383 research outputs found
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Reāevaluation of gellan gum (E 418) as food additive
The Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion reāevaluating the safety of gellan gum (E 418) as a food additive. Following the conceptual framework for the risk assessment of certain food additives reāevaluated under Commission Regulation (EU) No 257/2010, the Panel considered that adequate exposure and toxicity data were available. Based on the reported use levels, a refined exposure of up to 72.4 mg/kg body weight (bw) per day in toddlers at the 95th percentile was estimated. Gellan gum is unlikely to be absorbed intact and would not be fermented by human intestinal microbiota. There is no concern with respect to carcinogenicity and genotoxicity. No adverse effects were reported in chronic studies at the highest doses tested in mice and rats (3,627 and 1,460 mg gellan gum/kg bw per day, respectively). Repeated oral intake up to 200 mg/kg bw per day for 3 weeks had no adverse effects in humans. The Panel concluded that there is no need for a numerical acceptable daily intake (ADI) for gellan gum (E 418), and that there is no safety concern at the refined exposure assessment for the reported uses and use levels of gellan gum (E 418) as a food additive. The Panel recommended to better define the specifications of gellan gum including the absence of viable cells of the microbial source and the presence of polyhydroxybutyrate (PHB), protein and residual bacterial enzymatic activities
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Reāevaluation of calcium silicate (E 552), magnesium silicate (E 553a(i)), magnesium trisilicate (E 553a(ii)) and talc (E 553b) as food additives
The EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion reāevaluating the safety of calcium silicate (E 552), magnesium silicate (E 553a) and talc (E 553b) when used as food additives. In 1991, the Scientific Committee on Food (SCF) established a group acceptable daily intake (ADI) ānot specifiedā for silicon dioxide and silicates. The EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) recently provided a scientific opinion reāevaluating the safety of silicon dioxide (E 551) when used as a food additive. The Panel noted that the absorption of silicates and talc was very low; there was no indication for genotoxicity or developmental toxicity for calcium and magnesium silicate and talc; and no confirmed cases of kidney effects have been found in the EudraVigilance database despite the wide and longāterm use of high doses of magnesium trisilicate up to 4 g/person per day over decades. However, the Panel considered that accumulation of silicon from calcium silicate in the kidney and liver was reported in rats, and reliable data on subchronic and chronic toxicity, carcinogenicity and reproductive toxicity of silicates and talc were lacking. Therefore, the Panel concluded that the safety of calcium silicate (E 552), magnesium silicate (E 553a(i)), magnesium trisilicate (E 553a(ii)) and talc (E 553b) when used as food additives cannot be assessed. The Panel considered that there is no mechanistic rationale for a group ADI for silicates and silicon dioxide and the group ADI established by the SCF is obsolete. Based on the food supplement scenario considered as the most representative for risk characterisation, exposure to silicates (E 552ā553) for all population groups was below the maximum daily dose of magnesium trisilicate used as an antacid (4 g/person per day). The Panel noted that there were a number of approaches, which could decrease the uncertainties in the current toxicological database. These approaches include ā but are not limited to ā toxicological studies as recommended for a Tier 1 approach as described in the EFSA Guidance for the submission of food additives and conducted with an adequately characterised material. Some recommendations for the revision of the EU specifications were proposed by the Panel
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Reāevaluation of propaneā1,2ādiol alginate (E 405) as a food additive
The present opinion deals with the reāevaluation of propaneā1,2ādiol alginate (E 405) when used as a food additive. The Panel noted that absorption, distribution, metabolism and excretion (ADME) data on propaneā1,2ādiol alginate gave evidence for the hydrolysis of this additive into propaneā1,2ādiol and alginic acid. These two compounds have been recently reāevaluated for their safety of use as food additives (EFSA ANS Panel, 2017, 2018). Consequently, the Panel considered in this opinion the major toxicokinetic and toxicological data of these two hydrolytic derivatives. No adverse effects were reported in subacute and subchronic dietary studies with propaneā1,2ādiol alginate. The available data did not indicate a genotoxic concern for propaneā1,2ādiol alginate (E 405) when used as a food additive. Propaneā1,2ādiol alginate, alginic acid and propaneā1,2ādiol were not of concern with respect to carcinogenicity. The Panel considered that any adverse effect of propaneā1,2ādiol alginate would be due to propaneā1,2ādiol. Therefore, the acceptable daily intake (ADI) of the food additive E 405 is determined by the amount of free propaneā1,2ādiol and the propaneā1,2ādiol released from the food additive after hydrolysis. According to the EU specification, the concentration of free and bound propaneā1,2ādiol amounts to a maximum of 45% on a weight basis. On the worstācase assumption that 100% of propaneā1,2ādiol would be systemically available and considering the ADI for propaneā1,2ādiol of 25 mg/kg body weight (bw) per day, the Panel allocated an ADI of 55 mg/kg bw per day for propaneā1,2ādiol alginate. The Panel concluded that exposure estimates did not exceed the ADI in any of the population groups from the use of propaneā1,2ādiol alginate (E 405) as a food additive. Therefore, the Panel concluded that there is no safety concern at the authorised use levels
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Reāevaluation of glycerol esters of wood rosin (E 445) as a food additive
The present opinion deals with the reāevaluation of glycerol esters of wood rosin (GEWR, E 445) when used as a food additive. Regarding GEWR originating from Pinus palustris (longleaf pine) and Pinus elliottii (slash pine), based on the overall toxicity database, and given the absence of reproductive and developmental toxicity data, the Panel concluded that the current acceptable daily intake (ADI) of 12.5 mg/kg body weight (bw) per day for GEWR (E 445) as established by the Scientific Committee on Food (SCF) in 1994 should be temporary pending the provision of such data. This assessment is restricted to GEWR derived from P. palustris (longleaf pine) and P. elliottii (slash pine) and with a chemical composition in compliance with GEWR used in the toxicological testing. The Panel concluded that the mean and the high exposure levels (P95) of the brandāloyal refined exposure scenario did not exceed the temporary ADI in any of the population groups from the use of GEWR (E 445) as a food additive at the reported use levels. For GEWR originating from Pinus halepensis and Pinus brutia, the Panel noted that concentrations of the fractions of āglycerol monoestersā, āfree resin acidsā and āneutralsā, which are considered to be of particular toxicological relevance, are not known; therefore, the evaluation of chemical equivalence with GEWR originating from P. palustris (longleaf pine) and P. elliottii (slash pine) is not possible; no data on stability were available; no toxicological data were available. Therefore, the Panel concluded that a safety assessment of GEWR originating from P. halepensis and P. brutia could not be performed. The Panel recommended the European Commission to consider an update of the definition of GEWR (E 445) in the EU specifications. It should be indicated that GEWR (E 445) (i) contain, besides the mentioned glycerol diā and triesters, a residual fraction of glycerol monoesters, and (ii) contain residual free resin acids and neutrals (nonāacidic other saponifiable and unsaponifiable substances)
Risks for public health related to the presence of tetrodotoxin (TTX) and TTX analogues in marine bivalves and gastropods
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Risks to human and animal health related to the presence of deoxynivalenol and its acetylated and modified forms in food and feed
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Risk to human health related to the presence of perfluoroalkyl substances in food
Publisher Copyright: Ā© 2020 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.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 PanelĀ 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 āother childrenā showed a twofold higher exposure. Upper bound exposure was 4- to 49-fold higher than LB levels, but the latter were considered more reliable. āFish meatā, āFruit and fruit productsā and āEggs and egg productsā 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 long-term 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 PanelĀ concluded that parts of the European population exceed this TWI, which is of concern.Peer reviewe
Scientific Opinion on the presence of dioxins (PCDD/Fs) and dioxin-like PCBs (DL-PCBs) in commercially available foods for infants and young children
EFSA 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
Re-evaluation of l(+)-tartaric acid (EĀ 334), sodium tartrates (EĀ 335), potassium tartrates (EĀ 336), potassium sodium tartrate (EĀ 337) and calcium tartrate (EĀ 354) as food additives
Acknowledgements: The FAF Panel wishes to thank Claude Lambre and Lieve Herman for the support provided to this scientific output. The FAF Panel wishes to acknowledge all European competent institutions, Member State bodies and other organisations that provided data for this scientific output.Publisher PD
Evaluation of the health risks related to the presence of cyanogenic glycosides in foods other than raw apricot kernels
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