Commission Regulation (EU) No 284/2013Show full title

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 (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).

(b) Predicted environmental concentration in surface water (PEC_SW)

:

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 (PEC_SED)

:

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 (PEC_GW)

:

the level of residues in groundwater.

(e) 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).

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.