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.

Assessment of information as regards the toxicity of deoxynivalenol for horses and poultry.

In 2017, 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 deoxynivalenol (DON) and its acetylated and modified forms in food and feed. No observed adverse effect levels (NOAELs) and lowest observed adverse effect levels (LOAELs) were derived for different animal species. For horses, an NOAEL of 36 mg DON/kg feed was established, the highest concentration tested and not showing adverse effects. For poultry, an NOAEL of 5 mg DON/kg feed for broiler chickens and laying hens, and an NOAEL of 7 mg DON/kg feed for ducks and turkeys was derived. The European Commission requested EFSA to review the information regarding the toxicity of DON for horses and poultry and to revise, if necessary, the established reference points (RPs). Adverse effect levels of 1.9 and 1.7 mg DON/kg feed for, respectively, broiler chickens and turkeys were derived from reassessment of existing studies and newly available literature, showing that DON causes effects on the intestines, in particular the jejunum, with a decreased villus height but also histological damage. An RP for adverse animal health effects of 0.6 mg/kg feed for broiler chickens and turkeys, respectively, was established. For horses, an adverse effect level of 5.6 mg DON/kg feed was established from studies showing reduced feed intake, with an RP for adverse animal health effects of 3.5 mg/kg feed. For ducks and laying hens, RPs remain unchanged. Based on mean and P95 (UB) exposure estimates performed in the previous Opinion, the risk of adverse health effects of feeds containing DON was considered a potential concern for broiler chickens and turkeys. For horses, the risk for adverse health effects from feed containing DON is low.

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.

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.

Evaluation of the risks for animal health related to the presence of hydroxymethylfurfural (HMF) in feed for honey bees.

The European Commission has asked the EFSA to evaluate the risk for animal health related to the presence of hydroxymethylfurfural (HMF) in honey bee feed. HMF is a degradation product of particular sugars and can be present in bee feed. HMF is of low acute toxicity in bees but causes increased mortality upon chronic exposure. A benchmark dose lower limit 10% (BMDL10) of 1.16 µg HMF per bee per day has been calculated from mortalities observed in a 20-day study and established as a Reference Point covering also mortality in larvae, drones and queens for which no or insufficient toxicity data were available. Winter bees have a much longer lifespan than summer bees and HMF shows clear time reinforced toxicity (TRT) characteristics. Therefore, additional Reference Point intervals of 0.21-3.1, 0.091-1.1 and 0.019-0.35 µg HMF/bee per day were calculated based on extrapolation to exposure durations of 50, 90 and 180 days, respectively. A total of 219 analytical data of HMF concentrations in bee feed from EU Member States and 88 from Industry were available. Exposure estimates of worker bees and larvae ranged between 0.1 and 0.48, and between 0.1 and 0.51 µg HMF/per day, respectively. They were well below the BMDL10 of 1.16 µg HMF/bee per day, and thus, no concern was identified. However, when accounting for TRT, the probability that exposures were below established reference point intervals was assessed to be extremely unlikely to almost certain depending on exposure duration. A concern for bee health was identified when bees are exposed to HMF contaminated bee feed for several months.

Safety of water lentil powder from Lemnaceae as a Novel Food pursuant to Regulation (EU) 2015/2283.

Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on the safety of water lentil powder as a novel food (NF) pursuant to Regulation (EU) 2015/2283. Water lentils refer to aquatic plants belonging to the Araceae family and represented by five genera (Lemna, Wolffia, Wolffiella, Landoltia and Spirodela). The NF is thermally washed and dried water lentils, which are produced as a polyculture crop consisting of species from the Lemna genus (70-100%) and the Wolffia genus (0-30%). The main constituents of the NF are protein, fibre and fat. The Panel notes that the concentration of trace elements and contaminants in the NF is highly dependent on the conditions of cultivation of the plant and the fertiliser composition. The NF is expected to be stable and to comply with the specifications during the suggested shelf life. The NF is intended for human consumption as a food ingredient in herbs, spices and seasonings, sauces, soups and broths, protein products, dietary food for weight control and as a food supplement. The target population is the general population, except for food supplements which are exclusively intended for consumption by adults. The Panel considers that based on the composition of the NF and the proposed intended uses, the NF is not nutritionally disadvantageous, except for the concerns regarding intake of manganese from the NF. No adverse effect was observed in the submitted 90-day subchronic study, at the highest dose, 1,000 mg/kg body weight (bw) per day of NF. The Panel considers that, based on the protein concentration, the consumption of the NF may trigger allergic reactions. The Panel concluded that an increase in manganese intake from the NF used as food ingredient or food supplements is of safety concern and the safety of the NF cannot be established.

Evaluation of the shucking of certain species of scallops contaminated with domoic acid with a view to the production of edible parts meeting the safety requirements foreseen in the Union legislation.

EFSA was asked by the European Commission to provide information on the levels of domoic acid (DA) in whole scallops that would ensure that levels in edible parts are below the regulatory limit after shucking. This should include five species of scallops. In addition, EFSA was asked to recommend the number of scallops to be used in an analytical sample. To address these questions, EFSA received suitable data on DA for only one scallop species, Pecten maximus, i.e. data on pooled samples of edible and non-edible parts. A large part of the concentration levels was above the limit of quantification (LOQ) and only these data were used for the assessment. Shucking in most cases resulted in a strong decrease in the toxin levels. Statistical analysis of the data showed that levels in whole scallops should not exceed 24 mg DA/kg, 59 mg DA/kg and 127 mg DA/kg to ensure that levels in, respectively, gonads, muscle and muscle plus gonads are below the regulatory limit of 20 mg DA/kg with 99% certainty. Such an analysis was not possible for the other scallop species. In the absence of data from member states, published data of variations between scallops were used to calculate the sample size to ensure a 95% correct prediction on whether the level in scallops in an area or lot is correctly predicted to be compliant/non-compliant. It was shown that 10 scallops per sample would be sufficient to predict with 95% certainty if DA levels in the area/lot were twofold below or above the regulatory limit for the highest reported coefficient of variance (CV) of 1.06. To predict with 95% certainty for levels between 15 and 27 mg DA/kg, a pooled sample of more than 30 scallops would have to be tested.

Safety of calcidiol monohydrate produced by chemical synthesis as a novel food pursuant to Regulation (EU) 2015/2283.

Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on the safety of calcidiol monohydrate as a novel food (NF) pursuant to Regulation (EU) 2015/2283, including its bioavailability as a metabolite of vitamin D3 when added for nutritional purposes to food supplements. The NF is produced chemically. It is proposed in food supplements up to 10 µg/day for individuals ≥ 11 years of age, including pregnant and lactating women and up to 5 µg/day in 3- to 10-year-old children. The production process, composition, specifications and stability of the NF do not raise safety concerns. Animal and human data indicate efficient absorption. The NF contains a fraction of nanoparticles, which are fat soluble and unlikely to reach systemic distribution. There are no concerns regarding genotoxicity. Human adult studies do not raise safety concerns. Combined intake estimates of calcidiol from the NF and calcidiol and vitamin D from the diet were below the tolerable upper intake level (UL) for vitamin D for subjects above 11 years of age. The achieved mean serum 25(OH)D concentration in adults supplemented with 10 µg NF per day remained below 200 nmol/L. The Panel concludes that the NF is safe under the proposed conditions of use and use levels for individuals ≥ 11 years old, including pregnant and lactating women. The applicant did not provide data on the bioavailability and safety of the NF in children. The combined intake estimation in children (3-10 years) is close to the UL for vitamin D. Therefore, the Panel could not conclude on the safety of consumption of the NF in children (3-10 years) at the proposed daily intake. The NF is a bioavailable source of the biologically active metabolite of vitamin D, i.e. 1,25-dihydroxyvitamin D.

Evaluation of the shucking of certain species of scallops contaminated with lipophilic toxins with a view to the production of edible parts meeting the safety requirements foreseen in the Union legislation.

EFSA was asked by the European Commission to provide information on levels of lipophilic shellfish toxins in whole scallops that would ensure levels in edible parts below the regulatory limits after shucking, i.e. removal of non-edible parts. This should include the okadaic acid (OA), the azaspiracid (AZA) and the yessotoxin (YTX) groups, and five species of scallops. In addition, EFSA was asked to recommend the number of scallops in an analytical sample. To address these questions, EFSA received suitable data on the three toxin groups in two scallop species, Aequipecten opercularis and Pecten maximus, i.e. data on individual and pooled samples of edible and non-edible parts from contamination incidents. The majority of the concentration levels were below limit of quantification (LOQ)/limit of detection (LOD), especially in adductor muscle but also in gonads. Shucking in most cases resulted in a strong decrease in the toxin levels. For Pecten maximus, statistical analysis showed that levels in whole scallops should not exceed 256 µg OA eq/kg or 217 µg AZA1 eq/kg to ensure that levels in gonads are below the regulatory limits of 160 µg OA or AZA1 eq/kg with 99% certainty. Such an analysis was not possible for yessotoxins or any toxin in Aequipecten opercularis and an assessment could only be based on upper bound levels. To ensure a 95% correct prediction on whether the level in scallops in an area or lot is correctly predicted to be compliant/non-compliant, it was shown that 10 scallops per sample would be sufficient to predict with 95% certainty if levels of OA-group toxins in the area/lot were 25% below or above the regulatory limit. However, to predict with a 95% certainty for levels between 140 and 180 µg OA eq/kg, a pooled sample of more than 30 scallops would have to be tested.

Safety of astaxanthin for its use as a novel food in food supplements.

Following a request from the European Commission, the Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on the safety of astaxanthin when used as a novel food in food supplements at maximum levels of 8 mg/day, taking into account the overall cumulative intake of astaxanthin from all food sources. In 2014, the NDA Panel assessed the safety of the novel astaxanthin-rich ingredient derived from microalgae Haematococcus pluvialis in the context of an application submitted under Regulation (EC) No 258/1997. In that opinion, the NDA Panel considered that the acceptable daily intake (ADI) for astaxanthin was 0.034 mg/kg body weight (bw) set by the EFSA FEEDAP Panel in 2014. In 2019, the FEEDAP Panel adopted an opinion which concerned the renewal of the authorisation of dimethyldisuccinate-astaxanthin and a new use of the additive for crustaceans and other fish than salmonids. In that assessment, the FEEDAP Panel derived a new ADI of 0.2 mg astaxanthin/kg bw which replaced the ADI of 0.034 mg/kg bw established in 2014. By taking into account an updated exposure assessment for astaxanthin from the background diet (fish and crustaceans) in combination with 8 mg from food supplements, the NDA Panel concludes that (i) such combined exposure to astaxanthin is safe for adults, (ii) 14 to < 18 years old adolescents reach the ADI, and (iii) the ADI is exceeded by 28% in children aged 10 to < 14 years and up to 524% in infants aged 4-6 months.

Risk assessment of ochratoxin A in food.

The European Commission asked EFSA to update their 2006 opinion on ochratoxin A (OTA) in food. OTA is produced by fungi of the genus Aspergillus and Penicillium and found as a contaminant in various foods. OTA causes kidney toxicity in different animal species and kidney tumours in rodents. OTA is genotoxic both in vitro and in vivo; however, the mechanisms of genotoxicity are unclear. Direct and indirect genotoxic and non-genotoxic modes of action might each contribute to tumour formation. Since recent studies have raised uncertainty regarding the mode of action for kidney carcinogenicity, it is inappropriate to establish a health-based guidance value (HBGV) and a margin of exposure (MOE) approach was applied. For the characterisation of non-neoplastic effects, a BMDL 10 of 4.73 µg/kg body weight (bw) per day was calculated from kidney lesions observed in pigs. For characterisation of neoplastic effects, a BMDL 10 of 14.5 µg/kg bw per day was calculated from kidney tumours seen in rats. The estimation of chronic dietary exposure resulted in mean and 95th percentile levels ranging from 0.6 to 17.8 and from 2.4 to 51.7 ng/kg bw per day, respectively. Median OTA exposures in breastfed infants ranged from 1.7 to 2.6 ng/kg bw per day, 95th percentile exposures from 5.6 to 8.5 ng/kg bw per day in average/high breast milk consuming infants, respectively. Comparison of exposures with the BMDL 10 based on the non-neoplastic endpoint resulted in MOEs of more than 200 in most consumer groups, indicating a low health concern with the exception of MOEs for high consumers in the younger age groups, indicating a possible health concern. When compared with the BMDL 10 based on the neoplastic endpoint, MOEs were lower than 10,000 for almost all exposure scenarios, including breastfed infants. This would indicate a possible health concern if genotoxicity is direct. Uncertainty in this assessment is high and risk may be overestimated.

Combined hazard assessment of mycotoxins and their modified forms applying relative potency factors: Zearalenone and T2/HT2 toxin.

This paper describes a methodology for hazard assessment of groups of related substances for which toxicity data are insufficient, and which utilises, next to conventional toxicological assessments and mechanistic information, the derivation of relative toxicity potency factors (RPFs). Zearalenone (ZEN) and T-2 toxin (T2) and HT-2 toxin (HT2) and their modified forms have been used as examples. A tolerable daily intake (TDI) for ZEN of 0.25 µg/kg bw was established. In vitro and in vivo studies suggested that modified forms of ZEN act via the same mode of action as ZEN (oestrogenicity). Results from in vivo uterotrophic assays were used to establish RPFs, allowing inclusion the different modified forms in a group TDI with ZEN. A TDI for the sum of T2/HT2 of 0.02 µg/kg bw per day and an acute reference dose (ARfD) of 0.3 µg/kg bw for the sum of T2/HT2 was established. In vitro studies show that phase I metabolites of T2/HT2 act via a similar mode of action as their parent compounds, namely protein synthesis inhibition with immune- and haematotoxicity. The phase I metabolites as well as conjugates of T2/HT2 and their phase I metabolites can be included in a group TDI with T2/HT2 applying RPFs.

Scientific opinion on the risks for animal and human health related to the presence of quinolizidine alkaloids in feed and food, in particular in lupins and lupin-derived products.

The European Commission asked EFSA for a scientific opinion on the risks for animal and human health related to the presence of quinolizidine alkaloids (QAs) in feed and food. This risk assessment is limited to QAs occurring in Lupinus species/varieties relevant for animal and human consumption in Europe (i.e. Lupinus albus L., Lupinus angustifolius L., Lupinus luteus L. and Lupinus mutabilis Sweet). Information on the toxicity of QAs in animals and humans is limited. Following acute exposure to sparteine (reference compound), anticholinergic effects and changes in cardiac electric conductivity are considered to be critical for human hazard characterisation. The CONTAM Panel used a margin of exposure (MOE) approach identifying a lowest single oral effective dose of 0.16 mg sparteine/kg body weight as reference point to characterise the risk following acute exposure. No reference point could be identified to characterise the risk of chronic exposure. Because of similar modes of action for QAs, the CONTAM Panel used a group approach assuming dose additivity. For food, the highest mean concentration of Total QAs (TotQAs) (i.e. the 6 most abundant QAs) was found in lupin seed samples classified as 'Lupins (dry) and similar-'. Due to the limited data on occurrence and consumption, dietary exposure was calculated for some specific scenarios and no full human health risk characterisation was possible. The calculated margin of exposures (MOEs) may indicate a risk for some consumers. For example, when lupin seeds are consumed without a debittering step, or as debittered lupin seeds high in QA content and when 'lupin-based meat imitates' are consumed. For horses, companion and farm animals, other than salmonids, the available database on adverse effects was too limited to identify no-observed-adverse-effect levels and/or lowest-observed-adverse-effect levels and no risk characterisation was possible. For salmonids, the CONTAM Panel considers the risk for adverse effects to be low.

Safety and efficacy of astaxanthin-dimethyldisuccinate (Carophyll® Stay-Pink 10%-CWS) for salmonids, crustaceans and other fish.

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of astaxanthin-dimethyldisuccinate (ATX-DMDS) for salmonids, crustaceans and other fish. The applicant has provided evidence that ATX-DMDS currently on the market complies with the conditions of authorisation for salmon and trout. ATX and ATX-DMDS are safe for salmonids, crustaceans and fish up to 100 mg ATX/kg complete diet, corresponding to 138 mg ATX-DMDS/kg. The FEEDAP Panel re-assessed the toxicological profile of ATX based on data already considered in 2014, the literature review performed by the applicant and the data available in the context of an EFSA public call for data on ATX. The acceptable daily intake (ADI) of 0.2 mg astaxanthin/kg body weight (bw) per day obtained by applying an uncertainty factor of 200 to a lowest observed adverse effect level (LOAEL) of 40 mg/kg bw per day for the increased incidence of multinucleated hepatocytes observed in a 2-year carcinogenicity study replaces the one of 0.034 mg/kg bw established by the FEEDAP Panel in 2014. The use of ATX-DMDS in the nutrition of salmonids, other fish and crustaceans up to the maximum permitted dietary level is of no concern for the safety of the consumer. No dermal or ocular risk for the users is likely to occur under practical conditions. In the absence of inhalation toxicology study, the Panel is not in the position to establish the inhalation toxicity of the additive. The use of synthetic ATX-DMDS does not pose a significant additional risk to the environment compared with natural astaxanthin. ATX-DMDS is efficacious in colouring the flesh of salmonids and other fish. ATX-DMDS is an effective pigment for crustaceans at the proposed conditions of use.

Evaluation of the health risks related to the presence of cyanogenic glycosides in foods other than raw apricot kernels.

In 2016, the EFSA Panel on Contaminants in the Food Chain (CONTAM) published a scientific opinion on the acute health risks related to the presence of cyanogenic glycosides (CNGs) in raw apricot kernels in which an acute reference dose (ARfD) of 20 µg/kg body weight (bw) was established for cyanide (CN). In the present opinion, the CONTAM Panel concluded that this ARfD is applicable for acute effects of CN regardless the dietary source. To account for differences in cyanide bioavailability after ingestion of certain food items, specific factors were used. Estimated mean acute dietary exposures to cyanide from foods containing CNGs did not exceed the ARfD in any age group. At the 95th percentile, the ARfD was exceeded up to about 2.5-fold in some surveys for children and adolescent age groups. The main contributors to exposures were biscuits, juice or nectar and pastries and cakes that could potentially contain CNGs. Taking into account the conservatism in the exposure assessment and in derivation of the ARfD, it is unlikely that this estimated exceedance would result in adverse effects. The limited data from animal and human studies do not allow the derivation of a chronic health-based guidance value (HBGV) for cyanide, and thus, chronic risks could not be assessed.

Occurrence data of nickel in feed and animal exposure assessment.

Nickel (Ni) is a silvery-white, hard, ductile metal existing in oxidation states; in biological systems, Ni2+ is the prevalent form. All analytical results used to estimate animal dietary exposure were reported as Ni', without providing information on specific chemical species. Considering the data provided by Member states, among FoodEx level 1 feed categories, the highest mean Ni levels were measured in 'Minerals and products derived thereof' (n = 72). High mean Ni concentrations were also observed in 'Compound feed' (n = 516), in particular in complementary feeds for fattening cattles, unspecified complementary feed and complementary feeds for fattening pigs. Within grains used as feed (n = 597), the highest mean Ni concentrations were measured in oats. In addition, Ni concentrations in hydrogenated vegetable oils/fats were reported by industry. Exposure to Ni in livestock and companion animals varied according to the animal species. When considering the diets with hydrogenated vegetable oils/fats based on the reported Ni concentrations, the mean exposures varied between 6.0 µg Ni/kg body weight (bw) per day in cats and 79 µg Ni/kg bw per day in laying hens and the high exposure levels varied between 11 µg Ni/kg bw per day in cats and 127 µg Ni/kg bw per day in rabbits. The mean exposure estimates considering the maximum concentration of Ni assumed from good manufacturing practice in hydrogenated vegetable oils/fats (50 mg Ni/kg) varied between 27 µg Ni/kg bw per day in cats and 255 µg Ni/kg bw per day in rabbits; for the high concentration scenarios, exposures varied between 30 µg Ni/kg bw per day and 307 µg Ni/kg bw per day in the same species. The estimated exposures to Ni are in line with the one reported in the 2015 EFSA opinion, using a worst-case scenario. When estimating exposure with a realistic scenario, using the reported Ni concentration in hydrogenated vegetable oils/fats, the exposure of livestock and companion animals is lower (approximately from 1.5 to 6 times, depending on the species) than the 2015 assessment.

Risk for animal and human health related to the presence of dioxins and dioxin-like PCBs in feed and food.

The European Commission asked EFSA for a scientific opinion on the risks for animal and human health related to the presence of dioxins (PCDD/Fs) and DL-PCBs in feed and food. The data from experimental animal and epidemiological studies were reviewed and it was decided to base the human risk assessment on effects observed in humans and to use animal data as supportive evidence. The critical effect was on semen quality, following pre- and postnatal exposure. The critical study showed a NOAEL of 7.0 pg WHO2005-TEQ/g fat in blood sampled at age 9 years based on PCDD/F-TEQs. No association was observed when including DL-PCB-TEQs. Using toxicokinetic modelling and taking into account the exposure from breastfeeding and a twofold higher intake during childhood, it was estimated that daily exposure in adolescents and adults should be below 0.25 pg TEQ/kg bw/day. The CONTAM Panel established a TWI of 2 pg TEQ/kg bw/week. With occurrence and consumption data from European countries, the mean and P95 intake of total TEQ by Adolescents, Adults, Elderly and Very Elderly varied between, respectively, 2.1 to 10.5, and 5.3 to 30.4 pg TEQ/kg bw/week, implying a considerable exceedance of the TWI. Toddlers and Other Children showed a higher exposure than older age groups, but this was accounted for when deriving the TWI. Exposure to PCDD/F-TEQ only was on average 2.4- and 2.7-fold lower for mean and P95 exposure than for total TEQ. PCDD/Fs and DL-PCBs are transferred to milk and eggs, and accumulate in fatty tissues and liver. Transfer rates and bioconcentration factors were identified for various species. The CONTAM Panel was not able to identify reference values in most farm and companion animals with the exception of NOAELs for mink, chicken and some fish species. The estimated exposure from feed for these species does not imply a risk.

Appropriateness to set a group health-based guidance value for fumonisins and their modified forms.

The EFSA Panel on Contaminants in the Food Chain (CONTAM) established a tolerable daily intake (TDI) for fumonisin B1 (FB 1) of 1.0 µg/kg body weight (bw) per day based on increased incidence of megalocytic hepatocytes found in a chronic study with mice. The CONTAM Panel considered the limited data available on toxicity and mode of action and structural similarities of FB 2-6 and found it appropriate to include FB 2, FB 3 and FB 4 in a group TDI with FB 1. Modified forms of FBs are phase I and phase II metabolites formed in fungi, infested plants or farm animals. Modified forms also arise from food or feed processing, and include covalent adducts with matrix constituents. Non-covalently bound forms are not considered as modified forms. Modified forms of FBs identified are hydrolysed FB 1-4 (HFB 1-4), partially hydrolysed FB 1-2 (pHFB 1-2), N-(carboxymethyl)-FB 1-3 (NCM-FB 1-3), N-(1-deoxy-d-fructos-1-yl)-FB 1 (NDF-FB 1), O-fatty acyl FB 1, N-fatty acyl FB 1 and N-palmitoyl-HFB 1. HFB 1, pHFB 1, NCM-FB 1 and NDF-FB 1 show a similar toxicological profile but are less potent than FB 1. Although in vitro data shows that N-fatty acyl FBs are more toxic in vitro than FB 1, no in vivo data were available for N-fatty acyl FBs and O-fatty acyl FBs. The CONTAM Panel concluded that it was not appropriate to include modified FBs in the group TDI for FB 1-4. The uncertainty associated with the present assessment is high, but could be reduced provided more data are made available on occurrence, toxicokinetics and toxicity of FB 2-6 and modified forms of FB 1-4.

Appropriateness to set a group health based guidance value for T2 and HT2 toxin and its modified forms.

The EFSA Panel on Contaminants in the Food Chain (CONTAM) established a tolerable daily intake (TDI) for T2 and HT2 of 0.02 µg/kg body weight (bw) per day based on a new in vivo subchronic toxicity study in rats that confirmed that immune- and haematotoxicity are the critical effects of T2 and using a reduction in total leucocyte count as the critical endpoint. An acute reference dose (ARfD) of 0.3 µg for T2 and HT2/kg bw was established based on acute emetic events in mink. Modified forms of T2 and HT2 identified are phase I metabolites mainly formed through hydrolytic cleavage of one or more of the three ester groups of T2. Less prominent hydroxylation reactions occur predominantly at the side chain. Phase II metabolism involves conjugation with glucose, modified glucose, sulfate, feruloyl and acetyl groups. The few data on occurrence of modified forms indicate that grain products are their main source. The CONTAM Panel found it appropriate to establish a group TDI and a group ARfD for T2 and HT2 and its modified forms. Potency factors relative to T2 for the modified forms were used to account for differences in acute and chronic toxic potencies. It was assumed that conjugates (phase II metabolites of T2, HT2 and their phase I metabolites), which are not toxic per se, would be cleaved releasing their aglycones. These metabolites were assigned the relative potency factors (RPFs) of their respective aglycones. The RPFs assigned to the modified forms were all either 1 or less than 1. The uncertainties associated with the present assessment are considered as high. Using the established group, ARfD and TDI would overestimate any risk of modified T2 and HT2.

Appropriateness to set a group health based guidance value for nivalenol and its modified forms.

The EFSA Panel on Contaminants in the Food Chain (CONTAM) reviewed new studies on nivalenol since the previous opinion on nivalenol published in 2013, but as no new relevant data were identified the tolerable daily intake (TDI) for nivalenol (NIV) of 1.2 µg/kg body weight (bw) established on bases of immuno- and haematotoxicity in rats was retained. An acute reference dose (ARfD) of 14 µg/kg bw was established based on acute emetic events in mink. The only phase I metabolite of NIV identified is de-epoxy-nivalenol (DE-NIV) and the only phase II metabolite is nivalenol-3-glucoside (NIV3Glc). DE-NIV is devoid of toxic activity and was thus not further considered. NIV3Glc can occur in cereals amounting up to about 50% of NIV. There are no toxicity data on NIV3Glc, but as it can be assumed that it is hydrolysed to NIV in the intestinal tract it should be included in a group TDI and in a group ARfD with NIV. The uncertainty associated with the present assessment is considered as high and it would rather overestimate than underestimate any risk.