281 results on '"Bennekou, Susanne Hougaard"'
Search Results
2. Consensus statement on the need for innovation, transition and implementation of developmental neurotoxicity (DNT) testing for regulatory purposes
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Fritsche, Ellen, Grandjean, Philippe, Crofton, Kevin M, Aschner, Michael, Goldberg, Alan, Heinonen, Tuula, Hessel, Ellen VS, Hogberg, Helena T, Bennekou, Susanne Hougaard, Lein, Pamela J, Leist, Marcel, Mundy, William R, Paparella, Martin, Piersma, Aldert H, Sachana, Magdalini, Schmuck, Gabriele, Solecki, Roland, Terron, Andrea, Monnet-Tschudi, Florianne, Wilks, Martin F, Witters, Hilda, Zurich, Marie-Gabrielle, and Bal-Price, Anna
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Medical Biotechnology ,Biomedical and Clinical Sciences ,Pediatric ,Neurosciences ,Biotechnology ,Neurological ,Age Factors ,Animal Testing Alternatives ,Animals ,Brain ,Consensus ,Diffusion of Innovation ,Humans ,Neurons ,Neurotoxicity Syndromes ,Policy Making ,Reproducibility of Results ,Risk Assessment ,Stakeholder Participation ,Toxicity Tests ,Toxicology ,Developmental neurotoxicity ,In vitro testing ,Regulatory purposes ,Pharmacology and Pharmaceutical Sciences ,Pharmacology and pharmaceutical sciences - Abstract
This consensus statement voices the agreement of scientific stakeholders from regulatory agencies, academia and industry that a new framework needs adopting for assessment of chemicals with the potential to disrupt brain development. An increased prevalence of neurodevelopmental disorders in children has been observed that cannot solely be explained by genetics and recently pre- and postnatal exposure to environmental chemicals has been suspected as a causal factor. There is only very limited information on neurodevelopmental toxicity, leaving thousands of chemicals, that are present in the environment, with high uncertainty concerning their developmental neurotoxicity (DNT) potential. Closing this data gap with the current test guideline approach is not feasible, because the in vivo bioassays are far too resource-intensive concerning time, money and number of animals. A variety of in vitro methods are now available, that have the potential to close this data gap by permitting mode-of-action-based DNT testing employing human stem cells-derived neuronal/glial models. In vitro DNT data together with in silico approaches will in the future allow development of predictive models for DNT effects. The ultimate application goals of these new approach methods for DNT testing are their usage for different regulatory purposes.
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- 2018
3. Scientific Committee guidance on appraising and integrating evidence from epidemiological studies for use in EFSA's scientific assessments.
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More, Simon, Bampidis, Vasileios, Benford, Diane, Bragard, Claude, Hernandez‐Jerez, Antonio, Bennekou, Susanne Hougaard, Koutsoumanis, Konstantinos, Lambré, Claude, Machera, Kyriaki, Mullins, Ewen, Nielsen, Soren Saxmose, Schlatter, Josef, Schrenk, Dieter, Turck, Dominique, Younes, Maged, Fletcher, Tony, Greiner, Matthias, Ntzani, Evangelia, Pearce, Neil, and Vinceti, Marco
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RISK assessment ,INFERENTIAL statistics ,SCIENTIFIC observation ,HUMAN experimentation ,COMMITTEES - Abstract
EFSA requested its Scientific Committee to prepare a guidance document on appraising and integrating evidence from epidemiological studies for use in EFSA's scientific assessments. The guidance document provides an introduction to epidemiological studies and illustrates the typical biases, which may be present in different epidemiological study designs. It then describes key epidemiological concepts relevant for evidence appraisal. This includes brief explanations for measures of association, exposure assessment, statistical inference, systematic error and effect modification. The guidance then describes the concept of external validity and the principles of appraising epidemiological studies. The customisation of the study appraisal process is explained including tailoring of tools for assessing the risk of bias (RoB). Several examples of appraising experimental and observational studies using a RoB tool are annexed to the document to illustrate the application of the approach. The latter part of this guidance focuses on different steps of evidence integration, first within and then across different streams of evidence. With respect to risk characterisation, the guidance considers how evidence from human epidemiological studies can be used in dose–response modelling with several different options being presented. Finally, the guidance addresses the application of uncertainty factors in risk characterisation when using evidence from human epidemiological studies. [ABSTRACT FROM AUTHOR]
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- 2024
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4. An analysis of the limitations and uncertainties of in vivo developmental neurotoxicity testing and assessment to identify the potential for alternative approaches
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Paparella, Martin, Bennekou, Susanne Hougaard, and Bal-Price, Anna
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- 2020
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5. Neurotoxicity and underlying cellular changes of 21 mitochondrial respiratory chain inhibitors
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Delp, Johannes, Cediel-Ulloa, Andrea, Suciu, Ilinca, Kranaster, Petra, van Vugt-Lussenburg, Barbara MA, Munic Kos, Vesna, van der Stel, Wanda, Carta, Giada, Bennekou, Susanne Hougaard, Jennings, Paul, van de Water, Bob, Forsby, Anna, and Leist, Marcel
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- 2021
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6. Multiparametric assessment of mitochondrial respiratory inhibition in HepG2 and RPTEC/TERT1 cells using a panel of mitochondrial targeting agrochemicals
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van der Stel, Wanda, Carta, Giada, Eakins, Julie, Darici, Salihanur, Delp, Johannes, Forsby, Anna, Bennekou, Susanne Hougaard, Gardner, Iain, Leist, Marcel, Danen, Erik H. J., Walker, Paul, van de Water, Bob, and Jennings, Paul
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- 2020
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7. Development of a neurotoxicity assay that is tuned to detect mitochondrial toxicants
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Delp, Johannes, Funke, Melina, Rudolf, Franziska, Cediel, Andrea, Bennekou, Susanne Hougaard, van der Stel, Wanda, Carta, Giada, Jennings, Paul, Toma, Cosimo, Gardner, Iain, van de Water, Bob, Forsby, Anna, and Leist, Marcel
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- 2019
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8. An adverse outcome pathway for parkinsonian motor deficits associated with mitochondrial complex I inhibition
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Terron, Andrea, Bal-Price, Anna, Paini, Alicia, Monnet-Tschudi, Florianne, Bennekou, Susanne Hougaard, Leist, Marcel, Schildknecht, Stefan, Angeli, Karine, Fritsche, Ellen, Mantovani, Alberto, Viviani, Barbara, and EFSA WG EPI1 Members
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- 2017
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9. Guidance on protocol development for EFSA generic scientific assessments
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EFSA Scientific Committee, More, Simon, Bampidis, Vasileios, Benford, Diane, Bragard, Claude, Hernández-Jerez, Antonio, Bennekou, Susanne Hougaard, Koutsoumanis, Konstantinos Panagiotis, Lambré, Claude, Machera, Kyriaki, Mullins, Ewen, Nielsen, Søren Saxmose, Schlatter, Josef, Schrenk, Dieter, Turck, Dominique, Younes, Maged, Kraft, Andrew, Naegeli, Hanspeter, Tsaioun, Katya, Aiassa, Elisa, Arcella, Davide, Barizzone, Fulvio, Cushen, Maeve, Georgiadis, Marios, Gervelmeyer, Andrea, Lanzoni, Anna, Lenzi, Paolo, Lodi, Federica, Martino, Laura, Messens, Winy, Ramos Bordajandi, Luisa, Rizzi, Valentina, Stancanelli, Giuseppe, Supej, Špela, Halldorsson, Thorhallur Ingi, EFSA Scientific Committee, More, Simon, Bampidis, Vasileios, Benford, Diane, Bragard, Claude, Hernández-Jerez, Antonio, Bennekou, Susanne Hougaard, Koutsoumanis, Konstantinos Panagiotis, Lambré, Claude, Machera, Kyriaki, Mullins, Ewen, Nielsen, Søren Saxmose, Schlatter, Josef, Schrenk, Dieter, Turck, Dominique, Younes, Maged, Kraft, Andrew, Naegeli, Hanspeter, Tsaioun, Katya, Aiassa, Elisa, Arcella, Davide, Barizzone, Fulvio, Cushen, Maeve, Georgiadis, Marios, Gervelmeyer, Andrea, Lanzoni, Anna, Lenzi, Paolo, Lodi, Federica, Martino, Laura, Messens, Winy, Ramos Bordajandi, Luisa, Rizzi, Valentina, Stancanelli, Giuseppe, Supej, Špela, and Halldorsson, Thorhallur Ingi
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EFSA Strategy 2027 outlines the need for fit-for-purpose protocols for EFSA generic scientific assessments to aid in delivering trustworthy scientific advice. This EFSA Scientific Committee guidance document helps address this need by providing a harmonised and flexible framework for developing protocols for EFSA generic assessments. The guidance replaces the ?Draft framework for protocol development for EFSA's scientific assessments? published in 2020. The two main steps in protocol development are described. The first is problem formulation, which illustrates the objectives of the assessment. Here a new approach to translating the mandated Terms of Reference into scientifically answerable assessment questions and sub-questions is proposed: the ?APRIO' paradigm (Agent, Pathway, Receptor, Intervention and Output). Owing to its cross-cutting nature, this paradigm is considered adaptable and broadly applicable within and across the various EFSA domains and, if applied using the definitions given in this guidance, is expected to help harmonise the problem formulation process and outputs and foster consistency in protocol development. APRIO may also overcome the difficulty of implementing some existing frameworks across the multiple EFSA disciplines, e.g. the PICO/PECO approach (Population, Intervention/Exposure, Comparator, Outcome). Therefore, although not mandatory, APRIO is recommended. The second step in protocol development is the specification of the evidence needs and the methods that will be applied for answering the assessment questions and sub-questions, including uncertainty analysis. Five possible approaches to answering individual (sub-)questions are outlined: using evidence from scientific literature and study reports; using data from databases other than bibliographic; using expert judgement informally collected or elicited via semi-formal or formal expert knowledge elicitation processes; using mathematical/statistical models; and ? not covered in this g
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- 2023
10. Re-evaluation of the existing health-based guidance values for copper and exposure assessment from all sources
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More, Simon John, Bampidis, Vasileios, Benford, Diane, Bragard, Claude, Halldorsson, Thorhallur Ingi, Hernández-Jerez, Antonio F, Bennekou, Susanne Hougaard, Koutsoumanis, Kostas, Lambré, Claude, Machera, Kyriaki, Mullins, Ewen, Nielsen, Søren Saxmose, Schlatter, Josef R, Schrenk, Dieter, Turck, Dominique, Younes, Maged, Boon, Polly, Ferns, Gordon Aa, Lindtner, Oliver, Smolders, Erik, Wilks, Martin, Bastaki, Maria, de Sesmaisons-Lecarré, Agnès, Ferreira, Lucien, Greco, Luna, Kass, George E N, Riolo, Francesca, Leblanc, Jean-Charles, More, Simon John, Bampidis, Vasileios, Benford, Diane, Bragard, Claude, Halldorsson, Thorhallur Ingi, Hernández-Jerez, Antonio F, Bennekou, Susanne Hougaard, Koutsoumanis, Kostas, Lambré, Claude, Machera, Kyriaki, Mullins, Ewen, Nielsen, Søren Saxmose, Schlatter, Josef R, Schrenk, Dieter, Turck, Dominique, Younes, Maged, Boon, Polly, Ferns, Gordon Aa, Lindtner, Oliver, Smolders, Erik, Wilks, Martin, Bastaki, Maria, de Sesmaisons-Lecarré, Agnès, Ferreira, Lucien, Greco, Luna, Kass, George E N, Riolo, Francesca, and Leblanc, Jean-Charles
- Abstract
Copper is an essential micronutrient and also a regulated product used in organic and in conventional farming pest management. Both deficiency and excessive exposure to copper can have adverse health effects. In this Scientific Opinion, the EFSA 2021 harmonised approach for establishing health-based guidance values (HBGVs) for substances that are regulated products and also nutrients was used to resolve the divergent existing HBGVs for copper. The tightly regulated homeostasis prevents toxicity manifestation in the short term, but the development of chronic copper toxicity is dependent on copper homeostasis and its tissue retention. Evidence from Wilson disease suggests that hepatic retention is indicative of potential future and possibly sudden onset of copper toxicity under conditions of continuous intake. Hence, emphasis was placed on copper retention as an early marker of potential adverse effects. The relationships between (a) chronic copper exposure and its retention in the body, particularly the liver, and (b) hepatic copper concentrations and evidence of toxicity were examined. The Scientific Committee (SC) concludes that no retention of copper is expected to occur with intake of 5 mg/day and established an Acceptable Daily Intake (ADI) of 0.07 mg/kg bw. A refined dietary exposure assessment was performed, assessing contribution from dietary and non-dietary sources. Background copper levels are a significant source of copper. The contribution of copper from its use as plant protection product (PPP), food and feed additives or fertilisers is negligible. The use of copper in fertilisers or PPPs contributes to copper accumulation in soil. Infant formula and follow-on formula are important contributors to dietary exposure of copper in infants and toddlers. Contribution from non-oral sources is negligible. Dietary exposure to total copper does not exceed the HBGV in adolescents, adults, elderly and the very elderly. Neither hepatic copper retention nor adverse
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- 2023
11. Guidance on protocol development for EFSA generic scientific assessments
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More, Simon, Bampidis, Vasileios, Benford, Diane, Bragard, Claude, Hernández‐Jerez, Antonio, Bennekou, Susanne Hougaard, Koutsoumanis, Konstantinos Panagiotis, Lambré, Claude, Machera, Kyriaki, Mullins, Ewen, Nielsen, Søren Saxmose, Schlatter, Josef, Schrenk, Dieter, Turck, Dominique, Younes, Maged, Kraft, Andrew, Naegeli, Hanspeter; https://orcid.org/0000-0001-5762-1359, Tsaioun, Katya, Aiassa, Elisa, Arcella, Davide, Barizzone, Fulvio, Cushen, Maeve, Georgiadis, Marios, Gervelmeyer, Andrea, Lanzoni, Anna, Lenzi, Paolo, Lodi, Federica, Martino, Laura, Messens, Winy, et al, More, Simon, Bampidis, Vasileios, Benford, Diane, Bragard, Claude, Hernández‐Jerez, Antonio, Bennekou, Susanne Hougaard, Koutsoumanis, Konstantinos Panagiotis, Lambré, Claude, Machera, Kyriaki, Mullins, Ewen, Nielsen, Søren Saxmose, Schlatter, Josef, Schrenk, Dieter, Turck, Dominique, Younes, Maged, Kraft, Andrew, Naegeli, Hanspeter; https://orcid.org/0000-0001-5762-1359, Tsaioun, Katya, Aiassa, Elisa, Arcella, Davide, Barizzone, Fulvio, Cushen, Maeve, Georgiadis, Marios, Gervelmeyer, Andrea, Lanzoni, Anna, Lenzi, Paolo, Lodi, Federica, Martino, Laura, Messens, Winy, and et al
- Abstract
EFSA Strategy 2027 outlines the need for fit-for-purpose protocols for EFSA generic scientific assessments to aid in delivering trustworthy scientific advice. This EFSA Scientific Committee guidance document helps address this need by providing a harmonised and flexible framework for developing protocols for EFSA generic assessments. The guidance replaces the 'Draft framework for protocol development for EFSA's scientific assessments' published in 2020. The two main steps in protocol development are described. The first is problem formulation, which illustrates the objectives of the assessment. Here a new approach to translating the mandated Terms of Reference into scientifically answerable assessment questions and sub-questions is proposed: the 'APRIO' paradigm (Agent, Pathway, Receptor, Intervention and Output). Owing to its cross-cutting nature, this paradigm is considered adaptable and broadly applicable within and across the various EFSA domains and, if applied using the definitions given in this guidance, is expected to help harmonise the problem formulation process and outputs and foster consistency in protocol development. APRIO may also overcome the difficulty of implementing some existing frameworks across the multiple EFSA disciplines, e.g. the PICO/PECO approach (Population, Intervention/Exposure, Comparator, Outcome). Therefore, although not mandatory, APRIO is recommended. The second step in protocol development is the specification of the evidence needs and the methods that will be applied for answering the assessment questions and sub-questions, including uncertainty analysis. Five possible approaches to answering individual (sub-)questions are outlined: using evidence from scientific literature and study reports; using data from databases other than bibliographic; using expert judgement informally collected or elicited via semi-formal or formal expert knowledge elicitation processes; using mathematical/statistical models; and - not covered in this g
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- 2023
12. Correction to: Multiparametric assessment of mitochondrial respiratory inhibition in HepG2 and RPTEC/TERT1 cells using a panel of mitochondrial targeting agrochemicals
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van der Stel, Wanda, Carta, Giada, Eakins, Julie, Darici, Salihanur, Delp, Johannes, Forsby, Anna, Bennekou, Susanne Hougaard, Gardner, Iain, Leist, Marcel, Danen, Erik H. J., Walker, Paul, van de Water, Bob, and Jennings, Paul
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- 2020
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13. Adverse outcome pathways: opportunities, limitations and open questions
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Leist, Marcel, Ghallab, Ahmed, Graepel, Rabea, Marchan, Rosemarie, Hassan, Reham, Bennekou, Susanne Hougaard, Limonciel, Alice, Vinken, Mathieu, Schildknecht, Stefan, Waldmann, Tanja, Danen, Erik, van Ravenzwaay, Ben, Kamp, Hennicke, Gardner, Iain, Godoy, Patricio, Bois, Frederic Y., Braeuning, Albert, Reif, Raymond, Oesch, Franz, Drasdo, Dirk, Höhme, Stefan, Schwarz, Michael, Hartung, Thomas, Braunbeck, Thomas, Beltman, Joost, Vrieling, Harry, Sanz, Ferran, Forsby, Anna, Gadaleta, Domenico, Fisher, Ciarán, Kelm, Jens, Fluri, David, Ecker, Gerhard, Zdrazil, Barbara, Terron, Andrea, Jennings, Paul, van der Burg, Bart, Dooley, Steven, Meijer, Annemarie H., Willighagen, Egon, Martens, Marvin, Evelo, Chris, Mombelli, Enrico, Taboureau, Olivier, Mantovani, Alberto, Hardy, Barry, Koch, Bjorn, Escher, Sylvia, van Thriel, Christoph, Cadenas, Cristina, Kroese, D., van de Water, Bob, and Hengstler, Jan G.
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- 2017
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14. Chemical exposure and infant leukaemia: development of an adverse outcome pathway (AOP) for aetiology and risk assessment research
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Pelkonen, Olavi, Terron, Andrea, Hernandez, Antonio F., Menendez, Pablo, Bennekou, Susanne Hougaard, Angeli, Karine, Fritsche, Ellen, Leist, Marcel, Mantovani, Alberto, Price, Anna, Viviani, Barbara, and On behalf of the EFSA WG EPI1 and its other members
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- 2017
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15. Guidance on the use of the benchmark dose approach in risk assessment
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EFSA Scientific Committee, More, Simon John, Bampidis, Vasileios, Benford, Diane, Bragard, Claude, Halldorsson, Thorhallur Ingi, Hernández-Jerez, Antonio F, Bennekou, Susanne Hougaard, Koutsoumanis, Kostas, Lambré, Claude, Machera, Kyriaki, Mennes, Wim, Mullins, Ewen, Nielsen, Søren Saxmose, Schrenk, Dieter, Turck, Dominique, Younes, Maged, Aerts, Marc, Edler, Lutz, Sand, Salomon, Wright, Matthew, Binaglia, Marco, Bottex, Bernard, Abrahantes, Jose Cortiñas, and Schlatter, Josef
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NOAEL ,dose–response modelling ,BMD ,Veterinary (miscellaneous) ,Bayesian model averaging ,Animal Science and Zoology ,Parasitology ,Plant Science ,BMD software ,benchmark response ,Microbiology ,BMDL ,Food Science - Abstract
The Scientific Committee (SC) reconfirms that the benchmark dose (BMD) approach is a scientifically more advanced method compared to the no-observed-adverse-effect-level (NOAEL) approach for deriving a Reference Point (RP). The major change compared to the previous Guidance (EFSA SC, 2017) concerns the Section 2.5, in which a change from the frequentist to the Bayesian paradigm is recommended. In the former, uncertainty about the unknown parameters is measured by confidence and significance levels, interpreted and calibrated under hypothetical repetition, while probability distributions are attached to the unknown parameters in the Bayesian approach, and the notion of probability is extended to reflect uncertainty of knowledge. In addition, the Bayesian approach can mimic a learning process and reflects the accumulation of knowledge over time. Model averaging is again recommended as the preferred method for estimating the BMD and calculating its credible interval. The set of default models to be used for BMD analysis has been reviewed and amended so that there is now a single set of models for quantal and continuous data. The flow chart guiding the reader step-by-step when performing a BMD analysis has also been updated, and a chapter comparing the frequentist to the Bayesian paradigm inserted. Also, when using Bayesian BMD modelling, the lower bound (BMDL) is to be considered as potential RP, and the upper bound (BMDU) is needed for establishing the BMDU/BMDL ratio reflecting the uncertainty in the BMD estimate. This updated guidance does not call for a general re-evaluation of previous assessments where the NOAEL approach or the BMD approach as described in the 2009 or 2017 Guidance was used, in particular when the exposure is clearly lower (e.g. more than one order of magnitude) than the health-based guidance value. Finally, the SC firmly reiterates to reconsider test guidelines given the wide application of the BMD approach.
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- 2022
16. Roadmap for action on Risk Assessment of Combined Exposure to Multiple Chemicals (RACEMiC)
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de Jong, Esther, primary, van der Voet, Hilko, additional, Marx‐Stoelting, Philip, additional, Bennekou, Susanne Hougaard, additional, Sprong, Corinne, additional, Bloch, Denise, additional, Burchardt, Alina, additional, Lasch, Alexandra, additional, Opialla, Tobias, additional, Rotter, Stefanie, additional, Wedebye, Eva Bay, additional, Zwartsen, Anne, additional, Leys, Anke, additional, Jeddi, Maryam Zare, additional, Wolterink, Gerrit, additional, Kruisselbrink, Johannes, additional, de Boer, Waldo, additional, and van Klaveren, Jacob, additional
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- 2022
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17. Evaluation of existing guidelines for their adequacy for the food and feed risk assessment of microorganisms obtained through synthetic biology
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EFSA Scientific Committee, More, Simon John, Bampidis, Vasileios, Benford, Diane, Bragard, Claude, Halldorsson, Thorhallur, Hernández-Jerez, Antonio, Bennekou, Susanne Hougaard, Koutsoumanis, Kostas P, Lambré, Claude, Machera, Kyriaki, Mullins, Ewen, Nielsen, Søren Saxmose, Schlatter, Josef, Schrenk, Dieter, Turck, Dominique, Younes, Maged, Herman, Lieve, Pelaez, Carmen, van Loveren, Henk, Vlak, Just, Revez, Joana, Aguilera, Jaime, Schoonjans, Reinhilde, and Cocconcelli, Pier Sandro
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Veterinary (miscellaneous) ,food ,feed ,genetically modified microorganism (GMM) ,risk assessment ,Animal Science and Zoology ,Parasitology ,Plant Science ,synthetic biology ,Microbiology ,guidance ,Food Science ,agri-food use - Abstract
EFSA was asked by the European Commission to evaluate synthetic biology (SynBio) developments for agri-food use in the near future and to determine whether or not they are expected to constitute potential new hazards/risks. Moreover, EFSA was requested to evaluate the adequacy of existing guidelines for risk assessment of SynBio and if updated guidance is needed. The scope of this Opinion covers food and feed risk assessment, the variety of microorganisms that can be used in the food/feed chain and the whole spectrum of techniques used in SynBio. This Opinion complements a previously adopted Opinion with the evaluation of existing guidelines for the microbial characterisation and environmental risk assessment of microorganisms obtained through SynBio. The present Opinion confirms that microbial SynBio applications for food and feed use, with the exception of xenobionts, could be ready in the European Union in the next decade. New hazards were identified related to the use or production of unusual and/or new-to-nature components. Fifteen cases were selected for evaluating the adequacy of existing guidelines. These were generally adequate for assessing the product, the production process, nutritional and toxicological safety, allergenicity, exposure and post-market monitoring. The comparative approach and a safety assessment per se could be applied depending on the degree of familiarity of the SynBio organism/product with the non-genetically modified counterparts. Updated guidance is recommended for: (i) bacteriophages, protists/microalgae, (ii) exposure to plant protection products and biostimulants, (iii) xenobionts and (iv) feed additives for insects as target species. Development of risk assessment tools is recommended for assessing nutritional value of biomasses, influence of microorganisms on the gut microbiome and the gut function, allergenic potential of new-to-nature proteins, impact of horizontal gene transfer and potential risks of living cell intake. A further development towards a strain-driven risk assessment approach is recommended.
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- 2022
18. Development of a Roadmap for Action on New Approach Methodologies in Risk Assessment
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Escher, Sylvia E., primary, Partosch, Falko, additional, Konzok, Sebastian, additional, Jennings, Paul, additional, Luijten, Mirjam, additional, Kienhuis, Anne, additional, de Leeuw, Victoria, additional, Reuss, Rosmarie, additional, Lindemann, Katrina‐Magdalena, additional, and Bennekou, Susanne Hougaard, additional
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- 2022
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19. Zebrafish embryo neonicotinoid developmental neurotoxicity in the FET test and behavioral assays
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von Hellfeld, Rebecca, Ovcharova, Viktoriia, Bevan, Samantha, Lazaridi, Maria-Agapi, Bauch, Caroline, Walker, Paul, Bennekou, Susanne Hougaard, Forsby, Anna, Braunbeck, Thomas, von Hellfeld, Rebecca, Ovcharova, Viktoriia, Bevan, Samantha, Lazaridi, Maria-Agapi, Bauch, Caroline, Walker, Paul, Bennekou, Susanne Hougaard, Forsby, Anna, and Braunbeck, Thomas
- Abstract
The need for reliable, sensitive (developmental) neurotoxicity testing of chemicals has steadily increased. Given the limited capacities for routine testing according to accepted regulatory guidelines, there is potential risk to human health and the environment. Most toxicity studies are based on mammalian test systems, which have been questioned for low sensitivity, limited relevance for humans, and animal welfare considerations. This increased the need for alternative models, one of which is the zebrafish (Danio rerio) embryo. This study assessed selected neonicotinoids at sub-lethal concentrations for their effects on embryonic development and behavior. The fish embryo acute toxicity test (OECD TG 236) determined the lowest observable effective concentrations, which were used as the highest test concentrations in subsequent behavioral assays. In the FET test, no severe compound-induced sublethal effects were seen at < 100 µM. In the coiling assay, exposure to ≥ 1.25 µM nicotine (positive control) affected both the burst duration and burst count per minute, whereas ≥ 50 µM thiacloprid affected the mean burst duration. Exposure to ≥ 50 µM acetamiprid and imidacloprid induced significant alterations in both mean burst duration and burst count per minute. In the swimming assay, 100 µM acetamiprid induced alterations in the frequency and extent of movements, whilst nicotine exposure only induced non-significant changes. All behavioral changes could be correlated to findings in mammalian studies. Given the quest for alternative test methods of (developmental) neurotoxicity, zebrafish embryo behavior testing could be integrated into a future tiered testing scheme.
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- 2022
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20. Roadmap for action on Risk Assessment of Combined Exposure to Multiple Chemicals (RACEMiC)
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de Jong, Esther, van der Voet, Hilko, Marx‐Stoelting, Philip, Bennekou, Susanne Hougaard, Sprong, Corinne, Bloch, Denise, Burchardt, Alina, Lasch, Alexandra, Opialla, Tobias, Rotter, Stefanie, Wedebye, Eva Bay, Zwartsen, Anne, Leys, Anke, Jeddi, Maryam Zare, Wolterink, Gerrit, Kruisselbrink, Johannes, de Boer, Waldo, van Klaveren, Jacob, de Jong, Esther, van der Voet, Hilko, Marx‐Stoelting, Philip, Bennekou, Susanne Hougaard, Sprong, Corinne, Bloch, Denise, Burchardt, Alina, Lasch, Alexandra, Opialla, Tobias, Rotter, Stefanie, Wedebye, Eva Bay, Zwartsen, Anne, Leys, Anke, Jeddi, Maryam Zare, Wolterink, Gerrit, Kruisselbrink, Johannes, de Boer, Waldo, and van Klaveren, Jacob
- Abstract
EFSA's aim by 2030, is that the Agency and its partners will be equipped for the routine implementation of human health risk assessment to multiple chemicals, across EFSA's domains of activity. To facilitate this effort, a roadmap for action has been developed by mapping the methods, data and tools that are currently available for mixture risk assessment and identifying current scientific gaps including challenges and blockers. The results shows that extensive methods, data and tools are available for dietary mixture risk assessment for pesticides, but that several scientific gaps still exist for the non-dietary mixture exposure to pesticides. For food additives and for certain contaminants, the regulatory readiness for mixture risk assessment was also found to be fairly high compared to food contact materials and cross-silo mixture risk assessment. The scientific gaps identified were prioritised according to their impact on the implementation of mixture risk assessment and, as a result, ten multi-annual project proposals were defined to address these scientific gaps on the short-term, mid-term and long-term. The roadmap also proposes and prioritises a number of working areas in the regulatory domains of pesticides, food contact materials, contaminants, food additives, as well as in the overarching domain of chemicals. Besides the scientific proposals, recommendations to improve stakeholder engagement and communication on mixture risk assessment was investigated. These included, among others, creating an online catalogue of tools, methods and data for mixture risk assessment, as well as the organisation of regular webinars/workshop to promote exchange of information between stakeholders and making more efficient use of national communication hubs for food safety in communicating with the general public.
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- 2022
21. Risikovurdering af en færdigret med nudler, krydderipulver og tørre grøntsager med restindhold af ethylenoxid
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Jensen, Bodil Hamborg, Bennekou, Susanne Hougaard, Jensen, Bodil Hamborg, and Bennekou, Susanne Hougaard
- Abstract
Fødevarestyrelsen har bedt DTU Fødevareinstituttet om en sundhedsmæssig risikovurdering af en prøve af en færdigret indeholdende nudler med restindhold af ethylenoxid (sum) på 0,26 mg/kg, krydderipulver med restindhold af ethylenoxid (sum) på 0,16 mg/kg og tørre grøntsager med restindhold af ethylenoxid (sum) på 12,0 mg/kg.
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- 2022
22. Risikovurdering af nudler og grøntsagsmix med restindhold af ethylenoxid
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Jensen, Bodil Hamborg, Bennekou, Susanne Hougaard, Jensen, Bodil Hamborg, and Bennekou, Susanne Hougaard
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Fødevarestyrelsen har bedt DTU Fødevareinstituttet om en sundhedsmæssig risikovurdering af en prøve indeholdende nudler med restindhold af ethylenoxid (sum) på 0,08 mg/kg og grønsagsmix med restindhold af ethylenoxid (sum) på 1,1 mg/kg.
- Published
- 2022
23. Risikovurdering af hvidløgsblade med restindhold af bifenthrin
- Author
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Jensen, Bodil Hamborg, Bennekou, Susanne Hougaard, Jensen, Bodil Hamborg, and Bennekou, Susanne Hougaard
- Abstract
Fødevarestyrelsen har bedt DTU Fødevareinstituttet om en sundhedsmæssig risikovurdering af et restindhold på 0,046 mg/kg af bifenthrin i en prøve af hvidløgsblade. MRL er 0,01* mg/kg.
- Published
- 2022
24. Risikovurdering af kvæder med restindhold af chlorpyrifos, tau-fluvalinat og deltamethrin
- Author
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Jensen, Bodil Hamborg, Bennekou, Susanne Hougaard, Jensen, Bodil Hamborg, and Bennekou, Susanne Hougaard
- Abstract
Fødevarestyrelsen har bedt DTU Fødevareinstituttet om en sundhedsmæssig risikovurdering af et restindhold på 0,21 mg/kg af chlorpyrifos, 0,61 mg/kg af tau-fluvalinat og 0,14 mg/kg af deltamethrin i en prøve af kvæder. MRL er 0,01* mg/kg for chlorpyrifos, 0,3 mg/kg for tau-fluvalinat og 0,1 mg/kg fordeltamethrin.
- Published
- 2022
25. Risikovurdering af basilikum med restindhold af carbendazim og metalaxyl
- Author
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Jensen, Bodil Hamborg, Bennekou, Susanne Hougaard, Jensen, Bodil Hamborg, and Bennekou, Susanne Hougaard
- Abstract
Fødevarestyrelsen har bedt DTU Fødevareinstituttet om en sundhedsmæssig risikovurdering af et restindhold på 2,14 mg/kg af carbendazim og 5,03 mg/kg af metalaxyl i en prøve af basilikum. MRL er 0,1* mg/kg for carbendazim og 3 mg/kg for metalayl.
- Published
- 2022
26. Risikovurdering af byggræs og kosttilskud med restindhold af ethylenoxid
- Author
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Jensen, Bodil Hamborg, Bennekou, Susanne Hougaard, Jensen, Bodil Hamborg, and Bennekou, Susanne Hougaard
- Abstract
Fødevarestyrelsen har bedt DTU Fødevareinstituttet om en sundhedsmæssig risikovurdering af et batch byggræs med restindhold af ethylenoxid (sum) på henholdsvis 786 mg/kg og 1090 mg/kg. Det pågældende batch er anvendt i kosttilskud, der også ønskes en risikovurdering af.
- Published
- 2022
27. Risikovurdering af is med indhold af guargum og johannesbrødkernemel med restindhold af ethylenoxid
- Author
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Jensen, Bodil Hamborg, Bennekou, Susanne Hougaard, Jensen, Bodil Hamborg, and Bennekou, Susanne Hougaard
- Abstract
Fødevarestyrelsen har bedt DTU Fødevareinstituttet om en sundhedsmæssig risikovurdering af is med indhold af to emulgatorer, guargum og johannesbrødkernemel med et restindhold af ethylenoxid (sum) på henholdsvis 0,28 mg/kg og 3,0 mg/kg.
- Published
- 2022
28. Risikovurdering af kosttilskud med restindhold af ethylenoxid
- Author
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Jensen, Bodil Hamborg, Bennekou, Susanne Hougaard, Jensen, Bodil Hamborg, and Bennekou, Susanne Hougaard
- Abstract
Fødevarestyrelsen har bedt DTU Fødevareinstituttet om en sundhedsmæssig risikovurdering af et kosttilskud med restindhold af ethylenoxid (sum) på 416 mg/kg.
- Published
- 2022
29. Risikovurdering af ris med restindhold af propiconazol, thiamethoxam og tricyclazol
- Author
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Jensen, Bodil Hamborg, Bennekou, Susanne Hougaard, Jensen, Bodil Hamborg, and Bennekou, Susanne Hougaard
- Abstract
Fødevarestyrelsen har bedt DTU Fødevareinstituttet om en sundhedsmæssig risikovurdering af et restindhold på 0,011 mg/kg af propiconazol, 0,106 mg/kg af thiamethoxam og 0,116 mg/kg af tricyclazol i en prøve af ris. MRL er 0,01* mg/kg for alle stoffer.
- Published
- 2022
30. Risikovurdering af ris med restindhold af thiamethoxam og tricyclazol
- Author
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Jensen, Bodil Hamborg, Bennekou, Susanne Hougaard, Jensen, Bodil Hamborg, and Bennekou, Susanne Hougaard
- Abstract
Fødevarestyrelsen har bedt DTU Fødevareinstituttet om en sundhedsmæssig risikovurdering af et restindhold på 0,074 mg/kg af thiamethoxam og 0,055 mg/kg af tricyclazol i en prøve af ris. MRL er 0,01* mg/kg for begge stoffer.
- Published
- 2022
31. Risikovurdering af chilipeber med restindhold af Carbendazim
- Author
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Jensen, Bodil Hamborg, Bennekou, Susanne Hougaard, Jensen, Bodil Hamborg, and Bennekou, Susanne Hougaard
- Abstract
Fødevarestyrelsen har bedt DTU Fødevareinstituttet om en sundhedsmæssig risikovurdering af et restindhold på 0,778 mg/kg af carbendazim i en prøve af chilipeber. MRL er 0,01* mg/kg.
- Published
- 2022
32. Risikovurdering af ris protein med restindhold af ethylenoxid
- Author
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Jensen, Bodil Hamborg, Bennekou, Susanne Hougaard, Jensen, Bodil Hamborg, and Bennekou, Susanne Hougaard
- Abstract
Fødevarestyrelsen har bedt DTU Fødevareinstituttet om en sundhedsmæssig risikovurdering af ris protein indhold af ethylenoxid (sum) på højst 38,4 mg/kg.
- Published
- 2022
33. Risikovurdering af ris med restindhold af carbendazim, hexaconazol, propiconazol, thiamethoxam og tricyclazol
- Author
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Jensen, Bodil Hamborg, Bennekou, Susanne Hougaard, Jensen, Bodil Hamborg, and Bennekou, Susanne Hougaard
- Abstract
Fødevarestyrelsen har bedt DTU Fødevareinstituttet om en sundhedsmæssig risikovurdering af et restindhold på 0,011 mg/kg af carbendazim, 0,016 mg/kg af hexaconazol, 0,013 mg/kg af propiconazol, 0,049 mg/kg af thiamethoxam og 0,14 mg/kg af tricyclazol i en prøve af ris. MRL er 0,01* mg/kg for alle stoffer.
- Published
- 2022
34. Risikovurdering af ris med restindhold af carbendazim
- Author
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Jensen, Bodil Hamborg, Bennekou, Susanne Hougaard, Jensen, Bodil Hamborg, and Bennekou, Susanne Hougaard
- Abstract
Fødevarestyrelsen har bedt DTU Fødevareinstituttet om en sundhedsmæssig risikovurdering af et restindhold på 0,011 mg/kg af carbendazim i en prøve af ris. MRL er 0,01* mg/kg.
- Published
- 2022
35. Risikovurdering af lakridspulver med restindhold af matrine
- Author
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Jensen, Bodil Hamborg, Bennekou, Susanne Hougaard, Jensen, Bodil Hamborg, and Bennekou, Susanne Hougaard
- Abstract
Fødevarestyrelsen har bedt DTU Fødevareinstituttet om en sundhedsmæssig risikovurdering af to prøver af lakridspulver, begge med restindhold af matrine på 0,52 mg/kg.
- Published
- 2022
36. Risikovurdering af marcipanæg indeholdende lakridspulver med restindhold af matrine
- Author
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Jensen, Bodil Hamborg, Bennekou, Susanne Hougaard, Jensen, Bodil Hamborg, and Bennekou, Susanne Hougaard
- Abstract
Fødevarestyrelsen har bedt DTU Fødevareinstituttet om en sundhedsmæssig risikovurdering af marcipanæg med indhold af lakridspulver med restindhold af matrine på 0,020 mg/kg.
- Published
- 2022
37. Risikovurdering af emulgator og is med restindhold af ethylenoxid
- Author
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Jensen, Bodil Hamborg, Bennekou, Susanne Hougaard, Jensen, Bodil Hamborg, and Bennekou, Susanne Hougaard
- Abstract
Fødevarestyrelsen har bedt DTU Fødevareinstituttet om en sundhedsmæssig risikovurdering af en prøve af emulgator med et restindhold af ethylenoxid (sum) på 0,5 mg/kg. Emulgatoren er anvendt i is, som der også ønskes en risikovurdering af.
- Published
- 2022
38. Opdateret DTU notat vedr. Matrine og Oxymatrine
- Author
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Petersen, Annika Boye, Bennekou, Susanne Hougaard, Petersen, Annika Boye, and Bennekou, Susanne Hougaard
- Abstract
Fødevarestyrelsen har forespurgt DTU Fødevareinstituttet om evt. eksisterende tilgængelig toksikologisk viden på de to ovenstående stoffer matrine og oxymatrine. Stofferne er blevet klassificeret som pesticider i EU med virkning fra 2021, men har ikke været ansøgt eller godkendt hidtil. FVST har efterfølgende sendt relevant information omhandlende ovenstående stoffer indsendt i forbindelse med et EU-møde i 2022, som DTU bl.a. har anvendt til opdatering af notatet. Den nye relevante information består af German Risk Assessment (udført af konsulentfirmaet RDA Scientific Consultant GmbH) samt en NL Risk Assessment (dossier fra firmaet Ruitenberg). BfR (Federal Institute for Risk Assessment) har på opfordring indsendt valide kommentarer på DTU notat/vurdering af 3. maj 2022 samt indsendt yderligere oplysninger herunder information om igangsættelse af de manglende forsøg til afdækning af det genotoksiske potentiale for matrine. BfR forventer at disse forsøg forlægger slut 2022. DTU's vurdering af 3. maj 2022 er revideret på denne baggrund. Ingen originale studierapporter for forsøgene (herunder OECD guideline forsøg) har været tilgængelige for DTU, hvorfor vurderingen alene er baseret på informationen angivet i artiklerne og resume af studier heri. På den baggrund kan DTU ikke verificere compliance med OECD TG og GLP.
- Published
- 2022
39. Risikovurdering af rosiner med restindhold af chlorpyrifos og iprodion
- Author
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Jensen, Bodil Hamborg, Bennekou, Susanne Hougaard, Jensen, Bodil Hamborg, and Bennekou, Susanne Hougaard
- Abstract
Fødevarestyrelsen har bedt DTU Fødevareinstituttet om en sundhedsmæssig risikovurdering af et restindhold på 0,22 mg/kg af chlorpyrifos og 0,093 mg/kg af iprodion i en prøve af grønne rosiner. MRL er 0,01* mg/kg for begge stoffer.
- Published
- 2022
40. International STakeholder NETwork (ISTNET): creating a developmental neurotoxicity (DNT) testing road map for regulatory purposes
- Author
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Bal-Price, Anna, Crofton, Kevin M., Leist, Marcel, Allen, Sandra, Arand, Michael, Buetler, Timo, Delrue, Nathalie, FitzGerald, Rex E., Hartung, Thomas, Heinonen, Tuula, Hogberg, Helena, Bennekou, Susanne Hougaard, Lichtensteiger, Walter, Oggier, Daniela, Paparella, Martin, Axelstad, Marta, Piersma, Aldert, Rached, Eva, Schilter, Benoît, Schmuck, Gabriele, Stoppini, Luc, Tongiorgi, Enrico, Tiramani, Manuela, Monnet-Tschudi, Florianne, Wilks, Martin F., Ylikomi, Timo, and Fritsche, Ellen
- Published
- 2015
- Full Text
- View/download PDF
41. Guidance on technical requirements for regulated food and feed product applications to establish the presence of small particles including nanoparticles
- Author
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EFSA Scientific Committee, More, Simon, Bampidis, Vasileios, Benford, Diane, Bragard, Claude, Halldorsson, Thorhallur, Hernández-Jerez, Antonio, Bennekou, Susanne Hougaard, Koutsoumanis, Kostas, Lambré, Claude, Machera, Kyriaki, Naegeli, Hanspeter, Nielsen, Søren, Schlatter, Josef, Schrenk, Dieter, Silano Deceased, Vittorio, Turck, Dominique, Younes, Maged, Castenmiller, Jacqueline, Chaudhry, Qasim, Cubadda, Francesco, Franz, Roland, Gott, David, Mast, Jan, Mortensen, Alicja, Oomen, Agnes G, Weigel, Stefan, Barthelemy, Eric, Rincon, Ana, Tarazona, Jose, et al, and University of Zurich
- Subjects
Food contact materials ,dissolution/degradation rate ,Computer science ,Veterinary (miscellaneous) ,2405 Parasitology ,nanofraction ,Novel food ,Plant Science ,TP1-1185 ,EFSA Scientific Committee ,Dissolution/degradation rate ,Microbiology ,1110 Plant Science ,Electron microscopy ,European commission ,TX341-641 ,particle size distribution ,Small particles ,Product (category theory) ,Nanofraction ,1106 Food Science ,Safety studies ,Animal health ,electron microscopy ,Nutrition. Foods and food supply ,Cros1223 ,solubility ,Chemical technology ,2404 Microbiology ,Guidance documents ,10079 Institute of Veterinary Pharmacology and Toxicology ,sample dispersion protocol ,Nanomaterial ,Particle size distribution ,3401 Veterinary (miscellaneous) ,Solubility ,Risk analysis (engineering) ,Guidance ,570 Life sciences ,biology ,Animal Science and Zoology ,Parasitology ,nanomaterial ,1103 Animal Science and Zoology ,Food Science - Abstract
Following a mandate from the European Commission, EFSA has developed a Guidance on Technical Requirements (Guidance on Particle‐TR), defining the criteria for assessing the presence of a fraction of small particles, and setting out information requirements for applications in the regulated food and feed product areas (e.g. novel food, food/feed additives, food contact materials and pesticides). These requirements apply to particles requiring specific assessment at the nanoscale in conventional materials that do not meet the definition of engineered nanomaterial as set out in the Novel Food Regulation (EU) 2015/2283. The guidance outlines appraisal criteria grouped in three sections, to confirm whether or not the conventional risk assessment should be complemented with nanospecific considerations. The first group addresses solubility and dissolution rate as key physicochemical properties to assess whether consumers will be exposed to particles. The second group establishes the information requirements for assessing whether the conventional material contains a fraction or consists of small particles, and its characterisation. The third group describes the information to be presented for existing safety studies to demonstrate that the fraction of small particles, including particles at the nanoscale, has been properly evaluated. In addition, in order to guide the appraisal of existing safety studies, recommendations for closing the data gaps while minimising the need for conducting new animal studies are provided. This Guidance on Particle‐TR complements the Guidance on risk assessment of nanomaterials to be applied in the food and feed chain, human and animal health updated by the EFSA Scientific Committee as co‐published with this Guidance. Applicants are advised to consult both guidance documents before conducting new studies., This publication is linked to the following EFSA Journal article: http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2021.6768/full This publication is linked to the following EFSA Supporting Publications article: http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2021.EN-6804/full
- Published
- 2021
42. 25th anniversary of the Berlin workshop on developmental toxicology: DevTox database update, challenges in risk assessment of developmental neurotoxicity and alternative methodologies in bone development and growth
- Author
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Marx-Stoelting, Philip, Solano, Marize de L.M., Aoyama, Hiroaki, Adams, Ralf H., Bal-Price, Anna, Buschmann, Jochen, Chahoud, Ibrahim, Clark, Ruth, Fang, Tian, Fujiwara, Michio, Gelinsky, Michael, Grote, Konstanze, Horimoto, Masao, Bennekou, Susanne Hougaard, Kellner, Rupert, Kuwagata, Makiko, Leist, Marcel, Lang, Annemarie, Li, Weihua, Mantovani, Alberto, Makris, Susan L., Paumgartten, Francisco, Perron, Monique, Sachana, Magdalini, Schmitt, Anne, Schneider, Steffen, Schönfelder, Gilbert, Schulze, Frank, Shiota, Kohei, and Solecki, Roland
- Published
- 2021
- Full Text
- View/download PDF
43. Guidance on the use of the benchmark dose approach in risk assessment.
- Author
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More, Simon John, Bampidis, Vasileios, Benford, Diane, Bragard, Claude, Halldorsson, Thorhallur Ingi, Hernández‐Jerez, Antonio F, Bennekou, Susanne Hougaard, Koutsoumanis, Kostas, Lambré, Claude, Machera, Kyriaki, Mennes, Wim, Mullins, Ewen, Nielsen, Søren Saxmose, Schrenk, Dieter, Turck, Dominique, Younes, Maged, Aerts, Marc, Edler, Lutz, Sand, Salomon, and Wright, Matthew
- Subjects
RISK assessment ,DISTRIBUTION (Probability theory) ,FLOW charts ,PROBABILITY theory ,DEFAULT (Finance) - Abstract
The Scientific Committee (SC) reconfirms that the benchmark dose (BMD) approach is a scientifically more advanced method compared to the no‐observed‐adverse‐effect‐level (NOAEL) approach for deriving a Reference Point (RP). The major change compared to the previous Guidance (EFSA SC, 2017) concerns the Section 2.5, in which a change from the frequentist to the Bayesian paradigm is recommended. In the former, uncertainty about the unknown parameters is measured by confidence and significance levels, interpreted and calibrated under hypothetical repetition, while probability distributions are attached to the unknown parameters in the Bayesian approach, and the notion of probability is extended to reflect uncertainty of knowledge. In addition, the Bayesian approach can mimic a learning process and reflects the accumulation of knowledge over time. Model averaging is again recommended as the preferred method for estimating the BMD and calculating its credible interval. The set of default models to be used for BMD analysis has been reviewed and amended so that there is now a single set of models for quantal and continuous data. The flow chart guiding the reader step‐by‐step when performing a BMD analysis has also been updated, and a chapter comparing the frequentist to the Bayesian paradigm inserted. Also, when using Bayesian BMD modelling, the lower bound (BMDL) is to be considered as potential RP, and the upper bound (BMDU) is needed for establishing the BMDU/BMDL ratio reflecting the uncertainty in the BMD estimate. This updated guidance does not call for a general re‐evaluation of previous assessments where the NOAEL approach or the BMD approach as described in the 2009 or 2017 Guidance was used, in particular when the exposure is clearly lower (e.g. more than one order of magnitude) than the health‐based guidance value. Finally, the SC firmly reiterates to reconsider test guidelines given the wide application of the BMD approach. This publication is linked to the following EFSA Supporting Publications article: http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2022.EN-7585/full [ABSTRACT FROM AUTHOR]
- Published
- 2022
- Full Text
- View/download PDF
44. A systems-based approach to the environmental risk assessment of multiple stressors in honey bees
- Author
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EFSA Scientific Committee, More, Simon, Bampidis, Vasileios, Benford, Diane, Bragard, Claude, Halldorsson, Thorhallur, Hernández-Jerez, Antonio, Bennekou, Susanne Hougaard, Koutsoumanis, Kostas, Machera, Kyriaki, Naegeli, Hanspeter, Nielsen, Søren Saxmose, Schlatter, Josef, Schrenk, Dieter, Silano, Vittorio, Turck, Dominique, Younes, Maged, Arnold, Gerard, Dorne, Jean-Lou, Maggiore, Angelo, Pagani, Stephen, Szentes, Csaba, Terry, Simon, Tosi, Simone, Vrbos, Domagoj, Zamariola, Giorgia, Rortais, Agnes, and University of Zurich
- Subjects
Sociology of scientific knowledge ,Beekeeping ,040301 veterinary sciences ,Veterinary (miscellaneous) ,2405 Parasitology ,EU Bee Partnership ,Context (language use) ,Plant Science ,TP1-1185 ,010501 environmental sciences ,01 natural sciences ,Microbiology ,0403 veterinary science ,agent‐based simulation ,1110 Plant Science ,TX341-641 ,Environmental planning ,Risk management ,1106 Food Science ,0105 earth and related environmental sciences ,ApisRAM ,Data collection ,bee biological agents ,business.industry ,Nutrition. Foods and food supply ,Chemical technology ,2404 Microbiology ,04 agricultural and veterinary sciences ,Honey bee ,10079 Institute of Veterinary Pharmacology and Toxicology ,3. Good health ,Meth2188 ,3401 Veterinary (miscellaneous) ,sentinel hives ,plant protection products ,Scientific Opinion ,Geography ,General partnership ,570 Life sciences ,biology ,Animal Science and Zoology ,Parasitology ,1103 Animal Science and Zoology ,Apis mellifera ,business ,Risk assessment ,agent-based simulation ,Food Science - Abstract
The European Parliament requested EFSA to develop a holistic risk assessment of multiple stressors in honey bees. To this end, a systems‐based approach that is composed of two core components: a monitoring system and a modelling system are put forward with honey bees taken as a showcase. Key developments in the current scientific opinion (including systematic data collection from sentinel beehives and an agent‐based simulation) have the potential to substantially contribute to future development of environmental risk assessments of multiple stressors at larger spatial and temporal scales. For the monitoring, sentinel hives would be placed across representative climatic zones and landscapes in the EU and connected to a platform for data storage and analysis. Data on bee health status, chemical residues and the immediate or broader landscape around the hives would be collected in a harmonised and standardised manner, and would be used to inform stakeholders, and the modelling system, ApisRAM, which simulates as accurately as possible a honey bee colony. ApisRAM would be calibrated and continuously updated with incoming monitoring data and emerging scientific knowledge from research. It will be a supportive tool for beekeeping, farming, research, risk assessment and risk management, and it will benefit the wider society. A societal outlook on the proposed approach is included and this was conducted with targeted social science research with 64 beekeepers from eight EU Member States and with members of the EU Bee Partnership. Gaps and opportunities are identified to further implement the approach. Conclusions and recommendations are made on a way forward, both for the application of the approach and its use in a broader context., This publication is linked to the following EFSA Supporting Publications articles: http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2021.EN-6608/full
- Published
- 2021
45. Guidance on technical requirements for regulated food and feed product applications to establish the presence of small particles including nanoparticles
- Author
-
UCL - SST/ELI/ELIM - Applied Microbiology, More, Simon, Bampidis, Vasileios, Benford, Diane, Bragard, Claude, Halldorsson, Thorhallur, Hernández‐Jerez, Antonio, Bennekou, Susanne Hougaard, Koutsoumanis, Kostas, Lambré, Claude, Machera, Kyriaki, Naegeli, Hanspeter, Nielsen, Søren, Schlatter, Josef, Schrenk, Dieter, Silano (deceased), Vittorio, Turck, Dominique, Younes, Maged, Castenmiller, Jacqueline, Chaudhry, Qasim, Cubadda, Francesco, Franz, Roland, Gott, David, Mast, Jan, Mortensen, Alicja, Oomen, Agnes G., Weigel, Stefan, Barthelemy, Eric, Rincon, Ana, Tarazona, Jose, Schoonjans, Reinhilde, UCL - SST/ELI/ELIM - Applied Microbiology, More, Simon, Bampidis, Vasileios, Benford, Diane, Bragard, Claude, Halldorsson, Thorhallur, Hernández‐Jerez, Antonio, Bennekou, Susanne Hougaard, Koutsoumanis, Kostas, Lambré, Claude, Machera, Kyriaki, Naegeli, Hanspeter, Nielsen, Søren, Schlatter, Josef, Schrenk, Dieter, Silano (deceased), Vittorio, Turck, Dominique, Younes, Maged, Castenmiller, Jacqueline, Chaudhry, Qasim, Cubadda, Francesco, Franz, Roland, Gott, David, Mast, Jan, Mortensen, Alicja, Oomen, Agnes G., Weigel, Stefan, Barthelemy, Eric, Rincon, Ana, Tarazona, Jose, and Schoonjans, Reinhilde
- Abstract
Following a mandate from the European Commission, EFSA has developed a Guidance on Technical Requirements (Guidance on Particle-TR), defining the criteria for assessing the presence of a fraction of small particles, and setting out information requirements for applications in the regulated food and feed product areas (e.g. novel food, food/feed additives, food contact materials and pesticides). These requirements apply to particles requiring specific assessment at the nanoscale in conventional materials that do not meet the definition of engineered nanomaterial as set out in the Novel Food Regulation (EU) 2015/2283. The guidance outlines appraisal criteria grouped in three sections, to confirm whether or not the conventional risk assessment should be complemented with nanospecific considerations. The first group addresses solubility and dissolution rate as key physicochemical properties to assess whether consumers will be exposed to particles. The second group establishes the information requirements for assessing whether the conventional material contains a fraction or consists of small particles, and its characterisation. The third group describes the information to be presented for existing safety studies to demonstrate that the fraction of small particles, including particles at the nanoscale, has been properly evaluated. In addition, in order to guide the appraisal of existing safety studies, recommendations for closing the data gaps while minimising the need for conducting new animal studies are provided. This Guidance on Particle-TR complements the Guidance on risk assessment of nanomaterials to be applied in the food and feed chain, human and animal health updated by the EFSA Scientific Committee as co-published with this Guidance. Applicants are advised to consult both guidance documents before conducting new studies.
- Published
- 2021
46. New Approach Methods (NAMs) Supporting Read-Across : Two Neurotoxicity AOP-based IATA Case Studies
- Author
-
van der Stel, Wanda, Carta, Giada, Eakins, Julie, Delp, Johannes, Suciu, Ilinca, Forsby, Anna, Cediel Ulloa, Andrea, Attoff, Kristina, Troger, Florentina, Kamp, Hennicke, Gardner, Iain, Zdrazil, Barbara, Mone, Martijn J., Ecker, Gerhard F., Pastor, Manuel, Gomez-Tamayo, Jose Carlos, White, Andrew, Danen, Erik H. J., Leist, Marcel, Walker, Paul, Jennings, Paul, Bennekou, Susanne Hougaard, van de Water, Bob, van der Stel, Wanda, Carta, Giada, Eakins, Julie, Delp, Johannes, Suciu, Ilinca, Forsby, Anna, Cediel Ulloa, Andrea, Attoff, Kristina, Troger, Florentina, Kamp, Hennicke, Gardner, Iain, Zdrazil, Barbara, Mone, Martijn J., Ecker, Gerhard F., Pastor, Manuel, Gomez-Tamayo, Jose Carlos, White, Andrew, Danen, Erik H. J., Leist, Marcel, Walker, Paul, Jennings, Paul, Bennekou, Susanne Hougaard, and van de Water, Bob
- Abstract
Read-across approaches are considered key in moving away from in vivo animal testing towards addressing data-gaps using new approach methods (NAMs). Ample successful examples are still required to substantiate this strategy. Here we present and discuss the learnings from two OECD IATA endorsed read-across case studies. They involve two classes of pesticides - rotenoids and strobilurins - each having a defined mode-of-action that is assessed for its neurological hazard by means of an AOP-based testing strategy coupled to toxicokinetic simulations of human tissue concentrations. The endpoint in question is potential mitochondrial respiratory chain mediated neurotoxicity, specifically through inhibition of complex I or III. An AOP linking inhibition of mitochondrial respiratory chain complex I to the degeneration of dopaminergic neurons formed the basis for both cases but was deployed in two different regulatory contexts. The two cases also exemplify several different read-across concepts: analogue versus category approach, consolidated versus putative AOP, positive versus negative prediction (i.e., neurotoxicity versus low potential for neurotoxicity), and structural versus biological similarity. We applied a range of NAMs to explore the toxicodynamic properties of the compounds, e.g., in silico docking as well as in vitro assays and readouts - including transcriptomics - in various cell systems, all anchored to the relevant AOPs. Interestingly, although some of the data addressing certain elements of the read-across were associated with high uncertainty, their impact on the overall read-across conclusion remained limited. Coupled to the elaborate regulatory review that the two cases underwent, we propose some generic learnings of AOP-based testing strategies supporting read-across.
- Published
- 2021
- Full Text
- View/download PDF
47. Risikovurdering af guar gummi med restindhold af ethylenoxid
- Author
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Jensen, Bodil Hamborg, Bennekou, Susanne Hougaard, Jensen, Bodil Hamborg, and Bennekou, Susanne Hougaard
- Abstract
Fødevarestyrelsen har bedt DTU Fødevareinstituttet om en sundhedsmæssig risikovurdering af guar gummi med restindhold af ethylenoxid på 0,360 mg/kg.
- Published
- 2021
48. Risikovurdering af karrysaucemix med indhold af ethylenoxid
- Author
-
Jensen, Bodil Hamborg, Bennekou, Susanne Hougaard, Jensen, Bodil Hamborg, and Bennekou, Susanne Hougaard
- Abstract
Fødevarestyrelsen har bedt DTU Fødevareinstituttet om en sundhedsmæssig risikovurdering af karrysaucemix med indhold af ethylenoxid på 11,7 mg/kg.
- Published
- 2021
49. Guidance Document on Scientific criteria for grouping chemicals into assessment groups for human risk assessment of combined exposure to multiple chemicals
- Author
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EFSA Scientific Committee, More, Simon John, Bampidis, Vasileios, Benford, Diane, Bragard, Claude, Hernandez-Jerez, Antonio, Bennekou, Susanne Hougaard, Halldorsson, Thorhallur Ingi, Koutsoumanis, Konstantinos Panagiotis, Lambré, Claude, Machera, Kyriaki, Naegeli, Hanspeter, Nielsen, Søren Saxmose, Schlatter, Josef Rudolf, Schrenk, Dieter, Silano (deceased), Vittorio, Turck, Dominique, Younes, Maged, Benfenati, Emilio, Crépet, Amélie, Te Biesebeek, Jan Dirk, Testai, Emanuela, Dujardin, Bruno, Dorne, Jean Lou CM, Hogstrand, Christer, EFSA Scientific Committee, More, Simon John, Bampidis, Vasileios, Benford, Diane, Bragard, Claude, Hernandez-Jerez, Antonio, Bennekou, Susanne Hougaard, Halldorsson, Thorhallur Ingi, Koutsoumanis, Konstantinos Panagiotis, Lambré, Claude, Machera, Kyriaki, Naegeli, Hanspeter, Nielsen, Søren Saxmose, Schlatter, Josef Rudolf, Schrenk, Dieter, Silano (deceased), Vittorio, Turck, Dominique, Younes, Maged, Benfenati, Emilio, Crépet, Amélie, Te Biesebeek, Jan Dirk, Testai, Emanuela, Dujardin, Bruno, Dorne, Jean Lou CM, and Hogstrand, Christer
- Abstract
This guidance document provides harmonised and flexible methodologies to apply scientific criteria and prioritisation methods for grouping chemicals into assessment groups for human risk assessment of combined exposure to multiple chemicals. In the context of EFSA’s risk assessments, the problem formulation step defines the chemicals to be assessed in the terms of reference usually through regulatory criteria often set by risk managers based on legislative requirements. Scientific criteria such as hazard-driven criteria can be used to group these chemicals into assessment groups. In this guidance document, a framework is proposed to apply hazard-driven criteria for grouping of chemicals into assessment groups using mechanistic information on toxicity as the gold standard where available (i.e. common mode of action or adverse outcome pathway) through a structured weight of evidence approach. However, when such mechanistic data are not available, grouping may be performed using a common adverse outcome. Toxicokinetic data can also be useful for grouping, particularly when metabolism information is available for a class of compounds and common toxicologically relevant metabolites are shared. In addition, prioritisation methods provide means to identify low-priority chemicals and reduce the number of chemicals in an assessment group. Prioritisation methods include combined risk-based approaches, risk-based approaches for single chemicals and exposure-driven approaches. Case studies have been provided to illustrate the practical application of hazard-driven criteria and the use of prioritisation methods for grouping of chemicals in assessment groups. Recommendations for future work are discussed.
- Published
- 2021
50. Paving the way for application of next generation risk assessment to safety decision-making for cosmetic ingredients
- Author
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Dent, M. P., Vaillancourt, E., Thomas, R. S., Carmichael, P L, Ouedraogo, G., Kojima, H, Barroso, J., Ansell, J., Barton-Maclaren, T. S., Bennekou, Susanne Hougaard, Boekelheide, K., Ezendam, J., Field, J., Fitzpatrick, S., Hatao, M., Kreiling, R., Lorencini, M., Mahony, C., Montemayor, B., Mazaro-Costa, R., Oliveira, J., Rogiers, V., Smegal, D., Taalman, R., Tokura, Y., Verma, R., Willett, C., Yang, C., Dent, M. P., Vaillancourt, E., Thomas, R. S., Carmichael, P L, Ouedraogo, G., Kojima, H, Barroso, J., Ansell, J., Barton-Maclaren, T. S., Bennekou, Susanne Hougaard, Boekelheide, K., Ezendam, J., Field, J., Fitzpatrick, S., Hatao, M., Kreiling, R., Lorencini, M., Mahony, C., Montemayor, B., Mazaro-Costa, R., Oliveira, J., Rogiers, V., Smegal, D., Taalman, R., Tokura, Y., Verma, R., Willett, C., and Yang, C.
- Abstract
Next generation risk assessment (NGRA) is an exposure-led, hypothesis-driven approach that has the potential to support animal-free safety decision-making. However, significant effort is needed to develop and test the in vitro and in silico (computational) approaches that underpin NGRA to enable confident application in a regulatory context. A workshop was held in Montreal in 2019 to discuss where effort needs to be focussed and to agree on the steps needed to ensure safety decisions made on cosmetic ingredients are robust and protective. Workshop participants explored whether NGRA for cosmetic ingredients can be protective of human health, and reviewed examples of NGRA for cosmetic ingredients. From the limited examples available, it is clear that NGRA is still in its infancy, and further case studies are needed to determine whether safety decisions are sufficiently protective and not overly conservative. Seven areas were identified to help progress application of NGRA, including further investments in case studies that elaborate on scenarios frequently encountered by industry and regulators, including those where a 'high risk' conclusion would be expected. These will provide confidence that the tools and approaches can reliably discern differing levels of risk. Furthermore, frameworks to guide performance and reporting should be developed.
- Published
- 2021
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