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ANNEXU.K.UNIFORM PRINCIPLES FOR EVALUATION AND AUTHORISATION OF PLANT PROTECTION PRODUCTS, AS PROVIDED FOR IN [F1ARTICLE 29(6)(a)] OF REGULATION (EC) No 1107/2009

Textual Amendments

PART IIU.K.Uniform principles for evaluation and authorisation of plant protection products containing micro-organisms

C.DECISION-MAKINGU.K.

1.General principlesU.K.
1.1.Where appropriate, [F2competent authorities] 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.U.K.

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1.2.[F3Competent authorities] 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 [F4constituent territory of the competent authority].U.K.

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1.3.[F5Competent authorities] 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 in accordance with, 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.U.K.

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1.4.[F6Competent authorities] shall ensure that decisions respect the principles of integrated pest [F7management] if the plant protection product is intended for use in conditions where these principles are relied on.U.K.

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1.5.Since the evaluation is to be based on data concerning a limited number of representative species, [F8competent authorities] shall ensure that use of plant protection products does not have any long-term repercussions for the abundance and diversity of non-target species.U.K.

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1.6.Before issuing an authorisation, [F9competent authorities] shall ensure that the label of the plant protection product:U.K.

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(a)

fulfils the requirements setting out in Regulation (EU) No 547/2011;

(b)

also contains the information on protection of users required by [F10retained EU law] on worker protection;

(c)

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

(d)

and that the authorisation shall mention the particulars indicated in Annexes II and III to Regulation (EU) 547/2011 and [F11Articles 19, 21 and 22 of, and part 4 of Annex 2 to Regulation (EC) No 1272/2008 of the European Parliament and of the Council].

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1.7.Before issuing authorisations, [F12competent authorities] shall:U.K.

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(a)

ensure that the proposed packaging is in accordance with the provisions of [F13Regulation (EC) No 1272/2008];

(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.

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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:U.K.
(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 in accordance with the requirements provided for in this Annex, [F14competent authorities] may, by virtue of Article 44:U.K.

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(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.

[F15Competent authorities] 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.

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1.10.[F16Competent authorities] 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.U.K.

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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 [F17the EU-derived domestic legislation which transposed] Directive 2001/18/EC has been submitted, as required pursuant to Article 53(4) of Regulation (EC) No 1107/2009. The relevant decision taken by the competent authorities in accordance with [F17the EU-derived domestic legislation which transposed] Directive 2001/18/EC must be provided.U.K.

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1.12.In accordance with Article 53(4) of Regulation (EC) No 1107/2009, no authorisation shall be granted for a plant protection product containing a genetically modified organism unless authorisation is granted in accordance with [F18the EU-derived domestic legislation which transposed] part C of Directive 2001/18/EC under which that organism can be released into the environment.U.K.

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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.U.K.
1.14.[F19Competent authorities] 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.U.K.

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2.Specific principlesU.K.

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

2.1.IdentityU.K.

For each authorisation granted the [F20competent authorities] 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.

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2.2.Biological and technical propertiesU.K.
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. [F21Competent authorities] 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 in accordance with the ‘Catalogue of pesticide formulation types and international coding system (CropLife International Technical Monograph No 2, 5th Edition, 2002)’.U.K.

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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.U.K.
2.3.Further informationU.K.

No authorisation shall be granted unless full information is provided on the continuous quality control of the production method, production process and plant protection product. 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.EfficacyU.K.
2.4.1.PerformanceU.K.
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.U.K.
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.U.K.
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.U.K.
2.4.1.4.Conclusions as to the performance of the preparation must be valid for all areas of the [F22constituent territory] 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).U.K.

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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.U.K.

Where proposed label claims include recommendations for use of the preparation with specified plant protection products or adjuvants as a tank mix, [F23competent authorities] shall not accept the recommendations unless they are justified.

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2.4.1.6.If there is evidence of a development of resistance of pathogens towards the plant protection product, the [F24competent authority] shall decide if the submitted resistance management strategy addresses this adequately and sufficiently.U.K.

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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.U.K.
2.4.2.Absence of unacceptable effects on plants and plant productsU.K.
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.U.K.
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.U.K.
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.U.K.
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.U.K.
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.U.K.
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.U.K.
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.U.K.
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.U.K.
2.5.Identification/detection and quantification methodsU.K.

The methods proposed must reflect the latest techniques. Methods for post-authorisation monitoring shall 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.U.K.
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:U.K.
(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.

2.6.Impact on human and animal healthU.K.
2.6.1.Effects on human and animal health arising from the plant protection productU.K.
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.U.K.
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.U.K.

When making a decision on the authorisation of the microbial plant protection product, [F25competent authorities] shall consider possible effects on all human populations, namely professional users, non-professional users and humans exposed directly or indirectly through the environment and at work, and animals.

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2.6.1.3.All micro-organisms shall 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 shall not be inhaled. Moreover, the proposed conditions of use may require use of additional items of protective clothing and equipment.U.K.

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 [F26retained EU law], 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.

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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.U.K.
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 shall not be authorised for use by non-professional users.U.K.
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.U.K.
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.U.K.
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.U.K.
2.6.1.9.The conditions of authorisation shall be in compliance with [F27the EU-derived domestic legislation which transposed] Directive 98/24/EC and Directive 2000/54/EC of the European Parliament and of the Council(1). 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 [F27the EU-derived domestic legislation which transposed] Directive 2004/37/EC. The conditions of authorisation shall also be in compliance with Council Directive 89/656/EEC(2).U.K.

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2.6.2.Effects on human and animal health arising from residuesU.K.
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.U.K.
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.U.K.
2.7.Fate and behaviour in the environmentU.K.
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.U.K.
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 [F28the EU-derived domestic legislation which transposed] Directive 98/83/EC.U.K.

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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:U.K.
(a)

the parameters or maximum permissible concentrations laid down by [F29the EU-derived domestic legislation which transposed] 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 [F30the EU-derived domestic legislation which transposed] Directive 2000/60/EC; or

(c)

the parameters for the micro-organism or the maximum concentration laid down for components in the plant protection product such as relevant metabolites/toxins when approving the micro-organism in accordance with Regulation (EC) No 1107/2009, 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 approved in accordance with Regulation (EC) No 1107/2009,

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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:U.K.
(a)

exceeds, where the surface water in or from the area of envisaged use is intended for the extraction of drinking water, concentrations above which compliance with drinking water quality established in accordance with [F30the EU-derived domestic legislation which transposed] Directive 2000/60/EC is compromised; or

(b)

exceeds the parameters or values for components in the plant protection product, such as relevant metabolites/toxins, established in accordance with [F30the EU-derived domestic legislation which transposed] Directive 2000/60/EC; or

(c)

has an impact deemed unacceptable on non-target species, including animals, in accordance with [F30the EU-derived domestic legislation which transposed] 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.U.K.
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.U.K.
2.7.7.No authorisation shall be granted if it can be expected that the micro-organism and/or its possible relevant metabolites/toxins shall 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.U.K.
2.8.Effects on non-target organismsU.K.

[F31Competent authorities] 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.

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[F31Competent authorities] shall pay special attention to possible effects on beneficial organisms used for biological control and organisms playing an important role in integrated control.

2.8.1.Where there is a possibility of birds and other non-target terrestrial vertebrates being exposed, no authorisation shall be granted if:U.K.
(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 in accordance with the proposed conditions of use.

2.8.2.Where there is a possibility of aquatic organisms being exposed, no authorisation shall be granted if:U.K.
(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 in accordance with the proposed conditions of use.

2.8.3.Where there is a possibility of bees being exposed, no authorisation shall be granted:U.K.
(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 in accordance with 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:U.K.
(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 in accordance with 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 in accordance with the proposed conditions of use.U.K.
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 in accordance with the proposed conditions of use, taking account of the ability of micro-organisms to multiply.U.K.