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Publikationstyp
Wissenschaftlicher Artikel
Erscheinungsjahr
Autor:innen
Herausgeber
Quelle
Environmental Sciences Europe
25 (2013), H. 4, Seite 1-9
25 (2013), H. 4, Seite 1-9
Schlagwörter
Mischungstoxizität, Bewertung
Förderkennzeichen (FKZ)
Forschungskennzahl
Verbundene Publikation
Zitation
Proposal for environmental mixture risk assessment in the context of the biocidal product authorization in the EU. (2013). Environmental Sciences Europe, 25 (2013), H. 4, Seite 1-9. https://doi.org/10.60810/openumwelt-1451
Zusammenfassung englisch
Background
The EU Council and Parliament recently agreed on a new regulation that will implement a new EU-wide, harmonized system for the authorization for biocidal products. Such products are in most cases multi-component mixtures of one or more active substances plus a range of co-formulants that serve different purposes, e.g. as stabilizers or preservatives. They are only allowed on the European market if their intended use does not lead to unacceptable risks for the environment. Consequently, the assessment of possible combination effects is a critically important step during the regulatory environmental risk assessment of biocidal products. However, no specific guidance is at hand on how combination effects should be accounted for during the regulatory environmental risk assessment of biocidal products.
Results and Conclusions
A tiered approach was developed that accommodates different data situations, optimizes resource usage, limits biotesting as far as possible and ensures adequate protection of the environment. It mainly builds on using Concentration Addition as a component-based approach for mixture toxicity prediction, complemented by whole product tests where appropriate. Concentration Addition is either approximated by summing up PEC/PNEC ratios or as sums of toxic units. The competing concept of Independent Action was assessed as not being suitable for incorporation into a tiered approach without explicit confirmatory studies, as it might otherwise lead to an underestimation of the actual environmental risk.
Quelle: http://link.springer.com/
The EU Council and Parliament recently agreed on a new regulation that will implement a new EU-wide, harmonized system for the authorization for biocidal products. Such products are in most cases multi-component mixtures of one or more active substances plus a range of co-formulants that serve different purposes, e.g. as stabilizers or preservatives. They are only allowed on the European market if their intended use does not lead to unacceptable risks for the environment. Consequently, the assessment of possible combination effects is a critically important step during the regulatory environmental risk assessment of biocidal products. However, no specific guidance is at hand on how combination effects should be accounted for during the regulatory environmental risk assessment of biocidal products.
Results and Conclusions
A tiered approach was developed that accommodates different data situations, optimizes resource usage, limits biotesting as far as possible and ensures adequate protection of the environment. It mainly builds on using Concentration Addition as a component-based approach for mixture toxicity prediction, complemented by whole product tests where appropriate. Concentration Addition is either approximated by summing up PEC/PNEC ratios or as sums of toxic units. The competing concept of Independent Action was assessed as not being suitable for incorporation into a tiered approach without explicit confirmatory studies, as it might otherwise lead to an underestimation of the actual environmental risk.
Quelle: http://link.springer.com/