(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’

A.

B.

1.

2.

2.1.

2.1.1.

2.1.2.

2.2.

2.2.1.

2.2.2.

2.3.

2.3.1.

2.3.2.

2.4.

2.5.

2.5.1.

2.5.2.

2.6.

2.6.1.

2.6.2.

2.7.

2.8.

2.9.

C.

1.

2.

2.1.

2.2.

2.3.

2.4.

2.5.

2.6.

2.6.1.

2.6.2.

2.7.

2.8.

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:

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.

5.

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.

6.

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.

7.

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.

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).

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).

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.

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).

(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.

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:

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; representativeness; sensitivity; specificity; reproducibility; interlaboratory validations; predictiveness.

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.

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.

1.5.

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:

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.

2.2.1.1.

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:

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:

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).

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.

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:

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.

2.4.1.

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:

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:

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.

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.

(a)

the specificity and linearity of the proposed methods,

(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.

(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.

(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.

(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.

(a)

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;

(b)

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;

(c)

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;

(d)

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

(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).

2.6.1.1.

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.

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:

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:

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)

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:

(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:

(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:

(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:

(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:

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:

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 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.

2.8.1.1.

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:

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:

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.

2.8.2.1.

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:

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:

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.

2.8.3.1.

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:

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:

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.

2.8.4.1.

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:

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:

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.

2.8.5.1.

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:

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:

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.

2.8.6.1.

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:

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.

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:

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.

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.

1.3.

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.

1.4.

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.

1.5.

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:

1.7.

Before issuing authorisations, Member States shall:

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:

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):

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.

1.10.

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.

2.2.1.

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.

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.

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.

2.5.1.

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:

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.

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 (5), 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 (6). The experimental data and information relevant to the recognition of the symptoms of infection or pathogenicity and on the effectiveness of first aid and therapeutic measures provided shall be 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 (7). 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 (8).

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.

2.7.1.

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:

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:

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.

2.8.1.

Where there is a possibility of birds and other non-target terrestrial vertebrates being exposed, no authorisation shall be granted if:

2.8.2.

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

2.8.3.

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

2.8.4.

Where there is a possibility of arthropods other than bees being exposed, no authorisation shall be granted if:

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.

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.

1.

the rates of customs duties applicable in Serbia to textile products originating in the Community shall be dismantled according to the schedule in Annex II;

2.

the Community will continue to grant duty free treatment to textile products originating in Serbia in accordance with the applicable Community legislation.

(a)

to introduce quantitative restrictions against the same products originating in Serbia as those involved in circumvention or to take any other appropriate measures;

(b)

to set off the relevant quantities against the quantitative restrictions that are established under this Agreement.

(a)

serious injury to domestic producers of like or directly competitive products in the territory of the importing Party, or

(b)

serious disturbances in any related sector of the economy or difficulties which could bring about deterioration in the economic situation of a region,

the Party concerned may take appropriate measures after consultations are held in accordance with Article 8. In case the other Party considers the measure adopted is not justified, it shall be free to suspend the application of substantially equivalent concessions granted under this Agreement after consultations are held in accordance with Article 8.

(a)

any request for consultations shall be notified in writing to the other Party;

(b)

the request for consultations shall be followed, within a reasonable period of time and in any case not later than 15 days following the notification, by a report setting out the circumstances which, in the opinion of the requesting Party, justify the submission of such a request;

(c)

the Parties shall enter into consultations within 30 days of notification of the request at the latest, with a view to reaching a mutually acceptable solution within a further 30-day period at the latest, unless this period is extended by common accord.

1.

in any year advance use of a portion of the quantitative restriction established for the following year is authorised for each category of products up to 5 % of the quantitative restriction for the current year.

Amounts delivered in advance shall be deducted from the corresponding quantitative restrictions established for the following year;

2.

carryover to the corresponding quantitative restriction for the following year of the amounts not used during any year is authorised for each category of products up to 10 % of the quantitative restriction for the current year;

3.

transfers in respect of categories in group I shall not be made from any category except as follows:

Transfers into any category in groups II and III may be made from any category or categories in groups I, II and III up to 12 % of the quantitative restriction for the category to which the transfer is made;

4.

the table of equivalence applicable to the transfers referred to is given in Annex I;

5.

the increase in any category of products resulting from the cumulative application of the provisions in paragraphs 1, 2 and 3 during a year shall not exceed 17 %;

6.

prior notification shall be given by the Ministry of International Economic Relations of Serbia in the event of recourse to the provisions of paragraphs 1, 2 and 3, at least 15 days in advance.

1.

Re-imports into the Community referred to in Article 11 may be made subject to specific quantitative restrictions following consultations in accordance with the procedures set out in Article 8, provided the products concerned are subject to quantitative restrictions pursuant to this Agreement, to a double-checking system or to surveillance measures.

2.

Having regard to the interests of both Parties, the Community may at its discretion, or in response to a request under Article 8:

3.

However, the Community may apply automatically the flexibility rules set out in paragraph 2 within the following restrictions:

4.

The Community shall inform Serbia of any measures taken pursuant to the preceding paragraphs.

5.

The competent authorities in the Community shall debit the specific quantitative restrictions referred to in paragraph 1 at the time of issue of the prior authorisation required by the relevant Community legislation which governs economic outward processing arrangements. A specific quantitative restriction shall be debited for the year in which a prior authorisation is issued.

6.

A certificate of origin made out by the organisations authorised to do so under the law of Serbia shall be issued, in accordance with Annex V, for all products covered by this Title. This certificate shall bear a reference to the prior authorisation mentioned in paragraph 5 as evidence that the processing operation it describes has been carried out in Serbia.

7.

The Community shall provide Serbia with the names and addresses of, and specimens of the stamps used by, the competent authorities of the Community, which issue the prior authorisations referred to in paragraph 5.