Council Directive of 15 July 1991 concerning the placing of plant protection products on the market (91/414/EEC) (repealed)

[F1 PART B U.K.

Introduction U.K.

(i)

This Part provides data requirements for the authorisation of a plant protection product based on preparations of micro-organisms including viruses.

The term ‘ micro-organism ’ as defined in the introduction of Annex II, Part B, also applies to Annex III, Part B.

(ii)

Where relevant, data should be 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).

(iii)

Pending the acceptance of specific guidelines at international level, the information required shall be generated using test guidelines accepted by the competent authority (e.g. USEPA guideline (1) ); where appropriate test guidelines as described in Annex II, Part A, should be adapted in such a way that they are appropriate for micro-organisms. Testing should include viable and, if appropriate, non-viable micro-organisms, and a blank control.

(iv)

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

(v)

Where testing is done, a detailed description (specification) of the material used and its impurities, according to the provisions of section 1, point 1.4, must be provided.

(vi)

In cases where a new preparation is to be dealt with, extrapolation from Annex II, Part B, could be acceptable, provided that all the possible effects of the formulants and other components, especially on pathogenicity and infectiveness, are also evaluated.

1. IDENTITY OF THE PLANT PROTECTION PRODUCT U.K.

The information provided, taken together with that provided for the micro-organism(s), must be sufficient to precisely identify and define preparations. The information and data referred to, unless otherwise specified, are required for all plant protection products. This is with the view to identify if any factor could alter the properties of the micro-organism as a plant protection product in comparison to the micro-organism as such, which is treated in Annex II, Part B, to Directive 91/414/EEC.

1.1. Applicant U.K.

The name and address of the applicant (permanent community address) must be provided as must the name, position, telephone and fax 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 authorisation is being sought, the name and address of the local office, agent or representative should be provided, as should the name, position, telephone and fax number of the appropriate person to contact.

1.2. Manufacturer of the preparation and the micro-organism(s) U.K.

The name and address of the manufacturer of the preparation and of each micro-organism in the preparation must be provided as must the name and address of each manufacturing plant in which the preparation and micro-organism are manufactured.

A contact point (preferable a central contact point, to include name, telephone and fax numbers) must be provided for each manufacturer.

If the micro-organism originates from a producer from which data according to Annex II, Part B, had not been submitted previously, detailed information on the name and species description, as required in Annex II, Part B, section 1.3, and on impurities, as required in Annex II, Part B, section 1.4, 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 referred to in the dossier as well as the current names and numbers must be provided. Full detail of any differences must be provided. (The proposed trade name must not give rise to confusion with the trade name of already authorised plant protection products.)

1.4. Detailed quantitative and qualitative information on the composition of the preparation U.K.

(i)

Each micro-organism that is subject to the application should be identified and named at the species level. The micro-organism should be deposited at a recognised culture collection and given an accession number. The scientific name must be stated, as well as the group assignment (bacteria, virus, etc.) and any other denomination relevant to the micro-organism (e.g. strain, serotype). In addition, the development phase of the micro-organism (e.g. spores, mycelium) in the marketed product shall be stated.

(ii)

For preparations the following information must be reported:

• the content of the micro-organism(s) in the plant protection product and the content of the micro-organism in the material used for manufacturing of plant protection products. These must include the maximum, minimum and nominal content of the viable and non-viable material,

• the content of formulants,

• the content of other components (such as by-products, condensates, culture medium, etc.) and contaminating micro-organisms, derived from production process.

The contents should be expressed in terms as provided for in Article 6(2) of Directive 78/631/EEC for chemicals and appropriate terms for micro-organisms (number of active units per volume or weight or any other manner that is relevant to the micro-organism).

(iii)

Formulants must where possible, be identified either 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 EC (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.

(iv)

For formulants the function must be given:

• adhesive (sticker)

• antifoaming agent

• antifreeze

• binder

• buffer

• carrier

• deodorant

• dispersing agent

• dye

• emetic

• emulsifier

• fertiliser

• odorant

• parfume

• preservative

• propellant

• repellent

• safener

• solvent

• stabiliser

• synergist

• thickener

• wetting agent

• miscellaneous (specify).

(v)

Identification of contaminating micro-organisms and other components derived from production process.

Contaminating micro-organisms must be identified as outlined in Annex II, Part B, section 1, point 1.3.

Chemicals (inert components, by-products, etc.) must be identified as outlined in Annex II, Part A, section 1, point 1.10.

Where the information provided does not fully identify a component, such as condensate, culture medium, etc., detailed information on the composition must be provided for each such component.

1.5. Physical state and nature of the preparation U.K.

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) ’ .

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 U.K.

The biological function must be specified from among the following:

• control of bacteria,

• control of fungi,

• control of insects,

• control of mites,

• control of molluscs,

• control of nematodes,

• control of weeds,

• other (must be specified).

2. PHYSICAL, CHEMICAL AND TECHNICAL PROPERTIES OF THE PLANT PROTECTION PRODUCT U.K.

The extent to which plant protection products for which authorisation is sought comply with relevant FAO specifications, as agreed by the Group of Experts on Pesticide Specification 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. Storage stability and shelf-life U.K.

2.2.1. Effects of light, temperature and humidity on technical characteristics of the plant protection product U.K.

(i)

The physical and biological stability of the preparation at the recommended storage temperature including information on the growth of contaminating micro-organisms must be determined and reported. The conditions under which the test has been performed must be justified.

(ii)

Additionally in the case of liquid preparations, the effect of low temperatures on physical stability, must be determined and reported according to CIPAC (2) Methods MT 39, MT 48, MT 51 or MT 54 as appropriate.

(iii)

The shelf life of the preparation at the recommended storage 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 (3) Monograph No 17.

2.2.2. Other factors affecting stability U.K.

Effect of exposure to air, packaging, etc., on the product stability must be explored.

2.3. Explosivity and oxidising properties U.K.

Explosivity and oxidising properties will be determined as defined in Annex III, Part A, section 2, point 2.2, unless it can be justified that it is technically or scientifically not necessary to perform such studies.

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

Flash point and flammability must be determined, as defined in Annex III, Part A, section 2, point 2.3, unless it can be justified that it is technically or scientifically not necessary to perform such studies.

2.5. Acidity, alkalinity and if necessary pH value U.K.

Acidity, alkalinity and pH will be determined as defined in Annex III, Part A, section 2, point 2.4, unless it can be justified that it is technically or scientifically not necessary to perform such studies.

2.6. Viscosity and surface tension U.K.

Viscosity and surface tension will be determined as defined in Annex III, Part A, section 2, point 2.5, unless it can be justified that it is technically or scientifically not necessary to perform such studies.

2.7. 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. If tests have to be performed, they must be done at temperatures compatible with survival of the micro-organism.

2.7.1. Wettability U.K.

The wettability of solid preparations which are diluted for use (e.g. wettable powders and water dispersible granules), must be determined and reported according to CIPAC Method MT 53.3.

2.7.2. 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.

2.7.3. 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.

2.7.4. 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.

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

(i)

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

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.

(ii)

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

(iii)

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.

2.7.6. Emulsifiability, re-emulsifiability, emulsion stability U.K.

(i)

The emulsifiability, emulsion stability and re-emulsifiability of preparations which form emulsions, must be determined and reported according to CIPAC Method MT 36 or MT 173 as appropriate.

(ii)

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.

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

(i)

The flowability of granular preparations must be determined and reported according to CIPAC Method MT 172.

(ii)

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

(iii)

The dustability of dustable powders must be determined and reported according to CIPAC Method MT 34 or another suitable method.

2.8. Physical, chemical and biological compatibility with other products including plant protection products with which its use is to be authorised U.K.

2.8.1. Physical compatibility U.K.

The physical compatibility of recommended tank mixes must be determined and reported.

2.8.2. Chemical compatibility U.K.

The chemical compatibility of recommended 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.

2.8.3. Biological compatibility U.K.

The biological compatibility of tank mixes must be determined and reported. Effects (e.g. antagonism, fungicidal effects) on the activity of the micro-organism after mixing with other micro-organisms or chemicals must be described. The possible interaction of the plant protection product with other chemical products to be applied on the crops under the expected condition of use of the preparation should be investigated, based on the efficacy data. Intervals between application of the biological pesticide and chemical pesticides should be specified, if appropriate, in order to avoid loss of efficacy.

2.9. 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.

2.10. Summary and evaluation of data presented under points 2.1 to 2.9 U.K.

3. DATA ON APPLICATION U.K.

3.1. Field of use envisaged U.K.

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

• field use, such as agriculture, horticulture, forestry and viticulture,

• protected crops (e.g. in glasshouses),

• amenity,

• weed control on non-cultivated areas,

• home gardening,

• house plants,

• stored products,

• other (specify).

3.2. Mode of action U.K.

The way by which uptake of the product may occur (e.g. contact, stomach, inhalation) or the pest controlling action (fungitoxic, fungistatic action, nutrient competition, etc.) must be stated.

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

3.3. Details of intended use U.K.

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

Intervals between the application of the plant protection product containing micro-organisms and chemical pesticides, or a list with active substances of chemical plant protection products not to be used together with the plant protection product containing micro-organisms on the same crop, should also be provided.

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 or l for the preparation and in terms of appropriate units for the micro-organism, 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. Content of micro-organism in material used (e.g. in the diluted spray, baits or treated seed) U.K.

The content of micro-organism shall be reported, as appropriate, in number of active unit/ml or g or any other relevant unit.

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 and necessary 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 phytopathogenic 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 phytopathogenic effects on succeeding crops, must be stated, and follow from the data provided under section 6, point 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 and compatibility of the preparation with proposed packaging materials U.K.

(i)

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 ’ .

(ii)

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 standard 8317.

(iii)

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

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 determined, using e.g. biotests, 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 micro-organism(s) and that provided under sections 7 and 8.

(i)

Where relevant pre-harvest intervals, re-entry periods or withholding periods necessary to minimise 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.:

• 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.

(ii)

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.

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 relevant, information on combustion products must be provided. The risks likely to arise and the methods and procedures to minimise the hazards arising, must be specified. Procedures to preclude or minimise the generation of waste or leftovers must be provided.

Where relevant, assessment has to be done according to ISO TR 9122.

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. 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 accident, 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. Controlled incineration U.K.

In many cases the preferred or sole means to safely dispose of plant protection products and in particular the formulants contained in it, contaminated materials, or contaminated packaging, is through controlled incineration in a licensed incinerator.

The applicant must provide detailed instructions for safe disposal.

4.6.2. 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.

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.

It is desirable to have a plant protection product without contaminants, if possible. The level of acceptable contaminants should be judged from a risk assessment point of view, by the competent authority.

Both production and product must be subject to a continuous quality control by the applicant. The quality criteria for the product should be submitted.

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. The applicability of existing CIPAC methods must be reported.

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 (including contaminating micro-organisms and/or chemical substances) other than the specified micro-organism, originating from the manufacturing process or from degradation during storage

Relevant impurities

Impurities, as defined above, that are of concern for human or animal health and/or the environment

Metabolites

Metabolites include products resulting from degradative and biosynthetic reactions taking place within the micro-organism or other organisms used to produce the micro-organism of interest

Relevant metabolites

Metabolites that are of concern for human or animal health and/or the environment

Residues

Viable micro-organisms and substances produced in significant quantities by these micro-organisms which persist after the disappearance of the micro-organisms and are of concern for human or animal health and/or the environment.

On request the following samples must be provided:

(i)

samples of the preparation;

(ii)

samples of the micro-organism as manufactured;

(iii)

analytical standards of the pure micro-organism;

(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.

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

• Methods, which must be described in full, must be provided for the identification and the determination of the content of the micro-organism in the preparation. In the case of a preparation containing more than one micro-organism, methods capable of identifying and determining the content of each one should be provided.

• Methods to establish regular control of the final product (preparation) in order to show that it does not contain other organisms than the indicated ones and to establish its uniformity.

• Methods to identify any contaminating micro-organisms of the preparation.

• Methods used to determine the storage stability and shelf life of the preparation must be provided.

5.2. Methods to determine and quantify residues U.K.

Analytical methods for the determination of residues, as defined in Annex II, Part B, section 4, point 4.2, must be submitted unless it is justified that the information already submitted according to the requirements of Annex II, Part B, section 4, point 4.2, is sufficient.

6. EFFICACY DATA U.K.

The provisions for efficacy data have already been adopted under Commission Directive 93/71/EEC (4) .

7. EFFECTS ON HUMAN HEALTH U.K.

For proper evaluation of the toxicity including potential for pathogenicity and infectiveness of preparations sufficient information should be available on acute toxicity, irritation and sensitisation of the micro-organism. If possible, additional information on mode of toxic action, toxicological profile and all other known toxicological aspects of the micro-organism should be submitted. Special attention should be given to co-formulants.

While performing toxicology studies, all signs of infection or pathogenicity should be noted. Toxicology studies should include clearance studies.

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 authorised. In particular, it must be clear that the micro-organism used in the preparation, and the conditions of culturing it, are the same for which information and data are submitted in the context of Annex II, Part B.

A tiered testing system will be applied to the study of the plant protection product.

7.1. Basic acute toxicity studies 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, and in particular to establish, or indicate:

• the toxicity of the plant protection product,

• toxicity of the plant protection product relative to the micro-organism,

• 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 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. Acute oral toxicity 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 Directive 78/631/EEC can be invoked.

Test guideline U.K.

The test must be carried out in accordance with Method B.1 or B.1 bis of Commission Directive 92/69/EEC (5) .

7.1.2. Acute inhalation toxicity U.K.

Aim of the test U.K.

The test will provide the inhalation toxicity to rats of the plant protection product.

Circumstances in which required U.K.

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

• is used with fogging equipment,

• is an aerosol,

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

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

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

• contains a volatile component at greater than 10 %.

Test guideline U.K.

The test must be carried out in accordance with Method B.2 of Directive 92/69/EEC.

7.1.3. Acute percutaneous toxicity 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 Directive 78/631/EEC can be invoked.

Test guideline U.K.

The test must be carried out in accordance with Method B.3 of Directive 92/69/EEC.

7.2. Additional acute toxicity studies U.K.

7.2.1. 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 always be determined, except where the formulants are not expected to be skin irritant or the micro-organism is shown not to be skin irritant or where it is likely, as indicated in the test guideline, that severe skin effects can be excluded.

Test guideline U.K.

The test must be carried out in accordance with Method B.4 of Directive 92/69/EEC.

7.2.2. Eye irritation U.K.

Aim of the test U.K.

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

Circumstances in which required U.K.

The eye irritancy of the plant protection product must be determined, where the formulants are suspected to be eye irritant, except where the micro-organism is eye irritant or 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 Method B.5 of Directive 92/69/EEC.

7.2.3. Skin sensitisation 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 sensitisation reactions.

Circumstances in which required U.K.

The test must be carried out where the formulants are suspected to have skin sensitising properties, except where the micro-organism(s) or the formulants are known to have skin sensitising properties.

Test guideline U.K.

The tests have to be carried out in accordance with Method B.6 of Directive 92/69/EEC.

7.3. Data on exposure U.K.

The risks for those in contact with plant protection products (operators, bystanders, workers), depend on the physical, chemical and toxicological properties of the plant protection product as well as the type of the product (undiluted/diluted), formulation type, 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 plant protection product likely to occur under the proposed conditions of use.

In the cases where there is particular concern on the possibility of dermal absorption based on the information for the micro-organism available in Annex II, Part B, section 5, or from the information provided for the preparation in the present section of Annex III, Part B, further dermal absorption data can be necessary.

Results from exposure monitoring during production or use of the product must be submitted.

The abovementioned information and data must provide the basis for the selection of appropriate protective measures including personal protective equipment to be used by operators and workers and to be specified on the label.

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

A copy of the notification and the safety data sheet submitted in the context of European Parliament and Council Directive 1999/45/EC (6) 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 Directive 88/379/EEC (7) must be submitted for each formulant. All other available information should be submitted.

7.5. 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 to 7.2.3 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.

7.6. Summary and evaluation of health effects U.K.

A summary of all data and information provided under paragraphs 7.1 through 7.5, must be submitted, and 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 database.

8. RESIDUES IN OR ON TREATED PRODUCTS, FOOD AND FEED U.K.

The same provisions as detailed in Annex II, Part B, section 6, apply; the information required according to this section has to be provided unless it is possible to extrapolate the residue behaviour of the plant protection product on the basis of the data available for the micro-organism. Special attention should be paid towards the influence of formulation substances on the residue behaviour of the micro-organism and its metabolites.

9. FATE AND BEHAVIOUR IN THE ENVIRONMENT U.K.

The same provisions as detailed in Annex II, Part B, section 7, apply; the information required according to this section has to be provided unless it is possible to extrapolate the fate and behaviour of the plant protection product in the environment on the basis of the data available in Annex II, Part B, section 7.

10. EFFECTS ON NON-TARGET ORGANISMS U.K.

Introduction U.K.

(i)

The information provided, taken together with that for the micro-organism(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)

The choice of the appropriate non-target organisms for testing of environmental effects should be based on the information on the micro-organism, as required in Annex II, Part B, and on the information on the formulants and other components, as required by sections 1 to 9 of the present Annex. From such knowledge it would be possible to choose the appropriate test organisms, such as organisms closely related to the target organism.

(iii)

In particular, the information provided for the plant protection product, together with other relevant information, and that provided for the micro-organism, 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 whether special precautions are necessary for the protection of non-target species.

(iv)

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

(v)

In general, much of the data relating to impact on non-target species, required for authorisation of plant protection products, will have been submitted and evaluated for the inclusion of the micro-organism(s) in Annex I.

(vi)

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, Part B, section 9, should be used.

For the estimation of exposure of organisms all relevant information on the plant protection product and on the micro-organism must be taken into account. Where relevant the parameters provided for in this section should be used. Where it appears from available data that the plant protection product has a stronger effect than the micro-organism, the data on effects on non target organisms of the plant protection product have to be used for the calculation of relevant effect/exposure ratios.

(vii)

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 specified tests for effects on non target organisms.

10.1. Effects on birds U.K.

The same information as provided in Annex II, Part B, section 8, point 8.1, has to be reported where it is not possible to predict the effects of the plant protection product on the basis of the data available for the micro-organism, unless it can be justified that exposure of birds is unlikely to occur.

10.2. Effects on aquatic organisms U.K.

The same information as provided in Annex II, Part B, section 8, point 8.2, has to be reported where it is not possible to predict the effects of the plant protection product on the basis of the data available for the micro-organism, unless it can be justified that exposure of aquatic organisms is unlikely to occur.

10.3. Effects on bees U.K.

The same information as provided in Annex II, Part B, section 8, point 8.3, has to be reported where it is not possible to predict the effects of the plant protection product on the basis of the data available for the micro-organism, unless it can be justified that exposure of bees is unlikely to occur.

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

The same information as provided in Annex II, Part B, section 8, point 8.4, has to be reported where it is not possible to predict the effects of the plant protection product on the basis of the data available for the micro-organism, unless it can be justified that exposure of arthropods other than bees is unlikely to occur.

10.5. Effects on earthworms U.K.

The same information as provided in Annex II, Part B, section 8, point 8.5, has to be reported where it is not possible to predict the effects of the plant protection product on the basis of the data available for the micro-organism, unless it can be justified that exposure of earthworms is unlikely to occur.

10.6. Effects on soil micro-organisms U.K.

The same information as provided in Annex II, Part B, section 8, point 8.6, has to be reported where it is not possible to predict the effects of the plant protection product on the basis of the data available for the micro-organism, unless it can be justified that exposure of non target soil micro-organisms is unlikely to occur.

10.7. Additional studies U.K.

Expert judgement is required to decide whether additional studies are necessary. Such decision will take into consideration the available information in this and other sections, in particular data on the specificity of the micro-organism, and the expected exposure. Useful information may also be available from the observations carried out in efficacy testing.

Special attention should be given to possible effects on naturally occurring and deliberately released organisms of importance in IPM. In particular the compatibility of the product with IPM should be taken into consideration.

Additional studies might include further studies on additional species or higher tier studies such as studies on selected non-target organisms.

Before performing such studies, the applicant shall seek agreement of the competent authorities on the type of study to be performed.

11. SUMMARY AND EVALUATION OF ENVIRONMENTAL IMPACT U.K.

A summary and evaluation of all data relevant to the environmental impact 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 database. In particular the following issues should be addressed:

• prediction of distribution and fate in the environment, and the time courses involved,

• identification of non-target species and populations at risk, and prediction of the extent of potential exposure,

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

Textual Amendments

F1 Substituted by Commission Directive 2001/36/EC of 16 May 2001 amending Council Directive 91/414/EEC concerning the placing of plant protection products on the market (Text with EEA relevance).

(1)

[F1 USEPA Microbial Pesticide Test Guidelines, OPPTS Series 885, February 1996 (http://www.epa.gov/oppbppd1/biopesticides/guidelines/series885.htm).

(2)

Collaborative International Pesticides Analytical Council.

(3)

International Group of National Pesticide Manufacturers' Associations.

(4)

OJ L 221, 31.8.1993, p. 27 .

(5)

OJ L 383, 29.12.1992, p. 113 .

(6)

OJ L 200, 30.7.1999, p. 1 .

(7)

OJ L 76, 22.3.1991, p. 35 .]

Textual Amendments

F1 Substituted by Commission Directive 2001/36/EC of 16 May 2001 amending Council Directive 91/414/EEC concerning the placing of plant protection products on the market (Text with EEA relevance).