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Re-evaluation of guar gum (E 412) as a food additive.

ABSTRACT: 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.

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

PROVIDER: S-EPMC7010168 | biostudies-literature | 2017 Feb

REPOSITORIES: biostudies-literature

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Re-evaluation of guar gum (E 412) 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 Peters Paul P Wiesner Jacqueline J Christodoulidou Anna A Lodi Federica F Tard Alexandra A Dusemund Birgit B

EFSA journal. European Food Safety Authority 20170224 2

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 ...[more]

PMID: 32625396

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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 guar gum (E 412) as a food additive.

Publications

Re-evaluation of guar gum (E 412) as a food additive.

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