In recent times, there is an important interest in hazard coformulants assessment together with the active substances due to the impact in the safe use of the PPP. EFSA and European Commission staff have developed several proposed solutions to address and support transparency and identification, data, and hazard assessment. In this Part 1, two of the four items discussed will be commented on. The next two points will be discussed in a later post:
ITEM 1_Information about the identification concentration and function of the co-formulants.
The first issue to solve is how to fully identify the co-formulants. Data requirements as defined in Regulation (EU) No 284/2013, full composition of co-formulants mixture up to 100%, information on impurities contained and other physical chemical data are requested.
Follow-up actions as a checklist of data have been proposed to fully identity co-formulants and a list of working definitions (glossary) for the assessment of PPP and co-formulants. These actions could be inserted in the Guidance document on significant and non-significant changes to co-formulants (under revision). If this is not possible, a guidance document could be drafted specifically for the chemistry aspects of the formulation and co-formulants. Another proposal is to have separate document for each co-formulant rather than a document, dRR for the plant protection product (PPP).
The second issue is how to access the confidential data of compositions. A short-term solution is to be shared among Member States (MSs) in a dedicated platform or from the suppliers directly in contact with MSs. A long-term solution is the creation of an EU common database.
The third issue is to define relevant co-formulant and co-formulant of concern to be taken into account for the risk assessment and monitor them during the stability study. The new CLP hazard classes could be taken into account. In this sense, there is a proposal of drafting of a guidance document with the inclusion of a list of non-exhaustive criteria.
ITEM 2_Hazard evaluation of PPP/Co-formulants
In principle, the following data should be available to assess the hazard effects:
- Genotoxicity: screening of co-formulants to be performed as described in the Guidance document on the relevance of metabolites in groundwater metabolites, 2003.
- Acute toxicity (ecotoxicity): For PPP, acute data (non-vertebrate species) are available in most of the cases pending on exposure. There is a lack of data for aquatics when the application does not lead to direct contamination of surface water. The following tiered approach is proposed: 1) to check the physical chemical properties and the environmental fate and behaviour data of the PPP/co-formulants and 2) to compare the toxicity of the PPP versus the active substance. If the PPP is more toxic, it would be due to toxicity of the co-formulants (or synergistic effect). In the case of higher toxicity, an exposure assessment is needed in order for the risk to be assessed. For co-formulants, the proposed tiered approach as proposed for the mammalian toxicity section could be used. The exposure should be considered before requesting long term toxicity data.
- Acute toxicity (mammalian toxicity): For the majority of PPP, acute toxicity is addressed. Although depending on the “age” of the products, the data are available or not. For co-formulants, acute data are available in most of the cases from SDS or other legal framework than pesticide. Currently, the approaches taken by the MSs differ greatly so dedicated discussion to be organized with experts will be necessary in this point.
- Long-term toxicity (mammalian toxicity): only co-formulants for which all data sets are available (including long-term toxicity) would be acceptable, unless the applicant wishes to generate data. Co-formulants which are considered not to be of concern and/or where some data are not necessary can be included in a positive list (based on the endpoint) or perform a tiered approach to screen critical co-formulants, those with data or not.
Waiving data can be considered valid with a case-case justification and based on expert judgement.
Different sources can be used for hazard identification and data to be considered: ECHA, EMA, EFSA, EU Commission (cosmetic ingredients, annex III), non-EU agencies. The applicant can use these sources explaining why the extracted information is relevant to the risk assessment.
How to share and harmonise information and evaluation of co-formulants is another important topic. There are existing databases at MSs level based on the EU survey (November 2022-January 2023) collecting the composition of co-formulants, ECHA biocide database on co-formulants and non-EU databases (e.g., US EPA). As long-term solution, it is proposed to create an EU harmonised database available to MSs, the EC and EU agencies with public and confidential versions. As interim solution, it is proposed to share existing databases among MSs on CIRCABC / DMS, feasibility to be checked by the EC and EFSA.
On the other hand, bridging assessment of PPP, alternative co-formulants and equivalence assessment have been evaluated. The proposed solutions for PPP are to draft a guidance document to better defined criteria (comparison of toxicity data and formulation type, composition and physical chemical properties, dermal absorption values, etc). The proposed solutions for co-formulants are to use the CLP approach by applying the read across approach. In the ecotoxicity and mammalian toxicity, bridging of co-formulant data may be needed in the case there is no direct exposure to the PPP and drafting a guidance document has been proposed.
