(a)

(b)

take into account the Annex IIB data concerning the active substance consisting of micro-organisms (including viruses) in the plant protection product, submitted for the purpose of inclusion of the micro-organism concerned in Annex I, and the results of the evaluation of those data, without prejudice, where relevant, to the provisions of Article 13(1)(b), (2), (3) and (6) of this Directive;

(c)

take into consideration other relevant technical or scientific information they can reasonably possess with regard to the performance of the plant protection product or to the potentially adverse effects of the plant protection product, its components or its metabolites/toxins.

—

antibiotics, which refer to substances produced by or derived from micro-organisms, and

—

anticoccidials, which refer to substances that are active against coccidia, single cell protozoan parasites.

(a)

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

(b)

assess the performance in terms of efficacy and phytotoxicity/pathogenicity of the plant protection product for each use for which authorisation is sought.

(a)

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

(b)

be submitted to an evaluation as referred to in point 1.3.,

(c)

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

(d)

be relevant to the conditions in the area of use,

(e)

be supported with details indicating how the model calculates estimates provided, and explanations of all the inputs to the model and details of how they have been derived.

(a)

depending on the conditions (e.g. availability of substrates for growth and metabolism) micro-organisms can switch on or off the expression of given phenotypic traits;

(b)

the microbial strains most adapted to the environment can survive and multiply better than the non-adapted strains. Adapted strains have a selective advantage and can form the majority within a population after a number of generations;

(c)

the relatively rapid multiplication of micro-organisms leads to a higher frequency of mutations. If a mutation is promoting survival in the environment, the mutant strain can become dominant;

(d)

the properties of viruses, in particular, can change rapidly, including their virulence.

Therefore, where appropriate, information on the genetic stability of the micro-organism under the environmental conditions of proposed use must be evaluated, as well as information on the micro-organism's capacity to transfer genetic material to other organisms and information on the stability of encoded traits.

(a)

antibiosis,

(b)

induction of plant resistance,

(c)

interference with the virulence of a pathogenic target organism,

(d)

endophytic growth,

(e)

root colonisation,

(f)

competition of ecological niche (e.g. nutrients, habitats),

(g)

parasitisation,

(h)

invertebrate pathogenicity.

(a)

The ability of a micro-organism to be pathogenic for non-target organisms (humans, animals, and other non-target organisms) must be assessed. Any relationship to known plant, animal or human pathogens that are species of the genus of the active and/or contaminating micro-organisms must be assessed.

(b)

Pathogenicity as well as virulence is strongly related to the host-species (e.g. determined by body temperature, physiological environment) and to the host conditions (e.g. health condition, immune status). For example, multiplication in humans depends upon the ability of the micro-organism to grow at the body temperature of the host. Some micro-organisms can only grow and be metabolically active at temperatures far below or above human body temperature, and therefore can not be pathogenic for humans. However, the route of entry of the micro-organism into the host (oral, inhalation, skin/wound) can also be the critical factor. For example, a microbial species may cause a disease following entry via skin damage, but not via the oral route.

(a)

where a suitable Food and Agriculture Organisation of the United Nations (FAO) specification exists, the physical and chemical properties addressed in that specification,

(b)

where no suitable FAO specification exists, all relevant physical and chemical properties for the formulation referred to in the Manual on the development and use of FAO and World Health Organisation (WHO) specifications for pesticides.

(a)

the choice of the crop or cultivar,

(b)

the agricultural and environmental (including climatic) conditions (if necessary for acceptable efficacy such data/information should also be given for the time before and after application),

(c)

the presence and density of the harmful organism,

(d)

the development stage of crop and organism,

(e)

the amount of the microbial plant protection product used,

(f)

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

(g)

the frequency and timing of the applications,

(h)

the type of application equipment,

(i)

the need for any special cleaning measures for the application equipment.

(a)

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

(b)

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

Where no suitable reference product exists, Member States shall evaluate the performance of the plant protection product to determine whether there is a consistent and defined benefit under the agricultural, plant health and environmental (including climatic) conditions likely to be encountered in practice in the area of proposed use.

(a)

This evaluation will take into consideration the following information:

(b)

This evaluation will include:

(a)

all relevant information as provided for in Annex IIB and the results of the evaluation thereof, including the toxicological studies;

(b)

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

—

ability to persist and multiply in a host (indicative of colonisation or infectivity),

—

ability to produce non-adverse or adverse effects in a host, indicative of infectivity, pathogenicity, and/or toxicity;

(a)

This evaluation will take into consideration the following information:

(b)

On the basis of the information mentioned in (a) the following overall end-points should be established for single or repeated operator exposure following the intended use:

If there are indications of colonisation in the host and/or if any adverse effects, indicative of toxicity/infectivity are observed, taking into account the exposure scenario (i.e. acute or repeated exposure), further testing is indicated.

(c)

This evaluation shall be made for each type of application method and application equipment proposed for use of the plant protection product as well as for the different types and sizes of containers to be used, taking into account mixing, loading operations, application of the plant protection product and cleaning and routine maintenance of application equipment. Where relevant, other authorised uses of the plant protection product in the area of envisaged use containing the same active substance or which give rise to the same residues may also be taken into account. It should be taken into account that if replication of the micro-organism is expected, exposure assessment could be highly speculative.

(d)

The absence or presence of the potential for colonisation or the possibility of effects in operators at the tested dose levels as provided for in Annex IIB and IIIB should be assessed with regard to measured or estimated levels of human exposure. This risk assessment, preferably quantitative, should include consideration of e.g. mode of action, biological, physical and chemical properties of the micro-organism and other substances in the formulation.

(a)

the type of packaging,

(b)

its dimensions and capacity,

(c)

the size of the opening,

(d)

the type of closure,

(e)

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

(f)

its resistance to and compatibility with the contents.

(a)

obtainability and suitability,

(b)

effectiveness,

(c)

ease of wearing taking into account physical stress and climatic conditions,

(d)

resistance to and compatibility with the plant protection product.

(a)

the medical data and the toxicity, infectivity and pathogenicity studies provided for in Annex IIB, and the results of the evaluation thereof. Tier 1 tests should permit an evaluation to be made of a micro-organism with respect to its ability to persist or grow in the host and its ability to cause effects/reactions in the host. Parameters that indicate the absence of ability to persist and multiply in the host, and the absence of ability to produce non-adverse or adverse effects in a host, include rapid and complete clearance from the body, no activation of the immune system, no histopathological changes, and inability to replicate at mammalian body temperatures. These parameters can in some cases be assessed using acute studies and existing human data, and sometimes can only be assessed using repeated dose studies.

Evaluation based on relevant parameters of Tier 1 tests should lead to an assessment of the possible effects of occupational exposure, taking into account the intensity and duration of exposure, including exposure due to repeated use during practical use.

The toxicity of certain metabolites/toxins can only be assessed, if it has been demonstrated that the test animals are actually exposed to these metabolites/toxins;

(b)

other relevant information on the micro-organism, the metabolites/toxins, residual growth medium, contaminants and co-formulants in the plant protection product, such as their biological, physical and chemical properties (e.g. survival of the micro-organism at the body temperature of humans and animals, ecological niche, behaviour of the micro-organism and/or metabolites/toxins during application);

(c)

the toxicological studies provided for in Annex IIIB;

(d)

other relevant information on the plant protection product as provided for in Annex IIIB such as:

—

the stage of development of the micro-organism at which non-viable residues are produced,

—

the development stages/life cycle of the micro-organism under typical environmental conditions; in particular, attention shall be paid to the assessment of the likelihood of survival and multiplication of the micro-organism in or on crops, food or feed, and, as a consequence, the likelihood of the production of non-viable residues,

—

the stability of relevant non-viable residues (including the effects of factors such as temperature, UV light, pH and the presence of certain substances),

—

any experimental study showing whether or not relevant non-viable residues are translocated in plants,

—

data concerning the proposed good agricultural practice (including number and timing of applications, maximum application rate and minimum spray application volume, proposed pre-harvest intervals for envisaged uses, or withholding periods or storage periods, in the case of post-harvest uses) and additional data on application as provided for in Annex IIIB,

—

where relevant, other authorised uses of plant protection products in the area of envisaged use, i.e. containing the same residues, and

—

the natural occurrence of non-viable residues on edible plant parts as a consequence of naturally occurring micro-organisms.

—

analytical methods for the non-viable residues,

—

the growth curves of the micro-organism under optimal conditions,

—

the production/formation of non-viable residues at relevant moments (e.g. at the anticipated harvest time).

—

the likelihood of survival, the persistence and multiplication of the micro-organism in or on crops, food or feed. The various development stages/life cycle of the micro-organism should be addressed,

—

information concerning its ecological niche,

—

information on fate and behaviour in the various parts of the environment,

—

the natural occurrence of the micro-organism (and/or a related micro-organism),

—

data concerning the proposed good agricultural practice (including number and timing of applications, maximum application rate and minimum spray application volume, proposed pre-harvest intervals for envisaged uses, or withholding periods or storage periods in the case of post-harvest uses) and additional data on application as provided for in Annex IIIB,

—

where relevant, other authorised uses of plant protection products in the area of envisaged use, i.e. containing the same micro-organism or which result in the same residues.

—

the medical data and toxicity, infectivity and pathogenicity studies provided for in Annex IIB, and the results of the evaluation thereof,

—

the development stages/life cycle of the micro-organism under typical environmental conditions (e.g. in or on the treated crop),

—

the mode of action of the micro-organism,

—

the biological properties of the micro-organism (e.g. host specificity).

The various development stages/life cycle of the micro-organism should be addressed.

—

analytical methods for the viable residues,

—

the growth curves of the micro-organism under optimal conditions,

—

the possibilities of extrapolating data from one crop to another.

(a)

the biological properties of the micro-organism,

(b)

the survival of the micro-organism in the environment,

(c)

its ecological niche,

(d)

the natural background level of the micro-organism, where it is indigenous,

(e)

information on fate and behaviour in the various parts of the environment,

(f)

where relevant, information on potential interference with analytical systems used for the control of the quality of drinking water as provided for in Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption (3),

(g)

where relevant, other authorised uses of plant protection products in the area of envisaged use, e.g. containing the same active substance or which gives rise to the same residues.

(a)

the biological properties of the micro-organism,

(b)

the survival of the micro-organism in the environment,

(c)

its ecological niche,

(d)

the natural background level of the micro-organism, where it is indigenous,

(e)

information on fate and behaviour in the various parts of the environment,

(f)

where relevant, other authorised uses of plant protection products in the area of envisaged use, e.g. containing the same active substance or which gives rise to the same residues.

(a)

its mode of action,

(b)

other biological properties,

(c)

studies on mammalian toxicity, pathogenicity and infectivity,

(d)

studies on avian toxicity, pathogenicity and infectivity.

(a)

studies on mammalian toxicity,

(b)

studies on avian toxicity,

(c)

information on fate and behaviour in the various parts of the environment.

(a)

its mode of action,

(b)

other biological properties,

(c)

studies on toxicity, pathogenicity and infectivity.

(a)

studies on toxicity to aquatic organisms,

(b)

information on fate and behaviour in the various parts of the environment.

(a)

its mode of action,

(b)

other biological properties,

(c)

studies on toxicity, pathogenicity and infectivity.

(a)

studies on toxicity to bees,

(b)

information on fate and behaviour in the various parts of the environment.

(a)

its mode of action,

(b)

other biological properties,

(c)

studies on toxicity, pathogenicity and infectivity to honeybees and other arthropods.

(a)

studies on toxicity to arthropods,

(b)

information on fate and behaviour in the various parts of the environment,

(c)

available data from biological primary screening.

(a)

its mode of action,

(b)

other biological properties,

(c)

studies on earthworm toxicity, pathogenicity and infectivity.

(a)

studies on earthworm toxicity,

(b)

information on fate and behaviour in the various parts of the environment.

(a)

its mode of action,

(b)

other biological properties.

(a)

information on fate and behaviour in the various parts of the environment,

(b)

all available information from biological primary screening.

(a)

fulfils the requirements of Article 16 of this Directive,

(b)

also contains the information on protection of users required by Community legislation on worker protection,

(c)

specifies in particular the conditions or restrictions under which the plant protection product may or may not be used as referred to in points 1.1 to 1.5,

(d)

The authorisation shall mention the particulars indicated in Article 16(1)(g) and (h) of this Directive and Article 10(1.2), (2.4), (2.5) and (2.6) of Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations (4).

(a)

ensure that the proposed packaging is in accordance with the provisions of Directive 1999/45/EC;

(b)

ensure that:

(a)

advantages for and compatibility with integrated control measures or organic farming,

(b)

facilitating strategies to minimise the risk of development of resistance,

(c)

reduced risk for operators and consumers,

(d)

reduced contamination of the environment and reduced impact on non-target species.

(a)

define, where possible, preferably in close cooperation with the applicant, measures to improve the performance of the plant protection product, and/or

(b)

define, where possible, in close cooperation with the applicant, measures to reduce further the exposure that could occur during and after use of the plant protection product.

(a)

plants, plant products, foodstuffs of plant and animal origin and feedingstuffs if toxicologically relevant residues occur. Residues are considered relevant if a maximum residue level (MRL) or a waiting or re-entry safety period or other such precaution is required,

(b)

soil, water, air and/or body tissues if toxicologically, ecotoxicologically or environmentally relevant residues occur.

(a)

the parameters or maximum permissible concentrations laid down by Directive 98/83/EC, or

(b)

the parameters or maximum permissible concentrations laid down for components in the plant protection product such as relevant metabolites/toxins in accordance with Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy (9), or

(c)

the parameters for the micro-organism or the maximum concentration laid down by the Commission for components in the plant protection product such as relevant metabolites/toxins when including the micro-organism in Annex I, on the basis of appropriate data, in particular, toxicological data, or, where that concentration has not been laid down, the concentration corresponding to 1/10 of the acceptable daily intake (ADI) laid down when the micro-organism was included in Annex I,

(a)

exceeds, where the surface water in or from the area of envisaged use is intended for the extraction of drinking water, the parameters or values established in accordance with Council Directive 75/440/EEC of 16 June 1975 concerning the quality required of surface water intended for the abstraction of drinking water in the Member States (10), or

(b)

exceeds the parameters or values for components in the plant protection product, such as relevant metabolites/toxins, established in accordance with Directive 2000/60/EC or

(c)

has an impact deemed unacceptable on non-target species, including animals, according to the relevant requirements provided for in point 2.8.

(a)

the micro-organism is pathogenic to birds and other non-target terrestrial vertebrates,

(b)

in case of toxic effects due to components in the plant protection product, such as relevant metabolites/toxins, the toxicity/exposure ratio is less than 10 on the basis of the acute LD50 value or the long-term toxicity/exposure ratio is less than 5, unless it is clearly established through an appropriate risk assessment that under field conditions no unacceptable effects occur — directly or indirectly — after use of the plant protection product according to the proposed conditions of use.

(a)

the micro-organism is pathogenic to aquatic organisms,

(b)

in case of toxic effects due to components in the plant protection product such as relevant metabolites/toxins, the toxicity/exposure ratio is less than 100 in case of acute toxicity (EC50) to daphnia and fish and 10 for long-term/chronic toxicity to algae (EC50), daphnia (NOEC) and fish (NOEC), unless it is clearly established through an appropriate risk assessment that under field conditions no unacceptable impact on the viability of exposed species occurs — directly or indirectly — after use of the plant protection product according to the proposed conditions of use.

(a)

if the micro-organism is pathogenic to bees,

(b)

in case of toxic effects due to components in the plant protection product such as relevant metabolites/toxins, the hazard quotients for oral or contact exposure of honeybees are greater than 50, unless it is clearly established through an appropriate risk assessment that under field conditions there are no unacceptable effects on honeybee larvae, honeybee behaviour, or colony survival and development after use of the plant protection product according to the proposed conditions of use.

(a)

the micro-organism is pathogenic to arthropods other than bees,

(b)

in case of toxic effects due to components in the plant protection product such as relevant metabolites/toxins, unless it is clearly established through an appropriate risk assessment that under field conditions there is no unacceptable impact on those organisms after use of the plant protection product according to the proposed conditions of use. Any claims for selectivity and proposals for use in integrated pest management systems shall be substantiated by appropriate data.