Toxic effects of mineral oil saturated hydrocarbons (MOSH) and relation to accumulation in rat liver.

Humans are daily exposed to mineral oil saturated hydrocarbons (MOSH) from the diet. We exposed female Fischer 344 rats to a broad mixture and sub-fractions of MOSH. Chemical characterization of the MOSH mixture used and material accumulated in rat tissues were previously reported (Barp et al. 2017a, 2017b). Rats were exposed to feed containing 0-4000 mg/kg broad MOSH mixture for 30, 60, 90 and 120 days; and for 120 days to feed containing different MOSH fractions: i) mainly molecular masses < C25 (S-C25), ii) dewaxed, mainly molecular masses > C25 (L-C25) and iii) the L-C25 fraction mixed with wax largely consisting of n-alkanes > C25 (L-C25W). Treatments related effects were increased liver and spleen weight, as well as vacuolization and granuloma formation with lymphoid cell clusters in the liver, but effects varied strongly between the MOSH fractions tested. We conclude that increased liver and spleen weights were related to accumulated n-alkanes (wax) above C25, presumably not relevant for humans, but also to MOSH from S-C25, mainly consisting of iso-alkanes and substituted cycloalkanes below C25 with a small proportion of n-alkanes. Induction of liver granuloma appeared to be related to n-alkanes > C25 and not to the accumulated amount of MOSH. Immune responses to an injected antigen were not affected. Iso-alkanes and substituted cycloalkanes accumulating in rat liver and spleen were similar to those accumulating in humans.

Comparison of pesticide residue and specific nutrient levels in peeled and unpeeled apples.

BACKGROUND: Studies have shown that the consumption of apples has a beneficial effect on cardiovascular diseases and some cancers, largely as a result of their micronutrient and phytoconstituent contents. Apple peel not only contains more polyphenols than the flesh, but also is likely to contain pesticide residues. The present study aimed to compare the contents of certain micronutrients and residual pesticide levels in peeled and unpeeled apples. RESULTS: Peeled apples contained fewer pesticide residues at lower concentrations than unpeeled apples. However, whether samples were peeled or not, the exposure values for pesticide residues in apples never exceeded the acceptable daily intake (ADI), but ranged between 0.04% and 2.10% of the ADI in adults for food intake estimated at the 95th percentile (277 g per person per day). Determination of polyphenol, fibre, magnesium and vitamin C levels showed that the nutritional differences observed between peeled and unpeeled apples were marginal. CONCLUSION: The consumption of apples, such as the apples tested in the present study, results in an exposure to pesticides that is low for unpeeled apples, and lower for peeled apples. Moreover, there was no significant loss of nutritional value from eating peeled apples based on the nutrients investigated. © 2022 Society of Chemical Industry.

Prospective association between dietary pesticide exposure profiles and type 2 diabetes risk in the NutriNet-Santé cohort.

BACKGROUND: Studies focusing on dietary pesticides in population-based samples are scarce and little is known about potential mixture effects. We aimed to assess associations between dietary pesticide exposure profiles and Type 2 Diabetes (T2D) among NutriNet-Santé cohort participants. METHODS: Participants completed a Food Frequency Questionnaire at baseline, assessing conventional and organic food consumption. Exposures to 25 active substances used in European Union pesticides were estimated using the Chemisches und Veterinäruntersuchungsamt Stuttgart residue database accounting for farming practices. T2D were identified through several sources. Exposure profiles were established using Non-Negative Matrix Factorization (NMF), adapted for sparse data. Cox models adjusted for known confounders were used to estimate hazard ratios (HR) and 95% confidence interval (95% CI), for the associations between four NMF components, divided into quintiles (Q) and T2D risk. RESULTS: The sample comprised 33,013 participants aged 53 years old on average, including 76% of women. During follow-up (median: 5.95 years), 340 incident T2D cases were diagnosed. Positive associations were detected between NMF component 1 (reflecting highest exposure to several synthetic pesticides) and T2D risk on the whole sample: HRQ5vsQ1 = 1.47, 95% CI (1.00, 2.18). NMF Component 3 (reflecting low exposure to several synthetic pesticides) was associated with a decrease in T2D risk, among those with high dietary quality only (high adherence to French dietary guidelines, including high plant foods consumption): HRQ5vsQ1 = 0.31, 95% CI (0.10, 0.94). CONCLUSIONS: These findings suggest a role of dietary pesticide exposure in T2D risk, with different effects depending on which types of pesticide mixture participants are exposed to. These associations need to be confirmed in other types of studies and settings, and could have important implications for developing prevention strategies (regulation, dietary guidelines). TRIAL REGISTRATION: This study is registered in ClinicalTrials.gov ( NCT03335644 ).

Key Findings of the French BioNutriNet Project on Organic Food-Based Diets: Description, Determinants, and Relationships to Health and the Environment.

Few studies have investigated the relationships between organic food consumption, dietary patterns, monetary diet cost, health, and the environment. To address these issues, a consortium of French epidemiologists, nutritionists, economists, and toxicologists launched the BioNutriNet project in 2013. In 2014, an FFQ documented the usual organic and nonorganic (conventional) food consumption of approximately 35,000 NutriNet-Santé participants. Then, individual organic and conventional food intakes were merged with price, environmental, and pesticide residue data sets, which distinguished between conventional and organic farming methods. Many studies were conducted to characterize organic consumers and their environmental impacts (i.e., greenhouse gas emissions, energy demand, and land use) and organic food consumption impacts on health. We observed that organic consumers had diets that were healthier and richer in plant-based food than nonorganic consumers. Their diets were associated with higher monetary costs, lower environmental impacts, and reduced exposure to certain pesticide residues. Regular consumption of organic food was associated with reduced risks of obesity, type 2 diabetes, postmenopausal breast cancer, and lymphoma. Although several observations have been confirmed by several studies conducted in other countries, our results should be replicated in other cultural settings and coupled with experimental studies to be able to draw causal conclusions. Finally, the main finding of the BioNutriNet project is that while organic food consumption could be associated with positive externalities on human health and the environment, organic-based diets should be accompanied by dietary shifts toward plant-based diets to allow for better planetary and human health.

Adulteration of beeswax: A first nationwide survey from Belgium.

Beeswax is intended for use in the beekeeping sector but also in the agro-food, pharmaceutical or cosmetics sectors. The adulteration of beeswax is an emerging issue that was reported lately at several occasions in the scientific literature. This issue tends to become more frequent and global, but its exact extent is not accurately defined. The present study aims to assess the current situation in Belgium through a nationwide survey. Randomized beeswax samples originating from Belgian beekeepers (N = 98) and commercial suppliers (N = 9) were analysed with a Fourier transform infrared spectroscopy (FTIR) coupled with Attenuated Total Reflectance (ATR) accessory (FTIR-ATR spectroscopy) for adulteration. The survey revealed a frequency of 9.2% and 33.3% of adulteration in beekeepers beeswax samples (9 samples out of 98: 2 with paraffin and 7 with stearin/stearic acid) and commercial beeswax samples (3 samples out of 9: all adulterated with stearin/stearic acid), respectively. The analysed samples were adulterated with various percentages of paraffin (12 to 78.8%) and stearin/stearic acid (1.2 to 20.8%). This survey indicates that in the beekeepers samples, beeswax adulteration was more frequent in comb foundation and crude beeswax than in comb wax. With the example of this nationwide survey conducted in Belgium, this study shows the emergence of the issue and the urgent need for action to safeguard the health of both honey bees health and humans, in particular with the setting of a proper regulation legal framework and a specific routine analytical testing of commercial beeswax to ensure beeswax quality.

Estimated dietary exposure to pesticide residues based on organic and conventional data in omnivores, pesco-vegetarians, vegetarians and vegans.

PURPOSE: To examine dietary exposure to 25 pesticide residues in several diet groups including omnivores, pesco-vegetarians, vegetarians and vegans while accounting for the farming system (organic or conventional) of plant-based foods consumed. METHODS: Organic and conventional consumption data in combination with data on pesticide residues in plant-based foods were used to derive estimated dietary exposure to pesticide residues. Pesticide residue exposure was estimated based on observed data, and using two scenarios simulated for 100%-conventional and 100%-organic diets in 33,018 omnivores, 555 pesco-vegetarians, 501 vegetarians and 368 vegans from the NutriNet-Santé study. Pesticide residue exposure across groups was compared using Kruskal-Wallis tests. RESULTS: Exposure levels varied across diet groups depending on the pesticide studied. The highest exposure was observed for imazalil in all groups. Vegetarians appeared to be less exposed to the studied pesticides overall. Compared to omnivores - apart from pesticides authorised in organic farming - vegetarians had lowest exposure. The 100%-conventional scenario led to a sharp increase in exposure to pesticide residues, except for pesticides allowed in organic farming and conversely for the 100%-organic scenario. CONCLUSIONS: Despite their high plant-based product consumption, vegetarians were less exposed to synthetic pesticides than omnivores, due to their greater propensity to consume organic.

Prospective association between dietary pesticide exposure profiles and postmenopausal breast-cancer risk in the NutriNet-Santé cohort.

BACKGROUND: Some pesticides, used in large quantities in current agricultural practices all over Europe, are suspected of adverse effects on human reproductive health (breast and prostate cancers), through mechanisms of endocrine disruption and possible carcinogenic properties, as observed in agricultural settings. However, evidence on dietary pesticide exposure and breast cancer (BC) is lacking for the general population. We aimed to assess the associations between dietary exposure to pesticides and BC risk among postmenopausal women of the NutriNet-Santé cohort. METHODS: In 2014, participants completed a self-administered semi-quantitative food-frequency questionnaire distinguishing conventional and organic foods. Exposures to 25 active substances used in EU plant-protection products were estimated using a pesticide-residue database accounting for farming practices, from Chemisches und Veterinäruntersuchungsamt Stuttgart, Germany. Non-negative matrix factorization (NMF), adapted for data with excess zeros, was used to establish exposure profiles. The four extracted NMF components' quintiles were introduced into Cox models estimating hazard ratio (HR) and 95% confidence interval (95% CI), adjusted for known confounding factors. RESULTS: A total of 13 149 postmenopausal women were included in the analysis (169 BC cases, median follow-up = 4.83 years). Negative associations between Component 3, reflecting low exposure to synthetic pesticides, and postmenopausal BC risk were found [HRQ5 = 0.57; 95% CI (0.34; 0.93), p-trend = 0.006]. Positive association between Component 1 score (highly correlated to chlorpyrifos, imazalil, malathion, thiabendazole) and postmenopausal BC risk was found specifically among overweight and obese women [HRQ5 = 4.13; 95% CI (1.50; 11.44), p-trend = 0.006]. No associations were detected for the other components. CONCLUSION: These associations suggest a potential role of dietary pesticide exposure on BC risk. Further research is needed to investigate the mechanisms and confirm these results in other populations.

Infant total diet study in France: Exposure to substances migrating from food contact materials.

A total diet study (TDS) was conducted in France to assess the health risks related to the chemicals in food of non-breastfed children under three years of age (Infant TDS). For the first time, substances coming from food contact materials, such as bisphenol A (BPA), bisphenol A diglycidyl ether (BADGE) and its derivatives, some phthalates, and some ink photoinitiators, were targeted because of growing interest in these substances. Food samples were collected to be representative of the whole diet of non-breastfed children aged 1-36 months, and prepared as consumed prior to analysis. Dietary exposure was assessed for 705 representative children under three years of age. Generally, the substances from food contact materials were detected in few samples: 38% for BPA, 0% for BADGE and its derivatives, 0-35% for phthalates, 1.9% for benzophenone, and 0% for the other ink photoinitiators. Regarding exposure levels, the situation was deemed tolerable for BADGE and its hydrolysis products, di-isodecyl phthalate, dibutyl phthalate, butyl benzyl phthalate, bis(2-ethylhexyl) phthalate, and di-isononyl phthalate, benzophenone, and 4-methylbenzophenone. Only for BPA, the exposure levels of some children exceeded the lowest toxicological value established by the French Agency for Food, Environmental and Occupational Health & Safety at 0.083 µg.kg bw-1.d-1. The temporary tolerable daily intake of the European Food Safety Authority (EFSA), set at 4 µg.kg bw-1.d-1, was never exceeded. However, actual exposure to BPA was probably overestimated, as well as the associated risk, because the foods were sampled prior to the recent regulations banning BPA in food packaging. This study is the first worldwide to provide an estimate of infant food contamination levels and exposures of children under 3 years of age, based on a TDS approach. It therefore provides key data on the exposure of this particularly sensitive population to substances released from food contact materials, and presents useful data for studies evaluating exposure to mixtures or aggregated exposure.

Estimated dietary pesticide exposure from plant-based foods using NMF-derived profiles in a large sample of French adults.

PURPOSE: This study, conducted in participants of the NutriNet-Santé cohort, aims to identify dietary pesticide exposure profiles (derived from Non-negative Matrix Factorization) from conventional and organic foods among a large sample of general population French adults. METHODS: Organic and conventional dietary intakes were assessed using a self-administered semi-quantitative food frequency questionnaire. Exposure to 25 commonly used pesticides was evaluated using food contamination data from Chemisches und Veterinäruntersuchungsamt Stuttgart accounting for farming system (organic or conventional). Dietary pesticide exposure profiles were identified using Non-Negative Matrix factorization (NMF), especially adapted for non-negative data with excess zeros. The NMF scores were introduced in a hierarchical clustering process. RESULTS: Overall, the identified clusters (N = 34,193) seemed to be exposed to the same compounds with gradual intensity. Cluster 1 displayed the lowest energy intake and estimated dietary pesticide exposure, high organic food (OF) consumption (23.3%) and a higher proportion of male participants than other groups. Clusters 2 and 5 presented intermediate energy intake, lower OF consumption and intermediate estimated pesticide exposure. Cluster 3 showed high conventional fruits and vegetable (FV) intake, high estimated pesticide exposure, and fewer smokers. Cluster 4 estimated pesticide exposure varied more across compounds than for other clusters, with highest estimated exposures for acetamiprid, azadirachtin, cypermethrin, pyrethrins, spinosad. OF proportion in the diet was the highest (31.5%). CONCLUSION: Estimated dietary pesticide exposures appeared to vary across the clusters and to be related to OF proportion in the diet. TRIAL REGISTRATION: Clinical Trial Registry: NCT03335644.

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.

Dietary exposure to pesticide residues and associated health risks in infants and young children - Results of the French infant total diet study.

A total diet study (TDS) was undertaken to estimate the chronic dietary exposure to pesticide residues and health risks for the French infants and young children below 3 years old. As a whole, 516 pesticides and metabolites were analysed in 309 food composite samples including 219 manufactured baby foods and 90 common foods, which cover 97% of infants and young children's diet. These composite samples were prepared using 5,484 food products purchased during all seasons from 2011 to 2012 and processed as consumed. Pesticide residues were detected in 67% of the samples and quantified in 27% of the baby food samples and in 60% of the common foods. Seventy-eight different pesticides were detected and 37 of these quantified at levels ranging from 0.02 to 594 µg/kg. The most frequently detected pesticides (greater than 5% samples) were (1) the fungicides 2-phenylphenol, azoxystrobin, boscalid, captan and its metabolite tetrahydrophthalimide, carbendazim, cyprodinil, difenoconazole, dodine, imazalil, metalaxyl, tebuconazole, thiabendazole, (2) the insecticides acetamiprid, pirimiphos-methyl and thiacloprid, (3) the herbicide metribuzin and (4) the synergist piperonyl butoxide. Dietary intakes were estimated for each of the 705 individuals studied and for 431 pesticides incl. 281 with a toxicological reference value (TRV). In the lower-bound scenario, which tends to underestimate the exposure, the TRV were never exceeded. In the upper-bound scenario that overestimates exposure, the estimated intakes exceeded the TRV for dieldrin and lindane (two persistent organic pollutants) and propylene thiourea, a metabolite of propineb. For these three substances, more sensitive analyses are needed to refine the assessment. For 17 other detected and/or prioritised pesticides, the risk could not be characterised due to the lack of a valid TRV, of certain food analyses or the absence of analytical standards for their metabolites.

Improvement of diet sustainability with increased level of organic food in the diet: findings from the BioNutriNet cohort.

BACKGROUND: Organic food consumption has steadily increased over the past decade in westernized countries. OBJECTIVE: The aim of this study, based on observational data, was to compare some sustainability features of diets from consumers with varying levels of organic food. METHODS: The diet sustainability among 29,210 participants of the NutriNet-Santé study was estimated using databases developed within the BioNutriNet project. Four dimensions (nutrition, environment, economy, and toxicology) of diet sustainability were assessed using: 1) nutritional indicators through dietary intakes and dietary scores, and BMI; 2) environmental indicators (greenhouse gas emissions, cumulative energy demand, and land occupation); 3) economic indicators via diet monetary costs; and 4) estimated daily food exposures to 15 pesticides. Adjusted means (95% CI) across weighted quintiles of organic food consumption in the diet were estimated via ANCOVA. Breakdown methods were used to disentangle the contribution of the production system (organic compared with conventional) from the dietary pattern in the variation of diet-related environmental impacts, monetary costs, and pesticide exposure, between the 2 extreme quintiles. RESULTS: Higher organic food consumption was associated with higher plant-food and lower animal-food consumption, overall nutritional quality (higher dietary scores), and lower BMI. Diet-related greenhouse-gas emissions, cumulative energy demand, and land occupation gradually decreased with increasing organic food consumption, whereas total diet monetary cost increased. Diet exposure to most pesticides decreased across quintiles. CONCLUSIONS: Diets of high organic food consumers were generally characterized by strong nutritional and environmental benefits. The latter were mostly driven by the low consumption of animal-based foods, whereas the production system was responsible for the higher diet monetary costs, and the overall reduced dietary pesticide exposure.

Safety assessment of the substance poly((R)-3-hydroxybutyrate-co-(R)-3-hydroxyhexanoate) for use in food contact materials.

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP Panel) assessed the safety of poly((R)-3-hydroxybutyrate-co-(R)-3-hydroxyhexanoate) (PHBH), CAS No 147398-31-0 and food contact material (FCM) substance No 1059. This biodegradable copolymer is produced by fermentation of palm oil using a genetically modified microorganism (Cupriavidus necator). Overall migration was up to 5.4 mg/kg. Oligomers are hydroxyl-terminated or with crotyl- and hexenyl end-groups from dehydration of hydroxyl end-groups. In the absence of calibration standards, the total oligomer migration was set at the overall migration values. Other degradation products are crotonic acid and (E)-2-hexenoic acid. Crotonic acid is authorised for use in FCMs with a specific migration limit (SML) of 0.05 mg/kg food. For (E)-2-hexenoic acid, no indication for genotoxicity was identified by the EFSA CEF Panel in its group evaluation of flavouring substances in FGE.05Rev2 (EFSA CEF Panel, 2010b). The other migrating substances detected, ■■■■■, are from the authorised substance 'palm oil and/or palm fatty acid distillate' (FCM substance No 9) used as a carbon source for the fermentation and do not give rise to safety concern. A PHBH oligomer mixture was synthesized to simulate that migrating. It did not give rise to concern for genotoxicity. From the repeated dose 90-day oral toxicity study in rats, the Panel identified the no-observed-adverse-effect level (NOAEL) at the highest dose tested in males, 1,364 mg/kg body weight (bw) per day. The Panel concluded that the potential for bioaccumulation of oligomers is low. Overall, the CEP Panel concluded that the substance PHBH is not of safety concern for the consumer if it is used alone or blended with other polymers in contact with all kinds of food during more than 6 months at room temperature or below, including hot-fill or a short heating up phase. The specific migration of all oligomers < 1,000 Da should not exceed 5 mg/kg food. The migration of crotonic acid should not exceed the SML of 0.05 mg/kg food. As the migration of (E)-2-hexenoic acid can be expected to be always lower than that of crotonic acid, no individual restriction is necessary.

Safety assessment of the substance, montmorillonite clay modified with hexadecyltrimethylammonium bromide, for use in food contact materials.

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of montmorillonite clay modified with hexadecyltrimethylammonium bromide (HDTA) when used as an additive at up to ■■■■■ in polylactic acid (PLA) bottles intended for contact with water for long-term storage at ambient temperature or below. The modified clay, which 90% w/w of the particles have a dimension of 33.1 µm or less and the average size is 9 µm, has a layered structure with layers of a thickness below 100 nm. When incorporated in PLA, nanosized layers can be dispersed in the matrix, but are not expected to migrate. Thermal degradation is not expected at the maximum manufacturing temperature. No loss of integrity of the PLA surface due to interaction with bottled water was observed. The overall migration was very low. No migration of HDTA was detected at the limit of detection ■■■■■. Migration of aluminium was below or at the limit of detection ■■■■■, which would conservatively correspond to approximately ■■■■■. Comparative analysis of bottled water with and without the modified clay did not reveal additional peaks corresponding to impurities identified in the modifier and/or in the modified clay. Moreover, ■■■■■, and the modifier HDTA have been evaluated and authorised. Therefore, the CEP Panel concluded that the substance montmorillonite clay modified with HDTA bromide is not of safety concern for the consumer if the substance is used as an additive at up to ■■■■■ in PLA plastic bottles and other containers intended for long-term storage of water at ambient temperature or below, as requested by the applicant.

Safety assessment of the substance trimellitic acid, tris (2-ethylhexyl) ester, for use in food contact materials.

This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes and Processing aids (CEP Panel) is on the safety assessment of trimellitic acid, tris(2-ethylhexyl) ester, intended to be used as a plasticiser in the manufacture of soft poly(vinyl chloride) (PVC) materials and articles, such as wrap films (single uses) and tubing (repeated uses) at up to approximately 10% and 40%, respectively. Under the tested conditions, the substance migrated up to 165 µg/kg food from wrap films and was not detected in food simulant in contact with tubing. Based on the three reported in vitro genotoxicity studies, the Panel concluded that the substance does not raise concern for genotoxicity. The lowest no observed adverse effect level (NOAEL), derived from a 90-day oral toxicity study, was 225 mg/kg body weight (bw) per day. Based on data on toxicokinetic and metabolism, the substance does not give rise to concern for accumulation in humans. The substance does not cause developmental effects as induced by phthalic acid, bis(2-ethylhexyl) ester (DEHP). Assuming that impurities migrate pro-rata to a migration of the substance up to 5 mg/kg food, their estimated migration does not raise a safety concern. The Panel concluded that the substance does not raise safety concern for the consumer when used in the manufacture of soft PVC under the conditions requested by the applicant for (i) single use wrap films in contact with food for which simulants A, B and D1 are assigned, as well as (ii) tubing for repeated contacts with food for which simulants A and B are assigned. Overall, the use of the substance does not raise a safety concern if its migration does not exceed 5 mg/kg food. Due to the additional contribution from other sources of exposures, the application of an allocation factor should be considered.

Update of the risk assessment of di-butylphthalate (DBP), butyl-benzyl-phthalate (BBP), bis(2-ethylhexyl)phthalate (DEHP), di-isononylphthalate (DINP) and di-isodecylphthalate (DIDP) for use in food contact materials.

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP Panel) was asked by the European Commission to update its 2005 risk assessments of di-butylphthalate (DBP), butyl-benzyl-phthalate (BBP), bis(2-ethylhexyl)phthalate (DEHP), di-isononylphthalate (DINP) and di-isodecylphthalate (DIDP), which are authorised for use in plastic food contact material (FCM). Dietary exposure estimates (mean and high (P95)) were obtained by combining literature occurrence data with consumption data from the EFSA Comprehensive Database. The highest exposure was found for DINP, ranging from 0.2 to 4.3 and from 0.4 to 7.0 µg/kg body weight (bw) per day for mean and high consumers, respectively. There was not enough information to draw conclusions on how much migration from plastic FCM contributes to dietary exposure to phthalates. The review of the toxicological data focused mainly on reproductive effects. The CEP Panel derived the same critical effects and individual tolerable daily intakes (TDIs) (mg/kg bw per day) as in 2005 for all the phthalates, i.e. reproductive effects for DBP (0.01), BBP (0.5), DEHP (0.05), and liver effects for DINP and DIDP (0.15 each). Based on a plausible common mechanism (i.e. reduction in fetal testosterone) underlying the reproductive effects of DEHP, DBP and BBP, the Panel considered it appropriate to establish a group-TDI for these phthalates, taking DEHP as index compound as a basis for introducing relative potency factors. The Panel noted that DINP also affected fetal testosterone levels at doses around threefold higher than liver effects and therefore considered it conservative to include it within the group-TDI which was established to be 50 µg/kg bw per day, expressed as DEHP equivalents. The aggregated dietary exposure for DBP, BBP, DEHP and DINP was estimated to be 0.9-7.2 and 1.6-11.7 µg/kg bw per day for mean and high consumers, respectively, thus contributing up to 23% of the group-TDI in the worst-case scenario. For DIDP, not included in the group-TDI, dietary exposure was estimated to be always below 0.1 µg/kg bw per day and therefore far below the TDI of 150 µg/kg bw per day. This assessment covers European consumers of any age, including the most sensitive groups. Based on the limited scope of the mandate and the uncertainties identified, the Panel considered that the current assessment of the five phthalates, individually and collectively, should be on a temporary basis.

Safety assessment of the substance, titanium dioxide surface treated with fluoride-modified alumina, for use in food contact materials.

This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP Panel) is a safety assessment of the additive titanium dioxide surface treated with fluoride-modified alumina, a defined mixture of particles of which ■■■■■% in number have a diameter in the range of 1-100 nm. It is intended to be used as filler and colourant up to 25% w/w in potentially all polymer types. Materials and articles containing the additive are intended to be in contact with all food types for any time and temperature conditions. The data provided demonstrate that the additive particles stay embedded even in swollen polar polymers such as polyamide, and do not migrate. Moreover, the additive particles resisted release by abrasion and did not transfer into a simulant for solid/dry foods. Thus, the additive particles do not give rise to exposure via food and to toxicological concern. Migration of solubilised ionic fluoride and aluminium occurs from the surface of the additive particles and particularly from swollen plastic. The Panel concluded that the substance does not raise safety concern for the consumer if used as an additive up to 25% w/w in polymers in contact with all food types for any time and temperature conditions. However, uses in polar polymers swelling in contact with foodstuffs simulated by 3% acetic acid should be limited to conditions simulated by contact up to 4 h at 100°C. This is due to the fact that when used at 25%, and contact was followed by 10 days at 60°C, the migration of aluminium and fluoride largely exceeded the specific migration limit (SML) of 1 and 0.15 mg/kg food, respectively. The Panel emphasises that the existing SMLs for aluminium and fluoride should not be exceeded in any case.

Urinary pesticide concentrations in French adults with low and high organic food consumption: results from the general population-based NutriNet-Santé.

An organic diet may reduce dietary exposure to pesticides but findings based on observational data are scant. We aimed to compare urinary pesticide concentrations between "organic" and "conventional" consumers from the NutriNet-Santé study. Organic food consumption was determined using a self-reported food frequency questionnaire. Individuals with a proportion of organic food in the whole diet (in g/d) below 10% were defined as low organic food consumers and those whose proportion was above 50% as high organic food consumers. A propensity score matching procedure was then used to obtain two similar subsets of 150 participants, differing mostly by the organic valence of their diet. Urinary pesticide and metabolite concentrations (organophosphorus, pyrethroid, and azole compounds) were determined by UPLC-MS/MS, standardized with respect to creatinine. The molar sums of total diethylphosphates, dimethylphosphates, and dialkylphosphates were also computed. Differences in distributions across groups were tested using Wilcoxon signed-rank test for matched data. Mean age was 58.5 years and 70% of participants were women. Significantly lower urinary levels of diethylthiophosphate, dimethylthiophosphate, dialkylphosphates, and free 3-phenoxybenzoic acid were observed among organic consumers compared to conventional consumers. Our findings confirm that exposure to certain organophosphate and pyrethroïd pesticides in adults may be lowered by switching from conventional to organic foods. This is particularly of high interest among conventional fruit and vegetable consumers, as their exposure may be the highest.