Alexandra Tard

Estimated dietary exposure to principal food mycotoxins from The First French Total Diet Study

This study reports estimates on dietary exposure from the first French Total Diet Study (FTDS) and compares these estimates with both existing tolerable daily intakes for these toxins and the intakes calculated during previous French studies. To estimate the dietary exposure of the French population to the principal mycotoxins in the French diet (as consumed), 456 composite samples were prepared from 2280 individual samples and analysed for aflatoxins, ochratoxin A, trichothecenes, zearalenone, fumonisins and patulin. Average and high percentile intakes were calculated taking account of different eating patterns for adults, children and vegetarians. The results showed that contaminant levels observed in the foods examined ‘as consumed’ complied fully with current European legislation. However, particular attention needs to be paid to the exposure of specific population groups, such as children and vegans/macrobiotics, who could be exposed to certain mycotoxins in quantities that exceed the tolerable or weekly daily intake levels. This observation is particularly relevant with respect to ochratoxin A, deoxynivalenol and zearalenone. For these mycotoxins, cereals and cereal products were the main contributors to high exposure.

Dietary exposure to polychlorinated dibenzo-p-dioxins, polychlorinated dibenzofurans and polychlorinated biphenyls of the French population: Results of the second French Total Diet Study.

Polychlorinated dibenzo-p-dioxins (PCDDs), polychlorinated dibenzofurans (PCDFs) and polychlorinated biphenyls (PCBs) bioaccumulate through the food chain and are therefore of public health concern. Exposure to these compounds was assessed in the second French Total Diet Study (TDS). Food samples (n=583) were collected to be representative of the whole diet of the population, prepared as consumed, and analyzed. Contamination data were combined with national individual food consumption data. Mean exposure (95th percentile) to PCDD/F+DL-PCBs was assessed to be 0.57 (1.29) pg TEQ(WHO-98) (kg bw)(-1) d(-1) in the adult population and 0.89 (2.02) pg TEQ(WHO-98) (kg bw)(-1) d(-1) in the child and teenager population. Less than 4% of the population exceeded the health-based guidance value for PCDD/F+DL-PCBs. Mean exposure (95th percentile) to the six indicator PCBs (PCB 28, 52, 101, 138, 153, 180) was estimated at 2.71 (7.90) ng (kg bw)(-1) d(-1) in the adult population and 3.77 (11.7) ng (kg bw)(-1) d(-1) in the child and teenager population. Only 2.6% of the adults [CI(95%): 1.9; 3.3] and 6.5% of the children and teenagers [5.2; 7.8] exceeded the health-based guidance value for total PCBs. These results show that the contamination levels in food and therefore the exposure of the general French population to PCDD/Fs and PCBs have declined (by a factor of 3.2 for PCDD/F+DL-PCBs and about three for total PCBs) since the last evaluation, which was conducted using another methodology in 2005 and 2007, and show the efficiency of the European risk management measures which came into force after these evaluations.

Dioxins, furans and dioxin-like PCBs: Occurrence in food and dietary intake in France

PCDD/Fs and DL-PCBs contamination data in food products consumed in France collected from national monitoring programmes (2001–04) and representing analytical results for almost 800 individual food samples were combined with food consumption data from the French national dietary survey to estimate PCDD/Fs and DL-PCBs dietary intakes, expressed as toxic equivalents (WHO-TEQs). The mean PCDD/Fs and DL-PCBs intakes were estimated as 1.8 and 2.8 pg WHO-TEQ kg−1 b.w. day−1, respectively, for adults (aged 15 years and over) and children (aged 3–14 years). The main contributors to total intake were fish and milk products for both children and adults (48 and 31% for adults and 34 and 43% for children, respectively). DL-PCBs constituted the largest contributor to contamination in most foodstuffs. A life-long intake estimate showed that a non-negligible part of the French population (between 20 and 28%) had an intake above the tolerable monthly intake for dioxins and dioxin-like PCBs of 70 pg WHO-TEQ kg−1 b.w. month−1.

Human dietary exposure to polycyclic aromatic hydrocarbons: results of the second French Total Diet Study.

In the frame of the second French Total Diet Study (TDS), the 15+1 EU priority polycyclic aromatics hydrocarbons (PAHs) were analyzed in 725 foodstuffs habitually consumed by the French population, using gas chromatography coupled to tandem mass spectrometry, after pressurized liquid extraction and purification on PS-DVB stationary phase. The highest PAH concentrations recovered in foodstuffs corresponded to the following contributors: chrysene (25.7%), benzo[b]fluoranthene (15.0%) and benz[a]anthracene (9.0%) whereas the lowest concentrations were those of dibenz[a,h]anthracene, 5 methylchrysene and dibenzo[a,h]pyrene (below 2.0%). By food groups, the current highest levels of total PAH were detected in mollusks and crustaceans, followed by the different oil based products. To estimate French populations exposure, contamination data were combined with national individual food consumption data. Mean daily exposure to the sum of benzo[a]pyrene, benz[a]anthracene, chrysene and benzo[b]fluoranthene (PAH4) was estimated to be 1.48 ng/kg bw/day in adults and 2.26 ng/kg bw/day in children. The main contributors to PAH exposure for adults are fats, bread and dried bread products followed by crustaceans and mollusks. The margin of exposure (MOE) approach indicates that exposure to PAHs through food is not a major health problem for French consumers.

Food risk assessment for perfluoroalkyl acids and brominated flame retardants in the French population: Results from the second French total diet study

To determine the exposure of the French population to toxic compounds contaminating the food chain, a total diet study was performed in France between 2007 and 2009. This study was designed to reflect the consumption habits of the French population and covered the most important foods in terms of consumption, selected nutrients and contribution to contamination. Based on French consumption data, the present study reports the dietary exposure to perfluoroalkyl acids (16 congeners) and brominated flame retardants (polybrominated diphenyl ethers, hexabromocyclododecane and polybrominated biphenyls). Comparison of the calculated dietary exposures with the generally accepted health-based guidance values revealed that most compounds do not pose any risk. There are however knowledge gaps for some congeners in these large chemical classes.

Re‐evaluation of guar gum (E 412) as a food additive

Abstract The Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion re‐evaluating the safety of guar gum (E 412) as a food additive. In the EU, guar gum was evaluated by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 1970, 1974 and 1975, who allocated an acceptable daily intake (ADI) ‘not specified’. Guar gum has been also evaluated by the Scientific Committee for Food (SCF) in 1977 who endorsed the ADI ‘not specified’ allocated by JECFA. Following the conceptual framework for the risk assessment of certain food additives re‐evaluated under Commission Regulation (EU) No 257/2010, the Panel considered that adequate exposure and toxicity data were available. Guar gum is practically undigested, not absorbed intact, but significantly fermented by enteric bacteria in humans. No adverse effects were reported in subchronic and carcinogenicity studies at the highest dose tested; no concern with respect to the genotoxicity. Oral intake of guar gum was well tolerated in adults. The Panel concluded that there is no need for a numerical ADI for guar gum (E 412), and there is no safety concern for the general population at the refined exposure assessment of guar gum (E 412) as a food additive. The Panel considered that for uses of guar gum in foods intended for infants and young children the occurrence of abdominal discomfort should be monitored and if this effect is observed doses should be identified as a basis for further risk assessment. The Panel considered that no adequate specific studies addressing the safety of use of guar gum (E 412) in food categories 13.1.5.1 and 13.1.5.2 were available. Therefore, the Panel concluded that the available data do not allow an adequate assessment of the safety of guar gum (E 412) in infants and young children consuming these foods for special medical purposes.

Re‐evaluation of glycerol (E 422) as a food additive

Abstract The ANS Panel provides a scientific opinion re‐evaluating the safety of glycerol (E 422) used as a food additive. In 1981, the Scientific Committee on Food (SCF) endorsed the conclusion from the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 1976 of ‘acceptable daily intake (ADI) for man not specified’. The Panel concluded that glycerol has low acute toxicity and that local irritating effects of glycerol in the gastrointestinal tract reported in some gavage studies was likely due to hygroscopic and osmotic effects of glycerol. Glycerol did not raise concern with respect to genotoxicity and was of no concern with regard to carcinogenicity. Reproductive and prenatal developmental studies were limited to conclude on reproductive toxicity but no dose‐related adverse effects were reported. None of the animal studies available identified an adverse effect for glycerol. The Panel conservatively estimated the lowest oral dose of glycerol required for therapeutic effect to be 125 mg/kg bw per hour and noted that infants and toddlers can be exposed to that dose by drinking less than the volume of one can (330 mL) of a flavoured drink. The Panel concluded that there is no need for a numerical ADI and no safety concern regarding the use of glycerol (E 422) as a food additive at the refined exposure assessment for the reported uses. The Panel also concluded that the manufacturing process of glycerol should not allow the production of a food additive, which contains genotoxic and carcinogenic residuals at a level which would result in a margin of exposure below 10,000. The Panel recommended modification of the EU specifications for E 422. The Panel also recommended that more information on uses and use levels and analytical data should be made available to the Panel.

Re‐evaluation of propane‐1,2‐diol (E 1520) as a food additive

Abstract The EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion re‐evaluating the safety of propane‐1,2‐diol (E 1520) when used as a food additive. In 1996, the Scientific Committee on Food (SCF) established an acceptable daily intake (ADI) of 25 mg/kg body weight (bw) per day for propane‐1,2‐diol. Propane‐1,2‐diol is readily absorbed from the gastrointestinal and is expected to be widely distributed to organs and tissues. The major route of metabolism is oxidation to lactic acid and pyruvic acid. At high concentrations, free propane‐1,2‐diol is excreted in the urine. No treatment‐related effects were observed in subchronic toxicity studies. The available data did not raise concern with respect to genotoxicity. Haematological changes suggestive of an increased red blood cell destruction with a compensatory increased rate of haematopoiesis were observed at the highest dose level (5,000 mg/kg bw per day) in a 2‐year study in dogs. No adverse effects were reported in a 2‐year chronic study in rats with propane‐1,2‐diol (up to 2,500 mg/kg bw per day). The SCF used this study to derive the ADI. No adverse effects were observed in the available reproductive and developmental toxicity studies. Propane‐1,2‐diol (E 1520) is authorised according to Annex III in some food additives, food flavourings, enzymes and nutrients and it is then carried over to the final food. Dietary exposure to E 1520 was assessed based on the use levels and analytical data. The Panel considered that for the food categories for which information was available, the exposure was likely to be overestimated. Considering the toxicity database, the Panel concluded that there was no reason to revise the current ADI of 25 mg/kg bw per day. The Panel also concluded that the mean and the high exposure levels (P95) of the brand‐loyal refined exposure scenario did not exceed the ADI in any of the population groups from the use of propane‐1,2‐diol (E 1520) at the reported use levels and analytical results.

Approach followed for the refined exposure assessment as part of the safety assessment of food additives under re‐evaluation

Abstract This statement describes the approach followed by the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) for performing refined exposure assessment in the framework of the re‐evaluation of already permitted food additives. Estimation of exposure is obtained through combination of different type of data originating from different sources: food additive concentration is obtained from information provided to EFSA on use levels and/or information obtained by means of analytical measurements. In recent years, the use of market research data has also been used. The statement provides also a description of the three different scenarios used for the exposure assessment of food additives under re‐evaluation, from the more conservative regulatory maximum level exposure assessment scenario to more refined ones. Lastly, a description is provided on the approach used for the uncertainty analysis which accompanies the exposure assessment.

Safety of nisin (E 234) as a food additive in the light of new toxicological data and the proposed extension of use

Abstract The present scientific opinion deals with the evaluation of the safety of nisin (E 234) in the light of new toxicological data and with the proposed extension of use in unripened cheese and heat‐treated meat products. Nisin (E 234) is currently an authorised food additive in the EU under Annex II of Regulation (EC) 1333/2008 for use in several food categories. The safety of nisin (E 234) as a food additive has been evaluated in 2006 by the EFSA Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food, where an acceptable daily intake (ADI) of 0.13 mg/kg body weight (bw) was confirmed as previously established by Scientific Committee on Food (SCF). In addition to the studies previously evaluated by EFSA in 2006, the Panel considered in the present opinion, data from a new subchronic toxicity study. No adverse effects were observed in a repeated dose oral toxicity study in which rats were administered nisin A for 90 days. A no observed adverse effect level (NOAEL) of 225 mg nisin A/kg bw per day, the highest dose tested, was identified for this study. Using this NOAEL, an ADI of 1 mg nisin A/kg bw per day for nisin (E 234) was calculated applying a default uncertainty factor of 200 for extrapolation of subchronic to chronic exposure and inter‐ and intra‐species variability. The Panel calculated exposure estimates for both the current and the proposed uses based on the data available in the EFSA Comprehensive Database. The Panel considered that the overall exposure estimate was below the new ADI for nisin A for all population groups. The Panel concluded that the proposed extension of use of nisin (E 234) as a food additive in unripened cheese (at maximum level of 12 mg/kg) and in heat‐treated meat products (at maximum level of 25 mg/kg) would not be of safety concern.