ITEM 3_Strategy to identify combined effects and level of data
There is a non-exhaustive list of existing predictive tools that take into account potential interactions between substances as TEST, QSAR or BPR documents. The proposed solutions are to follow the guidance documents to assess combined exposure for ecotoxicology and toxicology. Also, the CLP calculation can be used to conduct additive assessment. It is proposed to collect data on synergistic effects by conducting a systematic literature search.
ITEM 4_Specific co-formulants
- a)Co-formulants that are approved/no more approved/not approved as pesticide a.s.
If a co-formulant has a proven pesticidal activity in the PPP, it should be declared as a.s. And the composition of PPP should be reviewed by the physical chemical experts.
- b)Co-formulants that are polymers in PPP
In principle, for human health, there is no concerns as currently they are exempt from REACH registration. For environment, there is concerns due to the accumulation of plastic in nature. However, due to the current concerns as stability, toxicologically relevant residual monomers, lack of data on toxicity, information on identity, assessment of alternatives so several solutions have been proposed. For example, acceptable PPP storage stability data to indicate the stability of polymer co-formulants and specifications of the co-formulant should be requested to demonstrate the concentration and identity of unreacted monomers present in the polymer co-formulant.
- c)Co-formulants that are UVCBs
Due to the exact composition is often unknown, it is difficult to generalize their risk profiles or establish standard test protocols for their evaluation. The proposed solutions are to use the ECHA definition and request the performance and composition specification.
- d)Co-formulants that are PFAS
There is a PFAS restriction proposals and a list of PFAS also identified as active substances. The proposed solutions are to use the OECD and ECHA definition and if there is a co-formulant meeting the PFAS definition, to consider for the risk assessment for mammalian toxicity and ecotoxicity.
- e)Co-formulants that are formaldehyde releasers
Formaldehyde cannot be used as a co-formulant with exceedance of 0.1% as an impurity in
a PPP. However, there are intentional and unintentional release of formaldehyde as impurities from co-formulants used in PPP. There is a list of formaldehyde releasers that can be checked and should be considered for risk assessment (mammalian toxicity and ecotoxicity).
