Maximum Permitted Level Research Articles

Re-evaluation of sodium ferrocyanide (E535), potassium ferrocyanide (E536) and calcium ferrocyanide (E538) as food additives.

The Panel on Food Additives and Nutrient Sources added to Food (ANS) provided a scientific opinion re‐evaluating the safety of sodium ferrocyanide (E 535), potassium ferrocyanide (E 536), and evaluating the safety of calcium ferrocyanide (E 538) as food additives. The Panel considered that adequate exposure and toxicity data were available. Ferrocyanides (E 535–538) are solely authorised in two food categories as salt substitutes. To assess the dietary exposure to ferrocyanides (E 535–538) from their use as food additives, the exposure was calculated based on regulatory maximum level exposure assessment scenario (maximum permitted level (MPL)) and the refined exposure assessment scenario. Dietary exposure to ferrocyanides was calculated based on mean and high levels consumption of salts in both the regulatory maximum level and the refined scenario. In the MPL scenario, the exposure to ferrocyanides (E 535–538) from their use as a food additive was up to 0.009 mg/kg body weight (bw) per day in children and adolescents. In the refined estimated exposure scenario, the exposure was up to 0.003 mg/kg bw per day in children and adolescents. Absorption of ferrocyanides is low and there is no accumulation in human. There is no concern with respect to genotoxicity and carcinogenicity. Reproductive studies were not available, but a no observed adverse effect level (NOAEL) of 1,000 mg sodium ferrocyanide/kg bw per day (highest dose tested) was identified from a prenatal developmental toxicity study. The kidney appeared to be the target organ for ferrocyanides toxicity and 4.4 mg sodium ferrocyanide/kg bw per day was identified as the NOAEL for the renal effects in a chronic (2‐year) study in rats. Assuming that the toxicity of this compound is due to the ferrocyanide ion only, the Panel established a group acceptable daily intake (ADI) for sodium, potassium and calcium ferrocyanide of 0.03 mg/kg bw per day expressed as ferrocyanide ion. The Panel concluded that ferrocyanides (E 535–538) are of no safety concern at the current authorised use and use levels.

Re-evaluation of stannous chloride (E512) as food additive.

The Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion re‐evaluating the safety of stannous chloride and stannous chloride dihydrate (E 512) as food additives. The Panel considered that adequate exposure and toxicity data were available. Stannous chloride is only permitted as food additives in one food category and no reply on the actual use level of stannous chloride (E 512) as a food additive and on its concentration in food was provided by any interested party. According to the Mintel's Global New Products Database (GNPD), stannous chloride was not labelled on any products in the EU nor in Norway. The regulatory maximum level exposure assessment scenario is based on the maximum permitted levels (MPLs) for stannous chloride (E 512), which is 25 mg Sn/kg. The mean exposure to stannous chloride (E 512) from its use as a food additive was below 1.3 μg Sn/kg body weight (bw) per day for all age groups. The 95th percentile of exposure to stannous chloride (E 512) ranged from 0.0 μg Sn/kg bw per day in all groups to 11.2 μg Sn/kg bw per day in adults. Absorption of stannous chloride from the gastrointestinal tract is low there is no concern with respect to carcinogenicity and genotoxicity. Gastrointestinal irritation was reported in humans after ingestion of a bolus dose of 40 mg Sn. The Panel concluded that stannous chloride (E 512) is of no safety concern in this current authorised use and use levels.

Dietary exposure of the Belgian population to emulsifiers E481 (sodium stearoyl-2-lactylate) and E482 (calcium stearoyl-2-lactylate)

ABSTRACTA dietary exposure assessment of food emulsifiers E481 (sodium stearoyl-2-lactylate) and E482 (calcium stearoyl-2-lactylate) in the Belgian population was performed. Nationally representative food consumption data from the Belgian National Food Consumption Surveys 2004 (BNFCS2004) and 2014 (BNFCS2014) were used for calculations. A conservative approach (combining individual food consumption data with the maximum permitted level (MPL) of foods (tier 2), was compared with more refined estimates (combining individual food consumption data with actual concentrations measured in food products available on the Belgian market (tier 3)). Estimated daily intakes were compared to the acceptable daily intake (ADI) of the stearoyl-2-lactylates. The results of tier 2 demonstrated that 92% of the children (3–9 years), 53% of the adolescents (10–17 years), 15% of the adults (18–64 years) and 26% of the elderly (64–98 years) had a potential intake higher than the ADI. When replacing the MPL with maximum analysed concentration levels in foods, daily intake estimates decreased dramatically. The estimated daily intake of the food emulsifiers was below the ADI for all age groups, except for a small percentage of children (1.9%) for which the intake exceeded the ADI. The main contributors to the exposure of E481 and E482 were bread, rolls and fine bakery wares.

Extension of use of lycopene (E160d) to certain meat preparations, meat products and fruit and vegetable preparations.

The present scientific opinion deals with the safety of the extension of use of lycopene (E 160d) in certain meat preparations, meat products and fruit and vegetable preparations. Lycopene (E 160d) is an authorised food additive in the EU for use in several food categories and an acceptable daily intake (ADI) of 0.5 mg/kg body weight (bw) per day was established. In the present opinion, the Panel decided that a comparison of the exposure resulting from the current uses and use levels with the exposure resulting from this additional proposed extension of uses would be sufficient to address the safety of lycopene. The Panel calculated that, considering the current maximum permitted levels (MPLs) and the proposed extension of uses and use levels, the mean dietary exposure to lycopene (E 160d) in the total population ranged from 0.01 mg/kg bw per day in infants to 0.82 mg/kg bw per day in toddlers. At the high level, dietary exposure to lycopene (E 160d) ranged from 0.03 mg/kg bw per day in infants to 1.39 mg/kg bw per day in toddlers. The Panel concluded that the proposed extension of uses of lycopene (E 160d) as a food additive in meat preparations, meat products and fruit and vegetable preparations up to 60 mg/kg would not add significantly to the intake of the food additive at its current MPL. However, the Panel noted that the overall intake at the MPL scenario would exceed the currently established ADI. The Panel acknowledged the uncertainties in the current estimates which could result in an overestimation of the exposure to lycopene (E 160d) as a food additive in European countries and therefore concluded that a refined exposure estimate would be recommended focusing on food categories contributing the most to its estimates, in order to decrease uncertainties in its current estimates.

Predictive modelling of the exposure to steviol glycosides in Irish patients aged 1-3 years with phenylketonuria and cow’s milk protein allergy

ABSTRACTChildren with Phenylketonuria (PKU) and severe cow’s milk protein allergy (CMPA) consume prescribed, specially formulated, foods for special medical purposes (FSMPs) as well as restricted amounts of normal foods. These patients are exposed to artificial sweeteners from the consumption of a combination of free and prescribed foods. Young patients with PKU and CMPA have a higher risk of exceeding acceptable daily intakes (ADI) for additives than age-matched healthy children. A predictive modelling approach has been adapted successfully to assess the additive exposure of young patients with PKU and CMPA to artificial sweeteners. Steviol glycosides (E960) are at various stages of regulatory approval for the various food categories in the EU but are not as yet permitted for use in products intended for young children. The aim of this study was to predict potential steviol glycoside exposure in young children with PKU and CMPA considering the potential for future provisions for the use of this sweetener. The recent introduction of steviol glycosides means that no exposure data are available for children with CMPA and PKU. Food consumption data were derived from the food consumption survey data of healthy young children in Ireland from the National Preschool and Nutrition Survey (NPNS, 2010–11). Specially formulated amino acid-based FSMPs are used to replace whole or milk protein foods and were included in the exposure model to replace restricted foods. The recommendations to ensure adequate protein intake in these patients were used to determine FSMP intake. Exposure assessment results indicated that the maximum permitted level (MPL) for FSMPs would warrant careful consideration to avoid exposures above the ADI. These data can be used to inform recommendations for the medical nutrition industry.

Exposure assessment of annatto colouring principles bixin and norbixin (E160b) when used as food additives.

Following a request for technical assistance, EFSA carried out an exposure assessment of the colouring principles bixin and norbixin of the food colour annatto extracts (E 160b), from its use as a food additive, taking into account new proposed uses and use levels. In 2016, the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) adopted a scientific opinion on the safety of annatto extracts (E 160b) as a food additive. In that opinion, the Panel concluded that the toxicological database was sufficient to derive an acceptable daily intake (ADI) of 6 mg bixin/kg body weight (bw) per day and an ADI of 0.3 mg norbixin/kg bw per day. Dietary exposure for annatto (E 160b), bixin‐ and norbixin‐based annatto extracts was estimated taking into account the maximum permitted levels (MPLs) as set in the Annex II to Regulation (EC) No 1333/2008, use levels provided by food industry as well as proposed use levels from an applicant for an extension of use. Exposure estimates for bixin were below the ADI for all population groups and for all refined exposure scenarios, including the proposed extension of use. For norbixin, exceedance was observed for the extension of use at the 95th percentile for some population groups. In the current estimates, the dietary exposure for bixin does not exceed the ADI. For norbixin, dietary exposure exceeds the ADI at the high level (95th percentile) for toddlers and children.

Re‐evaluation of konjac gum (E 425 i) and konjac glucomannan (E 425 ii) as food additives

The present opinion deals with the re‐evaluation of konjac (E 425), comprising konjac gum (E 425 i) and konjac glucomannan (E 425 ii) when used as food additives. 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 current use of konjac (E 425) was limited in all food categories to maximum permitted level (MPL) of 10 g/kg, and that the calculated indicative refined exposure assessment for all population groups was below 0.1 mg/kg body weight (bw) per day for the general population (mean and high level). Konjac gum and konjac glucomannan were unlikely to be absorbed intact and were significantly fermented by intestinal microbiota. The available database on toxicological studies was considered limited, however, no relevant adverse effects were seen in rats and dogs in 90‐day feeding studies according to the SCF, the no‐observed‐effect level (NOEL) in rats being 1,250 mg konjac glucomannan/kg bw per day. Konjac gum and konjac glucomannan were of no concern with respect to the genotoxicity. After a daily dosage of 3,000 mg in adults for 12 weeks, several individuals experienced abdominal discomfort including diarrhoea or constipation. The Panel concluded that there was no need for a numerical acceptable daily intake (ADI) and that there was no safety concern for the general population at the refined exposure assessment for the reported uses of konjac gum (E 425 i) and konjac glucomannan (E 425 ii) as food additives under the current conditions of use of 10 g/kg. The Panel agreed with the conclusions of the SCF (1997) that the uses of konjac (E 425) as an additive at the levels up to 10 g/kg in food are acceptable, provided that the total intake from all sources stays below 3 g/day.

The efficacy of supplying supplemental cobalt, selenium and vitamin B12 via the oral drench route in sheep

Cobalt and selenium are essential trace elements required for ruminants. There are many different methods of supplementation available to sheep including boluses, in feed, free access minerals, pasture dressing and oral drenches. Recent changes in European legislation have resulted in a reduction in the maximum permitted level (MPL) of cobalt to be included in ruminant diets from 2mg/kg at 88% DM to 1mg/kg at 88% DM with a suggested supplementary rate of 0.3mg Co/kg at 88% DM.This study aimed to determine the efficacy of cobalt plus/minus vitamin B12 and selenium supplementation from oral drenching over a 13day time period.Seven groups of grass silage fed Suffolk cross mule lambs (n=56) were randomly allocated to one of 7 treatments, a 5ml oral drench containing 700, 2300, 12000mg Co/l, with or without 2300mg vitamin B12/l in a factoral design, with an additional control group which received no drench. All drenches also contained selenium at 625mg/l. Lambs were weighed on days 0 and 13. The lambs were sampled by jugular venepuncture on days 0, 1, 2, 3, 4, 5, 6, 7, 9, 11 and 13, with samples analysed for plasma selenium and cobalt by ICP-MS, erythrocyte glutathione peroxidase by colourimetric assay and vitamin B12 by immunoassay.The results showed that cobalt via a drench was able to raise plasma cobalt in a dose dependent manner, with each dose level significantly higher than the previous level at all post drenching time points (P<0.05). However, the cobalt containing drenches did not significantly raise vitamin B12 concentrations in the plasma. Vitamin B12 containing drenches were able to elevate vitamin B12 in the plasma for a period of 7 days (P<0.05). The selenium content of the drench was able to significantly raise the plasma selenium from day 1 throughout the rest of the trial (day 13) (P<0.001). A significant increase in erythrocyte glutathione peroxidase activity of the sheep did eventually occur at day 13 (P<0.05).In summary, the addition of vitamin B12 via the drench route resulted in a short term elevation (7 days) of plasma vitamin B12 concentrations whereas cobalt sulphate alone was unable to significantly raise vitamin B12 concentrations within this trial in sheep with marginally adequate cobalt status, despite elevating plasma cobalt concentrations. The drench route was also able to elevate plasma selenium concentrations from a marginal selenium status.

Accumulation and distribution of zinc and manganese in aquatic ecosystem of Yavoriv water reservoir, Lviv region, Ukraine

The paper presents results of investigations of zinc and manganese concentration in the water, bottom deposits and ichthyofauna of Yavoriv water reservoir, which was formed in 2002 in frames of project of Yavoriv sulfur quarry revitalization. Mentioned elements are characterized by wide spectrum of action in fish body, which, depending on their concentration, can be either physiologic or toxic. It was revealed, that concentration of Zn and Mn in the water of Yavoriv water reservoir varied considerably depending on place of samples taking. The lowest Zn concentration in the water was below 1 MPL (maximum permitted level), namely 0.6 µg/l, and the highest – more than 7 MPL (70.5 µg/l). Similar differences were observed concerning Mn concentration in the water – the range of determined values varied from 3.3 (0.3 MPL) to 48.6 µg/l. The same peculiarities of Zn and Mn distribution were estimated in regard to their content in bottom deposits. In particular, difference of Zn concentration in samples of bottom deposits was near 23 times – from 5.4 to 230.0 mg/kg depending on the point of samples taking. Mn content in bottom deposits varies from 61.5 to 1500 mg/kg. Zn and Mn concentration in skeletal muscles, gills and skin of perch and rudd didn’t exceed MPL regardless their content in the water and bottom deposits. In most of cases, gills accumulated these elements more than other investigated tissues.

Exposure of Polish children to Southampton food colours

ABSTRACTA study published in 2007 showed that the intake of six food colours (the so-called ‘Southampton colours’) may have an adverse effect on activity and attention in children. The present study set out to assess the exposure of Polish children (3 and 8–9 years old, n = 149) to six of the target colours. Two methods were used to evaluate colour consumption by children: scenario 1 using the maximum permitted levels (MPLs) and actual food consumption data; and scenario 2 using the actual levels in food and actual food consumption data. The data on the actual consumption of food containing the colours was collected using a 7-day questionnaire survey. The results of laboratory analysis of food consumed by children provided data on the actual levels of the colours in food. Consumption of the colours estimated by scenario 1 in any case did not exceed the acceptable daily intakes (ADIs) of the colours in both age groups of children. For more refined colour intake (scenario 2), isolated cases exceeding the ADI were recorded for four colours, but assuming that manufacturers comply with the current legislation on MPL of colours in food, the intake of the colours assessed in scenario 2 should not be a reason for exceeding of ADIs for the target food colours.

Anionic fatty acids content in carp gills at different copper and zinc concentration in the water

Copper and Zinc belongs to essential elements with wide spectrum of physiological and biochemical action in fishes organism. In particular, the role of Zinc in growth, development and reproduction of fishes is established, both as its influence on protein and nucleic acids metabolism and genes activity regulation. Zinc, as well as Copper, is involved in enzyme link of antioxidant system. Besides, Copper takes part in erythropoiesis, energetic metabolism and immune system functioning. Abovementioned elements also influence on desaturases activity. The desaturases are catalyzing transformation of single bond between Carbon atoms in acyl chain into double unsaturated bond. At the same time, Zinc and Copper influence on fatty acids metabolism in fishes body and its tissue and organic specificity remains insufficiently explored. Presented results testified, that at concentration of Zinc and Copper in the water, equated to 1 MPL (maximum permitted level), Zinc accumulates in the gills in greater extend, than Copper. In its turn, at two maximum permitted levels in the water, Copper accumulates in the gills more, than Zinc. Increasing of Zinc and Copper concentration in carp’s gills has led to the increasing of total concentration of anionic forms of fatty acids, those are barely metabolically active. The increasing of anionic fatty acids was caused by saturated, monounsaturated and polyunsaturated fatty acids. Wherein, the ratio of anionic polyunsaturated fatty acids of ω–3 family to anionic polyunsaturated fatty acids of ω–6 family didn’t changed.

Meat quality of broiler chickens affected by cadmium toxicity

A 114 g decrease in the live weight gain and a 160 g increase in the mixed feed intake may become evident at the fifth maximum permitted level (MPL) for cadmium added to a broiler-chicken diet. The concentration of the pollutant increased two and a half as high in meat. A high concentration of the pollutant in the mixed fodder could cause decrease in the contents of muscle tissue fat, lysine and leucine, and vitamins B2, B6, and B12 by 6.4, 2.6–4.0, and 1.0–8.0%, respectively. In addition, the level of water reliably became approximately one and a half higher in tissues; the contents of threonine and vitamin B5 increased by 20.5 and 0.92%, respectively; the concentrations of chlorine and potassium decreased by 2.5 and 4.2%, respectively; the contents of iron and manganese increased by 1.7 and 1.8%, respectively.

Safety assessment of the active substance potassium metabisulfite, for use in active food contact materials

This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) deals with the safety assessment of the active substance potassium metabisulfite, food contact material (FCM) substances No 1056, intended to extend the shelf life of wine. The active substance is sulfur dioxide (SO2, E 220) which is generated in situ from potassium metabisulfite, E 224. Alternative precursors of SO2 are other authorised sulfites marketed as food preservatives. A gel of agar (E 406) is used as a physical support media for the E 224 and the E 220 generated from it. This mixture is contained within plastic containers that are closed with a membrane of polyethersulfone (PES). When the precursor comes in contact with water contained in the agar gel, sulfur dioxide is formed. The PES acts as a microporous membrane which ensures the controlled diffusion of SO2 from the active cap to the wine. Interactions and reactions between the active ingredients and the PES or the agar or the plastic caps, and any consequential release of reaction products into the wine, are not to be expected. The CEF Panel concluded that the substance potassium metabisulfite (E 224), as well as any of the other authorised ‘sulfites’ (E 221, E 222, E 223, E 226, E 227 and E 228) would not be a safety concern for the consumer if used as precursors for the release of sulfur dioxide (E 220) to wine under the conditions considered in the present opinion. The release of SO2 should not cause an exceedance of the maximum permitted levels (MPLs) for total SO2 (free SO2 plus combined SO2) in wine given in Regulation (EC) No 606/2009 and Regulation (EC) No 203/2012. The conclusions and the recommendations of the EFSA Panel on Food Additives and Nutrient Sources Added to Food (ANS) Panel on the re-evaluation of sulfur dioxide and sulfites should be considered.

Bloom of Dinophysis spp. dominated by D. sacculus and its related diarrhetic shellfish poisoning (DSP) outbreak in Alfacs Bay (Catalonia, NW Mediterranean Sea): Identification of DSP toxins in phytoplankton, shellfish and passive samplers

We report a comprehensive study of a diarrhetic shellfish poisoning (DSP) outbreak in a Mediterranean coastal embayment, integrating phytoplankton identification and quantification data, with toxin analysis by LC–MS/MS of shellfish samples (mussels and oysters), phytoplankton concentrates, and solid phase adsorbing toxin tracking (SPATT) devices. Alfacs Bay was proposed as a model for the study of semi-enclosed coastal embayments and it is the most important shellfish farming area in Catalonia (Spain, NW Mediterranean Sea). The bay suffered a ban for bivalve harvesting that lasted 78 days, from late winter to the end of the spring of 2012, due to a harmful algae bloom of the toxic dinoflagellate Dinophysis sacculusthat fluctuated in three abundance peaks, reaching maximum abundance of 2200 cell/L. Mussels sampled during the bloom contained okadaic acid (OA, maximum 592 μg/kg, 3.7 times the maximum permitted level (MPL) set by the European Commission), and pectenotoxin-2 (PTX2, maximum 61 μg/kg). Oysters also contained OA and PTX2, but always below the MPL. Toxin content per cell measured from phytoplankton concentrates in filters was most likely overestimated (up to 461 pg OA/cell and 668 pg PTX2/cell), but showed an increase of cell toxicity towards the end of the bloom. OA-diol esters were not detected in phytoplankton aggregates. Concentration of DSP toxins in SPATT devices were up to 94 ng OA/g resin⋅day, 42 ng PTX2/g resin⋅day and 7 ng PTX2-sa/g resin⋅day. The applied monitoring strategy, based on the measurement of Dinophysis cell abundance in the water column, was effective to protect public health and did not extended the regulatory closure unnecessarily. Concentration of DSP in SPATT bags followed Dinophysis abundance dynamics, thus SPATTs were confirmed as a valuable research tool for Dinophysis blooms.

Natural co-occurrence of ochratoxin A, ochratoxin B and aflatoxins in Sicilian red wines

The natural occurrence of ochratoxin A, ochratoxin B, aflatoxin B1, aflatoxin B2, aflatoxin G1 and aflatoxin G2 (OTA, OTB, AFB1, AFB2, AFG1, AFG2) in red wines was investigated by HPLC/FLD after immunoaffinity column clean-up in 57 market samples produced in Sicily (Italy). The results showed a very low incidence of these mycotoxins in analysed samples, confirming the high degree of quality and safety of Sicilian red wines. The results indicated 71.9% and 64.9% positive samples for OTA and OTB respectively, with an average level of 0.13 μg l–1, well below the European maximum permitted levels (MLs). The aflatoxin most frequently detected in the samples was AFG1, present in 57.9% of samples, while the other aflatoxins were rarely present. Recovery experiments were carried out on eight mycotoxin-free red wines spiked with OTA, OTB, AFB1, AFB2, AFG1 and AFG2 at two different levels. The limits of detection (LODs) in wines were 0.02 µg l–1 for OTA, 0.04 µg l–1 for OTB, 0.03 µg l–1 for AFG1, AFG2 and AFB2, and 0.05 µg l–1 for AFB1. A good correlation was found, with good performances in term of precision for the method.

Extension of use of extracts of rosemary (E 392) in fat‐based spreads

Following a request from the European Commission, a refined exposure assessment was carried out based on the maximum permitted levels (MPLs) authorised in Annex II of Regulation (EC) No 1333/2008 for extracts of rosemary (E 392) and the extension of its use in fat-based spreads at the levels proposed by the applicant of 30 mg/kg and 100 mg/kg. This was not covered by the previous re-evaluation of the safety of extracts of rosemary (E 392) as a food additive performed by EFSA in 2008. In that previous opinion, it was noted that, whilst the data were insufficient to establish a numerical ADI, the margin of safety was high enough to conclude that dietary exposure resulting from the proposed uses and use levels was not of safety concern. In providing a scientific opinion on the safety of the proposed extensions of use, the ANS Panel has decided that a comparison of the exposure resulting from the current uses and use levels with the exposure resulting from these additional proposed uses would be sufficient to address the safety of extracts of rosemary. The Panel concluded that, since the two additional uses for rosemary extracts in fat-based spreads would not change the estimated exposure to the food additive compared with the already approved permitted uses in any part of the population, the conclusions made by the AFC Panel in 2008 regarding safety remain valid. Therefore, the Panel considered that it is unlikely that there is a safety concern with the current permitted uses together with the additional proposed extension of uses compared with the current permitted uses alone. The Panel recommends that a refined exposure assessment is carried out to decrease the existing uncertainties arising from its conservative estimates based on current MPLs.

Dietary exposure to benzoates (E210–E213), parabens (E214–E219), nitrites (E249–E250), nitrates (E251–E252), BHA (E320), BHT (E321) and aspartame (E951) in children less than 3 years old in France

This study aimed to estimate the exposure to seven additives (benzoates, parabens, nitrites, nitrates, BHA, BHT and aspartame) in children aged less than 3 years old in France. A conservative approach, combining individual consumption data with maximum permitted levels, was carried out for all the additives. More refined estimates using occurrence data obtained from products’ labels (collected by the French Observatory of Food Quality) were conducted for those additives that exceeded the acceptable daily intake (ADI). Information on additives’ occurrence was obtained from the food labels. When the ADI was still exceeded, the exposure estimate was further refined using measured concentration data, if available. When using the maximum permitted level (MPL), the ADI was exceeded for benzoates (1.94 mg kg–1 bw day–1), nitrites (0.09 mg kg–1 bw day–1) and BHA (0.39 mg kg–1 bw day–1) in 25%, 54% and 20% of the entire study population respectively. The main food contributors identified with this approach were current foods as these additives are not authorised in specific infant food: vegetable soups and broths for both benzoates and BHA, delicatessen and meat for nitrites. The exposure estimate was significantly reduced when using occurrence data, but in the upper-bound scenario the ADI was still exceeded significantly by the age group 13–36 months for benzoates (2%) and BHA (1%), and by the age group 7–12 months (16%) and 13–36 months (58%) for nitrites. Measured concentration data were available exclusively for nitrites and the results obtained using these data showed that the nitrites’ intake was below the ADI for all the population considered in this study. These results suggest that refinement of exposure, based on the assessment of food levels, is needed to estimate the exposure of children to BHA and benzoates for which the risk of exceeding the ADI cannot be excluded when using occurrence data.

Refined exposure assessment for Allura Red AC (E 129)

Following a self-tasking request, the European Food Safety Authority (EFSA) carried out a refined exposure assessment for Allura Red AC (E 129) taking into account additional information on its use in foods. In 2009, the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) adopted a scientific opinion on the re-evaluation of Allura Red AC (E 129) used as a food additive. In that opinion, the Panel concluded that, at the high level, under both scenarios, that is using either the maximum permitted levels (MPLs) or the reported use levels provided by industry, intake estimates for 1- to 10-year old children can be above the Acceptable Daily Intake (ADI) of 7 mg/kg body weight (bw) per day. Following this conclusion, EFSA performed a refined exposure assessment for this food colour, using new usage data from industry, as well as analytical data submitted to EFSA by Member States and the EFSA Comprehensive European Food Consumption Database. Usage data from industry were provided to EFSA for six out of the 51 food categories in which Allura Red AC (E 129) is authorised as a food additive; while analytical data from Member States were provided to EFSA for 35 food categories. Using MPLs and these new data, none of the exposure estimates exceeded the ADI of 7 mg/kg bw per day in any population.

Refined exposure assessment of Brown HT (E 155)

The European Food Safety Authority (EFSA) carried out an exposure assessment of Brown HT (E 155) taking into account additional information on its use in foods as consumed. In 2010, the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) adopted a scientific opinion on the re-evaluation of Brown HT and concluded that dietary exposure in both adults and 1–10 year old children at the high level may exceed the Acceptable Daily Intake (ADI) for Brown HT of 1.5 mg/kg body weight (bw)/day at the upper end of the range. Following this conclusion, the European Commission requested EFSA to perform a refined exposure assessment for this food colour. Data on the presence of Brown HT in foods were requested from relevant stakeholders through a call for usage and concentration data. Usage levels were provided to EFSA for six out of 37 food categories in which Brown HT is authorised. A limited number of analytical results were also reported to EFSA, all below the limit of detection (LOD) or limit of quantification (LOQ). Exposure assessment was performed using the EFSA Comprehensive Food Consumption Database. Three different scenarios were considered, including i) exposure estimates based on Maximum Permitted Levels (MPLs), ii) a combination of MPLs and reported maximum use levels and iii) reported maximum use levels only. Considering the first two scenarios, high exposure levels (95th percentile) exceeded the ADI for all age groups, with exception for the elderly. In comparison to the previous assessment, for both children and adults, the current mean exposure estimates are of the same order of magnitude, while the 95th percentile exposure is lower, particularly in adults. The mean and high level exposure estimates of Brown HT are below the ADI for all population groups when considering the reported use levels only.

Risk Analysis of Sulfites Used as Food Additives in China

This study was to analyze the risk of sulfites in food consumed by the Chinese people and assess the health protection capability of maximum-permitted level (MPL) of sulfites in GB 2760-2011. Sulfites as food additives are overused or abused in many food categories. When the MPL in GB 2760-2011 was used as sulfites content in food, the intake of sulfites in most surveyed populations was lower than the acceptable daily intake (ADI). Excess intake of sulfites was found in all the surveyed groups when a high percentile of sulfites in food was in taken. Moreover, children aged 1-6 years are at a high risk to intake excess sulfites. The primary cause for the excess intake of sulfites in Chinese people is the overuse and abuse of sulfites by the food industry. The current MPL of sulfites in GB 2760-2011 protects the health of most populations.