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.

Re‐evaluation of mono‐ and di‐glycerides of fatty acids (E 471) as food additives

“…The Panel recommended that: the European Commission considers lowering the current limits for toxic elements (arsenic, lead, mercury and cadmium) in the EU specifications for mono‐ and di‐glycerides of fatty acids (E 471) in order to ensure that the food additive will not be a significant source of exposure to these toxic elements in food. the European Commission considers revising the EU specifications for mono‐ and di‐glycerides of fatty acids (E 471) including maximum limits for impurities currently included in the EU specifications for glycerol (E 422) or recommended by the Panel in the re‐evaluation of glycerol (E 422) (EFSA ANS Panel, ). the European Commission considers revising the EU specifications for mono‐ and di‐glycerides of fatty acids (E 471) including maximum limits for residual solvents which can be used when manufacturing mono‐ and di‐glycerides of fatty acids (E 471), i.e. tert ‐butanol or tert ‐pentanol. the European Commission considers revising the EU specifications for mono‐ and di‐glycerides of fatty acids (E 471) including maximum limits for trans fatty acids because mono‐ and di‐glycerides of fatty acids (E 471) can be manufactured by glycerolysis of hydrogenated fats and/or oils, which contain significant amounts of trans fatty acids. the European Commission considers revising the EU specifications for mono‐ and di‐glycerides of fatty acids (E 471) including maximum limits for glycidyl esters because refined vegetable oil, which can be used for manufacturing of mono‐ and di‐glycerides of fatty acids (E 471) is the only identified source of glycidyl esters of fatty acids, which are formed during deodorisation. the European Commission considers revising the EU specifications for mono‐ and di‐glycerides of fatty acids (E 471) including maximum limits for erucic acid because erucic acid can be present among the fatty acids in edible oils which can be used for manufacturing of mono‐ and di‐glycerides of fatty acids (E 471). more data should be generated to decrease uncertainty arising from the from the occurrence of compounds of toxicological concern (e.g.…”

“…Accordingly, the Panel considered that it is very likely that hydrolysis of mono‐ and di‐glycerides of fatty acids by lipases in the gastrointestinal tract would occur, resulting in the release of glycerol and fatty acids. The Panel re‐evaluated glycerol (E 422) and fatty acids (E 570) as food additives and concluded that there was no safety concern regarding their use as food additives (EFSA ANS Panel, ,b).…”

Re‐evaluation of acetic acid, lactic acid, citric acid, tartaric acid, mono‐ and diacetyltartaric acid, mixed acetic and tartaric acid esters of mono‐ and diglycerides of fatty acids (E 472a‐f) as food additives

“…All these hydrolysis products are authorised as food additives. Glycerol (E 422) and fatty acids (E 570) were re‐evaluated by the ANS Panel with the conclusion that there were no safety concerns and no numerical ADIs were needed (EFSA ANS Panel, 2017a). Acetic acid (E 260), lactic acid (E 270) and citric acid (E 330) will be re‐evaluated by EFSA.…”

“…According to the available information on the manufacturing process (Section 3.1.3), E 472a‐f can be manufactured by using glycerol as starting material. Therefore, the Panel considered the need to include maximum limits for impurities currently included in the EU specifications for the food additive glycerol (E 422) or recommended by the Panel in its re‐evaluation (EFSA ANS Panel, 2017a) in the EU specifications for the esters of mono‐ and diglycerides of fatty acids (E 472a‐f).…”

“…The Panel recommended that the European Commission: revises the EU specifications for E 472d,e,f by specifying that only l (+)‐tartaric acid can be used in the manufacturing process setting lower limits for toxic elements (arsenic, lead, mercury and cadmium) in the EU specifications for E 472a,b,d,e,f in order to ensure that the food additives will not be a significant source of exposure to those toxic elements in food and includes maximum limits for mercury, arsenic and cadmium, in addition to lead, in EU specifications for E 472c. revises the EU specifications for E 472a‐f including maximum limits for impurities currently set in the EU specifications for glycerol (E 422) as well as those recommended by the Panel in the re‐evaluation of glycerol (E 422) (EFSA ANS Panel et al., 2017a). revises the EU specifications for E 472a‐f including maximum limits for trans ‐fatty acids because partially hydrogenated fats and/or oils, which may contain significant amounts of trans ‐fatty acids; can be used as starting materials for E 472a‐f: revises the EU specifications for E 472a‐f including maximum limits for glycidyl esters/glycidol and 3‐MCPD esters, because it is likely that residues of those substances occur in the food additives E 472a‐f, if they were present in the raw materials used in the manufacturing process of these food additives or formed during the manufacturing process. revises the EU specifications for E 472a‐f including maximum limits for erucic acid since erucic acid can be present among the fatty acids in edible oils, which can be used for manufacturing process of E 472a‐f. includes maximum limits for oxalates in the EU specifications for E 472c,d,e,f, since oxalate can be present in citric acid and l (+)‐tartaric acid that are used in manufacturing process of these food additives. considers to merge specifications of E 472e and 472f, since E 472f is not markedly different from E 472e, when considering the description of their manufacturing process and their composition. …”