Dietary exposure and risk assessment to trace elements and iodine in seaweeds.

INTRODUCTION: Seaweeds are a rich source of elements such as iodine, and are also able to accumulate contaminants such as trace elements. METHODS: The aim of this study was to assess the dietary exposure as well as the risk from iodine and trace elements in edible seaweeds for the French population using current consumption data. The contribution of seaweeds to overall dietary exposure to trace elements and iodine was evaluated, and for those substances with minimal contribution to overall dietary exposure, simulations were performed to propose increased maximal limits in seaweeds. RESULTS: Cadmium, inorganic arsenic and mercury in seaweeds were very low contributors to total dietary exposure to these contaminants (0.7 % 1.1 % and 0.1 % on average, respectively). Dietary exposure to lead via seaweed may contribute up to 3.1 % of total dietary exposure. Dietary consumption of iodine via seaweed may contribute up to 33 % of total exposure to iodine, which makes seaweeds the strongest contributor to iodine in diet. DISCUSSION: New maximal values in seaweeds are proposed for the very low contributors to total dietary exposure: 1 mg/kg dw for cadmium, 10 mg/kg dw for inorganic arsenic and 0.3 mg/kg dw for mercury.

Sensitive Skin Syndrome: A Low-Noise Small-Fiber Neuropathy Related to Environmental Factors?

Background and Objectives: Patients frequently complain of mild, transient, unpleasant skin sensations that cannot be diagnosed as common neuropathies. Dermatologists have termed these symptoms "sensitive skin syndrome." This narrative review was performed for a better knowledge by other specialists. Databases and Data Treatment: Publications on pain in sensitive skin syndrome were obtained from PubMed. Results: There is a growing body of data supporting the concept that sensitive skin is a type of small-fiber neuropathy. The arguments are based on clinical data, a decrease in intra-epidermal nerve fiber density, quantitative sensory testing abnormalities and an association with irritable bowel syndrome and sensitive eyes. Sensitive skin is triggered by environmental factors. Sensitive skin is a frequent condition, with a lifetime prevalence of ~50% according to self-reports. Conclusions: Mild levels of skin pain or itch are frequently experienced by patients, who rarely report them. There is a need for a better knowledge of sensitive skin because it can be the first level of small-fiber neuropathies.

Seaweed consumption in France: Key data for exposure and risk assessment.

Seaweeds accumulate toxic contaminants present in the surrounding waters such as trace elements, ammonium, dioxins and pesticides. Seaweed consumption data are scarce in France as in Europe. Given that seaweed consumption data are essential to assess exposure and the risks for human health linked to toxic substances, it would appear essential to generate these data. The aim of the study was to assess the current consumption of seaweed foodstuffs by the French population via an online survey conducted on 780 adults (seaweed foodstuffs consumed, percentage of consumers and frequency of consumption). The daily consumption of seaweeds was assessed. Enquiries at points of purchase were also performed to reference the type of foodstuffs found on the French market, the seaweed species present, and the percentage of seaweed in the product. These new data generated in this work will be useful for safety assessors and for safety agencies.

Use of Cosmetic Products in Real Life by Women with Facial Sensitive Skin: Results from an Exposure Study and Comparison with Controls.

Triggering factors of sensitive skin are supposed to be physical, chemical (cosmetics, water, and pollutants), and occasionally psychological (stress). A recent meta-analysis showed that the most important triggering factor declared by subjects is the use of cosmetics. This study was designed to compare the consumption of cosmetic products in women with sensitive skin and controls. After a dermatological examination, women between the ages of 18 and 65 years with or without sensitive skin were recruited. They completed different questionnaires about the presence of sensitive skin and use of 28 cosmetics that could be applied on the face. The amount per application was recorded for all products used at least once a week on the face. In total, 160 women were included, with a mean age of 41 ± 13 years. Two groups of 40 women were created based on the sensitive scale (SS-10 score), with the lowest SS-10 scores (nonsensitive skin group) and the highest SS-10 score (sensitive skin group). The number of products used daily was similar in the 2 groups. Women with sensitive skin were significantly more frequent users of liquid soap/soap-free gel cleansers than those without sensitive skin (70 vs. 43%). There was no difference concerning the frequency of use of products in the 2 groups. Concerning the amount of product used by application, women with sensitive skin used twice as much cream per application compared with the women without sensitive skin: 511 ± 438 µg versus 290 ± 203 µg (p = 0.039). Concerning the composition of the cosmetic products used, the only difference concerned phenoxyethanol, which was more often present in the moisturizer of women without sensitive skin (66.7%) than in those with sensitive skin (32.4%) (p = 0.007). Women with sensitive skin were more likely to buy products recommended for sensitive skin by manufacturers. The relationship of causality between the use of cosmetics and sensitive skin cannot be established. Women with sensitive skin used different cosmetic products than women without sensitive skin. Women with sensitive skin used a higher amount of moisturizer, used products recommended for sensitive skin, and bought more cosmetic products at pharmacies than supermarkets. We hypothesized that subjects with sensitive skin are looking for products that improve the sensation of skin sensitivity.

Proposal for Cut-off Scores for Sensitive Skin on Sensitive Scale-10 in a Group of Adult Women.

Sensitive skin is commonly assessed on the basis of self-reports from patients, and sometimes questionnaires, such as the Sensitive Scale-10, are used. The severity of sensitive skin follows a continuum, from the absence of sensitive skin to very sensitive skin. The aims of this cross-sectional study were to compare subjects with and without symptomatic sensitive skin and to propose diagnostic criteria for sensitive skin. A total of 160 women, between 18 and 65 years of age, with and without sensitive skin, and without any associated skin diseases, were recruited. Mean age was 41 years old. Fifty-five percent of participants reported having "very sensitive" or "sensitive" skin. In the sensitive skin group, the participants mainly experienced skin irritability (100%), tautness (97.5%), discomfort (90%) and redness (90%). According to the receiver operating characteristic curve, a Sensitive Scale-10 (SS-10) cut-off value of 12.7 can be used to detect sensitive skin (with a sensitivity of 72.4% and specificity of 90.3%).

Risk to human health related to the presence of perfluoroalkyl substances in food.

The European Commission asked EFSA for a scientific evaluation on the risks to human health related to the presence of perfluoroalkyl substances (PFASs) in food. Based on several similar effects in animals, toxicokinetics and observed concentrations in human blood, the CONTAM Panel decided to perform the assessment for the sum of four PFASs: PFOA, PFNA, PFHxS and PFOS. These made up half of the lower bound (LB) exposure to those PFASs with available occurrence data, the remaining contribution being primarily from PFASs with short half-lives. Equal potencies were assumed for the four PFASs included in the assessment. The mean LB exposure in adolescents and adult age groups ranged from 3 to 22, the 95th percentile from 9 to 70 ng/kg body weight (bw) per week. Toddlers and 'other children' showed a twofold higher exposure. Upper bound exposure was 4- to 49-fold higher than LB levels, but the latter were considered more reliable. 'Fish meat', 'Fruit and fruit products' and 'Eggs and egg products' contributed most to the exposure. Based on available studies in animals and humans, effects on the immune system were considered the most critical for the risk assessment. From a human study, a lowest BMDL 10 of 17.5 ng/mL for the sum of the four PFASs in serum was identified for 1-year-old children. Using PBPK modelling, this serum level of 17.5 ng/mL in children was estimated to correspond to long-term maternal exposure of 0.63 ng/kg bw per day. Since accumulation over time is important, a tolerable weekly intake (TWI) of 4.4 ng/kg bw per week was established. This TWI also protects against other potential adverse effects observed in humans. Based on the estimated LB exposure, but also reported serum levels, the CONTAM Panel concluded that parts of the European population exceed this TWI, which is of concern.

Dietary exposure to mycotoxins in the French infant total diet study.

The present study evaluated the exposure of children aged from one to 36 months to seven groups of mycotoxins, in the context of the infant French Total Diet Study (iTDS). Exposure was then compared to the health-based guidance values (HBGVs) for each mycotoxin. The value of the 90th percentile of exposure to nivalenol, patulin, fumonisins and zearalenone was less than 40% of the HBGV considered relevant for children. On the other hand, a risk could not be excluded for ochratoxin A and aflatoxins as exposure was close to the HBGV for ochratoxin A and the margin of exposure was much lower than the critical margin of 10,000 for aflatoxins. The HBGVs for toxins T2 and HT2, and for deoxynivalenol (DON) and its acetylated compounds were exceeded. Five percent to 10% of the children aged 5-12 months exceeded the HBGV considering the lower bound hypothesis for toxins T2 and HT2 and 7.5%-27% of the children aged 5 months and above exceeded the HBGV for DON. Consequently, the exposure of young children raises safety concerns for T2/HT2 and DON. Efforts should therefore be pursued to decrease their exposure to these molecules.

Benchmark dose analyses of γH2AX and pH3 endpoints for quantitative comparison of in vitro genotoxicity potential of lipophilic phycotoxins.

The phycotoxins, okadaic acid (OA) and dinophysistoxins 1 and 2 (DTX-1 and -2), are protein phosphatase PP2A and PP1 inhibitors involved in diarrhetic shellfish poisoning (DSP) in humans. Data on the in vivo acute toxicity of the OA-group toxins show some differences and the European Food Safety Authority (EFSA) has determined toxicity equivalent factors (TEFs) of one for the reference toxin, OA, as well as for DTX-1 and 0.6 for DTX-2. However, recent in vitro studies indicated that DTX-1 seems to be more toxic than OA. As OA was described as apoptotic and aneugenic compound, we analyzed the DNA damage responses induced by the 3 toxins through γH2AX and pH3 biomarkers on proliferative HepaRG cells using High Content Analysis. We quantitatively examined the responses for γH2AX and pH3 by benchmark dose analyzing (BMD) using PROAST software. We found that the three toxins increased both γH2AX- and pH3-positive cells populations in a concentration-dependent manner. The 3 toxins induced mitotic arrest, characteristic of aneugenic compounds, as well as DNA strand-breaks concomitantly to cytotoxicity. BMD analysis showed that DTX-1 is the most potent inducer of DNA damage, followed by OA and DTX-2. The quantitative genotoxic data provided in this study are additional findings for reconsidering the estimated TEFs of this group of phycotoxins.

Sensitive Scalp: A Possible Association With the Use of Hair Conditioners.

A sensitive scalp is defined by the occurrence of unpleasant sensations (tingling, burning, pain, pruritus) triggered by stimuli that should not cause such sensations. Environmental factors, particularly cosmetics, can be triggering factors. The aims of this study were to assess hair cosmetic product consumption in subjects with sensitive scalp and to perform a clinical evaluation of sensitive scalp. After a dermatological examination, women between the ages of 18 and 65 years with or without a sensitive scalp completed different questionnaires. Their use of hair cosmetics (frequency, amount per application) was recorded. A total of 160 women with a mean age of 41 years were included. Twenty-seven subjects presented with seborrheic dermatitis or psoriasis, so only 133 were included in the analysis. Five percent of the subjects declared they had a very sensitive scalp, 25% had a sensitive scalp, 38% had a slightly sensitive scalp, and 32% had a scalp that was not sensitive. The mean sensitive scalp score (3S) score was 3.7 ± 1.6 in the very sensitive scalp group, 3.6 ± 2.1 in the sensitive group, 1.2 ± 1.2 in the slightly sensitive group and 0.1 ± 0.4 in the non-sensitive group. Two groups were analyzed: the 56 subjects with a sensitive scalp (3S ≥ 2 score) and the 56 subjects with a null 3S score. In the sensitive scalp group, 89% suffered from itch, and 45% suffered from tingling. No parameter (hormonal status, smoking, age, phototype, BMI) was associated with the 3S score. No differences in the exposure to shampoos and masks between the two groups were noted. The exposure to hair conditioners was significantly higher in the sensitive scalp group than in the group without sensitive scalp. Itch is the main symptom of a sensitive scalp. The frequency of a sensitive scalp was lower than that previously described when the subjects with scalp dermatosis were excluded. The amount of hair conditioners used was significantly higher in subjects with sensitive scalp than in those without sensitive scalp, suggesting a possible link.

Consumption and exposure to finished cosmetic products: A systematic review.

According to the European Regulation (EC) No. 1223/2009, cosmetic products should be safe for human health when used under normal or foreseeable conditions of use. To perform a safety evaluation, consumption data of finished cosmetic product are necessary to assess the corresponding consumer's exposure. The aim of this review was to highlight consumption (percentage of users, frequency of use, amount used, number of products daily used, types of products co-used …) and exposure data to cosmetic products available in the literature. A systematic approach was used following the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-analyses) guidelines. Literature search was performed in February 2018 using Pubmed and Scopus databases. The following information was collected for the 82 publications included in this review: type of study, characteristics of the population (number, age, sex, region of origin), period of data collection, types of products studied, method(s) of data collection, consumption and/or exposure parameters obtained. Because of the high number of quantitative results obtained in the different studies, these data are not presented here. Readers interested in one or more studies are invited to consult the results available in the original publication(s). This work could be very useful for safety assessors or other persons working in the risk assessment field.

Consumption and exposure assessment to toothpaste in French families.

The aim of the study was to assess the consumption and the exposure to toothpaste in French families leaving the consumers free to use their own product at home according to their habits. Consumption data were collected on 104 families. 206 adults (103 women and 103 men) and 195 children aged 2-17 participated in the study. Differences in toothpaste consumption depending on gender and on age were highlighted. As an example, frequency data were higher in adult women (2.0 day-1 on average) than in adult men (1.8 day-1 on average); amount per use data were higher in adult men (1.2 g on average) than in adult women (0.9 g on average). The frequency of use and the amount of toothpaste used per application increased with age. The exposure to toothpaste decreased with age. Children aged 2-6 were the most exposed to toothpaste with a P95 value equal to 8.2 mg/kg bw/day. Adult's P95 exposure value was equal to 2.8 mg/kg bw/day. Exposure values were in the same order of magnitude for both genders in children and in adults. These new data will be useful for safety assessors, especially children data which remain scarce.

Assessment of Aflatoxin M1 and M2 exposure risk through Oaxaca cheese consumption in southeastern Mexico.

The present study evaluated the exposure of Southeast Mexican population to Aflatoxin M1 (AFM1) and M2 (AFM2) through the consumption of Oaxaca cheese. The intake of Oaxaca cheese was assessed via a food 7-day dairy questionnaire (N = 1100, 2014 and 2015). Thirty Oaxaca cheeses were randomly sampled, and the origin of the samples was also investigated. AFM1 and AFM2 were quantified by HPLC-FD. The exposure was assessed through the combination of the Probabilistic Density Functions (probabilistic approach). The percentage of the population at risk was calculated through the population exceeding the toxicological reference values (TDI). The risk assessment revealed that the population at higher risk to AFM1 and AFM2 was the children, followed by the adolescents and adult women. To our knowledge, the present study is the first to assess the exposure risk of different age groups of a population to AFM1 and AFM2 through the consumption of cheese.

Update of the risk assessment on 3-monochloropropane diol and its fatty acid esters.

The CONTAM Panel updated the assessment of the risks for human health related to the presence of 3-monochloropropane diol (3-MCPD) and its fatty acid esters in food published in 2016 in view of the scientific divergence identified in the establishment of the tolerable daily intake (TDI) in the Joint FAO/WHO Expert Committee on Food Additives and Contaminants (FAO/WHO) report published in 2017. In this update, dose-response analysis was performed following the recent EFSA Scientific Committee guidance on the use of benchmark dose (BMD) approach in risk assessment, and a review of available data on developmental and reproduction toxicity was included. The outcome of this review indicates that in rats short-term exposure to 3-MCPD above 1 mg/kg body weight (bw) per day can induce reduced sperm motility associated with reduced male fecundity. Decreased sperm count and histopathological changes in the testis and epididymis were observed following longer treatment periods at higher doses. Regarding increased incidence kidney tubular hyperplasia, BMD analysis using model averaging resulted in a BMDL 10 of 0.20 mg/kg bw per day in male rats, which was selected as the new Reference Point (RP) for renal effects. For the effects on male fertility, decreased sperm motility was selected as the most sensitive relevant endpoint and a BMDL 05 of 0.44 mg/kg bw per day was calculated. The RP for renal effects was considered to derive an updated group TDI of 2 µg/kg bw per day for 3-MCPD and its fatty acid esters and was considered protective also for effects on male fertility. The established TDI of 2 µg/kg bw per day is not exceeded in the adult population. A slight exceedance of the TDI was observed in the high consumers of the younger age groups and in particular for the scenarios on infants receiving formula only.

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.

Risk to human health related to the presence of perfluorooctane sulfonic acid and perfluorooctanoic acid in food.

The European Commission asked EFSA for a scientific evaluation on the risks to human health related to the presence of perfluorooctane sulfonic acid (PFOS) and perfluorooctanoic acid (PFOA) in food. Regarding PFOS and PFOA occurrence, the final data set available for dietary exposure assessment contained a total of 20,019 analytical results (PFOS n = 10,191 and PFOA n = 9,828). There were large differences between upper and lower bound exposure due to analytical methods with insufficient sensitivity. The CONTAM Panel considered the lower bound estimates to be closer to true exposure levels. Important contributors to the lower bound mean chronic exposure were 'Fish and other seafood', 'Meat and meat products' and 'Eggs and egg products', for PFOS, and 'Milk and dairy products', 'Drinking water' and 'Fish and other seafood' for PFOA. PFOS and PFOA are readily absorbed in the gastrointestinal tract, excreted in urine and faeces, and do not undergo metabolism. Estimated human half-lives for PFOS and PFOA are about 5 years and 2-4 years, respectively. The derivation of a health-based guidance value was based on human epidemiological studies. For PFOS, the increase in serum total cholesterol in adults, and the decrease in antibody response at vaccination in children were identified as the critical effects. For PFOA, the increase in serum total cholesterol was the critical effect. Also reduced birth weight (for both compounds) and increased prevalence of high serum levels of the liver enzyme alanine aminotransferase (ALT) (for PFOA) were considered. After benchmark modelling of serum levels of PFOS and PFOA, and estimating the corresponding daily intakes, the CONTAM Panel established a tolerable weekly intake (TWI) of 13 ng/kg body weight (bw) per week for PFOS and 6 ng/kg bw per week for PFOA. For both compounds, exposure of a considerable proportion of the population exceeds the proposed TWIs.

Assessment of a decontamination process for dioxins and PCBs from fish meal by hexane extraction and replacement of fish oil.

Following a request from the European Commission, the EFSA Panel on Contaminants in the Food Chain (CONTAM) provided a scientific opinion on the assessment of a decontamination process for fish meal. This process entails solvent (hexane) extraction of fish oil from fish meal to remove dioxins (polychlorinated dibenzo-p-dioxins (PCDDs) and polychlorinated dibenzofurans (PCDFs)) as well as dioxin-like (DL-) and non-dioxin-like (NDL-) polychlorinated biphenyls (PCBs) followed by replacement with decontaminated fish oil. All feed decontamination processes must comply with the acceptability criteria specified in the Commission Regulation (EU) 2015/786. The data provided by the feed business operator were assessed with respect to the efficacy of the process, absence of solvent residues, and on information demonstrating that the process does not adversely affect the nature and characteristics of the product. According to data provided, the process was effective in removing PCDD/Fs and DL-PCBs by approximately 70% and NDL-PCBs by about 60%. The data showed that it is possible to meet the current EU requirements with respect to these contaminants, provided that the level of contamination of untreated fish meal is within the range of the tested batches. It is unlikely that hazardous substances (i.e. hexane) remain in the final product. The Panel considered that there is no evidence that fish oil extraction followed by replacement with decontaminated fish oil leads to detrimental changes in the nutritional composition of the fish meal, although some beneficial constituents (e.g. lipophilic vitamins) might be depleted. The feed business operator submitted information to demonstrate safe disposal of the waste material. The CONTAM Panel concluded that the proposed decontamination process to remove dioxins (PCDD/Fs) and PCBs from fish meal by means of solvent extraction and fish oil replacement was assessed to be compliant with the acceptability criteria provided for in Commission Regulation (EU) 2015/786 of 19 May 2015.

Assessment of a decontamination process for dioxins and PCBs from fish meal by replacement of fish oil.

Following a request from the European Commission, the EFSA Panel on Contaminants in the Food Chain (CONTAM) provided a scientific opinion on the assessment of a decontamination process of fish meal. It consisted of extraction of the fish oil, filtration and adsorption with activated carbon, and replacement with decontaminated fish oil in order to reduce the amount of dioxins (polychlorinated dibenzo-p-dioxins (PCDDs) and polychlorinated dibenzofurans (PCDFs)), and dioxin-like (DL-) and non-dioxin-like (NDL-) polychlorinated biphenyls (PCBs). All feed decontamination processes must comply with the acceptability criteria specified in the Commission Regulation (EU) 2015/786. Data provided by the feed business operator were assessed for efficacy of the process and to demonstrate that the process did not adversely affect the characteristics and the nature of the product. The process was effective in removing PCDD/Fs (97%) and DL- and NDL-PCBs (93%). The fish meal produced complied with EU regulations for these contaminants. The Panel considered that the reference to information available in published literature was a pragmatic approach to demonstrate that the replacement of fish oil and the use of activated carbon to adsorb these contaminants does not lead to any detrimental changes in the nature of the fish meal. However, it was noted that the process could deplete some beneficial constituents (e.g. oil-soluble vitamins). Information was provided to demonstrate the safe disposal of the waste material. The CONTAM Panel concluded that on the basis of the information submitted by the feed business operator the proposed decontamination process to remove dioxins (PCDD/Fs) and PCBs from the fish meal by oil extraction followed by replacement with decontaminated fish oil, was compliant with the acceptability criteria provided for in Commission Regulation (EU) 2015/786 of 19 May 2015.

Effect on public health of a possible increase of the maximum level for 'aflatoxin total' from 4 to 10 µg/kg in peanuts and processed products thereof, intended for direct human consumption or use as an ingredient in foodstuffs.

EFSA was asked to deliver a scientific opinion regarding the effect on public health of a possible increase of the maximum level (ML) for 'aflatoxin total' (AFT; sum of aflatoxin B1, aflatoxin B2, aflatoxin G1 and aflatoxin G2) from 4 to 10 µg/kg in peanuts and processed products thereof. Aflatoxins are genotoxic and cause hepatocellular carcinomas in humans. The Panel on Contaminants in the Food Chain (CONTAM Panel) evaluated 8,085 samples of peanuts and 472 samples of peanut butter, with > 60% left-censored. The mean concentration of AFT in peanuts was 2.65/3.56 µg/kg (lower bound (LB)/upper bound (UB)) with a maximum of 1,429 µg/kg. The mean concentration in peanut butter was 1.47/1.92 µg/kg (LB/UB) with a maximum of 407 µg/kg. Peanut oil was not included since all data were left-censored and the ML does not apply for oil. Exposure was calculated for a 'Current ML' and 'Increased ML' scenario, and mean chronic exposure estimates for consumers only, amounted to 0.04-2.74 ng/kg body weight (bw) per day and 0.07-4.28 ng/kg bw per day, respectively. The highest exposures were calculated for adolescents and other children. The CONTAM Panel used the cancer potencies estimated by the Joint FAO/WHO Expert Committee on Food Additives for the risk characterisation. Under the scenario of the current ML, the cancer risk was estimated to range between 0.001 and 0.213 aflatoxin-induced cancers per 100,000 person years. Under the scenario of the increased ML, it ranged between 0.001 and 0.333 aflatoxin-induced cancers per 100,000 person years. Comparing these data calculated under the current ML scenario with the yearly excess cancer risk of 0.014 shows a higher risk for consumers of peanuts and peanut butter in some surveys. The calculated cancer risks indicate that an increase of the ML would further increase the risk by a factor of 1.6-1.8.

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.