Following the post published on XX/XX/24, we continue with the summary of the items discussed by the EFSA and European Commission staff related to the assessment of coformulants:
ITEM 3: SPECIFIC EXPOSURE AND RISK ASSESSMENT METHODOLOGY ANDCONSIDERATIONS FOR PPP
| Possible solutions proposed | Proposed follow-up actions |
- Nature of residues:
- Grouping of co-formulants by structure and phys-chem properties, predict degradation behaviour of group of similar compounds and group of compounds of similar degradation behaviour (e.g., literature search as a first step; chemistry; transformation models; limited experiments on model crops for instance; fate in soil info)
- Magnitude:
Calculate a maximum application rate that is unlikely to lead to measurable residues (trigger)
- Theoretical worst-case calculation to ‘pass’ the screening RA i.e., using application rate, assuming no degradation for instance... several factors may be hypothesised.
- Look at approach similar to RUD -> need data.
- For RUD approach: define protection goal for consumers in view of uncertainty of this approach
Analysis of MS data, US EPA data, Swiss data...
- Targeted tests for most critical case GAPs close to harvest; post-harvest on representative categories -> extrapolation and envelope approach
- Derived DT50 for all co-formulants that are not persistent and compare to default DT50 of the a.s. to estimate residues (as for NDE).
| - Creation of a WG
Data collection i.e. literature search to narrow the focus
Stepwise approach: hazard, identification of co-formulant of potential concern -> exposure assessment
EFSA: Survey/call for data on exposure
-> Drafting of a GD
|
Data needed to estimate the dietary exposure to co-formulants and/or PPP
| Possible solutions proposed | Proposed follow-up actions |
- Use data retained for the a.s. considering the concentration of the co-formulant in the PPP (e.g. ratio co-formulant/a.s. and DT50)
- DFR default value, refinement needed based on PPP data (different depending on the zone) -> need for data from the APPL as a second tier
| - Creation of a WG
- Data collection i.e. literature search to narrow the focus
- Stepwise approach: hazard, identification of co-formulant of potential concern -> exposure assessment
- EFSA: Survey/call for data on exposure
-> Drafting of a GD
|
Data needed to estimate the fate and behaviour of the co-formulants and/or PPP in different compartments
| Possible solutions proposed | Proposed follow-up actions |
- Narrow down the co-formulants relevant for environmental assessment
- Grouping of co-formulants by structure and phys-chem properties, predict degradation behaviour of group of similar compounds and group of compounds of similar degradation
behaviour especially for long term exposure and GW (e.g. literature search as a first step; chemistry; transformation models; fate in soil info from REACH for instance)
- New data to be generated by APPL i.e. complete data package for env (PEC needed for coformulant too) - extrapolation to be applied in some cases
Further reflect on the protection goal for co-formulants in GW as not covered in the directive (only a.s.).
- Calculate a maximum application rate/% in the PPP that is unlikely to lead to measurable residues in the environment (trigger)
- Theoretical worst case calculation to pass screening RA i.e. using application rate, assuming no degradation for instance...several factors may be hypothesised.
- Analysis of data of other sources (literature, regulatory) when available
Derived DT50 for all co-formulants that are not persistent and compare to default DT50 of the a.s. to estimate residues (as for NDE).
- Use data used for the a.s. considering the concentration of the co-formulant in the PPP (e.g. ratio co-formulant/a.s. and DT50)
| - Creation of a WG, involving ECHA when relevant
- Data collection i.e. literature search to narrow the focus on some co-formulant depending on the concentration used in PPPs
- Stepwise approach: hazard data available, identification of co-formulant of potential concern -> exposure assessment
- EFSA: Survey/call for data on exposure
-> Drafting of a GD on the exposure assessment of the PPP and coformulants and building of a
database for co-formulants (as mentioned for item 1)
|
Data on exposure- models or tools exist to calculate or estimate exposure & exposure scenarios
| Possible solutions proposed | Proposed follow-up actions |
- EFSA calculator, 2022: for operators, workers, residents and bystanders.
- EFSA Pesticide Residues Intake Model (PRIMo): for consumers.
- FOCUS simulation models and FOCUS scenarios: concentrations of PPP in groundwater and surface water
- The US EPA Pesticide Handler Exposure Database (PHED): for workers
- CLE exposure assessment tools: OWB tool, SpERCs, LET: for workers and consumers and environment as well
- Pesticide Emission Assessment at Regional and Local scales (PEARL): pesticide behaviour in the soil-plant system
| - Check if the models are applicable to co-formulants
|
Methods to use for the risk assessment of the PPP/co-formulants
| Possible solutions proposed | Proposed follow-up actions |
- Standard approach based on hazard versus exposure.
- Look at the single component for assessing the whole PPP for humans, while for ecotox PPP data are available.
- Additional considerations required in case of synergistic/additive effects
| - May be covered by a WG
- Stepwise approach to be further elaborated
with the evolution of the knowledge
|
When a combined assessment be performed
Regulation (EC) 1107/2009, article 29 and Commission Regulation (EU) No. 284/2013 considers the interaction between ingredients shall be taken into account.
| Possible solutions proposed | Proposed follow-up actions |
- When reference values are set
- Look at targeted organ/AOP (single component approach) for performing a combined assessment
- When same residues of different co-formulants are retrieved in a PPP
- Same concept applies to co-formulants as for a.s.
- Investigate the frequency of use of co-formulants and prioritise the need for conducting a combined assessment
| - May be covered by a WG
- Tiered approach (maybe combined assessment not needed)
- Look at ECHA data/REACh dossiers (CSR for instance)
- Develop test methods to investigate the whole mixture
- Sharing data i.e. all databases to list the most commonly used co-formulants at national level
|
The use of uncertainty factors (in some cases) to compensate for possible synergistic effects was not discussed as such but it was agreed that could be covered by a WG above-mentioned.
In cases of co-formulants with particular properties (e.g. CMR, PBT), the same criteria as for the a.s. to be applied.
In silico tools (read across, QSAR, etc.), in vitro studies (e.g., comparative studies for active substance(s) and whole mixture) and in vivo studies are proposed as possible solutions for the use of additional data for PPPs for the derivation/confirmation of reference values.
ITEM 4: ORGANISATIONAL ISSUES AND ADAPTATION
In order to harmonised approach for the completeness check of the dossier, it is proposed the creation of a completeness check list by a Working Group. For time being, data collection, collaboration with ECHA to improve searchability of the information e.g., xml format. Minimum level of data required may be added in a checklist to be requested to the applicant and ensuring harmonisation among MSs (e.g., work done in the northern zone, PAI…).
Existing templates can be adapted to harmonise assessment and improve transparency (DAR, RAR, CLH report, dRR)
