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Biocidal Product

The Experts below are selected from a list of 156 Experts worldwide ranked by ideXlab platform

Tobias Porsbring – 1st expert on this subject based on the ideXlab platform

  • Proposal for environmental mixture risk assessment in the context of the Biocidal Product authorization in the EU
    Environmental Sciences Europe, 2013
    Co-Authors: Thomas Backhaus, Rolf Altenburger, Michael Faust, Daniel Frein, Tobias Frische, Per Johansson, Anja Kehrer, Tobias Porsbring

    Abstract:

    BackgroundThe 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 ConclusionsA 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.

  • proposal for environmental mixture risk assessment in the context of the Biocidal Product authorization in the eu
    Environmental Sciences Europe, 2013
    Co-Authors: Thomas Backhaus, Rolf Altenburger, Michael Faust, Daniel Frein, Tobias Frische, Per Johansson, Anja Kehrer, Tobias Porsbring

    Abstract:

    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.

Yves M. Galante – 2nd expert on this subject based on the ideXlab platform

  • Aerogel from chemo-enzymatically oxidized fenugreek gum: an innovative delivery system of isothiazolinones biocides
    Applied Microbiology and Biotechnology, 2018
    Co-Authors: Tiziana Silvetti, Luca Merlini, Milena Brasca, Yves M. Galante

    Abstract:

    Aerogels of chemo-enzymatically oxidized, lyophilized fenugreek gum (EOLFG) were evaluated as “delivery system” (DS) of the microbiocide mix 5-chloro-2-methyl-4-isothiazolin-3-one (CIT) and 2-methyl-4-isothiazolin-3-one (MIT). These biocides have a broad activity spectrum and a low MIC (minimal inhibitory concentration) in the ppm range. They are approved under the EU Biocidal Product Directive for various applications, including cosmetics, are classified as skin sensitizers, and are under increasing scrutiny to limit or eliminate their use. We demonstrate that CIT/MIT can be uptaken into EOLFG aerogel corks by immersion into aqueous solutions of microbiocides, followed by blotting and re-lyophilization to generate “loaded” EOLFG aerogels. Incubation of “loaded” corks in water brings about a slow and almost complete release of the absorbed actives having the same MIC of free biocides against selected bacterial pathogens. This new biomaterial could represent an innovative DS of microbiocides and other actives for a variety of industrial, food, cosmetic, and biomedical applications.

  • Aerogel from chemo-enzymatically oxidized fenugreek gum: an innovative delivery system of isothiazolinones biocides
    Applied Microbiology and Biotechnology, 2018
    Co-Authors: Tiziana Silvetti, Luca Merlini, Milena Brasca, Yves M. Galante

    Abstract:

    Aerogels of chemo-enzymatically oxidized, lyophilized fenugreek gum (EOLFG) were evaluated as “delivery system” (DS) of the microbiocide mix 5-chloro-2-methyl-4-isothiazolin-3-one (CIT) and 2-methyl-4-isothiazolin-3-one (MIT). These biocides have a broad activity spectrum and a low MIC (minimal inhibitory concentration) in the ppm range. They are approved under the EU Biocidal Product Directive for various applications, including cosmetics, are classified as skin sensitizers, and are under increasing scrutiny to limit or eliminate their use.

Anja Kehrer – 3rd expert on this subject based on the ideXlab platform

  • Environmental risk assessment of Biocidal Products: identification of relevant components and reliability of a component-based mixture assessment
    Environmental Sciences Europe, 2018
    Co-Authors: Anja Coors, Pia Vollmar, Jennifer Heim, Frank Sacher, Anja Kehrer

    Abstract:

    Background Biocidal Products are mixtures of one or more active substances (a.s.) and a broad range of formulation additives. There is regulatory guidance currently under development that will specify how the combined effects of the a.s. and any relevant formulation additives shall be considered in the environmental risk assessment of Biocidal Products. The default option is a component-based approach (CBA) by which the toxicity of the Product is predicted from the toxicity of ‘relevant’ components using concentration addition. Hence, unequivocal and practicable criteria are required for identifying the ‘relevant’ components to ensure protectiveness of the CBA, while avoiding unnecessary workload resulting from including by default components that do not significantly contribute to the Product toxicity. The present study evaluated a set of different criteria for identifying ‘relevant’ components using confidential information on the composition of 21 wood preservative Products. Theoretical approaches were complemented by experimentally testing the aquatic toxicity of seven selected Products. Results For three of the seven tested Products, the toxicity was underestimated for the most sensitive endpoint (green algae) by more than factor 2 if only the a.s. were considered in the CBA. This illustrated the necessity of including at least some additives along with the a.s. Considering additives that were deemed ‘relevant’ by the tentatively established criteria reduced the underestimation of toxicity for two of the three Products. A lack of data for one specific additive was identified as the most likely reason for the remaining toxicity underestimation of the third Product. In three other Products, toxicity was overestimated by more than factor 2, while prediction and observation fitted well for the seventh Product. Considering all additives in the prediction increased only the degree of overestimation. Conclusions Supported by theoretical calculations and experimental verifications, the present study developed criteria for the identification of CBA-relevant components in a Biocidal Product. These criteria are based on existing criteria stated in the regulation for classification, labelling and packaging of substances. The CBA was found sufficiently protective and reliable for the tested Products when applying the here recommended criteria. The lack of available aquatic toxicity data for some of the identified relevant components was the main reason for underestimation of Product toxicity.

  • Proposal for environmental mixture risk assessment in the context of the Biocidal Product authorization in the EU
    Environmental Sciences Europe, 2013
    Co-Authors: Thomas Backhaus, Rolf Altenburger, Michael Faust, Daniel Frein, Tobias Frische, Per Johansson, Anja Kehrer, Tobias Porsbring

    Abstract:

    BackgroundThe 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 ConclusionsA 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.

  • proposal for environmental mixture risk assessment in the context of the Biocidal Product authorization in the eu
    Environmental Sciences Europe, 2013
    Co-Authors: Thomas Backhaus, Rolf Altenburger, Michael Faust, Daniel Frein, Tobias Frische, Per Johansson, Anja Kehrer, Tobias Porsbring

    Abstract:

    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.