The Panel on Food Additives and Nutrient Sources added to Food (ANS) delivers an opinion re-evaluating the safety of butylated hydroxytoluene (BHT) (E 321). BHT is an authorised synthetic antioxidant that was previously evaluated by the Joint FAO/WHO Expert Committee on Food Additives (JECFA), the latest in 1996 and the EU Scientific Committee for Food (SCF) in 1987. The SCF established an ADI of 0-0.05 mg/kg bw/day based on thyroid, reproduction and haematological effects in the rat. JECFA allocated an ADI of 0-0.3 mg/kg bw/day for BHT based on effects in the reproduction segments and hepatic enzyme induction seen in two separate 2-generation studies in rats. The Panel concluded that BHT is not of concern with respect to genotoxicity and that any carcinogenicity would be thresholded. After the last SCF evaluation, two new 2-generation studies have been reported which were the basis for the ADI set by JECFA. Both studies revealed a NOAEL of 25 mg/kg bw/day. Overall, the Panel concluded that the present database gives reason to revise the ADI of 0.05 mg/kg bw/day. Based on the NOAEL of 25 mg/kg bw/day and an uncertainty factor of 100, the Panel derived an ADI of 0.25 mg/kg bw/day. Since the NOAEL of 25 mg/kg bw/day is below the BMDL10 value of 247 mg/kg bw/day derived from the data for the incidence of hepatocellular carcinomas in male rats, the Panel concluded that this NOAEL also covers the hepatocellular carcinomas observed in the long-term studies with BHT. Exposure of adults to BHT is unlikely to exceed the newly derived ADI at the mean and at the 95th percentile. For exposure of children to BHT from its use as food additive, the Panel noted that it is also unlikely that this ADI is exceeded at the mean, but is exceeded for some European countries (Finland, The Netherlands) at the 95th percentile.

The Panel on Food Additives and Nutrient Sources added to Food provides a scientific opinion evaluating the safety of glycerol esters of tall oil rosin (GETOR) for the proposed use as a stabilising and emulsifying food additive in certain beverages up to a maximum level of 100 mg/l. In view of the limited toxicity studies for GETOR, analytical data were submitted to demonstrate that GETOR are chemically equivalent to glycerol esters of wood rosin (GEWR) which have already been authorised as a food additive by Directive 95/2/EC. The Joint FAO/WHO Expert Committee on Food Additives decided that it could not evaluate GETOR without additional information on its composition, in order to clarify the extent and significance of any differences relative to other glycerol esters of rosins. GETOR are obtained by esterification of tall oil rosin and are described as a complex mixture of mono-, di- and tri-glycerol esters of resin acids (fraction (a)). Besides these esters, free resin acids (fraction (b)) and other saponifiable and unsaponifiable substances (fraction (c)) including sulphur compounds are present in GETOR. Conclusive analytical data on the proportions of fractions (a), (b), and (c) are not provided and also data on the identity and quantity of their individual components are absent. The results of two acute oral toxicity studies are the only toxicological data available for GETOR. Overall the Panel concluded that the chemical and toxicological characterisation of GETOR is not adequate. The Panel also could not conclude that GETOR is chemically equivalent to GEWR thus the toxicological data obtained with GEWR could not be used for read across. Therefore, the Panel concluded that the available data are too limited to conclude on the safety of GETOR as a food additive at the proposed uses and use levels. (C) European Food Safety Authority, 2011

Lutein is a carotenoid colour authorised as a food additive in the EU (E 161b) and reevaluated by the Panel on Food Additives and Nutrient Sources added to Food (ANS) in 2010. The ANS Panel established an ADI of 1 mg/kg bw/day and noted that this ADI refers to lutein derived from Tagetes erecta containing at least 80% carotenoids. In the present opinion the Panel considered whether additional studies made available address the gaps identified by the Panel in the toxicological database for lutein preparations other than lutein with high concentrations of total saponified carotenoids at levels of at least 80%. The Panel noted that in all additional studies made available, a specific lutein ester preparation extracted from Tagetes erecta was tested, containing > 60% carotenoid esters (> 93% lutein esters, remainder zeaxanthin esters). No additional data were provided on lutein with levels of similar to 5-12% total carotenoids. The Panel concluded that lutein esters are not of concern with respect to genotoxicity. The additional data also included a 90-day toxicity study and a reproductive and developmental toxicity study. The Panel established for both studies a NOAEL of 1000 mg/kg bw/day, the highest dose level tested (equivalent to 538 mg lutein equivalents/kg bw/day). The Panel noted that this NOAEL of 538 mg lutein equivalents/kg bw/day is higher than the NOAEL of 200 mg/kg bw/day (the highest dose level tested) in the 90-day rat study with lutein from which the ADI has been derived. Based on these results, the Panel concluded that the additional database supports the conclusion that the ADI of 1 mg/kg bw/ day also refers to lutein with high concentrations of total carotenoids extracted from Tagetes erecta and present as esters at levels of >= 60%. The Panel concluded that the toxicological data-base available is too limited to conclude that the ADI also applies to lutein preparations of lower purity or from other sources. (C) European Food Safety Authority, 2011

The Scientific Panel on Food Additives and Nutrient Sources added to Food has re-evaluated the safety of Erythrosine (E 127) when used as a food colouring substance. Erythrosine (E 127) is a xanthene-dye which has been previously evaluated by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 1990 and the EU Scientific Committee for Food (SCF) in 1989. Both committees have established an Acceptable Daily Intake (ADI) of 0-0.1 mg/kg bw/day. Erythrosine is exclusively authorised for use in cocktail and candied cherries, and Bigarreaux cherries (94/36/EC). The Panel considered the weight-of-evidence still showed that the tumorigenic effects of Erythrosine in the thyroid gland of rats are secondary to its effects on thyroid function and not related to any genotoxic activity. Erythrosine-induced rodent thyroid tumours may be considered of limited relevance to humans; an approach which is consistent with previous evaluation of Erythrosine. The Panel considered Erythrosine has a minimal effect in humans at a clinical oral dose of 200 mg daily over 14 days, while a dose of 60 mg daily was without effect (Gardner et al., 1987). The current ADI adopted by the JECFA and the SCF is based on this study. The Panel concurred with their identification of this as the critical study. The 60 mg dose was taken to be the equivalent of 1 mg/kg bw/day. By applying a safety factor of 10 to allow for the small number of subjects used in the study and its relatively short duration, an ADI of 0-0.1 mg/kg bw per day was derived. The Panel concludes that the present database does not provide a basis to revise the ADI of 0.1 mg/kg bw/day. The Panel concluded that at the current levels of use intake estimates for adults on average is 0.0031 mg/kg bw/day and 0.01 mg/kg bw/day at the 95th percentile, and consequently are below the ADI of 0.1 mg/kgbw/day. The Panel considered there would be no safety concerns at current levels of exposure including other sources of exposure. (C) European Food Safety Authority, 2011

The Panel on Food Additives and Nutrient Sources added to Food provides a scientific opinion re-evaluating the safety of calcium carbonate (E 170). Calcium carbonate is an inorganic salt authorised as a food additive in the EU, and is also included in the list of substances that may be added for specific nutritional purposes in foods for particular nutritional uses and in Directive 2002/46/EC relating to food supplements. Calcium carbonate was previously evaluated by JECFA in 1965, when the Committee established an ADI not limited. The SCF evaluated calcium carbonate in 1990 as part of a group of carbonates, when the Committee assigned a group ADI not specified. The Panel was not provided with a newly submitted dossier and based its evaluation on previous evaluations, additional literature that became available since then and the data available following a public call for data. The Panel noted that the available toxicological database on calcium carbonate is limited, but does not give rise to concern. The few effects seen in studies in humans and animals are associated with high calcium carbonate intakes, and are also seen with other calcium salts. The Panel agrees with the group ADI " not specified" assigned by the SCF to a group of carbonates including calcium carbonate, when considering the use of calcium carbonate as a food additive. The Panel notes that the estimated exposures to calcium from all sources, including the use of calcium carbonate as a food additive, taken together with intakes of calcium from supplements and from food fortification are below the UL of 2500 mg/day for calcium from all sources established by the SCF in 2003. The Panel concludes that trace levels of adventitious nanoscale material within macroscale calcium carbonate are not of toxicological concern. (C) European Food Safety Authority, 2011

The Panel on Food Additives and Nutrient Sources added to Food (ANS) delivers a scientific opinion re-evaluating the safety of butylated hydroxyanisole (BHA) (E 320). BHA is a synthetic antioxidant authorised as a food additive in the EU that was previously evaluated by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) several times, the latest in 1989 and the EU Scientific Committee for Food (SCF) in 1989. Both committees established an ADI of 0.5 mg/kg bw/day, with that of the SCF being classified as temporary. Both ADIs were based on proliferative changes in the rat forestomach. The Panel was not provided with a newly submitted dossier and based its evaluation on previous evaluations, additional literature that became available since then and the data available following an EFSA public call for data. The Panel concluded that BHA does not raise concern with respect to genotoxicity. A large number of long- term toxicity and carcinogenicity studies with BHA have been performed, demonstrating proliferative changes in the forestomach with BMDL10 values in the rat of 115 and 83 mg/kg bw/day. The Panel concluded that the present database does give reason to revise the ADI. The Panel considered that forestomach hyperplasia in rodents may no longer be relevant for human risk assessment. Based on a NOAEL of 100 mg/kg bw/day for growth retardation, increased mortality and behavioural effects in rat pups at higher dose levels, and using an uncertainty factor of 100 the Panel established an ADI of 1.0 mg/kg bw/day. This NOAEL also covers the BMDL10 values for forestomach hyperplasia observed in the rat. The Panel also concluded that at the current levels of use refined intake estimates are generally below the ADI of 1.0 mg/kg bw/day. (C) European Food Safety Authority, 2011

The Panel on Food Additives and Nutrient Sources added to Food provides a scientific opinion on the use of anionic methacrylate copolymer (AMC, a 30% dispersion of the dry copolymer in water) as a coating agent for solid food supplements and solid foods for special medical purposes (FSMPs). The dispersion contains 0.3% sodium lauryl sulphate, which is not an authorised food additive. The opinion does not include a safety evaluation of this substance. From studies on toxicokinetics, acute and subchronic oral toxicity, genotoxicity, and developmental toxicity it is concluded that AMC is essentially not absorbed and that if any very low amounts of material were absorbed such material would not be retained in the tissues. No data on reproductive toxicity, chronic toxicity and carcinogenicity are provided. In the absence of such data, chronic effects in the gastrointestinal tract following oral administration cannot be excluded. Therefore, the Panel considers that an ADI should not be established, and that a margin of safety (MOS) approach is appropriate. Data from in vitro Ames and mammalian cell mutation assays and an in vivo micronucleus assay do not raise concern with respect to genotoxicity. A subchronic toxicity study and a developmental toxicity study in the rat provided NOAELs of respectively 1500 mg/kg bw/day (highest dose tested) and 1000 mg/kg bw/day (one dose tested). The anticipated exposure to AMC from both its use in food supplements and in pharmaceuticals is 23.4 mg/kg bw/day for high consumer adults and 16 mg/kg bw/day for children. From the NOAELs, a coating level of 100 mg/tablet AMC and a combined exposure (food supplements and pharmaceuticals), MOS values between 43 to 64 for adults and 63 to 94 for children were calculated. The Panel considers these MOS sufficient given the lack of absorption and that the exposure estimates are based on worst case assumptions. The Panel concludes that the use of AMC in solid food supplements at the proposed use and use levels is not of safety concern. The Panel could not assess the safety of anionic methacrylate copolymer for uses in solid foods for special medical purposes.

The Panel on Food Additives and Nutrient Sources added to Food provides a scientific opinion on the safety of Ferrous Ammonium Phosphate (FAP) when added for nutritional purposes in foodstuffs for particular nutritional uses (PARNUTS) and foods intended for the general population (including food supplements) as a source of iron and on the bioavailability of iron from this source. FAP is stable at neutral pH in formulated foods. The bioavailability of iron from FAP was shown to be within the range of that from other iron salts used for fortification purposes, and specifically, less than that from ferrous sulphate and greater than that from ferric pyrophosphate. In intended food categories, FAP provides between 0.7 to 14 mg of iron per serving, which corresponds to 5 to 100% of the RDA for iron in adults. Studies evaluating the toxicity of FAP in experimental animals have not been conducted. FAP dissociates under the low pH conditions of the stomach in its components, thus releasing ferrous, ammonium and phosphate ions. Given the previous evaluations of ferrous, ammonium and phosphate salts as food additives and as nutrient sources by the SCF, EFSA and JECFA and that the available information on their toxicity did not identify toxicological effects, the Panel considers that additional toxicological data on FAP are not required. The Panel concludes that the use of FAP as a source of iron in PARNUTS and in foods intended for the general population (including food supplements), at the proposed use levels, is not of safety concern provided that established upper safety limits for iron are not exceeded.

The Panel on Food Additives and Nutrient Sources added to Food provides a scientific opinion on the use of sodium ascorbate as a food additive in vitamin D preparations intended to be used in formulae and weaning foods for infants and young children. Sodium ascorbate is already authorised as a vitamin C source for infant formulae/follow-on formulae (Annex III of Directive 2006/141/EC). According to Annexes I and II of this Directive, infant formulae/follow- on formulae are required to contain 2.5-7.5 mg/100 kJ vitamin C, which equals 62-221 mg/l vitamin C, and 5-14 mg sodium per 100 kJ, which equals 125-413 mg/l sodium. Given that sodium ascorbate contains 11.6% sodium, a maximum carry over of 1 mg/l sodium ascorbate, amounts to 0.12 mg/l sodium and 0.88 mg/l ascorbate. Based on this observation and the fact that infant formulae are required to contain 62-221 mg/l ascorbate and 125-413 mg/l sodium, the Panel concluded that the maximum carry over of 1 mg/l sodium ascorbate (0.12 mg/l sodium and 0.88 mg/l ascorbate) from use of sodium ascorbate (E 301) in vitamin D preparations would only marginally contribute to the vitamin C and sodium content of the finished products. Therefore, the Panel concluded that the proposed extension of use of the food additive sodium ascorbate (E 301), intended to be used as an antioxidant for the vitamin D preparations for use in infant formulae and follow- on formulae, is not of safety concern.

The Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion on the safety of allyl isothiocyanate ( AITC) when used as a food preservative. Rats appear to resemble humans in AITC metabolism, but have a much slower clearance than humans. AITC has been investigated in acute, short-term, subchronic toxicity studies and in carcinogenicity studies in rodents. AITC did not cause any developmental toxicity in rats, hamsters and rabbits. AITC may be fetotoxic to mice at doses higher than 6.0 mg/kg bw/day. AITC is not carcinogenic in mice but transitional cell papillomas of the urinary bladder of males were observed in a long-term rat study, however, AITC is not genotoxic in vivo in mice and rats. Hence it could be assumed that there is a threshold mechanism underlying these effects on urinary bladder. The Panel considered this long-term rat study as the pivotal study. The Panel derived an ADI of 0.018 mg/kg bw/day which was rounded up to 0.02 mg/kg bw/day based on a LOAEL of 9 mg/kg bw/day and applying an uncertainty factor of 500 in order to cover uncertainties resulting from extrapolation from the LOAEL to the NOAEL and from the absence of reproductive toxicity studies. The Panel noted that AITC intakes resulting only from application as an antispoilage agent could be estimated for children and adults at 0.3 up to 2.8 and 0.2 up to 1.6 times the ADI depending on the exposure scenario. Furthermore, the Panel noted that the mean daily total exposure to AITC from all sources including natural occurrence in food, use as a flavouring and application as an antispoilage agent, based on the more refined model, results in a two to four-fold exceedance of the ADI in children and up to eight-fold exceedance in 95th percentile adult consumers.

The Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion on the safety of oregano and lemon balm extracts when used as a food additive. The Panel notes that the petitioner has provided only limited chemical characterisation of the compounds present in the extracts and that the specifications as proposed are not in line with what would be expected for a botanical or botanical preparation. The Panel notes that oregano and lemon balm have a safe history of use as herbal food ingredients, and that oregano and lemon balm natural extractives are listed as natural extractives generally recognized as safe (GRAS). However, the Panel considers that this presumption of safety might not be applicable to the specific conditions of use and use levels as a food additive. The potential mean exposure to oregano or lemon balm extracts phenolics from the eight food category sources for which use and use levels were proposed by the petitioner amounted to respectively 2.0 mg/kg bw/day for women and 2.3 mg/kg bw/day for men. The Panel concludes that the intake of phenolics resulting from the use of oregano and lemon balm extracts as food additive at the proposed uses and use levels would be in the range of the intake resulting from the use of oregano and lemon balm leaves for preparation of herbal teas. However, the Panel also notes the inadequate specifications and characterisation of the extracts and the absence of data on genotoxicity, reproductive and developmental toxicity and long-term toxicity of oregano and lemon balm extracts. Altogether, with reference to the SCF ' Guidance on submissions for food additive evaluations, the Panel concludes that due to the lack of an appropriate dossier supporting the use of oregano and lemon balm extracts as additives, the safety of oregano and lemon balm extracts at the proposed uses and use levels cannot be assessed.

The Panel on Food Additives and Nutrient Sources added to Food provides a scientific opinion on the use of basic methacrylate copolymer (BMC) as a glazing agent in solid food supplements and in solid foods for special medical purposes. The NOAELs derived from the main studies are 1000 mg/kg bw/day (developmental study in rat, the only dose level tested) and 2000 mg/kg bw/day (26-week feeding study in rat, highest dose tested). BMC does not raise concern with respect to genotoxicity. No studies on reproductive toxicity were available and the database on developmental toxicity was limited. Therefore no ADI was derived. The estimated combined exposure for heavy users to BMC from both its use in food supplements and in pharmaceuticals is equal to 23.4 mg/kg bw/day for a 60 kg adult and 16 mg/kg bw/day for children (4-18 years). The calculated worst case exposure to the monomers (MMA, BMA, and DMAEMA) is < 50 mu g/kg bw/day for adults and < 32 mu g/kg bw/day for children, being significantly below the group TDI of 0.1 mg/kg bw/day (as methacrylic acid) set by the SCF. Using the above NOAELs, given a coating level of 100 mg/tablet and a combined exposure from food supplements and pharmaceuticals, the calculated margin of safety (MOS) for heavy users varies from at least 43 to 85 for adults and from 63 to 125 for children. The MOS from the exposure only from food supplements ranges from 85 to 171 for adults and from 125 to 250 for children. In the light of the high molecular weight of the substance, its lack of absorption and its low toxicity profile, the Panel considers these margins of safety adequate. In conclusion the use of BMC as a glazing agent/coating agent in solid food supplements is not of safety concern at the proposed use levels.

The Panel on Food Additives and Nutrient Sources added to Food provides a scientific opinion on the use of monomethylsilanetriol added for nutritional purposes to food supplements. The Panel was asked to evaluate to which extent newly submitted information addresses the uncertainties expressed in its opinion on "Monomethylsilanetriol added for nutritional purposes to food supplements" in 2009. The Panel noted that the newly submitted information relates to the bioavailability of silicon from, and to the toxicology of a source substance designated as monomethylsilanetriol orthohydroxybenzoate sodium salt (MSS). This substance differs from the substances evaluated by the Panel in 2009 since, unlike the substances evaluated previously, the commercial form of MSS consists of an aqueous solution of salicylic acid (orthohydroxybenzoic acid), monomethylsilanetriol and sodium chloride. In the light of the newly submitted information and given the fact that the presence of salicylic acid in MSS may influence the bioavailability of silicon from MSS, and the toxicity of MSS, the Panel concluded that the new data are insufficient to fill the data gaps on the bioavailability of silicon from monomethylsilanetriol and on the toxicity of monomethylsilanetriol, which were highlighted in the opinion of 2009. The Panel therefore concludes, that the newly submitted information does not adequately address the uncertainties expressed in the previous opinion and would not justify the re- evaluation of monomethylsilanetriol added for nutritional purposes in food supplements.

The Panel on Food Additives and Nutrient Sources added to Food provides a scientific opinion re-evaluating the safety of Litholrubine BK (E 180). Litholrubine BK has been previously evaluated by the Joint FAO/WHO Expert Committee on Food Additives (JECFA), with the latest evaluation in 1987 and by the EU Scientific Committee for Food (SCF) in 1983. JECFA was unable to establish an Acceptable Daily Intake (ADI), whereas the SCF established an ADI of 0-1.5 mg/kg bw/day. The Panel notes that SCF established the ADI of 01.5 mg/kg bw/day based on a reported NOAEL of 150 mg/kg bw/day identified in a long-term rat study. Overall, the Panel considers that the present database is too limited to continue supporting the ADI for Litholrubine BK set previously by the SCF or to establish a new ADI. The Panel was unable to identify a suitable NOAEL, LOAEL or BMD to establish an ADI from a combined repeated-dose and reproductive/developmental toxicity study with Litholrubine BK in rats; males were exposed for 42 days and females exposed for 17 days, in accordance with OECD Test Guideline 422 and GLP conditions. The Panel thus concludes that the existing SCF ADI of 0-1.5 mg/kg bw/day should be withdrawn. However, the Panel notes that the highest anticipated exposure to Litholrubine BK is 1700-fold lower than the identified effect level in female rats (100 mg/kg bw/day). Therefore, the Panel considers that it is unlikely there would be a significant safety concern for humans from the current single authorised use of Litholrubine BK in edible cheese rinds. No conclusion on the induction of hypersensitivity by Litholrubine BK could be drawn from the limited scientific evidence available, although after Litholrubine BK exposure from cosmetics, cheilitis has been documented in one case report.

The Panel on Food Additives and Nutrient Sources added to Food provides a scientific opinion reevaluating the safety of canthaxanthin (E 161g). Canthaxanthin is a carotenoid pigment, consisting predominantly of all-trans I3-carotene-4,4'-dione together with minor amounts of other carotenoids, which is authorised in the EU as a food additive for colouring of saucisse de Strasbourg and as a colouring matter in feeding stuffs, and this use contributes to the exposure in humans. Canthaxanthin was previously evaluated by JECFA in 1974, 1987, and 1995, and the SCF in 1983, 1987 and 1997. Both committees have established an ADI of 0.03 mg/kg bw/day based on the formation of crystalline deposits in the retina, which was observed in monkeys and humans. A NOAEL of 0.25 mg/kg bw/day for scotopic b-wave changes (without impairment of vision) was reported in a human study and a BMDL05 of 12-20 mg/day, amounting to 0.20-0.33 mg/kg bw/day for a 60 kg person, were derived in a worst case BMD analysis of the data from a meta-analysis on the crystal incidence in human eyes with increasing daily doses of canthaxanthin. Based on these two studies, the Panel derived a point of departure of 0.30 mg/kg bw/day and allocated an ADI of 0.03 mg/kg bw/day using an uncertainty factor of 10. This ADI is in line with the ADI derived previously by JECFA and the SCF.The Panel concluded that for both adults and children, total anticipated combined exposure to canthaxanthin from application as food and feed additive is unlikely to exceed the ADI. The Panel noted that the specifications of canthaxanthin need to be updated with respect to the heavy metal levels. In addition, the Panel noted that canthaxanthin used as a food additive is manufactured synthetically and the EC specifications should be modified accordingly.

The Panel on Food Additives and Nutrient Sources added to Food assess the data provided by the Danish authorities, evaluating in particular whether this information, or any other new scientific developments, indicate that there is scientific evidence for a revision of the maximum limits on nitrites in food adopted in Directive 2006/52/EC. The Panel considered that the terms of reference could be answered by considering three issues including 1) whether the data provided by the Danish authorities would support re-evaluation of the ADI for nitrite, 2) whether the current exposure to nitrite from the proposed uses and use levels would exceed the ADI and 3) what nitrite levels would be required to achieve its preservative effects. The Panel concludes that the data provided by the Danish authorities do not provide a basis to revise the ADI of 0.07 mg/kg bw/day for nitrite. The Panel notes that in several European countries the mean exposure at Tier 2 is above the ADI. At Tier 3, the adult high consumers are just above the ADI while for high consumer children exposure is 2.5 times above the ADI, and the higher range of the mean exposure of children is close to the ADI. The Panel concludes, in line with the SCF assessment in 1995 that exposure to preformed nitrosamines in food should be minimized by appropriate technological practices such as lowering the levels of nitrate and nitrite added to foods to the minimum required to achieve the necessary preservative effect and to ensure microbiological safety. Evaluation of the technological need for the maximum use levels for nitrite adopted in Directive 2006/52/EC of 5 July 2006 is outside the remit of the Panel. However, the Panel notes that this issue has been adequately assessed by others and that the technological need is product specific.

The Panel on Food Additives and Nutrient Sources added to Food provides a scientific opinion on the use of OSA modified gum acacia as an emulsifier for flavourings, and other uses. The SCF in 1990 and 1999 considered that the existing data on gum acacia (E 414) did not point to any toxicological concern. In 2009, JECFA allocated a temporary ADI "not specified" to OSA modified gum arabic. The Panel notes that OSA modified gum acacia is not of concern with respect to mutagenicity. From a 90-day study in the rat, NOAELS of 3411 and 4052 mg/kg bw/day (the highest dose tested), for male and female rats, respectively, were derived. The Panel considers that reading across from data on gum acacia (E 414) and food starch sodium octenyl succinate (E1450) there would be no requirements for additional toxicity data on OSA modified gum acacia. The Panel considers the available toxicological dataset to be insufficient to derive an ADI. The mean dietary exposure to OSA modified gum acacia from its combined uses as an emulsifier in flavour-oil emulsions and other emulsifier uses ranges from 4.1 mg/kg bw/day in female adults, to 12 mg/kg bw/day in children (age 1.5-4.5 years). The highest potential exposure (97.5th percentile) ranges from 12 mg/kg bw/day in male adults to 33 mg/kg bw/day in children. Given these intake estimates and taking the lowest derived NOAEL (3411 mg/kg bw/day), a margin of safety of about 280 for male adults and of about 100 for children can be calculated. The Panel considers in this case these margins adequate. Based on the results of the available studies, the information on gum acacia itself and on other OSA modified starches, the Panel concludes that the use of OSA modified gum acacia as an emulsifier in foods at the proposed uses and use levels is of no safety concern.

The Panel on Food Additives and Nutrient Sources added to Food provides a scientific opinion evaluating the safety of heme iron (blood peptonates) when added for nutritional purposes as a source of iron to food for the general population, including food supplements, and evaluating the bioavailability of iron from this source. The Panel concluded that iron from heme iron (blood peptonates) is bioavailable and absorbed to a significantly higher extent than iron from non-heme sources. No data on the toxicity of heme iron (blood peptonates) were provided by the petitioner except those from an acute toxicity study. The Panel is aware of the fact that heme iron is a constituent of the normal human diet and also an endogenous body constituent. However, given i) that the use levels of heme iron (blood peptonates) proposed by the petitioner result in exposure to iron at levels that are higher than the guidance value of 17 mg/day for supplemental intake of non-heme iron proposed by the EVM although they are in line with the Provisional Maximum Tolerable Daily Intake (PMTDI) value for iron of 0.8 mg/kg bw/day (50 mg/day for a 60 kg person) proposed by JECFA, ii) that the bioavailability of iron from heme iron as compared to iron from non-heme iron sources is significantly increased, iii) that epidemiological and animal model studies suggest that a high intake of heme iron may be associated with an increased risk of colon cancer, iv) that there are no genotoxicity data on heme iron (blood peptonates) but positive results reported for hemoglobin and hemin in a Comet assay in cells in vitro, and v) that there are no data from subchronic, reproductive, developmental, long-term toxicity and carcinogenicity studies on heme iron (blood peptonates), the Panel concludes that the available data are insufficient to demonstrate the safety of the proposed use and use levels of heme iron (blood peptonates) as a source of iron for nutritional purposes in foods intended for the general population, including food supplements.

Following a request from the European Commission, the Panel on Food Additives and Nutrient Sources added to Food delivers a statement on the divergence between the risk assessment of lycopene by the European Food Safety Authority (EFSA) and the Joint FAO/WHO Expert Committee on Food Additives (JECFA). The AFC Panel derived an ADI of 0.5 mg/kg bw/day based on a No-Observed-Adverse-Effect Level (NOAEL) of 50 mg/kg bw/day from a one-year rat study and a non-reversible increase in serum alanine transaminase (ALT) activity. In 2009 JECFA replaced the group ADI of 0-0.5 mg/kg bw with a group ADI "not specified" for lycopene from all sources. The JECFA evaluation also included the one-year rat study and described the effects on aspartate transaminase (AST) and ALT activities. The Panel noted that the evaluation by JECFA only provides a very limited rationale for disregarding the effects on ALT and AST in the one year rat study. The Panel also noted that compared to the EFSA 2008 evaluation, the JECFA evaluation does take into account an additional 28-day rat study, but since this study reveals a NOAEL of 200 mg/kg bw/day it is not the reason underlying the diverging outcome of the risk assessment. The Panel concluded that the divergence of scientific opinions is not based on data that were not available to EFSA during its evaluation of lycopene, but rather to a diverging interpretation of the toxicological relevance of the effects seen on AST and ALT levels in the one-year rat study. The ANS Panel agrees with the evaluation of the one year rat study by the AFC Panel, and the NOAEL of 50 mg/kg bw/day identified from that study based on a non-reversible increase in alanine transaminase (ALT) at the higher dose level.