Abstract
This paper does review and reflect on the state of implementation of mixture risk assessment in the guidance documents for environmental risk assessment of plant protection products under regulation 1107/2009/EC. In the past years and still on-going, the specific guidance documents for the relevant assessment areas (birds and mammals, aquatic organism, bees and wild pollinators, non-target terrestrial arthropods, soil organism, non-target terrestrial plants) have been under revision. This revision process—being led by the European Food Safety Agency (EFSA)—has substantially brought forward the consideration of the state of the science in mixture hazard and risk assessment in the recently updated guidance documents and proposals for new guidance, respectively. The application of component-based approaches is now advocated as essential new methodology; these do allow for calculating the expectable joint toxicity from toxicity data available for individual mixture components, with the reference concept of concentration addition suggested as reasonable default (tier 1) assumption within tiered approaches for mixture risk assessment. Further elements newly proposed—although differing in the degree considered in the distinct assessment areas—include the counter-checking of measured and calculated mixture toxicity as well as the identification of “drivers” of mixture toxicity/risk. The German Federal Environment Agency (UBA) does acknowledge the progress made in implementation of mixture risk assessment during the past years and is generally committed to the recently updated EFSA guidance documents and proposals for future guidance documents, respectively.
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Notes
For the sake of simplicity, we distinguish only between “active substances” (a.s.) and “co-formulants” throughout this paper. Active substances require approval on the Community level and inclusion in a corresponding positive list after thorough safety testing and risk assessment. Co-formulants do not. They may be used as product ingredients unless they are included in a negative list of undesirable co-formulants. However, as already detailed in chapter 1, under the new PPP Regulation 1107/2009 (EC 2009), the requirement for authorisation of single ingredients are no longer limited to a.s. only. They have been extended to include also “safeners” and “synergists”. During the current transition period, however, testing requirements have not yet been established for safeners and synergists and the data situation regarding non-target toxicity may therefore be the same as for other co-formulants.
Unfortunately, both, toxicity/exposure ratios (TER) and exposure/toxicity ratios (HQ for bees) are used as risk indicators under regulation 1107/2009/EC. In addition to this inconsistency within the same regulation, the use of TER values is unique in comparison to all other pieces of EU chemicals legislation, where risks are always characterized in terms of exposure-toxicity ratios, e.g. the PEC/PNEC ratio. The PPR Panel has repeatedly called for a harmonization and introduced a respective ETR-approach (exposure/toxicity ratio) just recently in the opinion on the risk assessment for aquatic organism (EFSA PPR Panel (EFSA Panel on Plant Protection Products and their Residues) 2013). However, for the sake of simplicity, this paper is still restricted to the TER-approach.
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Acknowledgments
Essential parts of this paper are funded on the results of the research project “Ecotoxicological combined effects from chemical mixtures—Relevance and adequate consideration in environmental risk assessment of plant protection products and biocides” funded by the environmental research plan of the Federal Ministry of the Environment, Nature Conservation and Nuclear Safety [Project No. (FKZ) 3709 65 404]. The report is publicly available via: http://www.umweltbundesamt.de/publikationen/ecotoxicological-combined-effects-from-chemical.
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Appendices
Appendix 1
1.1 Generic tiered approach for component-based mixture risk assessment (Altenburger et al. 2012)
Appendix 2
See Table 2.
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Frische, T., Matezki, S. & Wogram, J. Environmental risk assessment of pesticide mixtures under regulation 1107/2009/EC: a regulatory review by the German Federal Environment Agency (UBA). J. Verbr. Lebensm. 9, 377–389 (2014). https://doi.org/10.1007/s00003-014-0916-6
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DOI: https://doi.org/10.1007/s00003-014-0916-6