This paper relates to the assessment of transformation products (i.e. metabolites, degradation or reaction products), which are formed from plant protection products. It addresses a detail in Regulation (EC) No. 1107/2009 which is not in line with other substance regulations for REACH , medicinal products, and biocides. Our concern: Also transformation products can be hazardous substances. Meanwhile, they are not yet covered within the POP / PBT /vPvB assessment and the approval criteria for active substances. Our proposal: At least transformation products occurring in a relevant amount should be included in the assessment and the approval criteria in the same way as active substances. Veröffentlicht in Scientific Opinion Paper.
Mechanistic effect models (MEM) have become increasingly popular in the field of environmental risk assessment (ERA) of plant protection products. However there remains numerous open questions to risk assessors, modelers, applicants and the public. This report provides a scientific evaluation of 11 MEM or MEM families. It also critically assesses their relevance for ERA (e.g. as a refinement tool), based on case studies. Finally, the report offers suggestions for future improvements in model development for implementation in ERA. Outcomes were discussed with experts from industries, consultancies, academia and agencies at a European symposium (19-20 Sept 2019, Berlin); the presentations and minutes are available in the annex. Veröffentlicht in Texte | 41/2024.
In recent decades, with EU and national subsidies for farming in Germany, the conventional cultivation of crops has established itself as the basis of an increasingly intensified agriculture and food production. For many crops, a key requirement for this form of production is the intensive application of chemical plant protection products, on which the system is now practically dependent. This is reflected in the assumption that the amount of chemical plant production products currently used and the frequency of their application represents a “necessary minimum” (in German language: “notwendiges Maß”). However, products that protect crops and benefit farmers may have undesirable impacts on nature and the environment. Even for present-day insecticides, herbicides and fungicides, the general principle remains: No effects (i.e. plant protection) without side-effects (i.e. impacts on nature and the environment). In view of the considerable potential environmental threats they pose and because they are applied in large quantities over ample areas of land, plant protection products may only be used if they have successfully undergone strict testing and approval procedures. In Germany, the German Environment Agency ( UBA ) is responsible for assessing the environmental risks. Veröffentlicht in Position | 01/2016.
The EU regulation 1107/2009 introduces the substitution principle for active substances in plant protection products that meet certain human or environmental hazard criteria. For products containing such candidates for substitution, their risk must be compared to alternative products during authorisation procedure. This report presents an approach for comparative risk assessment based on a profile of all different endpoints currently used in environmental risk assessment of plant protection products. It further suggests decision criteria for identifying significant differences in environmental risk, which would justify the substitution of a candidate product by a less critical alternative. Veröffentlicht in Texte | 47/2017.
In previous investigations it was demonstrated that the tiered approach for groundwater risk assessment of plant protection products in Europe (FOCUS) also represents and covers German environmental conditions. However, since a new approach of endpoint selection for groundwater modelling in the EU was implemented 2015, a recalculation of the results is required. A comparison of recalculated leachate concentrations with measurements from lysimeter studies provide evidence that a safe prediction by modelling for a high percentage of the investigated substances is still ensured. No significant differences are observed between modelling results using new EU and national endpoints. Veröffentlicht in Texte | 147/2019.
Before a plant protection product is approved for placement on the market, an assessment of the overall acceptability of negative effects on non-target species in arable land and adjacent areas has to be performed according to European guidelines. The guideline for the risk assessment of non-target terrestrial plants (NTTP) is currently revised by the European Food Safety authority (EFSA) to integrate the current state of scientific knowledge and the new requirements of Regulation (EC) No 1107/2009 to protect biodiversity. In the view of this revision, this report has been conducted to evaluate the actual scientific state of knowledge on effect- and risk assessment for non-target terrestrial plants and to recommend amendments of the current practice in testing and subsequent risk assessment of NTTP. The authors conclude that fundamental issues like the representativeness of the species tested (mostly crop species) and the ecotoxicological endpoints currently used (growth effects in juveniles) are associated with a high degree of uncertainty. These uncertainties must be taken into account in the risk assessment to ensure an adequate level of protection. Also, the analysis of data available would indicate, among other things, that the current risk assessment, limited to growth effects, might not be sufficient to ensure protection of non-target terrestrial plants. Therefore, as a simple risk management measure for PPP causing negative effects on NTTP communities, the authors propose to implement an obligatory in-field no-spray buffer zone, notably without herbicide application. Furthermore, the authors stress the importance of wild arable plants as natural life-support system for many other arable species. They highlight the key position of NTTP in the food chain with birds and mammals on the top. Based on their own research, the authors show indirect effects that PPP, such as herbicides, can have on food availability in agricultural landscapes. In the author’s opinion further applied research is needed to implement all this present information into a scheme for risk assessment and risk management which adequately protects biodiversity in agricultural landscapes, as well as ecosystem services based thereupon. Veröffentlicht in Texte | 20/2015.
The European scenario Hamburg used in the tiered approach for groundwater risk assessment of plant protection products in Europe (FOCUS) is evaluated to ascertain whether it also represents and covers German environmental conditions. A German wide analysis using geodata provides evidence that national environmental soil and climate conditions are not suitably covered by the European scenario Hamburg. A national scenario development is scientifically recommended to appropriately protect groundwater against plant protection products in Germany. Model uncertainties and further scientific investigations are critically discussed in this context. Veröffentlicht in Texte | 146/2019.
Die EU Verordnung 1107/2009 führt das Substitutionsprinzip für die Zulassung von Pflanzenschutzmitteln ein, die Wirkstoffe enthalten, die als Substitutionskandidaten identifiziert wurden. Für dieses neue rechtliche Verfahren werden Wirkstoffe auf Kommissionsebene als Substitutionskandidaten gekennzeichnet, wenn sie bestimmte Kriterien hinsichtlich der Gefährdung der menschlichen Gesundheit oder der Umwelt erfüllen. Nachfolgend ist auf Ebene der Mitgliedstaaten eine vergleichende Risikobewertung für Präparate vorzunehmen, falls für ein Produkt eine Zulassung beantragt wird, welches einen solchen Substitutionskandidaten enthält. Fast ein Viertel der gegenwärtig in der EU zugelassenen Wirkstoffe könnten als Substitutionskandidaten gekennzeichnet werden, und viele davon werden aufgrund ihrer Persistenz, Bioakkumulation oder aquatischen Toxizität eine Kennzeichnung erfahren. Für Pflanzenschutzmittel, die gegenwärtig in Deutschland zugelassen sind, ist zu erwarten, dass rund ein Drittel der Präparate in die Kategorie fallen würde, für die bei einer Neuzulassung eine vergleichende Bewertung mit Alternativprodukten erforderlich werden könnte. Für rund 40% aller betroffenen Anwendungsgebiete existieren Alternativprodukte die keine Substitutionskandidaten enthalten, und alle Produkte mit Substitutionskandidaten weisen mindestens ein Anwendungsgebiet auf, in dem eine potentielle Alternative vorhanden ist. Die vergleichende Umweltrisikobewertung von Pflanzenschutzmitteln kann daher absehbar einen wesentlichen zusätzlichen Aufwand im Zulassungsprozess bewirken. Für die Durchführung einer vergleichenden Umweltrisikobewertung wird aus diesem Projekt heraus ein Satz von generischen Kriterien vorgeschlagen, die die rechtliche Bezugsgröße umsetzt, wonach ein Faktor von mindestens 10 für das Toxizitäts-/Expositions-Verhältnis als ein signifikanter Risikounterschied aufzufassen sei. Wir schlagen weiterhin vor, Risikovergleiche für alle unterschiedlichen Endpunkte vorzunehmen, die gegenwärtig in der Umweltrisikobewertung verwendet werden, und keinem Substitutionskandidaten die Zulassung zu verweigern, falls sich für das Alternativprodukt eine signifikante Risikoerhöhung in irgendeinem anderen Risikoendpunkt zeigt. Für zehn Fallstudien konnte dargelegt werden, dass mit Hilfe der verfügbaren zusammenfassenden nationalen Bewertungsberichte eine vergleichende Risikobewertung auf der Basis der vorgeschlagenen Prinzipien prinzipiell vorgenommen werden kann. Allerdings können bei Risikowerten, die nur als Grenzwertangaben vorliegen, beim Risikovergleich uneindeutige Befunde erzeugt werden. Um die bevorstehenden vergleichenden Bewertungen möglichst effizient vornehmen zu können, wäre es aus Ressourcensicht besonders lohnend, Risikomaße wie TER- oder HQ-Werte elektronisch zugänglich zu machen. Wir schlagen daher vor, die Etablierung von elektronischen Datenbasen vorzusehen, Bewertungsprozeduren zu harmonisieren und Konsens über Entscheidungsregeln herzustellen.<BR>Quelle: Forschungsbericht
This paper relates to the assessment of transformation products (i.e. metabolites, degradation or reaction products), which are formed from plant protection products. It addresses a detail in Regulation (EC) No. 1107/2009 which is not in line with other substance regulations for REACH, medicinal products, and biocides.Our concern: Also transformation products can be hazardous substances. Meanwhile, they are not yet covered within the POP/PBT/vPvB assessment and the approval criteria for active substances.Our proposal: At least transformation products occurring in a relevant amount should be included in the assessment and the approval criteria in the same way as active substances.
Mechanistic effect models (MEM) have become increasingly popular in the field of environmental risk assessment (ERA) of plant protection products. However there remains numerous open questions to risk assessors, modelers, applicants and the public. This report provides a scientific evaluation of 11 MEM or MEM families. It also critically assesses their relevance for ERA (e.g. as a refinement tool), based on case studies. Finally, the report offers suggestions for future improvements in model development for implementation in ERA. Outcomes were discussed with experts from industries, consultancies, academia and agencies at a European symposium (19-20 Sept 2019, Berlin); the presentations and minutes are available in the annex.
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