Dataset.

Update of the risk assessment of hexabromocyclododecanes (HBCDDs) in food: Occurrence data in food submitted to EFSA and dietary exposure assessment for humans

Digital.CSIC. Repositorio Institucional del CSIC
oai:digital.csic.es:10261/285518
Digital.CSIC. Repositorio Institucional del CSIC
  • EFSA CONTAM Panel
  • Schrenk, Dieter
  • Bignami, Margherita
  • Bodin, Laurent
  • Chipman, James Kevin
  • Del Mazo, Jesús
  • Grasl-Kraupp, Bettina
  • Hogstrand, Christer
  • Hoogenboom, Laurentius (Ron)
  • Leblanc, Jean-Charles
  • Nebbia, Carlo Stefano
  • Nielsen, Elsa
  • Ntzani, Evangelia
  • Petersen, Annette
  • Sand, Salomon
  • Schwerdtle, Tanja
  • Wallace, Heather
  • Benford, Diane
  • Fürst, Peter
  • Rose, Martin
  • Ioannidou, Sofia
  • Nikolic, Marina
  • Ramos Bordajandi, Luisa
  • Vleminckx, Christiane
Annex A – Protocol for the risk assessments for human health related to the presence of brominated flame retardants (BFRs) in food The Annex is provided as a separate pdf file containing the risk assessment protocol selected by the CONTAM Panel to update the previous risk assessments of brominated flame retardants (BFRs) in food. Annex B: Occurrence data on HBCDDs in food submitted to EFSA and dietary surveys per country and age group available in the EFSA Comprehensive Database, considered in the exposure assessment Table B.1 Number of analytical results excluded from the initial dataset during data cleaning, and justification for exclusion Table B.2 Occurrence values of HBCDDs calculated total (µg/kg) by food category in the final dataset Table B.3 Food categories of FoodEx and mean LB and UB values as used for the exposure assessment Table B.4 Dietary surveys and the number of subjects by country and population class, available for the chronic exposure assessment, in the EFSA Comprehensive European Food Consumption Database Table B.5 Summary statistics on data reported for HBCDDs total, analysed with GC-MS, not considered for the exposure Figure B.1 Frequency distribution of the occurrence values for the food categories of interest at the LB without zeros presented on a log 10 scale Figure B.2 Frequency distribution of the occurrence values for the food categories of interest at the UB presented on a log 10 scale HBCDDs_Raw_Occurrence_Data.CSV contains the raw occurrence dataset on Hexabromocyclododecanes (HBCDDs) contaminant as extracted from EFSA DWH in December 2019 on 2530 food samples presented in the opinion as described in its section 3.2.1. Occurrence data submitted to EFSA. The data is provided in .csv format. This dataset is compliant with EFSA SSD model and contains two additional columns documenting issues identified in the cleaning process (column: issue) and the action taken (column: outcome) to address the issue (e.g. delete record or update values in specific fields). The link to the catalogues of controlled terminologies can be found under "Related identifiers”. Annex D: Chronic dietary exposure to HBCDDs and the contribution of different food groups to the dietary exposure Table D.1 Mean chronic dietary exposure (ng/kg b.w. per day) to HBCDDs for total population across European dietary surveys Table D.2 95th percentile chronic exposures to HBCDDs (ng/kg b.w. per day) for total population for each dietary survey across age classes Table D.3 Relative contribution (%) of food categories to the LB and UB estimates of dietary exposure to HBCDDs across different age classes, dietary surveys and countries Table D.4 Relative contribution of food categories to the LB estimates of dietary exposure to HBCDDs and related figure Table D.5 Relative contribution of food categories to the UB estimates of dietary exposure to HBCDDs and related figure Annex E – Outcome of the Public consultation on the Update of the risk assessment of hexabromocyclododecanes (HBCDDs) in food The Annex is provided as a separate pdf file contain the outcome of the public consultation of the draft scientific Opinion, including the comments received and how they were taken into account when finalising the scientific Opinion, Peer reviewed
 
DOI: http://hdl.handle.net/10261/285518
Digital.CSIC. Repositorio Institucional del CSIC
oai:digital.csic.es:10261/285518

HANDLE: http://hdl.handle.net/10261/285518
Digital.CSIC. Repositorio Institucional del CSIC
oai:digital.csic.es:10261/285518
 
Ver en: http://hdl.handle.net/10261/285518
Digital.CSIC. Repositorio Institucional del CSIC
oai:digital.csic.es:10261/285518

Digital.CSIC. Repositorio Institucional del CSIC
oai:digital.csic.es:10261/229284
Artículo científico (article). 2020

UPDATE OF THE RISK ASSESSMENT OF NICKEL IN FOOD AND DRINKING WATER

Digital.CSIC. Repositorio Institucional del CSIC
  • EFSA CONTAM Panel
  • Schrenk, Dieter
  • Bignami, Margherita
  • Bodin, Laurent
  • Chipman, James Kevin
  • Del Mazo, Jesús
  • Grasl-Kraupp, Bettina
  • Hogstrand, Christer
  • Hoogenboom, Laurentius (Ron)
  • Leblanc, Jean-Charles
  • Nebbia, Carlo Stefano
  • Ntzani, Evangelia
  • Petersen, Annette
  • Sand, Salomon
  • Schwerdtle, Tanja
  • Vleminckx, Christiane
  • Wallace, Heather
  • Guérin, Thierry
  • Massanyi, Peter
  • van Loveren, Henk
  • Baert, Katleen
  • Gergelova, Petra
  • Nielsen, Elsa
101 p.-5 fig.-16 tab., The European Commission asked EFSA to update its previous Opinion on nickel in food and drinking water, taking into account new occurrence data, the updated benchmark dose (BMD) Guidance and newly available scientific information. More than 47,000 analytical results on the occurrence of nickel were used for calculating chronic and acute dietary exposure. An increased incidence of post‐implantation loss in rats was identified as the critical effect for the risk characterisation of chronic oral exposure and a BMDL10 of 1.3 mg Ni/kg body weight (bw) per day was selected as the reference point for the establishment of a tolerable daily intake (TDI) of 13 μg/kg bw. Eczematous flare‐up reactions in the skin elicited in nickel‐sensitised humans, a condition known as systemic contact dermatitis, was identified as the critical effect for the risk characterisation of acute oral exposure. A BMDL could not be derived, and therefore, the lowest‐observed‐adverse‐effect‐level of 4.3 μg Ni/kg bw was selected as the reference point. The margin of exposure (MOE) approach was applied and an MOE of 30 or higher was considered as being indicative of a low health concern. The mean lower bound (LB)/upper bound (UB) chronic dietary exposure was below or at the level of the TDI. The 95th percentile LB/UB chronic dietary exposure was below the TDI in adolescents and in all adult age groups, but generally exceeded the TDI in toddlers and in other children, as well as in infants in some surveys. This may raise a health concern in these young age groups. The MOE values for the mean UB acute dietary exposure and for the 95th percentile UB raises a health concern for nickel‐sensitised individuals. The MOE values for an acute scenario regarding consumption of a glass of water on an empty stomach do not raise a health concern., The Panel wishes to thank the following for the support provided to this scientific output: Elena Rovesti. The Panel wishes to acknowledge all European competent institutions,Member State bodies and other organisations that provided data for this scientific output., Peer reviewed




Digital.CSIC. Repositorio Institucional del CSIC
oai:digital.csic.es:10261/235568
Artículo científico (article). 2021

UPDATE OF THE RISK ASSESSMENT OF HEXABROMOCYCLODODECANES (HBCDDS) IN FOOD

Digital.CSIC. Repositorio Institucional del CSIC
  • EFSA CONTAM Panel
  • Schrenk, Dieter
  • Bignami, Margherita
  • Bodin, Laurent
  • Chipman, James Kevin
  • Del Mazo, Jesús
  • Grasl-Kraupp, Bettina
  • Hogstrand, Christer
  • Hoogenboom, Laurentius (Ron)
  • Leblanc, Jean-Charles
  • Nebbia, Carlo Stefano
  • Nielsen, Elsa
  • Ntzani, Evangelia
  • Petersen, Annette
  • Sand, Salomon
  • Schwerdtle, Tanja
  • Wallace, Heather
  • Benford, Diane
  • Fürst, Peter
  • Rose, Martin
  • Ioannidou, Sofia
  • Nikolic, Marina
  • Ramos Bordajandi, Luisa
  • Vleminckx, Christiane
130 p.-4 fig.-23 tab.-Appendix A-D (118-129), The European Commission asked EFSA to update its 2011 risk assessment on hexabromocyclododecanes (HBCDDs) in food. HBCDDs, predominantly mixtures of the stereoisomers a-, b- and c-HBCDD, were widely used additive flame retardants. Concern has been raised because of the occurrence of HBCDDs in the environment, food and in humans. Main targets for toxicity are neurodevelopment, the liver, thyroid hormone homeostasis and the reproductive and immune systems. The CONTAM Panel concluded that the neurodevelopmental effects on behaviour in mice can be considered the critical effects. Based on effects on spontaneous behaviour in mice, the Panel identified a lowest observed adverse effect level (LOAEL) of 0.9 mg/kg body weight (bw) as the Reference Point, corresponding to a body burden of 0.75 mg/kg bw. The chronic intake that would lead to the same body burden in humans was calculated to be 2.35 lg/kg bw per day. The derivation of a health-based guidance value (HBGV) was not considered appropriate. Instead, the margin of exposure (MOE) approach was applied to assess possible health concerns. Over 6,000 analytical results for HBCDDs in food were used to estimate the exposure across dietary surveys and age groups of the European population. The most important contributors to the chronic dietary LB exposure to HBCDDs were fish meat, eggs, livestock meat and poultry. The CONTAM Panel concluded that the resulting MOE values support the conclusion that current dietary exposure to HBCDDs across European countries does not raise a health concern.An exception is breastfed infants with high milk consumption, for which the lowest MOE values may raise a health concern., Peer reviewed




Digital.CSIC. Repositorio Institucional del CSIC
oai:digital.csic.es:10261/335541
Artículo científico (article). 2023

UPDATE OF THE RISK ASSESSMENT OF MINERAL OIL HYDROCARBONS IN FOOD

Digital.CSIC. Repositorio Institucional del CSIC
  • EFSA CONTAM Panel
  • Schrenk, Dieter
  • Bignami, Margherita
  • Bodin, Laurent
  • Del Mazo, Jesús
  • Grasl-Kraupp, Bettina
  • Hogstrand, Christer
  • Hoogenboom, Laurentius (Ron)
  • Leblanc, Jean-Charles
  • Nebbia, Carlo Stefano
  • Nielsen, Elsa
  • Ntzani, Evangelia
  • Petersen, Annette
  • Sand, Salomon
  • Schwerdtle, Tanja
  • Vleminckx, Christiane
  • Wallace, Heather
  • Alexander, Jan
  • Goldbeck, Christophe
  • Grob, Konrad
  • Gómez-Ruiz, José Ángel
  • Mosbach-Schulz, Olaf
  • Binaglia, Marco
  • Chipman, James Kevin
143 p.-21 fig.- 41 tab., Mineral oil hydrocarbons (MOH) are composed of saturated hydrocarbons (MOSH) and aromatic hydrocarbons (MOAH). Due to the complexity of the MOH composition, their complete chemical characterisation is not possible. MOSH accumulation is observed in various tissues, with species-specific differences. Formation of liver epithelioid lipogranulomas and inflammation, as well as increased liver and spleen weights, are observed in Fischer 344 (F344) rats, but not in Sprague–Dawley (SD) rats. These effects are related to specific accumulation of wax components in the liver of F344 rats, which is not observed in SD rats or humans. The CONTAM Panel concluded that F344 rats are not an appropriate model for effects of MOSH with wax components. A NOAEL of 236 mg/kg body weight (bw) per day, corresponding to the highest tested dose in F344 rats of a white mineral oil product virtually free of wax components, was selected as relevant reference point (RP). The highest dietary exposure to MOSH was estimated for the young population, with lower bound–upper bound (LB–UB) means and 95th percentiles of 0.085–0.126 and 0.157–0.212 mg/kg bw per day, respectively.Considering a margin of exposure approach, the Panel concluded that the present dietary exposure to MOSH does not raise concern for human health for all age classes. Genotoxicity and carcinogenicity are associated with MOAH with three or more aromatic rings. For this subfraction, a surrogate RP of 0.49 mg/kg bw per day, calculated from data on eight polycyclic aromatic hydrocarbons, was considered. The highest dietary exposure to MOAH was also in the young population, with LB–UB mean and 95th percentile estimations of 0.003–0.031 and 0.011–0.059 mg/kg bw per day,respectively. Based on two scenarios on three or more ring MOAH contents in the diet and lacking toxicological information on effects of 1 and 2 ring MOAH, a possible concern for human health was raised., Peer reviewed




Digital.CSIC. Repositorio Institucional del CSIC
oai:digital.csic.es:10261/285464
Dataset. 2020

ANNEXES TO THE UPDATE OF THE RISK ASSESSMENT OF NICKEL IN FOOD AND DRINKING WATER

Digital.CSIC. Repositorio Institucional del CSIC
  • EFSA CONTAM Panel
  • Schrenk, Dieter
  • Bignami, Margherita
  • Bodin, Laurent
  • Chipman, James Kevin
  • Del Mazo, Jesús
  • Grasl-Kraupp, Bettina
  • Hogstrand, Christer
  • Hoogenboom, Laurentius (Ron)
  • Leblanc, Jean-Charles
  • Nebbia, Carlo Stefano
  • Ntzani, Evangelia
  • Petersen, Annette
  • Sand, Salomon
  • Schwerdtle, Tanja
  • Vleminckx, Christiane
  • Wallace, Heather
  • Guérin, Thierry
  • Massanyi, Peter
  • van Loveren, Henk
  • Baert, Katleen
  • Gergelova, Petra
  • Nielsen, Elsa
Annex A – Benchmark dose analysis The Annex is provided as a separate pdf file containing the detailed results of the benchmark dose analyses from which no reference point was selected. Annex B – Dietary surveys per country and age group available in the EFSA Comprehensive Database, considered in the exposure assessment The Annex is provided as a separate Excel file containing the dietary surveys per country and age group. Annex C – Occurrence data on nickel in food and drinking water The Annex is provided as a separate Excel file containing summary statistics on occurrence data on nickel. Annex D – Chronic and acute dietary exposure to nickel and the contribution of different food groups to the dietary exposure The Annex is provided as a separate Excel file containing the chronic and acute dietary exposure to nickel per survey and the contribution of different food groups to the dietary exposure., Peer reviewed




Digital.CSIC. Repositorio Institucional del CSIC
oai:digital.csic.es:10261/285518
Dataset. 2021

UPDATE OF THE RISK ASSESSMENT OF HEXABROMOCYCLODODECANES (HBCDDS) IN FOOD: OCCURRENCE DATA IN FOOD SUBMITTED TO EFSA AND DIETARY EXPOSURE ASSESSMENT FOR HUMANS

Digital.CSIC. Repositorio Institucional del CSIC
  • EFSA CONTAM Panel
  • Schrenk, Dieter
  • Bignami, Margherita
  • Bodin, Laurent
  • Chipman, James Kevin
  • Del Mazo, Jesús
  • Grasl-Kraupp, Bettina
  • Hogstrand, Christer
  • Hoogenboom, Laurentius (Ron)
  • Leblanc, Jean-Charles
  • Nebbia, Carlo Stefano
  • Nielsen, Elsa
  • Ntzani, Evangelia
  • Petersen, Annette
  • Sand, Salomon
  • Schwerdtle, Tanja
  • Wallace, Heather
  • Benford, Diane
  • Fürst, Peter
  • Rose, Martin
  • Ioannidou, Sofia
  • Nikolic, Marina
  • Ramos Bordajandi, Luisa
  • Vleminckx, Christiane
Annex A – Protocol for the risk assessments for human health related to the presence of brominated flame retardants (BFRs) in food The Annex is provided as a separate pdf file containing the risk assessment protocol selected by the CONTAM Panel to update the previous risk assessments of brominated flame retardants (BFRs) in food. Annex B: Occurrence data on HBCDDs in food submitted to EFSA and dietary surveys per country and age group available in the EFSA Comprehensive Database, considered in the exposure assessment Table B.1 Number of analytical results excluded from the initial dataset during data cleaning, and justification for exclusion Table B.2 Occurrence values of HBCDDs calculated total (µg/kg) by food category in the final dataset Table B.3 Food categories of FoodEx and mean LB and UB values as used for the exposure assessment Table B.4 Dietary surveys and the number of subjects by country and population class, available for the chronic exposure assessment, in the EFSA Comprehensive European Food Consumption Database Table B.5 Summary statistics on data reported for HBCDDs total, analysed with GC-MS, not considered for the exposure Figure B.1 Frequency distribution of the occurrence values for the food categories of interest at the LB without zeros presented on a log 10 scale Figure B.2 Frequency distribution of the occurrence values for the food categories of interest at the UB presented on a log 10 scale HBCDDs_Raw_Occurrence_Data.CSV contains the raw occurrence dataset on Hexabromocyclododecanes (HBCDDs) contaminant as extracted from EFSA DWH in December 2019 on 2530 food samples presented in the opinion as described in its section 3.2.1. Occurrence data submitted to EFSA. The data is provided in .csv format. This dataset is compliant with EFSA SSD model and contains two additional columns documenting issues identified in the cleaning process (column: issue) and the action taken (column: outcome) to address the issue (e.g. delete record or update values in specific fields). The link to the catalogues of controlled terminologies can be found under "Related identifiers”. Annex D: Chronic dietary exposure to HBCDDs and the contribution of different food groups to the dietary exposure Table D.1 Mean chronic dietary exposure (ng/kg b.w. per day) to HBCDDs for total population across European dietary surveys Table D.2 95th percentile chronic exposures to HBCDDs (ng/kg b.w. per day) for total population for each dietary survey across age classes Table D.3 Relative contribution (%) of food categories to the LB and UB estimates of dietary exposure to HBCDDs across different age classes, dietary surveys and countries Table D.4 Relative contribution of food categories to the LB estimates of dietary exposure to HBCDDs and related figure Table D.5 Relative contribution of food categories to the UB estimates of dietary exposure to HBCDDs and related figure Annex E – Outcome of the Public consultation on the Update of the risk assessment of hexabromocyclododecanes (HBCDDs) in food The Annex is provided as a separate pdf file contain the outcome of the public consultation of the draft scientific Opinion, including the comments received and how they were taken into account when finalising the scientific Opinion, Peer reviewed




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