Revised exposure assessment for lycopene as a food colour

Following a request from the Commission, a revised exposure assessment of lycopene from use as a food colour and from natural occurrence, for children and adults, was carried out using the proposed revised maximum and typical use levels according to a range of scenarios defined in the terms of reference, and with reference to the exposure assessment presented in the former opinion on lycopene by the EFSA\u2019s Panel on Additives, Flavourings, Processing Aids and Materials in Contact with Food (AFC). Several food consumption databases were used to conduct the current exposure assessment. For children, data of the EXPOCHI project, UK data and additional French data were used. Estimates for adults were based on UK data only. Overall, the revised exposure assessment of lycopene from both the use as a food colour and the natural occurrence indicated that the potential average exposures for children were approximately of 200 \u3bcg/kg bw/day, and around or slightly below the ADI at the 95th percentile. In adults, the high exposure (95th percentile) to lycopene from use as a food colour and from natural origin was below the ADI. When exposure to lycopene from fortified foods was also included, the conservative estimates of the exposure were much higher in all populations studied. EFSA concluded that in this case, potential intakes might exceed the ADI, particularly for children. About 50 to 65% of the total exposure to lycopene (excluding lycopene added as a novel food ingredient) was originating from natural sources. The current revised exposure estimates indicated that, based on typical use levels, desserts, including flavoured milk products, non-alcoholic beverages and fine bakery products are important sources of lycopene from food colours

Scientific Opinion on the re-evaluation of Brown HT (E 155) as a food additive

The Panel on Food Additives and Nutrient Sources added to Food provides a scientific opinion re-evaluating the safety of Brown HT (E 155). Brown HT has been previously evaluated by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 1977 and 1984 and the EU Scientific Committee for Food (SCF) in 1975 and 1984. JECFA established an Acceptable Daily Intake (ADI) of 0-1.5 mg/kg body weight (bw)/day, while the SCF established an ADI of 0-3 mg/kg bw/day. 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 concluded that based on a long-term carcinogenicity and toxicity study in mice an ADI of 1.5 mg/kg bw/day can be derived. The Panel concludes that at both the maximum permitted level of use (Tier 2) and at the maximum reported levels of use of Brown HT (Tier 3), intake estimates are generally below the ADI of 1.5 mg/kg bw/day. However, in both adults and 1-10 years old children, the high percentile of exposure for both Tiers can be slightly higher than the ADI at the upper end of the range

Scientific Opinion on the safety of neutral methacrylate copolymer for the proposed uses as a food additive

The Panel on Food Additives and Nutrient Sources added to Food provides a scientific opinion on the use of neutral methacrylate copolymer (NMC, a 30% dispersion of the dry copolymer in water) as a glazing agent in solid food supplements and solid foods for special medical purposes (FSMPs). The dispersion contains 0.7% of polyethylene glycol monostearyl ether, which is not a authorised food additive; the opinion does not include a safety evaluation of this substance. From studies on metabolism/toxicokinetics, acute and subchronic oral toxicity, genotoxicity, and developmental toxicity it is concluded that NMC is essentially not absorbed and that any absorbed material is not retained in the tissues. No data on reproductive toxicity, chronic toxicity and carcinogenicity are provided. In the absence of such data, chronic effects on 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 show that NMC does not raise concern with respect to genotoxicity. The calculated anticipated exposure (coating level 200 mg/tablet) to NMC from both its proposed use in food supplements and its approved use in pharmaceuticals is 46.7 mg/kg bw/day for high consumer adults, and 32 mg/kg bw/day for children. Two subchronic toxicity studies in rats and a developmental study in rabbits revealed NOAELs of 2000 mg/kg/bw/day (highest dose level tested) resulting in a MOS of at least 43 for adults and at least 63 for children. The Panel considers these margins of safety sufficient given the lack of absorption and that the exposure estimates are based on worst case assumptions. The Panel concludes that the use of NMC in solid food supplements at the proposed use and use levels is not of safety concern. The Panel could not assess the safety of neutral methacrylate copolymer for uses in solid foods for special medical purposes

Statement on the divergence between the risk assessment of lycopene by EFSA and the Joint FAO/WHO Expert Committee on Food Additives (JECFA)

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 \u201cnot specified\u201d 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

Scientific Opinion on the use of Basic Methacrylate Copolymer as a food additive

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 \ub5g/kg bw/day for adults and < 32 \ub5g/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

Scientific Opinion on the re-evaluation of Allura Red AC (E 129) as a food additive

The Panel on Food Additives and Nutrient Sources added to Food provides a scientific opinion re-evaluating the safety of Allura Red AC (E 129). Allura Red AC has been previously evaluated by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 1980 and the EU Scientific Committee for Food (SCF) in 1984 and 1989. Both committees established an Acceptable Daily Intake (ADI) of 0-7 mg/kg body weight (bw)/day. 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. New studies included a study by Tsuda et al. from 2001 reporting effects on nuclear DNA migration in the mouse in vivo Comet assay, and a study by McCann et al. from 2007 that concluded that exposure to a mixture including Allura Red AC, resulted in increased hyperactivity in 8- to 9-years old children. The Panel notes that Allura Red AC was negative in in vitro genotoxicity as well as in long-term carcinogenicity studies and that the effects on nuclear DNA migration observed in the mouse in vivo Comet assay are not expected to result in carcinogenicity. The Panel also concurrs with the conclusion from a previous EFSA opinion on the McCann et al. study that the findings of the study cannot be used as a basis for altering the ADI. The Panel concluded that the present database does not give reason to revise the ADI of 7 mg/kg bw/day. The Panel also concludes that at the maximum reported levels of use refined intake estimates are generally below the ADI, although in 1-10 years old children the high percentile of exposure (95th) can be slightly higher than the ADI at the upper end of the range

Scientific Opinion on the safety of ferrous ammonium phosphate as a source of iron added for nutritional purposes to foods for the general population (including food supplements) and to foods for particular nutritional uses

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

Scientific Opinion on the use of calcium lignosulphonate (40-65) as a carrier for vitamins and carotenoids

The Panel on Food Additives and Nutrient Sources added to Food provides a scientific opinion on the safety of calcium lignosulphonate (40-65) when used as a carrier for vitamins and carotenoids intended to be added to foods for colouring and nutrient purposes. Calcium lignosulphonate (40-65) has been evaluated by JECFA and an ADI of 20 mg/kg bw/day was established. Calcium lignosulphonate (40-65) is poorly absorbed following oral administration. From the results obtained in vitro from one bacterial reverse mutation assay and one mammalian chromosomal aberration assay it can be concluded that there is no indication for a genotoxic potential of calcium lignosulphonate (40-65). In a short-term 28-da toxicity study, a NOAEL of 1500 mg/kg bw/day was identified for calcium lignosulphonate (40-65) based on minimal focal/multifocal chronic inflammation in the rectum of male rats. In a 90-day subchronic toxicity study the petitioner identified a NOAEL of 2000 mg/kg bw/day for calcium lignosulphonate (40-65), the highest dose tested. The Panel, however, considered this study inadequate for evaluating the safety of calcium lignosulphonate (40-65) due to the high incidence of lymphoid hyperplasia and lymphoid infiltration in the mandibular and mesenteric lymph nodes, in the Peyer\u2019s patches and in the liver in all animals, including controls. Therefore, the Panel considers that available data on calcium lignosulphonate (40-65) are insufficient to establish an ADI. Furthermore, the Panel considers that long-term toxicity studies are needed to elucidate whether the histiocytosis in the mesenteric lymph nodes of the rats observed in the inadequate 90-day toxicity study may progress into a more adverse state with time. Overall, based on the available information, the Panel concludes that the safety of use of calcium lignosulphonate (40-65), as a carrier for vitamins and carotenoids intended to be added to foods for colouring and nutrient purposes, cannot be assessed