Guidance for the assessment of detoxification processes in feed.

This statement provides scientific guidance on the information needed to support the risk assessment of the detoxification processes applied to products intended for animal feed in line with the acceptability criteria of the Commission Regulation (EU) 2015/786.

Assessment of the processing conditions which make the Ambrosia seeds non-viable.

The European Commission requested EFSA to provide an assessment of the processing conditions which make Ambrosia seeds non-viable in feed materials and compound feed. This assessment also includes information on a reliable procedure to verify the non-viability of the seeds. Ambrosia seeds are known contaminants in feed with maximum levels set in the Directive 2002/32/EC. The manufacturing processes and processing conditions applied to the feed may affect the viability of the Ambrosia seeds. Therefore, the CONTAM Panel compared these conditions with conditions that have been shown to be sufficient to render Ambrosia seeds non-viable. The Panel concluded with a certainty of 99-100% that solvent extraction and toasting of oilseed meals at temperatures of 120°C with steam injection for 10 min or more will make Ambrosia seeds non-viable. Since milling/grinding feed materials for compound feed of piglets, aquatic species and non-food producing animals would not allow particles of sizes ≥1 mm (the minimum size of viable Ambrosia seeds) passing the grinding process it was considered very likely (with ≥ 90% certainty) that these feeds will not contain viable Ambrosia seeds. In poultry, pig, and possibly cattle feed, particle sizes are ≥ 1 mm and therefore Ambrosia seeds could likely (66-90% certainty) survive the grinding process. Starch and gluten either from corn or wheat wet milling would not contain Ambrosia seeds with 99-100% certainty. Finally, ensiling fresh forages contaminated with A. artemisiifolia seeds for more than 3 months is very likely to render all seeds non-viable. The Panel concluded that a combination of the germination test and a subsequent triphenyl-tetrazolium-chloride (TTC) test will very likely (with ≥ 90% certainty) verify the non-viability of Ambrosia seeds. The Panel recommends that data on the presence of viable Ambrosia seeds before and after the different feed production processes should be generated.

Risk assessment of N-nitrosamines in food.

EFSA was asked for a scientific opinion on the risks to public health related to the presence of N-nitrosamines (N-NAs) in food. The risk assessment was confined to those 10 carcinogenic N-NAs occurring in food (TCNAs), i.e. NDMA, NMEA, NDEA, NDPA, NDBA, NMA, NSAR, NMOR, NPIP and NPYR. N-NAs are genotoxic and induce liver tumours in rodents. The in vivo data available to derive potency factors are limited, and therefore, equal potency of TCNAs was assumed. The lower confidence limit of the benchmark dose at 10% (BMDL10) was 10 µg/kg body weight (bw) per day, derived from the incidence of rat liver tumours (benign and malignant) induced by NDEA and used in a margin of exposure (MOE) approach. Analytical results on the occurrence of N-NAs were extracted from the EFSA occurrence database (n = 2,817) and the literature (n = 4,003). Occurrence data were available for five food categories across TCNAs. Dietary exposure was assessed for two scenarios, excluding (scenario 1) and including (scenario 2) cooked unprocessed meat and fish. TCNAs exposure ranged from 0 to 208.9 ng/kg bw per day across surveys, age groups and scenarios. 'Meat and meat products' is the main food category contributing to TCNA exposure. MOEs ranged from 3,337 to 48 at the P95 exposure excluding some infant surveys with P95 exposure equal to zero. Two major uncertainties were (i) the high number of left censored data and (ii) the lack of data on important food categories. The CONTAM Panel concluded that the MOE for TCNAs at the P95 exposure is highly likely (98-100% certain) to be less than 10,000 for all age groups, which raises a health concern.

Decontamination process for dioxins and dioxin-like PCBs from fish oil and vegetable oils and fats by a physical process with activated carbon.

Following a request from the European Commission, the EFSA Panel on Contaminants in the Food Chain (CONTAM) assessed a decontamination process of fish oils and vegetable oils and fats to reduce the concentrations of dioxins (polychlorinated dibenzo-p-dioxins and polychlorinated dibenzofurans, abbreviated together as PCDD/Fs) and dioxin-like polychlorinated biphenyls (DL-PCBs) by adsorption to activated carbon. All feed decontamination processes must comply with the acceptability criteria specified in the Commission Regulation (EU) 2015/786. Data provided by the feed food business operator (FBO) were assessed for the efficacy of the process and to demonstrate that the process did not adversely affect the characteristics and properties of the product. The limited information provided, in particular on the analysis of the samples before and after decontamination, did not allow the CONTAM Panel to conclude whether or not the proposed decontamination process is effective in reducing PCDD/Fs and DL-PCBs in the fish- and vegetable oils and fats. Although there is no evidence from the data provided that the decontamination process leads to detrimental changes in the nutritional composition of the fish- and vegetable oils, it is possible that the process could deplete some beneficial constituents (e.g. vitamins). Taken together, it was not possible for the CONTAM Panel to conclude that the decontamination process as proposed by the FBO is compliant with the acceptability criteria provided for in Commission Regulation (EU) 2015/786 of 19 May 2015.

The efficacy and safety of high-pressure processing of food.

High-pressure processing (HPP) is a non-thermal treatment in which, for microbial inactivation, foods are subjected to isostatic pressures (P) of 400-600 MPa with common holding times (t) from 1.5 to 6 min. The main factors that influence the efficacy (log10 reduction of vegetative microorganisms) of HPP when applied to foodstuffs are intrinsic (e.g. water activity and pH), extrinsic (P and t) and microorganism-related (type, taxonomic unit, strain and physiological state). It was concluded that HPP of food will not present any additional microbial or chemical food safety concerns when compared to other routinely applied treatments (e.g. pasteurisation). Pathogen reductions in milk/colostrum caused by the current HPP conditions applied by the industry are lower than those achieved by the legal requirements for thermal pasteurisation. However, HPP minimum requirements (P/t combinations) could be identified to achieve specific log10 reductions of relevant hazards based on performance criteria (PC) proposed by international standard agencies (5-8 log10 reductions). The most stringent HPP conditions used industrially (600 MPa, 6 min) would achieve the above-mentioned PC, except for Staphylococcus aureus. Alkaline phosphatase (ALP), the endogenous milk enzyme that is widely used to verify adequate thermal pasteurisation of cows' milk, is relatively pressure resistant and its use would be limited to that of an overprocessing indicator. Current data are not robust enough to support the proposal of an appropriate indicator to verify the efficacy of HPP under the current HPP conditions applied by the industry. Minimum HPP requirements to reduce Listeria monocytogenes levels by specific log10 reductions could be identified when HPP is applied to ready-to-eat (RTE) cooked meat products, but not for other types of RTE foods. These identified minimum requirements would result in the inactivation of other relevant pathogens (Salmonella and Escherichia coli) in these RTE foods to a similar or higher extent.

Presence of nitrofurans and their metabolites in gelatine.

Following the detection of semicarbazide (SEM) in gelatine by Italian Authorities, at levels exceeding by three times the reference point for action (RPA) of 1 µg/kg, set out by Commission Regulation (EU) 2019/1871 for nitrofurans and their metabolites, the European Commission mandated EFSA to investigate the available sources of nitrofurans and their metabolites in gelatine. European Commission also asked EFSA to provide approaches that would distinguish SEM occurring due to illegal treatment with nitrofurazone from SEM produced during food processing. The literature indicates that SEM, both free and bound to macromolecules, could occur also in food products such as gelatine, during food processing, arising from the use of disinfecting agents and/or from reactions of various food components and, therefore, SEM cannot be considered as an unequivocal marker of the abuse of nitrofurazone in animal production. It is recommended to investigate in more detail which processing conditions lead to the formation of SEM in gelatine during its production and what levels can be found. One potential approach to distinguishing between SEM from nitrofurazone and SEM from other sources in food products, such as gelatine, might be based on determining the ratio of bound:free SEM in a sample of gelatine. However, whether the ratio of bound:free SEM would unequivocally distinguish between SEM arising from nitrofurazone abuse or from other sources still needs to be demonstrated.

Assessment of an application on a detoxification process of groundnut press cake for aflatoxins by ammoniation.

Following a request from the European Commission, the EFSA Panel on Contaminants in the Food Chain (CONTAM) provided a scientific opinion on an application for a detoxification process of groundnut press cake for aflatoxins by ammoniation. Specifically, it is required that the feed decontamination process is compliant with the acceptability criteria specified in the Commission Regulation (EU) 2015/786 of 19 May 2015. The CONTAM Panel assessed the data provided by the feed business operator with respect to the efficacy of the process to remove the contaminant from groundnut press cake batches and on information demonstrating that the process does not adversely affect the characteristics and the nature of the product. Although according to the literature the process may be able to reduce aflatoxin levels below the legal limits, the Panel concluded that the proposed decontamination process, on the basis of the experimental data submitted by the feed business operator, cannot be confirmed for compliance with the acceptability criteria provided for in Commission Regulation (EU) 2015/786 of 19 May 2015. The Panel recommended sufficient sample testing before and after the process, under the selected conditions, to ensure that the process is reproducible and reliable and to demonstrate that the detoxification is not reversible. In addition, genotoxicity testing of extracts of the treated feedingstuff and of the identified degradation products would be necessary. Finally, information on the transfer rate of AFB1 to AFM1 excretion in milk for animals fed the ammoniated product, in comparison to the starting material and on the ammoniation process changes of the nutritional values of the feed material should be provided.

Risk assessment of nitrate and nitrite in feed.

The European Commission asked EFSA for a scientific opinion on the risks to animal health related to nitrite and nitrate in feed. For nitrate ion, the EFSA Panel on Contaminants in the Food Chain (CONTAM Panel) identified a BMDL 10 of 64 mg nitrate/kg body weight (bw) per day for adult cattle, based on methaemoglobin (MetHb) levels in animal's blood that would not induce clinical signs of hypoxia. The BMDL 10 is applicable to all bovines, except for pregnant cows in which reproductive effects were not clearly associated with MetHb formation. Since the data available suggested that ovines and caprines are not more sensitive than bovines, the BMDL 10 could also be applied to these species. Highest mean exposure estimates of 53 and 60 mg nitrate/kg bw per day in grass silage-based diets for beef cattle and fattening goats, respectively, may raise a health concern for ruminants when compared with the BMDL 10 of 64 mg nitrate/kg bw per day. The concern may be higher because other forages might contain higher levels of nitrate. Highest mean exposure estimates of 2.0 mg nitrate/kg bw per day in pigs' feeds indicate a low risk for adverse health effects, when compared with an identified no observed adverse effect level (NOAEL) of 410 mg nitrate/kg bw per day, although the levels of exposure might be underestimated due to the absence of data on certain key ingredients in the diets of this species. Due to the limitations of the data available, the CONTAM Panel could not characterise the health risk in species other than ruminants and pigs from nitrate and in all livestock and companion animals from nitrite. Based on a limited data set, both the transfer of nitrate and nitrite from feed to food products of animal origin and the nitrate- and nitrite-mediated formation of N-nitrosamines and their transfer into these products are likely to be negligible.

Evaluation of calcium lignosulfonate as a acceptable previous cargo for edible fats and oils.

Shipping of edible fats and oils into Europe is permitted in bulk tanks, provided that the previous cargo is included in a positive list. The European Commission requested EFSA to evaluate the acceptability of calcium lignosulfonate as previous cargo for fats and oils. The evaluation was based on the same criteria as those used for the evaluation of the substances currently on the list in the Annex to Commission Directive 96/3/EC as a acceptable previous cargoes for edible fats and oils. In 2017, the EFSA Panel on Contaminants in the Food Chain (CONTAM Panel) concluded that calcium lignosulfonate did not meet the acceptability criteria, due to uncertainties as regards the composition and toxicity of its low-molecular weight fraction (LMWF) below 1,000 Da. In the current evaluation, new information, showing lack of genotoxicity of the LMWF isolated from a technical grade of calcium lignosulfonate was provided. Due to uncertainties regarding the presence of lignosulfonate components below 200 Da in this LMWF tested for genotoxicity, the CONTAM Panel concluded that the information provided was insufficient to assess the acceptability of calcium lignosulfonate as previous cargo. The Panel recommends a better analysis of the LMWF and a new genotoxicity test using this LMWF, including components < 200 Da, and evidence that the tested material is representative of the LMWF in products intended to be shipped as previous cargo for edible fat and oils.

Opinion on the follow-up of the re-evaluation of sorbic acid (E200) and potassium sorbate (E202) as food additives.

In this opinion, the EFSA Panel on Food Additives and Flavourings (FAF Panel) was requested by the European Commission to carry out a scientific evaluation of an extended one-generation reproductive toxicity study (EOGRTS) to determine whether it would allow reconsideration of the temporary group acceptable daily intake (ADI) for sorbic acid (E 200) and potassium sorbate (E 202), established by the Panel on Food Additives and Nutrient Sources added to Food (ANS Panel) in 2015. From the EOGTRS, the FAF Panel identified a lower confidence limit of the benchmark dose (BMDL) of 1,110 mg sorbic acid/kg body weight (bw) per day. By applying a default uncertainty factor of 100, the Panel established a group ADI expressed as 11 mg sorbic acid/kg bw per day for sorbic acid (E 200) and its potassium salt (E 202). In addition, European Commission asked EFSA to review a report on the 'Stability of sorbic acid (E 200) and its potassium salt (E 202) during food processing and storage' provided by industry. No new information was provided in this report, and therefore, in this opinion, there was no re-assessment of the EFSA ANS opinion conclusions from 2015 regarding the stability of sorbates in food.

Re-evaluation of carrageenan (E 407) and processed Eucheuma seaweed (E 407a) as food additives.

The present opinion deals with the re-evaluation of the safety of food-grade carrageenan (E 407) and processes Eucheuma seaweed (E 407a) used as food additives. Because of the structural similarities, the Panel concluded that processed Eucheuma seaweed can be included in the evaluation of food-grade carrageenan. Poligeenan (average molecular weight 10-20 kDa) has not been authorised as a food additive and is not used in any food applications. In its evaluation of carrageenan (E 407) and processed Eucheuma seaweed (E 407a), the Panel noted that the ADME database was sufficient to conclude that carrageenan was not absorbed intact; in a subchronic toxicity study performed with carrageenan almost complying with the EU specification for E 407 in rats, the no-observed-adverse-effect level (NOAEL) was 3,400-3,900 mg/kg body weight (bw) per day, the highest dose tested; no adverse effects have been detected in chronic toxicity studies with carrageenan in rats up to 7,500 mg/kg bw per day, the highest dose tested; there was no concern with respect to the carcinogenicity of carrageenan; carrageenan and processed Eucheuma seaweed did not raise a concern with respect to genotoxicity; the NOAEL of sodium and calcium carrageenan for prenatal developmental dietary toxicity studies were the highest dose tested; the safety of processed Eucheuma seaweed was sufficiently covered by the toxicological evaluation of carrageenan; data were adequate for a refined exposure assessment for 41 out of 79 food categories. However, the Panel noted uncertainties as regards the chemistry, the exposure assessment and biological and toxicological data. Overall, taking into account the lack of adequate data to address these uncertainties, the Panel concluded that the existing group acceptable daily intake (ADI) for carrageenan (E 407) and processed Eucheuma seaweed (E 407a) of 75 mg/kg bw per day should be considered temporary, while the database should be improved within 5 years after publication of this opinion.

Re-evaluation of gellan gum (E 418) as food additive.

The Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion re-evaluating the safety of gellan gum (E 418) as a food additive. 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. Based on the reported use levels, a refined exposure of up to 72.4 mg/kg body weight (bw) per day in toddlers at the 95th percentile was estimated. Gellan gum is unlikely to be absorbed intact and would not be fermented by human intestinal microbiota. There is no concern with respect to carcinogenicity and genotoxicity. No adverse effects were reported in chronic studies at the highest doses tested in mice and rats (3,627 and 1,460 mg gellan gum/kg bw per day, respectively). Repeated oral intake up to 200 mg/kg bw per day for 3 weeks had no adverse effects in humans. The Panel concluded that there is no need for a numerical acceptable daily intake (ADI) for gellan gum (E 418), and that there is no safety concern at the refined exposure assessment for the reported uses and use levels of gellan gum (E 418) as a food additive. The Panel recommended to better define the specifications of gellan gum including the absence of viable cells of the microbial source and the presence of polyhydroxybutyrate (PHB), protein and residual bacterial enzymatic activities.

Re-evaluation of glycerol esters of wood rosin (E 445) as a food additive.

The present opinion deals with the re-evaluation of glycerol esters of wood rosin (GEWR, E 445) when used as a food additive. Regarding GEWR originating from Pinus palustris (longleaf pine) and Pinus elliottii (slash pine), based on the overall toxicity database, and given the absence of reproductive and developmental toxicity data, the Panel concluded that the current acceptable daily intake (ADI) of 12.5 mg/kg body weight (bw) per day for GEWR (E 445) as established by the Scientific Committee on Food (SCF) in 1994 should be temporary pending the provision of such data. This assessment is restricted to GEWR derived from P. palustris (longleaf pine) and P. elliottii (slash pine) and with a chemical composition in compliance with GEWR used in the toxicological testing. The Panel concluded that the mean and the high exposure levels (P95) of the brand-loyal refined exposure scenario did not exceed the temporary ADI in any of the population groups from the use of GEWR (E 445) as a food additive at the reported use levels. For GEWR originating from Pinus halepensis and Pinus brutia, the Panel noted that concentrations of the fractions of 'glycerol monoesters', 'free resin acids' and 'neutrals', which are considered to be of particular toxicological relevance, are not known; therefore, the evaluation of chemical equivalence with GEWR originating from P. palustris (longleaf pine) and P. elliottii (slash pine) is not possible; no data on stability were available; no toxicological data were available. Therefore, the Panel concluded that a safety assessment of GEWR originating from P. halepensis and P. brutia could not be performed. The Panel recommended the European Commission to consider an update of the definition of GEWR (E 445) in the EU specifications. It should be indicated that GEWR (E 445) (i) contain, besides the mentioned glycerol di- and triesters, a residual fraction of glycerol monoesters, and (ii) contain residual free resin acids and neutrals (non-acidic other saponifiable and unsaponifiable substances).

Re-evaluation of propane-1,2-diol alginate (E 405) as a food additive.

The present opinion deals with the re-evaluation of propane-1,2-diol alginate (E 405) when used as a food additive. The Panel noted that absorption, distribution, metabolism and excretion (ADME) data on propane-1,2-diol alginate gave evidence for the hydrolysis of this additive into propane-1,2-diol and alginic acid. These two compounds have been recently re-evaluated for their safety of use as food additives (EFSA ANS Panel, 2017, 2018). Consequently, the Panel considered in this opinion the major toxicokinetic and toxicological data of these two hydrolytic derivatives. No adverse effects were reported in subacute and subchronic dietary studies with propane-1,2-diol alginate. The available data did not indicate a genotoxic concern for propane-1,2-diol alginate (E 405) when used as a food additive. Propane-1,2-diol alginate, alginic acid and propane-1,2-diol were not of concern with respect to carcinogenicity. The Panel considered that any adverse effect of propane-1,2-diol alginate would be due to propane-1,2-diol. Therefore, the acceptable daily intake (ADI) of the food additive E 405 is determined by the amount of free propane-1,2-diol and the propane-1,2-diol released from the food additive after hydrolysis. According to the EU specification, the concentration of free and bound propane-1,2-diol amounts to a maximum of 45% on a weight basis. On the worst-case assumption that 100% of propane-1,2-diol would be systemically available and considering the ADI for propane-1,2-diol of 25 mg/kg body weight (bw) per day, the Panel allocated an ADI of 55 mg/kg bw per day for propane-1,2-diol alginate. The Panel concluded that exposure estimates did not exceed the ADI in any of the population groups from the use of propane-1,2-diol alginate (E 405) as a food additive. Therefore, the Panel concluded that there is no safety concern at the authorised use levels.

Re-evaluation of locust bean gum (E 410) 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 alginic acid and its sodium, potassium, ammonium and calcium salts (E 400-E 404) as food additives.

The present opinion deals with the re-evaluation of alginic acid and its sodium, potassium, ammonium and calcium salts (E 400-E 404) when used as food additives. Alginic acid and its salts (E 400-E 404) are authorised food additives in the EU in accordance with Annex II and Annex III to Regulation (EC) No 1333/2008. Following the conceptual framework for the risk assessment of certain food additives re-evaluated under Commission Regulation (EU) No 257/2010, the Panel concluded that there was no need for a numerical Acceptable Daily Intake (ADI) for alginic acid and its salts (E 400, E 401, E 402, E 403 and E 404), and that there was no safety concern at the level of the refined exposure assessment for the reported uses of alginic acid and its salts (E 400, E 401, E 402, E 403 and E 404) as food additives. The Panel further concluded that exposure of infants and young children to alginic acid and its salts (E 400, E 401, E 402, E 403 and E 404) by the use of these food additives should stay below therapeutic dosages for these population groups at which side-effects could occur. Concerning the use of alginic acid and its salts (E 400, E 401, E 402, E 403 and E 404) in 'dietary foods for special medical purposes and special formulae for infants' (Food category 13.1.5.1) and 'in dietary foods for babies and young children for special medical purposes as defined in Directive 1999/21/EC' (Food category 13.1.5.2), the Panel further concluded that the available data did not allow an adequate assessment of the safety of alginic acid and its salts (E 400, E 401, E 402, E 403 and E 404) in infants and young children consuming the food belonging to the categories 13.1.5.1 and 13.1.5.2.

Re-evaluation of guar gum (E 412) 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 acacia gum (E 414) 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 acacia gum (E 414) as a food additive. In the EU, acacia gum has not been formally evaluated by the Scientific Committee for Food (SCF), and therefore, no ADI has been allocated. However, it was accepted for use in weaning food (SCF, 1991). In 1999, the SCF considered 'that the use of acacia gum/gum arabic in coatings for nutrient preparations containing trace elements is acceptable provided carry-over levels in infant formulae, follow-on formulae or FSMP do not exceed 10 mg/kg'. Acacia gum was evaluated by JECFA in 1982 and 1990 and the specifications were amended in 1998. Based on the lack of adverse effects in the available toxicity studies, an ADI 'not specified' was allocated. 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. Acacia gum is unlikely to be absorbed intact and is slightly fermented by intestinal microbiota. No adverse effects were reported in subchronic and 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 acacia gum up to 30,000 mg acacia gum/person per day (approximately equivalent 430 mg acacia gum/kg bw per day) for up to 18 days was well tolerated in adults but some individuals experienced flatulence which was considered by the Panel as undesirable but not adverse effect. The Panel concluded that there is no need for a numerical ADI for acacia gum (E 414), and there is no safety concern for the general population at the refined exposure assessment of acacia gum (E 414) as a food additive.

Re-evaluation of lecithins (E 322) as a food additive.

The present opinion deals with the re-evaluation of lecithins (E 322) when used as a food additive. Lecithins (E 322) is an authorised food additive in the EU according to Annex II and Annex III to Regulation (EC) No 1333/2008 on food additives, and have been previously evaluated by JECFA in 1973 and by the SCF in 1982. Among lecithins, phosphatidylcholine is hydrolysed in choline in the cytidine-5-diphosphate-choline pathway in all cells of the body. Following the conceptual framework for the risk assessment of certain food additives re-evaluated under Commission Regulation (EU) No 257/2010, the Panel concluded that there was no need for a numerical ADI for lecithins (E 322) and that there was no safety concern for the general population from more than 1 year of age at the refined exposure assessment for the reported uses of lecithins (E 322) as a food additive. The Panel further concluded that there is no safety concern for the exposure to the choline from lecithins (E 322) as a food additive at use and use levels reported by industry. For infants (from 12 weeks up to 11 months of age), the Panel concluded that there was no safety concern at the refined exposure assessment for the reported uses of lecithins (E 322) as a food additive and for the choline from lecithins (E 322) as a food additive at use and use levels reported by industry. For infants and young children consuming foods for special medical purposes, the Panel concluded that there was no safety concern with respect to the refined exposure assessment for the reported uses of lecithins (E 322) as a food additive and for exposure to choline resulting from these uses of lecithins (E 322).

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.