Scientific Opinion on the re‐evaluation of ascorbyl palmitate (E 304(i)) and ascorbyl stearate (E 304(ii)) as food additives

Abstract

The EFSA Panel on Food Additives and Nutrient Sources added to Food provides a scientific opinion reevaluating the safety of ascorbyl palmitate (E 304(i)) and ascorbyl stearate (E 304(ii)) as food additives. The use of these food additives was evaluated by the Joint FAO/WHO Expert Committee on Food Additives and by the Scientific Committee on Food. Biological data on ascorbyl palmitate and stearate are sparse and the safety assessment of them for use as food additives is mainly based on the assumption that ascorbyl palmitate and ascorbyl stearate fully hydrolyse pre-systemically to ascorbic acid and their respective fatty acids. This was supported by an in vitro study reporting near-complete hydrolysis of ascorbyl palmitate in simulated intestinal fluid and by human data. The Panel considered that the toxicity of ascorbyl palmitate can be extrapolated from data describing the toxicity of ascorbic acid and palmitic acid and further considered that this assumption is also valid for ascorbyl stearate. The Panel concluded that the available toxicological data were too limited to establish an ADI for ascorbyl palmitate (E 304(i)) or ascorbyl stearate (E 304(ii)). Exposure estimates based on the high percentile for the maximum level exposure scenario range from 0.4 to 10.8 mg/kg bw/day across all population groups and from 0.3 to 9.9 mg/kg bw/day for the refined brand-loyal scenario. Considering the available data, the Panel concluded that there is no safety concern for the use of ascorbyl palmitate (E 304(i)) and ascorbyl stearate (E 304(ii)) as food additives at the reported uses and use levels. for the preparatory work on this scientific opinion and EFSA staff members: Ana Rincon and AlesandraTard for the support provided to this scientific opinion. The ANS Panel wishes to acknowledge all European competent institutions, Member State bodies and other organisations that provided data for this scientific output.Re-evaluation of ascorbyl palmitate (E 304(i)) and ascorbyl stearate (E 304(ii)) EFSA Journal 2015;13(11):4289 4

Effects of antioxidants on physicochemical properties and odorants in heat processed beef flavor and their antioxidant activity under different storage conditions

“…This could be associated with the initial acidity of HPBF or the stability and structure of L-AP. Under acidic conditions, L-AP could be entirely hydrolyzed to ascorbic acid and their respective fatty acids in the reporter of EFSA and ANS ( 43 ), which affect its own free radical scavenging ability. Comparatively, TBHQ had a noticeable effect on scavenging free radicals terminating the free radical chain reaction, which could be attributed to its molecular structure, high thermal resistance and stability.…”

Development of celiac-safe foods: prevention of transglutaminase 2 (TG2) deamidation of gluten in healthy non-celiac volunteers

“…E304i, ascorbyl palmitate, is generally recognized as safe (GRAS) and approved by the US Food and Drug Administration (USFDA) as a food additive. It is frequently used as an antioxidant or as a fat-soluble form of vitamin C. The European Food Safety Authority (EFSA) is in line with the American authorities and has also concluded that there is no safety concern regarding using E304i as a food additive ( 15 ). According to EFSA, E304i is considered to have the same biological effects as ascorbic acid, and from human data, it was concluded that supplementary doses of approximately 1 g/person per day in addition to normal dietary intake are not associated with adverse gastrointestinal effects, but gastrointestinal acute effects may occur at doses exceeding 3–4 g/day.…”

Natural Food Colorants and Preservatives: A Review, a Demand, and a Challenge

“…However, its application as a substitute for nitrites in foods is very limited due to its pro-oxidant behavior . Calcium ascorbate (E302) is used in dairy products, cured or cooked meat products, to dip freshly cut fruit and prevent browning, to intensify the color of cured meat, and to act as a synergist for other antioxidants. , Fatty acid esters of ascorbic acid (E304) can be used in dairy products, chewing gums, cereals, meats, desserts, salads, sauces, and others . Erythorbates (E315–E316) are mostly dissipated in cured meats, frozen fruits, vegetables, oils, fats, seafood, and fish with the function of reducing the formation of nitrosamines during curing or cooking .…”

“… 138 , 139 Fatty acid esters of ascorbic acid (E304) can be used in dairy products, chewing gums, cereals, meats, desserts, salads, sauces, and others. 140 Erythorbates (E315–E316) are mostly dissipated in cured meats, frozen fruits, vegetables, oils, fats, seafood, and fish with the function of reducing the formation of nitrosamines during curing or cooking. 141 Sodium lactate (E325) and potassium lactate (E326) are used as antimicrobials in processed and unprocessed meats, sausages, meat burgers, and fish.…”