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And Calcium Ascorbate (E 302) As Food Additives1

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And Calcium Ascorbate (E 302) As Food Additives1 EFSA Journal 2015;13(5):4087 SCIENTIFIC OPINION Scientific Opinion on the re-evaluation of ascorbic acid (E 300), sodium ascorbate (E 301) and calcium ascorbate (E 302) as food additives1 EFSA Panel on Food additives and Nutrient Sources added to Food (ANS)2,3 European Food Safety Authority (EFSA), Parma, Italy ABSTRACT The EFSA Panel on Food additives and Nutrient Sources added to Food (ANS Panel) provides a scientific opinion re-evaluating the safety of ascorbic acid (E 300), sodium ascorbate (E 301) and calcium ascorbate (E 302) as food additives. The use of ascorbic acid and its salts as food additives was evaluated by the Joint FAO/WHO Expert Committee on Food Additives and by the Scientific Committee on Food. Ascorbic acid is absorbed from the intestine by a sodium-dependent active transport process and, at low doses, the absorption is almost complete until a saturation point, after which increasing amounts of unabsorbed substance are excreted. Ascorbic acid and its salts have very low acute toxicities, and short-term tests in animals showed little effect, and even so only at high doses. The Panel concluded that there is no genotoxicity concern for ascorbic acid, sodium ascorbate or calcium ascorbate. Long-term carcinogenicity tests with ascorbic acid did not show any chronic toxicity, even at high doses, and also showed no signs of carcinogenicity. Prenatal developmental studies did not show adverse developmental effects. The Panel estimated the combined exposure to ascorbic acid (E 300), calcium ascorbate (E 301) and sodium ascorbate (E 302). The Panel concluded that, given the fact that adequate data on exposure and toxicity were available and no adverse effects were reported in animal studies, there is no safety concern for the use of ascorbic acid (E 300), sodium ascorbate (E 301) and calcium ascorbate (E 302) as food additives at the reported uses and use levels and there is no need for a numerical ADI for ascorbic acid and its salts. © European Food Safety Authority, 2015 KEY WORDS Food additives, ascorbic acid (E 300), sodium ascorbate (E 301), calcium ascorbate (E 302), vitamin C 1 On request from the European Commission, Question No EFSA-Q-2011-00470, No EFSA-Q-2011-00471 and No EFSA- Q-2011-00472 adopted on 14 April 2015. 2 Panel members: Fernando Aguilar, Riccardo Crebelli, Alessandro Di Domenico, Birgit Dusemund, Maria Jose Frutos, Pierre Galtier, David Gott, Ursula Gundert-Remy, Claude Lambré, Jean-Charles Leblanc, Oliver Lindtner, Peter Moldeus, Alicja Mortensen, Pasquale Mosesso, Dominique Parent-Massin, Agneta Oskarsson, Ivan Stankovic, Ine Waalkens- Berendsen, Rudolf Antonius Woutersen, Matthew Wright and Maged Younes. Correspondence: [email protected] 3 Acknowledgement: The Panel wishes to thank the members of the former Working Group “B” Food Additives and Nutrient Sources (2011–2014) and the members of the Standing Working Group on the re-evaluation of food additives other than gums and colours: Polly Ester Boon, Dimitrios Chrysafidis, Birgit Dusemund, David Gott, Rainer Gürtler, Ursula Gundert-Remy, Claude Lambré, Jean-Charles Leblanc, Daniel Marzin, Peter Moldeus, Pasquale Mosesso, Dominique Parent-Massin, Ivan Stankovic, Paul Tobback, Ine Waalkens-Berendsen, Rudolf Antonius Woutersen and Matthew Wright, for the preparatory work on this scientific opinion, and EFSA staff members, Anna Christodoulidou, Ana Rincon and Alexandra Tard, for the support provided to this scientific opinion. EFSA acknowledges those European competent authorities, food industry and other stakeholders that provided occurrence data (usage and analytical data) on ascorbic acid (E 300), sodium ascorbate (E 301) and calcium ascorbate (E 302) in food and beverages, and supported the data collection for the Comprehensive European Food Consumption Database. Suggested citation: EFSA ANS Panel (EFSA Panel on Food Additives and Nutrient Sources added to Food), 2015.Scientific Opinion on the re-evaluation of ascorbic acid (E 300), sodium ascorbate (E 301) and calcium ascorbate (E 302) as food additives. EFSA Journal 2015;13(5):4087, 124 pp. doi:10.2903/j.efsa.2015.4087 Available online: www.efsa.europa.eu/efsajournal © European Food Safety Authority, 2015 Re-evaluation of ascorbic acid, sodium ascorbate and calcium ascorbate as food additives SUMMARY Following a request from the European Commission (EC), the Panel on Food Additives and Nutrient Sources added to Food (ANS) was asked to deliver a scientific opinion re-evaluating the safety of ascorbic acid (E 300), sodium ascorbate (E 301) and calcium ascorbate (E 302) as food additives. The Panel was not provided with a newly submitted dossier and no new toxicological or biological information was submitted for the present re-evaluation. The Panel based its evaluation on previous evaluations, additional literature that had become available since the previous evaluations and the data available following a public call for data. Ascorbic acid (E 300), sodium ascorbate (E 301) and calcium ascorbate (E 302) are authorised in the European Union (EU) as food additives in accordance with Annex II and Annex III of Regulation (EC) No 1333/2008. The use of ascorbic acid and ascorbates as food additives has been evaluated by the Joint FAO/WHO expert Committee on Food Additives (JECFA), the latest evaluation being in 1981, and by the Scientific Committee on Food (SCF), in 1987. Both committees found the use of the substances acceptable. The question of the tolerable upper intake levels of calcium and sodium has been addressed by the SCF and by the European Food Safety Authority (EFSA) (SCF, 2003; EFSA, 2005). The SCF also evaluated the use of ascorbic acid and its salts as food additives in infant formulae and in food for infants in good health and in foods for special medical purposes for infants and young children (SCF, 1994, 1998). Ascorbic acid undergoes degradation in an aqueous environment as well as in food. The degradation rate and the decomposition pathways and products depend on various factors such as pH, temperature, light, concentration and matrix composition. Under specific conditions, degradation can proceed all the way down to very simple compounds (e.g. threonic acid, glyoxylic acid and carbon dioxide); however, in general, the presence of a variety of more complex products can be observed at intermediate degradation stages. For the majority of the degradation products, there is no indication of genotoxic and/or carcinogenic risk. Ascorbic acid is absorbed from the intestine by a sodium-dependent active transport process and, at low doses, the absorption is almost complete until a saturation point after which increasing amounts of unabsorbed substance are excreted with the faeces. The major metabolite in the organism is dehydroascorbic acid, which can be reduced back to ascorbic acid and still has vitamin C activity. Dehydroascorbic acid can be further irreversibly oxidised to mainly L-threonic acid and oxalic acid, as well as a number of minor metabolites. Ascorbic acid and its sodium and calcium salts have very low acute toxicities, and short-term tests on ascorbic acid in various laboratory animals show little effect, and even so only at high doses. Chronic toxicity and carcinogenicity studies with ascorbic acid do not show any chronic toxicity, even at high doses, and also show no signs of carcinogenicity. However, sodium ascorbate administered at 5 % in the feed, but not ascorbate in equimolar concentration, has been shown to promote bladder cancer in male rats treated with an initiator of bladder cancer. This effect was, however, attributed to the sodium ion in line with the mechanism behind the carcinogenic effect of sodium saccharin, rather than to an effect of ascorbate, and was thus considered of no relevance for the use of sodium ascorbate. The Panel noted that ascorbic acid or sodium ascorbate alone did not show any mutagenic potential. In some in vitro test systems including redox active substances, especially redox active metal ions, ascorbic acid and sodium ascorbate may act as pro-oxidants, thereby increasing the mutagenic potential of redox active metals or other compounds. These in vitro effects have not been confirmed in in vivo studies. EFSA Journal 2015;13(5):4087 2 Re-evaluation of ascorbic acid, sodium ascorbate and calcium ascorbate as food additives The Panel considered that it is unlikely that ascorbic acid and sodium ascorbate are genotoxic. In the absence of genotoxicity data on calcium ascorbate, the Panel considered that the read across approach for calcium ascorbate was possible. Overall, the Panel concluded that there is no genotoxicity concern for ascorbic acid, sodium ascorbate or calcium ascorbate. The Panel also noted that potential reaction products which may result from the interaction of sorbic acid with ascorbic acid in the presence of iron salts were demonstrated to be mutagenic in vitro and that there are certain food categories for which the use of these food additives is permitted in parallel. However, these reaction products have only been shown to be formed under optimal experimental conditions in an aqueous environment and are thus unlikely to be formed to any major extent in food matrices. Consequently these interactions appear to be of limited significance and concern. Prenatal developmental studies in mice, rats, hamsters and guinea pigs did not show adverse developmental effects. Studies on reproductive toxicity were not available. In studies in humans, vitamin C has been investigated for the treatment of vitamin C deficiency and various diseases. Typically, the studies focused on potential positive effects, and any description of possible side-effects were mostly anecdotal, lacked control groups and were difficult to interpret. The Panel also noted that a common concern is the possible formation of oxalate stones following the intake of large doses of ascorbic acid. The epidemiology studies give a strong indication that a daily intake of vitamin C below 1 500 mg is not a risk factor for the formation of kidney stones.
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