Council Directive 2005/25/EC of 14 March 2005 amending Annex VI to Directive 91/414/EEC as regards plant protection products containing micro-organisms (Text with EEA relevance).
Date: 2005-03-14
Institutions: Council of the European Union
Subjects: market approval, marketing standard, microorganism, plant health legislation, plant health product

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I

(Acts whose publication is obligatory)

COUNCIL DIRECTIVE 2005/25/EC

of 14 March 2005

amending Annex VI to Directive 91/414/EEC as regards plant protection products containing
micro-organisms

(Text with EEA relevance)

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European
Community,

Having regard to Council Directive 91/414/EC of 15 July 1991
concerning the placing of plant protection products on the
market (1), and in particular Article 18(1) thereof,

Having regard to the proposal from the Commission,

Whereas:

(1)

In accordance with Directive 91/414/EEC, Member States
have to ensure that plant protection products are not
authorised unless they comply with the requirements
provided for in that Directive.

(2) Directive 91/414/EEC provides for the establishment of
Uniform Principles pursuant to which the Member States
have to carry out the evaluation of plant protection
products with a view to their authorisation.

(3) Uniform Principles have been laid down for Member
States to use in the evaluation and authorisation of
chemical plant protection products only. However, there
are no equivalent principles for Member States to apply
in the evaluation and authorisation of plant protection
products containing micro-organisms. It is appropriate
to lay down additional Uniform Principles for this type of
plant protection product.

(1) OJ L 230, 19.8.1991, p. 1. Directive as last amended by
Commission Directive 2004/99/EC (OJ L 309, 16.10.2004,
p. 6).

(4) Requirements for
the dossiers to be submitted by
applicants for
the authorisation of plant protection
containing micro-organisms having been
products
included in Directive 91/414/EEC by Commission
Directive 2001/36/EEC (2),
it is now necessary to lay
down Uniform Principles for the evaluation of a dossier
concerning plant protection products containing micro-
organisms based on such data requirements.

including the provisions

(5) The provisions of this Directive concerning the protec-
tion of water,
related to
monitoring, are without prejudice to Member States'
obligations under
the Directives concerned, and in
particular Council Directives 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 (3), 80/68/EEC of 17 December 1979 on
the protection of groundwater against pollution caused
substances (4), 98/83/EC of
by
3 November 1998 on the quality of water intended for
human consumption (5) and Directive 2000/60/EC of
the European Parliament
the Council of
23 October 2000 establishing a framework for Com-
munity action in the field of water policy (6).

certain dangerous

and of

(2) OJ L 164, 20.6.2001, p. 1.
(3) OJ L 194, 25.7.1975, p. 26. Directive to be repealed from
22.12.2007 by Directive 2000/60/EC (OJ L 327, 22.12.2000,
p. 1).

(4) OJ L 20, 26.1.1980, p. 43. Directive to be repealed from

22.12.2013 by Directive 2000/60/EC.

(5) OJ L 330, 5.12.1998, p. 32. Directive as last amended by
Regulation (EC) No 1882/2003 of the European Parliament and
of the Council (OJ L 284, 31.10.2003, p. 1).

(6) OJ L 327, 22.12.2000, p. 1. Directive as amended by Decision

No 2455/2001/EC (OJ L 331, 15.12.2001, p. 1).

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(6) The provisions of this Directive concerning genetically
modified organisms are without prejudice to Member
States' obligations under Directive 2001/18/EC of the
European Parliament and of the Council of 12 March
2001 on the deliberate release into the environment of
genetically modified organisms (7).

(7) The Scientific Committee on Plants has provided an
opinion on this Directive, and this opinion has been
taken into account.

(8) Directive 91/414/EEC should therefore be amended

accordingly,

HAS ADOPTED THIS DIRECTIVE:

Article 1

When Member States adopt those measures, they shall contain
a reference to this Directive or shall be accompanied by such
reference on the occasion of their official publication. The
methods of making such reference shall be laid down by
Member States.

2. Member States shall communicate to the Commission the
text of the main provisions of national law which they adopt
in the field covered by this Directive.

Article 3

This Directive shall enter into force on the twentieth day
following its publication in the Official Journal of the European
Union.

Article 4

Annex VI to Directive 91/414/EEC is hereby amended in
accordance with the Annex to this Directive.

This Directive is addressed to the Member States.

Article 2

1. Member States shall bring into force the laws, regulations
and administrative provisions necessary to comply with this
Directive by 28 May 2006. They shall immediately forward to
the Commission the text of those measures together with a
correlation table between such measures and this Directive.

Done at Brussels, 14 March 2005.

For the Council

The President

F. BODEN

(7) OJ L 106, 17.4.2001, p. 1. Directive as last amended by
Regulation (EC) No 1830/2003 (OJ L 268, 18.10.2003, p. 24).

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ANNEX

Annex VI is hereby amended as follows:

(1)

The title ‘Uniform Principles for evaluation and authorisation of plant protection products’ shall be replaced by

‘PART I

UNIFORM PRINCIPLES FOR EVALUATION AND AUTHORISATION OF CHEMICAL PLANT
PROTECTION PRODUCTS’;

(2)

The following Part shall be added after Part I

‘PART II

UNIFORM PRINCIPLES FOR EVALUATION AND AUTHORISATION OF PLANT PROTECTION
PRODUCTS CONTAINING MICRO-ORGANISMS’

CONTENTS

A.

INTRODUCTION

B.

EVALUATION

1.

2.

General principles

Specific principles

2.1.

Identity

2.1.1.

Identity of the micro-organism in the plant protection product

2.1.2.

Identity of the plant protection product

2.2.

Biological, physical, chemical and technical properties

2.2.1.

Biological properties of the micro-organism in the plant protection product

2.2.2.

Physical, chemical and technical properties of the plant protection product

2.3.

Further information

2.3.1. Quality control of the production of the micro-organism in the plant protection product

2.3.2. Quality control of the plant protection product

2.4.

Efficacy

2.5.

Identification/detection and quantification methods

2.5.1.

Analytical methods for the plant protection product

2.5.2. Analytical methods for the determination of residues

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2.6.

Impact on human and animal health

2.6.1.

Effects on human or animal health arising from the plant protection product

2.6.2.

Effects on human or animal health arising from residues

2.7.

Fate and behaviour in the environment

2.8.

Effects on and exposure of non-target organisms

2.9.

Conclusions and proposals

C. DECISION-MAKING

1.

2.

General principles

Specific principles

2.1.

Identity

2.2.

Biological and technical properties

2.3.

Further information

2.4.

Efficacy

2.5.

Identification/detection and quantification methods

2.6.

Impact on human and animal health

2.6.1.

Effects on human or animal health arising from the plant protection product

2.6.2.

Effects on human or animal health arising from residues

2.7.

Fate and behaviour in the environment

2.8.

Effects on non-target organisms

A.

INTRODUCTION

1.

The principles developed in Part II of this Annex aim to ensure that evaluations and decisions with regard
to authorisation of plant protection products, provided they are microbial plant protection products,
result in the implementation of the requirements of Article 4(1)(b), (c), (d) and (e) of this Directive by all
Member States at a high level of protection of human and animal health and the environment.

2.

In evaluating applications for granting authorisations Member States shall:

(a) — ensure that dossiers on microbial plant protection products supplied are in accordance with
the requirements of Annex IIIB, at the latest at the time of finalisation of the evaluation for the
purpose of decision-making, without prejudice, where relevant, to the provisions of Article 13
(1)(a), (4) and (6) of this Directive,

— ensure that the data submitted are acceptable in terms of quantity, quality, consistency and

reliability and sufficient to permit a proper evaluation of the dossier,

— evaluate, where relevant, justifications submitted by the applicant for not supplying certain

data;

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(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.

3. Where,

in the specific principles on evaluation, reference is made to Annex IIB data, this shall be

understood as being the data referred to in point 2(b).

4. Where the data and information provided are sufficient to permit completion of the evaluation for one of

the proposed uses, applications must be evaluated and a decision made for the proposed use.

Taking account of justifications provided and with the benefit of any subsequent clarifications, Member
States shall reject applications for granting authorisations for which the data gaps are such that it is not
possible to finalise the evaluation and to make a reliable decision for at least one of the proposed uses.

During the process of evaluation and decision-making, the Member State shall cooperate with the
applicants in order to resolve any questions on the dossier quickly or to identify at an early stage any
additional studies necessary for a proper evaluation of the dossier, or to amend any proposed conditions
for the use of the plant protection product or to modify its nature or its composition in order to ensure
full satisfaction of the requirements of this Annex or of this Directive.

Member States shall normally come to a reasoned decision within 12 months of receiving a technically
complete dossier. A technically complete dossier is one that satisfies all the requirements of Annex IIIB.

The judgements made by the competent authorities of the Member States during the evaluation and
decision-making process must be based on scientific principles, preferably recognised at international
level, and be made with the benefit of expert advice.

A microbial plant protection product may contain viable and non-viable micro-organisms (including
viruses) and formulation substances. It may also contain relevant metabolites/toxins produced during
growth, residues from the growth medium, and microbial contaminants. The micro-organism, relevant
metabolites/toxins and the plant protection product with residual growth medium and microbial
contaminants present must all be evaluated.

5.

6.

7.

8. Member States must take into account those guidance documents taken note of in the Standing

Committee on the Food Chain and Animal Health (SCFCAH).

9.

For genetically modified micro-organisms, Directive 2001/18/EC of the European Parliament and of the
Council of 12 March 2001 on the deliberate release into the environment of genetically modified
organisms (1), must be taken into account. The evaluation completed in the framework of that Directive
must be provided and taken into account.

10. Definitions and explanations of microbiological terms

Antibiosis: A relationship between two or more species in which one species is actively harmed (as by the
production of toxins by the harming species).

(1)

OJ L 106, 17.4.2001, p. 1. Directive as last amended by Regulation (EC) No 1830/2003 (OJ L 268, 18.10.2003, p. 24).

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Antigenic: Any substance that, as a result of coming in contact with appropriate cells, induces a state of
sensitivity and/or immune responsiveness after a latent period (days to weeks) and which reacts in a
demonstrable way with antibodies and/or immune cells of the sensitised subject in vivo or in vitro.

Antimicrobial: Antimicrobial agents or antimicrobial(s) refer to naturally occurring, semi-synthetic or
synthetic substances that exhibit antimicrobial activity (kill or inhibit the growth of micro-organisms).

The term ‘Antimicrobial(s)’ includes:

— 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.

CFU: Colony-forming unit; one or more cells that grow to form a single visible colony.

Colonisation: Proliferation and persistence of a micro-organism in an environment, such as on external
(skin) or internal body surfaces (intestine, lungs). For colonisation, the micro-organism should at least
persist for a longer period than expected in a specific organ. The population of micro-organisms may
decline but at a slower rate than normal clearance; it may be a steady population or it may be a growing
population. Colonisation can be related to harmless and functional micro-organisms as well as to
pathogenic micro-organisms. The possible occurrence of effects is not indicated.

Ecological niche: Unique environmental position occupied by a particular species, perceived in terms of
actual physical space occupied and function performed within the community or ecosystem.

Host: An animal (including humans) or plant that harbours or nourishes another organism (parasite).

Host specificity: The range of different host-species that can be colonised by a microbial species or strain.
A host-specific micro-organism colonises or has adverse effects on one or only a small number of different
host-species. A non-host-specific micro-organism might colonise or might have adverse effects on a broad
range of different host-species.

Infection: The introduction or entry of a pathogenic micro-organism into a susceptible host, whether or
not it causes pathological effects or disease. The organism must enter the body of the host, usually the
cells, and be able to reproduce to form new infective units. Simply ingesting a pathogen does not imply
infection.

Infective: Capable of transmitting an infection.

Infectivity: The characteristics of a micro-organism that allow it to infect a susceptible host.

Invasion: The entry of a micro-organism into the host body (e.g. actual penetration of the integument, gut
epithelial cells, etc.). ‘Primary invasiveness’ is a property of pathogenic micro-organisms.

Multiplication: Ability of a micro-organism to reproduce and increase in numbers during an infection.

Mycotoxin: A fungal toxin.

Non-viable micro-organism: A micro-organism that is not capable of replication or of transferring genetic
material.

Non-viable residue: A residue that is not capable of replication or of transferring genetic material.

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Pathogenicity: The ability of a micro-organism to cause disease and/or inflict damage on the host. Many
pathogens cause disease by a combination of (i) toxicity and invasiveness or (ii) toxicity and colonising
ability. However, some invasive pathogens cause disease that results from an abnormal reaction of the
host's defence system.

Symbiosis: A type of interaction between organisms where one organism lives in intimate association with
another, which is favourable for both organisms.

Viable micro-organism: A micro-organism that is capable of replication or of transferring genetic material.

Viable residue: A residue that is capable of replication or of transferring genetic material.

Viroid: Any of a class of infectious agents consisting of a small strand of RNA not associated with any
protein. The RNA does not code for proteins and is not translated; it is replicated by host cell enzymes.
Viroids are known to cause several plant diseases.

Virulence: Measurement of the degree of disease producing ability of a micro-organism as indicated by the
severity of the disease produced. Measure of the dosage (inoculum size) required to cause a specific degree
of pathogenicity. It is measured experimentally by the median lethal dose (LD50) or median infective dose
(ID50).

B.

EVALUATION

The objective of an evaluation is to identify and assess, on a scientific basis and until further experience is
reached on a case-by-case basis, potential adverse effects on human and animal health and the environment of
the use of a microbial plant protection product. The evaluation shall also be carried out in order to identify the
need for risk management measures and to identify and recommend suitable measures.

Due to the ability of micro-organisms to replicate, there is a clear difference between chemicals and micro-
organisms used as plant protection products. Hazards arising are not necessarily of the same nature as those
presented by chemicals, especially in relation to the capacity of micro-organisms to persist and multiply in
different environments. Moreover, micro-organisms consist of a wide range of different organisms, all with their
own unique characteristics. These differences between micro-organisms should be taken into account in the
evaluation.

The micro-organism in the plant protection product should ideally function as a cell factory working directly on
the spot where the target organism is harmful. Thus understanding the mode of action is a crucial step in the
evaluation process.

Micro-organisms may produce a range of different metabolites (e.g. bacterial toxins or mycotoxins) many of
which may have toxicological significance, and one or more of which may be involved in the mode of action of
the plant protection product. The characterisation and identification of relevant metabolites should be assessed
and the toxicity of these metabolites should be addressed. Information on production and/or relevance of
metabolites may be deduced from:

(a)

toxicity studies,

(b)

biological properties of the micro-organism,

(c)

relationship to known plant, animal or human pathogens,

(d) mode of action,

(e)

analytical methods.

On the basis of this information, metabolites may be considered as possibly being relevant. Therefore potential
exposure to these metabolites should be assessed, in order to decide on their relevance.

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1.

General principles

1.1.

Having regard to current scientific and technical knowledge, Member States shall evaluate the
information provided in accordance with the requirements of Annex IIB and IIIB and in particular:

(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
protection product for each use for which authorisation is sought.

the plant

1.2.

The quality/methodology of tests, where there are no standardised test methods, must be evaluated and
the following characteristics, when available, of the methods described must be assessed:

relevance;
predictiveness.

representativeness;

sensitivity;

specificity;

reproducibility;

interlaboratory validations;

1.3.

In interpreting the results of evaluations, Member States shall take into consideration possible elements
of uncertainty in the information obtained during the evaluation, in order to ensure that the chances of
failing to detect adverse effects or of underestimating their importance are reduced to a minimum. The
decision-making process shall be examined to identify critical decision points or items of data for which
uncertainties could lead to a false classification of risk.

The first evaluation made shall be based on the best available data or estimates reflecting the realistic
conditions of use of the plant protection product. This must be followed by a repeat evaluation, taking
account of potential uncertainties in the critical data and of a range of use conditions that are likely to
occur and resulting in a realistic worst-case approach, to determine whether it is possible that the initial
evaluation could have been significantly different.

1.4.

1.5.

Member States shall evaluate each microbial plant protection product for which an application for
authorisation is made in that Member State — the information evaluated for the micro-organism can be
taken into account. Member States must take into account the fact that any co-formulants might have
an impact on the characteristics of the plant protection product compared to the micro-organism.

In evaluating applications and granting authorisations Member States shall consider the proposed
practical conditions of use and in particular the purpose of use, the dose, the manner, frequency and
timing of applications, and the nature and composition of the plant protection product. Whenever
possible Member States shall also take into account the principles of integrated pest control.

1.6.

In the evaluation, Member States shall consider the agricultural, plant health or environmental
(including climatic) conditions in the areas of use.

1.7. Where specific principles in Section 2 provide for the use of calculation models in the evaluation of a

plant protection product, those models shall:

(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,

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(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.

1.8.

The data requirements, specified in Annex IIB and IIIB, contain guidance as to when and how certain
information must be submitted and as to procedures that must be followed when preparing and
evaluating a dossier. That guidance must be respected.

2.

Specific principles

Member States shall implement the following principles in the evaluation of the data and information
submitted in support of applications, without prejudice to the general principles prescribed in
Section 1:

2.1.

Identity

2.1.1.

Identity of the micro-organism in the plant protection product

the micro-organism should be clearly established.

The identity of
It must be ensured that the
appropriate data are provided to allow for checking the identity of the micro-organism at strain level in
the plant protection product.

The identity of the micro-organism shall be evaluated on the strain level. Where the micro-organism is
either a mutant or a genetically modified organism (1), the specific differences from other strains within
the same species must be recorded. Occurrence of resting stages must be recorded.

The deposition of the strain at an internationally recognised culture collection must be checked.

2.1.2.

Identity of the plant protection product

Member States shall evaluate the detailed quantitative and qualitative information provided on the
composition of the plant protection product, such as that concerning the micro-organism (see above),
relevant metabolites/toxins, residual growth medium, co-formulants and microbial contaminants
present.

2.2.

Biological, physical, chemical, and technical properties

2.2.1. Biological properties of the micro-organism in the plant protection product

2.2.1.1. The origin of the strain, where relevant,

its natural habitat including indications on the natural
background level, life cycle and the possibilities for survival, colonisation, reproduction and dispersal
must be evaluated. Proliferation of indigenous micro-organisms should after a short growth period level
off and continue as for the background micro-organisms.

2.2.1.2. The ability of micro-organisms to adapt to the environment must be evaluated. In particular, Member

States must take account of the following principles:

(a)

(b)

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;

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;

(1)

See definition of ‘genetically modified’ in Directive 2001/18/EC.

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(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.

2.2.1.3. The mode of action of the micro-organism should be evaluated in as much detail as appropriate. The
possible role of metabolites/toxins for the mode of action should be evaluated and when identified, the
minimal effective concentration for each active metabolite/toxin should be established. Information on
mode of action can be a very valuable tool in identifying potential risks. Aspects to be considered in the
evaluation, are:

(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.

2.2.1.4. In order to evaluate possible effects on non-target organisms, information on the micro-organism's host
specificity must be evaluated, taking into account the characteristics and properties described in (a) and
(b).

(a)

(b)

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.

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.

2.2.1.5. Many micro-organisms produce antibiosis substances that cause normal interferences in the microbial
community. Resistance to antimicrobial agents of importance for human and veterinary medicine must
be assessed. The possibility for transfer of genes that code for resistance to antimicrobial agents must be
evaluated.

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2.2.2. Physical, chemical and technical properties of the plant protection product

2.2.2.1. Depending on the nature of the micro-organism and the formulation type, the technical properties of

the plant protection product must be evaluated.

2.2.2.2. Shelf-life and storage stability of the preparation must be evaluated, taking into account possible
changes in composition such as growth of the micro-organism or of contaminating micro-organisms,
production of metabolites/toxins, etc.

2.2.2.3. Member States shall evaluate the physical and chemical properties of the plant protection product and

the retention of these characteristics after storage and take into consideration:

(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.

2.2.2.4. Where the proposed label claims include requirements or recommendations for use of the preparation
with other plant protection products or adjuvants as a tank mix, and/or where the proposed label
includes indications concerning the compatibility of the preparation with other plant protection
products as a tank mix, those plant protection products or adjuvants must be physically and chemically
compatible in the tank mix. Biological compatibility must also be demonstrated for tank-mixtures, i.e. it
must be shown that each plant protection product in the mixture performs as expected and that no
antagonism occurs.

2.3.

Further information

2.3.1. Quality control of the production of the micro-organism in the plant protection product

The quality assurance criteria proposed for production of the micro-organism must be evaluated. In the
evaluation criteria relating to process control, good manufacturing practice, operational practices,
process flows, cleaning practices, microbial monitoring and hygiene conditions should be taken into
account to ensure good quality of the micro-organism. The quality, stability, purity etc., of the micro-
organism must be addressed in the quality control system.

2.3.2. Quality control of the plant protection product

The quality assurance criteria proposed must be evaluated. If the plant protection product contains
metabolites/toxins produced during growth and residues from the growth medium this should be
evaluated. The possibility of the occurrence of contaminating micro-organisms must be evaluated.

2.4.

Efficacy

2.4.1. Where the proposed use concerns the control of or protection against an organism, Member States shall
evaluate the possibility that this organism could be harmful under the agricultural, plant health and
environmental (including climatic) conditions in the area of the proposed use.

2.4.2. Member States shall evaluate whether significant damage, loss or inconvenience could occur under the
agricultural, plant health and environmental (including climatic) conditions in the area of proposed use
if the plant protection product were not used.

2.4.3. Member States shall evaluate the efficacy data provided for in Annex IIIB on the plant protection
product having regard to the degree of control or the extent of the effect desired and having regard to
relevant experimental conditions such as:

(a)

the choice of the crop or cultivar,

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(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.

2.4.4. Member States shall evaluate the performance of the plant protection product under the range of
agricultural, plant health and environmental (including climatic) conditions likely to be encountered in
practice in the area of proposed use. The effect on integrated control must be included in the evaluation.
In particular, consideration should be paid to:

(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
(including climatic) conditions likely to be
agricultural, plant health and environmental
encountered in practice in the area of proposed use.

2.4.5. Member States shall evaluate the degree of adverse effects on the treated crop after use of the plant
protection product according to the proposed conditions of use in comparison, where relevant, with a
suitable reference product or products, where they exist, and/or an untreated control.

(a)

This evaluation will take into consideration the following information:

(i)

efficacy data;

(ii)

other relevant information on the plant protection product such as nature of the plant
protection product, dose, method of application, number and timing of applications,
incompatibility with other crop treatments;

(iii)

all relevant information on the micro-organism, including biological properties e.g. mode of
action, survival, host specificity.

(b)

This evaluation will include:

(i)

the nature, frequency, level and duration of observed phytotoxic/phytopathogenic effects
and the agricultural, plant health and environmental (including climatic) conditions that
affect them;

(ii)

differences between main cultivars with regard to their
phytopathogenic effects;

sensitivity to phytotoxic/

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(iii)

the part of the treated crop or plant products where phytotoxic/phytopathogenic effects are
observed;

(iv)

adverse impact on the yield of the treated crop or plant products in terms of quantity and/or
quality;

(v)

adverse impact on treated plants or plant products to be used for propagation, in terms of
viability, germination, sprouting, rooting and establishment;

(vi) where micro-organisms are disseminated, the adverse impact on adjacent crops.

2.4.6. Where the plant protection product label includes requirements for use of the plant protection product
with other plant protection products and/or with adjuvants as a tank mix, Member States shall make the
evaluations referred to in points 2.4.3 to 2.4.5 in relation to the information supplied for the tank mix.

Where the plant protection product label includes recommendations for use of the plant protection
product with other plant protection products and/or with adjuvants as a tank mix, Member States shall
evaluate the appropriateness of the mix and of its conditions of use.

2.4.7. Where the available data indicate that the micro-organism or significant relevant metabolites/toxins,
degradation and reaction products of the formulants persist in soils and/or in or on plant substances in
significant quantities after use of the plant protection product according to the proposed conditions of
use, Member States shall evaluate the degree of adverse effects on subsequent crops.

2.4.8. Where the proposed use of a plant protection product is intended to have an effect on vertebrates,
Member States shall evaluate the mechanism by which this effect is obtained and the observed effects on
the behaviour and health of the target animals. When the intended effect is to kill the target animal they
shall evaluate the time necessary to obtain the death of the animal and the conditions under which
death occurs.

This evaluation will take into consideration the following information:

(a)

(b)

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

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

2.5.

Identification/detection and quantification methods

Member States shall evaluate the analytical methods proposed for post-registration control and
monitoring purposes of the viable and non-viable components both in the formulation and as residues
in or on treated crops. Sufficient validation is required for pre-authorisation methods and post-
authorisation monitoring methods. Methods that are considered suitable for post-authorisation
monitoring must be clearly identified.

2.5.1. Analytical methods for the plant protection product

2.5.1.1. Non-viable components

Member States shall evaluate the analytical methods proposed to identify and quantify the
toxicologically, ecotoxicologically or environmentally significant non-viable components resulting
from the micro-organism and/or present as impurity or co-formulant (including eventually resulting
breakdown and/or reaction products thereof).

This evaluation will take into consideration the information on analytical methods provided for in
Annex IIB and IIIB and the results of the evaluation thereof. In particular, the following information
must be taken into account:

(a)

the specificity and linearity of the proposed methods,

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(b)

the precision (repeatability) of the proposed methods,

(c)

the importance of interferences,

(d)

the accuracy of the proposed methods at appropriate concentrations,

(e)

the limit of quantification of the proposed methods.

2.5.1.2. Viable components

Member States shall evaluate the methods proposed to quantify and identify the specific strain
concerned and especially methods that discriminate that strain from closely related strains.

This evaluation will take into consideration the information on analytical methods provided for in
Annex IIB and IIIB and the results of the evaluation thereof. In particular, the following information
must be taken into account:

(a)

the specificity of the proposed methods,

(b)

the precision (repeatability) of the proposed methods,

(c)

the importance of interferences,

(d)

the quantifiability of the proposed methods.

2.5.2. Analytical methods for the determination of residues

2.5.2.1. Non-viable residues

Member States shall evaluate the analytical methods proposed to identify and quantify the
toxicologically, ecotoxicologically or environmentally significant non-viable residues resulting from
the micro-organism (including eventually resulting breakdown and/or reaction products thereof).

This evaluation will take into consideration the information on analytical methods provided for in
Annex IIB and IIIB and the results of the evaluation thereof. In particular, the following information
must be taken into account:

(a)

the specificity and linearity of the proposed methods,

(b)

the precision (repeatability) of the proposed methods,

(c)

the reproducibility (independent laboratory validation) of the proposed methods,

(d)

the importance of interferences,

(e)

the accuracy of the proposed methods at appropriate concentrations,

(f)

the limit of quantification of the proposed methods.

2.5.2.2. Viable residues

Member States shall evaluate the methods proposed to identify the specific strain concerned and
especially methods that discriminate that strain from closely related strains.

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This evaluation will take into consideration the information on analytical methods provided for in
Annex IIB and IIIB and the results of the evaluation thereof. In particular, the following information
must be taken into account:

(a)

the specificity of the proposed methods,

(b)

the precision (repeatability) of the proposed methods,

(c)

the importance of interferences,

(d)

the quantifiability of the proposed methods.

2.6.

Impact on human or animal health

The impact on human or animal health must be evaluated. In particular, Member States must take
account of the following principles:

(a)

(b)

(c)

(d)

due to the ability of micro-organisms to replicate, there is a clear difference between chemicals and
micro-organisms used as plant protection products. Hazards arising are not necessarily of the
same nature as those presented by chemicals, especially in relation to the capacity of micro-
organisms to persist and multiply in different environments;

the pathogenicity of the micro-organism to humans and non-target animals, the infectiveness of
the micro-organism, the ability of the micro-organism to colonise, the toxicity of metabolites/
toxins as well as the toxicity of the residual growth medium, contaminants and co-formulants, are
important endpoints in assessing adverse effects arising from the plant protection product;

colonisation, infectiveness and toxicity comprise a complex set of interactions between micro-
organisms and hosts and these endpoints may not be resolved easily as independent endpoints;

in combining these endpoints, the most important aspects of the micro-organism that must be
assessed are:

— 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;

(e) moreover, the complexity of the biological issues should be taken into account in evaluating the
hazards and risks presented by use of these plant protection products for human and animals. An
assessment of pathogenicity and infectiveness is necessary even if the potential of exposure is
deemed low;

(f)

for risk assessment purposes the acute toxicity studies used should, where available, include at
least two doses (e.g. one very high dose and one corresponding to the expected exposure under
practical conditions).

2.6.1.

Effects on human or animal health arising from the plant protection product

2.6.1.1. Member States shall evaluate operator exposure to the micro-organism, and/or to toxicologically
relevant compounds in the plant protection product (e.g. their metabolites/toxins, residual growth
medium, contaminants and co-formulants), likely to occur under the proposed conditions of use
(including in particular dose, application method and climatic conditions). Realistic data on exposure
levels must be used and, if such data are not available, a suitable, validated calculation model. When
available, a European harmonised generic exposure database for plant protection products should be
used.

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(a)

This evaluation will take into consideration the following information:

(i)

the medical data and the toxicity, infectivity and pathogenicity studies as 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 fast and complete clearance from the body, no activation of
the immune system, no histopathological changes, and for replication temperatures far
below or far above 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;

(ii)

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);

(iii)

the toxicological studies provided for in Annex IIIB;

(iv) other relevant information provided for in Annex IIIB such as:

— composition of the preparation,

— nature of the preparation,

— size, design and type of packaging,

— field of use and nature of the crop or target,

— method of application including handling, loading and mixing of the plant protection

product,

— exposure reduction measures recommended,

— protective clothing recommendations,

— maximum application rate,

— minimum spray application volume stated on the label,

— number and timing of applications.

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(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:

— persistence or growth of the micro-organism in the host,

— adverse effects observed,

— observed or expected effects of contaminants (including contaminating micro-organisms),

— observed or expected effects of relevant metabolites/toxins.

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.

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.

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.

(c)

(d)

2.6.1.2. Member States shall examine information relating to the nature and characteristics of the packaging

proposed with particular reference to the following aspects:

(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.

2.6.1.3. Member States shall examine the nature and characteristics of the protective clothing and equipment

proposed with particular reference to the following aspects:

(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.

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2.6.1.4. Member States shall evaluate the possibility of exposure of other humans (workers exposed after the
application of the plant protection product, such as re-entering workers, or bystanders) or animals to
the micro-organism and/or to other toxicologically relevant compounds in the plant protection product
under the proposed conditions of use. This evaluation will take into consideration the following
information:

(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:

— re-entry periods, necessary waiting periods or other precautions to protect humans and

animals,

— method of application, in particular spraying,

— maximum application rate,

— minimum spray application volume,

— composition of the preparation,

— excess remaining on plants and plant products after treatment, taking into account the
factors such as temperature, UV light, pH and the presence of certain

influence of
substances,

— further activities whereby workers are exposed.

2.6.2. Effects on human or animal health arising from residues

In the evaluation, non-viable and viable residues must be addressed separately. Viruses and viroids
should be considered as viable residues since they are capable of transferring genetic material, although
strictly speaking they are not living.

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2.6.2.1. Non-viable residues

(a) Member States shall evaluate the possibility of exposure of humans or animals to non-viable
residues and their degradation products via the food chain due to the possible occurrence of such
residues in or on edible parts of treated crops. In particular, the following information should be
taken into account:

— 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
temperature, UV light, pH and the presence of certain substances),

factors such as

— 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.

(b) Member States shall evaluate the toxicity of non-viable residues and their degradation products
having regard in particular to the specific information provided in accordance with Annex IIB and
IIIB.

(c) Where non-viable residues or their degradation products are considered toxicologically relevant
for humans and/or animals and when exposure is not considered negligible, the actual levels in or
on the edible parts of treated crops should be determined, taking into consideration:

— 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).

2.6.2.2. Viable residues

(a) Member States shall evaluate the possibility of exposure of humans or animals to viable residues
via the food chain due to the possible occurrence of such residues in or on edible parts of treated
crops. In particular, the following information should be taken into account:

— 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,

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— 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.

(b) Member States shall evaluate the specific information concerning the ability of viable residues to
persist or grow in the host and the ability of such residues to cause effects/reactions in the host. In
particular, the following information should be taken into account:

— 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.

(c)

In the event that viable residues are considered to be toxicologically relevant for humans and/or
animals and if exposure is not considered negligible, the actual levels in or on the edible parts of
treated crops should be determined, taking into consideration:

— 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.

2.7.

Fate and behaviour in the environment

The biocomplexity of the ecosystems and interactions in the microbial communities concerned must be
taken into account.

Information on the origin and properties (e.g. specificity) of
the micro-organism/its residual
metabolites/toxins and its intended use forms the basis for an assessment of environmental fate and
behaviour. The mode of action of the micro-organism should be taken into consideration.

An assessment shall be made of the fate and behaviour of any known relevant metabolite that is
produced by the micro-organism. The assessment shall be made for each environmental compartment,
and shall be triggered on the basis of the criteria specified in section 7 (iv) of Annex IIB.

In the assessment of the environmental fate and behaviour of plant protection products, Member States
shall have regard to all aspects of the environment, including biota. The potential for persistence and
multiplication of micro-organisms has to be assessed in all environmental compartments unless it can
be justified that particular micro-organisms will not reach a specific compartment. The mobility of
micro-organisms and their residual metabolites/toxins must be considered.

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2.7.1. Member States shall evaluate the possibility of contamination of ground water, surface water and

drinking water under the proposed conditions of use of the plant protection product.

In the overall assessment, Member States should pay particular attention to potential adverse effects on
humans through groundwater contamination, when the active substance is applied in regions with
vulnerable conditions, such as drinking water abstraction areas.

2.7.2. Member States shall evaluate the risk for the aquatic compartment where the possibility of the exposure
of aquatic organisms has been established. A micro-organism may give rise to risks because of its
potential through multiplication to establish itself in the environment and can therefore have a long-
lasting or permanent impact on microbial communities or their predators.

This evaluation will take into consideration the following information:

(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 (1),

(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.

2.7.3. Member States shall evaluate the possibility of exposure of organisms in the atmosphere to the plant
protection product under the proposed conditions of use; if this possibility exists they shall evaluate the
risk for the atmosphere. The transport, short-range and long-range, of the micro-organism in the
atmosphere should be taken into account.

2.7.4. Member States shall evaluate the possibility of exposure of organisms in the terrestrial compartment to
the plant protection product under the proposed conditions of use; if this possibility exists they shall
evaluate the risks arising for the terrestrial compartment. A micro-organism may give rise to risks
because of its potential through multiplication to establish itself in the environment and can therefore
have a long-lasting or permanent impact on microbial communities or their predators.

This evaluation will take into consideration the following information:

(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,

(1)

OJ L 330, 5.12.1998, p. 32. Directive as last amended by Regulation (EC) No 1882/2003 of the European Parliament and of
the Council (OJ L 284, 31.10.2003, p. 1).

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(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.

2.8.

Effects on and exposure of non-target organisms

Information on the ecology of the micro-organism and effects on the environment should be assessed
as well as possible exposure levels and the effects of its relevant metabolites/toxins. An overall
assessment of the environmental risks that the plant protection product may cause, taking into account
the normal levels of exposure to micro-organisms both in the environment as well as in the body of
organisms, is necessary.

Member States shall evaluate the possibility of exposure of non-target organisms under the proposed
conditions of use and if this possibility exists they shall evaluate the risks arising for the non-target
organisms concerned.

Where applicable, an assessment of infectivity and pathogenicity is necessary, unless it can be justified
that non-target organisms will not be exposed.

To assess the possibility of exposure the following information should also be taken into consideration:

(a)

the survival of the micro-organism in the respective compartment,

(b)

its ecological niche,

(c)

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

(d)

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

(e) 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.

2.8.1. Member States shall evaluate the possibility of exposure of and effects on terrestrial wildlife (non-

domestic birds, mammals and other terrestrial vertebrates).

2.8.1.1. A micro-organism may give rise to risks because of its potential to infect and multiply in avian and
mammalian host systems. Whether or not identified risks could be changed due to the formulation of
the plant protection product shall be assessed, taking into account the following information on the
micro-organism:

(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.

2.8.1.2. A plant protection product may give rise to toxic effects due to the action of toxins or co-formulants.

For the assessment of such effects, the following information should be taken into consideration:

(a)

studies on mammalian toxicity,

(b)

studies on avian toxicity,

(c)

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

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If mortality or signs of intoxication are observed in the tests the evaluation must include a calculation of
toxicity/exposure ratios based on the quotient of the LD50 value and the estimated exposure expressed
in mg/kg body weight.

2.8.2. Member States shall evaluate the possibility of exposure of and effects on aquatic organisms.

2.8.2.1. A micro-organism may give rise to risks because of its potential to infect and multiply in aquatic
organisms. Whether or not identified risks could be changed due to the formulation of the plant
protection product shall be assessed, taking into account the following information on the micro-
organism:

(a)

its mode of action,

(b)

other biological properties,

(c)

studies on toxicity, pathogenicity and infectivity.

2.8.2.2. A plant protection product may give rise to toxic effects due to the action of toxins or co-formulants.

For the assessment of such effects the following information should be taken into consideration:

(a)

studies on toxicity to aquatic organisms,

(b)

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

If mortality or signs of intoxication are observed in the tests the evaluation must include a calculation
of toxicity/exposure ratios based on the quotient of the EC50 value and/or the NOEC value and the
estimated exposure.

2.8.3. Member States shall evaluate the possibility of exposure of and effects on bees.

2.8.3.1. A micro-organism may give rise to risks because of its potential to infect and multiply in bees. Whether
or not identified risks could be changed due to the formulation of the plant protection product shall be
assessed, taking into account the following information on the micro-organism:

(a)

its mode of action,

(b)

other biological properties,

(c)

studies on toxicity, pathogenicity and infectivity.

2.8.3.2. A plant protection product may give rise to toxic effects due to the action of toxins or co-formulants.

For the assessment of such effects the following information should be taken into consideration:

(a)

studies on toxicity to bees,

(b)

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

If mortality or signs of intoxication are observed in the tests the evaluation must include a calculation
of the hazard quotient, based on the quotient of the dose in g/ha and the LD50 value in μg/bee.

2.8.4. Member States shall evaluate the possibility of exposure of and effects on arthropods other than bees.

2.8.4.1. A micro-organism may give rise to risks because of its potential to infect and multiply in arthropods
other than bees. Whether or not identified risks could be changed due to the formulation of the plant
protection product shall be assessed, taking into account the following information on the micro-
organism:

(a)

its mode of action,

(b)

other biological properties,

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(c)

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

2.8.4.2. A plant protection product may give rise to toxic effects due to the action of toxins or co-formulants.

For the assessment of such effects the following information should be taken into consideration:

(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.

If mortality or signs of intoxication are observed in the tests the evaluation must include a calculation
of toxicity/exposure ratios based on the quotient of the ER50 value (effective rate) and the estimated
exposure.

2.8.5. Member States shall evaluate the possibility of exposure of and effects on earthworms.

2.8.5.1. A micro-organism may give rise to risks because of its potential to infect and multiply in earthworms.
Whether or not identified risks could be changed due to the formulation of the plant protection
product shall be assessed, taking into account the following information on the micro-organism:

(a)

its mode of action,

(b)

other biological properties,

(c)

studies on earthworm toxicity, pathogenicity and infectivity.

2.8.5.2. A plant protection product may give rise to toxic effects due to the action of toxins or co-formulants.

For the assessment of such effects the following information should be taken into consideration:

(a)

studies on earthworm toxicity,

(b)

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

If mortality or signs of intoxication are observed in the tests the evaluation must include a calculation
of toxicity/exposure ratios based on the quotient of the LC50 value and the estimated exposure
expressed in mg/kg dry weight soil.

2.8.6. Member States shall evaluate the possibility of exposure of and effects on soil micro-organisms.

2.8.6.1. A micro-organism may give rise to risks because of its potential to interfere with nitrogen and carbon
mineralisation in the soil. Whether or not identified risks could be changed due to the formulation of
the plant protection product shall be assessed, taking into account the following information on the
micro-organism:

(a)

its mode of action,

(b)

other biological properties.

Experimental data are not normally required, i.e. where it can be justified that a proper risk assessment
can be performed with the available information.

2.8.6.2. Member States shall evaluate the impact of exotic/non-indigenous micro-organisms on non-target
micro-organisms and on their predators following use of the plant protection product according to the
proposed conditions of use. Experimental data are not normally required, i.e. where it can be justified
that a proper risk assessment can be performed with the available information.

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2.8.6.3. A plant protection product may give rise to toxic effects due to the action of toxins or co-formulants.

For the assessment of such effects the following information should be taken into consideration:

(a)

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

(b)

all available information from biological primary screening.

2.9.

Conclusions and proposals

Member States shall draw conclusions on the need for further information and/or testing and the need
for measures to limit the risks arising. Member States shall justify proposals for the classification and
labelling of plant protection products.

C. DECISION-MAKING

1.

General principles

1.1. Where appropriate, Member States shall impose conditions or restrictions on the authorisations they
grant. The nature and severity of these conditions or restrictions must be selected on the basis of, and
be appropriate to, the nature and extent of the expected advantages and the risks likely to arise.

1.2.

1.3.

1.4.

1.5.

Member States shall ensure that decisions taken to grant authorisations, take account of the agricultural,
plant health or environmental (including climatic) conditions in the areas of envisaged use. Such
considerations may result in specific conditions and restrictions on use, and, in authorisation being
granted for some but not other areas within the Member State in question.

Member States shall ensure that the authorised amounts, in terms of rates and number of applications,
are the minimum necessary to achieve the desired effect even where higher amounts would not result in
unacceptable risks to human or animal health or to the environment. The authorised amounts must be
differentiated according to, and be appropriate to, the agricultural, plant health or environmental
(including climatic) conditions in the various areas for which an authorisation is granted. However, the
rates and the number of applications may not give rise to undesirable effects such as the development of
resistance.

Member States shall ensure that decisions respect the principles of integrated pest control if the plant
protection product is intended for use in conditions where these principles are relied on.

Since the evaluation is to be based on data concerning a limited number of representative species,
Member States shall ensure that use of plant protection products does not have any long-term
repercussions for the abundance and diversity of non-target species.

1.6.

Before issuing an authorisation, Member States shall ensure that the label of the plant protection
product:

(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,

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(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 (1).

1.7.

Before issuing authorisations, Member States shall:

(a)

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

(b)

ensure that:

— the procedures for destruction of the plant protection product,

— the procedures for neutralisation of any adverse effects of the plant protection product if it is

accidentally dispersed, and

— the procedures for the decontamination and destruction of the packaging,

are in accordance with the relevant regulatory provisions.

1.8.

No authorisation shall be granted unless all the requirements referred to in point 2 are satisfied.
However, when one or more of the specific decision-making requirements referred to in point 2.4 are
not fully satisfied, authorisations shall be granted only where the advantages of the use of the plant
protection product under the proposed conditions of use outweigh the possible adverse effects of its
use. Any restrictions on use of the plant protection product relating to non-compliance with some of
the requirements referred to in point 2.4 must be mentioned on the label. These advantages can be in
terms of:

(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.

1.9. Where an authorisation has been granted according to the requirements provided for in this Annex,

Member States may, by virtue of Article 4(6):

(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.

Member States shall inform applicants of any measures identified under (a) or (b) and shall invite
applicants to provide any supplementary data and information necessary to demonstrate performance
or potential risks arising under the changed conditions.

(1)

OJ L 200, 30.7.1999, p. 1. Directive as last amended by Directive 2004/66/EC (OJ L 168, 1.5.2004, p. 35).

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1.10. Member States shall ensure, as far as is practically possible, that for all micro-organisms that are
considered for an authorisation, the applicant has taken into account all available relevant knowledge
and information in literature at the time of submission.

1.11. Where the micro-organism has been genetically modified, as defined in Directive 2001/18/EC, no
authorisation shall be granted unless the evaluation conducted in accordance with Directive 2001/18/
EC has been submitted, as required under Article 1(3) of that Directive. The relevant decision taken by
the competent authorities in accordance with Directive 2001/18/EC must be provided.

1.12.

In accordance with Article 1(3) of this Directive, no authorisation shall be granted for a plant protection
product containing a genetically modified organism unless authorisation is granted according to the
provisions in Directive 2001/18/EC, part C, under which that organism can be released into the
environment.

1.13. No authorisation shall be granted if relevant metabolites/toxins (i.e. those expected to be of concern for
human health and/or the environment) known to be formed by the micro-organism, and/or by
microbial contaminants are present in the plant protection product, unless it can be shown that the
amount present is at an acceptable level before and after its proposed use.

1.14. Member States shall ensure that adequate quality control measures are applied to ensure the identity of
the micro-organism and contents of the plant protection product. Such measures must include a
Hazard Analysis Critical Control Point (HACCP) system or equivalent system.

2.

Specific principles

The specific principles shall apply without prejudice to the general principles referred to in Section 1.

2.1.

Identity

For each authorisation granted the Member States shall ensure that the micro-organism concerned is
deposited at an internationally recognised culture collection and has an accession number. Each micro-
organism must be identified and named at the species level and characterised at the strain level. There
must also be information as to whether or not the micro-organism is a wild type or a spontaneous or
induced mutant, or a genetically modified organism.

2.2.

Biological and technical properties

2.2.1. There must be sufficient information to permit assessment of the minimum and maximum content of
the micro-organism in the material used for the manufacturing of plant protection products, as well as
in the plant protection product. The content of other components and formulants in the plant
protection product and contaminating micro-organisms derived from the production process must to
the extent possible be defined. Member States shall ensure that the level of contaminating organisms is
controlled to an acceptable level. In addition: the physical nature and state of the plant protection
product must be specified, preferably according to the ‘Catalogue of pesticide formulation types and
international coding system (CropLife International Technical Monograph No 2, 5th Edition, 2002)’.

2.2.2. No authorisation shall be granted if, at any stage in the development of a microbial plant protection
product, it becomes apparent, on the basis of a build-up of resistance, or transfer of resistance, or other
mechanism, that there may be interference with the effectiveness of an anti-microbial agent used in
human or animal medicine.

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2.3.

Further information

the production method, production process and plant protection product.

No authorisation shall be granted unless full information is provided on the continuous quality control
of
In particular, the
occurrence of spontaneous changes in major characteristics of the micro-organism and the absence/
presence of contaminating organisms shall be considered. The quality assurance criteria for production
and the techniques used to ensure a uniform plant protection product must to the extent possible be
described and specified.

2.4.

Efficacy

2.4.1.

Performance

2.4.1.1. No authorisation shall be granted where the proposed uses include recommendations for the control of
or protection against organisms which are not considered to be harmful on the basis of experience
acquired or scientific evidence under normal agricultural, plant health and environmental (including
climatic) conditions in the areas of proposed use or where the other intended effects are not considered
to be beneficial under those conditions.

2.4.1.2. The level, consistency and duration of control or protection or other intended effects must be similar to
those resulting from the use of suitable reference products. If no suitable reference product exists, the
plant protection product must be shown to give a defined benefit in terms of the level, consistency and
duration of control or protection or other intended effects under the agricultural, plant health and
environmental (including climatic) conditions in the area of proposed use.

2.4.1.3. Where relevant, yield response when the plant protection product is used and reduction of loss in
storage must be quantitatively and/or qualitatively similar to those resulting from the use of suitable
reference products. If no suitable reference product exists, the plant protection product must be shown
to give a consistent and defined quantitative and/or qualitative benefit in terms of yield response and
reduction of loss in storage under the agricultural, plant health and environmental (including climatic)
conditions in the area of proposed use.

2.4.1.4. Conclusions as to the performance of the preparation must be valid for all areas of the Member State in
which it is to be authorised, and for all conditions under which its use is proposed, except where the
proposed label specifies that the preparation is intended for use in certain specified circumstances (e.g.
light infestations, particular soil types or particular growing conditions).

2.4.1.5. Where proposed label claims include requirements for use of the preparation with other specified plant
protection products or adjuvants as a tank mix, the mixture must achieve the desired effect and comply
with the principles referred to in points 2.4.1.1 to 2.4.1.4.

Where proposed label claims include recommendations for use of the preparation with specified plant
protection products or adjuvants as a tank mix, Member States shall not accept the recommendations
unless they are justified.

2.4.1.6. If there is evidence of a development of resistance of pathogens towards the plant protection product,
the Member State shall decide if the submitted resistance management strategy addresses this adequately
and sufficiently.

2.4.1.7. Only plant protection products containing non-viable micro-organisms may be authorised for use to
control vertebrate species. The intended effect on vertebrates to be controlled shall be obtained without
unnecessary suffering and unnecessary pain for these animals.

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2.4.2. Absence of unacceptable effects on plants and plant products

2.4.2.1. There must be no relevant phytotoxic effects on treated plants or plant products except where the

proposed label indicates appropriate limitations of use.

2.4.2.2. There must be no reduction of yield at harvest due to phytotoxic effects below that which could be
obtained without the use of the plant protection product, unless this reduction is compensated for by
other advantages such as an enhancement of the quality of the treated plants or plant products.

2.4.2.3. There must be no unacceptable adverse effects on the quality of treated plants or plant products, except
in the case of adverse effects on processing where proposed label claims specify that the preparation
should not be applied to crops to be used for processing purposes.

2.4.2.4. There must be no unacceptable adverse effects on treated plants or plant products used for propagation
or reproduction, such as effects on viability, germination, sprouting, rooting and establishment, except
where proposed label claims specify that the preparation should not be applied to plants or plant
products to be used for propagation or reproduction.

2.4.2.5. There must be no unacceptable impact on succeeding crops, except where proposed label claims specify

that particular crops, which would be affected, should not be grown following the treated crop.

2.4.2.6. There must be no unacceptable impact on adjacent crops, except where proposed label claims specify

that the preparation should not be applied when particular sensitive adjacent crops are present.

2.4.2.7. Where proposed label claims include requirements for use of the preparation with other plant
protection products or adjuvants, as a tank mix, the mixture must comply with the principles referred
to in points 2.4.2.1 to 2.4.2.6.

2.4.2.8. The proposed instructions for cleaning the application equipment must be both practical and effective
so that they can be applied with ease so as to ensure the removal of residual traces of the plant
protection product which could subsequently cause damage.

2.5.

Identification/detection and quantification methods

The methods proposed must reflect the latest techniques. Methods for post-authorisation monitoring
should involve the use of commonly available reagents and equipment.

2.5.1. No authorisation shall be granted unless there is an adequate method of sufficient quality to identify and
quantify the micro-organism and non-viable components (e.g. toxins, impurities and co-formulants) in
the plant protection product. In the case of a plant protection product containing more than one micro-
organism, the recommended methods should be capable of identifying and determining the content of
each one.

2.5.2. No authorisation shall be granted unless there are adequate methods for post-registration control and
monitoring of viable and/or non-viable residues. Methods must be available for analysis of:

(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.

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2.6.

Impact on human and animal health

2.6.1.

Effects on human and animal health arising from the plant protection product

2.6.1.1. No authorisation shall be granted if on the basis of the information provided in the dossier it appears
that the micro-organism is pathogenic to humans or non-target animals under the proposed conditions
of use.

2.6.1.2. No authorisation shall be granted if the micro-organism and/or the plant protection product containing
the micro-organism might, under the recommended conditions of use, including a realistic worst case
scenario, colonise or cause adverse effects in humans or animals.

When making a decision on the authorisation of the microbial plant protection product, Member States
shall consider possible effects on all human populations, namely professional users, non-professional
users and humans exposed directly or indirectly though the environment and at work, and animals.

2.6.1.3. All micro-organisms should be regarded as potential sensitisers, unless it is established by means of
relevant information that there is no risk of sensitisation, taking into account immuno-compromised
and other sensitive individuals. Authorisations granted shall therefore specify that protective clothing
and suitable gloves be worn and that the plant protection product containing the micro-organism
should not be inhaled. Moreover, the proposed conditions of use may require use of additional items of
protective clothing and equipment.

Where the proposed conditions of use require use of items of protective clothing, no authorisation shall
be granted unless those items are effective and in accordance with relevant Community provisions, and
are readily obtainable by the user and unless it is feasible to use them under the conditions of use of the
plant protection product, taking into account climatic conditions in particular.

2.6.1.4. No authorisation shall be granted if it is known that transfer of genetic material from the micro-
organism to other organisms may lead to adverse effects on human and animal health, including
resistance to known therapeutic substances.

2.6.1.5. Plant protection products which, because of particular properties, or which, if mishandled or misused,
could lead to a high degree of risk must be subject to particular restrictions such as restrictions on the
size of packaging, formulation type, distribution, use or manner of use. Moreover, plant protection
products which are classified as very toxic may not be authorised for use by non-professional users.

2.6.1.6. Waiting and re-entry safety periods or other precautions must be established in such a way that no
colonisation of or adverse effects on bystanders or workers exposed after application of the plant
protection product are expected.

2.6.1.7. Waiting and re-entry safety periods or other precautions must be established in such a way that no

colonisation of or adverse effects on animals are expected.

2.6.1.8. Waiting and re-entry periods or other precautions to ensure that no colonisation or adverse effects are
expected must be realistic; if necessary, special precautionary measures must be prescribed.

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2.6.1.9. The conditions of authorisation shall be in compliance with Council Directive 98/24/EC of 7 April
1998 on the protection of the health and safety of workers from the risks related to chemical agents at
work (1), and Directive 2000/54/EC of the European Parliament and of the Council of 18 September
2000 on the protection of workers from risks related to exposure to biological agents at work (2). The
experimental data and information relevant to the recognition of the symptoms of infection or
first aid and therapeutic measures provided shall be
pathogenicity and on the effectiveness of
considered. The conditions of authorisation shall also be in compliance with Directive 2004/37/EC of
the European Parliament and of the Council of 29 April 2004 on the protection of workers from the
risks related to exposure to carcinogens or mutagens at work (3). The conditions of authorisation shall
also be in compliance with Council Directive 89/656/EEC of 30 November 1989 on the minimum
health and safety requirements for the use by workers of personal protective equipment at the
workplace (4).

2.6.2. Effects on human and animal health arising from residues

2.6.2.1. No authorisation shall be granted unless there is sufficient information for plant protection products
containing the micro-organism, to decide that there is no harmful effect on human or animal health
arising from exposure to the micro-organism, its residual traces and metabolites/toxins remaining in or
on plants or plant products.

2.6.2.2. No authorisation shall be granted unless viable residues and/or non-viable residues occurring reflect the
minimum quantities of
the plant protection product necessary to achieve adequate control
corresponding to good agricultural practice, applied in such a manner (including pre-harvest intervals
or withholding periods or storage periods) that the viable residues and/or toxins at harvest, slaughter or
after storage are reduced to a minimum.

2.7.

Fate and behaviour in the environment

2.7.1. No authorisation shall be granted if the available information indicates that there may be unacceptable
adverse environmental effects due to the fate and behaviour of the plant protection product in the
environment.

2.7.2. No authorisation shall be granted if contamination of ground water, surface water or drinking water
expected as a result of the use of a plant protection product under the proposed conditions of use, may
cause interference with the analytical systems for the control of the quality of drinking water provided
for in Directive 98/83/EC.

2.7.3. No authorisation shall be granted if the contamination of groundwater expected as a result of the use of
a plant protection product under the proposed conditions of use contravenes or exceeds whichever of
the following is the lower:

(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 (5), or

(1)
(2)
(3)
(4)
(5)

OJ L 131, 5.5.1998, p. 11.

OJ L 262, 17.10.2000, p. 21.

OJ L 158, 30.4.2004 p. 50.

OJ L 393, 30.12.1989, p. 18.

OJ L 327, 22.12.2000, p. 1. Directive as amended by Decision No 2455/2001/EC.

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(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,

unless it is scientifically demonstrated that under relevant field conditions the lower of the parameters
or concentrations is not contravened or exceeded.

2.7.4. No authorisation shall be granted if the contamination of surface water expected as a result of the use of

a plant protection product under the proposed conditions of use:

(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 (1), 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.

The proposed instruction for use of the plant protection product, including procedures for cleaning
application equipment, must be such that the likelihood of accidental contamination of surface water is
reduced to a minimum.

2.7.5. No authorisation shall be granted if it is known that transfer of genetic material from the micro-

organism to other organisms, may lead to unacceptable effects on the environment.

2.7.6. No authorisation shall be granted unless there is sufficient information on the possible persistence/
competitiveness of the micro-organism and relevant secondary metabolites/toxins in or on the crop
under the environmental conditions prevailing at and following the intended use.

2.7.7. No authorisation shall be granted if it can be expected that the micro-organism and/or its possible
relevant metabolites/toxins will persist in the environment in concentrations considerably higher than
the natural background levels, taking into account repeated applications over the years, unless a robust
risk assessment indicates that the risks from accumulated plateau concentrations are acceptable.

2.8.

Effects on non-target organisms

Member States shall ensure that the available information is sufficient to permit a decision to be taken
as to whether or not there may be unacceptable effects on non-target species (flora and fauna), due to
exposure to the plant protection product containing the micro-organism following its intended use.

Member States shall pay special attention to possible effects on beneficial organisms used for biological
control and organisms playing an important role in integrated control.

(1)

OJ L 194, 25.7.1975, p. 26. Directive to be repealed from 22.12.2007 by Directive 2000/60/EC (OJ L 327, 22.12. 2000, p. 1).

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2.8.1. Where there is a possibility of birds and other non-target terrestrial vertebrates being exposed, no

authorisation shall be granted if:

(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.

2.8.2. Where there is a possibility of aquatic organisms being exposed, no authorisation shall be granted if:

(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.

2.8.3. Where there is a possibility of bees being exposed, no authorisation shall be granted:

(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.

2.8.4. Where there is a possibility of arthropods other than bees being exposed, no authorisation shall be

granted if:

(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.

2.8.5. Where there is a possibility of earthworms being exposed, no authorisation shall be granted if the
micro-organism is pathogenic to earthworms or in the case of toxic effects due to components in the
plant protection product such as relevant metabolites/toxins, the acute toxicity/exposure ratio is less
than 10, 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 earthworm populations are not at risk after use
of the plant protection product according to the proposed conditions of use.

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2.8.6. Where there is a possibility of non-target soil micro-organisms being exposed, no authorisation shall be
granted if the nitrogen or carbon mineralisation processes in laboratory studies are affected by more
than 25 % after 100 days, unless it is clearly established through an appropriate risk assessment that
under field conditions there is no unacceptable impact on the microbial community after use of the
plant protection product according to the proposed conditions of use, taking account of the ability of
micro-organisms to multiply.