Council Directive of 15 July 1991 concerning the placing of plant protection products on the market (91/414/EEC) (repealed)

PART A U.K. Chemical preparations

[F1 1. Identity of the plant protection product U.K.

The information provided, taken together with that provided for the active substance(s), must be sufficient to precisely identify preparations and 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.) U.K.

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 Member State in which the authorization is being sought, 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) U.K.

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 (preferable 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 in Annex II have to be provided.

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

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 absolete), full details of the differences, must be provided. (The proposed trade name may not give rise to confusion with the trade name of already registered plant protection products.)

1.4. Detailed quantitative and qualitative information on the composition of the preparation (active substance(s), and formulants) U.K.

1.4.1. For preparations the following information must be reported: U.K.

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

• the content of formulants.

The concentrations should be expressed in terms as provided for in Article 6 (2) of Directive 78/631/EEC.

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. U.K.

1.4.3. Formulants must where possible, be identified both by their chemical name as given in Annex I to Directive 67/548/EEC, or, if not included in this Directive, in accordance with both IUPAC and CA nomenclature. Their structure or structural formula must be provided. For each component of the 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. U.K.

1.4.4. For formulants the function must be given: U.K.

• adhesive (sticker),

• antifoaming agent,

• antifreeze,

• binder,

• buffer,

• carrier,

• deodorant,

• dispersing agent,

• dye,

• emetic,

• emulsifier,

• fertilizer,

• preservative,

• odourant,

• perfume,

• propellant,

• repellent,

• safener,

• solvent,

• stabilizer,

• synergist,

• thickener,

• wetting agent,

• miscellaneous (specify).

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

1.5.1. The type and code of preparation must be designated according to the ‘ Catalogue of pesticide formulation types and international coding system (GIFAP Technical Monograph No 2. 1989) ’ . U.K.

Where a particular preparation is not defined precisely in this publication 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.) U.K.

The function must be specified from among the following:

• acaricide,

• bactericide,

• fungicide,

• herbicide

• insecticide,

• molluscicide,

• nematicide,

• plant growth regulator,

• repellant,

• rodenticide,

• semio-chemicals,

• talpicide,

• viricide,

• other (must be specified).

Textual Amendments

F1 Substituted by Commission Directive 94/37/EC of 22 July 1994 amending Council Directive 91/414/EEC concerning the placing of plant protection products on the market.

2. Physical, chemical and technical properties of the plant protection product U.K.

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) U.K.

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 U.K.

2.2.1. The explosive properties of preparations must be reported according to EEC method A 14. 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. U.K.

2.2.2. Oxidizing properties of preparations which are solids must be determined and exported according to EEC method A 17. For other preparations the method used must be justified. The 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. U.K.

2.3. Flash point and other indications of flammability or spontaneous ignition U.K.

The flash point of liquids which contain flammable solvents, must be determined and reported according to EEC Method A 9. The flammability of solid preparations and gases must be determined and reported according to EEC methods A 10, A 11 and A 12 as appropriate. The auto-flammability of preparations must be determined and reported in accordance with EEC methods 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, No 14.3.4).

2.4. Acidity/alkalinity and if necessary pH value U.K.

2.4.1. In the case of preparations which are acidic (pH < 4) or alkaline (pH > 10) the acidity or alkalinity and the pH value must be determined and reported according to CIPAC Method MT 31 and MT 75 respectively. U.K.

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 and reported according to CIPAC Method MT 75. U.K.

2.5. Viscosity and surface tension U.K.

2.5.1. In the case of liquid preparations for Ultra Low Volume use (ULV) the kinematic viscosity must be determined and reported according to OECD Test Guideline 114. U.K.

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

2.5.3. In the case of liquid preparations the surface tension has to be determined and reported according to EEC method A 5. U.K.

2.6. Relative density and bulk density U.K.

2.6.1. The relative density of liquid preparations must be determined and reported according to EEC Method A 3. U.K.

2.6.2. The bulk (tap) density of preparations which are powders or granules, must be determined and reported according to CIPAC Methods MT 33, MT 159 or MT 169 as appropriate. U.K.

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

2.7.1. The stability of the preparation after storage for 14 days at 54  ^o C must be determined and reported according to CIPAC Method MT 46. U.K.

Other times and/or temperatures may be needed (e.g. eight weeks at 40  ^o C or 12 weeks at 35  ^o C or 18 weeks at 30  ^o 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 initially found content, the minimum content shall be declared and information on the degradation products shall be supplied.

2.7.2. Additionally in the case of liquid preparations, the effect of low temperatures on stability, must be determined and reported according to CIPAC Methods MT 39, MT 48, MT 51 or MT 54 as appropriate. U.K.

2.7.3. The shelf life of the preparation at ambient temperature 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 is given in GIFAP Monograph No. 17. U.K.

2.8. Technical characteristics of the plant protection product U.K.

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

2.8.1. Wettability U.K.

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 and reported according to CIPAC Method MT 53.3.

2.8.2. Persistent foaming U.K.

The persistence of foaming of preparations to be diluted with water, must be determined and reported according to CIPAC Method MT 47.

2.8.3. Suspensibility and suspension stability U.K.

• The suspensibility of water dispersible products (e.g. wettable powders, water dispersible granules, suspension concentrates) must be determined and reported according to CIPAC Method MT 15, MT 161 or MT 168 as appropriate.

• The spontaneity of dispersion of water dispersible products (e.g. suspension concentrates and water dispersible granules) must be determined and reported according to CIPAC Methods MT 160 or MT 174 as appropriate.

2.8.4. Dilution stability U.K.

The dilution stability of water soluble products must be determined and reported according to CIPAC Method MT 41.

2.8.5. Dry sieve test and wet sieve test U.K.

In order to ensure that dustable powders have a suitable particle size distribution for ease of application, a dry sieve test must be conducted and reported according to CIPAC Method MT 59.1.

In the case of water dispersible products, a wet sieve test must be conducted and reported according to CIPAC Method MT 59.3 or MT 167 as appropriate.

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

2.8.6.1. The size distribution of particles in the case of powders, must be determined and reported according to OECD Method 110. U.K.

The nominal size range of granules for direct application must be determined and reported in accordance with CIPAC MT 58.3, for water dispersible granules in accordance with CIPAC MT 170.

2.8.6.2. The dust content of granular preparations, must be determined and reported according CIPAC Method MT 171. If relevant for operator exposure the particle size of dust must be determined and reported according to OECD Method 110. U.K.

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

2.8.7. Emulsifiability, Re-emulsifiability, emulsion stability U.K.

2.8.7.1. The emulsifiability, emulsion stability and re-emul-sifiability of preparations which form emulsions, must be determined and reported according to CIPAC Methods MT 36 or MT 173 as appropriate. U.K.

2.8.7.2. The stability of dilute emulsions and of preparations which are emulsions, must be determined and reported according to CIPAC Method MT 20 or MT 173. U.K.

2.8.8. Flowability, pourability (rinsability) and dustability U.K.

2.8.8.1. The flowability of granular preparations must be determined and reported according to CIPAC Mehtod MT 172. U.K.

2.8.8.2. The pourability (including rinsed residue) of suspensions (e.g. suspension concentrates, suspo-emulsions), must be determined and reported according to CIPAC Method MT 148. U.K.

2.8.8.3. The dustability of dustable powders following accelerated storage according 2.7.1 must be determined and reported according to CIPAC Method MT 34 or another suitable method. U.K.

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

2.9.1. The physical compatibility of tank mixes must be reported based on in-house test methods. A practical test would be an acceptable alternative. U.K.

2.9.2. The chemical compatibility of tank mixes must be determined and reported except where examination of the individual properties of the preparations would establish 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 practically determining the chemical compatibility. U.K.

2.10. Adherence and distribution to seeds U.K.

In the case of preparations for seed treatment, both distribution and adhesion must be investigated and reported; in the case of distribution according to CIPAC Method MT 175.

2.11. Summary and evaluation of data presented under points 2.1. to 2.10 U.K.

3. Data on application U.K.

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

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

• field use, such as agriculture, horticulture, forestry and 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 U.K.

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 product is translocated in plants.

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

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 U.K.

For each method of application and each use, the rate of application per unit (ha, m ² , m ³ ) 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/m ³ and where appropriate in g or kg/tonne; for protected crops and home gardening use rates shall be expressed in g or kg/100 m ² or g or kg/m ³ .

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

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 U.K.

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 U.K.

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 U.K.

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 U.K.

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 U.K.

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

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 ’ . U.K.

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 and reported according to ADR Methods 3552, 3553, 3560, 3554, 3555, 3556 3558, or appropriate ADR Methods for intermediate bulk containers, and, where for the preparation child-resistant closures are required, according to ISO standards 8317. U.K.

4.1.3. The resistance of the packaging material to its contents must be reported according to GIFAP Monograph No 17. U.K.

4.2. Procedures for cleaning application equipment U.K.

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 U.K.

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 treated areas or spaces, with a view to protecting man or livestock, must be specified e.g.: U.K.

• 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 the 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. U.K.

4.4. Recommended methods and precautions concerning: handling, storage, transport or fire U.K.

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 has to be done according to ISO — TR 9122.

Where appropriate the nature and characteristics of protective clothing and equipment proposed must be provided. The data provided must be sufficient to evaluate the suitability and effectiveness under realistic conditions of use (e.g. field or glasshouse circumstances).

4.5. Emergency measures in the case of an accident U.K.

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

• containment of spillages,

• decontamination of areas, vehicles and buildings,

• disposal of damaged packaging, adsorbents and other materials,

• protection of emergency workers and bystanders,

• first aid measures.

4.6. Procedures for destruction or decontamination of the plant protection product and its packaging U.K.

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 U.K.

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 practically or theoretically evaluated and reported.

4.6.2. Controlled incineration U.K.

In many cases the preferred or sole means to safely dispose of active substances as well as plant protection products containing it, contaminated materials, or contaminated packaging, is through controlled incineration in a lincensed 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 defined residence time) at 800  ^o 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 U.K.

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.]

[F2 5. Analytical methods U.K.

Introduction U.K.

The provisions of this section only cover analytical methods required for post-registration control and monitoring purposes.

For analytical methods used for generation of data as required in this Directive or for other purposes the applicant has to provide a justification for the method used; where necessary separate guidance will be developed for such methods on the basis of the same requirements as defined for methods for post-registration control and monitoring purposes.

Descriptions of methods must be provided and include details of equipment, materials and conditions used.

As far as practicable these methods must employ the simplest approach, involve the minimum cost, and require commonly available equipment.

For this section the following applies:

Impurities	Any component other than the pure active substance which is present in the active substance as manufactured (including non-active isomers) originating from the manufacturing process or from degradation during storage
Relevant impurities	Impurities of toxicological and/or ecotoxicological or environmental concern
Metabolites	Metabolites include products resulting from degradation or reaction of the active substance
Relevant metabolites	Metabolites of toxicological and/or ecotoxicological or environmental concern

On request the following samples must be provided:

(i)

samples of the preparation;

(ii)

analytical standards of the pure active substance;

(iii)

samples of the active substance as manufactured;

(iv)

analytical standards of relevant metabolites and all other components included in the residue definition;

(v)

if available, samples of reference substances for the relevant impurities.

For definitions see Annex II, Section 4, points 4.1 and 4.2.

5.1. Methods for the analysis of the preparation U.K.

5.1.1. Methods, which must be described in full, must be provided for the determination of the active substance in the preparation. In the case of a preparation containing more than one active substance a method capable of determining each, in the presence of the other, should be provided. If a combined method is not submitted, the technical reasons must be stated. The applicability of existing Cipac methods must be reported. U.K.

5.1.2. Methods must also be provided for the determination in the preparation of relevant impurities, if the composition of the preparation is such that — on the basis of theoretical consideration — such impurities may be formed by its manufacturing process or from degradation during storage. U.K.

If required, methods for the determination of formulants or constituents of formulants in the preparation must be submitted.

5.1.3. Specificity, linearity, accuracy and repeatability U.K.

5.1.3.1. Specificity of methods submitted, must be demonstrated and reported. In addition the extent of interference by other substances present in the preparation must be determined. U.K.

While interferences due to other components may be identified as systematic errors in the assessment of the accuracy of methods proposed, an explanation must be provided for any interference occurring which contribute more than ± 3 % to the total quantity determined.

5.1.3.2. The linearity of proposed methods over an appropriate range, must be determined and reported. The calibration range must extend (by at least 20 %) the highest and lowest nominal content of the analyte in relevant analytical solutions of the preparation. Duplicate calibration determinations must be made at three or more concentrations. Alternatively, five concentrations, each as single measurements, are acceptable. Reports submitted must include the equation of the calibration line and the correlation coefficient and representative and properly labelled documentation from the analysis, e.g. chromatograms. U.K.

5.1.3.3. Accuracy will normally only be required for methods for the determination of pure active substance and relevant impurities in the preparation. U.K.

5.1.3.4. For the repeatability in principle a minimum of five determinations must be made. The relative standard deviation (% RSD) must be reported. Outliers identified through an appropriate method (e.g. Dixons or Grubbs test), may be discarded. Where outliers have been discarded, that fact must be clearly indicated. An explanation as to the reason for the occurrence of individual outliers, must be attempted. U.K.

5.2. Analytical methods for the determination of residues U.K.

Analytical methods for the determination of residues must be submitted unless it is justified that the methods already submitted according to the requirements of Annex II, Section 4, point 4.2 can be applied.

The same provisions as provided in Annex II, Section 4, point 4.2 apply.]

Textual Amendments

F2 Substituted by Commission Directive 96/46/EC of 16 July 1996 amending Council Directive 91/414/EEC concerning the placing of plant protection products on the market (Text with EEA relevance).

[F3 6. Efficacy data U.K.

General U.K.

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 actieve 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 agriculral 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 product 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 to 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 seaons'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 U.K.

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 production product. Where this information is not submitted a justification which is acceptable to the competent authority must be provided.

6.2. Testing effectiveness U.K.

Aim of the tests U.K.

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 U.K.

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 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 of 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 how 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 medthod 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 production is unlikely to be affected to a significant degree by environemental factors, such as temperature or rain, an investigation of the effects of such factors on performace must be carried out and reported, particularly where it is known that the performance of chemically related products os 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 U.K.

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 Organization (EPPO) guidelines 152 and 181. The report shall include a detailed and critical assessment of the data.

The trials must be carried out in accordance to specific EPPO guidelines, where available, or when a requires so and when the test is carried out on the territory of this, with guidelines satisfying at least the requirements of the corresponding EPPO guideline.

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 U.K.

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 actived substances, must be provided. Where such information is not directly relevant to the uses for which authorization is ought or to be renewed (different species of harmful organism or different crops), it must, if available, nevertheless be provided, as it may provide and 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 or 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 U.K.

6.4.1. Effects on the quality of plants or plant product U.K.

Aim of the tests U.K.

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 U.K.

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

• the nature of the products 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 ingredient 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 it use could have an adverse influence on other quality aspects (for example in the case of use of plant growth regulators close or harvest), or

• other products based on the same or a closely similar active ingredient 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 of 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, 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 U.K.

Aim of the tests U.K.

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 U.K.

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 ingredient 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 U.K.

Aim of the tests U.K.

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

Circumstances in which required U.K.

The effects of plant protection products on the yield or yield components of treated 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 starage 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 U.K.

Aim of the tests U.K.

The test 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 U.K.

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 transient, evidence to support this claim is required. If necessary yield measurement 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 growh stage, vigour, and other factors which may influence suspectibility 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), the provisions of the previous paragraphs apply for the mixture.

Test guideline U.K.

Observations concerning phytotoxicity must be performed 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 or when a Member State requires so and when the test is carried out on the territory of this Member State, with guidelines satisfying at least the requirements of this EPPO guideline.

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) U.K.

6.6.1. Impact on succeeding crops U.K.

Aim of the information required U.K.

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 U.K.

Where data, generated in accordance with Section 9, point 9.1, shows that signification 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 succeedings crops.

6.6.2. Impact on other plants, including adjacent crops U.K.

Aim of the information required U.K.

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 U.K.

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 U.K.

Aim of the information required U.K.

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 ot be used for propagation.

Circumstances in which required U.K.

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 U.K.

Seeds testing shall be done according to ISTA Methods (1) .

6.6.4. Effects on beneficial and other non-target organisms U.K.

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 U.K.

A summary of all data and informations 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.]

Textual Amendments

F3 Substituted by Commission Directive 93/71/EEC of 27 July 1993 amending Council Directive 91/414/EEC concerning the placing of plant protection products on the market.

[F4 7. Toxicological studies U.K.

For proper evaluation of the toxicity of preparations sufficient information should be available on acute toxicity, irritation and sensitization of the active substance. If possible, additional information on mode of toxic action, toxicological profile and all other known toxicological aspects of the active substance should be submitted.

In the context of the influence that impurities and other components can have on toxicological behaviour, it is essential that for each study submitted, a detailed description (specification) of the material used, be provided. Tests must be conducted using the plant protection product to be authorized.

7.1. Acute toxicity U.K.

The studies, data and information to be provided and evaluated, must be sufficient to permit the identification of effects following a single exposure to the plant protection product, to be assessed, and in particular to establish, or indicate:

• the toxicity of the plant protection products,

• toxicity of the plant protection product relative to the active substance,

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

• where possible the mode of toxic action, and

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

While the emphasis must be on estimating the toxicity ranges involved, the information generated must also permit the plant protection product to be classified in accordance with Council Directive 78/631/EEC. The information generated through acute toxicity testing is of particular value in assessing hazards likely to arise in accident situations.

7.1.1. Oral U.K.

Circumstances in which required U.K.

An acute oral test should always be carried out unless the applicant can justify to the satisfaction of the competent authority that Article 3.2 of Council Directive 78/631/EEC can be invoked.

Test guidelines U.K.

The test must be carried out in accordance with Directive 92/69/EEC Method B1 or B1 bis.

7.1.2. Percutaneous U.K.

Circumstances in which required U.K.

An acute percutaneous test should always be carried out unless the applicant can justify to the satisfaction of the competent authority that Article 3.2 of Council Directive 78/631/EEC can be invoked.

Test guideline U.K.

The test must be carried out in accordance with Directive 92/69/EEC Method B3.

7.1.3. Inhalation U.K.

Aim of the test U.K.

The test will provide the inhalation toxicity to rats of the plant protection product or of the smoke it generates.

Circumstances in which required U.K.

The test must be carried out where the plant protection product:

• is a gas or liquified gas,

• is a smoke generating formulation or fumigant,

• is used with fogging equipment,

• is a vapour releasing preparation,

• is an aerosol,

• is a powder containing a significant proportion of particles of diameter <50 µm (> 1 % on a weight basis),

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

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

• is to be applied in a manner which generates a significant proportion of particles or droplets of diameter <50 µm (> 1 % on a weight basis).

Test guideline U.K.

The test must be carried out in accordance with Directive 92/69/EEC Method B2.

7.1.4. Skin irritation U.K.

Aim of the test U.K.

The test will provide the potential of skin irritancy of the plant protection product including the potential reversibility of the effects observed.

Circumstances in which required U.K.

The skin irritancy of the plant protection product must be determined except where it is likely, as indicated in the test guideline, that severe skin effects may be produced or that effects can be excluded.

Test guideline U.K.

The test must be carried out in accordance with Directive 92/69/EEC Method B4.

7.1.5. Eye irritation U.K.

Aim of the test U.K.

The test will provide the protential for eye irritation of the plant protection product, including the potential reversibility of the effects observed.

Circumstances in which required U.K.

Eye irritation tests must be conducted except where it is likely, as indicated in the test guideline, that severe effects on the eyes may be produced.

Test guideline U.K.

The eye irritation must be determined in accordance with Directive 92/69/EEC Method B5.

7.1.6. Skin sensitization U.K.

Aim of the test U.K.

The test will provide sufficient information to assess the potential of the plant protection product to provoke skin sensitization reactions.

Circumstances in which required U.K.

The tests must always be carried out except where the active substance(s) or co-formulants are known to have sensitizing properties.

Test guideline U.K.

The tests have to be carried out in accordance with Directive 92/69/EEC Method B6.

7.1.7. Supplementary studies for combinations of plant protection products U.K.

Aim of the test U.K.

In certain cases it may be necessary to carry out the studies as referred to under points 7.1.1 to 7.1.6 for a combination of plant protection products where the product label includes requirements for use of the plant protection product with other plant protection products and/or with adjuvants as a tank mix. Decisions as to the need for supplementary studies must be made on a case by case basis, taking into account the results of the acute toxicity studies of the individual plant protection products, the possibility for exposure to the combination of the products concerned and available information or practical experience with the products concerned or similar products.

7.2. Data on exposure U.K.

[F5 When measuring exposure to a plant protection product in the air within the breathing area of operators, bystanders or workers the requirements for measuring procedures described in Annex II A to Council Directive 80/1107/EEC of 27 November 1980 on the protection of workers from the risks related to exposure to chemical, physical and biological agents at work (2) have to be taken into account.]

Textual Amendments

F5 Inserted by Commission Directive 96/68/EC of 21 October 1996 amending Council Directive 91/414/EEC concerning the placing of plant protection products on the market (Text with EEA relevance).

7.2.1. Operator exposure U.K.

The risks for those using plant protection products depend on the physical, chemical and toxicological properties of the plant protection product as well as the type of the product (undiluted/diluted), and on the route, the degree and duration of exposure. Sufficient information and data must be generated and reported to permit an assessment of the extent of exposure to the active substance(s) and/or toxicologically relevant compounds in the plant protection product likely to occur under the proposed conditions of use. It must also provide a basis for the selection of the appropriate protective measures including personal protective equipment to be used by operators and to be specified on the label.

7.2.1.1. Estimation of operator exposure U.K.

Aim of the estimation U.K.

An estimation shall be made, using where available a suitable calculation model, in order to permit an evaluation of the operator exposure likely to arise under the proposed conditions of use.

Circumstances in which required U.K.

An estimation of operator exposure must always be completed.

Estimation conditions U.K.

An estimation shall be made for each type of application method and application equipment proposed for use of the plant protection product taking account of the requirements resulting from the implementation of the classification and labelling provisions of Directive 78/631/EEC for handling the undiluted or diluted product as well as the different types and sizes of containers to be used, mixing, loading operations, application of the plant protection product, the climatic conditions and cleaning and routine maintenance of application equipment.

At first an estimation shall be made with the assumption that the operator is not using any personal protective equipment.

Where appropriate, a second estimation shall be made with the assumption that the operator is using effective and readily obtainable protective equipment which is feasible to be used by the operator. Where protective measures are specified on the label, the estimation will take these into account.

7.2.1.2. Measurement of operator exposure U.K.

Aim of the test U.K.

The test shall provide sufficient data to permit an evaluation of the operator exposure likely to arise under the proposed conditions of use.

Circumstances in which required U.K.

Actual exposure data for the relevant exposure route(s) must be reported where the risk assessment indicates that a health-based limit value is exceeded. This will, for example, be the case when the results of the estimation of operator exposure provided for under point 7.2.1.1 indicate that:

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

• the Limit Values established for the active substance and/or toxicologically relevant compound(s) of the plant protection product in accordance with Council Directive 80/1107/EEC and Council Directive 90/394/EEC of 28 June 1990 on the protection of workers from the risks related to exposure to carcinogens at work (3) ,

may be exceeded.

Actual exposure data must also be reported when no appropriate calculation model or no appropriate data are available to do the estimation provided for under point 7.2.1.1.

In cases where dermal exposure is the most important exposure route, a dermal absorption test or the results of a sub-acute dermal study, if not already available, may be a useful alternative test to provide data in order to refine the estimate provided for under point 7.2.1.1.

Test conditions U.K.

The test must be done under realistic exposure conditions taking into account the proposed conditions of use.

7.2.2. Bystander exposure U.K.

Bystanders can be exposed during the application of plant protection products. Sufficient information and data must be reported to provide a basis for the selection of appropriate conditions of use, including the exclusion of bystanders from treatment areas and separation distances.

Aim of the estimation U.K.

An estimation shall be made, using where available a suitable calculation model in order to permit an evaluation of the bystander exposure likely to arise under the proposed conditions of use.

Circumstances in which required U.K.

An estimation of bystander exposure must always be completed.

Estimation conditions U.K.

An estimation of bystander exposure must be made for each type of application method. The estimation shall be made with the assumption that bystanders do not use any personal protective equipment.

Measurement of bystander exposure may be required when estimates indicate a cause for concern.

7.2.3. Worker exposure U.K.

Workers can be exposed following application of plant protection products, when entering treated fields or premises or handling treated plants or plant products on which residues remain. Sufficient information and data must be reported to provide a basis for the selection of appropriate protective measures, including waiting and re-entry periods.

7.2.3.1. Estimation of worker exposure U.K.

Aim of the estimation U.K.

An estimation shall be made using where available a suitable calculation model, in order to permit an evaluation of the worker exposure likely to arise under the proposed conditions of use.

Circumstances in which required U.K.

The estimation of worker exposure must always be completed.

Estimation conditions U.K.

An estimation of worker exposure must be made for each crop and task to be carried out.

At first the estimation shall be made using available data on the exposure to be expected with the assumption that the worker is not using any personal protective equipment.

Where appropriate, a second estimation shall be made with the assumption that the worker is using effective and readily obtainable protective equipment which is feasible to be used.

Where appropriate, a further estimation shall be made using data generated on the amount of dislodgeable residues under the proposed conditions of use.

7.2.3.2. Measurement of worker exposure U.K.

Aim of the test U.K.

The test shall provide sufficient data to permit an evaluation of the worker exposure likely to arise under the proposed conditions of use.

Circumstances in which required U.K.

Actual exposure data for the relevant exposure route(s) must be reported where the risk assessment indicates that a health-based limit value is exceeded. This will, for example, be the case where the results of the estimation of worker exposure provided for under point 7.2.3.1 indicate that:

• the AOEL(s) established in the context of inclusion of the active substance(s) in Annex I,

  and/or

• the Limit Values established for the active substance and/or toxicologically relevant compound(s) of the plant protection product in accordance with Council Directives 80/1107/EEC and 90/394/EEC,

may be exceeded.

Actual exposure data must also be reported when no appropriate calculation model or no appropriate data are available to do the estimation provided for under point 7.2.3.1.

Where dermal exposure is the most important exposure route, a dermal absorption test, if not already available, may be a useful alternative test to provide data in order to refine the estimate provided for under point 7.1.3.1.

Test conditions U.K.

The test must be done under realistic exposure conditions taking into account the proposed conditions of use.

7.3. Dermal absorption U.K.

Aim of the test U.K.

The test shall provide a measurement of the absorption of the active substance and toxicologically relevant compounds through the skin.

Circumstances in which required U.K.

The study must be conducted when dermal exposure is a significant exposure route and where the risk assessment indicates that a health-based limit value is exceeded. This will, for example, be the case where the results of the estimation or measurement of operator exposure provided for under points 7.2.1.1 or 7.2.1.2 indicate that:

• the AOEL(s) established in the context of inclusion of the active substance(s) in Annex I,

  and/or

• the limit values established for the active substance and/or toxicologically relevant compound(s) of the plant protection product in accordance with Council Directives 80/1107/EEC and 90/394/EEC may be exceeded.

Test conditions U.K.

In principle data of an in vivo rat skin absorption study must be reported. If, when the results of the estimation using these in vivo skin absorption data are incorporated in the risk assessment, there remains an indication of excessive exposure, it may be necessary to perform an in vivo comparative absorption study on rat and human skin.

Test guideline U.K.

Appropriate elements of OECD guideline 417 are to be used. For the design of the studies it may be necessary to take into account the results of the skin absorption studies with the active substance(s).

7.4. Available toxicological data relating to non-active substances U.K.

Where available, a copy of the notification and the safety data sheet submitted in the context of Directive 67/548/EEC and Commission Directive 91/155/EEC of 5 March 1991 defining and laying down the detailed arrangements for the system of specific information relating to dangerous preparations in implementation of Article 10 of Council Directive 88/379/EEC (4) must be submitted for each formulant. All other available information should be submitted.]

Textual Amendments

F4 Substituted by Commission Directive 94/79/EC of 21 December 1994 amending Council Directive 91/414/EEC concerning the placing of plant protection products on the market.

[F6 8. Residues in or on treated products, food and feed U.K.

Introduction U.K.

The provisions of Annex II, Section 6, Introduction apply.

8.1. Metabolism, distribution and expression of residue in plants or livestock U.K.

Aim of the tests U.K.

The objectives of these studies are:

• to provide an estimate of total terminal residues in the relevant portion of crops at harvest following treatment as proposed,

• to quantify the rate of degradation and excretion of the total residue in certain animal products (milk or eggs) and excreta,

• to identify the major components of the total terminal residue in crops and in edible animal products respectively,

• to indicate the distribution of residues between relevant crop parts and between relevant edible animal products respectively,

• to quantify the major components of the residue and to show the efficiency of extraction procedures for these components,

• to generate data from which a decision on the need for livestock feeding studies as provided for in point 8.3 can be made,

• to decide on the definition and expression of a residue.

Circumstances in which required U.K.

Supplementary metabolism studies only need to be performed where it is not possible to extrapolate from data obtained on the active substance in accordance to the requirements of Annex II, Section 6, points 6.1 and 6.2. This might be the case for crops or for livestock for which data were not submitted in the framework of inclusion of the active substance in Annex I or were not necessary for amending the conditions of its inclusion in Annex I or where it could be expected that a different metabolism will occur.

Test conditions U.K.

The same provisions as provided under the corresponding paragraphs of Annex II, Section 6, points 6.1 and 6.2 apply.

8.2. Residue trials U.K.

Aim of the tests U.K.

The objectives of these studies are:

• to quantify the highest likely residue levels in treated crops at harvest or outloading from store following the proposed good agricultural practice (GAP),

  and

• to determine, when appropriate, the rate of decline of pesticide deposits.

Circumstances in which required U.K.

Supplementary residue trials only need to be performed where it is not possible to extrapolate from data obtained on the active substance in accordance to the requirements of Annex II, Section 6, point 6.3. This might be the case for special formulations, for special application methods or for crops for which data were not submitted in the framework of inclusion of the active substance in Annex I or were not necessary for amending the conditions of its inclusion in Annex I.

Test conditions U.K.

The same provisions as provided under the corresponding paragraphs of Annex II, Section 6, point 6.3 apply.

8.3. Livestock feeding studies U.K.

Aim of the tests U.K.

The objective of these studies is to determine the residue in products of animal origin which will result from residues in feedingstuffs or fodder crops.

Circumstances in which required U.K.

Supplementary feeding studies for the purpose of assessing maximum residue levels for products of animal origin are only required where it is not possible to extrapolate from data obtained on the active substance in accordance to the requirements of Annex II, Section 6, point 6.4. This might be the case where additional fodder crops are to be authorized which leads to an increased intake of residues of livestock for which data were not submitted in the framework of inclusion of the active substance in Annex I or were not necessary for amending the conditions of its inclusion in Annex I.

Test conditions U.K.

The same provisions as provided under the corresponding paragraphs of Annex II, Section 6, point 6.4 apply.

8.4. Effects of industrial processing and/or household preparations U.K.

Aim of the tests U.K.

The main objectives of these studies are:

• to establish whether or not breakdown or reaction products arise from residues in the raw products during processing which may require a separate risk assessment,

• to determine the quantitative distribution of residues in the various intermediate and end products, and to estimate transfer factors,

• to enable a more realistic estimate to be made of dietary intake of residues.

Circumstances in which required U.K.

Supplementary studies only need to be performed where it is not possible to extrapolate from data obtained on the active substance in accordance to the requirements of Annex II, Section 6, point 6.5. This might be the case for crops for which data were not submitted in the framework of inclusion of the active substance in Annex I or were not necessary for amending the conditions of its inclusion in Annex I.

Test conditions U.K.

The same provisions as provided under the corresponding paragraphs of Annex II, Section 6, point 6.5 apply.

8.5. Residues in succeeding crops U.K.

Aim of the test U.K.

The objective of these studies is to permit an evaluation of possible residues in succeeding crops.

Circumstances in which required U.K.

Supplementary studies are only required where it is not possible to extrapolate from data obtained on the active substance in accordance to the requirements of Annex II, Section 6, point 6.6. This might be the case for special formulations, for special application methods or for crops for which data were not submitted in the framework of inclusion of the active substance in Annex I or were not necessary for amending the conditions of its inclusion in Annex I.

Test conditions U.K.

The same provisions as provided under the corresponding paragraphs of Annex II, Section 6, point 6.6 apply.

8.6. Proposed maximum residue levels (MRLs) and residue definition U.K.

A full justification for the proposed MRLs must be provided, including, where relevant, full details of the statistical analysis used.

If the metabolism studies submitted in accordance with the provisions of point 8.1 indicate that the residue definition should be changed taking into account the actual residue definition and the necessary judgement as outlined under the corresponding paragraph of Annex II, Section 6, point 6.7, a re-evaluation of the active substance may be necessary.

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

A full justification for the proposals must be provided.

8.8. Estimation of the potential and actual exposure through diet and other means U.K.

Consideration will be given to the calculation of a realistic prediction of dietary intake. This may be done in a step-wise fashion leading to an increasingly realistic prediction of intake. Where relevant, other sources of exposure such as residues arising from the use of medicines or veterinary drugs have to be taken into account.

8.9. Summary and evaluation of residue behaviour U.K.

A summary and evaluation of all data presented in this Section should be carried out according to the guidance given by the competent authorities of the Member States concerning the format of such summaries and evaluations. It should include a detailed and critical assessment of those data in the context of relevant evaluative and decision-making criteria and guidelines, with particular reference to the risks for man and animals that may or do arise, and the extent, quality and reliability of the data base.

Where metabolism data have been submitted the toxicological significance of any non-mammalian metabolites must be addressed.

A schematic diagram should be prepared of the metabolic pathway in plants and animals with a brief explanation of the distribution and chemical changes involved if metabolism data have been submitted.]

Textual Amendments

F6 Substituted by Commission Directive 96/68/EC of 21 October 1996 amending Council Directive 91/414/EEC concerning the placing of plant protection products on the market (Text with EEA relevance).

[F7 9. Fate and behaviour in the environment U.K.

Introduction U.K.

(i)

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

(ii)

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

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

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

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

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

(iii)

Where radio-labelled test material is used, the provisions of Annex II, Chapter 7, introduction, point (iv) apply.

(iv)

Where relevant tests should be designed and data analysed using appropriate statistical methods.

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

(v)

Predicted environmental concentrations in soil (PEC _S ), water (PEC _SW and PEC _GW ) and air (PEC _A ).

Justified estimates must be made of the expected concentrations of the active substance and relevant metabolites, degradation and reaction products, in soil, groundwater, surface water and air, following use as proposed or already occurring. In addition a realistic worst-case estimation must be made.

For the purposes of the estimation of such concentrations the following definitions apply:

• Predicted environmental concentration in soil (PEC _S )

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

• Predicted environmental concentration in surface water (PEC _SW )

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

• Predicted environmental concentration in groundwater (PEC _GW )

  The level of residues in groundwater.

• Predicted environmental concentration in air (PEC _A )

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

For the estimation of these concentrations all relevant information on the plant protection product and on the active substance must be taken into account. A useful approach for these estimations is provided in the EPPO schemes for environmental risk assessment (5) . Where relevant the parameters provided for in this section should be used.

When models are used for estimation of predicted environmental concentrations they must:

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

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

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

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

9.1 Fate and behaviour in soil U.K.

Where appropriate, the same provisions relating to the information to be provided on the soil used and on its selection apply as provided for under Annex II, point 7.1.

9.1.1. Rate of degradation in soil U.K.

9.1.1.1. Laboratory studies U.K.

Aim of the test

The soil degradation studies should provide best possible estimates of the time taken for degradation of 50 and 90 % (DT _50lab and DT _90lab ) of the active substance under laboratory conditions.

Circumstances in which required

The persistence and behaviour of plant protection products in soil must be investigated unless it is possible to extrapolate from data obtained on the active substance and relevant metabolites, degradation and reaction products in accordance to the requirements of Annex II, point 7.1.1.2. This extrapolation is, for example, not possible for slow release formulations.

Test conditions

The rate of aerobic and/or anaerobic degradation in soil must be reported.

The duration of the study is normally 120 days except if more than 90 % of the active substance is degraded before that period expires.

Test guideline

SETAC — Procedures for assessing the environmental fate and ecotoxicity of pesticides.

9.1.1.2. Field studies U.K.

• Soil dissipation studies

  Aim of the test

  The soil dissipation studies should provide best-possible estimates of the time taken for dissipation of 50 and 90 % (DT _50f and DT _90f ), of the active substance under field conditions. Where relevant, information on relevant metabolites, degradation and reaction products must be collected.

  Circumstances in which required

  The dissipation and behaviour of plant protection products in soil must be investigated unless it is possible to extrapolate from data obtained on the active substance and relevant metabolites, degradation and reaction products in accordance to the requirements of Annex II, point 7.1.1.2. This extrapolation is, for example, not possible for slow-release formulations.

  Test conditions and test guideline

  The same provisions as provided under the corresponding paragraph of Annex II, point 7.1.1.2.2. apply.

• Soil residue studies

  Aim of the test

  Soil residue studies should provide estimates of the soil residue levels at harvest or at time of sowing or planting succeeding crops.

  Circumstances in which required

  Soil residue studies must be reported unless it is possible to extrapolate from data obtained on the active substance and relevant metabolites, degradation and reaction products in accordance with the requirements of Annex II, point 7.1.1.2.2. This extrapolation is, for example, not possible for slow-release formulations.

  Test conditions

  The same provisions as provided under the corresponding paragraph of Annex II, point 7.1.1.2.2. apply.

  Test guideline

  SETAC — Procedures for assessing the environmental fate and ecotoxicity of pesticides.

• Soil accumulation studies

  Aim of the tests

  The tests should provide sufficient data to evaluate the possibility of accumulation of residues of the active substance and of relevant metabolites, degradation and reaction products.

  Circumstances in which required

  Soil accumulation studies must be reported unless it is possible to extrapolate from data obtained on the active substance and relevant metabolites, degradation and reaction products in accordance with the requirements of Annex II, point 7.1.1.2.2. This extrapolation is, for example, not possible for slow-release formulations.

  Test conditions

  The same provisions as provided under the corresponding paragraph of Annex II, point 7.1.1.2.2. apply.

  Test guideline

  SETAC — Procedures for assessing the environmental fate and ecotoxicity of pesticides.

9.1.2. Mobility in the soil U.K.

Aim of the test

The test should provide sufficient data to evaluate the mobility and leaching potential of the active substance and relevant metabolites, degradation and reaction products.

9.1.2.1. Laboratory studies U.K.

Circumstances in which required

The mobility of plant protection products in soil must be investigated unless it is possible to extrapolate from data obtained in accordance with the requirements of Annex II, points 7.1.2 and 7.1.3.1. This extrapolation is, for example, not possible for slow-release formulations.

Test guideline

SETAC — Procedures for assessing the environmental fate and ecotoxicity of pesticides.

9.1.2.2. Lysimeter studies or field leaching studies U.K.

Aim of the tests

The test should provide data on:

• the mobility of the plant protection product in soil,

• the potential for leaching to ground water,

• the potential distribution in soils.

Circumstances in which required

Expert judgement will be necessary to decide whether field leaching studies or lysimeter studies should be carried out, taking into account the results of degradation and mobility studies and the calculated PEC _s . The type of study to be conducted should be discussed with the competent authorities.

These studies must be performed unless it is possible to extrapolate from data obtained on the active substance and relevant metabolites, degradation and reaction products in accordance with the requirements of Annex II, point 7.1.3. This extrapolation is, for example, not possible for slow release formulations.

Test conditions

The same provisions as provided for under the corresponding paragraph of Annex II, point 7.1.3.3 apply.

9.1.3. Estimation of expected concentrations in soil U.K.

PEC _s estimations must relate both to a single application at the highest rate of application for which authorization is sought, and to the maximum number and highest rates of application for which authorization is sought, for each relevant soil tested, and are expressed in terms of mg of active substance and of relevant metabolites, degradation and reaction products per kg of soil.

The factors to be considered in making PEC _s estimations relate to direct and indirect application to soil, drift, run off, and leaching and include processes such as volatilization, adsorption, hydrolysis, photolysis, aerobic and anaerobic degradation. For the purposes of PEC _s calculations, the bulk density of soils can be assumed to be 1,5 g/cm ³ dry weight, while the depth of the soil layer is assumed to be 5 cm for applications at the soil surface and 20 cm when incorporation in the soil is involved. Where ground cover is present at time of application, it is to be assumed that 50 % (minimum) of the applied dose reaches the soil surface unless actual experimental data give more specific information.

Initial, short-term and long-term PEC _s calculations (time weighted averages) must be provided:

• initial: immediately after application,

• short-term: 24 hours, 2 days and 4 days after last application,

• long-term: 7, 28, 50 and 100 days after last application, where relevant.

9.2. Fate and behaviour in water U.K.

9.2.1. Estimation of concentrations in groundwater U.K.

The groundwater contamination routes have to be defined taking into account relevant agricultural, plant health, and environmental (including climatic) conditions.

Suitable estimations (calculations) of predicted environmental concentration in groundwater PEC _GW , of active substance and relevant metabolites, degradation and reaction products, must be submitted.

PEC estimations must relate to the maximum number and highest rates of application, for which authorization is sought.

Expert judgment is required to decide if additional field tests could provide useful information. Before performing these studies the applicant shall seek the agreement of the competent authorities on the type of study to be performed.

9.2.2. Impact on water treatment procedures U.K.

In cases where this information is necessary in the framework of a conditional authorization as meant in Annex VI, Part C, point 2.5.1.2 (b), the information provided should permit to establish or to estimate effectiveness of water treatment procedures (drinking water and sewage treatment), and impact on such procedures. Before performing any studies the applicant shall seek the agreement of the competent authorities on the type of information to be provided.

9.2.3. Estimation of concentrations in surface water U.K.

The surface water contamination routes have to be defined taking into account relevant agricultural, plant health, and environmental (including climatic) conditions.

Suitable estimations (calculations) of predicted environmental concentration in surface water PEC _sw , of active substance and relevant metabolites, degradation and reaction products, must be submitted.

PEC estimations must relate to the maximum number and highest rates of application, for which authorization is sought, and be relevant to lakes, ponds, rivers, canals, streams, irrigation/drainage canals and drains.

The factors to be considered in making PEC _sw estimations relate to direct application to water, drift, run-off, discharge via drains and atmospheric deposition, and include processes such as volatilization, adsorption, advection, hydrolysis, photolysis, biodegradation, sedimentation and re-suspension.

Initial, short-term and long-term PEC _sw calculations relevant to static and slow moving water bodies (time weighted averages) must be provided:

• initial: immediately after application,

• short-term: 24 hours, 2 days and 4 days after last application,

• long-term: 7, 14, 21, 28, and 42 days after last application, where relevant.

Expert judgment is required to decide if additional field tests could provide useful information. Before performing these studies the applicant shall seek the agreement of the competent authorities on the type of study to be performed.

9.3. Fate and behaviour in air U.K.

Guidance under development.]

Textual Amendments

F7 Substituted by Commission Directive 95/36/EC of 14 July 1995 amending Council Directive 91/414/EEC concerning the placing of plant protection products on the market (Text with EEA relevance).

[F8 10. Ecotoxicological studies U.K.

Introduction U.K.

(i)

The information provided, taken together with that for the active substance(s), must be sufficient to permit an assessment of the impact on non-target species (flora and fauna), of the plant protection product, when used as proposed. Impact can result from single, prolonged or repeated exposure, and can be reversible, or irreversible.

(ii)

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

• specify the hazard symbols, the indications of danger, and relevant risk and safety phrases for the protection of the environment, to be mentioned on packaging (containers),

• permit an evaluation of the short- and long-term risks for non-target species — populations, communities, and processes as appropriate,

• permit an evaluation of whether special precautions are necessary for the protection of non-target species.

(iii)

There is a need to report all potentially adverse effects found during routine ecotoxicological investigations and to undertake and report such additional studies which may be necessary to investigate the mechanisms involved and assess the significance of these effects.

(iv)

In general, much of the data relating to impact on non-target species, required for authorization of plant protection products, will have been submitted and evaluated for the inclusion of the active substance(s) in Annex I. The information on fate and behaviour in the environment, generated and submitted in accordance with points 9.1 to 9.3, and on residue levels in plants generated and submitted in accordance with point 8 is central to the assessment of impact on non-target species, in that it provides information on the nature and extent of potential or actual exposure. The final PEC estimations are to be adapted according to the different groups of organisms taking in particular into consideration the biology of the most sensitive species.

The toxicological studies and information submitted in accordance with point 7.1 provide essential information as to toxicity to vertebrate species.

(v)

Where relevant, tests should be designed and data analysed using appropriate statistical methods. Full details of the statistical analysis should be reported (e.g. all point estimates should be given with confidence intervals, exact p-values should be given rather than stating significant/non significant).

(vi)

Whenever a study implies the use of different doses, the relationship between dose and adverse effect must be reported.

(vii)

Where exposure data are necessary to decide whether a study has to be performed, the data obtained in accordance with the provisions of Annex III, point 9 should be used.

For the estimation of exposure of organisms all relevant information on the plant protection product and on the active substance must be taken into account. A useful approach for these estimations is provided in the EPPO/Council of Europe schemes for environmental risk assessment (6) . Where relevant the parameters provided for in this section should be used. Where it appears from available data that the plant protection product is more toxic as the active substance, the toxicity data of the plant protection product have to be used for the calculation of relevant toxicity/exposure ratios.

(viii)

In the context of the influence that impurities can have on ecotoxicological behaviour, it is essential that for each study submitted, a detailed description (specification) of the material used as provided for under point 1.4, be provided.

(ix)

In order to facilitate the assessment of the significance of test results obtained the same strain of each relevant species should where possible be used in the various toxicity tests specified.

10.1. Effects on birds U.K.

Possible effects on birds must be investigated except where the possibility that birds will be exposed, directly or indirectly, can be ruled out such as for use in enclosed spaces or wound healing treatments.

The acute toxicity/exposure ratio (TER _a ), the short term dietary toxicity/exposure ratio (TER _st ) and the long term dietary toxicity/exposure ratio (TER _lt ) must be reported, where:

TER _a

=

LD ₅₀ (mg a.s./kg body weight) / ETE (mg a.s./kg body weight)

TER _st

=

LC ₅₀ (mg a.s./kg food) / ETE (mg a.s./kg food)

TER _lt

=

NOEC (mg a.s./kg food) / ETE (mg a.s./kg food)

where ETE = estimated theoretical exposure.

In the case of pellets, granules or treated seeds the amount of a.s. in each pellet, granule or seed must be reported as well as the proportion of the LD ₅₀ for the a.s. in 100 particles and per gram of particles. The size and shape of pellets or granules must be reported.

In the case of baits the concentration of a.s. in the bait (mg/kg) must be reported.

10.1.1. Acute oral toxicity U.K.

Aim of the test U.K.

The test should provide, where possible, LD ₅₀ values, the lethal threshold dose, time courses of response and recovery, the NOEL, and must include relevant gross pathological findings.

Circumstances in which required U.K.

The acute oral toxicity of preparations must be reported, where TER _a or TER _st for the active substance(s) in birds are between 10 and 100 or where results from mammal testing give evidence of a significantly higher toxicity of the prepration compared to the active substance unless it can be justified that it is not likely that birds are exposed to the plant protection product itself.

Test conditions U.K.

The study must be conducted on the most sensitive species identified in the studies provided for in Annex II, point 8.1.1 or 8.1.2.

10.1.2. Supervised cage or field trials U.K.

Aim of the test U.K.

The test will provide sufficient data to evaluate the nature and the extent of the risk in practical conditions of use.

Circumstances in which required U.K.

Where the TER _a and TER _st are > 100 and when there is no evidence of risk from any further study on the active substance (e.g. reproduction study) no further testing is required. In the other cases, expert judgement is necessary to decide whether there is a need to carry out further studies. This expert judgement will take into account, where relevant, foraging behaviour, repellency, alternative food, actual residue content in the food, persistence of the compound in the vegetation, degradation of the formulated product or treated produce, the amount of predation of the food, acceptance of bait, granules or treated seed and the possibility for bioconcentration.

Where TER _a and TER _st ≤ 10 or TER _lt ≤ 5, cage or field trials must be conducted and reported unless a final assessment is possible on the basis of studies according to point 10.1.3.

Test conditions U.K.

Before performing these studies the applicant should seek the agreement of the competent authorities on the type and conditions of the study to be performed.

10.1.3. Acceptance of bait, granules or treated seeds by birds U.K.

Aim of the test U.K.

The test will provide sufficient data to evaluate the possibility of consumption of the protection product or plant products treated with it.

Circumstances in which required U.K.

In the case of seed dressings, pellets, baits and preparations which are granules and where TER _a ≤ 10, acceptability (palatability) tests must be conducted.

10.1.4. Effects of secondary poisoning U.K.

Expert judgment is required to decide whether the effects of secondary poisoning should be investigated.

10.2. Effects on aquatic organisms U.K.

Possible effects on aquatic species must be investigated except where the possibility that aquatic species will be exposed can be ruled out.

TER _a and TER _lt must be reported, where:

TER _a

=

acute LC ₅₀ (mg a.s./l)/realistic worst case PEC _sw (initial or short-term, in mg a.s./l)

TER _lt

=

chronic NOEC (mg a.s./l)/long term PEC _sw (mg a.s./l)

10.2.1. Acute toxicity to fish, aquatic invertebrates or effects on algal growth U.K.

Circumstances in which required U.K.

In principle tests should be carried out on one species from each of the three groups of aquatic organisms as referred to in Annex II, point 8.2 (fish, aquatic invertebrates and algae) in case the plant protection product itself can contaminate water. However where the available information permits to conclude that one of these groups is clearly more sensitive, tests on only the most sensitive species of the relevant group have to be performed.

The test must be performed where:

• the acute toxicity of the plant protection product can not be predicted on the basis of the data for the active substance which is especially the case if the formulation contains two or more active substances or formulants such as solvents, emulgators, surfactants, dispersants, fertilizers which are able to increase the toxicity in comparison with the active substance, or

• the intended use includes direct application on water

unless suitable studies referred to under point 10.2.4 are available.

Test conditions and test guidelines U.K.

The relevant provisions as under the corresponding paragraphs of Annex II, points 8.2.1, 8.2.4 and 8.2.6 apply.

10.2.2. Microcosm or mesocom study U.K.

Aim of the test U.K.

The tests must provide sufficient data to evaluate the essential impact on aquatic organisms under field conditions.

Circumstances in which required U.K.

Where TER _a ≤ 100 or where TER _lt ≤ 10, expert judgment must be used to decide whether a microcosm or mesocom study is appropriate. This judgment will take into account the results of any additional data over and above those required by the provisions of Annex II, point 8.2 and of point 10.2.1.

Test conditions U.K.

Before performing these studies the applicant shall seek the agreement of the competent authorities on the specific aims of the study to be performed and consequently on the type and conditions of the study to be performed.

The study should include at least the highest likely exposure rate, whether from direct applicaiton, drift, drainage or run-off. The duration of the study must be sufficient to permit evaluation of all effects.

Test guideline U.K.

Appropriate guidelines are included in:

Setac — Guidance document on testing procedures for pesticides in freshwater mesocosms/Workshop Huntingdon, 3 and 4 July 1991

or

Freshwater field tests for hazard assessment of chemicals — European Workshop on Freshwater Field Tests (EWOFFT).

10.2.3. Residue data in fish U.K.

Aim of the test U.K.

The test will provide sufficient data to evaluate the potential for occurrence of residues in fish.

Circumstances in which required U.K.

In general data are available from bioconcentration studies in fish.

Where bioconcentration has been observed in the study performed in accordance with Annex II, point 8.2.3 expert judgement is required to decide whether a long-term microcosm or mesocosm study has to be carried out in order to establish the maximum residues likely to be encountered.

Test guideline U.K.

Setac — Guidance document on testing procedures for pesticides in freshwater mesocosms/Workshop Huntingdon, 3 and 4 July 1991 .

10.2.4. Additional studies U.K.

The studies referred to in Annex II, points 8.2.2 and 8.2.5 may be required for particular plant protection products where it is not possible to extrapolate from data obtained in the corresponding studies on the active substance.

10.3. Effects on terrestrial vertebrates other than birds U.K.

Possible effects on wild vertebrate species must be investigated except where it can be justified that it is not likely that terrestrial vertebrates other than birds are exposed, directly or indirectly. TER _a , TER _st and TER _lt must be reported, where:

TER _a

=

LD ₅₀ (mg a.s./kg body weight) / ETE (mg a.s./kg body weight)

TER _st

=

subchronic NOEL (mg a.s./kg food) / ETE (mg a.s./kg food)

TER _lt

=

chronic NOEL (mg a.s./kg food) / ETE (mg a.s./kg food)

where ETE = estimated theoretical exposure.

In principle the evaluation sequence for the assessment of risks to such species is similar to that for birds. In practice it is not often necessary to perform further testing as the studies conducted in accordance with the requirements of Annex II, point 5 and Annex III, point 7 would provide the required information.

Aim of the test U.K.

The test will provide sufficient information to evaluate the nature and the extent of risks for terrestrial vertebrates other than birds in practical conditions of use.

Circumstances in which required U.K.

Where TER _a and TER _st > 100 and where there is no evidence of risk from any further study no further testing is required. In the other cases, expert judgment is necessary to decide whether there is a need to carry out further studies. This expert judgment will take into account, where relevant, foraging behaviour, repellency, alternative food, actual residue content in the food, persistence of the compound in the vegetation, degradation of the formulated product or treated produce, the amount of predation of the food, acceptance of bait, granules or treated seed and the possibility for bioconcentration.

Where TER _a and TER _st ≤ 10 or TER _lt ≤ 5 cage or field trials or other appropriate studies must be reported.

Test conditions U.K.

Before performing these studies the applicant shall seek the agreement of the competent authorities on the type and conditions of the study to be performed and whether the effects of secondary poisoning should be investigated.

10.4. Effects on bees U.K.

The possible effects on bees must be investigated except where the product is for exclusive use in situations where bees are not likely to be exposed such as:

• food storage in enclosed spaces,

• non-systemic seed dressings,

• non-systemic preparations for application to soil,

• non-systemic dipping treatments for transplanted crops and bulbs,

• wound sealing and healing treatments,

• rodenticidal baits,

• use in glasshouses without pollinators.

The hazard quotients for oral and contact exposure (Q _HO and Q _HC ), must be reported:

Q _HO

=

dose/oral LD ₅₀ (µg a.s. per bee)

Q _HC

=

dose/contact LD ₅₀ (µg a.s. per bee)

where

dose

=

the maximum application rate, for which authorization is sought, in g of active substance per hectare.

10.4.1. Acute oral and contact toxicity U.K.

Aim of the test U.K.

The test should provide the LD ₅₀ values (by oral and contact exposure).

Circumstances in which required U.K.

Testing is required if:

• the product contains more than one active substance;

• the toxicity of a new formulation cannot be reliably predicted to be either the same or lower than a formulation tested according to the provisions of Annex II, point 8.3.1.1 or of this point.

Test guideline U.K.

The test must be carried out according to EPPO Guideline 170.

10.4.2. Residue test U.K.

Aim of the test U.K.

The test should provide sufficient information to evaluate possible risks to foraging bees from residual traces of plant protection products remaining on crops.

Circumstances in which required U.K.

Where Q _HC ≥ 50, expert judgment is required to decide whether the effect of residues must be determined unless there is evidence that there are no significant residual traces remaining on crops which could affect foraging bees or unless sufficient information is available from cage, tunnel or field tests.

Test conditions U.K.

The median lethal time (LT ₅₀ ) (in hours) following 24-hour exposure to residues on leaves aged during eight hours must be determined, and reported. Where LT ₅₀ is more than eight hours, no further testing is required.

10.4.3. Cage tests U.K.

Aim of the test U.K.

The test should provide sufficient information to evaluate possible risks from the plant protection product for bee survival and behaviour.

Circumstances in which required U.K.

Where Q _HO and Q _HC are < 50, further testing is not required except if significant effects are observed in the bee brood feeding test or if there are indications for indirect effects such as delayed action or modification of bee behaviour, in those cases cage and/or field tests shall be carried out.

Where Q _HO and Q _HC are > 50, cage and/or field testing is required.

Where field testing is conducted and reported in accordance with point 10.4.4, it is not necessary to conduct cage tests. However, cage tests where conducted, must be reported.

Test conditions U.K.

The test should be carried out using healthy bees. If bees have been treated, e.g. with a varroacide, it is necessary to wait for four weeks before using the colony.

Test guideline U.K.

The tests must be conducted in accordance with EPPO Guideline 170.

10.4.4. Field tests U.K.

Aim of the test U.K.

The test should provide sufficient information to evaluate possible risks from the plant protection product on bee behaviour, colony survival and development.

Circumstances in which required U.K.

Field tests must be conducted where on the basis of expert judgement, taking into account the proposed manner of use and the fate and behaviour of the active substance, significant effects are observed in cage testing.

Test conditions U.K.

The test should be carried out using healthy honeybee colonies of similar natural strength. If bees have been treated, e.g. with a varroacide, it is necessary to wait for four weeks before using the colony. The tests shall be conducted under conditions reasonably representative of the proposed use.

Special effects (larval toxicity, long residual effect, disorienting effects on bees) identified by the field tests may require further investigation using specific methods.

Test guideline U.K.

The tests must be conducted in accordance with EPPO Guideline 170.

10.4.5. Tunnel tests U.K.

Aim of the test U.K.

The test should provide sufficient information to evaluate the impact on bees resulting from feeding on contaminated honey dew or flowers.

Circumstances in which required U.K.

Where it is not possible to investigate certain effects in cage or field trials, a tunnel test should be carried out, e.g. in the case of plant protection products intended for control of aphids and other sucking insects.

Test conditions U.K.

The test should be carried out using healthy bees. If bees have been treated, e.g. with a varroacide, it is necessary to wait for four weeks before using the colony.

Test guideline U.K.

The test must be carried out in accordance with EPPO Guideline 170.

10.5. Effects on arthropods other than bees U.K.

The effects of plant protection products on non-target terrestrial arthropods (e.g. predators or parasitoids of harmful organisms) must be investigated. The information obtained for these species can also be used to indicate the potential for toxicity to non-target species inhabiting the same environment.

10.5.1. Laboratory, extended laboratory and semi-field tests U.K.

Aim of the test U.K.

The test should provide sufficient information to evaluate the toxicity of the plant protection product for selected arthropod species that are relevant to the intended use of the product.

Circumstances in which required U.K.

Testing is not required where severe toxicity (> 99 % effect on the organisms compared to control) can be predicted from relevant available data or where the plant protection product is for exclusive use in situations where non-target arthropods are not exposed such as:

• food storage in enclosed spaces,

• wound sealing and healing treatments,

• rodenticidal baits.

Testing is required when significant effects on the organisms in comparison with the control are reported in the laboratory tests at the maximum recommended dose, conducted in accordance with the requirements of Annex II, point 8.3.2. Effects on a particular test species are considered to be significant when they exceed the threshold values as defined in the EPPO schemes for the environmental risk assessment unless species-specific threshold values are defined in the respective test guidelines.

Testing is also required if:

• the product contains more than one active substance,

• the toxicity of a new formulation cannot be reliably predicted to be either the same or lower than a formulation tested according to the provisions of Annex II, point 8.3.2 or of this point,

• on the basis of the proposed manner of use or on the basis of the fate and behaviour continued or repeated exposure can be anticipated,

• there is a significant change in the proposed use, e.g. from arable crops to orchards, and species relevant to the new use have not previously been tested,

• there is an increase in the recommended application rate, above that previously tested under Annex II.

Test conditions U.K.

Where significant effects were observed in the studies performed in accordance with the requirements of Annex II, point 8.3.2, or in the case of change of use such as arable crops to orchards, the toxicity of two additional relevant species must be investigated and reported. These must be different to the relevant species already tested under Annex II, point 8.3.2.

For a new mixture or formulation, the toxicity should initially be assessed using the two most sensitive species as identified in studies already performed for which the threshold values were exceeded but effects still remain below 99 %. This will enable a comparison to be made; if it significantly more toxic two species relevant to its proposed use must be tested.

Testing must be conducted at a rate equivalent to the maximum rate of application for which authorization is sought. A sequential testing approach should be adopted, i.e. laboratory, and if necessary extended laboratory and/or semi-field.

Where there will be more than one application per season, the product should be applied at twice the recommended application rate unless this information is already available from studies performed in accordance with Annex II, point 8.3.2.

Where on the basis of the proposed manner of use or on the basis of the fate and behaviour continued or repeated exposure can be anticipated (such as the product is to be applied more than three times per season with a re-application of 14 days or less), expert judgment is required to examine whether further testing is required, beyond initial laboratory testing, which will reflect the proposed use pattern. These tests may be performed in the laboratory or under semi-field conditions. When the test is done in the laboratory a realistic substrate such as plant material or a natural soil should be used. However it may be more appropriate to carry out field tests.

Test guideline U.K.

Where relevant testing should be done according to appropriate guidelines which satisfy as least the requirements for testing as included in Setac - Guidance document on regulatory testing procedures for pesticides with non-target arthropods.

10.5.2. Field tests U.K.

Aim of the test U.K.

The tests should provide sufficient information to evaluate the risk of the plant protection product for arthropods under field conditions.

Circumstances in which required U.K.

Where significant effects are seen following laboratory and semi-field exposure, or where on the basis of the proposed manner of use or on the basis of the fate and behaviour continued or repeated exposure can be anticipated expert judgment is required to examine whether more extensive testing is necessary to permit an accurate risk assessment.

Test conditions U.K.

The tests must be conducted under representative agricultural conditions and in accordance with the proposed recommendations for use, resulting in a realistic worst case study.

A toxic standard should be included in all tests.

Test guideline U.K.

Where relevant testing should be done according to appropriate guidelines which satisfy at least the requirements for testing as included in Setac — Guidance document on regulatory testing procedures for pesticides with non-target arthropods.

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

10.6.1. Effects on earthworms U.K.

The possible impact on earthworms must be reported except where it can be justified that it is not likely that earthworms are exposed, directly or indirectly.

TER _a and TER _lt must be reported where:

TER _a

=

LC ₅₀ (mg a.s./kg)/realistic worst case PEC _s (initial or short-term, in mg a.s./kg)

TER _lt

=

NOEC (mg a.s./kg)/long term PECs (mg a.s./kg).

10.6.1.1. Acute toxicity tests U.K.

Aim of the test U.K.

The test should provide the LC ₅₀ , where possible the highest concentration causing no mortality and the lowest concentration causing 100 % mortality and must include observed morphological and behavioural effects.

Circumstances in which required U.K.

These studies are only required where

• the product contains more than one active substance,

• the toxicity of a new formulation cannot be reliably predicted from the formulation tested according to the provisions of Annex II, point 8.4 or of this point.

Test guideline U.K.

The tests must be conducted in accordance to OECD Method 207.

10.6.1.2. Tests for sublethal effects U.K.

Aim of the test U.K.

The test should provide the NOEC and the effects on growth, reproduction and behaviour.

Circumstances in which required U.K.

These studies are only required where

• the product contains more than one active substance,

• the toxicity of a new formulation cannot be reliably predicted from the formulation tested according to the provisions of Annex II, point 8.4 or of this point,

• there is an increase in the recommended application rate, above that previously tested.

Test conditions U.K.

The same provisions as under the corresponding paragraphs of Annex II, point 8.4.2 apply.

10.6.1.3. Field studies U.K.

Aim of the test U.K.

The test should provide sufficient data to evaluate the effects on earthworms in field conditions.

Circumstances in which required U.K.

Where TER _lt < 5 a field study to determine effects under practical field conditions must be conducted and reported.

Expert judgment is required to decide whether residue contents of earthworms should be investigated.

Test conditions U.K.

Fields selected shall have a reasonable earthworm population.

The test must be carried out at the maximum proposed application rate. A toxic reference product must be included in the test.

10.6.2. Effects on other soil non-target macro-organisms U.K.

Aim of the test U.K.

The test should provide sufficient data to evaluate the impact of the plant protection product on macro-organisms that contribute to the breakdown of dead plant and animal organic matter.

Circumstances in which required U.K.

Testing is not required where in accordance with Annex III, point 9.1, it is evident that DT ₉₀ values are less than 100 days, or the nature and manner of use of the plant protection product are such that exposure does not occur or when data from studies on the active substance performed in accordance with the provisions of Annex II, points 8.3.2, 8.4 and 8.5 indicate that there is no risk for soil macrofauna, earthworms or soil microflora.

Impact on organic matter breakdown must be investigated and reported, where the DT _90f values determined in field dissipation studies (point 9.1) are > 365 days.

10.7. Effects on soil non-target micro-organisms U.K.

10.7.1. Laboratory testing U.K.

Aim of the test U.K.

The test should provide sufficient data to evaluate the impact of the plant protection product on soil microbial activity in terms of nitrogen transformation and carbon mineralization.

Circumstances in which required U.K.

Where the DT _90f values determined in field dissipation studies (point 9.1) are > 100 days, impact on soil non-target micro-organisms must be investigated through laboratory testing. Testing is, however, not required if in the studies performed in accordance with the provisions of Annex II, point 8.5 deviations from control values in terms of metabolic activity of the microbial biomass after 100 days is < 25 %, and such data are relevant to the uses, nature, and properties of the particular preparation to be authorized.

Test guideline U.K.

Setac — Procedures for assessing the environmental fate and ecotoxicity of pesticides.

10.7.2. Additional testing U.K.

Aim of the test U.K.

The test should provide sufficient data to evaluate the impact of the plant protection product under field conditions on microbial activitiy.

Circumstances in which required U.K.

Where at the end of 100 days, measured activity deviates by more than 25 % from the control, in the laboratory testing further testing in the laboratory, under glass and/or in the field may be necessary.

10.8. Available data from biological primary screening in summary form U.K.

A summary of available data from preliminary tests used to assess the biological activity and dose range finding whether positive or negative, which provides information with respect to possible impact on non/target species, both flora and fauna, must be provided, together with a critical assessment as to its relevance to potential impact on non-target species.

Textual Amendments

F8 Substituted by Commission Directive 96/12/EC of 8 March 1996 amending Council Directive 91/414/EEC concerning the placing of plant protection products on the market (Text with EEA relevance).

11. Summary and evaluation of points 9 and 10 U.K.

A summary and evaluation of all data presented in points 9 and 10 should be carried out according to the guidance given by the competent authorities of the Member States concerning the format of such summaries and evaluations. It should include a detailed and critical assessment of those data in the context of relevant evaluative and decision making criteria and guidelines, with particular reference to the risks for the environment and non-target species that may or do arise, and the extent, quality and reliability of the data base. In particular the following issues should be addressed:

• predicting distribution and fate in the environment, and the time courses involved,

• identifying non-target species and populations at risk, and predicting the extent of potential exposure,

• evaluation as to the short- and long-term risks for non-target species — populations, communities, and processes — as appropriate,

• evaluation as to the risk of fish kills, and fatalities in large vertebrates, or terrestrial predators, regardless of effects at population or community level, and

• identification of precautions necessary to avoid or minimize contamination of the environment, and for the protection of non-target species.]

12. Further information U.K.

12.1. Information on authorizations in other countries U.K.

12.2. Information on established maximum residue limits (MRL) in other countries U.K.

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

• Hazard symbol(s)

• Indications 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 U.K.

12.5. Specimens of proposed packaging U.K.

(1)

[F3 International rules for seed testing, 1985. Proceedings of the International Seed Testing Association, Seed Science and Technology , Volume 13, No 2, 1985.]

(2)

[F4 [F5 OJ No L 327, 3. 12. 1980, p. 8 .]

(3)

OJ No L 196, 26. 7. 1990, p. 1 .

(4)

OJ No L 76, 22. 3. 1991, p. 35 .]

(5)

[F7 OEPP/EPPO (1993). Decision-making schemes for the environmental risk assessment of plant protection products. Bulletin OEPP/EPPO Bulletin 23, 1-154 and Bulletin 24, 1-87.]

(6)

[F8 OEPP/EPPO (1993). Decision-making schemes for the environmental risk assessment of plant protection products. Bulletin OEPP/EPPO Bulletin 23, 1-154 and Bulletin 24, 1-87.]

Textual Amendments

F3 Substituted by Commission Directive 93/71/EEC of 27 July 1993 amending Council Directive 91/414/EEC concerning the placing of plant protection products on the market.

F4 Substituted by Commission Directive 94/79/EC of 21 December 1994 amending Council Directive 91/414/EEC concerning the placing of plant protection products on the market.

F5 Inserted by Commission Directive 96/68/EC of 21 October 1996 amending Council Directive 91/414/EEC concerning the placing of plant protection products on the market (Text with EEA relevance).

F7 Substituted by Commission Directive 95/36/EC of 14 July 1995 amending Council Directive 91/414/EEC concerning the placing of plant protection products on the market (Text with EEA relevance).

F8 Substituted by Commission Directive 96/12/EC of 8 March 1996 amending Council Directive 91/414/EEC concerning the placing of plant protection products on the market (Text with EEA relevance).