Dataset Information

Re-evaluation of fatty acids (E 570) as a food additive.

ABSTRACT: 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.

SUBMITTER: EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS)

PROVIDER: S-EPMC7009963 | biostudies-literature | 2017 May

REPOSITORIES: biostudies-literature

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Re-evaluation of fatty acids (E 570) as a food additive.

Mortensen Alicja A Aguilar Fernando F Crebelli Riccardo R Di Domenico Alessandro A Dusemund Birgit B Frutos Maria Jose MJ Galtier Pierre P Gott David D Gundert-Remy Ursula U Leblanc Jean-Charles JC Lindtner Oliver O Moldeus Peter P Mosesso Pasquale P Parent-Massin Dominique D Oskarsson Agneta A Stankovic Ivan I Waalkens-Berendsen Ine I Woutersen Rudolf Antonius RA Wright Matthew M Younes Maged M Boon Polly P Chrysafidis Dimitrios D Gürtler Rainer R Tobback Paul P Gergelova Petra P Rincon Ana Maria AM Lambré Claude C

EFSA journal. European Food Safety Authority 20170505 5

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 (myri ...[more]

PMID: 32625490

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Project description:The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion re-evaluating the safety of propane-1,2-diol esters of fatty acids (E 477) when used as a food additive. The Scientific Committee on Food (SCF) in 1978 endorsed the acceptable daily intake (ADI) of 25 mg/kg body weight (bw) per day, expressed as propane-1,2-diol, established by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 1974. No adverse effects were observed in short-term studies in rats and dogs at the highest doses tested. The Panel considered that E 477 did not raise a concern for genotoxicity. No chronic toxicity, carcinogenicity, reproductive and developmental toxicity studies with propane-1,2-diol esters of fatty acids were available to the Panel. The Panel considered that any potential adverse effect of propane-1,2-diol ester of fatty acids would be due to propane-1,2-diol, previously re-evaluated as a food additive and for which an ADI of 25 mg/kg bw per day was established. Considering the overall metabolic and toxicity database, the Panel confirmed the previously established ADI for propane-1,2-diol esters of fatty acids (E 477) of 25 mg/kg bw per day expressed as propane 1,2 diol. This corresponds to an ADI for E 477 of 80 mg/kg bw per day, based on the concentration of free and bound propane-1,2-diol amounting to a maximum of 31% as laid down in the EU specification. The Panel concluded that there would not be a safety concern at the reported use levels for E 477 because exposure estimates from the refined non-brand loyal scenario did not exceed the ADI for E 477 in any of the population groups. However, the Panel aims to explore the feasibility of establishing a group ADI for those food additives that result in an exposure to propane-1,2-diol, such as E 477, E 1520 and E 405. Additionally, the Panel will also consider performing a combined exposure assessment to propane-1,2-diol resulting from the use of these food additives. The Panel also recommended some modifications of the EU specifications for E 477.

Project description:The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion re-evaluating the safety of thermally oxidised soya bean oil interacted with mono- and diglycerides of fatty acids (TOSOM) (E 479b) when used as a food additive. The Scientific Committee on Food (SCF) and the Joint FAO/WHO Expert Committee on Food Additives (JECFA) derived an acceptable daily intake (ADI) of 25 and 30 mg/kg body weight (bw) per day, respectively. There was no reliable information regarding the absorption, distribution, metabolism, excretion (ADME) for TOSOM. No adverse effects have been detected in a limited subchronic toxicity study in pigs. The Panel identified a no observed adverse effect level (NOAEL) of 5,400, the highest dose tested, from a chronic and carcinogenicity study in rats. No genotoxicity data were available. No reliable studies for reproductive or developmental toxicity were available. From the chronic and carcinogenicity study, no lesions in reproductive organs were described and the lack of carcinogenic effect alleviated the concern for genotoxicity at the first site of contact. The Panel concluded that the available toxicological data were insufficient to support the current ADI, in particular, due to the lack of ADME data and absence of developmental toxicity studies TOSOM (E 479b) is only authorised in one food category and only one reported use level that equals the maximum permitted level was submitted. The estimated high (P95) exposure reached an upper value of 10.1 mg/kg bw per day for toddlers. When comparing the highest estimated exposure of 10 mg/kg bw per day in toddlers with the NOAEL of 5,400 mg/kg bw per day (the highest dose tested), the margin of safety (MoS) would be 540. Therefore, the Panel considered the use of TOSOM (E 479b) to be of no safety concern, in particular when considering the limited current use of this food additive. The Panel also recommended some modifications of the EU specifications for E 479b.

Project description:This opinion deals with the re-evaluation of polydextrose (E 1200) when used as a food additive. The Panel followed the conceptual framework for the risk assessment of certain additives and considered that: adequate exposure estimates were available; the margin of safety (MOS)/margin of exposure (MOE) for arsenic was between 0.5-14 and 8.5 for lead; the exhaustions of the tolerable weekly intake (TWI) for cadmium would be 165%, 10% for mercury, whereas the exhaustion of the tolerable daily intake (TDI) for nickel would be 9%; the absorption is limited and part of polydextrose is fermented in the large intestine into short-chain fatty acids (SCFA); adequate toxicity data were available; there is no concern with respect to genotoxicity; no adverse effects were reported in subchronic studies in rats, dogs or monkeys nor in chronic or carcinogenicity studies in mice and rats at the highest doses tested of up 12,500 mg/kg body weight (bw) per day and 15,000 mg/kg bw per day, respectively; the nephrocalcinosis in dogs given high doses of polydextrose was considered to be a treatment-related but a secondary effect related to diarrhoea, and hence not relevant for the risk assessment; no adverse effects were reported in reproductive or developmental toxicity studies in rats administered up to 10,000 mg polydextrose/kg bw per day, or in a developmental toxicity study in rabbits up to 1,818 mg/kg bw per day (the highest dose tested). Therefore, the Panel concluded that there is no need for numerical acceptable daily intake (ADI) for polydextrose (E 1200), and that there is no safety concern for the reported uses and use levels of polydextrose as a food additive. The Panel recommended that European Commission considers to lower the maximum limit for lead and to introduce limits for arsenic, cadmium and mercury in the EU specifications for polydextrose (E 1200), and to verify that polydextrose-N as a food additive (E 1200) is no longer marketed in the EU.

Dataset Information

Re-evaluation of fatty acids (E 570) as a food additive.

Publications

Re-evaluation of fatty acids (E 570) as a food additive.

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