.2.2

Short-term toxicity

Data as outlined under point 5.1.2 and tests for infectivity carried out by bio-assay or on a suitable cell culture at least seven days after the last administration to the test animals

5.2.3

Supplementary toxicological and/or pathogenicity and infectivity studies as outlined under point 5.1.3.

5.3

Toxic effects on livestock and pets

5.4

Medical data

5.4.1

Medical surveillance on manufacturing plant personnel

5.4.2

Health records, both from industry and agriculture

5.4.3

Observations on exposure of the general population and epidemiological data, if appropriate

5.4.4

Diagnosis of poisoning, specific signs of poisoning, clinical tests, if appropriate

5.4.5

Sensitization/allergenicity observations, if appropriate

5.4.6

Proposed treatment: first aid measures, antidotes, medical treatment, if appropriate

5.4.7

Prognosis of expected effects of poisoning, if appropriate

5.5

Summary of mammalian toxicology and conclusions (including NOAEL, NOEL and ADI, if appropriate). Overall evaluation with regard to all toxicological pathogenicity and infectivity data, and infectivity and other information concerning the active substance

6

Residues in or on treated products, food and feed

6.1

Identification of viable and non-viable (e.g. toxins) residues in or on treated plants or products, the viable residue by culture or bio-assay and the non-viable by appropriate techniques

6.2

Likelihood of multiplication of the active substance in or on crops or food together with a report on any effect on food quality

6.3

In cases where residues of toxins remain in or on an edible plant product, data as outlined under points 4.2.1 and 6 of part A are required

6.4

Summary and evaluation of residue behaviour resulting from data submitted under points 6.1 to 6.3

7

Fate and behaviour to the environment

7.1

Spread, mobility, multiplication and persistence in air, water, soil

7.2

Information concerning possible fate in food chains

7.3

In cases where toxins are produced, data as outlined under part A, point 7 are required, where relevant

8

Ecotoxicological studies

8.1

Birds — acute oral toxicity and/or pathogenicity and infectivity

8.2

Fish — acute toxicity and/or pathogenicity and infectivity

8.3

Toxicity — Daphnia magna (if appropriate)

8.4

Effects on algal growth

8.5

Important parasites and predators of target species; acute toxicity and/or pathogenicity and infectivity

8.6

Honey bees: acute toxicity and/or pathogenicity and infectivity

8.7

Earthworms: acute toxicity and/or pathogenicity and infectivity

8.8

Other non-target organisms believed to be at risk: acute toxicity and/or pathogenicity and infectivity

8.9

Extent of indirect contamination on adjacent non-target crops, wild plants, soil and water

8.10

Effects on other flora and fauna

8.11

In cases where toxins are produced, data as outlined under Part A, points 8.1.2, 8.1.3, 8.2.2, 8.2.3, 8.2.4, 8.2.5, 8.2.6, 8.2.7 and 8.3.3 are required, where relevant

9

Summary and evaluation of points 7 and 8

10

Proposals including justification of the proposals for the classification and labelling of the active substance in accordance with Directive 67/548/EEC

— Hazard symbol(s)

— Indications of danger

— Risk phrases

— Safety phrases

11

A dossier referred to in Annex III, part B, for a representative plant protection product

1.1

include a technical dossier supplying the information necessary for evaluating efficacy and the foreseeable risks, whether immediate or delayed, which the plant protection product may entail for humans, animals and the environment and containing at least the information and results of the studies referred to below;

1.2

where relevant, be generated using test guidelines referred to or described in this Annex; in the case of studies initiated before the adoption of the modification of this Annex, the information shall be generated using suitable internationally or nationally validated test guidelines or, in the absence thereof, test guidelines accepted by the competent authority;

1.3

in the event of a test guideline being inappropriate or not described, or where another one than those referred to in this annex has been used, include a justification, which is acceptable to the competent authority for the gidelines used;

1.4

include, a full description of test guidelines used, except if they are referred to or described in this Annex, and a full description of any deviations from them including a justification, which is acceptable to the competent authority, for these deviations;

1.5

include a full and unbiased report of the studies conducted as well as a full description of them or a justification, which is acceptable to the competent authority where:

— 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.

1.6

where relevant, have been generated in accordance with the requirements of Directive 86/609/EEC.

2.1

Tests and analyses must be conducted in accordance with the principles laid down in Directive 87/18/EEC, where testing is done to obtain data on the properties and/or safety with respect to human health or the environment.

2.2

Tests and analyses, required under the provisions of section 6 points 6.2 to 6.6 of this annex, shall, where they are conducted outside the territory of the state, be conducted by official or officially recognized testing facilities or organisations in the Member State concerned, which satisfy at least the requirements specified in points 2.2 and 2.3 of the introduction to Annex III to Directive 93/71/EEC.

2.3

Tests and analyses, required under the provisions of section 6 points 6.2 to 6.6 of this annex, shall, where they are conducted within the territory of the state, be conducted in accordance with the Principles of Good Experimental Practice set out in the Sixth Schedule, or in compliance with Irish/European Standard IS/EN 45001 and in accordance with the authorization for trials or trials permit concerned.

2.4

Notwithstanding the provisions of point 2.1, during the period to 31 December 1999, tests and analyses done to obtain data on the properties and/or safety with respect to honeybees and beneficial arthropods other than bees may have been conducted by officially recognized testing facilities or organisations, in accordance with the principles laid down in the Sixth Schedule, or in compliance with Irish/European Standard IS/EN 45001, where they are conducted within the territory of the state, and in accordance with the requirements of points 2.2 and 2.3 of the introduction to Annex III to Directive 93/71/EEC, where they are conducted outside the territory of the state.

3

The information required shall include the proposed classification and labelling of the plant protection product in accordance with relevant Community Directives.

4

In individual cases it may be necessary to require certain information as provided for in Annex II, Part A, for formulants. Before such information will be required and before possibly new studies have to be performed, all information on the formulant, made available to the competent authority, shall be considered, in particular when:

— 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.

1

Identity of the plant protection product

The information provided, taken together with that provided for the active substance(s), must be sufficient to identify preparations, with precision, and to define them in terms of their specification and nature. The information and data referred to, unless otherwise specified, are required for all plant protection products.

1.1

Applicant (name and address, etc.)

The name and address of the applicant (permanent community address) must be provided as must the name, position, telephone and telefax number of the appropriate person to contact.

Where, in addition, the applicant has an office, agent or representative in the territory of the State, the name and address of the local office, agent or representative should be provided, as should the name, position, telephone and telefax number of the appropriate person to contact.

1.2

Manufacturer of the preparation and the active substance(s) (names and addresses, etc. including location of plants)

The name and address of the manufacturer of the preparation and of each active substance in the preparation must be provided as must the name and address of each manufacturing plant in which the preparation and active substance are manufactured. A contact point (preferably a central contact point, to include name, telephone and telefax numbers) must be provided for each.

If the active substance originates from a manufacturer from which data according to Annex II had not been submitted previously, a statement of purity and detailed information on the impurities as required in Annex II must be provided.

1.3

Trade name or proposed trade name, and manufacturer's development code number of the preparation if appropriate

All former and current trade names and proposed trade names and development code numbers of the preparation as well as the current names and numbers must be provided. Where trade names and code numbers referred to, relate to similar but different preparations (possibly obsolete), full details of the differences, must be provided. (The proposed trade name may not give rise to confusion with the trade name of plant protection products already authorized).

1.4

Detailed quantitative and qualitative information on the composition of the preparation (active substance(s), and formulant (s)

1.4.1

For preparations the following information must be reported—

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

— the content of formulants,

The concentrations must be expressed in terms as provided for in Article 6(2) of the Directive of 197.

1.4.2

For active substances their ISO common names or proposed ISO common names and their CIPAC numbers, and, where available, the EEC (EINECS or ELINCS) numbers must be provided. Where relevant it must be stated which salt, ester, anion or cation is present.

1.4.3

Formulants must where possible, be identified both by their chemical name as given in Annex I to the Directive of 1967, or, if not included in that Directive, in accordance with both IUPAC and CA nomenclature. Their structure or structural formula must be provided. For each component of formulants the relevant EEC (EINECS or ELINCS) number and CAS number where they exist, must be provided. Where the information provided does not fully identify a formulant, an appropriate specification must be provided. The trade name of formulants, where they exist, must also be provided.

1.4.4

For formulants the function must be given:

adhesive (sticker)

preservative

antifoaming agent

odourant

antifreeze

perfume

binder

propellant

buffer

repellent

carrier

safener

deodorant

solvent

dispersing agent

stabiliser

dye

synergist

emetic

thickener

emulsifier

wetting agent

fertilizer

miscellaneous (specify)

1.5

Physical state and nature of the preparation (emulsifiable concentrate, wettable powder, solution etc.)

1.5.1

The type and code of preparation must be designated in accordance with Annex 2 to Part 2 of the Fourth Schedule.

Where a particular preparation is not defined precisely in that Annex, a full description of the physical nature and state of the preparation must be provided, together with a proposal for a suitable description of the type of preparation and a proposal for its definition.

1.6

Function (herbicide, insecticide, etc.)

The function must be specified from among the following:

acaricide

plant growth regulator

bactericide

repellant

fungicide

rodenticide

herbicide

semio-chemicals

insecticide

talpicide

molluscicide

viricide

nematicide

other (must be specified)

2

Physical, chemical and technical properties of the plant protection product

The extent to which plant protection products for which authorization is sought, comply with relevant FAO specifications as agreed by the Group of Experts on Pesticide Specifications, of the FAO Panel of Experts on Pesticide Specifications, Registration Requirements and Application Standards, must be stated. Divergences from FAO specifications must be described in detail, and justified.

2.1

Appearance (colour and odour)

A description of both the colour and odour, if any, and the physical state of the preparation, must be provided.

2.2

Explosivity and oxidizing properties

2.2.1

The explosive properties of preparations must be determined in accordance with EEC Method A 14 and be reported. Where available thermodynamic information establishes beyond reasonable doubt, that the preparation is incapable of exothermic reaction, it is sufficient to provide that information as a justification for not determining the explosive properties of the preparation.

2.2.2

The oxidizing properties of preparations which are solids, must be determined in accordance with EEC Method A 17 and be reported. For other preparations the method used must be justified. Oxidizing properties do not have to be determined if it can be shown without reasonable doubt, on the basis of thermodynamic information, that the preparation is incapable of reacting exothermically with combustible materials.

2.3

Flash point and other indications of flammability or spontaneous ignition

The flash point of liquids which contain flammable solvents, must be determined in accordance with EEC Method A 9 and be reported. The flammability of solid preparations and gasses must be determined in accordance with EEC Method A 10, A 11 or A 12, as appropriate, and be reported. The auto-flammability of preparations, determined in accordance with EEC Method A 15 or A 16 as appropriate, and/or, where necessary, in accordance with the UN-Bowes-Cameron-Cage-Test (UN-Recommendations on the Transport of Dangerous Goods, Chapter 14, Nr. l4.3.4), must be reported.

2.4

Acidity/alkalinity and if necessary pH value

2.4.1

In the case of preparations which are acidic (pH10) the acidity or alkalinity and the pH value must be determined in accordance with CIPAC Method MT31 and MT75 respectively, and be reported.

2.4.2

Where relevant (if to be applied as aqueous dilution) the pH of a 1% aqueous dilution, emulsion or dispersion of the preparation, must be determined in accordance with CIPAC Method MT75 and be reported.

2.5

Viscosity and surface tension

2.5.1

In the case of liquid preparations for Ultra Low Volume use (ULV) the kinematic viscosity must be determined in accordance with OECD Test Guideline 14 and be reported.

2.5.2

For non newtonian liquids the viscosity must be determined and reported together with the test conditions.

2.5.3

In the case of liquid preparations the surface tension must be determined in accordance with EEC Method A 5 and be reported,

2.6

Relative density and bulk density

2.6.1

The relative density of liquid preparations must be determined in accordance with EEC Method A 3 and be reported.

2.6.2

The bulk (tap) density of preparations which are powders or granules, must be determined in accordance with CIPAC Methods MT33, MT159 or MT169, as appropriate, and be reported.

2.7

Storage stability — stability and shelf-life. Effects of light, temperature and humidity on technical characteristics of the plant protection product

2.7.1

The stability of the preparation after storage for 14 days at 54°C must be determined in accordance with CIPAC Method MT46 and be reported. Other storage times and/or temperatures may be needed (e.g. 8 weeks at 40°C or 12 weeks at 35°C or 18 weeks at 30°C) if the preparation is heat sensitive.

If the active substance content after the heat stability test has decreased by more than 5% of the initial determined content, the minimum content must be declared and information on the degradation products must be supplied.

2.7.2

Additionally in the case of liquid preparations, the effect of low temperatures on stability, must be determined in accordance with CIPAC Methods MT39, MT48, MT51 or MT54, as appropriate, and be reported.

2.7.3

The shelf life of the preparation at ambient temperatures must be reported. Where shelf life is less than two years, the shelf life in months, with appropriate temperature specifications, must be reported. Useful information relating to such testing is contained in GIFAP Monograph No 17.

2.8

Technical characteristics of the plant protection product

The technical characteristics of the preparation must be determined to permit a decision to be made as to its acceptability.

2.8.1

Wettability

The wettability of solid preparations which are diluted for use (e.g. wettable powders, water soluble powders, water soluble granules and water dispersible granules), must be determined in accordance with CIPAC Method MT53.3 and be reported.

2.8.2

Persistent foaming

The persistence of foaming of preparations to be diluted with water, must be determined in accordance with CIPAC Method MT47 must be reported.

2.8.3

Suspensibility and suspension stability

2.8.3.1

The suspensibility of water dispersible products (e.g. wettable powders, water dispersible granules, suspension concentrates) must be determined in accordance with CIPAC Method MT15, MT161 or MT168, as appropriate and be reported.

2.8.3.2

The spontaneity or dispersibility of water dispersible products (e.g. suspension concentrates and water dispersible granules) must be determined in accordance with CIPAC Methods MT160 or MT174, as appropriate, and be reported.

2.8.4

Dilution stability

The dilution stability of water soluble products must be determined in accordance with CIPAC Method MT41 and be reported.

2.8.5

Dry sieve test and wet sieve test

In order to ensure that dustable powders have a suitable particle size distribution for ease of application, a dry sieve test must be conducted in accordance with CIPAC Method MT59.1 and be reported.

In the case of water dispersible products, a wet sieve test must be conducted in accordance with CIPAC Method MT59.3 or MT167, as appropriate, must be reported.

2.8.6

Particle size distribution (dustable and wettable powders, granules), content of dust/fines (granules), attrition and friability (granules)

2.8.6.1

The size distribution of particles in the case of powders, must be determined in accordance with OECD Method 110 and be reported.

The nominal size range of granules for direct application must be determined in accordance with CIPAC MT58.3 and for water dispersible granules and in accordance with CIPAC MT170, and be reported.

2.8.6.2

The dust content of granular preparations, must be determined in accordance with CIPAC Method MT171 and be reported. If relevant for operator exposure the particle size of dust must be determined in accordance with OECD Method 110 and be reported.

2.8.6.3

The friability and attrition characteristics of granules, must be determined and reported once internationally agreed methods are available. Where relevant data are available they must be reported together with details of the method used.

2.8.7

Emulsifiability, Re-emulsifiability, emulsion stability

2.8.7.1

The emulsifiability, emulsion stability and re-emulsifiability of preparations which form emulsions, must be determined in accordance with CIPAC Methods MT36 or MT173, as appropriate, and be reported.

2.8.7.2

The stability of dilute emulsions and of preparations which are emulsions, must be determined in accordance with CIPAC Method MT20 or MT173, as appropriate, and be reported.

2.8.8

Flowability, pourability (rinsability) and dustability

2.8.8.1

The flowability of granular preparations must be determined in accordance with CIPAC Method MT172 and be reported.

2.8.8.2

The pourability (including rinsed residue) of suspensions (e.g. suspension concentrates, suspo-emulsions), must be determined in accordance with CIPAC Method MT148 and be reported.

2.8.8.3

The dustability of dustable powders following accelerated storage as specified in paragraph 2.7.1 must be determined in accordance with CIPAC Method MT34 or another suitable method and be reported.

2.9

Physical and chemical compatibility with other products including plant protection products with which its use is to be authorized

2.9.1

The physical compatibility of tank mixes must be determined using in-house test methods and be reported. A practical test is an acceptable alternative.

2.9.2

The chemical compatibility of tank mixes must be determined and reported except where examination of the individual properties of the preparations establishes beyond reasonable doubt that there is no possibility of reaction taking place. In such cases it is sufficient to provide that information as justification for not determining chemical compatibility.

2.10

Adherence and distribution to seeds

In the case of preparations for seed treatment, both distribution and adhesion must be investigated and reported; in the case of distribution in accordance with CIPAC Method MT175.

2.1.1

Summary and evaluation of data presented under points 2.1 to 2.10

3

Data on application

3.1

Field of use envisaged, e.g. field, protected crops, storage of plant products, home gardening

The field(s) of use, existing and proposed, for preparations containing the active substance must be specified from among the following:

Field use

— Agriculture

— Horticulture

— Forestry

— Viticulture

Protected crops

Amenity

Weed control on non-cultivated areas

Home gardening

House plants

Plant products storage practice

Other (specify)

3.2

Effects on harmful organisms, e.g. contact, inhalation or stomach poison, fungitoxic or fungistatic, etc., systemic or not in plants

3.2.1

The nature of the effects on harmful organisms must be stated:

contact action

stomach action

inhalation action

fungitoxic action

fungistatic action

desiccant

reproduction inhibitor

other (must be specified)

It must be stated whether or not the active substance is translocated in plants and where relevant whether such translocation is apoplastic, symplastic or both.

3.3

Details of intended use e.g. types of harmful organisms controlled and/or plants or plant products to be protected

Details of the intended use must be provided.

Where relevant, effects achieved e.g. sprout suppression, retardation of ripening, reduction in stem length, enhanced fertilization etc. must be reported.

3.4

Application rate

For each method of application and each use, the rate of application per unit (ha, m , m³) treated, in terms of g or kg of both preparation and active substance, must be provided.

Application rates shall normally be expressed in g or kg/ha or in kg/m³ and where appropriate in g or kg/tonne; for protected crops and home gardening use rates shall be expressed in g or kg/100mor g or kg/m³.

3.5

Concentration of active substance in material used (e.g. in the diluted spray, baits or treated seed)

The content of active substance shall be reported, as appropriate, in g/l, g/kg, mg/kg or in g/tonne.

3.6

Method of application

The method of application proposed must be described fully, indicating the type of equipment to be used, if any, as well as the type and volume of diluent to be used per unit of area or volume.

3.7

Number and timing of applications and duration of protection

The maximum number of applications to be used and their timing, must be reported. Where relevant the growth stages of the crop or plants to be protected and the development stages of the harmful organisms, must be indicated. Where possible the interval between applications, in days, must be stated.

The duration of protection afforded both by each application and by the maximum number of applications to be used, must be indicated.

3.8

Necessary waiting periods or other precautions to avoid Phytotoxic effects on succeeding crops

Where relevant, minimum waiting periods between last application and sowing or planting of succeeding crops, which are necessary to avoid phytotoxic effects on succeeding crops, must be stated, and follow from the data provided under paragraph 6.6.

Limitations on choice of succeeding crops, if any, must be stated.

3.9

Proposed instructions for use

The proposed instructions for use of the preparation, to be printed on labels and leaflets, must be provided.

4

Further information on the plant protection product

4.1

Packaging (type, materials, size etc.), compatibility of the preparation with proposed packaging materials

4.1.1

Packaging to be used must be fully described and specified in terms of the materials used, manner of construction (e.g. extruded, welded etc.), size and capacity, size of opening, type of closure and seals. It must be designed in accordance with the criteria and guidelines specified in the FAO "Guidelines for the Packaging of Pesticides".

4.1.2

The suitability of the packaging, including closures, in terms of its strength, leakproofness and resistance to normal transport and handling, must be determined in accordance with ADR Methods 3552, 3553, 3560, 3554, 3555, 3556 and 3558, or ADR methods for intermediate bulk containers, as appropriate, and where child resistant closures are required, in accordance with ISO Standard 8317, and be reported.

4.1.3

The resistance of the packaging material to its contents must be determined in accordance with GIFAP Monograph no. 17, and be reported.

4.2

Procedures for cleaning application equipment

Cleaning procedures for both application equipment and protective clothing must be described in detail. The effectiveness of the cleaning procedure, must be fully investigated and reported.

4.3

Re-entry periods, necessary waiting periods or other precautions to protect man, livestock and the environment

The information provided must follow from and be supported by the data provided for the active substance(s) and that provided under sections 7 and 8.

4.3.1

Where relevant, pre-harvest intervals, re-entry periods or withholding periods necessary to minimize the presence of residues in or on crops, plants and plant products, or in or on treated areas or spaces, with a view to protecting man or livestock, must be specified e.g.

— 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.

4.3.2

Where necessary, in the light of test results, information on any specific agricultural, plant health or environmental conditions under which the preparation may or may not be used, must be provided.

4.4

Recommended methods and precautions concerning: handling, storage, transport or fire

The recommended methods and precautions concerning handling procedures (detailed) for the storage, at both warehouse and user level of plant protection products, for their transport and in the event of fire must be provided, Where available, information on combustion products must be provided. The risks likely to arise and the methods and procedures to minimize the hazards arising, must be specified. Procedures to preclude or minimize the generation of waste or leftovers must be provided.

Where relevant, assessment must be conducted in accordance with ISO-TR 9122.

Where relevant, the nature and characteristics of protective clothing and equipment proposed must be reported. The data provided must be sufficient to permit an evaluation to be made of the suitability and effectiveness of the protective clothing under realistic conditions of use (e.g. field or glasshouse circumstances).

4.5

Emergency measures in the case of an accident

Whether arising during transport, storage or use, detailed procedures to be followed in the event of an emergency, must be provided, and include procedures for—

— 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.

4.6

Procedures for destruction or decontamination of the plant protection product and its packaging

Procedures for destruction and decontamination must be developed for both small quantities (user level) and large quantities (warehouse level). The procedures must be consistent with provisions in place relating to the disposal of waste and of toxic waste. The means of disposal proposed should be without unacceptable influence on the environment and be the most cost effective and practical means of disposal feasible.

4.6.1

Possibility of neutralization

Neutralization procedures (e.g. by reaction with alkali to form less toxic compounds) for use in the event of accidental spillages, must where they are feasible, be described. The products produced after neutralization should be identified (through analysis or on the basis of theoretical considerations)and be reported.

4.6.2

Controlled incineration

In many cases the preferred or sole means to safely dispose of active substances as well as plant protection products containing them, contaminated materials, or contaminated packaging, is through controlled incineration in a licensed incinerator.

Where the content of halogens of the active substance(s) in the preparation is greater than 60%, the pyrolytic behaviour of the active substance under controlled conditions (including, where relevant, supply of oxygen and residence time), at 800°C and the content of polyhalogenated dibenzo-p-dioxins and dibenzo-furans in the products of pyrolysis must be reported. The applicant must provide detailed instructions for safe disposal.

4.6.3

Others

Other methods to dispose of plant protection products, packaging and contaminated materials, where proposed, must be fully described. Data must be provided for such methods, to establish their effectiveness and safety.

5

Analytical methods

5.1

Analytical methods for determining the composition of the plant protection product

5.2

In so far as not covered by Annex II, Part A, point 4.2, analytical methods including recovery rates and the limits of determination for residues and where relevant on, the following;

5.2.1

Treated plants, plant products, foodstuffs, feeding-stuffs

5.2.2

Soil

5.2.3

Water (including drinking water)

5.2.4

Air

5.2.5

Animal and human body fluids and tissues

6

Efficacy data

General

The data supplied must be sufficient to permit an evaluation of the plant protection product to be made. In particular it must be possible to evaluate the nature and extent of benefits that accrue following use of the preparation, where they exist in comparison to suitable reference products and damage thresholds, and to define its conditions of use.

The number of trials to be conducted and reported depends mainly on factors such as the extent to which the properties of the active substance(s) it contains are known and on the range of conditions that arise, including variability in plant health conditions, climatic differences, the range of agricultural practices, the uniformity of the crops, the mode of application, the type of harmful organism and the type of plant protection product.

Sufficient data must be generated and submitted to confirm that patterns determined hold for the regions and the range of conditions, likely to be encountered in the regions concerned, for which its use is to be recommended. Where an applicant claims that tests in one or more of the proposed regions of use are unnecessary because conditions are comparable with those in other regions where tests have been carried out, the applicant must substantiate the claim for comparability with documentary evidence.

In order to assess seasonal differences, if any, sufficient data must be generated and submitted to confirm the performance of the plant protection products in each agronomically and climatically different region for each particular crop (or commodity)/ harmful organism combination. Normally trials on effectiveness or phytotoxicity, where relevant, in at least two growing seasons must be reported.

If in the opinion of the applicant the trials from the first season adequately confirm the validity of claims made on the basis of extrapolation of results from other crops, commodities or situations or from tests with closely similar preparations, a justification, which is acceptable to the competent authority for not carrying out a second seasons's work must be provided. Conversely, where, because of climatic or plant health conditions or other reasons, the data obtained in any particular season are of limited value for the assessment of performance, trials in one or more further seasons must be conducted and reported.

6.1

Preliminary tests

Reports in summary form of preliminary tests, including glasshouse and field studies, used to assess the biological activity and dose range finding of the plant protection product and of the active substance(s) it contains, must be submitted when requested by the competent authority. These reports will provide additional information for the competent authority when it evaluates the plant protection product. Where this information is not submitted a justification which is acceptable to the competent authority must be provided.

6.2

Testing effectiveness

Aim of the tests

The tests shall provide sufficient data to permit an evaluation of the level, duration and consistency of control or protection or other intended effects of the plant protection product in comparison to suitable reference products, where they exist.

Test conditions

Normally a trial consists of three components: test product, reference product and untreated control.

The performance of the plant protection product must be investigated in relation to suitable reference products, where they exist. A suitable reference product is defined as an authorized plant protection product which has proved to have a sufficient performance in practice under the agricultural, plant health and environmental (including climatic) conditions in the area of proposed use. In general, formulation type, effects on the harmful organisms, working spectrum and method of application should be close to those of the tested plant protection product.

Plant protection products must be tested in circumstances where the target harmful organism has been shown to have been present at a level causing or known to cause adverse effects (yield, quality, operational benefit) on an unprotected crop or area or on plants or plant products which have not been treated or where the harmful organism is present at such a level that an evaluation of the plant protection product can be made.

Trials to provide data on plant protection products for control of harmful organisms must show the level of control of the species of harmful organisms concerned or of species representative of groups for which claims are made. Trials must include the different stages of growth or life cycle of the harmful species, where this is relevant and the different strains or races, where these are likely to show different degrees of susceptibility.

Similarly, trials to provide data on plant protection products which are plant growth regulators, must show the level of effects on the species to be treated, and include investigation of differences in the response of a representative sample of the range of cultivars on which its use is proposed.

In order to clarify the dose response, dose rates lower than the recommended one must be included in some trials in order to enable to assess whether the recommended rate is the minimum necessary to achieve the desired effect.

The duration of the effects of treatment must be investigated in relation to the control of the target organism or effect on the treated plants or plant products, as appropriate. When more than one application is recommended, trials must be reported which establish the duration of the effects of an application, the number of applications necessary and the desired intervals between them.

Evidence must be submitted to show that the dose, timing and method of application recommended give adequate control, protection or have the intended effect in the range of circumstances likely to be encountered in practical use.

Unless there are clear indications that the performance of the plant protection product is unlikely to be affected to a significant degree by environmental factors, such as temperature or rain, an investigation of the effects of such factors on performance must be carried out and reported, particularly where it is known that the performance of chemically related products is so affected.

Where proposed label claims include recommendations for the use of the plant protection product with other plant protection product(s) or adjuvant(s) information on the performance of the mixture must be provided.

Test guideline

Trials must be designed to investigate specified issues, to minimize the effects of random variation between different parts of each site and to enable statistical analysis to be applied to results amenable to such analysis. The design, analysis and reporting of trials must be in accordance with European and Mediterranean Plant Protection Organisation (EPPO) guidelines 152 and 181. The report shall include a detailed and critical assessment of the data.

When conducted within the territory of the state, the trials must be carried out in accordance with specific EPPO guidelines, where available. When conducted within the territory of another Member State, the trials must be carried out in accordance with specific EPPO guidelines, where available or when the Member State concerned so requires, in accordance with guidelines satisfying at least the requirements of the corresponding EPPO guidelines.

A statistical analysis of results amenable to such analysis must be carried out; where necessary the test guideline used must be adapted to enable such analysis.

6.3

Information on the occurrence or possible occurrence of the development of resistance

Laboratory data and where it exists, field information relating to the occurrence and development of resistance or cross-resistance in populations of harmful organisms to the active substance(s), or to related active substances, must be provided. Where such information is not directly relevant to the uses for which authorization is sought or to be renewed (different species of harmful organism or different crops), it must, if available, nevertheless be provided, as it may provide an indication of the likelihood of resistance developing in the target population.

Where there is evidence or information to suggest that, in commercial use, the development of resistance is likely, evidence must be generated and submitted as to the sensitivity of the population of the harmful organism concerned to the plant protection product. In such cases a management strategy designed to minimize the likelihood of resistance of cross-resistance developing in target species must be provided.

6.4

Effects on the yield of treated plants or plant products in terms of quantity and/or quality

6.4.1

Effects on the quality of plants or plant products

Aim of the tests

The tests shall provide sufficient data to permit an evaluation of the possible occurrence of taint or odour or other quality aspects of plants or plant products after treatment with the plant protection product.

Circumstances in which required

The possibility of the occurrence of taint or odour in food crops must be investigated and be reported where:

— 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 effects of plant protection products on other quality aspects of treated plants or plant products must be investigated and reported where:

— 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.

Testing should be conducted initially on the main crops on which the plant protection product is to be used, at twice the normal rates of application and using, where relevant, the main methods of processing, where effects are observed it is necessary to perform testing at the normal rate of application.

The extent of investigation necessary on other crops will depend on their degree of similarity to the main crops already tested, the quantity and quality of data available on those main crops and how far the manner of use of the plant protection product and methods of processing the crops, if relevant, are similar. it is generally sufficient to perform the test with the main formulation type to be authorized.

6.4.2

Effects on transformation processes

Aim of the tests

The tests shall provide sufficient data to permit an evaluation of the possible occurrence of adverse effects after treatment with the plant protection product on transformation processes or on the quality of their products.

Circumstances in which required

When the treated plants or plant products are normally intended for use in transformation process such as wine making, brewing or bread making and when at harvest significant residues are present, the possibility of the occurrence of adverse effects must be investigated and reported where:

— 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.

It is generally sufficient to perform the test with the main formulation type to be authorized.

6.4.3

Effects on the yield of treated plants or plant products

Aim of the tests

The tests shall provide sufficient data to permit an evaluation of the performance of the plant protection product and of the possible occurrence of yield reduction or loss in storage of treated plants or plant products.

Circumstances in which required

The effects of plant protection products on the yield or yield components of treated plants or plant products must be determined where relevant. When treated plants or plant products are likely to be stored the effect on the yield after storage, including data on storage life must be determined where relevant.

This information will normally be available from the tests required under the provisions of point 6.2.

6.5

Phytotoxicity to target plants (including different cultivars), or to target plant products

Aim of the tests

The tests shall provide sufficient data to permit an evaluation of the performance of the plant protection product and of the possible occurrence of phytotoxicity after treatment with the plant protection product.

Circumstances in which required

For herbicides and for other plant protection products for which adverse effects, however transitory, are seen during the trials, performed in accordance to point 6.2, the margins of selectivity on target crops must be established, using twice the recommended rate of application. Where serious phytotoxic effects are seen, an intermediate application rate must also be investigated.

Where adverse effects occur, but are claimed to be unimportant in comparison with the benefits of use or to be transient, evidence to support this claim is required. If necessary yield measurements must be submitted.

The safety of a plant protection product to the main cultivars of the main crops for which it is recommended must be demonstrated, including effects of crop growth stage, vigour, and other factors which may influence susceptibility to damage or injury.

The extent of investigation necessary on other crops will depend on their degree of similarity to the main crops already tested, the quantity and quality of data available on those main crops and how far the manner of use of the plant protection product, if relevant, is similar. It is generally sufficient to perform the test with the main formulation type to be authorized.

Where proposed label claims include recommendations for the use of the plant protection product with other plant protection product(s) or adjuvant(s), the provision of the previous paragraphs apply for the mixture.

Test guideline

Observations concerning phytotoxicity must be recorded and reported in the tests provided for under point 6.2.

Where phytotoxic effects are seen, they must be accurately assessed and recorded in accordance with EPPO Guideline 135, where testing is conducted within the territory of the state. When conducted within the territory of another Member State, the trials must be carried out in accordance with EPPO Guideline 135, or when the Member State concerned so requires, in accordance with guidelines satisfying at least the requirements of EPPO Guideline 135.

A statistical analysis of results amenable to such analysis must be carried out, where necessary the test guideline used must be adapted to enable such analysis.

6.6

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)

6.6.1

Impact on succeeding crops

Aim of the information required

Sufficient data must be reported to permit an evaluation of possible adverse effects of a treatment with the plant protection product on succeeding crops.

Circumstances in which required

Where data, generated in accordance with section 9, point 9.1, shows that significant residues of the active substance, its metabolites or degradation products, which have or may have biological activity on succeeding crops, remain in soil or in plant materials, such as straw or organic material up to sowing or planting time of possible succeeding crops, observations must be submitted on effects on the normal range of succeeding crops.

6.6.2

Impact on other plants, including adjacent crops

Aim of the information required

Sufficient data must be reported to permit an evaluation of possible adverse effects of a treatment with the plant protection product on other plants, including adjacent crops.

Circumstances in which required

Observations must be submitted on adverse effects on other plants, including the normal range of adjacent crops, when there are indications that the plant protection product could affect these plants via vapour drift.

6.6.3

Impact on treated plants or plant products to be used for propagation

Aim of the information required

Sufficient data must be reported to permit an evaluation of possible adverse effects of a treatment with the plant protection product on plants or plant products to be used for propagation.

Circumstances in which required

Observations must be submitted on the impact of plant protection products on plant parts used for propagation except where the proposed uses preclude use on crops intended for production of seeds, cuttings, runners or tubers for planting, as appropriate:

(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

Test guideline

For seeds testing shall be done according to ISTA methods²⁵.

6.6.4

Effects on beneficial and other non-target organisms

Any effects, positive or negative, on the incidence of other harmful organisms, observed in the tests performed in accordance with the requirements of this section, shall be reported. Any observed environmental effects must also be reported, especially effects on wildlife and/or beneficial organisms.

6.7

Summary and evaluation of data presented under 6.1 to 6.6

A summary of all data and information provided under points 6.1 to 6.6 must be provided, together with a detailed and a critical assessment of the data, with particular reference to the benefits that the plant protection product offers, adverse effects that do or may arise and measures necessary to avoid or minimize adverse effects.

7

Toxicological studies

7.1

Acute toxicity

7.1.1

Oral

7.1.2

Percutaneous

7.1.3

Inhalation

7.1.4

Skin and, where relevant, eye irritation

²⁵ International Rules for Seed Testing, 1985. Proceedings of the International Seed Testing Association, Seed Science and Technology, Volume 13, Number 2,1985.

7.1.5

Skin sensitization

7.1.6

Where appropriate, acute dermal toxicity, skin and eye irritation for combinations of plant protection products for which authorization is sought for use in such combinations

7.2

Operator exposure

7.2.1

Dermal absorption

7.2.2

Likely operator exposure under field conditions, including where relevant quantitative analysis of operator exposure

7.2.3

Available toxicological data relating to non-active substances

8

Residues in or on treated products, food and feed

8.1

Data from supervised trials in crops, food or feeding stuffs, for which authorized use is sought, giving all experimental conditions and details, including residue data concerning the active substance, relevant metabolites and relevant other constituents of the plant protection product, from time of application until harvest, or in the case of post-harvest treatment, breakdown of residues during storage and levels of residues at time of release from storage for marketing. Data should be available for the range of climatic and agronomic conditions likely to be encountered in the proposed area of use.

8.2

Effects of industrial processing and/or household preparation on the nature and magnitude of residues

8.3

Effects on taint, odour, taste or other quality aspects due to residues in or on fresh or processed products

8.4

Estimation of residues in products of animal origin resulting from ingestion of feeding stuffs or resulting from contact with bedding, on the basis of residue data referred to in point 8.1 and studies in livestock referred to in Annex II, Part A, point 6.5

8.5

Residue data in succeeding or rotational crops where presence of residues might be expected

8.6

Proposed pre-harvest intervals for envisaged uses, or withholding periods or storage periods, in the case of post-harvest uses

8.7

Proposed maximum residue levels (MRLs) and justification of the acceptability of these residues

8.8

Summary and evaluation of the residue behaviour on the basis of the data submitted under points 8.1 to 8.7

9

Fate and behaviour in the environment

The information provided must, where relevant, include that referred to in Annex II, part A. point 7, and

9.1

Testing for distribution and dissipation in soil

9.2

Testing for distribution and dissipation in water

G

9.3

Testing for distribution and dissipation in air

10

Ecotoxicological studies

10.1

Effects on birds

10.1.1

Acute oral toxicity

10.1.2

Supervised trials to assess risks to avian species under field conditions

10.1.3

If appropriate, studies on acceptance of bait, granules, or treated seeds by birds

10.2

Effects on aquatic organisms

10.2.1

Acute toxicity to fish

10.2.2

Acute toxicity to Daphnia magna

10.2.3

Overspray study (if toxic to fish or other aquatic organisms and persistent in water) to assess risks to aquatic organisms under field conditions

10.2.4

In case of application in/at surface waters

10.2.4.1

Particular studies with fish and other aquatic organisms

10.2.4.2

Residue data in fish concerning the active substance and including toxicologically relevant metabolites

10.2.5

The studies referred to in Annex II, Part A, points 8.2.2, 8.2.3, 8.2.4, 8.2.6, and 8.2.7 may be required for particular plant protection products

10.3

Effects on other non-target organisms

10.3.1

Effects on terrestrial vertebrates other than birds

10.3.2

Toxicity to honey-bees

10.3.3

Toxicity to foraging bees under field conditions

10.3.4

Effects on beneficial arthropods other than bees

10.3.5

Effects on earthworms and other soil non-target macro-organisms, believed to be at risk

10.3.6

Effects on soil non-target micro-organisms

10.3.7

Available data from biological primary screening in summary form

11

Summary and evaluation of points 9 and 10

12

Further information

12.1

Information on authorization in other countries

12.2

Information on established maximum residue limits (MRL) in other countries

12.3

Proposals including justification for the classification and labelling proposed in accordance with Directive 67/548/EEC and Directive 78/631/EEC

— Hazard symbol(s)

— Indication of danger

— Risk phrases

— Safety phrases

12.4

Proposals for risk and safety phrases in accordance with Article 15(1), (g) and (h) and proposed label

12.5

Specimens of proposed packaging

1

Identity of the plant protection product

1.1

Applicant (name, address, etc.)

1.2

Manufacturer of the preparation and the active agent(s) (names, addresses, etc., including location of plants)

1.3

Trade name or proposed trade name and manufacturer's development code number for the plant protection product, if appropriate

1.4

Detailed quantitative and qualitative information on the composition of the plant protection product (active organism(s), insert components, extraneous organisms, etc.)

1.5

Physical state and nature of the plant protection product (emulsifiable concentrate, wettable powder, etc.)

1.6

Use category (insecticide, fungicide, etc.)

2

Technical properties of the plant protection product

2.1

Appearance (colour and odour)

2.2

Storage stability — stability and shelf-life. Effects of temperature, method of packaging and storage, etc. on retention of biological activity

2.3

Methods for establishing storage and shelf-life stability

2.4

Technical characteristics of the preparation

2.4.1

Wettability

2.4.2

Persistent foaming

2.4.3

Suspensibility and suspension stability

2.4.4

Wet sieve test and dry sieve test

2.4.5

Particle size distribution, content of dust/fines, attrition and friability

2.4.6

In the case of granules, sieve test and indications of weight distribution of the granules, at least of the fraction with particle sizes bigger than 1 mm

2.4.7

Content of active substance in or on bait particles, granules, or treated seed

2.4.8

Emulsifiability, re-emulsifiability, emulsion stability

2.4.9

Flowability, pourability and dustability

2.5

Physical and chemical compatibility with other products including plant protection products with which its use is to be authorized

2.6

Wetting, adherence and distribution to target plants

3

Data on applications

3.1

Field of use, e.g. field, glasshouse, food or feed storage, home garden

3.2

Details of intended use, e.g. types of harmful organism controlled and/or plants or plant products to be protected

3.3

Application rate

3.4

Where necessary, in the light of the test results, any specific agricultural, plant health and/or environmental conditions under which the product may or may not be used

3.5

Concentration of active substance in material used (e.g. % concentration in the diluted spray)

3.6

Method of application

3.7

Number and timing of application

3.8

Phytopathogenicity

3.9

Proposed instructions for use

4

Further information on the preparation

4.1

Packaging (type, materials, size, etc.), compatibility of the preparation with proposed packaging materials

4.2

Procedures for cleaning applications equipment

4.3

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

4.4

Recommended methods and precautions concerning handling, storage, transport

4.5

Emergency measures in case of an accident

4.6

Procedures for destruction of decontamination of the plant protection product and its packaging

5

Analytical methods

5.1

Analytical methods for determining the composition of the plant protection product

5.2

Methods for determining residues in or on treated plants or in or on plant products (e.g. biotest)

5.3

Methods used to show microbiological purity of the plant protection product

5.4

Methods used to show the plant protection product to be free from any human and other mammalian pathogens or, if need be, from honey-bee pathogens

5.5

Techniques used to ensure a uniform product and assay methods for its standardization

6

Efficacy data

6.1

Preliminary range-finding tests

6.2

Field experimentation

6.3

Information on the possible occurrence of the development of resistance

6.4

Effects on the quality and where appropriate on the yield of treated plants or effects on the quality of treated plant products

6.5

Phytotoxicity to target plants (including different cultivars), or to target plant products

6.6

Observations concerning 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 propagation purposes (e.g. seeds, cuttings, runners)

6.7

Summary and evaluation of data presented under points 6.1 to 6.6

7

Toxicity and/or pathogenicity and infectivity studies

7.1

Oral single dose

7.2

Percutaneous single dose

7.3

Inhalation

7.4

Skin and where relevant eye irritation

7.5

Skin sensitization

7.6

Available toxicological data relating to non-active substances

7.7

Operator exposure

7.7.1

Percutaneous absorption

7.7.2

Likely operator exposure under field conditions, including where relevant quantitative analysis of operator exposure

8

Residues in or on treated products, food and feed

8.1

Residue data concerning the active substance including data from supervised trials in crops, food or feeding stuffs for which authorization for use is sought, giving all experimental conditions and details. Data should be available for the range of different climatic and agronomic conditions encountered in the proposed area of use. It is also necessary to identify viable and non-viable residues in treated crops

8.2

Effects of industrial processing and/or household preparation on the nature and magnitude of residues, if appropriate

8.3

Effects on taint, odour, taste or other quality aspects due to residues on or in fresh or processed products, if appropriate

8.4

Residue data in products of animal origin resulting from ingestion of feeding stuffs or contact with bedding, if appropriate

8.5

Residue data in succeeding or rotational crops where presence of residues might be expected

8.6

Proposed pre-harvest intervals for envisaged uses or withholding periods, or storage periods, in the case of post-harvest uses

8.7

Proposed maximum residue levels (MRLs) and the justification of the acceptability of these levels (for toxins), if appropriate

8.8

Summary and evaluation of the residue behaviour on the basis of the data submitted under points 8.1 to 8.7

9

Fate and behaviour in the environment

9.1

In cases where toxins are produced, data as outlined under Part A, point 9 are required, if appropriate

10

Ecotoxicological studies

10.1

Effects on aquatic organisms

10.1.1

Fish

10.1.2

Studies in Daphnia magna and in species closely related to the target organisms

10.1.3

Studies in aquatic micro-organisms

10.2

Effects on beneficial and other non-target organisms

10.2.1

Effects on honey-bees, if appropriate

10.2.2

Effects on other beneficial organisms

10.2.3

Effects on earthworms

10.2.4

Effects on other soil fauna

10.2.5

Effects on other non-target organisms believed to be at risk

10.2.6

Effects on soil microflora

11

Summary and evaluation of points 9 and 10

12

Further information

12.1

Information on authorization in other countries

12.2

Information on established maximum residue limits (MRLs) in other countries

12.3

Proposals including justification for the classification and labelling proposed in accordance with Directives 67/548/EEC and 78/631/EEC

— Hazard symbol(s)

— Indication of danger

— Risk phrases

— Safety phrases

12.4

Proposals for risk and safety phrases in accordance with Article 15(1)(g) and (h) and proposed label

12.5

Specimens of proposed packaging

1.

Re-closable packages

Child-proof fastenings used on re-closable packages shall comply with ISO Standard 8317 (1 July 1989 edition) relating to Child-resistant packages — Requirements and methods of testing for re-closable packages adopted by the International Standard Organization (ISO).

2.

Non-re-closable packages

(pro memoria)

3.

Notes

1. Evidence of conformity with the above standard may be certified only by laboratories which conform with European Standards Series EN 45 000.

2. Specific cases

If it seems obvious that packaging is sufficiently safe for children because they cannot get access to the contents without the help of a tool, the test doesn't need to be performed.

In all other cases and when there are sufficient grounds for doubting the security of the closure for a child, the competent authority may ask the person responsible for putting the product on the market to give him a certificate from a test house described below, that either:

— the type of closure is such that it is not necessary to test to the ISO standard referred to above, or

— the closure has been tested and has been found to conform with the standard referred to above.

E

O

Explosive

Oxidizing

F

F+

Highly flammable

Extremely flammable

F

T+

Toxic

Very toxic

C

Xn

Corrosive

Harmful

Xi

N

Irritant

Dangerous for the environment

R1

Explosive when dry.

R2

Risk of explosion by shock, friction, fire or other sources of ignition.

R3

Extreme risk of explosion by shock, friction, fire or other sources of ignition.

R4

Forms very sensitive explosive metallic compounds.

R5

Heating may cause an explosion.

R6

Explosive with or without contact with air.

R7

May cause fire.

R8

Contact with combustible material may cause fire.

R9

Explosive when mixed with combustible material.

R10

Flammable.

R11

Highly flammable.

R12

Extremely flammable.

R14

Reacts violently with water.

R15

Contact with water liberates extremely flammable gases.

R16

Explosive when mixed with oxidising substances.

R17

Spontaneously flammable in air.

R18

In use, may form flammable/explosive vapour-air mixture.

R19

May form explosive peroxides.

R20

Harmful by inhalation.

R21

Harmful in contact with skin.

R22

Harmful if swallowed.

R23

Toxic by inhalation.

R24

Toxic in contact with skin.

R25

Toxic if swallowed.

R26

Very toxic by inhalation.

R27

Very toxic in contact with skin.

R28

Very toxic if swallowed.

R29

Contact with water liberates toxic gas.

R30

Can become highly flammable in use.

R31

Contact with acids liberates toxic gas.

R32

Contact with acids liberates very toxic gas.

R33

Danger of cumulative effects.

R34

Causes burns.

R35

Causes severe burns.

R36

Irritating to eyes.

R37

Irritating to respiratory system.

R38

Irritating to skin.

R39

Danger of very serious irreversible effects.

R40

Possible risks of irreversible effects.

R41

Risk of serious damage to eyes.

R42

May cause sensitization by inhalation.

R43

May cause sensitization by skin contact.

R44

Risk of explosion if heated under confinement.

R45

May cause cancer.

R46

May cause heritable genetic damage.

R48

Danger of serious damage to health by prolonged exposure.

R49

May cause cancer by inhalation.

R50

Very toxic to aquatic organisms.

R51

Toxic to aquatic organisms.

R52

Harmful to aquatic organisms.

R53

May cause long-term adverse effects in the aquatic environment.

R54

Toxic to flora.

R55

Toxic to fauna.

R56

Toxic to soil organisms.

R57

Toxic to bees.

R58

May cause long-term adverse effects in the environment.

R59

Dangerous for the ozone layer.

R60

May impair fertility.

R61

May cause harm to the unborn child.

R62

Possible risk of impaired fertility.

R63

Possible risk of harm to the unborn child.

R64

May cause harm to breastfed babies.

R14/15

Reacts violently with water, liberating extremely flammable gases.

R15/29

Contact with water liberates toxic, extremely flammable gas.

R20/21

Harmful by inhalation and in contact with skin.

R20/22

Harmful by inhalation and if swallowed.

R20/21/22

Harmful by inhalation, in contact with skin and if swallowed.

R21/22

Harmful in contact with skin and if swallowed.

R23/24

Toxic by inhalation and in contact with skin.

R23/25

Toxic by inhalation and if swallowed.

R23/24/25

Toxic by inhalation, in contact with skin and if swallowed.

R24/25

Toxic in contact with skin and if swallowed.

R26/27

Very toxic by inhalation and in contact with skin.

R26/28

Very toxic by inhalation and if swallowed.

R26/27/28

Very toxic by inhalation, in contact with skin and if swallowed.

R27/28

Very toxic in contact with skin and if swallowed.

R36/37

Irritating to eyes and respiratory system.

R36/38

Irritating to eyes and skin.

R36/37/38

Irritating to eyes, respiratory system and skin.

R37/38

Irritating to respiratory system and skin.

R39/23

Toxic: danger of very serious irreversible effects through inhalation.

R39/24

Toxic: danger of very serious irreversible effects in contact with skin.

R39/25

Toxic: danger of very serious irreversible effects if swallowed.

R39/23/24

Toxic: danger of very serious irreversible effects through inhalation and in contact with skin.

R39/23/25