Commission Regulation (EU) No 284/2013Dangos y teitl llawn

PART B PREPARATIONS OF MICRO-ORGANISMS INCLUDING VIRUSES

INTRODUCTION

(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 part B of the Annex to Regulation (EU) No 283/2013, also applies to the Part B of this Annex.

(ii) Where relevant, data shall be analysed using appropriate statistical methods. Full details of the statistical analysis shall be reported (e.g. all point estimates shall 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 Part A of the Annex to Regulation (EU) No 283/2013, shall be adapted in such a way that they are appropriate for micro-organisms. Testing shall 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, in accordance with the provisions of point 1.4, must be provided.

(vi) In cases where a new preparation is to be dealt with, extrapolation from Part B of the Annex to Regulation (EU) No 283/2013, could be acceptable, provided that all the possible effects of the co-formulants and other components, especially on pathogenicity and infectiveness, are also evaluated.

1. IDENTITY OF THE PLANT PROTECTION PRODUCT

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 Part B of the Annex to Regulation (EU) No 283/2013.

1.1. Applicant

The name and address of the applicant 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 shall be provided, as shall the name, position, telephone and fax number of the appropriate person to contact.

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

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 in accordance with Part B of the Annex to Regulation (EU) No 283/2013 had not been submitted previously, detailed information on the name and species description, as required in point 1.3 of Part B of the Annex to Regulation (EU) No 283/2013 and on impurities, as required in point 1.4 of Part B of the Annex to Regulation (EU) No 283/2013 have to be provided.

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

All former and current trade names and proposed trade names and development code numbers of the preparation 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

(i) Each micro-organism that is subject to the application shall be identified and named at the species level. The micro-organism shall 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 co-formulants,

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

The contents shall be expressed in terms as provided for in Directive 1999/45/EC of the European Parliament and of the Council(2) 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) Co-formulants must where possible, be identified either by their International Chemical Identification as given in Annex VI to Regulation (EC) No1272/2008, or, if not included in that Regulation, in accordance with both IUPAC and CA nomenclature. Their structure or structural formula must be provided. For each component of the co-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 co-formulant, an appropriate specification must be provided. The trade name of co-formulants, where they exist, must also be provided.

(iv) For co-formulants the function must be given:

• adhesive (sticker),

• antifoaming agent,

• antifreeze,

• binder,

• buffer,

• carrier,

• deodorant,

• dispersing agent,

• dye,

• emetic,

• emulsifier,

• fertiliser,

• odorant,

• perfume,

• 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 point 1.3 of Part B of the Annex to Regulation (EU) No 283/2013.

Chemicals (inert components, by-products, etc.) must be identified as outlined in point 1.10 of Part A of the Annex to Regulation (EU) No 283/2013.

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

The type and code of preparation must be designated in accordance with 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 that catalogue, 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

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

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)

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

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

(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 in accordance with CIPAC 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 Monograph No 17.

2.2.2. Other factors affecting stability

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

2.3. Explosivity and oxidising properties

Explosivity and oxidising properties will be determined as defined in point 2.2 of Part A of this Annex, 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

Flash point and flammability must be determined, as defined in point 2.3 of Part A of this Annex, 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

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

2.6. Viscosity and surface tension

Viscosity and surface tension will be determined as defined in point 2.5 of Part A of this Annex, 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

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

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

2.7.2. Persistent foaming

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

2.7.3. Suspensibility and suspension stability

• The suspensibility of water dispersible products (e.g. wettable powders, water dispersible granules, suspension concentrates) must be determined and reported in accordance with 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 in accordance with CIPAC Methods MT 160 or MT 174 as appropriate.

2.7.4. Dry sieve test and wet sieve test

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

In the case of water dispersible products, a wet sieve test must be conducted and reported in accordance with 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)

(i) The size distribution of particles in the case of powders, must be determined and reported in accordance with 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 in accordance with CIPAC Method MT 171. If relevant for operator exposure the particle size of dust must be determined and reported in accordance with 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

(i) The emulsifiability, emulsion stability and re-emulsifiability of preparations which form emulsions, must be determined and reported in accordance with 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 in accordance with CIPAC Method MT 20 or MT 173.

2.7.7. Flowability, pourability (rinsability) and dustability

(i) The flowability of granular preparations must be determined and reported in accordance with CIPAC Method MT 172.

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

(iii) The dustability of dustable powders must be determined and reported in accordance with 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

2.8.1. Physical compatibility

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

2.8.2. Chemical compatibility

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

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 shall be investigated, based on the efficacy data. Intervals between application of the biological pesticide and chemical pesticides shall be specified, if appropriate, in order to avoid loss of efficacy.

2.9. Adherence and distribution to seeds

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

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

3. DATA ON APPLICATION

3.1. Field of use envisaged

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

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

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, shall also be provided.

3.4. Application rate

For each method of application and each use, the rate of application per unit (ha, m², m³) 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/m³ and where appropriate in g or kg/tonne; for protected crops and home gardening use rates shall be expressed in g or kg/100 m² or g or kg/m³.

3.5. Content of micro-organism in material used (e.g. in the diluted spray, baits or treated seed)

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

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

3.7. Number and timing of applications and duration of protection

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

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

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

4. FURTHER INFORMATION ON THE PLANT PROTECTION PRODUCT

4.1. Packaging and compatibility of the preparation with proposed packaging materials

(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 in accordance with 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, in accordance with ISO standard 8317.

(iii) The resistance of the packaging material to its contents must be reported in accordance with GIFAP Monograph No 17.

4.2. Procedures for cleaning application equipment

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

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

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 in accordance with 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

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

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 shall be without unacceptable influence on the environment and be the most cost effective and practical means of disposal feasible.

4.6.1. Controlled incineration

In many cases the preferred or sole means to safely dispose of plant protection products and in particular the co-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

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

Introduction

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 shall 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 shall be submitted.

For analytical methods used for generation of data as required in this Regulation 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, metabolites, relevant metabolites, residues	As defined in Article 3 of Regulation (EC) No 1107/2009
Relevant impurities	Impurities, as defined above, that 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

• 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

Analytical methods for the determination of residues, as defined in point 4.2 of Part B of the Annex to Regulation (EU) No 283/2013 must be submitted unless it is justified that the information already submitted in accordance with the requirements of point 4.2 of Part B of the Annex to Regulation (EU) No 283/2013 is sufficient.

6. EFFICACY DATA

General

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

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

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

In order to assess seasonal differences, if any, sufficient data must be generated and submitted to confirm the performance of the plant protection 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 season's work must be provided. Conversely, where, because of climatic or plant health conditions or other reasons the data obtained in any particular season are of limited value for the assessment of performance, trials in one or more further seasons must be conducted and reported.

6.1. Preliminary tests

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

6.2. Testing effectiveness

Aim of the tests

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

Test conditions

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

The performance of the plant protection product must be investigated in relation to suitable reference products, where they exist. A suitable reference product is defined as an authorised 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 shall 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 show the level of effects on the species to be treated, and include investigation of differences in the response of a representative sample of the range of cultivars on which its use is proposed.

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

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

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

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

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

Test guideline

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

The trials must be carried out in accordance to specific EPPO guidelines, where available, or 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

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

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

6.4.1. Effects on the quality of plants or plant products

Aim of the tests

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

Circumstances in which required

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

• the nature of the 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 to the 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 shall 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 authorised.

6.4.2. Effects on transformation processes

Aim of the tests

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

Circumstances in which required

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

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

6.4.3. Effects on the yield of treated plants or plant products

Aim of the tests

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

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 storage life must be determined where relevant.

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

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

Aim of the tests

The 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

For herbicides and for other plant protection products for which adverse effects, however transitory, are seen during the trials, performed in accordance with 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 growth stage, vigour, and other factors which may influence susceptibility to damage or injury.

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

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

Test guideline

Observations concerning phytotoxicity must be performed in the tests provided for in 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)

6.6.1. Impact on succeeding crops

Aim of the information required

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

Circumstances in which required

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

6.6.2. Impact on other plants, including adjacent crops

Aim of the information required

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

Circumstances in which required

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

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

Aim of the information required

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

Circumstances in which required

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

(i)

for seeds — viability, germination and vigour;

(ii)

for cuttings — rooting and growth rates;

(iii)

for runners — establishment and growth rates;

(iv)

for tubers — sprouting and normal growth.

Test guideline

Seeds testing shall be done in accordance with ISTA Methods.

6.6.4. Effects on beneficial and other non-target organisms

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

6.7. Summary and evaluation of data presented under 6.1 to 6.6

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

7. EFFECTS ON HUMAN HEALTH

For proper evaluation of the toxicity including potential for pathogenicity and infectiveness of preparations sufficient information shall 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 shall be submitted. Special attention shall be given to co-formulants.

While performing toxicology studies, all signs of infection or pathogenicity shall be noted. Toxicology studies shall 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 Part B of the Annex to Regulation (EU) No 283/2013.

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

7.1. Basic acute toxicity studies

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 1999/45/EC or Regulation (EC) No 1272/2008. 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

Circumstances in which required

An acute oral test shall always be carried only if the applicant cannot justify an alternative approach under Directive 1999/45/EC or Regulation (EC) No 1272/2008, where applicable.

Test method

The test must be carried out in accordance with Method B.1 bis or B.1 tris of Regulation (EC) No 440/2008.

7.1.2. Acute inhalation toxicity

Aim of the test

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

Circumstances in which required

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 method

The test must be carried out in accordance with Method B.2 of Regulation (EC) No 440/2008.

7.1.3. Acute percutaneous toxicity

Circumstances in which required

An acute percutaneous test shall be conducted only if the applicant cannot justify an alternative approach under Directive 1999/45/EC or Regulation (EC) No 1272/2008, where applicable.

Test method

The test must be carried out in accordance with Method B.3 of Regulation (EC) No 440/2008.

7.2. Additional acute toxicity studies

7.2.1. Skin irritation

Aim of the test

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

The skin irritancy of the plant protection product must always be determined, except where the co-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 method

The test must be carried out in accordance with Method B.4 of Regulation (EC) No 440/2008.

7.2.2. Eye irritation

Aim of the test

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

The eye irritancy of the plant protection product must be determined, where the co-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 method

The eye irritation must be determined in accordance with Method B.5 of Regulation (EC) No 440/2008.

7.2.3. Skin sensitisation

Aim of the test

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

Circumstances in which required

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

Test method

The tests have to be carried out in accordance with Method B.6 of Regulation (EC) No 440/2008.

7.3. Data on exposure

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 Section 5 of Part B of the Annex to Regulation (EU) No 283/2013, or from the information provided for the preparation in this Section, 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

Where relevant, the following information shall be submitted for each co-formulant:

(a)

the registration number as referred to in Article 20(3) of Regulation (EC) No 1907/2006(3),

(b)

the study summaries included in the technical dossier as referred to in Article 10(a)(vi) of Regulation (EC) No 1907/2006, and

(c)

the safety data sheet as referred to in Article 31 of Regulation (EC) No 1907/2006.

All other available information shall be submitted.

7.5. Supplementary studies for combinations of plant protection products

Aim of the test

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

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

The same provisions as detailed in Section 6 of Part B of the Annex to Regulation (EU) No 283/2013, apply; the information required in accordance with 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 shall 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

The same provisions as detailed in Section 7 of Part B of the Annex to Regulation (EU) No 283/2013 apply; the information required in accordance with 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 Section 7 of Part B of the Annex to Regulation (EU) No 283/2013.

10. EFFECTS ON NON-TARGET ORGANISMS

Introduction

(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 shall be based on the information on the micro-organism, as required in Part B of the Annex to Regulation (EU) No 283/2013, and on the information on the co-formulants and other components, as required by Sections 1 to 9 of this 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, shall be sufficient to:

• specify the hazard symbols, the indications of danger, and relevant risk and safety phrases or the pictograms, signal words, relevant hazard and precautionary statements, 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 approval of the micro-organism(s).

(vi) Where exposure data are necessary to decide whether a study has to be performed, the data obtained in accordance with Section 9 of Part B of this Annex, shall 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 shall 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 shall where possible be used in the various specified tests for effects on non target organisms.

10.1. Effects on birds

The same information as provided in point 8.1 of Part B of the Annex to Regulation (EU) No 283/2013 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

The same information as provided in point 8.2 of Part B of the Annex to Regulation (EU) No 283/2013 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

The same information as provided in point 8.3 of Part B of the Annex to Regulation (EU) No 283/2013 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

The same information as provided in point 8.4 of Part B of the Annex to Regulation (EU) No 283/2013 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

The same information as provided in point 8.5 of Part B of the Annex to Regulation (EU) No 283/2013 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

The same information as provided in point 8.6 Part B of the Annex to Regulation (EU) No 283/2013 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

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 shall 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 shall 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

A summary and evaluation of all data relevant to the environmental impact shall be carried out in accordance with the guidance given by the competent authorities of the Member States concerning the format of such summaries and evaluations. It shall 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 shall 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.

(1)

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

(2)

OJ L 200, 30.7.1999, p. 1.

(3)

OJ L 396, 30.12.2006, p. 1.