Commission Regulation (EU) No 284/2013 of 1 March 2013 setting out the data requirements for plant protection products, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market Text with EEA relevance

A test for dermal toxicity shall be carried out on a case by case basis, unless the applicant can justify an alternative approach under Regulation (EC) No 1272/2008. In the latter case, acute dermal toxicity of all components shall be provided or reliably predicted with a validated method. Consideration shall be given to the possible effects of components on the toxic potential of the total mixture.

Findings of severe skin irritation or corrosion in the dermal study may be used instead of performing a specific irritation study.

7.1.3.   Inhalation toxicity

The study shall provide the inhalation toxicity to rats of the plant protection product or of the smoke it generates.

Circumstances in which required

The study shall be carried out where the plant protection product:

• (a) is a gas or liquified gas;

• (b) is a smoke generating plant protection product or fumigant;

• (c) is used with fogging/misting equipment;

• (d) is a vapour releasing plant protection product;

• (e) is supplied in an aerosol dispenser;

• (f) is in a form of a powder or granules containing a significant proportion of particles of diameter < 50 μm (> 1 % on a weight basis);

• (g) is to be applied from aircraft in cases where inhalation exposure is relevant;

• (h) contains an active substance with a vapour pressure > 1 × 10^–2 Pa and is to be used in enclosed spaces such as warehouses or glasshouses;

• (i) is to be applied by spraying.

A study shall not be required if the applicant can justify an alternative approach under Regulation (EC) No 1272/2008, where applicable. For this purpose, acute inhalation toxicity of all components shall be provided or reliably predicted with a validated method. Consideration shall be given to the possible effects of components on the toxic potential of the total mixture.

The head/nose only exposure shall be used, unless whole body exposure can be justified.

7.1.4.   Skin irritation

The results of the study shall provide the potential for skin irritancy of the plant protection product including the potential reversibility of the effects observed.

Before undertaking in vivo studies for corrosion/irritation of the plant protection product, a weight-of-evidence analysis shall be performed on the existing relevant data. Where insufficient data are available, they can be developed through application of sequential testing.

The testing strategy shall follow a tiered approach:

• (1) the assessment of dermal corrosivity using a validated in vitro test method;

• (2) the assessment of dermal irritation using a validated in vitro test method (such as human reconstituted skin models);

• (3) an initial in vivo dermal irritation study using one animal, and where no adverse effects are noted;

• (4) confirmatory testing using one or two additional animals.

Consideration shall be given to use the dermal toxicity study to provide irritancy information.

Findings of severe skin irritation or corrosion in the dermal study may be used instead of performing a specific irritation study.

Circumstances in which required

The skin irritancy of the plant protection product shall be reported based on the tiered approach, unless the applicant can justify an alternative approach under Regulation (EC) No 1272/2008. In the latter case, skin irritation properties of all components shall be provided or reliably predicted with a validated method. Consideration shall be given to the possible effects of components on the irritant potential of the total mixture.

7.1.5.   Eye irritation

The results of the study shall provide the potential for eye irritation of the plant protection product, including the potential reversibility of the effects observed.

Before undertaking in vivo studies for eye corrosion/irritation of the plant protection product, a weight-of-evidence analysis shall be performed on the existing relevant data. Where available data are considered insufficient, further data may be developed through application of sequential testing.

The testing strategy shall follow a tiered approach:

• (1) the use of an in vitro dermal irritation/corrosion test to predict eye irritation/corrosion;

• (2) the performance of a validated or accepted in vitro eye irritation study to identify severe eye irritants/corrosives (such as BCOP, ICE, IRE, HET-CAM), and where negative results are obtained;

• (3) the assessment of eye irritation using an available, in vitro test method validated for plant protection products for identification of non-irritants or irritants, and when not available;

• (4) an initial in vivo eye irritation study using one animal, and where no adverse effects are noted;

• (5) confirmatory testing using one or two additional animals.

Circumstances in which required

Eye irritation tests shall be provided, unless it is likely that severe effects on the eyes may be produced or the applicant can justify an alternative approach under Regulation (EC) No 1272/2008. In the latter case, eye irritation properties of all components shall be provided or reliably predicted with a validated method. Consideration shall be given to the possible effects of components on the irritant potential of the total mixture.

7.1.6.   Skin sensitisation

The study shall provide information to assess the potential of the plant protection product to provoke skin sensitisation reactions.

Circumstances in which required

The skin sensitisation test shall be carried out unless the active substances or co-formulants are known to have sensitising properties or the applicant can justify an alternative approach under Regulation (EC) No 1272/2008. In the latter case, skin sensitisation properties of all components shall be provided or reliably predicted with a validated method. Consideration shall be given to the possible effects of components on the sensitising potential of the total mixture.

The local lymph node assay (LLNA) shall be used, including where appropriate the reduced variant of the assay. In case the LLNA cannot be conducted, a justification shall be provided and the Guinea Pig Maximisation Test shall be performed. Where a guinea pig assay (Maximisation or Buehler), meeting OECD guidelines and providing a clear result, is available, further testing shall not be carried out for animal welfare reasons.

Since a skin sensitiser can potentially induce hypersensitivity reaction, potential respiratory sensitisation shall be taken into account when appropriate tests are available or when there are indications of respiratory sensitisation effects.

7.1.7.   Supplementary studies on the plant protection product

The need to perform supplementary studies on the plant protection product shall be discussed with the national competent authorities on a case by case basis in the light of the particular parameters to be investigated and the objectives to be achieved (for example for plant protection products containing active substances or other components suspected to have synergistic or additive toxicological effects).

The type of the study shall be adapted to the endpoint of concern.

7.1.8.   Supplementary studies for combinations of plant protection products

In cases where the product label includes requirements for use of the plant protection product with other plant protection products or with adjuvants as a tank mix, it may be necessary to carry out studies for a combination of plant protection products or for the plant protection product with adjuvant. The need to perform supplementary studies shall be discussed with the national competent authorities on a case by case basis, taking into account the results of the acute toxicity studies of the individual plant protection products and the toxicological properties of the active substances, the possibility for exposure to the combination of the products concerned, with particular regard to vulnerable groups, and available information or practical experience with the products concerned or similar products.

7.2.   Data on exposure

For the purpose of this Regulation the following definitions apply:

• (a) operators are people who are involved in activities relating to the application of a plant protection product, such as mixing, loading, application, or relating to cleaning and maintenance of equipment containing a plant protection product; operators may be professionals or amateurs;

• (b) workers are people who, as part of their employment, enter an area that has previously been treated with a plant protection product or who handle a crop that has been treated with a plant protection product;

• (c) bystanders are people who casually are located within or directly adjacent to an area where application of a plant protection product is in process or has taken place, but not for the purpose of working on the treated area or with the treated commodity;

• (d) residents are people who live, work or attend any institution near to areas that are treated with plant protection products, but not for the purpose of working on the treated area or with the treated commodity.

In cases where the product label includes requirements for use of the plant protection product with other plant protection products or with adjuvants as a tank mix, the exposure assessment shall cover the combined exposure. Cumulative and synergistic effects shall be taken into account and reported in the dossier.

7.2.1.   Operator exposure

Information shall be provided to permit an assessment of the extent of exposure to the active substances and toxicologically relevant compounds in the plant protection product likely to occur under the proposed conditions of use, taking into account cumulative and synergistic effects. It shall also provide a basis for the selection of the appropriate protective measures including personal protective equipment to be used by operators and to be specified on the label.

7.2.1.1.   Estimation of operator exposure

An estimation shall be made, using where available a suitable calculation model, in order to permit an evaluation of the operator exposure likely to arise under the proposed conditions of use. Where relevant, this estimation shall take into account cumulative and synergistic effects resulting from the exposure to more than one active substance and toxicologically relevant compounds, including those in the product and tank mix.

Circumstances in which required

An estimation of operator exposure shall always be performed.

Estimation conditions

An estimation shall be made for each type of application method and application equipment proposed for use of the plant protection product taking account of the requirements resulting from Regulation (EC) No 1272/2008, where applicable, for handling the undiluted or diluted product.

The estimation shall address mixing/loading and application, and shall include clean-up activities and routine maintenance of the application equipment. Specific information on local use conditions (types and sizes of containers to be used, application equipment, typical work rates and application rates, spray concentration, field sizes, crop growing climatic conditions) shall be included.

At first an estimation shall be made with the assumption that the operator is not using any personal protective equipment.

Where appropriate, a further estimation shall be made with the assumption that the operator is using effective and readily obtainable protective equipment, which is feasible to be used in practice. Where protective measures are specified on the label, the estimation shall take these into account.

7.2.1.2.   Measurement of operator exposure

The study shall provide data to permit an evaluation of the operator exposure likely to arise under the specific proposed conditions of use. The study shall be ethically sound.

Circumstances in which required

Exposure data for the relevant exposure routes shall be reported where there are no representative data in available calculation models or where the model-based risk assessment indicates that the relevant reference value is exceeded.

This will be the case, where the results of the estimation of operator exposure in accordance with point 7.2.1.1 indicate that one or both of the following conditions are fulfilled:

• (a) the AOEL established in the context of approval of the active substance may be exceeded;

• (b) the Limit Values established for the active substance and toxicologically relevant compounds of the plant protection product in accordance with Directive 98/24/EC and Directive 2004/37/EC may be exceeded.

The study shall be done under realistic exposure conditions taking into account the proposed conditions of use.

7.2.2.   Bystander and resident exposure

Information shall be provided to permit an assessment of the extent of exposure to the active substances and toxicologically relevant compounds likely to occur under the proposed conditions of use, taking into account, where relevant, cumulative and synergistic effects. It shall also provide a basis for the selection of appropriate protective measures, including restricted entry intervals, exclusion of residents and bystanders from treatment areas and separation distances.

7.2.2.1   Estimation of bystander and resident exposure

An estimation shall be made, using where available a suitable calculation model in order to permit an evaluation of the bystander and resident exposure likely to arise under the proposed conditions of use. Where relevant, this estimation shall take into account cumulative and synergistic effects resulting from the exposure to more than one active substance and toxicologically relevant compounds, including those in the product and tank mix.

The applicant shall take into consideration that bystanders can be exposed during or after the application of plant protection products and residents may be exposed to plant protection products, mainly, but not only, by inhalation and dermal route and that infants and toddlers exposure may also occur by the oral route (through hand-mouth transfer).

Circumstances in which required

An estimation of bystander and resident exposure shall always be performed.

Estimation conditions

An estimation of bystander and resident exposure shall be made for each relevant type of application method. Specific information including maximum total dose and spray concentration shall be included. The estimation shall be made with the assumption that bystanders and residents do not use any personal protective equipment.

7.2.2.2.   Measurement of bystander and resident exposure

The study shall provide data to permit an evaluation of the bystander and resident exposure likely to arise under the specific proposed conditions of use. The study shall be ethically sound.

Circumstances in which required

Exposure data for the relevant exposure routes shall be required where the model based risk assessment indicates that the relevant reference value is exceeded or where there are no representative data in available calculation models.

The study shall be done under realistic exposure conditions taking into account the proposed conditions of use.

7.2.3.   Worker exposure

Information shall be provided to permit an assessment of the extent of exposure to the active substances and toxicologically relevant compounds in the plant protection product likely to occur under the proposed conditions of use and agricultural practices, taking into account cumulative and synergistic effects. It shall also provide a basis for the selection of appropriate protective measures, including waiting and re-entry periods.

7.2.3.1.   Estimation of worker exposure

An estimation shall be made using, where available, a suitable calculation model, in order to permit an evaluation of the worker exposure likely to arise under the proposed conditions of use. Where relevant, this estimation shall take into account cumulative and synergistic effects resulting from the exposure to more than one active substance and toxicologically relevant compounds, including those in the product and tank mix.

Circumstances in which required

The estimation of worker exposure shall be completed when such exposure could arise under the proposed conditions of use.

Estimation conditions

An estimation of worker exposure shall be made for crops and tasks to be carried out. Specific information including description of post-applications activities, exposure duration, application rate, number of applications, minimum spray interval and growth stage, shall be provided. If data on the amount of dislodgeable residues under the proposed conditions of use are not available, default assumptions shall be used.

At first, the estimation shall be made using available data on the exposure to be expected with the assumption that the worker is not using any personal protective equipment. Where appropriate, a second estimation shall be made with the assumption that the worker is using effective and readily obtainable protective equipment which is feasible to be used and will be worn habitually by workers, for example because it was necessitated by other aspects of task being undertaken.

7.2.3.2.   Measurement of worker exposure

The study shall provide data to permit an evaluation of the worker exposure likely to arise under the proposed conditions of use. The study shall be ethically sound.

Circumstances in which required

Exposure data for the relevant exposure routes shall be reported where the model based risk assessment indicates that the relevant reference value is exceeded or where there are no representative data in available calculation models.

This will be the case, where the results of the estimation of worker exposure in accordance with point 7.2.3.1 indicate that one or both of the following conditions are fulfilled:

• (a) the AOEL established in the context of approval of the active substance may be exceeded;

• (b) the Limit Values established for the active substance and toxicologically relevant compounds of the plant protection product in accordance with Directive 98/24/EC and Directive 2004/37/EC may be exceeded.

The study shall be done under realistic exposure conditions taking into account the proposed conditions of use.

7.3.   Dermal absorption

The studies shall provide a measurement of the absorption through the skin of the active substances and toxicologically relevant compounds in the plant protection product to be authorised.

Circumstances in which required

The study shall be conducted when dermal exposure is a significant exposure route, and no acceptable risk is estimated using default absorption value.

Test conditions

Data from absorption studies, preferably using human skin in vitro, shall be reported.

Studies shall be performed on representative plant protection products at both in use dilution (when applicable) as well as the concentrated form.

In case studies do not correspond with the anticipated exposure situation (for example with regard to the type of co-formulant or the concentration), scientific argument shall be provided before such data can be used with confidence.

7.4.   Available toxicological data relating to co-formulants

Where relevant, the applicant shall submit and assess the following information:

• (a) the registration number in accordance with Article 20(3) of Regulation (EC) No 1907/2006);

• (b) the study summaries included in the technical dossier submitted in accordance with Article 10(a)(vi) of Regulation (EC) No 1907/2006; and

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

The safety data sheet under point (c) shall also be submitted and assessed for the plant protection product.

Any other available information shall be submitted.

SECTION 8

Residues in or on treated products, food and feed

Data and information on residues in or on treated products, food and feed in accordance with Section 6 of Part A of the Annex to Regulation (EU) No 283/2013 shall be submitted, unless the applicant shows that the data and information already submitted for the active substance can be applied.

SECTION 9

Fate and behaviour in the environment

Introduction

• 1.Predicted environmental concentrations (PEC).

• 1.1.A realistic worst-case estimation shall be made of the expected concentrations of the active substance and metabolites, breakdown and reaction products:

• — which account for more than 10 % of the amount of active substance added,

• — which account for more than 5 % of the amount of active substance added, in at least two sequential measurements,

• — for whose individual components (> 5 %) the maximum of formation is not yet reached at the end of the study, in soil, surface in soil, groundwater, surface water, sediment and air, following use as proposed or already occurring.

• 1.2.For the purposes of the estimation of such concentrations the following definitions apply:

• (a) Predicted environmental concentration in soil (PECS) : the level of residues in the top layer of the soil and to which non-target soil organisms may be exposed (acute and chronic exposure).

• (b) Predicted environmental concentration in surface water (PECSW) : the level of residues, in surface water to which non-target organisms may be exposed (acute and chronic exposure).

• (c) Predicted environmental concentration in sediment (PECSED) : the level of residues, in sediment to which non-target benthic organisms may be exposed (acute and chronic exposure).

• (d) Predicted environmental concentration in groundwater (PECGW) : the level of residues in groundwater.

• (e) Predicted environmental concentration in air (PECA) : the level of residues in air, to which man, animals and other non-target organisms may be exposed (acute and chronic exposure).

• 1.3.For the estimation of these concentrations all relevant information on the plant protection product and on the active substance shall be taken into account. Where relevant the parameters set out in Section 7 of Part A of the Annex to Regulation (EU) No 283/2013 shall be used.

• 1.4.When models are used for estimation of predicted environmental concentrations they shall:

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

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

• — be relevant to the conditions in the area of use.

• 1.5.The information provided shall, where relevant, include that referred to in Section 7 of Part A of the Annex to Regulation (EU) No 283/2013.

• 2.For solid plant protection products, treated and coated seeds there shall be an assessment of the risk from dust drift on to non-target species during application or sowing. Until agreed dust dissipation rates are available, then likely exposure levels shall be determined using a range of application techniques, suitable dust measurement methodology and, where appropriate, mitigation measures.

9.1.   Fate and behaviour in soil

9.1.1.   Rate of degradation in soil

9.1.1.1.   Laboratory studies

Laboratory studies on soil degradation shall provide best possible estimates of the time required for degradation of 50 % and 90 % (DegT50lab and DegT90lab) of the active substance under laboratory conditions.

Circumstances in which required

The persistence and behaviour of plant protection products in soil shall be investigated unless it is possible to extrapolate from data obtained on the active substance and metabolites, breakdown and reaction products in accordance with the requirements set out in point 7.1.2.1 of Part A of the Annex to Regulation (EU) No 283/2013.

Where it is not possible to extrapolate from anaerobic incubation data obtained on the active substance and metabolites, breakdown and reaction products in accordance with the requirements set out in point 7.1.2.1 of Part A of the Annex to Regulation (EU) No 283/2013, an anaerobic degradation study shall be submitted unless the applicant shows that exposure of the plant protection product containing the active substance to anaerobic conditions is unlikely to occur for the intended uses.

Test conditions

Studies on the rate of aerobic degradation of the active substance shall be reported for at least four soils. Soil properties shall be comparable to those used for the aerobic studies performed in accordance with point 7.1.1 and 7.1.2.1 of Part A of the Annex to Regulation (EU) No 283/2013. Reliable DegT50 and 90 values shall be available for a minimum of four different soils.

Studies on the rate of anaerobic degradation of the active substance shall be carried out using the same procedure and comparable soil as for the anaerobic study performed in accordance with point 7.1.1.2 of Part A of the Annex to Regulation (EU) No 283/2013.

The kinetic formation fraction and degradation rates of potentially relevant metabolites shall be established, in the studies under both aerobic and anaerobic conditions by extension of the study for the active substance, where it is not possible to extrapolate from points 7.1.2.1.2 and 7.1.2.1.4 of Part A of the Annex to Regulation (EU) No 283/2013.

In order to assess the influence of temperature on degradation, a calculation with an adequate Q10 factor or an adequate number of additional studies at a range of temperatures shall be performed.

Reliable DegT50 and 90 values for metabolites, breakdown and reaction products shall be provided for at least three soils from the studies under aerobic conditions.

9.1.1.2.   Field studies

9.1.1.2.1.   Soil dissipation studies

The soil dissipation studies shall provide best-possible estimates of the time taken for dissipation of 50 % and 90 % (DisT50field and DisT90field) and if possible the time taken for degradation of 50 % and 90 % (DegT50field and DegT90field), of the active substance under field conditions. Where relevant, information on metabolites, breakdown and reaction products shall be reported.

Circumstances in which required

The dissipation and behaviour of plant protection products in soil shall be investigated unless it is possible to extrapolate from data obtained on the active substance and metabolites, breakdown and reaction products in accordance with the requirements set out in point 7.1.2.2.1 of Part A of the Annex to Regulation (EU) No 283/2013.

Test conditions

Individual studies on a range of representative soils (normally at least four different types at different geographical locations) shall be continued until at least 90% of the amount applied has dissipated from the soil or been transformed to substances that are not the subject of the investigation.

9.1.1.2.2.   Soil accumulation studies

The tests shall provide sufficient data to evaluate the possibility of accumulation of residues of the active substance and of metabolites, breakdown and reaction products.

Circumstances in which required

Soil accumulation studies shall be reported unless it is possible to extrapolate from data obtained on the active substance and metabolites, breakdown and reaction products in accordance with the requirements set out in point 7.1.2.2.2 of Part A of the Annex to Regulation (EU) No 283/2013.

Test conditions

Long term field studies shall be performed on at least two relevant soils at different geographical locations and involve multiple applications.

In absence of guidance being included in the list referred to under point 6 of the introduction, the type and conditions of the study to be performed shall be discussed with the national competent authorities.

9.1.2.   Mobility in soil

The information made available shall provide sufficient data to evaluate the mobility and leaching potential of the active substance and metabolites, breakdown and reaction products.

9.1.2.1.   Laboratory studies

Circumstances in which required

The mobility of plant protection products in soil shall be investigated unless it is possible to extrapolate from data obtained in accordance with the requirements set out in points 7.1.2 and 7.1.3.1 of Part A of the Annex to Regulation (EU) No 283/2013.

Test conditions

The same provisions as provided under points 7.1.2 and 7.1.3.1 of Part A of the Annex to Regulation (EU) No 283/2013 apply.

9.1.2.2.   Lysimeter studies

Lysimeter studies shall be performed, where necessary, to provide information on:

• — the mobility in soil,

• — the potential for leaching to ground water,

• — the potential distribution in soil.

Circumstances in which required

The decision whether lysimeter studies are to be carried out, as an experimental outdoor study in the framework of a tiered leaching assessment scheme shall take into account the results of degradation and mobility studies and the calculated PECGW. The type of study to be conducted shall be discussed with the national competent authorities.

These studies shall be performed unless it is possible to extrapolate from data obtained on the active substance and metabolites, breakdown and reaction products in accordance with the requirements set out in point 7.1.4.2 of Part A of the Annex to Regulation (EU) No 283/2013.

Test conditions

Studies shall cover the realistic worst case situation, and the duration necessary for observation of potential leaching, taking into account the soil type, climatic conditions, the application rate and the frequency and period of application.

Water percolating from soil columns shall be analysed at suitable intervals, while residues in plant material shall be determined at harvest. Residues in the soil profile in at least five layers shall be determined on termination of experimental work. Intermediate sampling shall be avoided, since removal of plants (except for harvesting in accordance with normal agricultural practice) and soil influence the leaching process.

Precipitation, soil and air temperatures shall be recorded at regular intervals, at least on a weekly base.

The depth of the lysimeters shall be at least 100 cm. The soil cores shall be undisturbed. Soil temperatures shall be similar to those pertaining in the field. Where necessary, supplementary irrigation shall be provided to ensure optimal plant growth and to ensure that the quantity of percolation water is similar to that in the regions for which authorisation is sought. When during the study the soil has to be disturbed for agricultural reasons it shall not be disturbed deeper than 25 cm.

9.1.2.3.   Field leaching studies

Field leaching studies shall be performed, where necessary, to provide information on:

• — the mobility in soil,

• — the potential for leaching to ground water,

• — the potential distribution in soil.

Circumstances in which required

The decision whether field leaching studies are to be carried out, as an experimental outdoor study in the framework of a tiered leaching assessment scheme shall take into account the calculated PECGW and the results of degradation and mobility studies. The type of study to be conducted shall be discussed with the national competent authorities. These studies shall be performed unless it is possible to extrapolate from data obtained on the active substance and metabolites, breakdown and reaction products in accordance with the requirements set out in point 7.1.4.3 of Part A of the Annex to Regulation (EU) No 283/2013.

Test conditions

Studies shall cover the realistic worst case situation, taking into account the soil type, climatic conditions, the application rate and the frequency and period of application.

Water shall be analysed at suitable intervals. Residues in the soil profile in at least five layers shall be determined on termination of experimental work. Intermediate sampling of plant and soil material shall be avoided (except for harvesting in accordance with normal agricultural practice), since removal of plants and soil influence the leaching process.

Precipitation, soil and air temperatures shall be recorded at regular intervals (at least on a weekly base).

Information on the groundwater table in the experimental fields shall be submitted. Depending on the experimental design, a detailed hydrological characterisation of the test field shall be carried out. If soil cracking is observed during the study this shall be fully described.

Attention shall be given to the number and the location of water collection devices. The placement of these devices in the soil shall not result in preferential flow paths.

9.1.3.   Estimation of concentrations in soil

PECS estimations shall relate both to a single application at the highest rate of application for which authorisation is sought, and to the maximum number at the shortest interval and highest rates of application for which authorisation is sought, and shall be expressed in terms of mg of active substance per kg of dry soil.

The factors which shall be considered in making PECS estimations relate to direct and indirect application to soil, drift, run off, and leaching and include processes such as volatilisation, adsorption, hydrolysis, photolysis, aerobic and anaerobic degradation. Appropriate soil layer depths shall be used depending on the application method and soil cultivation. Where ground cover is present at time of application, the impact of crop interception in reducing soil exposure may be included in estimations.

Initial PECS, immediately after application, shall be provided for the active substance, metabolites, breakdown and reaction products. Appropriate short-term and long-term PECS calculations (time weighted averages) shall be provided for the active substance, metabolites, breakdown and reaction products with respect to data from ecotoxicological studies.

Calculation of plateau concentrations in soil shall be provided where on the basis of soil dissipation studies it is established that DisT90 > one year, and where repeated application is envisaged, whether in the same growing season or in succeeding years.

9.2.   Fate and behaviour in water and sediment

9.2.1.   Aerobic mineralisation in surface water

Circumstances in which required

The persistence and behaviour of plant protection products in open water (freshwater, estuarine and marine) shall be investigated unless it is possible to extrapolate from data obtained on the active substance and metabolites, breakdown and reaction products in accordance with the requirements set out in point 7.2.2.2 of Part A of the Annex to Regulation (EU) No 283/2013.

The test shall be reported unless the applicant shows that contamination of open water will not occur.

Test conditions

The rate of degradation and the pathway or pathways shall be reported either for a ‘pelagic’ test system or for a ‘suspended sediment’ system. Where relevant, additional test systems, which differ with respect to organic carbon content, texture or pH shall be used.

Results obtained shall be presented in the form of schematic drawings showing the pathways involved, and in the form of balance sheets which show the distribution of radio-label in water and, where relevant, sediment as a function of time, as between:

• (a) active substance;

• (b) CO2;

• (c) volatile compounds other than CO2;

• (d) individual identified transformation products;

• (e) extractable substances not identified; and

• (f) non-extractable residues in sediment.

The duration of the study shall not exceed 60 days unless the semi-continuous procedure with periodical renewal of the test suspension is applied. However, the period for the batch test may be extended to a maximum of 90 days, if the degradation of the test substance has started within the first 60 days.

9.2.2.   Water/sediment study

Circumstances in which required

The persistence and behaviour of plant protection products in aquatic systems shall be investigated unless it is possible to extrapolate from data obtained on the active substance and metabolites, breakdown and reaction products in accordance with the requirements set out in point 7.2.2.3 of Part A of the Annex to Regulation (EU) No 283/2013.

The test shall be reported unless the applicant shows that contamination of surface water will not occur.

Test conditions

The degradation pathway or pathways shall be reported for two water/sediment systems. The two sediments selected shall differ with respect to organic carbon content and texture, and where relevant, with respect to pH.

Results obtained shall be presented in the form of schematic drawings showing the pathways involved, and in the form of balance sheets which show the distribution of radio-label in water and sediment as a function of time, as between:

• (a) active substance;

• (b) CO2;

• (c) volatile compounds other than CO2;

• (d) individual identified transformation products;

• (e) extractable substances not identified; and

• (f) non-extractable residues in sediment.

The duration of the study shall be at least 100 days. It shall be longer where this is necessary to establish the degradation pathway and water/sediment distribution pattern of the active substance and its metabolites, breakdown and reaction products. If more than 90% of the active substance is degraded before the period of 100 days expires, the test duration may be shorter.

The degradation pattern of potentially relevant metabolites occurring within the water/sediment study shall be established by extension of the study for the active substance, when it is not possible to extrapolate from point 7.2.2.3 of Part A of the Annex to Regulation (EU) No 283/2013.

9.2.3.   Irradiated water/sediment study

If photochemical degradation is of importance, a water/sediment study under influence of a light/dark regime may additionally be reported.

Test conditions

The type and conditions of the study to be performed shall be discussed with the national competent authorities.

9.2.4.   Estimation of concentrations in groundwater

The groundwater contamination routes shall be defined taking into account relevant agricultural, plant health, and environmental (including climatic) conditions.

9.2.4.1.   Calculation of concentrations in groundwater

PECGW estimations shall relate to the maximum number and highest rates of application, at the shortest interval, and to the time of application for which authorisation is sought.

Relevant EU groundwater models shall be run. Where specific crops and circumstances are relevant, specific scenarios for typical use situations for the regions of use, for the respective crop or other situation of use shall be used. In case the behaviour in soil is dependent on soil parameters, respective parameters on degradation and adsorption in soil (DegT50 and Koc values) reflecting this dependency shall be used. If identified metabolites, breakdown or reaction products are found to occur in concentrations above 0,1 μg/L in the leachate, an assessment of their relevance shall be required.

Suitable estimations (calculations) of predicted environmental concentration in groundwater PECGW, of active substance shall be submitted, unless it is clearly evident from the data on degradation or adsorption, taking worst case values, that leaching would be negligible under the intended areas of use.

For all metabolites, breakdown or reaction products identified as a part of the residue definition for risk assessment with respect to groundwater (see point 7.4.1 of Part A of the Annex to Regulation (EU) No 283/2013) a PECGW calculation shall be required for assessing their relevance.

Where identified metabolites, breakdown or reaction products are found to occur in concentrations above 0,1 μg/L in the leachate, an assessment of their relevance shall be required.

9.2.4.2.   Additional field tests

The need to perform additional field tests and the type and conditions of the tests to be performed shall be discussed with the national competent authorities.

9.2.5.   Estimation of concentrations in surface water and sediment

The surface water and sediment contamination routes shall be defined taking into account relevant agricultural, plant health, and environmental (including climatic) conditions. Suitable estimations (calculations) of predicted environmental concentration in surface water PECSW and sediment PECSED of active substance shall be submitted, unless the applicant shows that contamination will not occur. PECSW and PECSED estimations shall relate to the maximum number and highest rates of application, at the shortest interval, for which authorisation is sought, and be relevant to ditches, ponds, and streams.

Relevant EU surface water modelling tools shall be run. The factors which shall be considered in making PECSW and PECSED estimations relate to direct application to water, drift, run-off, discharge via drains and atmospheric deposition, and include processes such as volatilisation, adsorption, advection, hydrolysis, photolysis, biodegradation, sedimentation and re-suspension, and transfer between water and sediment. Initial maximum concentration following an application (global maximum), short-term and long-term PECSW calculations for relevant water bodies (time weighted averages) shall be provided. Corresponding initial maximum concentration following an application (global maximum), short-term and long-term PECSED calculations for relevant water bodies (time weighted averages) shall also be provided. These PEC values shall be provided for the active substance and all metabolites, breakdown and reaction products identified as a part of the residue definition for the risk assessment with respect to surface water and sediment. They shall be used to complete risk assessments, through a comparison with the endpoints derived from data from ecotoxicological studies.

Short-term and long-term PECSW and corresponding short-term and long-term PECSED calculations for relevant static water bodies (ponds; time weighted averages) and for relevant slow moving water bodies (ditches and streams; time weighted averages), shall be calculated with the aid of a moving time-window. Appropriate time windows with respect to data from ecotoxicological studies shall be applied.

The need to perform additional higher tier tests and the type and conditions of the tests to be performed shall be discussed with the national competent authorities.

9.3.   Fate and behaviour in air

9.3.1.   Route and rate of degradation in air and transport via air

If the trigger for volatilisation, Vp = 10^– 5 Pa (for volatilisation from plant) or 10^– 4 Pa (for volatilisation from soil) at a temperature of 20 °C is exceeded and (drift) mitigation measures are required to reduce exposure to non-target organisms, model calculations of off-site deposition (PEC) originating from volatilisation shall be provided. The volatilisation term (PEC) shall be added into the relevant risk assessment procedures for PECS and PECSW. The calculation may be refined using data from confined experiments. Where relevant, laboratory, wind-tunnel or field experiments to determine PECS from deposition following volatilisation and mitigation measures shall be provided.

9.4.   Estimation of concentrations for other routes of exposure

Suitable estimations (calculations) of predicted environmental concentration, of active substance and metabolites, breakdown and reaction products shall be submitted unless the applicant shows that contamination will not occur in case of exposure by other routes, such as:

• — deposition of dust containing plant protection products by drift during sowing,

• — indirect exposure of surface water via a sewage treatment plant (STP) after application of a plant protection product in storage rooms, and

• — amenity use.

PEC estimations shall relate to the maximum number and highest rates of application, at the shortest interval, for which authorisation is sought, and be relevant to the relevant environmental compartments.

The type of information to be provided shall be discussed with the national competent authorities.

SECTION 10

Ecotoxicological studies

Introduction

• 1.Testing of the plant protection product shall be necessary where its toxicity cannot be predicted on the basis of data on the active substance. Where testing is necessary, the aim shall be to demonstrate whether the plant protection product, taking account of content of active substance, is more toxic than the active substance. Thus bridging studies or a limit test may be sufficient. However, where a plant protection product is more toxic than the active substance (expressed in comparable units), definitive testing shall be required. Possible effects on organisms/ecosystems shall be investigated, unless the applicant shows that exposure of the organisms or ecosystems does not occur.

• Tests and studies conducted using the plant protection product as test material necessary to assess the toxicity of the active substance shall be reported in the context of the relevant data requirement concerning the active substance.

• 2.All potentially adverse effects found during routine ecotoxicological investigations shall be reported and such additional studies, which may be necessary to investigate the mechanisms involved and assess the significance of these effects, shall be undertaken and reported.

• 3.Whenever a study implies the use of different doses, the relationship between dose and adverse effect shall be reported.

• 4.Where exposure data are necessary to decide whether a study has to be performed, the data obtained in accordance with Section 9 shall be used.

• For the estimation of exposure of organisms, all information on the plant protection product and on the active substance shall be taken into account. A tiered approach shall start with default worst-case parameters for exposure and be followed by a parameter refinement based on the identification of representative organisms. Where relevant, the parameters set out in this Section shall be used. Where it appears from available data that the plant protection product is more toxic than the active substance, the toxicity data for the plant protection product shall be used for the calculation of appropriate risk quotients (see point 8 of this introduction).

• 5.The requirements laid down in this Section shall include certain study types that are set out in Section 8 of Part A of the Annex to Regulation (EU) No 283/2013 (such as standard laboratory tests with birds, aquatic organisms, bees, arthropods, earthworms, soil micro-organisms, soil meso-fauna and non-target plants). While each point shall be addressed, experimental data with a plant protection product shall be generated only if its toxicity cannot be predicted on the basis of data on the active substance. It may be sufficient to test the plant protection product with that species of a group that was most sensitive with the active substance.

• 6.A detailed description (specification) of the material used as provided for in accordance with point 1.4 shall be provided.

• 7.In order to facilitate the assessment of the significance of test results obtained, the same strain of each species shall, where possible, be used in the various toxicity tests specified.

• 8.The ecotoxicological assessment shall be based on the risk that the proposed plant protection product poses to non-target organisms. In carrying out a risk assessment, toxicity shall be compared with exposure. The general term for the output from such a comparison is ‘risk quotient’ (RQ). RQ may be expressed in several ways, for example, toxicity:exposure ratio (TER) and as a hazard quotient (HQ).

• 9.For those guidelines which allow for study to be designed to determine an effective concentration (ECx), the study shall be conducted to determine an EC10 and EC20 along with corresponding 95 % confidence intervals. If an ECx approach is used, a NOEC shall still be determined.

• Existing acceptable studies that have been designed to generate a NOEC shall not be repeated. An assessment of the statistical power of the NOEC derived from those studies shall be carried out.

• 10.For solid formulations an assessment of the risk from dust drift on to non-target arthropods and plants shall be required. Details on the likely exposure levels shall be presented in accordance with Section 9 of this Annex. For aquatic life, the risk of movement of the whole particle as well as dust particles shall be considered. Until agreed dust dissipation rate assessments are available likely exposure levels shall be used in the risk assessment.

• 11.Higher tier studies using a plant protection product shall be designed and data analysed using suitable statistical methods. Full details of the statistical methods shall be reported. Where appropriate, higher tier studies shall be supported by chemical analysis to verify exposure has occurred at an appropriate level.

• 12.Pending the validation and adoption of new studies and of a new risk assessment scheme, existing protocols shall be used to address the acute and chronic risk to bees, including those on colony survival and development, and the identification and measurement of sub-lethal effects in the risk assessment.

10.1.   Effects on birds and other terrestrial vertebrates

10.1.1.   Effects on birds

Possible risks to birds shall be investigated if the toxicity of the plant protection product cannot be predicted on the basis of the data for the active substance, except, for example, where the plant protection product is used in enclosed spaces or for wound-healing treatments where birds will experience neither direct nor secondary exposure.

In the case of pellets, granules or treated seeds the amount of active substance in each pellet, granule or seed shall be reported as well as the size, weight and shape of pellets or granules. From that data, the number as well as the weight of pellets, granules or seeds required to achieve the LD50 ([^E0009]) shall be calculated and reported as well.

In the case of baits the concentration of as in the bait (mg active substance/kg) shall be reported.

A risk assessment for birds shall be conducted in accordance with the relevant risk quotient analysis.

10.1.1.1.   Acute oral toxicity to birds

Circumstances in which required

The acute oral toxicity of the plant protection product shall be investigated if toxicity cannot be predicted on the basis of the data for the active substance, or where results from mammalian testing give evidence of higher toxicity of the plant protection product compared to the active substance, unless the applicant shows that it is not likely that birds are exposed to the plant protection product itself.

Test conditions

The test shall provide, where possible, LD50 values, the lethal threshold dose, time courses of response and recovery, the No Observed Effect Level (NOEL), and shall include gross pathological findings. Study design shall be optimised for the achievement of an accurate LD50 rather than for any secondary endpoint.

The study shall be conducted on the species used in the study referred to in point 8.1.1 of Part A of the Annex to Regulation (EU) No 283/2013.

The highest dose used in tests shall not exceed 2 000  mg active substance/kg body weight, however, depending on the expected exposure levels in the field following the intended use of the compound, higher doses may be required.

10.1.1.2.   Higher tier data on birds

Higher tier studies on birds shall be conducted where the first tiers of the risk assessment do not demonstrate that risk is acceptable.

10.1.2.   Effects on terrestrial vertebrates other than birds

Possible risks to vertebrate species other than birds shall be investigated except when the test substance is included in plant protection products used, for example, in enclosed spaces and wound-healing treatments where vertebrate species other than birds will experience neither direct nor secondary exposure.

Experimental testing of vertebrates shall only be carried out where the data required for risk assessment cannot be derived from the data generated in accordance with the requirements set out in Section 5 and 7 of Part A of the Annex to Regulation (EU) No 283/2013.

An acute and reproductive risk assessment for terrestrial vertebrates other than birds shall be conducted in accordance with the relevant risk quotient analysis.

10.1.2.1.   Acute oral toxicity to mammals

Circumstances in which required

If exposure to the formulation is considered possible and the toxicity cannot be predicted on the basis of the data for the active substance, data on the acute oral toxicity of the plant protection product from the mammalian toxicological assessment shall also be considered (see point 5.8 of Part A of the Annex to Regulation (EU) No 283/2013).

10.1.2.2.   Higher tier data on mammals

Higher tier studies on mammals shall be conducted where the first tiers of the risk assessment do not demonstrate that risk is acceptable.

10.1.3.   Effects on other terrestrial vertebrate wildlife (reptiles and amphibians)

Where it cannot be predicted from the active substance data and, if relevant, the risk to amphibians and reptiles from plant protection products shall be addressed. The type and conditions of the studies to be provided shall be discussed with the national competent authorities.

10.2.   Effects on aquatic organisms

Possible effects on aquatic species (fish, aquatic invertebrates, algae and in the case of herbicides and plant growth regulators, aquatic macrophytes) shall be investigated except where the possibility that aquatic species will be exposed can be ruled out.

A risk assessment for aquatic organisms shall be conducted in accordance with the relevant risk quotient analysis.

10.2.1.   Acute toxicity to fish, aquatic invertebrates, or effects on aquatic algae and macrophytes.

Circumstances in which required

Testing shall be performed where:

• (a) the acute toxicity of the plant protection product cannot be predicted on the basis of the data for the active substance; or

• (b) the intended use includes direct application on water;

• (c) extrapolation on the basis of available data for a similar plant protection product is not possible.

Tests shall be carried out on one species from each of the three/four groups of aquatic organisms, that is to say fish, aquatic invertebrates, algae and, where relevant, macrophytes as referred to in point 8.2 of Part A of the Annex to Regulation (EU) No 283/2013, if the plant protection product itself may contaminate water.

However, where the available information permits to conclude that one of these groups is clearly more sensitive, tests on only the relevant group shall be performed.

If the plant protection product contains two or more active substances, and the most sensitive taxonomic groups for the individual active substances are not the same, testing on all three/four aquatic groups, that is to say fish, aquatic invertebrates, algae and, where relevant macrophytes, shall be required.

Test conditions

The relevant provisions as under points 8.2.1, 8.2.4, 8.2.6 and 8.2.7 of Part A of the Annex to Regulation (EU) No 283/2013 apply. In order to minimise fish testing a threshold approach shall be considered for testing acute toxicity in fish (see point 8.2.1 of Part A of the Annex to Regulation (EU) No 283/2013)

10.2.2.   Additional long-term and chronic toxicity studies on fish, aquatic invertebrates and sediment dwelling organisms

The studies referred to in points 8.2.2 and 8.2.5 of Part A of the Annex to Regulation (EU) No 283/2013 shall be conducted for particular plant protection products, where it is not possible to extrapolate from data obtained in the corresponding studies on the active substance (for example the plant protection product is more acutely toxic than the active substance as manufactured by a factor of 10), unless it is demonstrated that exposure will not occur.

If chronic toxicity studies with the plant protection product are required, the type and conditions of the studies to be provided shall be discussed with the national competent authorities.

10.2.3.   Further testing on aquatic organisms

The studies referred to in point 8.2.8 of Part A of the Annex to Regulation (EU) No 283/2013 may be required for particular plant protection products where it is not possible to extrapolate from data obtained in the corresponding studies for the active substance or another plant protection product.

10.3.   Effects on arthropods

10.3.1.   Effects on bees

The possible effects on bees shall be investigated except where the plant protection product is for exclusive use in situations where bees are not likely to be exposed such as:

• (a) food storage in enclosed spaces;

• (b) non-systemic plant protection products for application to soil, except granules;

• (c) non-systemic dipping treatments for transplanted crops and bulbs;

• (d) wound sealing and healing treatments;

• (e) non-systemic rodenticidal baits;

• (f) use in greenhouses without bees as pollinators.

Testing shall be required if:

• — the plant protection product contains more than one active substance,

• — the toxicity of a plant protection product cannot be reliably predicted to be either the same or lower than the active substance tested, in accordance with the requirements set out in points 8.3.1 and 8.3.2 of Part A of the Annex to Regulation (EU) No 283/2013.

For seed treatments the risk from drift of dust during drilling of the treated seed shall be taken into account. As regards granules and slug pellets the risk from drift of dust during application shall be taken into account. If the plant protection product is systemic and to be used on seeds, bulbs, roots, applied directly to soil, for example sprayed on to soil, granules/pellets applied to soil, irrigation water, or applied directly to or into the plant, for example by spraying or stem injection, then the risk to bees foraging those plants shall be assessed, including the risk deriving from residues of the plant protection product in nectar, pollen and water, including guttation.

Where bees are likely to be exposed, testing by both acute (oral and contact) and chronic toxicity, including sub-lethal effects, shall be conducted.

Where exposure of bees to residues in nectar, pollen or water resulting from systemic properties of the active substance may occur and where the acute oral toxicity is < 100 μg/bee or a considerable toxicity for larvae occurs, residues concentrations in these matrices shall be provided and the risk assessment shall be based on a comparison of the relevant endpoint with those residue concentrations. If this comparison indicates that an exposure to toxic levels cannot be excluded, effects shall be investigated with higher tier tests.

10.3.1.1.   Acute toxicity to bees

Where bee acute testing with the plant protection product is required, both acute oral and contact toxicity tests shall be conducted.

10.3.1.1.1.   Acute oral toxicity

A test for acute oral toxicity shall be provided establishing the acute LD50 values together with the NOEC. Sub-lethal effects, if observed, shall be reported.

Test conditions

Results shall be presented in terms of μg plant protection product/bee.

10.3.1.1.2.   Acute contact toxicity

A test for acute contact toxicity shall be provided establishing the acute LD50 values together with the NOEC. Sub-lethal effects, if observed, shall be reported.

Test conditions

Results shall be presented in terms of μg plant protection product/bee.

10.3.1.2.   Chronic toxicity to bees

A test for chronic toxicity to bees shall be provided establishing the chronic oral EC10, EC20, EC50 together with the NOEC. Where the chronic oral EC10, EC20, EC50 cannot be estimated, an explanation shall be provided. Sub-lethal effects, if observed, shall be reported.

Circumstances in which required

The test shall be carried out where bees are likely to be exposed.

Test conditions

Results shall be presented in terms of μg plant protection product/bee.

10.3.1.3.   Effects on honey bee development and other honey bee life stages

A bee brood study shall be conducted to determine effects on honey bee development and brood activity.

The bee brood test shall provide sufficient information to evaluate possible risks from the plant protection product on honey bee larvae.

The test shall provide the EC10, EC20 and EC50 for adult bees/larvae (or an explanation if they cannot be estimated) together with the NOEC. Sub-lethal effects, if observed, shall be reported.

10.3.1.4.   Sub-lethal effects

Tests investigating sub-lethal effects, such as behavioural and reproductive effects, on bees and, where applicable, on colonies may be required.

10.3.1.5.   Cage and tunnel tests

The test shall provide sufficient information to evaluate:

• — possible risks from the plant protection product for bee survival and behaviour, and

• — impact on bees resulting from feeding on contaminated honey dew or flowers.

Sub-lethal effects shall be addressed, if necessary, by carrying out specific tests (for example foraging behaviour).

Circumstances in which required

When acute or chronic effects on colony survival and development cannot be ruled out, further testing shall be required especially if effects are observed in the honeybee brood feeding test (see point 8.3.1.3 of Part A of the Annex to Regulation (EU) No 283/2013) or if there are indications for indirect effects such as delayed action, effects on juvenile stages, or modification of bee behaviour; or other effects such as prolonged residual effects; in those cases cage/tunnel tests shall be carried out and reported.

Test conditions

The test shall be carried out using healthy queen-right honey bee colonies in which pathogens are low and regularly monitored.

10.3.1.6.   Field tests with honeybees

The test shall have an adequate statistical power and shall provide sufficient information to evaluate possible risks from the plant protection product on bee behaviour, colony survival and development.

Sub-lethal effects shall be addressed, if necessary by carrying out specific tests (for example homing flight).

Circumstances in which required

When acute or chronic effects on colony survival and development cannot be ruled out, further testing shall be required if:

• — effects are observed in the honeybee brood feeding test (see point 8.3.1.3 of Part A of the Annex to Regulation (EU) No 283/2013), or

• — there are indications for indirect effects such as delayed action, effects on juvenile stages, or modification of bee behaviour or other effects such as prolonged residual effects.

In those cases field tests shall be carried out.

Test conditions

The test shall be carried out using healthy queen-right honey bee colonies in which pathogens are low and regularly monitored.

Test guideline

The design of higher tier studies to be used shall be discussed with the relevant competent authorities.

10.3.2.   Effects on non-target arthropods other than bees

Circumstances in which required

Effects on non-target terrestrial arthropods shall be investigated for all plant protection products except where plant protection products containing the active substance are for exclusive use in situations where non-target arthropods are not exposed such as:

• (a) food storage in enclosed spaces that preclude exposure;

• (b) wound sealing and healing treatments;

• (c) enclosed spaces with rodenticidal baits.

Testing shall be required if:

• — the plant protection product contains more than one active substance,

• — the toxicity of a plant protection product cannot be reliably predicted to be either the same or lower than the active substance tested, in accordance with the requirements set out in point 8.3.2 of Part A of the Annex to Regulation (EU) No 283/2013.

For plant protection products, two indicator species, the cereal aphid parasitoid Aphidius rhopalosiphi (Hymenoptera: Braconidae) and the predatory mite Typhlodromus pyri (Acari: Phytoseiidae) shall be tested. Initial testing shall be performed using glass plates, and both mortality and effects on reproduction (if assessed) shall be reported. Testing shall determine a rate-response relationship and LR50 ([^E0010]), ER50 ([^E0011]) and NOEC endpoints shall be reported for assessment of the risk to these species in accordance with the relevant risk quotient analysis.

For a plant protection product containing an active substance suspected of having a special mode of action (for example insect growth regulators, insect feeding inhibitors) additional tests involving sensitive life stages, special routes of uptake or other modifications, may be required. The rationale for the choice of test species used shall be provided.

Testing shall provide sufficient information to evaluate the toxicity (mortality) of the plant protection product to arthropods in the in-field as well as in the off-field area.

10.3.2.1.   Standard laboratory testing for non-target arthropods

The test shall provide sufficient information to evaluate the toxicity of the plant protection product to the two indicator species (Aphidius rhopalosiphi (Hymenoptera: Braconidae) and Typhlodromus pyri) (Acari: Phytoseiidae) in accordance with the relevant risk quotient analysis.

Where adverse effects are indicated, testing using higher tier studies shall be required (see points 10.3.2.2 to 10.3.2.5) for further details. In higher tier assessment the risk quotient analysis used for standard laboratory non-target arthropod testing is not appropriate.

10.3.2.2.   Extended laboratory testing, aged residue studies with non-target arthropods

The tests shall provide sufficient information to evaluate the risk of the plant protection product for arthropods using a more realistic test substrate or exposure regime.

Circumstances in which required

Further testing shall be required where effects are seen following laboratory testing in accordance with the requirements set out in point 10.3.2.1 and where the relevant risk quotient analysis indicates a risk to the standard indicator non-target arthropod species.

Firstly, the indicator species affected in standard Tier 1 laboratory testing (point 10.3.2.1) shall be tested. In addition, where an in-field risk is indicated to one or both standard indicator species, testing of one additional species shall be required. Where an off-field risk to the standard indicator species is indicated, testing of one further additional species shall be required.

An aged residue study shall be conducted with the most sensitive species to give information on the time scale needed for potential re-colonisation of treated in-field areas.

Test conditions

(a) Extended laboratory studies

Extended laboratory studies shall be carried out under controlled environmental conditions, by exposing laboratory-reared test organisms, or field collected specimens, to fresh and dried pesticide deposits applied to natural substrates, for example leaves, plants or natural soil under laboratory or field conditions.

(b) Aged residue studies

Aged residue studies shall assess the duration of effects on in-field non-target arthropods. They shall involve ageing of plant protection product deposits under field conditions (use of rain protection may be advisable), with exposure of the test organisms on treated leaves or plants either in the laboratory, under semi-field conditions or a combination of both (such as mortality assessment under semi-field conditions and reproduction assessment under laboratory conditions).

10.3.2.3.   Semi-field studies with non-target arthropods

The tests shall provide sufficient information to evaluate the risk of the plant protection product for arthropods taking field conditions into account.

Circumstances in which required

Where effects are seen following laboratory testing in accordance with the requirements set out in point 8.3.2 of Part A of the Annex to Regulation (EU) No 283/2013 or point 10.3.2 of this Annex (for example relevant trigger values are breached), semi-field testing shall be required.

Test conditions

The tests shall be conducted under representative agricultural conditions and in accordance with the proposed recommendations for use, resulting in a realistic worst case study.

In semi-field testing the results from lower tier testing as well as the specific questions to be addressed shall be taken in to account. In the selection of species for semi-field testing, the results from lower tier testing as well as the specific questions to be addressed shall be taken into account.

Testing shall include lethal and sub-lethal endpoints (for example integrated parameters in field studies), but such endpoints shall be interpreted with care since they are subject to high variability.

10.3.2.4.   Field studies with non-target arthropods

The tests shall provide sufficient information to evaluate the risk of the plant protection product for arthropods taking field conditions into account.

Circumstances in which required

Where effects are seen following testing in accordance with the requirements set out in point 8.3.2 of Part A of the Annex to Regulation (EU) No 283/2013 or in accordance with points 10.3.2.2 or 10.3.2.3 of this Annex, and where the relevant risk quotient analysis indicates a risk to non-target arthropods, field testing shall be required.

Test conditions

The tests shall be conducted under representative agricultural conditions and in accordance with the proposed recommendations for use, resulting in a realistic worst case study.

Field trials shall allow the determination of short- and long-term effects on naturally occurring arthropod populations of a plant protection product following application in accordance with the proposed use pattern for the plant protection product under normal agricultural conditions.

10.3.2.5.   Other routes of exposure for non-target arthropods