Crop Country Denmark Estonia Finland Latvia Lithuania Norway Sweden Potatoes 4 2-3 4 2-3 Sugar beets 3 2-3 4 Winter cereals 1 2-3 1 Beans 4 2-3 4 Cabbage 1 2-3 Carrots 1 2-3 Linseed 1 2-3 1 2-3 3 Spring OSR 4 2-3 2-3 Winter OSR 4 2-3 2-3 Onions 1 2-3 Peas 4 2-3 4 Spring cereals 1 2-3 1 Strawberries 2-3 4.5.3 Surface water No adjustments of the standard parameters and scenario conditions of the FOCUS models are accepted. is to be calculated with the FOCUS STEP3 scenarios D1-D6 and R1-R4 in accordance with the country specific requirements (Table 4.5.3-1). Simulations have to be conducted for all crops included in the GAP. When a crop is not included in the list of relevant scenarios, the user should select a crop resembling the intended crop based on expert judgement. Step 2 PEC calculations are sufficient for parents and metabolites IF the resulting TER- threshold values for aquatic ecotoxicology are exceeded by a factor of 10. For DT50 in soil, sediment and modelling endpoints in accordance with the FOCUS degradation kinetics report (SANCO 10058/2005 v2.0) should be used. If Koc and/or DT50 are pH dependent, worst case data representative for the concerned member states should be applied in the simulations (see Table 4.5.2-1). FOCUS default values should be applied where appropriate. All input values used for the simulations have to be reported, including the application window chosen for the step 3 & 4 simulations. The core assessment should contain all national scenarios for the countries where authorisation is applied for: 4.5.3-1 Country specific requirements for FOCUS scenarios considered in the assessment of surface water and sediment exposure Country Scenarios D1 D2 D3 D4 D5 D6 R1 R2 R3 R4 Denmark X X Estonia X X X X Sweden X X X Norway X X X X X X X X X X Lithuania X X X X Latvia X X X X
Ecotoxicology General Birds and Mammals Higher tier guidance on risk assessment for birds and mammals Aquatic organisms Specific aquatic risk assessment Soil organisms Specific requirements for persistent substances Geometric mean approach not accepted Danish refinement options for: FS, PD, PT, RUD, DT50 and interception Specific assessment principles for mesocosm studies Field effect studies for substances with DT50 soil between 3 and 6 months Danish/English Danish: English: Estonia Section Supplementary data requirements for Annex III dossier Yes/NO Goal(s) of Guidance document Guidance Document available Yes/No and language of the document Address or contact point to obtain GD Phys. Chem. properties and anal. method NO Toxicology NO Residues NO Efficacy NO Fate and behaviour NO Ecotoxicology No
Finland Section Supplementary data requirements for Annex III dossier Yes/NO Goal(s) of Guidance document Guidance Document available Yes/No and language of the document Address or contact point to obtain GD Phys. Chem. properties and anal. method NO Toxicology Exposure assessment: The operator exposure assessment is done mainly by using EUROPOEM I, but when needed, UK POEM and German model can be exploited. Non-professional use: Authorization of plant-protection product for non-professional use is done in case-by-case basis. However, plant protection products may not be authorized for non-professional users if those have any of the following characteristics: Product is acutely toxic or very toxic Product is carcinogenic, toxic to reproduction or mutagenic The operator exposure (without personal protective equipment) under the proposed conditions of use exceeds the AOEL. No Residues NO Efficacy Dossier must Finnish conditions Fate and behaviour NO PECsoil should be calculated by using the Finnish PECsoil Fate and behaviour NO
equipment could be used in combination with spray drift buffer zones to further reduce the risk (if the efficacy is maintained).. Non target plants Spray drift buffer zones alone or in combination with drift reducing equipment could be used to reduce the risk (see point “Non target arthropods” above). Arable crops: 50, 75 or 90% Orchards: 25, 50, 75, 90 or 99% Bees Risk mitigation options in SPe 8 in Appendix III of “Commission Regulation (EU) No 547/2011 of 8 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards labeling requirements for protection products” could be used. Additionally, spray drift buffer zones could be used to reduce the risk for bees (see point “Non target arthropods” above).