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Abstract: The Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion re‐evaluating the safety of gellan gum (E 418) as a 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 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. [ABSTRACT FROM AUTHOR]

The EFSA Panel on Food Additives and Nutrient Sources added to Food ( ANS) provides a scientific opinion re-evaluating the safety of ammonium phosphatides (E 442) as a food additive. The Scientific Committee on Food ( SCF) and the Joint FAO/ WHO Expert Committee on Food Additives ( JECFA) allocated an acceptable daily intake ( ADI) of 30 mg/kg body weight (bw) per day in 1978 and 1974, respectively. The Panel noted that after oral administration of E 442 ([32P] YN), a proportion of the radioactivity passed through the gastrointestinal tract and was excreted via faeces and also a quantity of radioactivity was absorbed rapidly after dosing as indicated by its presence in the skeletal tissue and liver. Acute oral toxicity of ammonium phosphatides is low and no adverse effects were observed in a 90-day rats study. The Panel considered that ammonium phosphatides did not raise concern for genotoxicity. The Panel identified no observed adverse effect levels ( NOAELs) of 8,500 and 3,000 mg/kg bw per day, the highest doses tested, from dietary chronic and carcinogenicity studies with ammonium phosphatides in mice and rats, respectively. No effects on reproduction and development were observed in a dietary two-generation reproductive toxicity study at the only dose tested of 3,000 mg/kg bw per day, and in addition, no maternal or developmental effects were recognised in a dietary prenatal developmental toxicity study up to a dose of 4,774 mg/kg bw per day. Based on the available toxicological database, the Panel concluded that there is no reason to revise the current ADI for ammonium phosphatides of 30 mg/kg bw per day. Considering that the ADI is not exceeded in any population group, the Panel also concluded that the use of ammonium phosphatides (E 442) as a food additive, at the permitted or reported use and use levels, would not be of safety concern. [ABSTRACT FROM AUTHOR]

The present scientific opinion deals with the safety of trimagnesium dicitrate anhydrous ( TMDC) when used as a stabiliser and anticaking agent in food supplements in solid and chewable forms. TMDC is a magnesium salt of citric acid in the anhydrous form. Following oral ingestion, TMDC is expected to fully and readily dissociate into magnesium and citrate ions. The toxicological data provided in support of the current application were not in accordance with the Tier 1 requirement of the 'Guidance for submission for food additive evaluations'; however, this was considered to be justified by the Panel given that both magnesium and citrate are natural constituents of the diet and also the human body. Exposure estimates to TMDC from its proposed use were calculated for both typical and maximum use levels alongside the resulting intake of magnesium and citrate. At the proposed typical level, the intake of magnesium resulting from the use of TMDC would be below the tolerable upper level ( UL) of 250 mg/day for supplemental magnesium. In the worst case scenario of high-level intakes of TMDC when used at the maximum proposed use level of 120,000 mg/kg, the maximum estimated intake of magnesium would be 311 mg/day per day in the elderly and 389 mg/day in adults, in both cases above the UL. The Panel noted that the intake of both magnesium and citrate resulting from the proposed use and use levels of TMDC appears to be within the normal dietary intake in the general population. The Panel concluded that there was no safety concern from the proposed typical use levels of TMDC as a stabiliser and anticaking agent in food supplements, whereas at the proposed maximum use levels, the resulting exposure to magnesium in adults and the elderly at the high-level would be above the UL. [ABSTRACT FROM AUTHOR]