Numerical Acceptable Daily Intake Research Articles

Re‐evaluation of tragacanth (E 413) as a food additive

The Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion re‐evaluating the safety of tragacanth (E 413) as a food additive. In the EU, tragacanth (E 413) has been evaluated by the Scientific Committee for Food (SCF, 1989) and by the Joint FAO/WHO Expert Committee on Food Additives (JECFA, 1987), who both allocated an acceptable daily intake (ADI) ‘not specified’ for this gum. 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. Tragacanth (E 413) is unlikely to be absorbed intact and is partially fermented by intestinal microbiota. No adverse effects were reported in carcinogenicity studies at the highest dose tested and there is no concern with respect to the genotoxicity. Oral daily intake of a large amount of tragacanth up to 9,900 mg tragacanth/person per day (approximately equivalent 141 mg tragacanth/kg body weight (bw) per day) for up to 21 days was well tolerated in humans. The Panel concluded that there is no need for a numerical ADI for tragacanth (E 413) and that there is no safety concern for the general population at the refined exposure assessment of tragacanth (E 413) as a food additive at the reported uses and use levels.

Re-evaluation of soybean hemicellulose (E426) as a food additive.

Following a request from the European Commission, the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) was asked to deliver a scientific opinion on the re‐evaluation of soybean hemicellulose (E 426) as a food additive. Soybean hemicellulose is not absorbed intact, but is extensively fermented by the intestinal microflora in animals and humans. No adverse effects were reported in a 90‐day dietary toxicity study in rats at the highest doses tested of 2,430 mg/kg body weight (bw) per day for males and 2,910 mg/kg bw per day for females. Furthermore, soybean hemicellulose is not of genotoxic concern. The highest exposure estimates calculated based on the maximum permitted levels were up to 191 mg/kg bw per day for children (95th percentile). Given the limited uses, if any, reported, the Panel considered it probable that the actual dietary exposure to soybean hemicellulose (E 426) would be negligible. Following the conceptual framework for the risk assessment of certain food additives, the Panel concluded that it is very unlikely that there is a safety concern from the current use of soybean hemicellulose (E 426) as a food additive, and that there is no need for a numerical acceptable daily intake (ADI). The Panel recommended that the amount of residual proteins in E 426 should be reduced as much as possible, and that consumers should be informed of the presence of potentially allergenic proteins in the food additive.

Re-evaluation of glycerol (E422) as a food additive.

The ANS Panel provides a scientific opinion re‐evaluating the safety of glycerol (E 422) used as a food additive. In 1981, the Scientific Committee on Food (SCF) endorsed the conclusion from the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 1976 of ‘acceptable daily intake (ADI) for man not specified’. The Panel concluded that glycerol has low acute toxicity and that local irritating effects of glycerol in the gastrointestinal tract reported in some gavage studies was likely due to hygroscopic and osmotic effects of glycerol. Glycerol did not raise concern with respect to genotoxicity and was of no concern with regard to carcinogenicity. Reproductive and prenatal developmental studies were limited to conclude on reproductive toxicity but no dose‐related adverse effects were reported. None of the animal studies available identified an adverse effect for glycerol. The Panel conservatively estimated the lowest oral dose of glycerol required for therapeutic effect to be 125 mg/kg bw per hour and noted that infants and toddlers can be exposed to that dose by drinking less than the volume of one can (330 mL) of a flavoured drink. The Panel concluded that there is no need for a numerical ADI and no safety concern regarding the use of glycerol (E 422) as a food additive at the refined exposure assessment for the reported uses. The Panel also concluded that the manufacturing process of glycerol should not allow the production of a food additive, which contains genotoxic and carcinogenic residuals at a level which would result in a margin of exposure below 10,000. The Panel recommended modification of the EU specifications for E 422. The Panel also recommended that more information on uses and use levels and analytical data should be made available to the Panel.

Re-evaluation of guar gum (E412) as a food additive.

The Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion re‐evaluating the safety of guar gum (E 412) as a food additive. In the EU, guar gum was evaluated by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 1970, 1974 and 1975, who allocated an acceptable daily intake (ADI) ‘not specified’. Guar gum has been also evaluated by the Scientific Committee for Food (SCF) in 1977 who endorsed the ADI ‘not specified’ allocated by JECFA. 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. Guar gum is practically undigested, not absorbed intact, but significantly fermented by enteric bacteria in humans. No adverse effects were reported in subchronic and carcinogenicity studies at the highest dose tested; no concern with respect to the genotoxicity. Oral intake of guar gum was well tolerated in adults. The Panel concluded that there is no need for a numerical ADI for guar gum (E 412), and there is no safety concern for the general population at the refined exposure assessment of guar gum (E 412) as a food additive. The Panel considered that for uses of guar gum in foods intended for infants and young children the occurrence of abdominal discomfort should be monitored and if this effect is observed doses should be identified as a basis for further risk assessment. The Panel considered that no adequate specific studies addressing the safety of use of guar gum (E 412) in food categories 13.1.5.1 and 13.1.5.2 were available. Therefore, the Panel concluded that the available data do not allow an adequate assessment of the safety of guar gum (E 412) in infants and young children consuming these foods for special medical purposes.

Re-evaluation of locust bean gum (E410) as a food additive.

Following a request from European Commission, the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion re‐evaluating the safety of locust bean gum (E 410) as a food additive. Locust bean gum (E 410) is an authorised food additive in the EU. Locust bean gum (E 410) as specified in the Commission Regulation (EU) No 231/2012 is derived from the ground endosperm of the seeds of the strains of carob tree, Ceratonia siliqua (L.) Taub. (Family Leguminosae). An acceptable daily intake (ADI) ‘not specified’ was allocated by the Joint Food and Agriculture Organization/World Health Organization Expert Committee on Food Additives (JECFA) in 1981. Although not evaluated by the Scientific Committee for Food (SCF), it was accepted by the SCF in 1991 for use in weaning food, and in 1994, in infant formulae for special medical purposes. Locust bean gum is practically undigested, not absorbed intact, but significantly fermented by enteric bacteria in humans. No adverse effects were reported in 90‐day toxicity and carcinogenicity studies in rodents at the highest doses tested and there was no concern with respect to the genotoxicity and to reproductive and developmental toxicity of locust bean gum (E 410). The Panel concluded that there is no need for a numerical ADI for locust bean gum (E 410), and that there is no safety concern for the general population at the refined exposure assessment for its reported uses as a food additive. However, infants and young children consuming foods for special medical purposes may show a higher susceptibility to gastrointestinal effects of locust bean gum due to their underlying medical condition. The Panel concluded that the available data do not allow an adequate assessment of the safety of locust bean gum (E 410) in these foods for infants and young children.

Re‐evaluation of karaya gum (E 416) as a food additive

Following a request from the European Commission, the EFSA Panel on Food Additives and Nutrient sources added to Food (ANS) was asked to deliver a scientific opinion on the re-evaluation of karaya gum (E 416) as a food additive. Karaya gum (E 416) is an authorised food additive in the EU. Karaya gum (E 416) as specified in the Commission Regulation (EU) No 231/2012 is derived from the exudates from the stems and branches of strains of Sterculia urens Roxburgh and other species of Sterculia (family Sterculiaceae) or from Cochlospermum gossypium A.P. De Candolle or other species of Cochlospermum (family Bixaceae). An acceptable daily intake (ADI) ‘not specified’ was allocated by the Joint Food and Agriculture Organization/World Health Organization Expert Committee on Food Additives (JECFA), whereas the Scientific Committee for Food (SCF) allocated an ADI of 12.5 mg/kg body weight (bw) per day. Karaya gum is practically undigested and not degraded by intestinal microflora and it is most probably not or only negligibly absorbed unchanged in humans. There is no concern with respect to the genotoxicity of karaya gum from Sterculia spp. Karaya gum (E 416) from Sterculia spp. did not induce toxic effects in animals at dose levels up to 1,250 mg/kg bw per day, the highest dose tested. Karaya gum from Sterculia spp. was well tolerated in humans at dose about 100 mg/kg bw per day for 4 weeks. The Panel concluded that there is no safety concern at the refined exposure assessment for the use of karaya gum as a food additive and that there is no need for a numerical ADI for karaya gum. The Panel further concluded that exposure to karaya gum by the use of this food additive should not exceed 7,000 mg/person per day in adults, the level at which some experienced abdominal discomfort.

Scientific Opinion on the re‐evaluation of chlorophylls (E 140(i)) as food additives

Chlorophylls (E 140(i)) were previously evaluated by Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 1969 and the Scientific Committee on Food (SCF) in 1975 and 1983 and, in relation to special medical purposes, for young children in 1996. Neither of the Committees established a numerical Acceptable Daily Intake (ADI). Specifications should be updated to adequately cover chlorophylls (E 140(i)), as currently up to 90 % of the extract is unidentified and chlorophylls (E 140(i)) may be obtained from sources that could not be regarded as regular edible plant materials or foods (grass, lucerne, nettle) for humans. Based on the origin of chlorophylls (E 140(i)), the Panel also concluded that data on pesticides, mycotoxins and other components with biological activity (e.g. phytoestrogens, phytotoxins and allergens) should be included in the specification and kept as low as possible to avoid any potential adverse effects (allergenicity, endocrinal effects). The few biological data available indicate that chlorophylls are poorly absorbed by humans and are not metabolised to chlorophyllins (the dephytylated form of chlorophylls). The Panel considered that the few toxicological studies available for chlorophylls were limited and did not comply with the Organisation of Economic Co-operation and Development (OECD) guidelines or current regulatory requirements, and therefore did not allow for an ADI to be established. The Panel concluded that the available database for chlorophylls was inadequate for risk assessment. However, chlorophylls are natural dietary constituents, which are present at relatively high concentrations in a number of foods. In addition, the exposure resulting from the use of chlorophylls (E 140(i)) as food additives is lower than the exposure to chlorophylls from the regular diet. Therefore, the Panel concluded that, at the reported use levels, chlorophylls (E 140(i)) are not of safety concern as regards their current use as food additives.

Dietary exposure of the Belgian adult population to 70 food additives with numerical ADI

The safety of the use of food additives is evaluated through the intake assessment of the additives for the consumer. A stepwise approach (using EFSA's Food Additives intake model (FAIM), followed by Tier 2 and refined Tier 2) was used to assess the exposure of the Belgian adult population to food additives. Additives for which the daily intake exceeded the acceptable daily intake (ADI) were subjected to the next evaluation step. In total 70 additives with numerical ADI were identified on labels of food products for sale in the 5 most frequented supermarkets in Belgium. According to the refined Tier 2 assessment, the ADI could be exceeded for the stearoyl-2-lactylates and polysorbates. It was further concluded that the exposure to phosphates, sorbitan monolaurate, sorbitan monooleate, as well as to those additives with numerical ADI which are permitted as quantum satis, are to be studied further by using real use levels (Tier 3).

An Analysis of the Possibility for Health Implications of Joint Actions and Interactions between Food Additives

The possibility that structurally unrelated food additives could show either joint actions or interactions has been assessed based on their potential to share common sites and mechanisms of action or common pathways of elimination. All food additives approved in the European Union and allocated numerical acceptable daily intake values were studied, initially based on the reports by the FAO–WHO Joint Expert Committee for Food Additives. Target organs were identified based on the effects reported at doses above the no-observed-adverse-effect level (NOAEL) in animal and human studies. The descriptions of the pathological and other changes reported were used to assess whether different additives, sharing the same target organ, would produce a common toxic effect. In all but a very few cases, the possibility of joint actions or interactions could be excluded on scientific grounds. The exceptions were on the liver (curcumin, thiabendazole, propyl gallate, and BHT), the kidney (diphenyl, o-phenylphenol, and ferrocyanide salts), the blood (azorubine and propyl gallate), and the thyroid (erythosine, thiabendazole, and nitrate). Toxicokinetic interactions were considered unlikely because of the low dosages involved, the diverse nature of the routes of metabolism and elimination, and the fact that enzyme induction or inhibition would have influenced selection of the NOAEL. Many of those additives which could not be excluded from showing joint actions or interactions would have low intakes; in some cases they were alternatives for the same application, thereby further lowering the combined intake. In consequence, joint actions or interactions between additives do not represent a significant health concern.