TABLE 2.

Groundwater. ^a

Compound (name and/or code)	> 0.1 μg/L at 1 m depth for the representative uses b Step 2	Biological (pesticidal) activity/relevance Step 3a	Hazard identified c Steps 3b and 3c	Consumer RA triggered Steps 4 and 5	Human health relevance
Fludioxonil (all uses)	No	Yes	–	–	Yes
Unidentified MF2 (all uses except soil‐less growing systems)	Worst case default values (soil DT50 and Koc) assessment Cereal seed treatment Yes 0.303–1.8 μg/L Foliar spray applications Yes 2.76–28.8 μg/L	Open	Not assessed (open) Proposed classification of the active substance as reprotoxic would indicate the metabolite would be considered relevant unless it is demonstrated that it does not share the reproductive toxicity potential of fludioxonil	Open	Open c
CGA192155 (all non seed treatment uses)	No strawberries Yes pome fruit 1/9 FOCUS scenarios 0.106 μg/L Yes vines 3/7 FOCUS scenarios 0.223–0.392 μg/L	No	No, when considering the existing Annex VI entry of the CLP Regulation for fludioxonil Unlikely to be genotoxic Proposed classification of the active substance as reprotoxic would indicate the metabolite would be considered relevant unless it is demonstrated that it does not share the reproductive toxicity potential of fludioxonil	Low consumer risk from representative uses (step 5) ADI of fludioxonil can apply c	No, when considering the existing Annex VI entry of the CLP Regulation for fludioxonil c
CGA265378 (all non seed treatment uses)	No	Assessment not triggered	Assessment not triggered Unlikely to be genotoxic Proposed classification of the active substance as reprotoxic would indicate the metabolite would be considered relevant unless it is demonstrated that it does not share the reproductive toxicity potential of fludioxonil	Assessment not triggered	Assessment not triggered
CGA339833 (all non seed treatment uses except soil‐less growing systems)	Yes strawberries 3/4 FOCUS scenarios 0.528–3.356 μg/L Yes pome fruit 0.131–4.016 μg/L Yes vines 0.555–3.213 μg/L	No	No, when considering the existing Annex VI entry of the CLP Regulation for fludioxonil Unlikely to be genotoxic. Proposed classification of the active substance as reprotoxic would indicate the metabolite would be considered relevant unless it is demonstrated that it does not share the reproductive toxicity potential of fludioxonil	Low consumer risk from representative uses (step 5). ADI of 0.29 mg/kg bw per day c	No, when considering the existing Annex VI entry of the CLP Regulation for fludioxonil c
SYN545245 (all non seed treatment uses)	No	Assessment not triggered	Assessment not triggered	Assessment not triggered	Assessment not triggered
Unidentified D9 (all non seed treatment uses except soil‐less growing systems)	Worst case default values (soil DT50 and Koc) assessment Yes 2.27–23.6 μg/L	Open	Not assessed (open) Proposed classification of the active substance as reprotoxic would indicate the metabolite would be considered relevant unless it is demonstrated that it does not share the reproductive toxicity potential of fludioxonil	Open c	Open c

Note: The ‘all non seed treatment uses’ indication is given because these are soil photolysis metabolites that will not be formed when seed is drilled and there is limited active substance exposure to light.

^a Assessment according to European Commission guidance of the relevance of groundwater metabolites (2003).

^b FOCUS scenarios or relevant lysimeter. Ranges indicated for FOCUS scenarios include the result from the model giving the highest concentration at each scenario, as needed to comply with European Commission (2014a) guidance.

^c Based on the newly submitted two‐generation toxicity study after the stop the clock to address endocrine disruption, EFSA agreed with the RMS that the criteria for classification according to Regulation (EC) No 1272/2008 may be met for reproductive toxicity, category 2, having an impact on the relevance assessment of groundwater metabolites. RMS is invited to submit a CLH proposal to ECHA for potential revision of the current harmonised classification accordingly.