1,721,131 research outputs found
Statement on further elaboration on consumption figure of 400 g shellfish meat on the basis of new consumption data
No full textThe EFSA Panel on Contaminants in the Food Chain (CONTAM Panel) has prepared a series of opinions since 2007 on various marine biotoxins, including emerging toxins, to assess the current European Union (EU) limits with regard to human health and methods of analysis as established in the EU legislation. In order to protect high consumers against acute effects of marine biotoxins, the CONTAM Panel identified 400 g of shellfish meat as an appropriate estimate of a large portion size consumed in Europe to be used in the risk assessments. This portion size was then applied to all the scientific opinions on marine biotoxins. Recently EFSA has received new data from Belgium, France, Portugal and Spain on the shellfish portion sizes consumed. In addition, new consumption data have been submitted to EFSA for inclusion in the Comprehensive European food consumption database (Comprehensive Database). Based on the assessment of the new data provided to EFSA and the information included in the EFSA Comprehensive Database, the CONTAM Panel concluded that the earlier established estimate of the consumption figure of 400 g shellfish meat is appropriate for protecting high consumers against acute effects of marine biotoxins
Scientific opinion on the risk for public and animal health related to the presence of sterigmatocystin in food and feed
Full text linkThe European Food Safety Authority (EFSA) was asked by the European Commission to deliver a scientific opinion on sterigmatocystin (STC) in food and feed. STC is a polyketide mycotoxin that shares its biosynthetic pathway with aflatoxins. Following an EFSA call for data, analytical results from 247 food and 334 feed samples were submitted. In food, analytical results on STC were reported to be all below the limit of detection or limit of quantification. In feed, only four quantified results were reported. Therefore, the EFSA Panel on Contaminants in the Food Chain (CONTAM Panel) concluded that the available occurrence data are too limited to carry out a reliable human and animal dietary exposure assessment. Acute oral toxicity of STC is relatively low, and liver and kidneys are the target organs. STC is mutagenic in both bacterial and mammalian cells after metabolic activation and forms DNA adducts. Tumourigenicity has been observed after oral, intraperitoneal, subcutaneous and dermal administration resulting in hepatocellular carcinomas, haemangiosarcomas in the liver, angiosarcomas in brown fat and lung adenomas. Since no exposure data were available, the margin of exposure approach for substances that are genotoxic and carcinogenic could not be applied for STC, and thus the CONTAM Panel could not characterise the risk for human health. Regarding animals, the Panel noted that STC is hepatotoxic in poultry and pigs, and nephrotoxic in poultry and toxic in several fish species. However, in the absence of exposure data for livestock, fish and companion animals, and given the limited knowledge on the adverse effects of STC, the CONTAM Panel could not characterise the risk for animal health. More occurrence data on STC in food and feed need to be collected to allow dietary exposure assessment. For food, methods with a limit of quantification of less than 1.5 µg/kg should be applied
Scientific opinion on the evaluation of the substances currently on the list in the annex to Commission Directive 96/3/EC as acceptable previous cargoes for edible fats and oils - Part III of III
No full text<p>Shipping of edible fats and oils into Europe is permitted in bulk tanks, in which substances, included in a positive list, had been previously transported. The European Commission requested EFSA to evaluate the list of substances in the Annex to Commission Directive 96/3/EC as acceptable previous cargoes for edible fats and oils, taking into account its review of the Scientific Committee on Food criteria for acceptable previous cargoes and criteria proposed by the Codex Committee for Fats and Oils. This is the third and last scientific opinion of the EFSA Panel on Contaminants in the Food Chain (CONTAM Panel) on this topic, in which sixteen of these substances or groups of substances have been evaluated. The CONTAM Panel concluded that sodium silicate (water glass) solution, iso-octanol, iso-nonanol, iso-decanol, 1,3-propanediol, isobutyl acetate, sec-butyl acetate, tert-butyl acetate, n-butyl acetate, propylene tetramer, paraffin wax, candelilla wax, white mineral oils and glycerol would not be of health concern as previous cargoes. The CONTAM Panel concluded that carnauba wax was not acceptable as a previous cargo because of its insolubility in water and high melting point, which raise concerns regarding the efficiency of tank cleaning. There was insufficient information available on the composition of montan wax for the CONTAM Panel to conclude that it would be of no health concern when used as previous cargo and hence it does not meet the criteria for acceptability as previous cargo. The CONTAM Panel made several recommendations regarding the way in which the substances are described in the Annex to Commission Directive 96/3/EC, to correct inaccuracies and to better reflect current transport practices. Shipping of edible fats and oils into Europe is permitted in bulk tanks, in which substances, included in a positive list, had been previously transported. The European Commission requested EFSA to evaluate the list of substances in the Annex to Commission Directive 96/3/EC as acceptable previous cargoes for edible fats and oils, taking into account its review of the Scientific Committee on Food criteria for acceptable previous cargoes and criteria proposed by the Codex Committee for Fats and Oils. This is the third and last scientific opinion of the EFSA Panel on Contaminants in the Food Chain (CONTAM Panel) on this topic, in which sixteen of these substances or groups of substances have been evaluated. The CONTAM Panel concluded that sodium silicate (water glass) solution, iso-octanol, iso-nonanol, iso-decanol, 1,3-propanediol, isobutyl acetate, sec-butyl acetate, tert-butyl acetate, n-butyl acetate, propylene tetramer, paraffin wax, candelilla wax, white mineral oils and glycerol would not be of health concern as previous cargoes. The CONTAM Panel concluded that carnauba wax was not acceptable as a previous cargo because of its insolubility in water and high melting point, which raise concerns regarding the efficiency of tank cleaning. There was insufficient information available on the composition of montan wax for the CONTAM Panel to conclude that it would be of no health concern when used as previous cargo and hence it does not meet the criteria for acceptability as previous cargo. The CONTAM Panel made several recommendations regarding the way in which the substances are described in the Annex to Commission Directive 96/3/EC, to correct inaccuracies and to better reflect current transport practices. Shipping of edible fats and oils into Europe is permitted in bulk tanks, in which substances, included in a positive list, had been previously transported. The European Commission requested EFSA to evaluate the list of substances in the Annex to Commission Directive 96/3/EC as acceptable previous cargoes for edible fats and oils, taking into account its review of the Scientific Committee on Food criteria for acceptable previous cargoes and criteria proposed by the Codex Committee for Fats and Oils. This is the third and last scientific opinion of the EFSA Panel on Contaminants in the Food Chain (CONTAM Panel) on this topic, in which sixteen of these substances or groups of substances have been evaluated. The CONTAM Panel concluded that sodium silicate (water glass) solution, iso-octanol, iso-nonanol, iso-decanol, 1,3-propanediol, isobutyl acetate, sec-butyl acetate, tert-butyl acetate, n-butyl acetate, propylene tetramer, paraffin wax, candelilla wax, white mineral oils and glycerol would not be of health concern as previous cargoes. The CONTAM Panel concluded that carnauba wax was not acceptable as a previous cargo because of its insolubility in water and high melting point, which raise concerns regarding the efficiency of tank cleaning. There was insufficient information available on the composition of montan wax for the CONTAM Panel to conclude that it would be of no health concern when used as previous cargo and hence it does not meet the criteria for acceptability as previous cargo. The CONTAM Panel made several recommendations regarding the way in which the substances are described in the Annex to Commission Directive 96/3/EC, to correct inaccuracies and to better reflect current transport practices.</p></p
Scientific Opinion on marine biotoxins in shellfish - Cyclic imines (spirolides, gymnodimines, pinnatoxins and pteriatoxins)
No full textThe EFSA Panel on Contaminants in the Food Chain (CONTAM Panel) assessed the risks to human health related to the consumption of spirolides (SPXs), gymnodimines (GYMs), pinnatoxins (PnTXs) and pteriatoxins (PtTXs) in shellfish. They are cyclic imines (CIs), a family of marine biotoxins. SPXs and GYMs are produced by the dinoflagellates Alexandrium ostenfeldii and Karenia selliformis, respectively. The organism producing PnTXs has not been identified but has been described as a peridinoid dinoflagellate. PtTXs are suggested to be bio-transformed from PnTXs in shellfish. No information has been reported linking CIs to poisoning events in humans. SPXs have been detected in Europe while GYMs have not been found. Recently PnTXs were identified for the first time in shellfish in Europe but PtTXs have not been detected. There are no regulatory limits for CIs in shellfish. The toxicological database for SPXs, GYMs, PnTXs and PtTXs is limited, comprising mostly acute toxicity studies. In view of the acute toxicity and the lack of chronic toxicity data for CIs, the CONTAM Panel considered that an acute reference dose should be established but due to the lack of data this was not possible. By comparing the lowest lethal dose (LD50) values for SPXs (50 and 500 µg/kg body weight (b.w.) administered by gavage or in feed, respectively) and the estimated 95th percentile of exposure (0.06 µg/kg b.w.) a margin of exposure in the range of 1000-10000 was calculated. The mouse bioassay has traditionally been used to detect CIs. However, due to poor specificity and ethical concerns it is not considered an appropriate method. The receptor-based fluorescence polarisation method has been developed as alternative, but it needs further development. Liquid chromatography-tandem mass spectrometry methods would be of value for the quantification of CIs, but certified reference standards and reference materials are needed to allow method development and (inter-laboratory) validation
Guidance on methodological principles and scientific methods to be taken into account when establishing Reference Points for Action (RPAs) for non-allowed pharmacologically active substances present in food of animal origin
No full textEFSA was asked by the European Commission to deliver a Scientific Opinion on guidance on methodological principles and scientific methods to be taken into account when establishing Reference Points for Action (RPAs) for non-allowed pharmacologically active substances in food of animal origin. This guidance document presents a simple and pragmatic approach which takes into account both analytical and toxicological considerations. The aim is to define an analytical concentration for a non-allowed pharmacologically active substance that can be determined by official control laboratories and is low enough to adequately protect the consumers of food commodities that contain that substance. The proposed step-wise approach considers factors such as analytical capability, toxic potential and pharmacological activity of the substance in question, and includes the identification of the Reasonably Achievable Lowest Limit of Quantification (RALLOQ), the establishment of a Toxicological Screening Value (TSV) and the derivation of a Toxicologically Based Limit of Quantification (TBLOQ). The TBLOQ is compared with the RALLOQ for the respective substance. If the TBLOQ is equal to or higher than the RALLOQ, then the latter can be accepted as the RPA. If the TBLOQ is lower than the RALLOQ, then the sensitivity of the analytical method needs to be improved. In the case where no further analytical improvements are feasible, a substance-specific risk assessment should be considered. The CONTAM Panel concluded that RPAs should be matrix independent. The CONTAM Panel noted that sometimes non-edible matrices are monitored to identify the administration of non-allowed pharmacologically active substances. In these cases, RPAs cannot be applied. The CONTAM Panel also proposed several criteria where the European Commission might consider it appropriate to consult EFSA for a substance-specific risk assessment
Risks for human health related to the presence of pyrrolizidine alkaloids in honey, tea, herbal infusions and food supplements
No full textEFSA was asked by the European Commission to deliver a scientific opinion on the risks for human health related to the presence of pyrrolizidine alkaloids (PAs) in honey, tea, herbal infusions and food supplements and to identify the PAs of relevance in the aforementioned food commodities and in other feed and food. PAs are a large group of toxins produced by different plant species. In 2011, the EFSA Panel on Contaminants in the Food Chain (CONTAM Panel) assessed the risks related to the presence of PAs in food and feed. Based on occurrence data limited to honey, the CONTAM Panel concluded that there was a possible health concern for those toddlers and children who are high consumers of honey. A new exposure assessment including new occurrence data was published by EFSA in 2016 and was used to update the risk characterisation. The CONTAM Panel established a new Reference Point of 237 μg/kg body weight per day to assess the carcinogenic risks of PAs, and concluded that there is a possible concern for human health related to the exposure to PAs, in particular for frequent and high consumers of tea and herbal infusions. The Panel noted that consumption of food supplements based on PA-producing plants could result in exposure levels too close (i.e. less than 100 times lower) to the range of doses known to cause severe acute/short term toxicity. From the analysis of the available occurrence data, the CONTAM Panel identified a list of 17 PAs of relevance for monitoring in food and feed. The Panel recommended continuing the efforts to monitor the presence of PAs in food and feed, including the development of more sensitive and specific analytical methods. A recommendation was also issued on the generation of data to identify the toxic and carcinogenic potency of the PAs commonly found in food
Scientific Opinion on Tetrabromobisphenol A (TBBPA) and its derivatives in food
No full textEFSA was asked by the European Commission to deliver a scientific opinion on tetrabromobisphenol A (TBBPA) and its derivatives in food. TBBPA and its derivatives are widely used as flame retardants. TBBPA is primarily used as reactive flame retardant covalently bound to epoxy and polycarbonate resins. TBBPA derivatives are used as either reactive or additive intermediates in polymer manufacture. Data from the analysis of TBBPA in 652 food samples were submitted to EFSA by four European countries (Ireland, Norway, Spain and the UK), covering the period from 2003 to 2010. All analytical results were reported as less than the limit of quantification (LOQ) and the majority of the samples were in the food group “Fish and other seafood” (n=465). Toxicological studies with TBBPA have been carried out using different experimental designs with single or repeated administration during gestation, postnatally or in adulthood. The main target is thyroid hormone homeostasis. TBBPA is not genotoxic. There are no indications that TBBPA might be carcinogenic. The Panel on Contaminants in the Food Chain (CONTAM Panel) identified a lower confidence limit for a benchmark response of 10 % (BMDL10) of 16 mg/kg b.w. reported for changes in thyroid hormones as the critical reference point. Due to the limitations and uncertainties in the database, the Panel concluded that it was inappropriate to use this BMDL to establish a health based guidance value, and therefore used a margin of exposure (MOE) approach for the health risk assessment of TBBPA. In view of the large MOEs, the Panel concluded that current dietary exposure to TBBPA in the European Union does not raise a health concern. Also exposure of infants via human milk does not raise a health concern. Additional exposure, particularly of young children, to TBBPA from house dust is unlikely to raise a health concern
Scientific Opinion on the presence of dioxins (PCDD/Fs) and dioxin-like PCBs (DL-PCBs) in commercially available foods for infants and young children
No full textEFSA was asked by the Federal Institute for Risk Assessment (BfR) to deliver a scientific opinion on the presence of dioxins and dioxin-like polychlorinated biphenyls (DL-PCBs) in commercially available foods for infants and young children. It was requested to describe the relation of important parameters of the distribution of the occurrence data to the new EU maximum levels (MLs), and to assess whether these MLs are sufficient to aim to decrease the dietary exposure of infants and young children to dioxins and DL-PCBs. The CONTAM Panel did not perform an exposure or risk assessment, but evaluated whether the enforcement of the new EU MLs will result in a decrease in the concentration of dioxins and DL-PCBs in foods for infants and young children, and thus in a potential decrease in exposure of this population group. A total of 516 samples was included in the evaluation, reported by 13 European countries and covering the period 2003 to 2011. All accepted data (upper-bound) were below the current MLs for foods for infants and young children of 0.1 pg WHO2005-TEQ/g w.w. for dioxins and 0.2 pg WHO2005-TEQ/g w.w. for the sum of dioxins and DL-PCBs. Therefore, the CONTAM Panel concluded that, based on the available data, the current MLs are not an incentive to decrease the concentrations of dioxins and DL-PCBs in the relevant foods. From the reported data, it is not possible to conclude on any time trend concerning the dioxin and DL-PCB levels in foods for infants and young children. The Panel recommended that more occurrence data on representative samples are needed, particularly for those foods for infants and young children where only a few results are available so far. Moreover, the sensitivity of the analytical methods should be improved, if lower MLs were to be considered in the future
Scientific Opinion on the risks to public health related to the presence of chromium in food and drinking water
No full textEFSA received a request from the Hellenic Food Authority for a scientific opinion on estimation of the risk to human health from the presence of chromium (Cr) in food, particularly in vegetables, and Cr(VI) in bottled water. The CONTAM Panel derived a TDI of 0.3 mg/kg b.w. per day for Cr(III) from the lowest NOAEL identified in an NTP chronic oral toxicity study in rats. Under the assumption that all chromium in food is Cr(III), the mean and 95th percentile dietary exposure across all age groups were well below the TDI and therefore does not raise concerns for public health. In the case of drinking water, the Panel considered all chromium in water as Cr(VI). For non-neoplastic effects the lowest BMDL10 for diffuse epithelial hyperplasia of duodenum in female mice and the lowest BMDL05 for haematotoxicity in male rats in a 2-year NTP study were selected as reference points. The MOEs indicate that for non-neoplastic effects the current exposure levels to Cr(VI) via drinking water are of no concern for public health. For neoplastic effects, the CONTAM Panel selected a lowest BMDL10 for combined adenomas and carcinomas of the mouse small intestine as the reference point. Overall, the calculated MOEs indicate low concern regarding Cr(VI) intake via drinking water (water intended for human consumption and natural mineral waters) for all age groups when considering the mean chronic exposure values with the exception of infants at the upper bound (UB) exposure estimates. MOEs below 10 000 were calculated at the UB 95th percentile exposure estimates, particularly for ‘Infants’, ‘Toddlers’ and ‘Other children’, which were highly influenced by the relatively high occurrence values under the UB assumption. To improve the risk assessment, there is a need for data on the content of Cr(III) and Cr(VI) in food and drinking water
Scientific Opinion on marine biotoxins in shellfish - Emerging toxins: Brevetoxin group
No full textThe EFSA Panel on Contaminants in the Food Chain (CONTAM Panel) assessed the risks to human health related to the consumption of brevetoxin-(BTX) group toxins in shellfish and fish. They are marine biotoxins which can accumulate in shellfish and fish. BTX-group toxins are primarily produced by the dinoflagellate Karenia brevis and cause neurologic shellfish poisoning (NSP). Symptoms and signs of NSP include e.g. nausea, vomiting, diarrhoea, parasthesia, cramps, bronchoconstriction, paralysis, seizures and coma. To date BTX-group toxins have not been reported in shellfish or fish from Europe and currently there are no regulatory limits for BTX-group toxins in shellfish or fish in Europe. The toxicological database for BTX-group toxins is limited, comprising mostly acute toxicity studies. In view of the acute toxicity and the lack of chronic toxicity data for BTX-group toxins, the CONTAM Panel considered that an acute reference dose (ARfD) should be established but due to the lack of data this was not possible. There is some evidence that BTX-2 forms DNA adducts. This raises concern about its potential carcinogenicity and consequential long term effects. Due to the lack of occurrence data on shellfish or fish in Europe, the limited data on acute toxicity and the lack of data on chronic toxicity, the CONTAM Panel could not comment on the risk associated with the BTX-group toxins in shellfish and fish that could reach the European market. The mouse bioassay (MBA) has traditionally been used to detect BTX-group toxins. However, due to poor specificity and ethical concerns it is not considered an appropriate method. In vitro and immunoassays have been developed as alternative, but they need further development. Liquid chromatography-tandem mass spectrometry (LC-MS/MS) methods would be of value for the quantification of BTX-group toxins, but certified reference materials are needed to allow further method development and (interlaboratory) validation
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