Dominique Parent‐Massin

Probabilistic dietary exposure to phycotoxins in a recreational shellfish harvester subpopulation (France)

Phycotoxins, secondary phytoplankton metabolites, are considered as an important food safety issue because their accumulation by shellfish may render them unfit for human consumption. However, the likely intakes of phycotoxins via shellfish consumption are almost unknown because both contamination and consumption data are very scarce. Thus, two 1-year surveys were conducted (through the same population: recreational shellfish harvesters and from the same geographical area) to assess: shellfish consumption and contamination by major toxins (domoic acid (DA) group, okadaic acid (OA) group and spirolides (SPXs)). Recreational shellfish harvesters had been targeted as an at-risk subpopulation because they consume more shellfish than general population and because they eat not only commercial shellfish species controlled by official authorities but also their own harvests of shellfish species may be in non-controlled areas and more over shellfish species non-considered in the official control species. Then, these two kinds of data were combined with deterministic and probabilistic approaches for both acute and chronic exposures, on considering the impact of shellfish species and cooking on phycotoxin levels. For acute risk, monitoring programs seem to be adequate for DAs, whereas OAs could be a matter of concern for high consumers (their acute intakes were up to ninefold the acute reference dose (ARfD)). About chronic risk, OAs are a matter of concern. The daily OAs intakes were close to the ARfD, which is, by definition, greater than the tolerable daily intake. Moreover, SPX contamination is low but regular, no (sub)chronic SPX toxicity data exist; but in case of (sub)chronic toxicity, SPX exposure should be considered.

Relevant shellfish consumption data for dietary exposure assessment among high shellfish consumers, Western Brittany, France

Shellfish consumption can be a major pathway of exposure to pollutants for humans. It is fundamental to know if people eat enough shellfish to cause health problems, firstly in high consumers as recreational shellfish harvesters. The objectives of this study were to investigate the types of shellfish eaten, number of meals, portion size, sources of shellfish and shellfish consumption rates among French recreational shellfish harvesters; to determine factors affecting consumption patterns and to examine the reliability of the two methods used: a Food Frequency Questionnaire and a one-month food diary. The mean consumption rates were 11.63 and 26.21 g/person/day for shellfish derived from a self-harvested source only and from all sources, respectively. Harvester consumption rates were between 6- and 15-fold higher than the general French population. The comparison between the FFQ and the food diary showed that results were reliable. Thereby, our results are relevant to assess risk due to shellfish consumption.

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

Abstract 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

Abstract 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.

Exposure to Dishwashing Liquid Assessed in University Students from Brest City: A Preliminary Study—A First Approach to Household Products Exposure in France

ABSTRACT In recent years, more attention has been paid to exposure of the general population to household products. In order to assess exposure, it is necessary to generate exposure data. For this reason, a preliminary study of dishwashing liquid contact on Brest university students was performed. Dishwashing liquid is frequently used and when it is improperly mixed it can liberate harmful molecules. As for university students, they may have a repetitive contact with dishwashing liquid during their academic studies. Relevant parameters as frequency of dishwashing, duration, and amount of dishwashing liquid were assessed from questionnaires and laboratory tests. Tests revealed that overall no difference between the sexes and the type of residential household on dishwashing was present on this population. Amount of washed items and duration was significantly correlated, which could seem logical but remarkable considering the lack of correlation between other parameters. Values of 1.39 and 58.8 μg/kg bw/day for the 95th percentile of dermal and inhalation probabilistic exposure were found, respectively. Dermal exposure coincides with deterministic published data. In the case of inhalation exposure no published data are available. Higher inhalation exposure value may show that dermal exposure is diminished by high dilution of dishwashing liquid in water.

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.

Re-evaluation of tara gum (E 417) 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 tara gum (E 417) as a food additive. Tara gum (E 417) has been evaluated by the EU Scientific Committee for Food (SCF, 1992) and by the Joint FAO/WHO Expert Committee on Food Additives (JECFA, 1987), who both allocated an acceptable daily intake (ADI) ‘not specified’ for this gum. 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 for tara gum (E 417). Tara gum (E 417) is unlikely to be absorbed intact and is expected to be fermented by intestinal microbiota. No adverse effects were reported at the highest doses tested in subchronic, chronic and carcinogenicity studies and there is no concern with respect to the genotoxicity. The Panel concluded that there is no need for a numerical ADI for tara gum (E 417) and that there is no safety concern for the general population at the refined exposure assessment of tara gum (E 417) as a food additive at the reported uses and use levels.