Re-evaluation of tara gum (E 417) as a food additive.
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ABSTRACT:
SUBMITTER: EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS)
PROVIDER: S-EPMC7009841 | biostudies-literature | 2017 Jun
REPOSITORIES: biostudies-literature
Publications
Re-evaluation of tara gum (E 417) as a food additive.
Mortensen Alicja A Aguilar Fernando F Crebelli Riccardo R Di Domenico Alessandro A Frutos Maria Jose MJ Galtier Pierre P Gott David D Gundert-Remy Ursula U Lambré Claude C Leblanc Jean-Charles JC Lindtner Oliver O Moldeus Peter P Mosesso Pasquale P Oskarsson Agneta A Parent-Massin Dominique D Stankovic Ivan I Waalkens-Berendsen Ine I Woutersen Rudolf Antonius RA Wright Matthew M Younes Maged M Brimer Leon L Christodoulidou Anna A Lodi Federica F Tard Alexandra A Dusemund Birgit B
EFSA journal. European Food Safety Authority 20170628 6
The Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion re-evaluating the safety of tara gum (E 417) as a food additive. Tara gum (E 417) has been evaluated by the EU Scientific Committee for Food (SCF, 1992) and by the Joint FAO/WHO Expert Committee on Food Additives (JECFA, 1987), who both allocated an acceptable daily intake (ADI) 'not specified' for this gum. Following the conceptual framework for the risk assessment of certain food additives, re-ev ...[more]
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Project description:The Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion re-evaluating the safety of guar gum (E 412) as a food additive. In the EU, guar gum was evaluated by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 1970, 1974 and 1975, who allocated an acceptable daily intake (ADI) 'not specified'. Guar gum has been also evaluated by the Scientific Committee for Food (SCF) in 1977 who endorsed the ADI 'not specified' allocated by JECFA. Following the conceptual framework for the risk assessment of certain food additives re-evaluated under Commission Regulation (EU) No 257/2010, the Panel considered that adequate exposure and toxicity data were available. Guar gum is practically undigested, not absorbed intact, but significantly fermented by enteric bacteria in humans. No adverse effects were reported in subchronic and carcinogenicity studies at the highest dose tested; no concern with respect to the genotoxicity. Oral intake of guar gum was well tolerated in adults. The Panel concluded that there is no need for a numerical ADI for guar gum (E 412), and there is no safety concern for the general population at the refined exposure assessment of guar gum (E 412) as a food additive. The Panel considered that for uses of guar gum in foods intended for infants and young children the occurrence of abdominal discomfort should be monitored and if this effect is observed doses should be identified as a basis for further risk assessment. The Panel considered that no adequate specific studies addressing the safety of use of guar gum (E 412) in food categories 13.1.5.1 and 13.1.5.2 were available. Therefore, the Panel concluded that the available data do not allow an adequate assessment of the safety of guar gum (E 412) in infants and young children consuming these foods for special medical purposes.
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Project description:The Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion re-evaluating the safety of acacia gum (E 414) as a food additive. In the EU, acacia gum has not been formally evaluated by the Scientific Committee for Food (SCF), and therefore, no ADI has been allocated. However, it was accepted for use in weaning food (SCF, 1991). In 1999, the SCF considered 'that the use of acacia gum/gum arabic in coatings for nutrient preparations containing trace elements is acceptable provided carry-over levels in infant formulae, follow-on formulae or FSMP do not exceed 10 mg/kg'. Acacia gum was evaluated by JECFA in 1982 and 1990 and the specifications were amended in 1998. Based on the lack of adverse effects in the available toxicity studies, an ADI 'not specified' was allocated. Following the conceptual framework for the risk assessment of certain food additives re-evaluated under Commission Regulation (EU) No 257/2010, the Panel considered that adequate exposure and toxicity data were available. Acacia gum is unlikely to be absorbed intact and is slightly fermented by intestinal microbiota. No adverse effects were reported in subchronic and carcinogenicity studies at the highest dose tested and there is no concern with respect to the genotoxicity. Oral daily intake of a large amount of acacia gum up to 30,000 mg acacia gum/person per day (approximately equivalent 430 mg acacia gum/kg bw per day) for up to 18 days was well tolerated in adults but some individuals experienced flatulence which was considered by the Panel as undesirable but not adverse effect. The Panel concluded that there is no need for a numerical ADI for acacia gum (E 414), and there is no safety concern for the general population at the refined exposure assessment of acacia gum (E 414) as a food additive.
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Project description:The Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion re-evaluating the safety of xanthan gum (E 415) as food additive. Following the conceptual framework for the risk assessment of certain food additives re-evaluated 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 64 mg/kg bw per day in children for the general population, 38 mg/kg bw per day for children consumers only of food supplements at the high level exposure and 115 mg/kg bw per day for infants consuming foods for special medical purposes and special formulae (FSMPs), were estimated. Xanthan gum (E 415) is unlikely to be absorbed intact and is expected to be fermented by intestinal microbiota. No adverse effects were reported at the highest doses tested in chronic and carcinogenicity studies and there is no concern with respect to the genotoxicity. Repeated oral intake by adults of xanthan gum up to 214 mg/kg bw per day for ten days was well tolerated, but some individuals experienced abdominal discomfort, an undesirable but not adverse effect. The Panel concluded that there is no need for a numerical ADI for xanthan gum (E 415), and that there is no safety concern for the general population at the refined exposure assessment of xanthan gum (E 415) as food additive. Considering the outcome of clinical studies and post-marketing surveillance, the Panel concluded that there is no safety concern from the use of xanthan gum (E 415) in FSMPs for infants and young children at concentrations reported by the food industry. The current re-evaluation of xanthan gum (E 415) as a food additive is not considered to be applicable for infants under the age of 12 weeks.
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Project description:The present opinion deals with the re-evaluation of thaumatin (E 957) when used as a food additive. Thaumatin is a natural plant protein, consisting of thaumatin I and thaumatin II proteins together with minor amounts of plant constituents, obtained by acidic aqueous extraction of the arils of the fruit of Thaumatococcus daniellii plant. The Panel followed the conceptual framework for the risk assessment of certain food additives and considered that thaumatin is a digestible protein; adequate exposure estimates were available; there was no concern with respect to the genotoxicity; no conclusion on oral allergenicity could be drawn from the available human data; no adverse effects were observed in sub-chronic toxicity studies in rats and dogs at the highest dose tested of up 5,200 and 1,476 mg/kg bodyweight (bw) per day, respectively, and in a prenatal developmental toxicity study up to 2,000 mg/kg bw per day; moderate confidence in the body of evidence supported the absence of association between exposure to thaumatin and adverse health outcomes. Therefore, the Panel concluded that there is no need for a numerical acceptable daily intake (ADI) for thaumatin (E 957) and, based on a margin of safety (MOS) of 5,417, considered to be an underestimate and derived using the highest 95th percentile (P95) exposure of 0.48 mg/kg bw per day in consumers only, there is no safety concern for thaumatin (E 957) at the regulatory maximum level exposure assessment scenario, which was considered the most appropriate. The Panel recommended that European Commission considers introducing in the EU specifications for thaumatin (E 957) a new specification limit for the minimum combined content of thaumatin I and II proteins in E 957, a specification limit for yeast, mould counts and Salmonella spp and lowering the existing maximum limit for arsenic along with the inclusion of maximum limits for mercury and cadmium.
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Project description:The EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion re-evaluating the safety of fatty acids (E 570) when used as a food additive. The food additive includes caprylic- (C8), capric- (C10), lauric- (C12), myristic- (C14), palmitic- (C16), stearic- (C18) and oleic acid (C18:1), present alone or in combination. In 1991, the Scientific Committee on Food (SCF) established a group acceptable daily intake (ADI) 'not specified' for the fatty acids (myristic, stearic, palmitic and oleic acid). The fatty acids (E 570) are absorbed in the same way as the free fatty acids from the regular diet. They show low acute toxicity. The available studies on subchronic toxicity were limited but there was no evidence for toxic effects at doses up to 10% in the diet (equivalent to 9,000 mg lauric acid/kg body weight (bw) per day). The Panel considered that the fatty acids (E 570) did not raise a concern for genotoxicity. Data on chronic toxicity, reproductive toxicity and developmental toxicity were too limited to reach a conclusion on these endpoints. The Panel noted that the contribution of fatty acids (E 570) represented on average only 1% of the overall exposure to saturated fatty acids from all dietary sources (food additive and regular diet). Based on the approach described in the conceptual framework for the risk assessment of certain food additives re-evaluated under Commission Regulation (EU) No 257/2010 and taking into account the considerations mentioned above, the Panel concluded that the food additive fatty acids (E 570) was of no safety concern at the reported uses and use levels.
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