The information provided, taken together with that for the active substance as provided for in Annex II, must be sufficient to permit an assessment of the fate and behaviour of the plant protection product in the environment, and of the non-target species likely to be at risk from exposure to it.
In particular, the information provided for the plant protection product, together with other relevant information, and that provided for the active substance, should be sufficient to:
specify the hazard symbols, the indications of danger, and relevant risk and safety phrases for the protection of the environment, which are to be included on packaging (containers),
predict the distribution, fate, and behaviour in the environment as well as the time courses involved,
identify non-target species and populations for which hazards arise because of potential exposure, and
identify measures necessary to minimize contamination of the environment and impact on non-target species.
Where radio-labelled test material is used, the provisions of Annex II, Chapter 7, introduction, point (iv) apply.
Where relevant tests should be designed and data analysed using appropriate statistical methods.
Full details of the statistical analysis should be reported (e.g. all point estimates should be given with confidence intervals, exact p-values should be given rather than stating significant/non significant).
Predicted environmental concentrations in soil (PEC S ), water (PEC SW and PEC GW ) and air (PEC A ).
Justified estimates must be made of the expected concentrations of the active substance and relevant metabolites, degradation and reaction products, in soil, groundwater, surface water and air, following use as proposed or already occurring. In addition a realistic worst-case estimation must be made.
For the purposes of the estimation of such concentrations the following definitions apply:
Predicted environmental concentration in soil (PEC S )
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).
Predicted environmental concentration in surface water (PEC SW )
The level of residues, in surface water to which non-target aquatic organisms may be exposed (acute and chronic exposure).
Predicted environmental concentration in groundwater (PEC GW )
The level of residues in groundwater.
Predicted environmental concentration in air (PEC A )
The level of residues in air, to which man, animals and other non-target organisms may be exposed (acute and chronic exposure).
For the estimation of these concentrations all relevant information on the plant protection product and on the active substance must be taken into account. A useful approach for these estimations is provided in the EPPO schemes for environmental risk assessment (1) . Where relevant the parameters provided for in this section should be used.
When models are used for estimation of predicted environmental concentrations they must:
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.
The information provided must, where relevant, include that referred to in Annex II, Part A, point 7: and
Where appropriate, the same provisions relating to the information to be provided on the soil used and on its selection apply as provided for under Annex II, point 7.1.
Aim of the test
The soil degradation studies should provide best possible estimates of the time taken for degradation of 50 and 90 % (DT 50lab and DT 90lab ) of the active substance under laboratory conditions.
Circumstances in which required
The persistence and behaviour of plant protection products in soil must be investigated unless it is possible to extrapolate from data obtained on the active substance and relevant metabolites, degradation and reaction products in accordance to the requirements of Annex II, point 7.1.1.2. This extrapolation is, for example, not possible for slow release formulations.
Test conditions
The rate of aerobic and/or anaerobic degradation in soil must be reported.
The duration of the study is normally 120 days except if more than 90 % of the active substance is degraded before that period expires.
Test guideline
SETAC — Procedures for assessing the environmental fate and ecotoxicity of pesticides.
Soil dissipation studies
Aim of the test
The soil dissipation studies should provide best-possible estimates of the time taken for dissipation of 50 and 90 % (DT 50f and DT 90f ), of the active substance under field conditions. Where relevant, information on relevant metabolites, degradation and reaction products must be collected.
Circumstances in which required
The dissipation and behaviour of plant protection products in soil must be investigated unless it is possible to extrapolate from data obtained on the active substance and relevant metabolites, degradation and reaction products in accordance to the requirements of Annex II, point 7.1.1.2. This extrapolation is, for example, not possible for slow-release formulations.
Test conditions and test guideline
The same provisions as provided under the corresponding paragraph of Annex II, point 7.1.1.2.2. apply.
Soil residue studies
Aim of the test
Soil residue studies should provide estimates of the soil residue levels at harvest or at time of sowing or planting succeeding crops.
Circumstances in which required
Soil residue studies must be reported unless it is possible to extrapolate from data obtained on the active substance and relevant metabolites, degradation and reaction products in accordance with the requirements of Annex II, point 7.1.1.2.2. This extrapolation is, for example, not possible for slow-release formulations.
Test conditions
The same provisions as provided under the corresponding paragraph of Annex II, point 7.1.1.2.2. apply.
Test guideline
SETAC — Procedures for assessing the environmental fate and ecotoxicity of pesticides.
Soil accumulation studies
Aim of the tests
The tests should provide sufficient data to evaluate the possibility of accumulation of residues of the active substance and of relevant metabolites, degradation and reaction products.
Circumstances in which required
Soil accumulation studies must be reported unless it is possible to extrapolate from data obtained on the active substance and relevant metabolites, degradation and reaction products in accordance with the requirements of Annex II, point 7.1.1.2.2. This extrapolation is, for example, not possible for slow-release formulations.
Test conditions
The same provisions as provided under the corresponding paragraph of Annex II, point 7.1.1.2.2. apply.
Test guideline
SETAC — Procedures for assessing the environmental fate and ecotoxicity of pesticides.
Aim of the test
The test should provide sufficient data to evaluate the mobility and leaching potential of the active substance and relevant metabolites, degradation and reaction products.
Circumstances in which required
The mobility of plant protection products in soil must be investigated unless it is possible to extrapolate from data obtained in accordance with the requirements of Annex II, points 7.1.2 and 7.1.3.1. This extrapolation is, for example, not possible for slow-release formulations.
Test guideline
SETAC — Procedures for assessing the environmental fate and ecotoxicity of pesticides.
Aim of the tests
The test should provide data on:
the mobility of the plant protection product in soil,
the potential for leaching to ground water,
the potential distribution in soils.
Circumstances in which required
Expert judgement will be necessary to decide whether field leaching studies or lysimeter studies should be carried out, taking into account the results of degradation and mobility studies and the calculated PEC s . The type of study to be conducted should be discussed with the competent authorities.
These studies must be performed unless it is possible to extrapolate from data obtained on the active substance and relevant metabolites, degradation and reaction products in accordance with the requirements of Annex II, point 7.1.3. This extrapolation is, for example, not possible for slow release formulations.
Test conditions
The same provisions as provided for under the corresponding paragraph of Annex II, point 7.1.3.3 apply.
PEC s estimations must relate both to a single application at the highest rate of application for which authorization is sought, and to the maximum number and highest rates of application for which authorization is sought, for each relevant soil tested, and are expressed in terms of mg of active substance and of relevant metabolites, degradation and reaction products per kg of soil.
The factors to be considered in making PEC s estimations relate to direct and indirect application to soil, drift, run off, and leaching and include processes such as volatilization, adsorption, hydrolysis, photolysis, aerobic and anaerobic degradation. For the purposes of PEC s calculations, the bulk density of soils can be assumed to be 1,5 g/cm 3 dry weight, while the depth of the soil layer is assumed to be 5 cm for applications at the soil surface and 20 cm when incorporation in the soil is involved. Where ground cover is present at time of application, it is to be assumed that 50 % (minimum) of the applied dose reaches the soil surface unless actual experimental data give more specific information.
Initial, short-term and long-term PEC s calculations (time weighted averages) must be provided:
initial: immediately after application,
short-term: 24 hours, 2 days and 4 days after last application,
long-term: 7, 28, 50 and 100 days after last application, where relevant.
The groundwater contamination routes have to be defined taking into account relevant agricultural, plant health, and environmental (including climatic) conditions.
Suitable estimations (calculations) of predicted environmental concentration in groundwater PEC GW , of active substance and relevant metabolites, degradation and reaction products, must be submitted.
PEC estimations must relate to the maximum number and highest rates of application, for which authorization is sought.
Expert judgment is required to decide if additional field tests could provide useful information. Before performing these studies the applicant shall seek the agreement of the competent authorities on the type of study to be performed.
In cases where this information is necessary in the framework of a conditional authorization as meant in Annex VI, Part C, point 2.5.1.2 (b), the information provided should permit to establish or to estimate effectiveness of water treatment procedures (drinking water and sewage treatment), and impact on such procedures. Before performing any studies the applicant shall seek the agreement of the competent authorities on the type of information to be provided.
The surface water contamination routes have to be defined taking into account relevant agricultural, plant health, and environmental (including climatic) conditions.
Suitable estimations (calculations) of predicted environmental concentration in surface water PEC sw , of active substance and relevant metabolites, degradation and reaction products, must be submitted.
PEC estimations must relate to the maximum number and highest rates of application, for which authorization is sought, and be relevant to lakes, ponds, rivers, canals, streams, irrigation/drainage canals and drains.
The factors to be considered in making PEC sw estimations relate to direct application to water, drift, run-off, discharge via drains and atmospheric deposition, and include processes such as volatilization, adsorption, advection, hydrolysis, photolysis, biodegradation, sedimentation and re-suspension.
Initial, short-term and long-term PEC sw calculations relevant to static and slow moving water bodies (time weighted averages) must be provided:
initial: immediately after application,
short-term: 24 hours, 2 days and 4 days after last application,
long-term: 7, 14, 21, 28, and 42 days after last application, where relevant.
Expert judgment is required to decide if additional field tests could provide useful information. Before performing these studies the applicant shall seek the agreement of the competent authorities on the type of study to be performed.
Guidance under development.]
Textual Amendments
[F1OEPP/EPPO (1993). Decision-making schemes for the environmental risk assessment of plant protection products. Bulletin OEPP/EPPO Bulletin 23, 1-154 and Bulletin 24, 1-87.]