Polyglycerol esters of fatty acids (PEFA) (E 475) is authorised as a food additive in the European Union (EU) in accordance with Annex II and Annex III to Regulation (EC) No 1333/2008 on food additives and specific purity criteria have been defined in the Commission Regulation (EU) No 231/2012.
In 1978, the Scientific Committee on Food (SCF) endorsed an acceptable daily intake (ADI) of 25 mg/kg body weight (bw) per day previously established by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 1974 based on a long-term feeding study in rats showing no adverse effects at 5% PEFA in the diet (corresponding to 2,500 mg/kg bw per day). In addition, JECFA stated that alterations in the fatty acids distribution or the polyglycerol content of the food additive polyglycerol esters of fatty acids would have no toxicological bearing but requested proper biochemical studies on other members of PEFA, particularly those containing short-chain fatty acids. In 1990, JECFA discussed a request to alter the specifications of PEFA and to increase the average polyglycerol chain lengths permitted from three to ten glycerol units. However, the Committee was unable to accept this request since no data supporting this request were submitted. Finally, JECFA decided to maintain the ADI of 0–25 mg/kg bw per day for PEFA having an average chain length of up to three glycerol units.
According to the EU specifications for E 475, PEFA (E 475) is a mixture of reaction products formed by the esterification of polyglycerols with food fats and oils or with fatty acids occurring in foods, fats and oils. The polyglycerol moiety is predominantly di-, tri- and tetraglycerol and contains not more than 10% of polyglycerols equal to or higher than heptaglycerol. According to the information provided by industry on fatty acid composition of vegetable fats and oils used for the manufacturing process of E 475, palmitic acid, stearic acid, oleic acid and linoleic acid are the main fatty acids present in the raw materials.
Depending on manufacturing processes and starting materials, toxic and potentially carcinogenic impurities such as epichlorohydrin, glycidol, erucic acid and trans-fatty acids may be present in PEFA (E 475). There is thus a need to include maximal levels for these impurities in the specifications of polyglycerol esters of fatty acids (E 475).
The dietary exposure to PEFA (E 475) from its use as a food additive was calculated according to different scenarios. PEFA (E 475) is authorised in 16 food categories; seven data on use levels were provided for only three food categories. The majority of these data (six out of seven) were related to niche products. Furthermore, the Panel noted that, considering information from the Mintel’s Global New Products Database (GNPD), PEFA (E 475) is used in some food categories for which no use levels were provided to the European Food Safety Authority (EFSA), such as dietary supplements, eggs and egg products, desserts and dairy analogues, including beverage whiteners. The Panel further noted that the exposure to polyglycerol esters of fatty acids (E 475) from its use according the Annex III to Regulation (EC) No 1333/2008 (Part 1, 2, 5) was not considered in the exposure assessment. Therefore, the exposure to polyglycerol esters of fatty acids (E 475) in the refined exposure scenarios may have been underestimated. However, the possible underestimation of the exposure may have been negated by the assumption that all foods belonging to one of the three included food categories contain the food additive, whereas according to the Mintel’s GNPD on average only 1.2% of the authorised food items contained polyglycerol esters of fatty acids (E 475). The use of use levels in niche products in the refined exposure estimation may also have contributed to an overestimation of the exposure. Niche products are often specific products that contain different, often higher, levels of a food additive than the other foods belonging to the same food category. Applying these levels to all foods may have resulted in an overestimation of the exposure. The exposure in the regulatory maximum level exposure scenario is very likely overestimated; 11 food categories were included assuming that all foods belonging to a food category contain the additive at a level equal to the maximum permitted level (MPL).
Based on the considerations described above, the Panel considered that the uncertainties identified would, in general, result in an overestimation of the exposure to PEFA (E 475) as a food additive in all exposure scenarios assuming that the food additive is not used in the food categories in which it is permitted but for which no usage data were provided.
The Panel did not identify brand loyalty to a specific food category for the exposure to polyglycerol esters of fatty acids (E 475), and therefore considered the non-brand-loyal scenario covering the general population as the most appropriate and realistic scenario for risk characterisation of the food additive. It is assumed that the population is most likely exposed long-term to polyglycerol esters of fatty acids (E 475) present at the mean reported use in processed food. Based on these exposure estimates, it is not likely that the exposure to PEFA (E 475) will exceed the current ADI of 25 mg/kg bw per day set by JECFA and endorsed by the SCF.
Polyglycerol esters of fatty acids were hydrolysed in the gastrointestinal tract followed by absorption of polyglycerol and the fatty acid moiety. Although the polyglycerol appears to be excreted unchanged, the fatty acids were either rapidly metabolised to carbon dioxide or incorporated in the body.
The Panel noted that the available data showed a very low acute oral toxicity of polyglycerol esters of fatty acids. There were several short-term or subchronic toxicity studies with PEFA. The studies have limitations; however, no adverse effects were observed up to 10% in the diet (equivalent to 9,000 mg/kg bw per day), the highest dose tested. The available limited information on the genotoxicity of PEFA did not indicate a genotoxic potential. The available chronic toxicity and carcinogenicity studies with PEFA in mice and rats also had limitations. However, none of these studies gave any indication of a carcinogenic potential of polyglycerol esters of fatty acids. No maternal, reproductive or developmental toxicity were reported from two old dietary three-generation reproductive toxicity studies. Prenatal developmental toxicity studies were not available.
In a clinical study with limited information, 37 volunteers were exposed to 2–20 g polyglycerol esters of fatty acids per day (up to 300 mg/kg bw per day) for 3 weeks. Clinical chemistry and urinalysis did not reveal any adverse effects.
The Panel noted that very few relevant studies on the biological effects of PEFA have been published since the JECFA and the SCF evaluations. The Panel also noted that no adverse effects of polyglycerol esters of fatty acids at any dose have been observed in short-term, subchronic or chronic toxicity studies. A no observed adverse effect level (NOAEL) of 9,000 mg/kg bw per day was identified from subchronic studies and of 2,500 mg/kg bw per day from chronic studies, the highest doses tested. The limited information on genetic toxicity did not identify any genotoxic potential of polyglycerol esters of fatty acids. The available reproductive toxicity studies showed no adverse effects of PEFA but had major limitations.
Furthermore, the Panel noted that the absorption of intact polyglycerol esters of fatty acids before hydrolysis to polyglycerols and fatty acids in the gastrointestinal tract is extremely low. The safety of polyglycerols and fatty acids has recently been assessed in the opinions on the re-evaluation of polyglycerol polyricinoleate (E 476) and of fatty acids (E 570). No adverse effects of polyglycerols or fatty acids were identified in studies reported in these opinions.
- absorption of intact PEFA in the gastrointestinal tract was extremely low;
- PEFA was rapidly and almost fully hydrolysed to polyglycerols and fatty acids in the gastrointestinal tract;
- The safety of polyglycerols and specific fatty acids has recently been assessed and no adverse effects were identified in the available studies even at the highest doses tested;
- Although limited, the available database on PEFA did not give any indication of adverse effects in short-term, subchronic, chronic, or reproductive toxicity studies neither of any genotoxic potential;
- in a clinical study with limited information, volunteers exposed to PEFA (up to 300 mg/kg bw per day for 3 weeks), clinical chemistry and urinalysis did not reveal any adverse effects;
- the highest exposure to PEFA used as a food additive was 2.6 and 6.4 mg/kg bw per day in children at the mean and the 95th percentile, respectively, at the non-brand loyal scenario.
The Panel concluded that the food additive polyglycerol esters of fatty acids (E 475) was not of safety concern at the reported uses and use levels and that there was no need for a numerical ADI.
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 PEFA (E 475 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 PEFA (E 475) including maximum limits for epichlorohydrin and glycidol, given that during the manufacturing processes of polyglycerols these genotoxic impurities could be present.
- the European Commission considers revising the EU specifications for PEFA (E 475) including maximum limits for trans fatty acids because PEFA (E 475) 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 PEFA (E 475) including maximum limits for glycidyl esters/glycidol and 3-monochloropropane-1,2-diol (3-MCPD) esters, because it is likely that residues of those substances occur in the food additive PEFA (E 475), if they were present in the raw materials used in the manufacturing of the food additive by transesterification.
- the European Commission considers revising the EU specifications for PEFA (E 475) 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 of PEFA (E 475).
- the European Commission considers revising the EU specifications for PEFA (E 475) 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, 2017a,b,c).