Update of the scientific opinion on tetrabromobisphenol A (TBBPA) and its derivatives in food.

The European Commission asked EFSA to update its 2011 risk assessment on tetrabromobisphenol A (TBBPA) and five derivatives in food. Neurotoxicity and carcinogenicity were considered as the critical effects of TBBPA in rodent studies. The available evidence indicates that the carcinogenicity of TBBPA occurs via non-genotoxic mechanisms. Taking into account the new data, the CONTAM Panel considered it appropriate to set a tolerable daily intake (TDI). Based on decreased interest in social interaction in male mice, a lowest observed adverse effect level (LOAEL) of 0.2 mg/kg body weight (bw) per day was identified and selected as the reference point for the risk characterisation. Applying the default uncertainty factor of 100 for inter- and intraspecies variability, and a factor of 3 to extrapolate from the LOAEL to NOAEL, a TDI for TBBPA of 0.7 µg/kg bw per day was established. Around 2100 analytical results for TBBPA in food were used to estimate dietary exposure for the European population. The most important contributors to the chronic dietary LB exposure to TBBPA were fish and seafood, meat and meat products and milk and dairy products. The exposure estimates to TBBPA were all below the TDI, including those estimated for breastfed and formula-fed infants. Accounting for the uncertainties affecting the assessment, the CONTAM Panel concluded with 90%-95% certainty that the current dietary exposure to TBBPA does not raise a health concern for any of the population groups considered. There were insufficient data on the toxicity of any of the TBBPA derivatives to derive reference points, or to allow a comparison with TBBPA that would support assignment to an assessment group for the purposes of combined risk assessment.

Risk assessment of small organoarsenic species in food.

The European Commission asked EFSA for a risk assessment on small organoarsenic species in food. For monomethylarsonic acid MMA(V), decreased body weight resulting from diarrhoea in rats was identified as the critical endpoint and a BMDL10 of 18.2 mg MMA(V)/kg body weight (bw) per day (equivalent to 9.7 mg As/kg bw per day) was calculated as a reference point (RP). For dimethylarsinic acid DMA(V), increased incidence in urinary bladder tumours in rats was identified as the critical endpoint. A BMDL10 of 1.1 mg DMA(V)/kg bw per day (equivalent to 0.6 mg As/kg bw per day) was calculated as an RP. For other small organoarsenic species, the toxicological data are insufficient to identify critical effects and RPs, and they could not be included in the risk assessment. For both MMA(V) and DMA(V), the toxicological database is incomplete and a margin of exposure (MOE) approach was applied for risk characterisation. The highest chronic dietary exposure to DMA(V) was estimated in 'Toddlers', with rice and fish meat as the main contributors across population groups. For MMA(V), the highest chronic dietary exposures were estimated for high consumers of fish meat and processed/preserved fish in 'Infants' and 'Elderly' age class, respectively. For MMA(V), an MOE of ≥ 500 was identified not to raise a health concern. For MMA(V), all MOEs were well above 500 for average and high consumers and thus do not raise a health concern. For DMA(V), an MOE of 10,000 was identified as of low health concern as it is genotoxic and carcinogenic, although the mechanisms of genotoxicity and its role in carcinogenicity of DMA(V) are not fully elucidated. For DMA(V), MOEs were below 10,000 in many cases across dietary surveys and age groups, in particular for some 95th percentile exposures. The Panel considers that this would raise a health concern.

Risks for animal and human health related to the presence of polychlorinated naphthalenes (PCNs) in feed and food.

EFSA was asked for a scientific opinion on the risks for animal and human health related to the presence of polychlorinated naphthalenes (PCNs) in feed and food. The assessment focused on hexaCNs due to very limited data on other PCN congeners. For hexaCNs in feed, 217 analytical results were used to estimate dietary exposures for food-producing and non-food-producing animals; however, a risk characterisation could not be performed because none of the toxicological studies allowed identification of reference points. The oral repeated dose toxicity studies performed in rats with a hexaCN mixture containing all 10 hexaCNs indicated that the critical target was the haematological system. A BMDL20 of 0.05 mg/kg body weight (bw) per day was identified for a considerable decrease in the platelet count. For hexaCNs in food, 2317 analytical results were used to estimate dietary exposures across dietary surveys and age groups. The highest exposure ranged from 0.91 to 29.8 pg/kg bw per day in general population and from 220 to 559 pg/kg bw per day for breast-fed infants with the highest consumption of breast milk. Applying a margin of exposure (MOE) approach, the estimated MOEs for the high dietary exposures ranged from 1,700,000 to 55,000,000 for the general population and from 90,000 to 230,000 for breast-fed infants with the highest consumption of breast milk. These MOEs are far above the minimum MOE of 2000 that does not raise a health concern. Taking account of the uncertainties affecting the assessment, the Panel concluded with at least 99% certainty that dietary exposure to hexaCNs does not raise a health concern for any of the population groups considered. Due to major limitations in the available data, no assessment was possible for genotoxic effects or for health risks of PCNs other than hexaCNs.

Update of the risk assessment of polybrominated diphenyl ethers (PBDEs) in food.

The European Commission asked EFSA to update its 2011 risk assessment on polybrominated diphenyl ethers (PBDEs) in food, focusing on 10 congeners: BDE-28, -47, -49, -99, -100, -138, -153, -154, -183 and ­209. The CONTAM Panel concluded that the neurodevelopmental effects on behaviour and reproductive/developmental effects are the critical effects in rodent studies. For four congeners (BDE-47, -99, -153, -209) the Panel derived Reference Points, i.e. benchmark doses and corresponding lower 95% confidence limits (BMDLs), for endpoint-specific benchmark responses. Since repeated exposure to PBDEs results in accumulation of these chemicals in the body, the Panel estimated the body burden at the BMDL in rodents, and the chronic intake that would lead to the same body burden in humans. For the remaining six congeners no studies were available to identify Reference Points. The Panel concluded that there is scientific basis for inclusion of all 10 congeners in a common assessment group and performed a combined risk assessment. The Panel concluded that the combined margin of exposure (MOET) approach was the most appropriate risk metric and applied a tiered approach to the risk characterisation. Over 84,000 analytical results for the 10 congeners in food were used to estimate the exposure across dietary surveys and age groups of the European population. The most important contributors to the chronic dietary Lower Bound exposure to PBDEs were meat and meat products and fish and seafood. Taking into account the uncertainties affecting the assessment, the Panel concluded that it is likely that current dietary exposure to PBDEs in the European population raises a health concern.

Risks for animal health related to the presence of ergot alkaloids in feed.

The European Commission requested EFSA to provide an update of the 2012 Scientific Opinion of the Panel on Contaminants in the Food Chain (CONTAM) on the risks for animal health related to the presence of ergot alkaloids (EAs) in feed. EAs are produced by several fungi of the Claviceps and Epichloë genera. This Opinion focussed on the 14 EAs produced by C. purpurea (ergocristine, ergotamine, ergocornine, α- and ß-ergocryptine, ergometrine, ergosine and their corresponding 'inine' epimers). Effects observed with EAs from C. africana (mainly dihydroergosine) and Epichloë (ergovaline/-inine) were also evaluated. There is limited information on toxicokinetics in food and non-food producing animals. However, transfer from feed to food of animal origin is negligible. The major effects of EAs are related to vasoconstriction and are exaggerated during extreme temperatures. In addition, EAs cause a decrease in prolactin, resulting in a reduced milk production. Based on the sum of the EAs, the Panel considered the following as Reference Points (RPs) in complete feed for adverse animal health effects: for pigs and piglets 0.6 mg/kg, for chickens for fattening and hens 2.1 and 3.7 mg/kg, respectively, for ducks 0.2 mg/kg, bovines 0.1 mg/kg and sheep 0.3 mg/kg. A total of 19,023 analytical results on EAs (only from C. purpurea) in feed materials and compound feeds were available for the exposure assessment (1580 samples). Dietary exposure was assessed using two feeding scenarios (model diets and compound feeds). Risk characterisation was done for the animals for which an RP could be identified. The CONTAM Panel considers that, based on exposure from model diets, the presence of EAs in feed raises a health concern in piglets, pigs for fattening, sows and bovines, while for chickens for fattening, laying hens, ducks, ovines and caprines, the health concern related to EAs in feed is low.

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.

Update of the risk assessment of inorganic arsenic in food.

The European Commission asked EFSA to update its 2009 risk assessment on arsenic in food carrying out a hazard assessment of inorganic arsenic (iAs) and using the revised exposure assessment issued by EFSA in 2021. Epidemiological studies show that the chronic intake of iAs via diet and/or drinking water is associated with increased risk of several adverse outcomes including cancers of the skin, bladder and lung. The CONTAM Panel used the benchmark dose lower confidence limit based on a benchmark response (BMR) of 5% (relative increase of the background incidence after adjustment for confounders, BMDL05) of 0.06 µg iAs/kg bw per day obtained from a study on skin cancer as a Reference Point (RP). Inorganic As is a genotoxic carcinogen with additional epigenetic effects and the CONTAM Panel applied a margin of exposure (MOE) approach for the risk characterisation. In adults, the MOEs are low (range between 2 and 0.4 for mean consumers and between 0.9 and 0.2 at the 95th percentile exposure, respectively) and as such raise a health concern despite the uncertainties.

Re-evaluation of erythritol (E 968) as a food additive.

This opinion addresses the re-evaluation of erythritol (E 968) as food additive and an application for its exemption from the laxative warning label requirement as established under Regulation (EU) No 1169/2011. Erythritol is a polyol obtained by fermentation with Moniliella pollinis BC or Moniliella megachiliensis KW3-6, followed by purifications and drying. Erythritol is readily and dose-dependently absorbed in humans and can be metabolised to erythronate to a small extent. Erythritol is then excreted unchanged in the urine. It does not raise concerns regarding genotoxicity. The dataset evaluated consisted of human interventional studies. The Panel considered that erythritol has the potential to cause diarrhoea in humans, which was considered adverse because its potential association with electrolyte and water imbalance. The lower bound of the range of no observed adverse effect levels (NOAELs) for diarrhoea of 0.5 g/kg body weight (bw) was identified as reference point. The Panel considered appropriate to set a numerical acceptable daily intake (ADI) at the level of the reference point. An ADI of 0.5 g/kg bw per day was considered by the Panel to be protective for the immediate laxative effect as well as potential chronic effects, secondary to diarrhoea. The highest mean and 95th percentile chronic exposure was in children (742 mg/kg bw per day) and adolescents (1532 mg/kg bw per day). Acute exposure was maximally 3531 mg/kg bw per meal for children at the 99th percentile. Overall, the Panel considered both dietary exposure assessments an overestimation. The Panel concluded that the exposure estimates for both acute and chronic dietary exposure to erythritol (E 968) were above the ADI, indicating that individuals with high intake may be at risk of experiencing adverse effects after single and repeated exposure. Concerning the new application, the Panel concluded that the available data do not support the proposal for exemption.

Risks for animal health related to the presence of ochratoxin A (OTA) in feed.

In 2004, the EFSA Panel on Contaminants in the Food Chain (CONTAM) adopted a Scientific Opinion on the risks to animal health and transfer from feed to food of animal origin related to the presence of ochratoxin A (OTA) in feed. The European Commission requested EFSA to assess newly available scientific information and to update the 2004 Scientific Opinion. OTA is produced by several fungi of the genera Aspergillus and Penicillium. In most animal species it is rapidly and extensively absorbed in the gastro-intestinal tract, binds strongly to plasma albumins and is mainly detoxified to ochratoxin alpha (OTalpha) by ruminal microbiota. In pigs, OTA has been found mainly in liver and kidney. Transfer of OTA from feed to milk in ruminants and donkeys as well as to eggs from poultry is confirmed but low. Overall, OTA impairs function and structure of kidneys and liver, causes immunosuppression and affects the zootechnical performance (e.g. body weight gain, feed/gain ratio, etc.), with monogastric species being more susceptible than ruminants because of limited detoxification to OTalpha. The CONTAM Panel considered as reference point (RP) for adverse animal health effects: for pigs and rabbits 0.01 mg OTA/kg feed, for chickens for fattening and hens 0.03 mg OTA/kg feed. A total of 9,184 analytical results on OTA in feed, expressed in dry matter, were available. Dietary exposure was assessed using different scenarios based on either model diets or compound feed (complete feed or complementary feed plus forage). Risk characterisation was made for the animals for which an RP could be identified. The CONTAM Panel considers that the risk related to OTA in feed for adverse health effects for pigs, chickens for fattening, hens and rabbits is low.

Update of the risk assessment of mineral oil hydrocarbons in food.

Mineral oil hydrocarbons (MOH) are composed of saturated hydrocarbons (MOSH) and aromatic hydrocarbons (MOAH). Due to the complexity of the MOH composition, their complete chemical characterisation is not possible. MOSH accumulation is observed in various tissues, with species-specific differences. Formation of liver epithelioid lipogranulomas and inflammation, as well as increased liver and spleen weights, are observed in Fischer 344 (F344) rats, but not in Sprague-Dawley (SD) rats. These effects are related to specific accumulation of wax components in the liver of F344 rats, which is not observed in SD rats or humans. The CONTAM Panel concluded that F344 rats are not an appropriate model for effects of MOSH with wax components. A NOAEL of 236 mg/kg body weight (bw) per day, corresponding to the highest tested dose in F344 rats of a white mineral oil product virtually free of wax components, was selected as relevant reference point (RP). The highest dietary exposure to MOSH was estimated for the young population, with lower bound-upper bound (LB-UB) means and 95th percentiles of 0.085-0.126 and 0.157-0.212 mg/kg bw per day, respectively. Considering a margin of exposure approach, the Panel concluded that the present dietary exposure to MOSH does not raise concern for human health for all age classes. Genotoxicity and carcinogenicity are associated with MOAH with three or more aromatic rings. For this subfraction, a surrogate RP of 0.49 mg/kg bw per day, calculated from data on eight polycyclic aromatic hydrocarbons, was considered. The highest dietary exposure to MOAH was also in the young population, with LB-UB mean and 95th percentile estimations of 0.003-0.031 and 0.011-0.059 mg/kg bw per day, respectively. Based on two scenarios on three or more ring MOAH contents in the diet and lacking toxicological information on effects of 1 and 2 ring MOAH, a possible concern for human health was raised.

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.

Risks for human health related to the presence of grayanotoxins in certain honey.

The European Commission asked EFSA for a scientific opinion on the risks for human health of the presence of grayanotoxins (GTXs) in 'certain honey' from Ericaceae plants. The risk assessment included all structurally related grayananes occurring with GTXs in 'certain' honey. Oral exposure is associated with acute intoxication in humans. Acute symptoms affect the muscles, nervous and cardiovascular systems. These may lead to complete atrioventricular block, convulsions, mental confusion, agitation, syncope and respiratory depression. For acute effects, the CONTAM Panel derived a reference point (RP) of 15.3 µg/kg body weight for the sum of GTX I and III based on a BMDL10 for reduced heart rate in rats. A similar relative potency was considered for GTX I. Without chronic toxicity studies, an RP for long-term effects could not be derived. There is evidence for genotoxicity in mice exposed to GTX III or honey containing GTX I and III, showing increased levels of chromosomal damage. The mechanism of genotoxicity is unknown. Without representative occurrence data for the sum of GTX I and III and consumption data from Ericaceae honey, acute dietary exposure was estimated based on selected concentrations for GTX I and III reflecting concentrations measured in 'certain' honeys. Applying a margin of exposure (MOE) approach, the estimated MOEs raised health concerns for acute toxicity. The Panel calculated the highest concentrations for GTX I and III below which no acute effects would be expected following 'certain honey' consumption. The Panel is 75% or more certain that the calculated highest concentration of 0.05 mg for the sum of GTX I and III per kg honey is protective for all age groups regarding acute intoxications. This value does not consider other grayananes in 'certain honey' and does not cover the identified genotoxicity.

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.

Re-evaluation of neohesperidine dihydrochalcone (E 959) as a food additive.

The present opinion deals with the re-evaluation of neohesperidine dihydrochalcone (E 959) when used as a food additive. It is obtained by catalytic hydrogenation of a flavanone - neohesperidine - which is naturally occurring and thus isolated by alcohol extraction in bitter oranges (Citrus aurantium). Based on in vivo data in rat, neohesperidine dihydrochalcone is likely to be absorbed, also in humans, and to become systemically available. It does not raise a concern regarding genotoxicity. The toxicity data set consisted of studies on subchronic and prenatal developmental toxicity. No human studies were available. The data set was considered sufficient to derive a new acceptable daily intake (ADI). Based on the weight of evidence (WoE) analysis, the Panel considered unlikely that neohesperidine dihydrochalcone would lead to adverse effects on health in animals in the dose ranges tested. The Panel also considered that a carcinogenicity study was not warranted and that the lack of human data did not affect the overall confidence in the body of evidence. The Panel derived an ADI of 20 mg/kg bodyweight (bw) per day based on a no observed adverse effect level (NOAEL) of 4,000 mg/kg bw per day from a 13-week study in rat, applying the standard default factors of 100 for inter- and intraspecies differences and of 2 for extrapolation from subchronic to chronic exposure. For the refined brand-loyal exposure assessment scenario, considered to be the most appropriate for the risk assessment, the exposure estimates at the mean ranged from < 0.01 to 0.09 mg/kg bw per day and at the 95th percentile (P95) from 0.01 to 0.24 mg/kg bw per day. Considering the derived ADI of 20 mg/kg bw per day, the exposure estimates were below the reference value in all age groups. Therefore, the Panel concluded that dietary exposure to the food additive neohesperidine dihydrochalcone (E 959) at the reported uses and use levels would not raise a safety concern.

Assessment of information as regards the toxicity of T-2 and HT-2 toxin for ruminants.

In 2011, the EFSA Panel on Contaminants in the Food Chain (CONTAM) adopted a Scientific Opinion on the risks for animal health related to the presence of T-2 (T2) and HT-2 (HT2) toxin in food and feed. No observed adverse effect levels (NOAELs) and lowest observed adverse effect levels (LOAELs) were derived for different animal species. In ruminants a LOAEL was established for the sum of T2 and HT2 of 0.3 mg/kg body weight (bw) per day, based on studies with calves and lambs. The CONTAM Panel noted that the effects observed in nutritionally challenged heifers and ewes give rise to the assumption that rumen detoxification of T2 may not always be complete and therefore effective to prevent adverse effects in ruminants. However, the limited data on the effects of T2 on adult ruminants did not allow a conclusion. The European Commission requested EFSA to review the information regarding the toxicity of T2 and HT2 for ruminants and to revise, if necessary, the established Reference Point (RP). Adverse effect levels of 0.001 and 0.01 mg T2/kg bw per day for, respectively, sheep and cows, were derived from case studies, estimated to correspond to feed concentrations of 0.035 mg T2/kg for sheep and 0.6 mg T2/kg for cows. RPs for adverse animal health effects of 0.01 mg/kg feed for sheep and 0.2 mg/kg feed for cows were established. For goats, the RP for cows was selected, in the absence of data that they are more sensitive. Based on mean exposure estimates performed in the previous Opinion, the risk of adverse health effects of feeds containing T2 and HT2 was considered a concern for lactating sheep. For milking goats, a comparison performed between dietary exposure and the RP derived for cows, indicates a potential risk for adverse health effects. For dairy cows and fattening beef, the risk is considered low.

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.

Assessment of information as regards the toxicity of fumonisins for pigs, poultry and horses.

In 2018, the EFSA Panel on Contaminants in the Food Chain (CONTAM) adopted a Scientific Opinion on the risks for animal health related to the presence of fumonisins, their modified forms and hidden forms in feed. A no observed adverse effect level (NOAEL) of 1 mg/kg feed was established for pigs. In poultry a NOAEL of 20 mg/kg feed and in horses a reference point for adverse animal health effect of 8.8 mg/kg feed was established, referred to as NOAEL. The European Commission (EC) requested EFSA to review the information regarding the toxicity of fumonisins for pigs, poultry and horses and to revise, if necessary, the established NOAELs. The EFSA CONTAM Panel considered that the term reference point (RP) for adverse animal health effects better reflects the uncertainties in the available studies. New evidence which had become available since the previous opinion allowed to revise an RP for adverse animal health effects for poultry from 20 mg/kg to 1 mg/kg feed (based on a LOAEL of 2.5 mg/kg feed for reduced intestinal crypt depth) and for horses from 8.8 to 1.0 mg/kg feed (based on case studies on equine leukoencephalomalacia (ELEM)). For pigs, the previously established NOAEL was confirmed as no further studies suitable for deriving an RP for adverse animal health effects could be identified. Based on exposure estimates performed in the previous opinion, the risk of adverse health effects of feeds containing FB1-3 was considered a concern for poultry, when taking into account the RP of 1 mg/kg feed for intestinal effects. For horses and other solipeds, the risk is considered low, although a large uncertainty associated with exposure was identified. The same conclusions apply to the sum of FB1-3 and their hidden forms.

Assessment of the genotoxicity of acrylamide.

EFSA was requested to deliver a statement on a recent publication revisiting the evidence for genotoxicity of acrylamide (AA). The statement was prepared by a Working Group and was endorsed by the CONTAM Panel before its final approval. In interpreting the Terms of Reference, the statement considered the modes of action underlying the carcinogenicity of AA including genotoxic and non-genotoxic effects. Relevant publications since the 2015 CONTAM Panel Opinion on AA in food were reviewed. Several new studies reported positive results on the clastogenic and mutagenic properties of AA and its active metabolite glycidamide (GA). DNA adducts of GA were induced by AA exposure in experimental animals and have also been observed in humans. In addition to the genotoxicity of AA, there is evidence for both secondary DNA oxidation via generation of reactive oxygen species and for non-genotoxic effects which may contribute to carcinogenesis by AA. These studies extend the information assessed by the CONTAM Panel in its 2015 Opinion, and support its conclusions. That Opinion applied the margin of exposure (MOE) approach, as recommended in the EFSA Guidance for substances that are both genotoxic and carcinogenic, for risk characterisation of the neoplastic effects of AA. Based on the new data evaluated, the MOE approach is still considered appropriate, and an update of the 2015 Opinion is not required at the present time.

Re-evaluation of thaumatin (E 957) as food additive.

The present opinion deals with the re-evaluation of thaumatin (E 957) when used as a food additive. Thaumatin is a natural plant protein, consisting of thaumatin I and thaumatin II proteins together with minor amounts of plant constituents, obtained by acidic aqueous extraction of the arils of the fruit of Thaumatococcus daniellii plant. The Panel followed the conceptual framework for the risk assessment of certain food additives and considered that thaumatin is a digestible protein; adequate exposure estimates were available; there was no concern with respect to the genotoxicity; no conclusion on oral allergenicity could be drawn from the available human data; no adverse effects were observed in sub-chronic toxicity studies in rats and dogs at the highest dose tested of up 5,200 and 1,476 mg/kg bodyweight (bw) per day, respectively, and in a prenatal developmental toxicity study up to 2,000 mg/kg bw per day; moderate confidence in the body of evidence supported the absence of association between exposure to thaumatin and adverse health outcomes. Therefore, the Panel concluded that there is no need for a numerical acceptable daily intake (ADI) for thaumatin (E 957) and, based on a margin of safety (MOS) of 5,417, considered to be an underestimate and derived using the highest 95th percentile (P95) exposure of 0.48 mg/kg bw per day in consumers only, there is no safety concern for thaumatin (E 957) at the regulatory maximum level exposure assessment scenario, which was considered the most appropriate. The Panel recommended that European Commission considers introducing in the EU specifications for thaumatin (E 957) a new specification limit for the minimum combined content of thaumatin I and II proteins in E 957, a specification limit for yeast, mould counts and Salmonella spp and lowering the existing maximum limit for arsenic along with the inclusion of maximum limits for mercury and cadmium.

Medical Case Report on Repeat Treatment of Restless Legs Syndrome with Intravenous Infusion of Iron.

Restless legs syndrome (RLS) is a debilitating neurological disorder for which a range of medical interventions with varied efficacy has been employed. Based on evidence of iron deficiency in the substantia nigra of the midbrain, there are reports of substantial benefits from intravenous iron infusion. This case report demonstrates a strong statistically significant negative correlation between serum ferritin and RLS severity of symptoms in a subject with RLS who received 2 intravenous infusions of ferric carboxymaltose over a period of 464 days. The results provide further evidence to support the treatment strategy.