6 research outputs found
Re-evaluation of propane-1,2-diol esters of fatty acids (EÂ 477) as a food additive
Acknowledgements: The Panel wishes to thank the Working Group on the re-evaluation of food additives other than gums and colours of the former EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) for the preparatory work on this scientific output, in particular Pasquale Mosesso and Rudolf Antonius Woutersen. 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
Re-evaluation of oxidised soya bean oil interacted with mono- and diglycerides of fatty acids (EÂ 479b) as a food additive
Acknowledgements: The Panel wishes to thank the Working Group on the re-evaluation of food additives other than gums and colours of the former EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) for the preparatory work on this scientific output, in particular Pasquale Mosesso and Rudolf Antonius Woutersen. 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
Recommended from our members
Reâevaluation of sodium, potassium and calcium salts of fatty acids (E 470a) and magnesium salts of fatty acids (E 470b) as food additives
The EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion reâevaluating the safety of sodium, potassium and calcium salts of fatty acids (E 470a) and magnesium salts of fatty acids (E 470b) when used as food additives. In 1991, the Scientific Committee on Food (SCF) established a group acceptable daily intake (ADI) ânot specifiedâ for the fatty acids (myristicâ, stearicâ, palmiticâ and oleic acid) and their salts. The sodium, potassium, calcium and magnesium salts of fatty acids are expected to dissociate in the gastrointestinal tract to fatty acid carboxylates and their corresponding cations. There were no data on subchronic toxicity, chronic toxicity, reproductive and developmental toxicity of the salts of fatty acids. There was no concern for mutagenicity of calcium caprylate, potassium oleate and magnesium stearate. From a carcinogenicity study with sodium oleate, a no observed adverse effect level (NOAEL) could not be identified but the substance was considered not to present a carcinogenic potential. Palmiticâ and stearic acid which are the main fatty acids in E 470a and E 470b were already considered of no safety concern in the reâevaluation of the food additive E 570. The fatty acid moieties of E 470a and E 470b contributed maximally for 5% to the overall intake of saturated fatty acids from all dietary sources. Overall, the Panel concluded that there was no need for a numerical ADI and that the food additives sodium, potassium, calcium and magnesium salts of fatty acids (E 470a and E 470b) were of no safety concern at the reported uses and use levels
Recommended from our members
Reâevaluation of propaneâ1,2âdiol (E 1520) as a food additive
The EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion reâevaluating the safety of propaneâ1,2âdiol (E 1520) when used as a food additive. In 1996, the Scientific Committee on Food (SCF) established an acceptable daily intake (ADI) of 25 mg/kg body weight (bw) per day for propaneâ1,2âdiol. Propaneâ1,2âdiol is readily absorbed from the gastrointestinal and is expected to be widely distributed to organs and tissues. The major route of metabolism is oxidation to lactic acid and pyruvic acid. At high concentrations, free propaneâ1,2âdiol is excreted in the urine. No treatmentârelated effects were observed in subchronic toxicity studies. The available data did not raise concern with respect to genotoxicity. Haematological changes suggestive of an increased red blood cell destruction with a compensatory increased rate of haematopoiesis were observed at the highest dose level (5,000 mg/kg bw per day) in a 2âyear study in dogs. No adverse effects were reported in a 2âyear chronic study in rats with propaneâ1,2âdiol (up to 2,500 mg/kg bw per day). The SCF used this study to derive the ADI. No adverse effects were observed in the available reproductive and developmental toxicity studies. Propaneâ1,2âdiol (E 1520) is authorised according to Annex III in some food additives, food flavourings, enzymes and nutrients and it is then carried over to the final food. Dietary exposure to E 1520 was assessed based on the use levels and analytical data. The Panel considered that for the food categories for which information was available, the exposure was likely to be overestimated. Considering the toxicity database, the Panel concluded that there was no reason to revise the current ADI of 25 mg/kg bw per day. The Panel also concluded that the mean and the high exposure levels (P95) of the brandâloyal refined exposure scenario did not exceed the ADI in any of the population groups from the use of propaneâ1,2âdiol (E 1520) at the reported use levels and analytical results
Reâevaluation of ÎČâcyclodextrin (EÂ 459) as a food additive
Abstract The EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion reâevaluating the safety of ÎČâcyclodextrin (E 459) as a food additive. ÎČâCyclodextrin is a nonâreducing cyclic oligosaccharide consisting of seven αâ1,4âlinked dâglucopyranosyl units. The Scientific Committee on Food (SCF) allocated an acceptable daily intake (ADI) of 5 mg/kg body weight (bw) per day to ÎČâcyclodextrin (E 459) in 1996. ÎČâCyclodextrin is poorly absorbed following oral administration in animals and humans. It is hydrolysed to maltose and glucose by the gut microflora and endogenous amylases in the colon; consequently, ÎČâcyclodextrin levels in tissues and serum are low (< 1%). ÎČâCyclodextrin has a low acute oral toxicity. Shortâterm and subchronic toxicity studies were available in rats and dogs. In rats, the main reported effect was an adaptive enlargement of the caecum, resulting from consumption of poorly digestible carbohydrates. From a 6âmonth study in rats, a no observed adverse effect levels (NOAEL) of 600 mg/kg bw per day was identified and from a 52âweek dogs study, the NOAEL was 466 and 476 mg/kg bw per day in males and females, respectively. The Panel considered that there was no indication for genotoxicity of ÎČâcyclodextrin. From a chronic toxicity studies in rats, a NOAEL of 654 and 864 mg/kg bw per day in males and females, respectively, was identified. Carcinogenicity studies in mice and rats were available and no evidence for carcinogenicity was found. The Panel concluded that, based on the available toxicological database, there is no reason to revise the current ADI of 5 mg/kg bw per day for ÎČâcyclodextrin. Based on the available reported use and use levels, the Panel also concluded that the ADI was exceeded in the refined brandâloyal scenario (considered the most relevant scenario) in all population groups except for infants at the mean and in all population groups at the 95th percentile
Reâevaluation of glutamic acid (EÂ 620), sodium glutamate (EÂ 621), potassium glutamate (EÂ 622), calcium glutamate (EÂ 623), ammonium glutamate (EÂ 624) and magnesium glutamate (EÂ 625) as food additives
Abstract The EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion reâevaluating the safety of glutamic acidâglutamates (E 620â625) when used as food additives. Glutamate is absorbed in the intestine and it is presystemically metabolised in the gut wall. No adverse effects were observed in the available shortâterm, subchronic, chronic, reproductive and developmental studies. The only effect observed was increased kidney weight and increased spleen weight; however, the increase in organ weight was not accompanied by adverse histopathological findings and, therefore, the increase in organ weight was not considered as an adverse effect. The Panel considered that glutamic acidâglutamates (E 620â625) did not raise concern with regards to genotoxicity. From a neurodevelopmental toxicity study, a no observed adverse effect level (NOAEL) of 3,200 mg monosodium glutamate/kg body weight (bw) per day could be identified. The Panel assessed the suitability of human data to be used for the derivation of a healthâbased guidance value. Although effects on humans were identified human data were not suitable due to the lack of doseâresponse data from which a dose without effect could be identified. Based on the NOAEL of 3,200 mg monosodium glutamate/kg bw per day from the neurodevelopmental toxicity study and applying the default uncertainty factor of 100, the Panel derived a group acceptable daily intake (ADI) of 30 mg/kg bw per day, expressed as glutamic acid, for glutamic acid and glutamates (E 620â625). The Panel noted that the exposure to glutamic acid and glutamates (E 620â625) exceeded not only the proposed ADI, but also doses associated with adverse effects in humans for some population groups