326 results on '"Vleminckx, Christiane"'
Search Results
2. Titanium dioxide particles frequently present in face masks intended for general use require regulatory control
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Verleysen, Eveline, Ledecq, Marina, Siciliani, Lisa, Cheyns, Karlien, Vleminckx, Christiane, Blaude, Marie-Noelle, De Vos, Sandra, Brassinne, Frédéric, Van Steen, Frederic, Nkenda, Régis, Machiels, Ronny, Waegeneers, Nadia, Van Loco, Joris, and Mast, Jan
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- 2022
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3. Risk assessment of small organoarsenic species in food.
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Schrenk, Dieter, Bignami, Margherita, Bodin, Laurent, Chipman, James Kevin, del Mazo, Jesús, Grasl‐Kraupp, Bettina, Hogstrand, Christer, Hoogenboom, Laurentius, Leblanc, Jean‐Charles, Nebbia, Carlo Stefano, Nielsen, Elsa, Ntzani, Evangelia, Petersen, Annette, Sand, Salomon, Vleminckx, Christiane, Wallace, Heather, Barregård, Lars, Benford, Diane, Dogliotti, Eugenia, and Francesconi, Kevin
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CACODYLIC acid ,BLADDER ,AGE groups ,NUTRITION surveys ,FISHERY processing - Abstract
The European Commission asked EFSA for a risk assessment on small organoarsenic species in food. For monomethylarsonic acid MMA(V), decreased body weight resulting from diarrhoea in rats was identified as the critical endpoint and a BMDL10 of 18.2 mg MMA(V)/kg body weight (bw) per day (equivalent to 9.7 mg As/kg bw per day) was calculated as a reference point (RP). For dimethylarsinic acid DMA(V), increased incidence in urinary bladder tumours in rats was identified as the critical endpoint. A BMDL10 of 1.1 mg DMA(V)/kg bw per day (equivalent to 0.6 mg As/kg bw per day) was calculated as an RP. For other small organoarsenic species, the toxicological data are insufficient to identify critical effects and RPs, and they could not be included in the risk assessment. For both MMA(V) and DMA(V), the toxicological database is incomplete and a margin of exposure (MOE) approach was applied for risk characterisation. The highest chronic dietary exposure to DMA(V) was estimated in 'Toddlers', with rice and fish meat as the main contributors across population groups. For MMA(V), the highest chronic dietary exposures were estimated for high consumers of fish meat and processed/preserved fish in 'Infants' and 'Elderly' age class, respectively. For MMA(V), an MOE of ≥ 500 was identified not to raise a health concern. For MMA(V), all MOEs were well above 500 for average and high consumers and thus do not raise a health concern. For DMA(V), an MOE of 10,000 was identified as of low health concern as it is genotoxic and carcinogenic, although the mechanisms of genotoxicity and its role in carcinogenicity of DMA(V) are not fully elucidated. For DMA(V), MOEs were below 10,000 in many cases across dietary surveys and age groups, in particular for some 95th percentile exposures. The Panel considers that this would raise a health concern. [ABSTRACT FROM AUTHOR]
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- 2024
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4. Update of the risk assessment of mineral oil hydrocarbons in food
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European Food Safety Authority, Schrenk, Dieter [0000-0002-7717-5533], Bignami, Margherita [0000-0002-1525-6864], Bodin, Laurent [0000-0001-5671-3139], Del Mazo, Jesús [0000-0003-3269-3895], Grasl-Kraupp, Bettina [0000-0003-4889-6531], Hogstrand, Christer [0000-0001-7545-6975], Hoogenboom, Laurentius (Ron) [0000-0002-8913-5328], Leblanc, Jean-Charles [0000-0003-2872-3414], Nielsen, Elsa [0000-0002-6874-2575], Ntzani, Evangelia [0000-0003-3712-4181], Petersen, Annette [0000-0003-3996-2701], Sand, Salomon [0000-0002-3360-0534], Schwerdtle, Tanja [0000-0002-4873-7488], Vleminckx, Christiane [0000-0002-9928-1601], Goldbeck, Christophe [0000-0003-1539-464X], Gómez-Ruiz, José Ángel [0000-0001-9386-6185], 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, European Food Safety Authority, Schrenk, Dieter [0000-0002-7717-5533], Bignami, Margherita [0000-0002-1525-6864], Bodin, Laurent [0000-0001-5671-3139], Del Mazo, Jesús [0000-0003-3269-3895], Grasl-Kraupp, Bettina [0000-0003-4889-6531], Hogstrand, Christer [0000-0001-7545-6975], Hoogenboom, Laurentius (Ron) [0000-0002-8913-5328], Leblanc, Jean-Charles [0000-0003-2872-3414], Nielsen, Elsa [0000-0002-6874-2575], Ntzani, Evangelia [0000-0003-3712-4181], Petersen, Annette [0000-0003-3996-2701], Sand, Salomon [0000-0002-3360-0534], Schwerdtle, Tanja [0000-0002-4873-7488], Vleminckx, Christiane [0000-0002-9928-1601], Goldbeck, Christophe [0000-0003-1539-464X], Gómez-Ruiz, José Ángel [0000-0001-9386-6185], 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, and Chipman, James Kevin
- Abstract
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.
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- 2023
5. Risks for animal and human health related to the presence of polychlorinated naphthalenes (PCNs) in feed and food.
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Schrenk, Dieter, Bignami, Margherita, Bodin, Laurent, Chipman, James Kevin, del Mazo, Jesús, Grasl‐Kraupp, Bettina, Hogstrand, Christer, Hoogenboom, Laurentius, Leblanc, Jean‐Charles, Nebbia, Carlo Stefano, Ntzani, Evangelia, Petersen, Annette, Sand, Salomon, Schwerdtle, Tanja, Vleminckx, Christiane, Wallace, Heather, Falandysz, Jerzy, Hart, Andrew, Rose, Martin, and Anastassiadou, Maria
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POLYCHLORINATED naphthalenes ,ANIMAL health ,BREAST milk ,PLATELET count ,NUTRITION surveys - Abstract
EFSA was asked for a scientific opinion on the risks for animal and human health related to the presence of polychlorinated naphthalenes (PCNs) in feed and food. The assessment focused on hexaCNs due to very limited data on other PCN congeners. For hexaCNs in feed, 217 analytical results were used to estimate dietary exposures for food‐producing and non‐food‐producing animals; however, a risk characterisation could not be performed because none of the toxicological studies allowed identification of reference points. The oral repeated dose toxicity studies performed in rats with a hexaCN mixture containing all 10 hexaCNs indicated that the critical target was the haematological system. A BMDL20 of 0.05 mg/kg body weight (bw) per day was identified for a considerable decrease in the platelet count. For hexaCNs in food, 2317 analytical results were used to estimate dietary exposures across dietary surveys and age groups. The highest exposure ranged from 0.91 to 29.8 pg/kg bw per day in general population and from 220 to 559 pg/kg bw per day for breast‐fed infants with the highest consumption of breast milk. Applying a margin of exposure (MOE) approach, the estimated MOEs for the high dietary exposures ranged from 1,700,000 to 55,000,000 for the general population and from 90,000 to 230,000 for breast‐fed infants with the highest consumption of breast milk. These MOEs are far above the minimum MOE of 2000 that does not raise a health concern. Taking account of the uncertainties affecting the assessment, the Panel concluded with at least 99% certainty that dietary exposure to hexaCNs does not raise a health concern for any of the population groups considered. Due to major limitations in the available data, no assessment was possible for genotoxic effects or for health risks of PCNs other than hexaCNs. [ABSTRACT FROM AUTHOR]
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- 2024
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6. Weight and head circumference at birth in function of placental paraben load in Belgium: an ENVIRONAGE birth cohort study
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Vrijens, Karen, Van Overmeire, Ilse, De Cremer, Koen, Neven, Kristof Y., Carollo, Riccardo M., Vleminckx, Christiane, Van Loco, Joris, and Nawrot, Tim S.
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- 2020
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7. Guidance for the assessment of detoxification processes in feed.
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Schrenk, Dieter, Bignami, Margherita, Bodin, Laurent, Chipman, James Kevin, del Mazo, Jesus, Grasl‐Kraupp, Bettina, Hoogenboom, Laurentius, Leblanc, Jean‐Charles, Nebbia, Carlo Stefano, Nielsen, Elsa, Ntzani, Evangelia, Petersen, Annette, Sand, Salomon, Schwerdtle, Tanja, Vleminckx, Christiane, Wallace, Heather, Rose, Martin, Cottrill, Bruce, Lundebye, Anne Katrine, and Metzler, Manfred
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ANIMAL products ,ANIMAL feeds ,RISK assessment - Abstract
This statement provides scientific guidance on the information needed to support the risk assessment of the detoxification processes applied to products intended for animal feed in line with the acceptability criteria of the Commission Regulation (EU) 2015/786. [ABSTRACT FROM AUTHOR]
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- 2024
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8. Risks for animal health related to the presence of ergot alkaloids in feed.
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Schrenk, Dieter, Bignami, Margherita, Bodin, Laurent, Chipman, James Kevin, del Mazo, Jesús, Grasl‐Kraupp, Bettina, Hogstrand, Christer, Leblanc, Jean‐Charles, Nebbia, Carlo Stefano, Nielsen, Elsa, Ntzani, Evangelia, Petersen, Annette, Sand, Salomon, Schwerdtle, Tanja, Vleminckx, Christiane, Wallace, Heather, Gropp, Jürgen, Mulder, Patrick, Oswald, Isabelle P., and Woutersen, Ruud
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SWINE farms ,ERGOT alkaloids ,ANIMAL health ,FOOD of animal origin ,HENS ,MILK yield - Abstract
The European Commission requested EFSA to provide an update of the 2012 Scientific Opinion of the Panel on Contaminants in the Food Chain (CONTAM) on the risks for animal health related to the presence of ergot alkaloids (EAs) in feed. EAs are produced by several fungi of the Claviceps and Epichloë genera. This Opinion focussed on the 14 EAs produced by C. purpurea (ergocristine, ergotamine, ergocornine, α‐ and β‐ergocryptine, ergometrine, ergosine and their corresponding 'inine' epimers). Effects observed with EAs from C. africana (mainly dihydroergosine) and Epichloë (ergovaline/−inine) were also evaluated. There is limited information on toxicokinetics in food and non‐food producing animals. However, transfer from feed to food of animal origin is negligible. The major effects of EAs are related to vasoconstriction and are exaggerated during extreme temperatures. In addition, EAs cause a decrease in prolactin, resulting in a reduced milk production. Based on the sum of the EAs, the Panel considered the following as Reference Points (RPs) in complete feed for adverse animal health effects: for pigs and piglets 0.6 mg/kg, for chickens for fattening and hens 2.1 and 3.7 mg/kg, respectively, for ducks 0.2 mg/kg, bovines 0.1 mg/kg and sheep 0.3 mg/kg. A total of 19,023 analytical results on EAs (only from C. purpurea) in feed materials and compound feeds were available for the exposure assessment (1580 samples). Dietary exposure was assessed using two feeding scenarios (model diets and compound feeds). Risk characterisation was done for the animals for which an RP could be identified. The CONTAM Panel considers that, based on exposure from model diets, the presence of EAs in feed raises a health concern in piglets, pigs for fattening, sows and bovines, while for chickens for fattening, laying hens, ducks, ovines and caprines, the health concern related to EAs in feed is low. [ABSTRACT FROM AUTHOR]
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- 2024
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9. Update of the risk assessment of inorganic arsenic in food.
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Schrenk, Dieter, Bignami, Margherita, Bodin, Laurent, Chipman, James Kevin, del Mazo, Jesús, Grasl‐Kraupp, Bettina, Hogstrand, Christer, Hoogenboom, Laurentius, Leblanc, Jean‐Charles, Nebbia, Carlo Stefano, Nielsen, Elsa, Ntzani, Evangelia, Petersen, Annette, Sand, Salomon, Vleminckx, Christiane, Wallace, Heather, Barregård, Lars, Benford, Diane, Broberg, Karin, and Dogliotti, Eugenia
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ARSENIC ,RISK assessment ,CONFIDENCE intervals ,SKIN cancer ,DRINKING water - Abstract
The European Commission asked EFSA to update its 2009 risk assessment on arsenic in food carrying out a hazard assessment of inorganic arsenic (iAs) and using the revised exposure assessment issued by EFSA in 2021. Epidemiological studies show that the chronic intake of iAs via diet and/or drinking water is associated with increased risk of several adverse outcomes including cancers of the skin, bladder and lung. The CONTAM Panel used the benchmark dose lower confidence limit based on a benchmark response (BMR) of 5% (relative increase of the background incidence after adjustment for confounders, BMDL05) of 0.06 μg iAs/kg bw per day obtained from a study on skin cancer as a Reference Point (RP). Inorganic As is a genotoxic carcinogen with additional epigenetic effects and the CONTAM Panel applied a margin of exposure (MOE) approach for the risk characterisation. In adults, the MOEs are low (range between 2 and 0.4 for mean consumers and between 0.9 and 0.2 at the 95th percentile exposure, respectively) and as such raise a health concern despite the uncertainties. [ABSTRACT FROM AUTHOR]
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- 2024
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10. Risks for animal health related to the presence of ochratoxin A (OTA) in feed.
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Schrenk, Dieter, Bignami, Margherita, Bodin, Laurent, Chipman, James Kevin, del Mazo, Jesús, Grasl‐Kraupp, Bettina, Hogstrand, Christer, Hoogenboom, Laurentius, Leblanc, Jean‐Charles, Nielsen, Elsa, Ntzani, Evangelia, Sand, Salomon, Schwerdtle, Tanja, Vleminckx, Christiane, Wallace, Heather, Gropp, Jürgen, Antonissen, Gunther, Rychen, Guido, Gómez Ruiz, José Ángel, and Innocenti, Matteo Lorenzo
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ANIMAL health ,FOOD of animal origin ,ANIMAL industry ,CATTLE feeding & feeds ,SERUM albumin ,WEIGHT gain ,ANIMAL species - Abstract
In 2004, the EFSA Panel on Contaminants in the Food Chain (CONTAM) adopted a Scientific Opinion on the risks to animal health and transfer from feed to food of animal origin related to the presence of ochratoxin A (OTA) in feed. The European Commission requested EFSA to assess newly available scientific information and to update the 2004 Scientific Opinion. OTA is produced by several fungi of the genera Aspergillus and Penicillium. In most animal species it is rapidly and extensively absorbed in the gastro‐intestinal tract, binds strongly to plasma albumins and is mainly detoxified to ochratoxin alpha (OTalpha) by ruminal microbiota. In pigs, OTA has been found mainly in liver and kidney. Transfer of OTA from feed to milk in ruminants and donkeys as well as to eggs from poultry is confirmed but low. Overall, OTA impairs function and structure of kidneys and liver, causes immunosuppression and affects the zootechnical performance (e.g. body weight gain, feed/gain ratio, etc.), with monogastric species being more susceptible than ruminants because of limited detoxification to OTalpha. The CONTAM Panel considered as reference point (RP) for adverse animal health effects: for pigs and rabbits 0.01 mg OTA/kg feed, for chickens for fattening and hens 0.03 mg OTA/kg feed. A total of 9,184 analytical results on OTA in feed, expressed in dry matter, were available. Dietary exposure was assessed using different scenarios based on either model diets or compound feed (complete feed or complementary feed plus forage). Risk characterisation was made for the animals for which an RP could be identified. The CONTAM Panel considers that the risk related to OTA in feed for adverse health effects for pigs, chickens for fattening, hens and rabbits is low. [ABSTRACT FROM AUTHOR]
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- 2023
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11. Assessment of the processing conditions which make the Ambrosia seeds non-viable
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Schrenk, Dieter, Bignami, Margherita, Bodin, Laurent, Chipman, James Kevin, del Mazo, Jesús, Grasl-Kraupp, Bettina, Hoogenboom, Laurentius, Leblanc, Jean Charles, Nebbia, Carlo Stefano, Nielsen, Elsa, Ntzani, Evangelia, Petersen, Annette, Sand, Salomon, Schwerdtle, Tanja, Vleminckx, Christiane, Wallace, Heather, Christodoulidou, Anna, Hogstrand, Christer, Schrenk, Dieter, Bignami, Margherita, Bodin, Laurent, Chipman, James Kevin, del Mazo, Jesús, Grasl-Kraupp, Bettina, Hoogenboom, Laurentius, Leblanc, Jean Charles, Nebbia, Carlo Stefano, Nielsen, Elsa, Ntzani, Evangelia, Petersen, Annette, Sand, Salomon, Schwerdtle, Tanja, Vleminckx, Christiane, Wallace, Heather, Christodoulidou, Anna, and Hogstrand, Christer
- Abstract
The European Commission requested EFSA to provide an assessment of the processing conditions which make Ambrosia seeds non-viable in feed materials and compound feed. This assessment also includes information on a reliable procedure to verify the non-viability of the seeds. Ambrosia seeds are known contaminants in feed with maximum levels set in the Directive 2002/32/EC. The manufacturing processes and processing conditions applied to the feed may affect the viability of the Ambrosia seeds. Therefore, the CONTAM Panel compared these conditions with conditions that have been shown to be sufficient to render Ambrosia seeds non-viable. The Panel concluded with a certainty of 99–100% that solvent extraction and toasting of oilseed meals at temperatures of 120°C with steam injection for 10 min or more will make Ambrosia seeds non-viable. Since milling/grinding feed materials for compound feed of piglets, aquatic species and non-food producing animals would not allow particles of sizes ≥1 mm (the minimum size of viable Ambrosia seeds) passing the grinding process it was considered very likely (with ≥ 90% certainty) that these feeds will not contain viable Ambrosia seeds. In poultry, pig, and possibly cattle feed, particle sizes are ≥ 1 mm and therefore Ambrosia seeds could likely (66–90% certainty) survive the grinding process. Starch and gluten either from corn or wheat wet milling would not contain Ambrosia seeds with 99–100% certainty. Finally, ensiling fresh forages contaminated with A. artemisiifolia seeds for more than 3 months is very likely to render all seeds non-viable. The Panel concluded that a combination of the germination test and a subsequent triphenyl-tetrazolium-chloride (TTC) test will very likely (with ≥ 90% certainty) verify the non-viability of Ambrosia seeds. The Panel recommends that data on the presence of viable Ambrosia seeds before and after the different feed production processes should be generated.
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- 2023
12. Assessment of information as regards the toxicity of deoxynivalenol for horses and poultry
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Schrenk, Dieter, Bignami, Margherita, Bodin, Laurent, del Mazo, James Kevin Chipman Jesús, Grasl-Kraupp, Bettina, Hogstrand, Christer, Leblanc, Jean Charles, Nielsen, Elsa, Ntzani, Evangelia, Petersen, Annette, Sand, Salomon, Schwerdtle, Tanja, Vleminckx, Christiane, Wallace, Heather, Dänicke, Sven, Nebbia, Carlo Stefano, Oswald, Isabelle P., Rovesti, Elena, Steinkellner, Hans, Hoogenboom, Laurentius, Schrenk, Dieter, Bignami, Margherita, Bodin, Laurent, del Mazo, James Kevin Chipman Jesús, Grasl-Kraupp, Bettina, Hogstrand, Christer, Leblanc, Jean Charles, Nielsen, Elsa, Ntzani, Evangelia, Petersen, Annette, Sand, Salomon, Schwerdtle, Tanja, Vleminckx, Christiane, Wallace, Heather, Dänicke, Sven, Nebbia, Carlo Stefano, Oswald, Isabelle P., Rovesti, Elena, Steinkellner, Hans, and Hoogenboom, Laurentius
- Abstract
In 2017, the EFSA Panel on Contaminants in the Food Chain (CONTAM) adopted a Scientific Opinion on the risks for animal health related to the presence of deoxynivalenol (DON) and its acetylated and modified forms in food and feed. No observed adverse effect levels (NOAELs) and lowest observed adverse effect levels (LOAELs) were derived for different animal species. For horses, an NOAEL of 36 mg DON/kg feed was established, the highest concentration tested and not showing adverse effects. For poultry, an NOAEL of 5 mg DON/kg feed for broiler chickens and laying hens, and an NOAEL of 7 mg DON/kg feed for ducks and turkeys was derived. The European Commission requested EFSA to review the information regarding the toxicity of DON for horses and poultry and to revise, if necessary, the established reference points (RPs). Adverse effect levels of 1.9 and 1.7 mg DON/kg feed for, respectively, broiler chickens and turkeys were derived from reassessment of existing studies and newly available literature, showing that DON causes effects on the intestines, in particular the jejunum, with a decreased villus height but also histological damage. An RP for adverse animal health effects of 0.6 mg/kg feed for broiler chickens and turkeys, respectively, was established. For horses, an adverse effect level of 5.6 mg DON/kg feed was established from studies showing reduced feed intake, with an RP for adverse animal health effects of 3.5 mg/kg feed. For ducks and laying hens, RPs remain unchanged. Based on mean and P95 (UB) exposure estimates performed in the previous Opinion, the risk of adverse health effects of feeds containing DON was considered a potential concern for broiler chickens and turkeys. For horses, the risk for adverse health effects from feed containing DON is low.
- Published
- 2023
13. Update of the risk assessment of mineral oil hydrocarbons in food
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Schrenk, Dieter, Bignami, Margherita, Bodin, Laurent, del Mazo, Jesús, Grasl-Kraupp, Bettina, Hogstrand, Christer, Hoogenboom, Laurentius, 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, Jose Ángel, Mosbach-Schulz, Olaf, Binaglia, Marco, Chipman, James Kevin, Schrenk, Dieter, Bignami, Margherita, Bodin, Laurent, del Mazo, Jesús, Grasl-Kraupp, Bettina, Hogstrand, Christer, Hoogenboom, Laurentius, 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, Jose Ángel, Mosbach-Schulz, Olaf, Binaglia, Marco, and Chipman, James Kevin
- Abstract
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.
- Published
- 2023
14. EFSA Opinion Update of risks for animal health related to the presence of ochratoxin A (OTA) in feed: Annexes on Occurrence data in feed submitted to EFSA
- Author
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Schrenk, Dieter, Bignami, Margherita, Bodin, Laurent, Chipman, James Kevin, del Mazo, Jesús, Grasl-Kraupp, Bettina, Hogstrand, Christer, Hoogenboom, Laurentius, Leblanc, Jean Charles, Nielsen, Elsa, Ntzani, Evangelia, Sand, Salomon, Schwerdtle, Tanja, Vleminckx, Christiane, Wallace, Heather, Gropp, Jürgen, Antonissen, Gunther, Rychen, Guido, Gómez Ruiz, José Ángel, Innocenti, Matteo Lorenzo, Rovesti, Elena, Petersen, Annette, Schrenk, Dieter, Bignami, Margherita, Bodin, Laurent, Chipman, James Kevin, del Mazo, Jesús, Grasl-Kraupp, Bettina, Hogstrand, Christer, Hoogenboom, Laurentius, Leblanc, Jean Charles, Nielsen, Elsa, Ntzani, Evangelia, Sand, Salomon, Schwerdtle, Tanja, Vleminckx, Christiane, Wallace, Heather, Gropp, Jürgen, Antonissen, Gunther, Rychen, Guido, Gómez Ruiz, José Ángel, Innocenti, Matteo Lorenzo, Rovesti, Elena, and Petersen, Annette
- Abstract
Annexes to EFSA's Update Opinion on the risks for animal health related to the presence of OTA in feed. Annex B includes the occurrence data in feed extracted from EFSA Data Warehouse for the period from 2012 to 2021. Annex C contains the occurrence data expressed in dry matter following analysis and cleansing of the dataset as detailed in EFSA's Opinion. Annex D lists the samples of 'Compound feed' and other feed materials except forage expressed in whole weight. The number of samples across some of the feed categories differ among the two annex C and D because in few cases the moisture content was not reported (and no assumption on the moisture could be done), precluding the conversion of the analytical results to either whole weight or dry matter., Annexes to EFSA's Update Opinion on the risks for animal health related to the presence of OTA in feed. Annex B includes the occurrence data in feed extracted from EFSA Data Warehouse for the period from 2012 to 2021. Annex C contains the occurrence data expressed in dry matter following analysis and cleansing of the dataset as detailed in EFSA's Opinion. Annex D lists the samples of 'Compound feed' and other feed materials except forage expressed in whole weight. The number of samples across some of the feed categories differ among the two annex C and D because in few cases the moisture content was not reported (and no assumption on the moisture could be done), precluding the conversion of the analytical results to either whole weight or dry matter.
- Published
- 2023
15. Occurrence data on N-nitrosamines provided to EFSA
- Author
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Schrenk, Dieter, Bignami, Margherita, Bodin, Laurent, Chipman, James Kevin, del Mazo, Jesús, Hogstrand, Christer, Hoogenboom, Laurentius, Leblanc, Jean Charles, Nebbia, Carlo Stefano, Nielsen, Elsa, Ntzani, Evangelia, Petersen, Annette, Sand, Salomon, Schwerdtle, Tanja, Vleminckx, Christiane, Wallace, Heather, Romualdo, Benigni, Cristina, Fortes, Stephen, Hecht, Iammarino, Marco, Mosbach-Schulz, Olaf, Riolo, Francesca, Christodoulidou, Anna, Grasl-Kraupp, Bettina, Schrenk, Dieter, Bignami, Margherita, Bodin, Laurent, Chipman, James Kevin, del Mazo, Jesús, Hogstrand, Christer, Hoogenboom, Laurentius, Leblanc, Jean Charles, Nebbia, Carlo Stefano, Nielsen, Elsa, Ntzani, Evangelia, Petersen, Annette, Sand, Salomon, Schwerdtle, Tanja, Vleminckx, Christiane, Wallace, Heather, Romualdo, Benigni, Cristina, Fortes, Stephen, Hecht, Iammarino, Marco, Mosbach-Schulz, Olaf, Riolo, Francesca, Christodoulidou, Anna, and Grasl-Kraupp, Bettina
- Abstract
The file contains the raw occurrence dataset on nitrosamines in food as extracted from EFSA DWH on 3 July 2021 and presented in the EFSA opinion on Risk assessment of N-nitrosamines in food available at https://doi.org/10.2903/j.efsa.2023.7884. The data is provided in csv format. This dataset is compliant with EFSA SSD2 data model and contains two additional columns documenting issues identified in the cleaning process (column: issue) and the action taken (column: action) to address the issue (e.g. delete record or update values in specific fields). The link to the catalogues of controlled terminologies for the updated textual description of fields values can be found under "Related identifiers”., The file contains the raw occurrence dataset on nitrosamines in food as extracted from EFSA DWH on 3 July 2021 and presented in the EFSA opinion on Risk assessment of N-nitrosamines in food available at https://doi.org/10.2903/j.efsa.2023.7884. The data is provided in csv format. This dataset is compliant with EFSA SSD2 data model and contains two additional columns documenting issues identified in the cleaning process (column: issue) and the action taken (column: action) to address the issue (e.g. delete record or update values in specific fields). The link to the catalogues of controlled terminologies for the updated textual description of fields values can be found under "Related identifiers”.
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- 2023
16. Harmonised approach for reporting reliability and relevance of genotoxicity studies.
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Andreoli, Cristina, Aquilina, Gabriele, Bignami, Margherita, Bolognesi, Claudia, Crebelli, Riccardo, Dusinska, Maria, Gürtler, Rainer, Louro, Henriqueta, Marcon, Francesca, Nielsen, Elsa, Schlatter, Josef, Vleminckx, Christiane, Astuto, Maria Chiara, Nathanail, Alexis V, and Benford, Diane
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GENETIC toxicology ,EVALUATION - Abstract
This technical report describes an approach developed by the EFSA cross‐cutting Working Group on Genotoxicity for the reporting of reliability and relevance of genotoxicity studies. The scope of this document is to ensure harmonisation and transparency of the approach for evaluation of genotoxicity evidence among EFSA Units dealing with scientific assessments. It is recommended to be used as a template for the drafting of genotoxicity assessments in EFSA Opinions. [ABSTRACT FROM AUTHOR]
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- 2023
- Full Text
- View/download PDF
17. Tiered dietary exposure assessment of steviol glycosides in the Belgian population
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Van Loco, Joris, primary, Janssens, Raphael, additional, Goscinny, Séverine, additional, Van Hoeck, Els, additional, Vleminckx, Christiane, additional, and Andjelkovic, Mirjana, additional
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- 2023
- Full Text
- View/download PDF
18. Silver-based biocides and titanium dioxide particles from face masks for general use. Final report of the TiO2Mask and AgMask COVID-19 projects
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Montalvo, Daniela, Wouters, Charlotte, Siciliani, Lisa, Vleminckx, Christiane, Van Miert, Erik, Waegeneers, Nadia, Van Loco, Joris, Verleysen, Eveline, and Mast, Jan
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FOS: Nano-technology - Published
- 2023
- Full Text
- View/download PDF
19. Evaluation of the shucking of certain species of scallops contaminated with domoic acid with a view to the production of edible parts meeting the safety requirements foreseen in the Union legislation
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EFSA CONTAM Panel, Schrenk, Dieter, Bignami, Margherita, Bodin, Laurent, Del Mazo, Jesús, Grasl-Kraupp, Bettina, Hogstrand, Christer, Chipman, Kevin James, Leblanc, Jean-Charles, Nebbia, Carlo Stefano, Nielsen, Elsa, Ntzani, Evangelia, Petersen, Annette, Sand, Salomon, Schwerdtle, Tanja, Vleminckx, Christiane, Wallace, Heather, Gago Martínez, Ana, Gerssen, Arjen, Tubaro, Aurelia, Cascio, Claudia, Cortiñas Abrahantes, José, Steinkellner, Hans, Hoogenboom, Laurentius (Ron), European Commission, Schrenk, Dieter, Bignami, Margherita, Bodin, Laurent, Del Mazo, Jesús, Grasl-Kraupp, Bettina, Hogstrand, Christer, Leblanc, Jean-Charles, Nielsen, Elsa, Ntzani, Evangelia, Petersen, Annette, Sand, Salomon, Schwerdtle, Tanja, Vleminckx, Christiane, Gago Martínez, Ana, Gerssen, Arjen, Tubaro, Aurelia, Cascio, Claudia, Cortiñas Abrahantes, José, Hoogenboom, Laurentius (Ron), Schrenk, Dieter [0000-0002-7717-5533], Bignami, Margherita [0000-0002-1525-6864], Bodin, Laurent [0000-0001-5671-3139], Del Mazo, Jesús [0000-0003-3269-3895], Grasl-Kraupp, Bettina [0000-0003-4889-6531], Hogstrand, Christer [0000-0001-7545-6975], Leblanc, Jean-Charles [0000-0003-2872-3414], Nielsen, Elsa [0000-0002-6874-2575], Ntzani, Evangelia [0000-0003-3712-4181], Petersen, Annette [0000-0003-3996-2701], Sand, Salomon [0000-0002-3360-0534], Schwerdtle, Tanja [0000-0002-4873-7488], Vleminckx, Christiane [0000-0002-9928-1601], Gago Martínez, Ana [0000-0001-5178-2338], Gerssen, Arjen [0000-0003-4271-1516], Tubaro, Aurelia [0000-0003-2773-2589], Cascio, Claudia [0000-0002-3810-4134], Cortiñas Abrahantes, José [0000-0002-4805-9429], and Hoogenboom, Laurentius (Ron) [0000-0002-8913-5328]
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scallops ,Pooled Sample ,Project- en Accountmanagement ,Veterinary (miscellaneous) ,BU Contaminanten & Toxines ,Team Toxicology ,TP1-1185 ,Plant Science ,Scallops ,Microbiology ,Domoic acid ,chemistry.chemical_compound ,BU Contaminants & Toxins ,Animal science ,Pecten maximus ,TX341-641 ,Statistical analysis ,Food8822 ,VLAG ,biology ,Nutrition. Foods and food supply ,Shucking ,Sample size ,Chemical technology ,Member states ,Contamination ,biology.organism_classification ,sample size ,Team Natural Toxins ,shucking ,Scientific Opinion ,chemistry ,Sample size determination ,Scallop ,Animal Science and Zoology ,Parasitology ,Food Science - Abstract
57 p.-12 fig.-6 tab., EFSA was asked by the European Commission to provide information on the levels of domoic acid (DA) in whole scallops that would ensure that levels in edible parts are below the regulatory limit after shucking. This should include five species of scallops. In addition, EFSA was asked to recommend the number of scallops to be used in an analytical sample. To address these questions, EFSA received suitable data on DA for only one scallop species, Pecten maximus, i.e. data on pooled samples of edible and non-edible parts. A large part of the concentration levels was above the limit of quantification (LOQ) and only these data were used for the assessment. Shucking in most cases resulted in a strong decrease in the toxin levels. Statistical analysis of the data showed that levels in whole scallops should not exceed 24 mg DA/kg, 59 mg DA/kg and 127 mg DA/kg to ensure that levels in, respectively, gonads, muscle and muscle plus gonads are below the regulatory limit of 20 mg DA/kg with 99% certainty. Such an analysis was not possible for the other scallop species. In the absence of data from member states, published data of variations between scallops were used to calculate the sample size to ensure a 95% correct prediction on whether the level in scallops in an area or lot is correctly predicted to be compliant/non-compliant. It was shown that 10 scallops per sample would be sufficient to predict with 95% certainty if DA levels in the area/lot were twofold below or above the regulatory limit for the highest reported coefficient of variance (CV) of 1.06. To predict with 95% certainty for levels between 15 and 27 mg DA/kg, a pooled sample of more than 30 scallops would have to be tested.
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- 2021
20. Decontamination process for dioxins and dioxin‐like PCBs from fish oil and vegetable oils and fats by a physical process with activated carbon
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Schrenk, Dieter, Bignami, Margherita, Bodin, Laurent, Chipman, James Kevin, del Mazo, Jesus, Grasl-Kraupp, Bettina, Hoogenboom, Laurentius, Leblanc, Jean Charles, Nebbia, Carlo Stefano, Nielsen, Elsa, Ntzani, Evangelia, Petersen, Annette, Sand, Salomon, Schwerdtle, Tanja, Vleminckx, Christiane, Wallace, Heather, Rose, Martin, Cottrill, Bruce, Lundebye, Anne Katrine, Metzler, Manfred, Christodoulidou, Anna, and Hogstrand, Christer
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physical filtration ,decontamination process ,vegetable oil and fat ,Veterinary (miscellaneous) ,Team Toxicology ,Plant Science ,fish oil ,Microbiology ,PCDD/Fs ,Animal Science and Zoology ,Parasitology ,PCBs ,VLAG ,Food Science - Abstract
Following a request from the European Commission, the EFSA Panel on Contaminants in the Food Chain (CONTAM) assessed a decontamination process of fish oils and vegetable oils and fats to reduce the concentrations of dioxins (polychlorinated dibenzo-p-dioxins and polychlorinated dibenzofurans, abbreviated together as PCDD/Fs) and dioxin-like polychlorinated biphenyls (DL-PCBs) by adsorption to activated carbon. All feed decontamination processes must comply with the acceptability criteria specified in the Commission Regulation (EU) 2015/786. Data provided by the feed food business operator (FBO) were assessed for the efficacy of the process and to demonstrate that the process did not adversely affect the characteristics and properties of the product. The limited information provided, in particular on the analysis of the samples before and after decontamination, did not allow the CONTAM Panel to conclude whether or not the proposed decontamination process is effective in reducing PCDD/Fs and DL-PCBs in the fish- and vegetable oils and fats. Although there is no evidence from the data provided that the decontamination process leads to detrimental changes in the nutritional composition of the fish- and vegetable oils, it is possible that the process could deplete some beneficial constituents (e.g. vitamins). Taken together, it was not possible for the CONTAM Panel to conclude that the decontamination process as proposed by the FBO is compliant with the acceptability criteria provided for in Commission Regulation (EU) 2015/786 of 19 May 2015.
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- 2022
21. Follow-up of the re-evaluation of sulfur dioxide (E 220), sodium sulfite (E 221), sodium bisulfite (E 222), sodium metabisulfite (E 223), potassium metabisulfite (E 224), calcium sulfite (E 226), calcium bisulfite (E 227) and potassium bisulfite (E 228)
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Younes, Maged, Aquilina, Gabriele, Castle, Laurence, Engel, Karl-Heinz, Fowler, Paul J, Frutos Fernandez, Maria Jose, Fürst, Peter, Gundert-Remy, Ursula, Gürtler, Rainer, Husøy, Trine, Manco, Melania, Mennes, Wim, Moldeus, Peter, Passamonti, Sabina, Shah, Romina, Waalkens-Berendsen, Ine, Boon, Polly, Cheyns, Karlien, Crebelli, Riccardo, FitzGerald, Rex, Lambré, Claude, Mirat, Manuela, Ulbrich, Beate, Vleminckx, Christiane, Mech, Agnieszka, Rincon, Ana Maria, Tard, Alexandra, Horvath, Zsuzsanna, Wright, Matthew, Younes, Maged, Aquilina, Gabriele, Castle, Laurence, Engel, Karl-Heinz, Fowler, Paul J, Frutos Fernandez, Maria Jose, Fürst, Peter, Gundert-Remy, Ursula, Gürtler, Rainer, Husøy, Trine, Manco, Melania, Mennes, Wim, Moldeus, Peter, Passamonti, Sabina, Shah, Romina, Waalkens-Berendsen, Ine, Boon, Polly, Cheyns, Karlien, Crebelli, Riccardo, Fitzgerald, Rex, Lambré, Claude, Mirat, Manuela, Ulbrich, Beate, Vleminckx, Christiane, Mech, Agnieszka, Rincon, Ana Maria, Tard, Alexandra, Horvath, Zsuzsanna, and Wright, Matthew
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potassium metabisulfite ,CAS 16731‐55‐8 ,CAS 13780‐03‐5 ,CAS 7631‐90‐5 ,CAS 10257‐55‐3 ,CAS 7446‐09‐5 ,sodium metabisulfite ,potassium bisulfite ,sulfur dioxide ,sodium bisulfite ,CAS 7773‐03‐7 ,CAS 7757‐83‐7 ,calcium bisulfite ,food additive ,E 221 ,sodium sulfite ,E 220 ,E 223 ,CAS 7681‐57‐4 ,E 222 ,E 224 ,E 226 ,E 227 ,E 228 ,calcium sulfite - Abstract
Sulfur dioxide-sulfites (E 220-228) were re-evaluated in 2016, resulting in the setting of a temporary ADI of 0.7 mg SO2 equivalents/kg bw per day. Following a European Commission call for data, the present follow-up opinion assesses data provided by interested business operators (IBOs) and additional evidence identified in the publicly available literature. No new biological or toxicological data addressing the data gaps described in the re-evaluation were submitted by IBOs. Taking into account data identified from the literature search, the Panel concluded that there was no substantial reduction in the uncertainties previously identified in the re-evaluation. Therefore, the Panel considered that the available toxicity database was inadequate to derive an ADI and withdrew the current temporary group acceptable daily intake (ADI). A margin of exposure (MOE) approach was considered appropriate to assess the risk for these food additives. A lower confidence limit of the benchmark dose of 38 mg SO2 equivalents/kg bw per day, which is lower than the previous reference point of 70 mg SO2 equivalents/kg bw per day, was estimated based on prolonged visual evoked potential latency. An assessment factor of 80 was applied for the assessment of the MoE. At the estimated dietary exposures, when using a refined exposure scenario (Data set D), MOEs at the maximum of 95th percentile ranges were below 80 for all population groups except for adolescents. The dietary exposures estimated using the maximum permitted levels would result in MOEs below 80 in all population groups at the maximum of the ranges of the mean, and for most of the population groups at both minimum and maximum of the ranges at the 95th percentile. The Panel concluded that this raises a safety concern for both dietary exposure scenarios. The Panel also performed a risk assessment for toxic elements present in sulfur dioxide-sulfites (E 220-228), based on data submitted by IBOs, and concluded that the maximum limits in the EU specifications for arsenic, lead and mercury should be lowered and a maximum limit for cadmium should be introduced.
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- 2022
22. Update of the risk assessment of hexabromocyclododecanes (HBCDDs) in food
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European Commission, Schrenk, Dieter [0000-0002-7717-5533], Bignami, Margherita [0000-0002-1525-6864], Bodin, Laurent [0000-0001-5671-3139], Del Mazo, Jesús [0000-0003-3269-3895], Grasl-Kraupp, Bettina [0000-0003-4889-6531], Hogstrand, Christer [0000-0001-7545-6975], Hoogenboom, Laurentius (Ron) [0000-0002-8913-5328], Leblanc, Jean-Charles [0000-0003-2872-3414], Nielsen, Elsa [0000-0002-6874-2575], Ntzani, Evangelia [0000-0003-3712-4181], Petersen, Annette [0000-0003-3996-2701], Sand, Salomon [0000-0002-3360-0534], Schwerdtle, Tanja [0000-0002-4873-7488], Benford, Diane [0000-0002-7113-639X], Ioannidou, Sofia 0000-0001-6375-3243], Vleminckx, Christiane [0000-0002-9928-1601], 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, European Commission, Schrenk, Dieter [0000-0002-7717-5533], Bignami, Margherita [0000-0002-1525-6864], Bodin, Laurent [0000-0001-5671-3139], Del Mazo, Jesús [0000-0003-3269-3895], Grasl-Kraupp, Bettina [0000-0003-4889-6531], Hogstrand, Christer [0000-0001-7545-6975], Hoogenboom, Laurentius (Ron) [0000-0002-8913-5328], Leblanc, Jean-Charles [0000-0003-2872-3414], Nielsen, Elsa [0000-0002-6874-2575], Ntzani, Evangelia [0000-0003-3712-4181], Petersen, Annette [0000-0003-3996-2701], Sand, Salomon [0000-0002-3360-0534], Schwerdtle, Tanja [0000-0002-4873-7488], Benford, Diane [0000-0002-7113-639X], Ioannidou, Sofia 0000-0001-6375-3243], Vleminckx, Christiane [0000-0002-9928-1601], 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, and Vleminckx, Christiane
- Abstract
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.
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- 2021
23. Assessment of an application on a detoxification process of groundnut press cake for aflatoxins by ammoniation
- Author
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Schrenk, Dieter [0000-0002-7717-5533], Bignami, Margherita [0000-0002-1525-6864], Bodin, Laurent [0000-0001-5671-3139], Del Mazo, Jesús [0000-0003-3269-3895], Grasl-Kraupp, Bettina [0000-0003-4889-6531], Hoogenboom, Laurentius (Ron) [0000-0002-8913-5328], Leblanc, Jean-Charles [0000-0003-2872-3414], Nielsen, Elsa [0000-0002-6874-2575], Ntzani, Evangelia [0000-0003-3712-4181], Petersen, Annette [0000-0003-3996-2701], Sand, Salomon [0000-0002-3360-0534], Schwerdtle, Tanja [0000-0002-4873-7488], Vleminckx, Christiane [0000-0002-9928-1601], Christodoulidou, Anna [0000-0003-1799-7153], Hogstrand, Christer [0000-0001-7545-6975], EFSA CONTAM Panel, Schrenk, Dieter, Bignami, Margherita, Bodin, Laurent, Chipman, Kevin James, Del Mazo, Jesús, Grasl-Kraupp, Bettina, Hoogenboom, Laurentius (Ron), Leblanc, Jean-Charles, Nebbia, Carlo Stefano, Nielsen, Elsa, Ntzani, Evangelia, Petersen, Annette, Sand, Salomon, Schwerdtle, Tanja, Vleminckx, Christiane, Wallace, Heather, Rose, Martin, Cottrill, Bruce, Lundebye, Anne Katrine, Metzler, Manfred, Christodoulidou, Anna, Hogstrand, Christer, Schrenk, Dieter [0000-0002-7717-5533], Bignami, Margherita [0000-0002-1525-6864], Bodin, Laurent [0000-0001-5671-3139], Del Mazo, Jesús [0000-0003-3269-3895], Grasl-Kraupp, Bettina [0000-0003-4889-6531], Hoogenboom, Laurentius (Ron) [0000-0002-8913-5328], Leblanc, Jean-Charles [0000-0003-2872-3414], Nielsen, Elsa [0000-0002-6874-2575], Ntzani, Evangelia [0000-0003-3712-4181], Petersen, Annette [0000-0003-3996-2701], Sand, Salomon [0000-0002-3360-0534], Schwerdtle, Tanja [0000-0002-4873-7488], Vleminckx, Christiane [0000-0002-9928-1601], Christodoulidou, Anna [0000-0003-1799-7153], Hogstrand, Christer [0000-0001-7545-6975], EFSA CONTAM Panel, Schrenk, Dieter, Bignami, Margherita, Bodin, Laurent, Chipman, Kevin James, Del Mazo, Jesús, Grasl-Kraupp, Bettina, Hoogenboom, Laurentius (Ron), Leblanc, Jean-Charles, Nebbia, Carlo Stefano, Nielsen, Elsa, Ntzani, Evangelia, Petersen, Annette, Sand, Salomon, Schwerdtle, Tanja, Vleminckx, Christiane, Wallace, Heather, Rose, Martin, Cottrill, Bruce, Lundebye, Anne Katrine, Metzler, Manfred, Christodoulidou, Anna, and Hogstrand, Christer
- Abstract
Following a request from the European Commission, the EFSA Panel on Contaminants in the Food Chain (CONTAM) provided a scientific opinion on an application for a detoxification process of groundnut press cake for aflatoxins by ammoniation. Specifically, it is required that the feed decontamination process is compliant with the acceptability criteria specified in the Commission Regulation (EU) 2015/786 of 19 May 2015. The CONTAM Panel assessed the data provided by the feed business operator with respect to the efficacy of the process to remove the contaminant from groundnut press cake batches and on information demonstrating that the process does not adversely affect the characteristics and the nature of the product. Although according to the literature the process may be able to reduce aflatoxin levels below the legal limits, the Panel concluded that the proposed decontamination process, on the basis of the experimental data submitted by the feed business operator, cannot be confirmed for compliance with the acceptability criteria provided for in Commission Regulation (EU) 2015/786 of 19 May 2015. The Panel recommended sufficient sample testing before and after the process, under the selected conditions, to ensure that the process is reproducible and reliable and to demonstrate that the detoxification is not reversible. In addition, genotoxicity testing of extracts of the treated feedingstuff and of the identified degradation products would be necessary. Finally, information on the transfer rate of AFB1 to AFM1 excretion in milk for animals fed the ammoniated product, in comparison to the starting material and on the ammoniation process changes of the nutritional values of the feed material should be provided.
- Published
- 2021
24. Evaluation of the shucking of certain species of scallops contaminated with domoic acid with a view to the production of edible parts meeting the safety requirements foreseen in the Union legislation
- Author
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European Commission, Schrenk, Dieter [0000-0002-7717-5533], Bignami, Margherita [0000-0002-1525-6864], Bodin, Laurent [0000-0001-5671-3139], Del Mazo, Jesús [0000-0003-3269-3895], Grasl-Kraupp, Bettina [0000-0003-4889-6531], Hogstrand, Christer [0000-0001-7545-6975], Leblanc, Jean-Charles [0000-0003-2872-3414], Nielsen, Elsa [0000-0002-6874-2575], Ntzani, Evangelia [0000-0003-3712-4181], Petersen, Annette [0000-0003-3996-2701], Sand, Salomon [0000-0002-3360-0534], Schwerdtle, Tanja [0000-0002-4873-7488], Vleminckx, Christiane [0000-0002-9928-1601], Gago Martínez, Ana [0000-0001-5178-2338], Gerssen, Arjen [0000-0003-4271-1516], Tubaro, Aurelia [0000-0003-2773-2589], Cascio, Claudia [0000-0002-3810-4134], Cortiñas Abrahantes, José [0000-0002-4805-9429], Hoogenboom, Laurentius (Ron) [0000-0002-8913-5328], EFSA CONTAM Panel, Schrenk, Dieter, Bignami, Margherita, Bodin, Laurent, Del Mazo, Jesús, Grasl-Kraupp, Bettina, Hogstrand, Christer, Chipman, Kevin James, Leblanc, Jean-Charles, Nebbia, Carlo Stefano, Nielsen, Elsa, Ntzani, Evangelia, Petersen, Annette, Sand, Salomon, Schwerdtle, Tanja, Vleminckx, Christiane, Wallace, Heather, Gago Martínez, Ana, Gerssen, Arjen, Tubaro, Aurelia, Cascio, Claudia, Cortiñas Abrahantes, José, Steinkellner, Hans, Hoogenboom, Laurentius (Ron), European Commission, Schrenk, Dieter [0000-0002-7717-5533], Bignami, Margherita [0000-0002-1525-6864], Bodin, Laurent [0000-0001-5671-3139], Del Mazo, Jesús [0000-0003-3269-3895], Grasl-Kraupp, Bettina [0000-0003-4889-6531], Hogstrand, Christer [0000-0001-7545-6975], Leblanc, Jean-Charles [0000-0003-2872-3414], Nielsen, Elsa [0000-0002-6874-2575], Ntzani, Evangelia [0000-0003-3712-4181], Petersen, Annette [0000-0003-3996-2701], Sand, Salomon [0000-0002-3360-0534], Schwerdtle, Tanja [0000-0002-4873-7488], Vleminckx, Christiane [0000-0002-9928-1601], Gago Martínez, Ana [0000-0001-5178-2338], Gerssen, Arjen [0000-0003-4271-1516], Tubaro, Aurelia [0000-0003-2773-2589], Cascio, Claudia [0000-0002-3810-4134], Cortiñas Abrahantes, José [0000-0002-4805-9429], Hoogenboom, Laurentius (Ron) [0000-0002-8913-5328], EFSA CONTAM Panel, Schrenk, Dieter, Bignami, Margherita, Bodin, Laurent, Del Mazo, Jesús, Grasl-Kraupp, Bettina, Hogstrand, Christer, Chipman, Kevin James, Leblanc, Jean-Charles, Nebbia, Carlo Stefano, Nielsen, Elsa, Ntzani, Evangelia, Petersen, Annette, Sand, Salomon, Schwerdtle, Tanja, Vleminckx, Christiane, Wallace, Heather, Gago Martínez, Ana, Gerssen, Arjen, Tubaro, Aurelia, Cascio, Claudia, Cortiñas Abrahantes, José, Steinkellner, Hans, and Hoogenboom, Laurentius (Ron)
- Abstract
EFSA was asked by the European Commission to provide information on the levels of domoic acid (DA) in whole scallops that would ensure that levels in edible parts are below the regulatory limit after shucking. This should include five species of scallops. In addition, EFSA was asked to recommend the number of scallops to be used in an analytical sample. To address these questions, EFSA received suitable data on DA for only one scallop species, Pecten maximus, i.e. data on pooled samples of edible and non-edible parts. A large part of the concentration levels was above the limit of quantification (LOQ) and only these data were used for the assessment. Shucking in most cases resulted in a strong decrease in the toxin levels. Statistical analysis of the data showed that levels in whole scallops should not exceed 24 mg DA/kg, 59 mg DA/kg and 127 mg DA/kg to ensure that levels in, respectively, gonads, muscle and muscle plus gonads are below the regulatory limit of 20 mg DA/kg with 99% certainty. Such an analysis was not possible for the other scallop species. In the absence of data from member states, published data of variations between scallops were used to calculate the sample size to ensure a 95% correct prediction on whether the level in scallops in an area or lot is correctly predicted to be compliant/non-compliant. It was shown that 10 scallops per sample would be sufficient to predict with 95% certainty if DA levels in the area/lot were twofold below or above the regulatory limit for the highest reported coefficient of variance (CV) of 1.06. To predict with 95% certainty for levels between 15 and 27 mg DA/kg, a pooled sample of more than 30 scallops would have to be tested.
- Published
- 2021
25. Assessment of an application on a detoxification process of groundnut press cake for aflatoxins by ammoniation
- Author
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EFSA Panel on Contaminants in the Food Chain (CONTAM), Schrenk, Dieter, Bignami, Margherita, Bodin, Laurent, Chipman, Kevin James, Del Mazo, Jesús, Grasl-Kraupp, Bettina, Hoogenboom, Laurentius (Ron), Leblanc, Jean-Charles, Nebbia, Carlo Stefano, Nielsen, Elsa, Ntzani, Evangelia, Petersen, Annette, Sand, Salomon, Schwerdtle, Tanja, Vleminckx, Christiane, Wallace, Heather, Rose, Martin, Cottrill, Bruce, Lundebye, Anne Katrine, Metzler, Manfred, Christodoulidou, Anna, Hogstrand, Christer, Schrenk, Dieter [0000-0002-7717-5533], Bignami, Margherita [0000-0002-1525-6864], Bodin, Laurent [0000-0001-5671-3139], Del Mazo, Jesús [0000-0003-3269-3895], Grasl-Kraupp, Bettina [0000-0003-4889-6531], Hoogenboom, Laurentius (Ron) [0000-0002-8913-5328], Leblanc, Jean-Charles [0000-0003-2872-3414], Nielsen, Elsa [0000-0002-6874-2575], Ntzani, Evangelia [0000-0003-3712-4181], Petersen, Annette [0000-0003-3996-2701], Sand, Salomon [0000-0002-3360-0534], Schwerdtle, Tanja [0000-0002-4873-7488], Vleminckx, Christiane [0000-0002-9928-1601], Christodoulidou, Anna [0000-0003-1799-7153], Hogstrand, Christer [0000-0001-7545-6975], Schrenk, Dieter, Bignami, Margherita, Bodin, Laurent, Del Mazo, Jesús, Grasl-Kraupp, Bettina, Hoogenboom, Laurentius (Ron), Leblanc, Jean-Charles, Nielsen, Elsa, Ntzani, Evangelia, Petersen, Annette, Sand, Salomon, Schwerdtle, Tanja, Vleminckx, Christiane, Christodoulidou, Anna, and Hogstrand, Christer
- Subjects
Nutrition. Foods and food supply ,decontamination process ,Veterinary (miscellaneous) ,Chemical technology ,aflatoxin ,groundnut press cake ,Decontamination process ,Team Toxicology ,Plant Science ,TP1-1185 ,Microbiology ,Groundnut press cake ,Scientific Opinion ,ammoniation ,Aflatoxin ,Life Science ,Animal Science and Zoology ,Parasitology ,TX341-641 ,Ammoniation ,Food Science ,VLAG - Abstract
12 p.-2 fig.-2 tab., Following a request from the European Commission, the EFSA Panel on Contaminants in the Food Chain (CONTAM) provided a scientific opinion on an application for a detoxification process of groundnut press cake for aflatoxins by ammoniation. Specifically, it is required that the feed decontamination process is compliant with the acceptability criteria specified in the Commission Regulation (EU) 2015/786 of 19 May 2015. The CONTAM Panel assessed the data provided by the feed business operator with respect to the efficacy of the process to remove the contaminant from groundnut press cake batches and on information demonstrating that the process does not adversely affect the characteristics and the nature of the product. Although according to the literature the process may be able to reduce aflatoxin levels below the legal limits, the Panel concluded that the proposed decontamination process, on the basis of the experimental data submitted by the feed business operator, cannot be confirmed for compliance with the acceptability criteria provided for in Commission Regulation (EU) 2015/786 of 19 May 2015. The Panel recommended sufficient sample testing before and after the process, under the selected conditions, to ensure that the process is reproducible and reliable and to demonstrate that the detoxification is not reversible. In addition, genotoxicity testing of extracts of the treated feedingstuff and of the identified degradation products would be necessary. Finally, information on the transfer rate of AFB1 to AFM1 excretion in milk for animals fed the ammoniated product, in comparison to the starting material and on the ammoniation process changes of the nutritional values of the feed material should be provided., The Panel wishes to thank Federico Cruciani and Carina Wenger for the support provided to this scientific output, and the hearing expert Professor Dr Wayne L Bryden, for the overview on aflatoxin inactivation by ammoniation.
- Published
- 2021
26. Update of the risk assessment of hexabromocyclododecanes (HBCDDs) in food
- Author
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EFSA Panel on Contaminants in the Food Chain (CONTAM), 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, European Commission, Schrenk, Dieter [0000-0002-7717-5533], Bignami, Margherita [0000-0002-1525-6864], Bodin, Laurent [0000-0001-5671-3139], Del Mazo, Jesús [0000-0003-3269-3895], Grasl-Kraupp, Bettina [0000-0003-4889-6531], Hogstrand, Christer [0000-0001-7545-6975], Hoogenboom, Laurentius (Ron) [0000-0002-8913-5328], Leblanc, Jean-Charles [0000-0003-2872-3414], Nielsen, Elsa [0000-0002-6874-2575], Ntzani, Evangelia [0000-0003-3712-4181], Petersen, Annette [0000-0003-3996-2701], Sand, Salomon [0000-0002-3360-0534], Schwerdtle, Tanja [0000-0002-4873-7488], Benford, Diane [0000-0002-7113-639X], Ioannidou, Sofia 0000-0001-6375-3243], Vleminckx, Christiane [0000-0002-9928-1601], Schrenk, Dieter, Bignami, Margherita, Bodin, Laurent, Del Mazo, Jesús, Grasl-Kraupp, Bettina, Hogstrand, Christer, Hoogenboom, Laurentius (Ron), Leblanc, Jean-Charles, Nielsen, Elsa, Ntzani, Evangelia, Petersen, Annette, Sand, Salomon, Schwerdtle, Tanja, Benford, Diane, and Vleminckx, Christiane
- Subjects
040301 veterinary sciences ,Veterinary (miscellaneous) ,Team Toxicology ,human exposure ,TP1-1185 ,Plant Science ,010501 environmental sciences ,occurrence ,Body weight ,Toxicology ,01 natural sciences ,Microbiology ,0403 veterinary science ,Occurrence ,Age groups ,Environmental health ,Medicine ,TX341-641 ,hexabromocyclododecanes ,VLAG ,0105 earth and related environmental sciences ,Risk assessment ,Hexabromocyclododecanes ,Nutrition. Foods and food supply ,business.industry ,Dietary exposure ,food ,Chemical technology ,HBCDDs ,risk assessment ,04 agricultural and veterinary sciences ,European population ,Human exposure ,Lowest-observed-adverse-effect level ,Scientific Opinion ,Food ,Toxicity ,Animal Science and Zoology ,Parasitology ,Livestock ,business ,toxicology ,Food Science - Abstract
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.
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- 2021
27. Update of the risk assessment of nickel in food and drinking water
- Author
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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, European Commission, Schrenk, Dieter, Bignami, Margherita, Bodin, Laurent, Del Mazo, Jesús, Grasl-Kraupp, Bettina, Hogstrand, Christer, Hoogenboom, Laurentius (Ron), Leblanc, Jean-Charles, Ntzani, Evangelia, Sand, Salomon, Schwerdtle, Tanja, Vleminckx, Christiane, Guérin, Thierry, Massanyi, Peter, van Loveren, Henk, Nielsen, Elsa, Schrenk, Dieter [0000-0002-7717-5533], Bignami, Margherita [0000-0002-1525-6864], Bodin, Laurent [0000-0001-5671-3139], Del Mazo, Jesús [0000-0003-3269-3895], Grasl-Kraupp, Bettina [0000-0003-4889-6531], Hogstrand, Christer [0000-0001-7545-6975], Hoogenboom, Laurentius (Ron) [0000-0002-8913-5328], Leblanc, Jean-Charles [0000-0003-2872-3414], Ntzani, Evangelia [0000-0003-3712-4181], Sand, Salomon [0000-0002-3360-0534], Schwerdtle, Tanja [0000-0002-4873-7488], Vleminckx, Christiane [0000-0002-9928-1601], Guérin, Thierry [0000-0003-4060-6616], Massanyi, Peter [0000-0002-4216-0948], van Loveren, Henk [0000-0002-1805-6198], and Nielsen, Elsa [0000-0002-6874-2575]
- Subjects
Tolerable daily intake ,Percentile ,margin of exposure (MOE) ,tolerable daily intake (TDI) ,040301 veterinary sciences ,Veterinary (miscellaneous) ,Team Toxicology ,TP1-1185 ,Plant Science ,010501 environmental sciences ,01 natural sciences ,Microbiology ,Adult age ,0403 veterinary science ,Nickel ,Environmental health ,Medicine ,TX341-641 ,VLAG ,0105 earth and related environmental sciences ,Nutrition. Foods and food supply ,Dietary exposure ,business.industry ,Chemical technology ,food ,Incidence (epidemiology) ,sensitisation ,toxicity ,04 agricultural and veterinary sciences ,Young age ,Scientific Opinion ,dietary exposure ,Toxicity ,Animal Science and Zoology ,Parasitology ,business ,Risk assessment ,Food Science - Abstract
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.
- Published
- 2020
28. Risk to human health related to the presence of perfluoroalkyl substances in food
- Author
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European Commission, Schrenk, Dieter [0000-0002-7717-5533], Bignami, Margherita [0000-0002-1525-6864], Bodin, Laurent [0000-0001-5671-3139], Del Mazo, Jesús [0000-0003-3269-3895], Grasl-Kraupp, Bettina [0000-0003-4889-6531], Hogstrand, Christer [0000-0001-7545-6975], Hoogenboom, Laurentius (Ron) [0000-0002-8913-5328], Leblanc, Jean-Charles [0000-0003-2872-3414], Nielsen, Elsa [0000-0002-6874-2575], Ntzani, Evangelia [0000-0003-3712-4181], Petersen, Annette [0000-0003-3996-2701], Sand, Salomon [0000-0002-3360-0534], Vleminckx, Christiane [0000-0002-9928-1601], Barregard, Lars [0000-0002-4662-0841], Ceccatelli, Sandra [0000-0002-9367-8480], Cravedi, Jean-Pierre [0000-0001-9247-7567], Halldorsson, Thorhallur Ingi [0000-0002-3488-0777], Haug,Line Smastuen [0000-0001-6746-6399], Knutsen,Helle Katrine [0000-0003-2041-8917], Roudot, Alain-Claude [0000-0001-5948-5813], Loveren, Henk van [0000-0002-1805-6198], Mackay, Karen [0000-0002-0626-2904], Schwerdtle, Tanja [0000-0002-4873-7488], 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, Vleminckx, Christiane, Wallace, Heather, Barregard, Lars, Ceccatelli, Sandra, Cravedi, Jean-Pierre, Halldorsson, Thorhallur Ingi, Haug,Line Smastuen, Johansson, Niklas, Knutsen,Helle Katrine, Rose, Martin, Roudot, Alain-Claude, Loveren, Henk van, Vollmer, Günter, Mackay, Karen, Riolo, Francesca, Schwerdtle, Tanja, European Commission, Schrenk, Dieter [0000-0002-7717-5533], Bignami, Margherita [0000-0002-1525-6864], Bodin, Laurent [0000-0001-5671-3139], Del Mazo, Jesús [0000-0003-3269-3895], Grasl-Kraupp, Bettina [0000-0003-4889-6531], Hogstrand, Christer [0000-0001-7545-6975], Hoogenboom, Laurentius (Ron) [0000-0002-8913-5328], Leblanc, Jean-Charles [0000-0003-2872-3414], Nielsen, Elsa [0000-0002-6874-2575], Ntzani, Evangelia [0000-0003-3712-4181], Petersen, Annette [0000-0003-3996-2701], Sand, Salomon [0000-0002-3360-0534], Vleminckx, Christiane [0000-0002-9928-1601], Barregard, Lars [0000-0002-4662-0841], Ceccatelli, Sandra [0000-0002-9367-8480], Cravedi, Jean-Pierre [0000-0001-9247-7567], Halldorsson, Thorhallur Ingi [0000-0002-3488-0777], Haug,Line Smastuen [0000-0001-6746-6399], Knutsen,Helle Katrine [0000-0003-2041-8917], Roudot, Alain-Claude [0000-0001-5948-5813], Loveren, Henk van [0000-0002-1805-6198], Mackay, Karen [0000-0002-0626-2904], Schwerdtle, Tanja [0000-0002-4873-7488], 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, Vleminckx, Christiane, Wallace, Heather, Barregard, Lars, Ceccatelli, Sandra, Cravedi, Jean-Pierre, Halldorsson, Thorhallur Ingi, Haug,Line Smastuen, Johansson, Niklas, Knutsen,Helle Katrine, Rose, Martin, Roudot, Alain-Claude, Loveren, Henk van, Vollmer, Günter, Mackay, Karen, Riolo, Francesca, and Schwerdtle, Tanja
- Abstract
The European Commission asked EFSA for a scientific evaluation on the risks to human health related to the presence of perfluoroalkyl substances (PFASs) in food. Based on several similar effects in animals, toxicokinetics and observed concentrations in human blood, the CONTAM Panel decided to perform the assessment for the sum of four PFASs: PFOA, PFNA, PFHxS and PFOS. These made up half of the lower bound (LB) exposure to those PFASs with available occurrence data, the remaining contribution being primarily from PFASs with short half-lives. Equal potencies were assumed for the four PFASs included in the assessment. The mean LB exposure in adolescents and adult age groups ranged from 3 to 22, the 95th percentile from 9 to 70 ng/kg body weight (bw) per week. Toddlers and ‘other children’ showed a twofold higher exposure. Upper bound exposure was 4- to 49-fold higher than LB levels, but the latter were considered more reliable. ‘Fish meat’, ‘Fruit and fruit products’ and ‘Eggs and egg products’contributed most to the exposure. Based on available studies in animals and humans, effects on the immune system were considered the most critical for the risk assessment. From a human study, a lowest BMDL10 of 17.5 ng/mL for the sum of the four PFASs in serum was identified for 1-year-old children.Using PBPK modelling, this serum level of 17.5 ng/mL in children was estimated to correspond to longterm maternal exposure of 0.63 ng/kg bw per day. Since accumulation over time is important, a tolerable weekly intake (TWI) of 4.4 ng/kg bw per week was established. This TWI also protects against other potential adverse effects observed in humans. Based on the estimated LB exposure, but also reported serum levels, the CONTAM Panel concluded that parts of the European population exceed this TWI,which is of concern.
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- 2020
29. Risk assessment of glycoalkaloids in feed and food, in particular in potatoes and potato-derived products
- Author
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European Commission, Schrenk, Dieter [0000-0002-7717-5533], Bignami, Margherita [0000-0002-1525-6864], Bodin, Laurent [0000-0001-5671-3139], Del Mazo, Jesús [0000-0003-3269-3895], Hogstrand, Christer [0000-0001-7545-6975], Hoogenboom, Laurentius (Ron) [0000-0002-8913-5328], Leblanc, Jean-Charles [0000-0003-2872-3414], Nielsen, Elsa [0000-0002-6874-2575], Ntzani, Evangelia [0000-0003-3712-4181], Petersen, Annette [0000-0003-3996-2701], Sand, Salomon [0000-0002-3360-0534], Schwerdtle, Tanja [0000-0002-4873-7488], Vleminckx, Christiane [0000-0002-9928-1601], Grasl-Kraupp, Bettina [0000-0003-4889-6531], Schrenk, Dieter, Bignami, Margherita, Bodin, Laurent, Chipman, James Kevin, Del Mazo, Jesús, 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, Brimer, Leon, Cottrill, Bruce, Dusemund, Birgit, Mulder, Patrick, Vollmer, Günter, Binaglia, Marco, Ramos Bordajandi, Luisa, Riolo, Francesca, Roldan-Torres, Ruth, European Commission, Schrenk, Dieter [0000-0002-7717-5533], Bignami, Margherita [0000-0002-1525-6864], Bodin, Laurent [0000-0001-5671-3139], Del Mazo, Jesús [0000-0003-3269-3895], Hogstrand, Christer [0000-0001-7545-6975], Hoogenboom, Laurentius (Ron) [0000-0002-8913-5328], Leblanc, Jean-Charles [0000-0003-2872-3414], Nielsen, Elsa [0000-0002-6874-2575], Ntzani, Evangelia [0000-0003-3712-4181], Petersen, Annette [0000-0003-3996-2701], Sand, Salomon [0000-0002-3360-0534], Schwerdtle, Tanja [0000-0002-4873-7488], Vleminckx, Christiane [0000-0002-9928-1601], Grasl-Kraupp, Bettina [0000-0003-4889-6531], Schrenk, Dieter, Bignami, Margherita, Bodin, Laurent, Chipman, James Kevin, Del Mazo, Jesús, 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, Brimer, Leon, Cottrill, Bruce, Dusemund, Birgit, Mulder, Patrick, Vollmer, Günter, Binaglia, Marco, Ramos Bordajandi, Luisa, Riolo, Francesca, and Roldan-Torres, Ruth
- Abstract
The European Commission asked EFSA for a scientific opinion on the risks for animal and human health related to the presence of glycoalkaloids (GAs) in feed and food. This risk assessment covers edible parts of potato plants and other food plants containing GAs, in particular, tomato and aubergine. In humans, acute toxic effects of potato GAs (a-solanine and a-chaconine) include gastrointestinal symptoms such as nausea, vomiting and diarrhoea. For these effects, the CONTAM Panel identified a lowest-observed-adverse-effect level of 1 mg total potato GAs/kg body weight (bw) per day as a reference point for the risk characterisation following acute exposure. In humans, no evidence of health problems associated with repeated or long-term intake of GAs via potatoes has been identified. No reference point for chronic exposure could be identified from the experimental animal studies. Occurrence data were available only for a-solanine and a-chaconine, mostly for potatoes. The acute dietary exposure to potato GAs was estimated using a probabilistic approach and applying processing factors for food. Due to the limited data available, a margin of exposure (MOE) approach was applied. The MOEs for the younger age groups indicate a health concern for the food consumption surveys with the highest mean exposure, as well as for the P95 exposure in all surveys.For adult age groups, the MOEs indicate a health concern only for the food consumption surveys with the highest P95 exposures. For tomato and aubergine GAs, the risk to human health could not be characterised due to the lack of occurrence data and the limited toxicity data. For horses, farm and companion animals, no risk characterisation for potato GAs could be performed due to insufficient data on occurrence in feed and on potential adverse effects of GAs in these species.
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- 2020
30. Risk assessment of ochratoxin A in food
- Author
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Schrenk, Dieter [0000-0002-7717-5533], Bodin, Laurent [0000-0001-5671-3139], Del Mazo, Jesús [0000-0003-3269-3895], Grasl-Kraupp, Bettina [0000-0003-4889-6531], Hogstrand, Christer [0000-0001-7545-6975], Hoogenboom, Laurentius (Ron) [0000-0002-8913-5328], Leblanc, Jean-Charles [0000-0003-2872-3414], Nielsen, Elsa [0000-0002-6874-2575], Ntzani, Evangelia [0000-0003-3712-4181], Sand, Salomon [0000-0002-3360-0534], Schwerdtle, Tanja [0000-0002-4873-7488], Vleminckx, Christiane [0000-0002-9928-1601], Dall'Asta, Chiara [http://orcid.org/0000-0003-0716-8394], Mally, Angela [https://orcid.org/0000-0002-5013-5080], Bignami, Margherita [0000-0002-1525-6864], Schrenk, Dieter, 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, Vleminckx, Christiane, Wallace, Heather, Alexander, Jan, Dall'Asta, Chiara, Mally, Angela, Metzler, Manfred, Binaglia, Marco, Horvath, Zsuzsanna, Steinkellner, Hans, Bignami, Margherita, Schrenk, Dieter [0000-0002-7717-5533], Bodin, Laurent [0000-0001-5671-3139], Del Mazo, Jesús [0000-0003-3269-3895], Grasl-Kraupp, Bettina [0000-0003-4889-6531], Hogstrand, Christer [0000-0001-7545-6975], Hoogenboom, Laurentius (Ron) [0000-0002-8913-5328], Leblanc, Jean-Charles [0000-0003-2872-3414], Nielsen, Elsa [0000-0002-6874-2575], Ntzani, Evangelia [0000-0003-3712-4181], Sand, Salomon [0000-0002-3360-0534], Schwerdtle, Tanja [0000-0002-4873-7488], Vleminckx, Christiane [0000-0002-9928-1601], Dall'Asta, Chiara [http://orcid.org/0000-0003-0716-8394], Mally, Angela [https://orcid.org/0000-0002-5013-5080], Bignami, Margherita [0000-0002-1525-6864], Schrenk, Dieter, 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, Vleminckx, Christiane, Wallace, Heather, Alexander, Jan, Dall'Asta, Chiara, Mally, Angela, Metzler, Manfred, Binaglia, Marco, Horvath, Zsuzsanna, Steinkellner, Hans, and Bignami, Margherita
- Abstract
The European Commission asked EFSA to update their 2006 opinion on ochratoxin A (OTA) in food. OTA is produced by fungi of the genus Aspergillus and Penicillium and found as a contaminant in various foods. OTA causes kidney toxicity in different animal species and kidney tumours in rodents. OTA is genotoxic both in vitro and in vivo; however, the mechanisms of genotoxicity are unclear. Direct and indirect genotoxic and non-genotoxic modes of action might each contribute to tumour formation. Since recent studies have raised uncertainty regarding the mode of action for kidney carcinogenicity, it is inappropriate to establish a health-based guidance value (HBGV) and a margin of exposure (MOE) approach was applied. For the characterisation of non-neoplastic effects, a BMDL10 of 4.73 lg/kg body weight (bw) per day was calculated from kidney lesions observed in pigs. For characterisation of neoplastic effects, a BMDL10 of 14.5 lg/kg bw per day was calculated from kidney tumours seen in rats. The estimation of chronic dietary exposure resulted in mean and 95th percentile levels ranging from 0.6 to 17.8 and from 2.4 to 51.7 ng/kg bw per day, respectively. Median OTA exposures in breastfed infants ranged from 1.7 to 2.6 ng/kg bw per day, 95th percentile exposures from 5.6 to 8.5 ng/kg bw per day in average/high breast milk consuming infants, respectively. Comparison of exposures with the BMDL10 based on the non-neoplastic endpoint resulted in MOEs of more than 200 in most consumer groups, indicating a low health concern with the exception of MOEs for high consumers in the younger age groups, indicating a possible health concern. When compared with the BMDL10 based on the neoplastic endpoint, MOEs were lower than 10,000 for almost all exposure scenarios, including breastfed infants. This would indicate a possible health concern if genotoxicity is direct. Uncertainty in this assessment is high and risk may be overestimated.
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- 2020
31. Assessment of information as regards the toxicity of fumonisins for pigs, poultry and horses
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Schrenk, Dieter, Bignami, Margherita, Bodin, Laurent, Chipman, James Kevin, del Mazo, Jesús, Grasl-Kraupp, Bettina, Hogstrand, Christer, Leblanc, Jean Charles, Nielsen, Elsa, Ntzani, Evangelia, Petersen, Annette, Sand, Salomon, Schwerdtle, Tanja, Vleminckx, Christiane, Wallace, Heather, Daenicke, Sven, Nebbia, Carlo Stefano, Oswald, Isabelle P., Rovesti, Elena, Steinkellner, Hans, Hoogenboom, Laurentius, Schrenk, Dieter, Bignami, Margherita, Bodin, Laurent, Chipman, James Kevin, del Mazo, Jesús, Grasl-Kraupp, Bettina, Hogstrand, Christer, Leblanc, Jean Charles, Nielsen, Elsa, Ntzani, Evangelia, Petersen, Annette, Sand, Salomon, Schwerdtle, Tanja, Vleminckx, Christiane, Wallace, Heather, Daenicke, Sven, Nebbia, Carlo Stefano, Oswald, Isabelle P., Rovesti, Elena, Steinkellner, Hans, and Hoogenboom, Laurentius
- Abstract
In 2018, the EFSA Panel on Contaminants in the Food Chain (CONTAM) adopted a Scientific Opinion on the risks for animal health related to the presence of fumonisins, their modified forms and hidden forms in feed. A no observed adverse effect level (NOAEL) of 1 mg/kg feed was established for pigs. In poultry a NOAEL of 20 mg/kg feed and in horses a reference point for adverse animal health effect of 8.8 mg/kg feed was established, referred to as NOAEL. The European Commission (EC) requested EFSA to review the information regarding the toxicity of fumonisins for pigs, poultry and horses and to revise, if necessary, the established NOAELs. The EFSA CONTAM Panel considered that the term reference point (RP) for adverse animal health effects better reflects the uncertainties in the available studies. New evidence which had become available since the previous opinion allowed to revise an RP for adverse animal health effects for poultry from 20 mg/kg to 1 mg/kg feed (based on a LOAEL of 2.5 mg/kg feed for reduced intestinal crypt depth) and for horses from 8.8 to 1.0 mg/kg feed (based on case studies on equine leukoencephalomalacia (ELEM)). For pigs, the previously established NOAEL was confirmed as no further studies suitable for deriving an RP for adverse animal health effects could be identified. Based on exposure estimates performed in the previous opinion, the risk of adverse health effects of feeds containing FB1–3 was considered a concern for poultry, when taking into account the RP of 1 mg/kg feed for intestinal effects. For horses and other solipeds, the risk is considered low, although a large uncertainty associated with exposure was identified. The same conclusions apply to the sum of FB1–3 and their hidden forms.
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- 2022
32. Assessment of information as regards the toxicity of T-2 and HT-2 toxin for ruminants
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Schrenk, Dieter, Bignami, Margherita, Bodin, Laurent, Chipman, James Kevin, del Mazo, Jesús, Grasl-Kraupp, Bettina, Hogstrand, Christer, Leblanc, Jean Charles, Nielsen, Elsa, Ntzani, Evangelia, Petersen, Annette, Sand, Salomon, Schwerdtle, Tanja, Vleminckx, Christiane, Wallace, Heather, Daenicke, Sven, Nebbia, Carlo Stefano, Oswald, Isabelle P., Rovesti, Elena, Steinkellner, Hans, Hoogenboom, Laurentius, Schrenk, Dieter, Bignami, Margherita, Bodin, Laurent, Chipman, James Kevin, del Mazo, Jesús, Grasl-Kraupp, Bettina, Hogstrand, Christer, Leblanc, Jean Charles, Nielsen, Elsa, Ntzani, Evangelia, Petersen, Annette, Sand, Salomon, Schwerdtle, Tanja, Vleminckx, Christiane, Wallace, Heather, Daenicke, Sven, Nebbia, Carlo Stefano, Oswald, Isabelle P., Rovesti, Elena, Steinkellner, Hans, and Hoogenboom, Laurentius
- Abstract
In 2011, the EFSA Panel on Contaminants in the Food Chain (CONTAM) adopted a Scientific Opinion on the risks for animal health related to the presence of T-2 (T2) and HT-2 (HT2) toxin in food and feed. No observed adverse effect levels (NOAELs) and lowest observed adverse effect levels (LOAELs) were derived for different animal species. In ruminants a LOAEL was established for the sum of T2 and HT2 of 0.3 mg/kg body weight (bw) per day, based on studies with calves and lambs. The CONTAM Panel noted that the effects observed in nutritionally challenged heifers and ewes give rise to the assumption that rumen detoxification of T2 may not always be complete and therefore effective to prevent adverse effects in ruminants. However, the limited data on the effects of T2 on adult ruminants did not allow a conclusion. The European Commission requested EFSA to review the information regarding the toxicity of T2 and HT2 for ruminants and to revise, if necessary, the established Reference Point (RP). Adverse effect levels of 0.001 and 0.01 mg T2/kg bw per day for, respectively, sheep and cows, were derived from case studies, estimated to correspond to feed concentrations of 0.035 mg T2/kg for sheep and 0.6 mg T2/kg for cows. RPs for adverse animal health effects of 0.01 mg/kg feed for sheep and 0.2 mg/kg feed for cows were established. For goats, the RP for cows was selected, in the absence of data that they are more sensitive. Based on mean exposure estimates performed in the previous Opinion, the risk of adverse health effects of feeds containing T2 and HT2 was considered a concern for lactating sheep. For milking goats, a comparison performed between dietary exposure and the RP derived for cows, indicates a potential risk for adverse health effects. For dairy cows and fattening beef, the risk is considered low.
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- 2022
33. Annex B – Raw data on occurrence of HMF in bee feed
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Schrenk, Dieter, Bignami, Margherita, Bodin, Laurent, Chipman, James, del Mazo, Jesús, Grasl-Kraupp, Bettina, Hogstrand, Christer, Hoogenboom, Laurentius, Leblanc, Jean Charles, Nebbia, Carlo Stefano, Nielsen, Elsa, Ntzani, Evangelia, Petersen, Annette, Schwerdtle, Tanja, Vleminckx, Christiane, Wallace, Heather, Focks, Andreas, Gregorc, Ales, Metzler, Manfred, Sgolastra, Fabio, Tosi, Simone, Horvath, Zsuzsanna, Ippolito, Alessio, Rortais, Agnes, Steinkellner, Hans, Szentes, Csaba, Sand, Salomon, Schrenk, Dieter, Bignami, Margherita, Bodin, Laurent, Chipman, James, del Mazo, Jesús, Grasl-Kraupp, Bettina, Hogstrand, Christer, Hoogenboom, Laurentius, Leblanc, Jean Charles, Nebbia, Carlo Stefano, Nielsen, Elsa, Ntzani, Evangelia, Petersen, Annette, Schwerdtle, Tanja, Vleminckx, Christiane, Wallace, Heather, Focks, Andreas, Gregorc, Ales, Metzler, Manfred, Sgolastra, Fabio, Tosi, Simone, Horvath, Zsuzsanna, Ippolito, Alessio, Rortais, Agnes, Steinkellner, Hans, Szentes, Csaba, and Sand, Salomon
- Abstract
HMF_raw_occurrence_zenodo.CSV contains the raw occurrence dataset on hydroxymethylfurfural (HMF) contaminant as extracted from EFSA DWH in August 2021 on 219 samples of bee feed 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)., HMF_raw_occurrence_zenodo.CSV contains the raw occurrence dataset on hydroxymethylfurfural (HMF) contaminant as extracted from EFSA DWH in August 2021 on 219 samples of bee feed 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).
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- 2022
34. Risk assessment of N‐nitrosamines in food.
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Schrenk, Dieter, Bignami, Margherita, Bodin, Laurent, Chipman, James Kevin, del Mazo, Jesús, Hogstrand, Christer, Hoogenboom, Laurentius, Leblanc, Jean‐Charles, Nebbia, Carlo Stefano, Nielsen, Elsa, Ntzani, Evangelia, Petersen, Annette, Sand, Salomon, Schwerdtle, Tanja, Vleminckx, Christiane, Wallace, Heather, Romualdo, Benigni, Cristina, Fortes, Stephen, Hecht, and Marco, Iammarino
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HEALTH attitudes ,RISK assessment ,SMOKELESS tobacco ,CENSORING (Statistics) ,CONFIDENCE intervals ,AGE groups - Abstract
EFSA was asked for a scientific opinion on the risks to public health related to the presence of N‐nitrosamines (N‐NAs) in food. The risk assessment was confined to those 10 carcinogenic N‐NAs occurring in food (TCNAs), i.e. NDMA, NMEA, NDEA, NDPA, NDBA, NMA, NSAR, NMOR, NPIP and NPYR. N‐NAs are genotoxic and induce liver tumours in rodents. The in vivo data available to derive potency factors are limited, and therefore, equal potency of TCNAs was assumed. The lower confidence limit of the benchmark dose at 10% (BMDL10) was 10 μg/kg body weight (bw) per day, derived from the incidence of rat liver tumours (benign and malignant) induced by NDEA and used in a margin of exposure (MOE) approach. Analytical results on the occurrence of N‐NAs were extracted from the EFSA occurrence database (n = 2,817) and the literature (n = 4,003). Occurrence data were available for five food categories across TCNAs. Dietary exposure was assessed for two scenarios, excluding (scenario 1) and including (scenario 2) cooked unprocessed meat and fish. TCNAs exposure ranged from 0 to 208.9 ng/kg bw per day across surveys, age groups and scenarios. 'Meat and meat products' is the main food category contributing to TCNA exposure. MOEs ranged from 3,337 to 48 at the P95 exposure excluding some infant surveys with P95 exposure equal to zero. Two major uncertainties were (i) the high number of left censored data and (ii) the lack of data on important food categories. The CONTAM Panel concluded that the MOE for TCNAs at the P95 exposure is highly likely (98–100% certain) to be less than 10,000 for all age groups, which raises a health concern. [ABSTRACT FROM AUTHOR]
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- 2023
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35. Risks for human health related to the presence of grayanotoxins in certain honey.
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Schrenk, Dieter, Bignami, Margherita, Bodin, Laurent, Chipman, James Kevin, del Mazo, Jesús, Grasl‐Kraupp, Bettina, Hogstrand, Christer, Hoogenboom, Laurentius, Leblanc, Jean‐Charles, Nebbia, Carlo Stefano, Nielsen, Elsa, Ntzani, Evangelia, Petersen, Annette, Sand, Salomon, Schwerdtle, Tanja, Vleminckx, Christiane, Dusemund, Birgit, Hart, Andrew, Mulder, Patrick, and Viviani, Barbara
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HONEY ,HEART beat ,RESPIRATORY insufficiency ,CARDIOVASCULAR system ,FIREPROOFING agents ,NERVOUS system - Abstract
The European Commission asked EFSA for a scientific opinion on the risks for human health of the presence of grayanotoxins (GTXs) in 'certain honey' from Ericaceae plants. The risk assessment included all structurally related grayananes occurring with GTXs in 'certain' honey. Oral exposure is associated with acute intoxication in humans. Acute symptoms affect the muscles, nervous and cardiovascular systems. These may lead to complete atrioventricular block, convulsions, mental confusion, agitation, syncope and respiratory depression. For acute effects, the CONTAM Panel derived a reference point (RP) of 15.3 μg/kg body weight for the sum of GTX I and III based on a BMDL10 for reduced heart rate in rats. A similar relative potency was considered for GTX I. Without chronic toxicity studies, an RP for long‐term effects could not be derived. There is evidence for genotoxicity in mice exposed to GTX III or honey containing GTX I and III, showing increased levels of chromosomal damage. The mechanism of genotoxicity is unknown. Without representative occurrence data for the sum of GTX I and III and consumption data from Ericaceae honey, acute dietary exposure was estimated based on selected concentrations for GTX I and III reflecting concentrations measured in 'certain' honeys. Applying a margin of exposure (MOE) approach, the estimated MOEs raised health concerns for acute toxicity. The Panel calculated the highest concentrations for GTX I and III below which no acute effects would be expected following 'certain honey' consumption. The Panel is 75% or more certain that the calculated highest concentration of 0.05 mg for the sum of GTX I and III per kg honey is protective for all age groups regarding acute intoxications. This value does not consider other grayananes in 'certain honey' and does not cover the identified genotoxicity. [ABSTRACT FROM AUTHOR]
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- 2023
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36. Evaluation of the types, efficient use and health risks of application of silver-based biocides to provide antimicrobial properties to face masks applied during the Covid-19 crisis
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Mast, Jan, Blaude, Marie-Noëlle, Siciliani, Lisa, Cheyns, Karlien, Waegeneers, Nadia, Vleminckx, Christiane, Van Loco, Joris, and Verleysen, Eveline
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face mask ,COVID-19 ,nanomaterials - Published
- 2022
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37. Guidance on aneugenicity assessment
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EFSA Scientific Committee (SC), More, Simon John, Bampidis, Vasileios, Bragard, Claude, Halldorsson, Thorhallur Ingi, Hernández-Jerez, Antonio F, Hougaard Bennekou, Susanne, Koutsoumanis, Kostas, Lambré, Claude, Machera, Kyriaki, Naegeli, Hanspeter, Nielsen, Søren Saxmose, Schlatter, Josef, Schrenk, Dieter, Turck, Dominique, Younes, Maged, Aquilina, Gabriele, Bignami, Margherita, Bolognesi, Claudia, Crebelli, Riccardo, Gürtler, Rainer, Marcon, Francesca, Nielsen, Elsa, Vleminckx, Christiane, Carfì, Maria, Martino, Carla, Maurici, Daniela, Parra Morte, Juan, Rossi, Annamaria, Benford, Diane, and University of Zurich
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Veterinary (miscellaneous) ,Aneugenicity ,2405 Parasitology ,TP1-1185 ,Genotoxicity in vivo and in vitro ,Plant Science ,Gene mutation ,Bioinformatics ,Microbiology ,Clastogen ,In vitro ,Micronucleus test ,1110 Plant Science ,In vivo ,medicine ,TX341-641 ,1106 Food Science ,Nutrition. Foods and food supply ,business.industry ,Chemical technology ,Cros1223 ,genotoxicity in vivo and in vitro ,2404 Microbiology ,10079 Institute of Veterinary Pharmacology and Toxicology ,aneugenicity ,3401 Veterinary (miscellaneous) ,micronucleus test ,Scientific Opinion ,medicine.anatomical_structure ,570 Life sciences ,biology ,Animal Science and Zoology ,Parasitology ,Bone marrow ,1103 Animal Science and Zoology ,Genotoxicity ,business ,Risk assessment ,Food Science - Abstract
The EFSA Scientific Committee was asked to provide guidance on the most appropriate in vivo tests to follow up on positive in vitro results for aneugenicity, and on the approach to risk assessment for substances that are aneugenic but not clastogenic nor causing gene mutations. The Scientific Committee confirmed that the preferred approach is to perform an in vivo mammalian erythrocyte micronucleus test with a relevant route of administration. If this is positive, it demonstrates that the substance is aneugenic in vivo. A negative result with evidence that the bone marrow is exposed to the test substance supports a conclusion that aneugenic activity is not expressed in vivo. If there is no evidence of exposure to the bone marrow, a negative result is viewed as inconclusive and further studies are required. The liver micronucleus assay, even though not yet fully validated, can provide supporting information for substances that are aneugenic following metabolic activation. The gastrointestinal micronucleus test, conversely, to be further developed, may help to assess aneugenic potential at the initial site of contact for substances that are aneugenic in vitro without metabolic activation. Based on the evidence in relation to mechanisms of aneugenicity, the Scientific Committee concluded that, in principle, health‐based guidance values can be established for substances that are aneugenic but not clastogenic nor causing gene mutations, provided that a comprehensive toxicological database is available. For situations in which the toxicological database is not sufficient to establish health‐based guidance values, some approaches to risk assessment are proposed. The Scientific Committee recommends further development of the gastrointestinal micronucleus test, and research to improve the understanding of aneugenicity to support risk assessment., This publication is linked to the following EFSA Supporting Publications article: http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2021.EN-6814/full
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- 2021
38. Scientific opinion on the risks for animal and human health related to the presence of quinolizidine alkaloids in feed and food, in particular in lupins and lupin-derived products
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Schrenk, Dieter [0000-0002-7717-5533], Bodin, Laurent [0000-0001-5671-3139], Del Mazo, Jesús [0000-0003-3269-3895], Grasl-Kraupp, Bettina [0000-0003-4889-6531], Hogstrand, Christer [0000-0001-7545-6975], Hoogenboom, Laurentius (Ron) [0000-0002-8913-5328], Leblanc, Jean-Charles [0000-0003-2872-3414], Nielsen, Elsa [0000-0002-6874-2575], Ntzani, Evangelia [0000-0003-3712-4181], Sand, Salomon [0000-0002-3360-0534], Schwerdtle, Tanja [0000-0002-4873-7488], Vleminckx, Christiane [0000-0002-9928-1601], Arcella, Davide [https://orcid.org/0000-0003-3179-1426], Cascio, Claudia [0000-0002-3810-4134], Bignami, Margherita [0000-0002-1525-6864], Schrenk, Dieter, 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, Vleminckx, Christiane, Wallace, Heather, Alexander, Jan, Cottrill, Bruce, Dusemund, Birgit, Mulder, Patrick, Arcella, Davide, Baert, Katleen, Cascio, Claudia, Steinkellner, Hans, Bignami, Margherita, Schrenk, Dieter [0000-0002-7717-5533], Bodin, Laurent [0000-0001-5671-3139], Del Mazo, Jesús [0000-0003-3269-3895], Grasl-Kraupp, Bettina [0000-0003-4889-6531], Hogstrand, Christer [0000-0001-7545-6975], Hoogenboom, Laurentius (Ron) [0000-0002-8913-5328], Leblanc, Jean-Charles [0000-0003-2872-3414], Nielsen, Elsa [0000-0002-6874-2575], Ntzani, Evangelia [0000-0003-3712-4181], Sand, Salomon [0000-0002-3360-0534], Schwerdtle, Tanja [0000-0002-4873-7488], Vleminckx, Christiane [0000-0002-9928-1601], Arcella, Davide [https://orcid.org/0000-0003-3179-1426], Cascio, Claudia [0000-0002-3810-4134], Bignami, Margherita [0000-0002-1525-6864], Schrenk, Dieter, 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, Vleminckx, Christiane, Wallace, Heather, Alexander, Jan, Cottrill, Bruce, Dusemund, Birgit, Mulder, Patrick, Arcella, Davide, Baert, Katleen, Cascio, Claudia, Steinkellner, Hans, and Bignami, Margherita
- Abstract
The European Commission asked EFSA for a scientific opinion on the risks for animal and human health related to the presence of quinolizidine alkaloids (QAs) in feed and food. This risk assessment is limited to QAs occurring in Lupinus species/varieties relevant for animal and human consumption in Europe (i.e. Lupinus albus L., Lupinus angustifolius L., Lupinus luteus L. and Lupinus mutabilis Sweet). Information on the toxicity of QAs in animals and humans is limited. Following acute exposure to sparteine (reference compound), anticholinergic effects and changes in cardiac electric conductivity are considered to be critical for human hazard characterisation. The CONTAM Panel used a margin of exposure (MOE) approach identifying a lowest single oral effective dose of 0.16 mg sparteine/kg body weight as reference point to characterise the risk following acute exposure. No reference point could be identified to characterise the risk of chronic exposure. Because of similar modes of action for QAs, the CONTAM Panel used a group approach assuming dose additivity. For food, the highest mean concentration of Total QAs (TotQAs) (i.e. the 6 most abundant QAs) was found in lupin seed samples classified as ‘Lupins (dry) and similar-’. Due to the limited data on occurrence and consumption, dietary exposure was calculated for some specific scenarios and no full human health risk characterisation was possible. The calculated margin of exposures (MOEs) may indicate a risk for some consumers. For example, when lupin seeds are consumed without a debittering step, or as debittered lupin seeds high in QA content and when ‘lupin-based meat imitates’ are consumed. For horses, companion and farm animals, other than salmonids, the available database on adverse effects was too limited to identify no-observed-adverse-effect levels and/or lowest-observed-adverse-effect levels and no risk characterisation was possible. For salmonids, the CONTAM Panel considers the risk for adverse effects to be
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- 2019
39. Evaluation of calcium lignosulfonate as a acceptable previous cargo for edible fats and oils
- Author
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Schrenk, Dieter [0000-0002-7717-5533], Bignami, Margherita [0000-0002-1525-6864], Bodin, Laurent [0000-0001-5671-3139], Del Mazo, Jesús [0000-0003-3269-3895], Grasl-Kraupp, Bettina [0000-0003-4889-6531], Hogstrand, Christer [0000-0001-7545-6975], Hoogenboom, Laurentius (Ron) [0000-0002-8913-5328], Leblanc, Jean-Charles [0000-0003-2872-3414], Nielsen, Elsa [0000-0002-6874-2575], Ntzani, Evangelia [0000-0003-3712-4181], Sand, Salomon [0000-0002-3360-0534], Schwerdtle, Tanja [0000-0002-4873-7488], Vleminckx, Christiane [0000-0002-9928-1601], 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, Grob, Konrad, Castle, Laurence, Christodoulidou, Anna, Vleminckx, Christiane, Schrenk, Dieter [0000-0002-7717-5533], Bignami, Margherita [0000-0002-1525-6864], Bodin, Laurent [0000-0001-5671-3139], Del Mazo, Jesús [0000-0003-3269-3895], Grasl-Kraupp, Bettina [0000-0003-4889-6531], Hogstrand, Christer [0000-0001-7545-6975], Hoogenboom, Laurentius (Ron) [0000-0002-8913-5328], Leblanc, Jean-Charles [0000-0003-2872-3414], Nielsen, Elsa [0000-0002-6874-2575], Ntzani, Evangelia [0000-0003-3712-4181], Sand, Salomon [0000-0002-3360-0534], Schwerdtle, Tanja [0000-0002-4873-7488], Vleminckx, Christiane [0000-0002-9928-1601], 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, Grob, Konrad, Castle, Laurence, Christodoulidou, Anna, and Vleminckx, Christiane
- Abstract
Shipping of edible fats and oils into Europe is permitted in bulk tanks, provided that the previous cargo is included in a positive list. The European Commission requested EFSA to evaluate the acceptability of calcium lignosulfonate as previous cargo for fats and oils. The evaluation was based on the same criteria as those used for the evaluation of the substances currently on the list in the Annex to Commission Directive 96/3/EC as a acceptable previous cargoes for edible fats and oils. In 2017, the EFSA Panel on Contaminants in the Food Chain (CONTAM Panel) concluded that calcium lignosulfonate did not meet the acceptability criteria, due to uncertainties as regards the composition and toxicity of its low-molecular weight fraction (LMWF) below 1,000 Da. In the current evaluation, new information, showing lack of genotoxicity of the LMWF isolated from a technical grade of calcium lignosulfonate was provided. Due to uncertainties regarding the presence of lignosulfonate components below 200 Da in this LMWF tested for genotoxicity, the CONTAM Panel concluded that the information provided was insufficient to assess the acceptability of calcium lignosulfonate as previous cargo. The Panel recommends a better analysis of the LMWF and a new genotoxicity test using this LMWF, including components < 200 Da, and evidence that the tested material is representative of the LMWF in products intended to be shipped as previous cargo for edible fat and oils.
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- 2019
40. Risk assessment of chlorinated paraffins in feed and food
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European Commission, Schrenk, Dieter [0000-0002-7717-5533], Bodin, Laurent [0000-0001-5671-3139], Del Mazo, Jesús [0000-0003-3269-3895], Grasl-Kraupp, Bettina [0000-0003-4889-6531], Hogstrand, Christer [0000-0001-7545-6975], Hoogenboom, Laurentius (Ron) [0000-0002-8913-5328], Leblanc, Jean-Charles [0000-0003-2872-3414], Ntzani, Evangelia [0000-0003-3712-4181], Sand, Salomon [0000-0002-3360-0534], Schwerdtle, Tanja [0000-0002-4873-7488], Vleminckx, Christiane [0000-0002-9928-1601], Leonards, Pim [0000-0002-3052-8848], Nielsen, Elsa [0000-0002-6874-2575], Bignami, Margherita [0000-0002-1525-6864], 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, Brüschweiler, Beat, Leonards, Pim, Rose, Martin, Binaglia, Marco, Horvath, Zsuzsanna, Bordajandi, Luisa R., Nielsen, Elsa, European Commission, Schrenk, Dieter [0000-0002-7717-5533], Bodin, Laurent [0000-0001-5671-3139], Del Mazo, Jesús [0000-0003-3269-3895], Grasl-Kraupp, Bettina [0000-0003-4889-6531], Hogstrand, Christer [0000-0001-7545-6975], Hoogenboom, Laurentius (Ron) [0000-0002-8913-5328], Leblanc, Jean-Charles [0000-0003-2872-3414], Ntzani, Evangelia [0000-0003-3712-4181], Sand, Salomon [0000-0002-3360-0534], Schwerdtle, Tanja [0000-0002-4873-7488], Vleminckx, Christiane [0000-0002-9928-1601], Leonards, Pim [0000-0002-3052-8848], Nielsen, Elsa [0000-0002-6874-2575], Bignami, Margherita [0000-0002-1525-6864], 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, Brüschweiler, Beat, Leonards, Pim, Rose, Martin, Binaglia, Marco, Horvath, Zsuzsanna, Bordajandi, Luisa R., and Nielsen, Elsa
- Abstract
The European Commission asked EFSA for a scientific opinion on the risks for animal and human health related to the presence of chlorinated paraffins in feed and food. The data for experimental animals were reviewed and the CONTAM Panel identified the liver, kidney and thyroid as the target organs for the SCCP and MCCP mixtures tested in repeated dose toxicity studies. Decreased pup survival and subcutaneous haematoma/haemorrhage were also identified as critical effects for an MCCP mixture. For the LCCP mixtures tested, the liver was identified as the target organ. The Panel selected as reference points a BMDL10 of 2.3 mg/kg bw per day for increased incidence of nephritis in male rats, and of 36 mg/kg bw per day for increased relative kidney weights in male and female rats for SCCPs and MCCPs, respectively. For LCCPs, a reference point relevant for humans could not be identified. Due to the limitations in the toxicokinetic and toxicological database, the Panel concluded that derivation of a health-based guidance value was not appropriate. Only limited data on the occurrence of SCCPs and MCCPs in some fish species were submitted to EFSA. No data were submitted for LCCPs. Thus, a robust exposure assessment and consequently a complete risk characterisation could not be performed. A preliminary risk characterisation based only on the consumption of fish was performed, and the calculated margins of exposure suggested no health concern for this limited scenario. The Panel noted that dietary exposure will be higher due to the contribution of CPs from other foods. The Panel was not able to identify reference points for farm animals, horses and companion animals. No occurrence data for feed were submitted to EFSA.Therefore, no risk characterisation could be performed for any of these animal species.
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- 2019
41. Technical Report on the request for technical assistance in relation to the safety of hydroxyanthracene derivatives.
- Author
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Aquilina, Gabriele, Bignami, Margherita, Bolognesi, Claudia, Crebelli, Riccardo, Dusinska, Maria, Gürtler, Rainer, Marcon, Francesca, Nielsen, Elsa, Schlatter, Josef, Vleminckx, Christiane, Nathanail, Alexis V, and Benford, Diane
- Subjects
TECHNICAL assistance ,DNA damage - Abstract
In accordance with Article 31 of Regulation (EC) No 178/2002, the European Commission asked EFSA to provide technical assistance in the context of its 'Opinion on the safety of hydroxyanthracene derivatives for use in food' (EFSA ANS Panel, 2018). In this regard, EFSA was asked to assess whether the data from two new scientific publications presented by the Italian Society of Toxicology were sufficient to revise the conclusions of EFSA on the safety of hydroxyanthracene derivatives for use in food. The scientific publications under assessment were two in vivo comet assays in mice conducted on Aloe‐emodin and dried whole Aloe ferox juice, respectively. The results of the study with aloe‐emodin were considered inconclusive for the induction of DNA strand breaks with the standard comet assay protocol. Results obtained with the modified comet assay protocol with a lesion‐specific enzyme (hOGG1) suggest that aloe‐emodin can induce oxidative DNA damage in colon cells in vivo. The lack of DNA damage observed in the study on Aloe ferox juice was considered of low relevance with respect to the genotoxicity of hydroxyanthracene derivatives, because of the low concentrations of hydroxyanthracene derivatives and the potential counteracting effect of other components present in the juice (e.g. antioxidants). Based on the available evidence, EFSA concluded that the new information presented does not justify a revision of the conclusions of the EFSA ANS Panel Opinion on hydroxyanthracene derivatives. [ABSTRACT FROM AUTHOR]
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- 2022
- Full Text
- View/download PDF
42. Identification, physicochemical characterisation and preliminary risk analysis of titanium dioxide particles in face masks
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Mast, Jan, Blaude, Marie-No��lle, Siciliana, Lisa, Cheyns, Karlien, Waegeneers, Nadia, Van Loco, Joris, Vleminckx, Christiane, and Verleysen, Eveline
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- 2021
- Full Text
- View/download PDF
43. Evaluation of the shucking of certain species of scallops contaminated with lipophilic toxins with a view to the production of edible parts meeting the safety requirements foreseen in the Union legislation
- Author
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Schrenk, Dieter, Bignami, Margherita, Bodin, Laurent, Chipman, Kevin James, del Mazo, Jesús, Grasl-Kraupp, Bettina, Hogstrand, Christer, Leblanc, Jean Charles, Nebbia, Carlo Stefano, Nielsen, Elsa, Ntzani, Evangelia, Petersen, Annette, Sand, Salomon, Schwerdtle, Tanja, Vleminckx, Christiane, Wallace, Heather, Martinez, Ana Gago, Gerssen, Arjen, Tubaro, Aurelia, Cascio, Claudia, Abrahantes, José Cortiñas, Steinkellner, Hans, Hoogenboom, Laurentius, Schrenk, Dieter, Bignami, Margherita, Bodin, Laurent, Chipman, Kevin James, del Mazo, Jesús, Grasl-Kraupp, Bettina, Hogstrand, Christer, Leblanc, Jean Charles, Nebbia, Carlo Stefano, Nielsen, Elsa, Ntzani, Evangelia, Petersen, Annette, Sand, Salomon, Schwerdtle, Tanja, Vleminckx, Christiane, Wallace, Heather, Martinez, Ana Gago, Gerssen, Arjen, Tubaro, Aurelia, Cascio, Claudia, Abrahantes, José Cortiñas, Steinkellner, Hans, and Hoogenboom, Laurentius
- Abstract
The file contains the raw occurrence dataset on lipophilic toxins as extracted from EFSA DWH on 9 June 2020 on 16,845 analytical results presented in the opinion as described in its section 1.3.2. 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: action) 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”., The file contains the raw occurrence dataset on lipophilic toxins as extracted from EFSA DWH on 9 June 2020 on 16,845 analytical results presented in the opinion as described in its section 1.3.2. 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: action) 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”.
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- 2021
44. Evaluation of the shucking of certain species of scallops contaminated with domoic acid with a view to the production of edible parts meeting the safety requirements foreseen in the Union legislation
- Author
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Schrenk, Dieter, Bignami, Margherita, Bodin, Laurent, Chipman, Kevin James, del Mazo, Jesús, Grasl-Kraupp, Bettina, Hogstrand, Christer, Leblanc, Jean Charles, Nebbia, Carlo Stefano, Nielsen, Elsa, Ntzani, Evangelia, Petersen, Annette, Sand, Salomon, Schwerdtle, Tanja, Vleminckx, Christiane, Wallace, Heather, Martinez, Ana Gago, Gerssen, Arjen, Tubaro, Aurelia, Cascio, Claudia, Abrahantes, José Cortiñas, Steinkellner, Hans, Hoogenboom, Laurentius, Schrenk, Dieter, Bignami, Margherita, Bodin, Laurent, Chipman, Kevin James, del Mazo, Jesús, Grasl-Kraupp, Bettina, Hogstrand, Christer, Leblanc, Jean Charles, Nebbia, Carlo Stefano, Nielsen, Elsa, Ntzani, Evangelia, Petersen, Annette, Sand, Salomon, Schwerdtle, Tanja, Vleminckx, Christiane, Wallace, Heather, Martinez, Ana Gago, Gerssen, Arjen, Tubaro, Aurelia, Cascio, Claudia, Abrahantes, José Cortiñas, Steinkellner, Hans, and Hoogenboom, Laurentius
- Abstract
DomoicAcid_Raw_Occurrence_Data.CSV contains the raw occurrence dataset on Domoic Acid contaminant in scallops as extracted from EFSA DWH on the 9 June 2020, 16,369 samples presented in the opinion as described in its section 1.3.2. 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_ DomoicAcid: Table of contents Table A1: Description of FoodEx2 codes used to describe scallop species and their anatomical parts Table A2: Data cleaning steps applied to occurrence data on domoic acid in scallops Table A3: Percentage of Left-Censored data and descriptive statistics for Limits of detection (LODs) and Limits of quantification (LOQs) for domoic acid in scallops (mg/kg) Table A4: Descriptive statistics for domoic acid in scallops (mg/kg) as reported in the cleaned database (statistics weighted by number of units per sample) Table A5: Descriptive statistics of body tissue weights (g) of scallops as submitted by data providers, DomoicAcid_Raw_Occurrence_Data.CSV contains the raw occurrence dataset on Domoic Acid contaminant in scallops as extracted from EFSA DWH on the 9 June 2020, 16,369 samples presented in the opinion as described in its section 1.3.2. 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_ DomoicAcid Table of contents Table A1 Description of FoodEx2 codes used to describe scallop species and their anatomical parts Table A2 Data cleaning steps applied to occurrence data on domoic acid in scallops Table A3 Percentage of Left-Censored data and descriptive statistics for Limits of detection (LODs) and Limits of quantification (LOQs) for domoic acid in scallops (mg/kg) Table A4 Descriptive statistics for domoic acid in scallops (mg/kg) as reported in the cleaned database (statistics weighted by number of units per sample) Table A5 Descriptive statistics of body tissue weights (g) of scallops as submitted by data providers
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- 2021
45. Update of the risk assessment of hexabromocyclododecanes (HBCDDs) in food: Occurrence data in food submitted to EFSA and dietary exposure assessment for humans
- Author
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Schrenk, Dieter, Bignami, Margherita, Bodin, Laurent, Chipman, James Kevin, del Mazo, Jesús, Grasl-Kraupp, Bettina, Hogstrand, Christer, Hoogenboom, Laurentius, 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, Nikolič, Marina, Bordajandi, Luisa Ramos, Vleminckx, Christiane, Schrenk, Dieter, Bignami, Margherita, Bodin, Laurent, Chipman, James Kevin, del Mazo, Jesús, Grasl-Kraupp, Bettina, Hogstrand, Christer, Hoogenboom, Laurentius, 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, Nikolič, Marina, Bordajandi, Luisa Ramos, and Vleminckx, Christiane
- Abstract
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, 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: outcom
- Published
- 2021
46. Evaluation of the shucking of certain species of scallops contaminated with lipophilic toxins with a view to the production of edible parts meeting the safety requirements foreseen in the Union legislation - Summary statistics on occurrence and consumption data and exposure assessment results
- Author
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European Commission, EFSA CONTAM Panel, Schrenk, Dieter, Bignami, Margherita, Bodin, Laurent, Chipman, James Kevin, Del Mazo, Jesús, Grasl-Kraupp, Bettina, Hogstrand, Christer, Leblanc, Jean-Charles, Nebbia, Carlo Stefano, Nielsen, Elsa, Ntzani, Evangelia, Petersen, Annette, Sand, Salomon, Schwerdtle, Tanja, Vleminckx, Christiane, Wallace, Heather, Martinez, Ana Gago, Gerssen, Arjen, Tubaro, Aurelia, Cascio, Claudia, Cortiñas Abrahantes, José, Steinkellner, Hans, Hoogenboom, Laurentius (Ron), European Commission, EFSA CONTAM Panel, Schrenk, Dieter, Bignami, Margherita, Bodin, Laurent, Chipman, James Kevin, Del Mazo, Jesús, Grasl-Kraupp, Bettina, Hogstrand, Christer, Leblanc, Jean-Charles, Nebbia, Carlo Stefano, Nielsen, Elsa, Ntzani, Evangelia, Petersen, Annette, Sand, Salomon, Schwerdtle, Tanja, Vleminckx, Christiane, Wallace, Heather, Martinez, Ana Gago, Gerssen, Arjen, Tubaro, Aurelia, Cascio, Claudia, Cortiñas Abrahantes, José, Steinkellner, Hans, and Hoogenboom, Laurentius (Ron)
- Abstract
The file contains the raw occurrence dataset on lipophilic toxins as extracted from EFSA DWH on 9 June 2020 on 16,845 analytical results presented in the opinion as described in its section 1.3.2. 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: action) to address the issue (e.g. delete record or update values in specific fields).
- Published
- 2021
47. Update of the risk assessment of hexabromocyclododecanes (HBCDDs) in food: Occurrence data in food submitted to EFSA and dietary exposure assessment for humans
- Author
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European Commission, 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, European Commission, 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, and Vleminckx, Christiane
- Published
- 2021
48. Evaluation of the shucking of certain species of scallops contaminated with domoic acid with a view to the production of edible parts meeting the safety requirements foreseen in the Union legislation - Summary statistics on occurrence and consumption data and exposure assessment results
- Author
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European Commission, EFSA CONTAM Panel, Schrenk, Dieter, Bignami, Margherita, Bodin, Laurent, Chipman, James Kevin, Del Mazo, Jesús, Grasl-Kraupp, Bettina, Hogstrand, Christer, Leblanc, Jean-Charles, Nebbia, Carlo Stefano, Nielsen, Elsa, Ntzani, Evangelia, Petersen, Annette, Sand, Salomon, Schwerdtle, Tanja, Vleminckx, Christiane, Wallace, Heather, Martinez, Ana Gago, Gerssen, Arjen, Tubaro, Aurelia, Cascio, Claudia, Cortiñas Abrahantes, José, Steinkellner, Hans, Hoogenboom, Laurentius (Ron), European Commission, EFSA CONTAM Panel, Schrenk, Dieter, Bignami, Margherita, Bodin, Laurent, Chipman, James Kevin, Del Mazo, Jesús, Grasl-Kraupp, Bettina, Hogstrand, Christer, Leblanc, Jean-Charles, Nebbia, Carlo Stefano, Nielsen, Elsa, Ntzani, Evangelia, Petersen, Annette, Sand, Salomon, Schwerdtle, Tanja, Vleminckx, Christiane, Wallace, Heather, Martinez, Ana Gago, Gerssen, Arjen, Tubaro, Aurelia, Cascio, Claudia, Cortiñas Abrahantes, José, Steinkellner, Hans, and Hoogenboom, Laurentius (Ron)
- Abstract
DomoicAcid_Raw_Occurrence_Data.CSV contains the raw occurrence dataset on Domoic Acid contaminant in scallops as extracted from EFSA DWH on the 9 June 2020, 16,369 samples presented in the opinion as described in its section 1.3.2. 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).
- Published
- 2021
49. Assessment of an application on a detoxification process of groundnut press cake for aflatoxins by ammoniation
- Author
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Schrenk, Dieter, Bignami, Margherita, Bodin, Laurent, Chipman, James Kevin, del Mazo, Jesus, Grasl-Kraupp, Bettina, Hoogenboom, Laurentius, Leblanc, Jean Charles, Nebbia, Carlo Stefano, Nielsen, Elsa, Ntzani, Evangelia, Petersen, Annette, Sand, Salomon, Schwerdtle, Tanja, Vleminckx, Christiane, Wallace, Heather, Rose, Martin, Cottrill, Bruce, Lundebye, Anne Katrine, Metzler, Manfred, Christodoulidou, Anna, Hogstrand, Christer, Schrenk, Dieter, Bignami, Margherita, Bodin, Laurent, Chipman, James Kevin, del Mazo, Jesus, Grasl-Kraupp, Bettina, Hoogenboom, Laurentius, Leblanc, Jean Charles, Nebbia, Carlo Stefano, Nielsen, Elsa, Ntzani, Evangelia, Petersen, Annette, Sand, Salomon, Schwerdtle, Tanja, Vleminckx, Christiane, Wallace, Heather, Rose, Martin, Cottrill, Bruce, Lundebye, Anne Katrine, Metzler, Manfred, Christodoulidou, Anna, and Hogstrand, Christer
- Abstract
Following a request from the European Commission, the EFSA Panel on Contaminants in the Food Chain (CONTAM) provided a scientific opinion on an application for a detoxification process of groundnut press cake for aflatoxins by ammoniation. Specifically, it is required that the feed decontamination process is compliant with the acceptability criteria specified in the Commission Regulation (EU) 2015/786 of 19 May 2015. The CONTAM Panel assessed the data provided by the feed business operator with respect to the efficacy of the process to remove the contaminant from groundnut press cake batches and on information demonstrating that the process does not adversely affect the characteristics and the nature of the product. Although according to the literature the process may be able to reduce aflatoxin levels below the legal limits, the Panel concluded that the proposed decontamination process, on the basis of the experimental data submitted by the feed business operator, cannot be confirmed for compliance with the acceptability criteria provided for in Commission Regulation (EU) 2015/786 of 19 May 2015. The Panel recommended sufficient sample testing before and after the process, under the selected conditions, to ensure that the process is reproducible and reliable and to demonstrate that the detoxification is not reversible. In addition, genotoxicity testing of extracts of the treated feedingstuff and of the identified degradation products would be necessary. Finally, information on the transfer rate of AFB1 to AFM1 excretion in milk for animals fed the ammoniated product, in comparison to the starting material and on the ammoniation process changes of the nutritional values of the feed material should be provided.
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- 2021
50. Guidance on aneugenicity assessment
- Author
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EFSA Scientific Committee, More, Simon John, Bampidis, Vasileios, Bragard, Claude, Halldorsson, Thorhallur Ingi, Hernández-Jerez, Antonio F, Hougaard Bennekou, Susanne, Koutsoumanis, Kostas, Lambré, Claude, Machera, Kyriaki, Naegeli, Hanspeter, Nielsen, Søren Saxmose, Schlatter, Josef, Schrenk, Dieter, Turck, Dominique, Younes, Maged, Aquilina, Gabriele, Bignami, Margherita, Bolognesi, Claudia, Crebelli, Riccardo, Gürtler, Rainer, Marcon, Francesca, Nielsen, Elsa, Vleminckx, Christiane, Carfì, Maria, Martino, Carla, Maurici, Daniela, Parra Morte, Juan, Rossi, Annamaria, Benford, Diane, EFSA Scientific Committee, More, Simon John, Bampidis, Vasileios, Bragard, Claude, Halldorsson, Thorhallur Ingi, Hernández-Jerez, Antonio F, Hougaard Bennekou, Susanne, Koutsoumanis, Kostas, Lambré, Claude, Machera, Kyriaki, Naegeli, Hanspeter, Nielsen, Søren Saxmose, Schlatter, Josef, Schrenk, Dieter, Turck, Dominique, Younes, Maged, Aquilina, Gabriele, Bignami, Margherita, Bolognesi, Claudia, Crebelli, Riccardo, Gürtler, Rainer, Marcon, Francesca, Nielsen, Elsa, Vleminckx, Christiane, Carfì, Maria, Martino, Carla, Maurici, Daniela, Parra Morte, Juan, Rossi, Annamaria, and Benford, Diane
- Abstract
The EFSA Scientific Committee was asked to provide guidance on the most appropriate in vivo tests to follow up on positive in vitro results for aneugenicity, and on the approach to risk assessment for substances that are aneugenic but not clastogenic nor causing gene mutations. The Scientific Committee confirmed that the preferred approach is to perform an in vivo mammalian erythrocyte micronucleus test with a relevant route of administration. If this is positive, it demonstrates that the substance is aneugenic in vivo. A negative result with evidence that the bone marrow is exposed to the test substance supports a conclusion that aneugenic activity is not expressed in vivo. If there is no evidence of exposure to the bone marrow, a negative result is viewed as inconclusive and further studies are required. The liver micronucleus assay, even though not yet fully validated, can provide supporting information for substances that are aneugenic following metabolic activation. The gastrointestinal micronucleus test, conversely, to be further developed, may help to assess aneugenic potential at the initial site of contact for substances that are aneugenic in vitro without metabolic activation. Based on the evidence in relation to mechanisms of aneugenicity, the Scientific Committee concluded that, in principle, health-based guidance values can be established for substances that are aneugenic but not clastogenic nor causing gene mutations, provided that a comprehensive toxicological database is available. For situations in which the toxicological database is not sufficient to establish health-based guidance values, some approaches to risk assessment are proposed. The Scientific Committee recommends further development of the gastrointestinal micronucleus test, and research to improve the understanding of aneugenicity to support risk assessment.
- Published
- 2021
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