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Impact of a modification of food regulation on cadmium exposure
Regulatory Toxicology and Pharmacology xxx (2015) 1e6
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Impact of a modification of food regulation on cadmium exposure ronique Sirot a, 1, Paule Vasseur b, Jean-François Narbonne c, Julien Jean a, 1, Ve re a, * Jean-Charles Leblanc a, Jean-Luc Volatier a, Gilles Rivie a
Risk Assessment Directorate e French Agency for Food Environmental and Occupational Health and Safety (ANSES), Maisons-Alfort, France CNRS Universit e Paul Verlaine, 57050 Metz, France c Laboratoire de Physico-Toxico Chimie des Syst emes Naturels, Universit e Bordeaux 1, Talence, France b
a r t i c l e i n f o
a b s t r a c t
Article history: Received 5 June 2015 Received in revised form 30 July 2015 Accepted 31 July 2015 Available online xxx
The 2nd French Total Diet Study demonstrated that 0.6% of adults and 14.9% of children exceeded the tolerable weekly intake set by EFSA. The overexposure of several consumers (adults and children) can be partially due to the high consumption of bread and dried bread products, of bivalve mollusks and of potatoes. Except for mollusks, these foods are the main contributors identified for the general population. On this basis, the French agency for food, environmental and occupational health and safety (ANSES) assessed whether a decrease of the European maximum limits in foodstuffs could significantly reduce the level of exposure of French consumers. Applying ML set at P90 of the main contributors would neither significantly reduce exposure levels to cadmium for the general population, nor the percentage of subjects exceeding the TWI. To reduce background consumer exposure to cadmium, actions to be taken include efforts on sources that are at the origin of the soil contamination and the efficacy of consumption recommendations. © 2015 Elsevier Inc. All rights reserved.
Keywords: Cadmium Dietary exposure Maximum limits Regulation
1. Introduction Cadmium (Cd) is a widespread metallic trace element, naturally present in the environment but also found in high concentrations at certain sites as a result of human activities (metalworking, mines and other industries) and is of potential concern as a contaminant in the food chain. Consequently, the European Union has passed and amended a series of Regulations on cadmium. These are based on setting maximum levels (ML) of cadmium in several foodstuffs (EU, 2006) and are, among others, 1 mg/kg fresh weight (fw) for mollusks, 0.2 mg/kg fw for bran and durum wheat and 0.1 mg/kg fw for flour. However, since EFSA lowered the health based guidance value (tolerable weekly intake or TWI) by a factor of almost three in 2009 (From 7 to 2.5 mg/kg bw/week, EFSA, 2009) and since new data became available concerning food contamination and the exposure
Abbreviations: TWI, Tolerable Weekly Intake; EFSA, European Food Safety Authority; ANSES, French agency for food environmental and occupational health and safety; ML, Maximum Limits; NHANES, National Health and Nutrition Examination Survey; TDS, Total Diet Study; BMI, Body Mass Index. * Corresponding author. re). E-mail address: [email protected] (G. Rivie 1 These authors equally contributed to this work.
and body burden of different population groups, the European Commission and the Member States have put in motion a revision of the ML for cadmium in foodstuffs. In the adult population (between 18 and 74 years old) studied in ry et al., 2011) the the French biosurveillance study (ENNS) (Fre mean and median concentrations of urine cadmium in France were both equal to 0.29 mg Cd/g creatinine, and the 95th percentile to 0.91 mg Cd/g creatinine. Those recent data for body burden suggest that 3.6% of French adults exceed the 1 mg Cd/g creatinine threshold of toxicological concern set by EFSA (EFSA, 2009). It is of importance to note that none of the subjects in the study exceeded the action threshold proposed by the German Human Biomonitoring ry et al., 2011). Commission (5 mg Cd/g creatinine, Fre These mean levels are in agreement with those found in France during previous investigations carried out by the French institute of surveillance (InVS) in 1997, 2000 and 2005 in different French cities (about 0.3 mg Cd/g creatinine at Salsigne and its surrounding area; RNSP, 1997) as well as in Marseilles (ORS PACA, 2011) and 0.27 mg Cd/g creatinine in the national study on incineration plants (Afssa, 2009). Mean human urinary cadmium levels measured in the ENNS study were similar to those observed in the National Health and Nutrition Examination Survey (NHANES) carried out in 2003e2004 (CDC, 2009) on a representative sample of the population of the
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Please cite this article in press as: Jean, J., et al., Impact of a modification of food regulation on cadmium exposure, Regulatory Toxicology and Pharmacology (2015), http://dx.doi.org/10.1016/j.yrtph.2015.07.027
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J. Jean et al. / Regulatory Toxicology and Pharmacology xxx (2015) 1e6
United States, in the Canadian Health Measures Survey performed in 2007e2009 (Health Canada, 2010) and in the population of the Czech Republic in 2005 (NIPH, 2006, 2010). On the other hand, the levels observed in Germany in the adult population ten years ago were slightly lower (Becker et al., 2003): 1.5 times lower than the mean in the adult French population and 1.25 times lower at the 95th percentile. In 2006, the French agency for food, environmental and occupational health and safety (ANSES) showed that high consumers of seafood (fish, mollusks and crustaceans) had a higher body burden than the national average, with mean cadmium levels of 0.65 mg Cd/ g creatinine and 1.19 mg Cd/g creatinine at 95th percentile (Sirot et al., 2008). In this study, subjects over the age of 64 years had mean body burden of 0.95 mg Cd/g creatinine and 1.94 mg Cd/g creatinine at P95. Fifteen percent of subjects in the study had body burden exceeding the threshold of concern. On the other hand, none exceeded the level of 5 mg Cd/g creatinine. In 2006, Anses launched the second French total diet study (TDS2) to assess the dietary exposure of the general population to 445 substances of public health interest, including cadmium. The TDS consisted in three major steps: (i) food sampling and sample preparation as consumed by the population, (ii) analysis of the samples, and (iii) dietary exposure assessment by combining the occurrence data with the national consumption data. The food sampling methodology has already been described in details elsewhere (Sirot et al., 2009) as well as results for the substances re et al., 2012; Bemrah et al., 2012; measured in the TDS (Nougade re et al., 2014; Sirot et al., 2012b). The reSirot et al., 2012; Rivie sults for trace elements (including cadmium) can also be found (Millour et al., 2011; Arnich et al., 2012). The French population's mean exposure to cadmium was estimated at 1.12 mg/kg bw/wk in adults (18e79 years old) and 1.68 mg/kg bw/wk in children (3e18 years old). At the 95th percentile, exposure was estimated at 1.89 mg/kg bw/wk in adults and 3.15 mg/kg bw/wk in children. The main contributors to cadmium exposure both in adults and children were bread and dried bread products (22% and 13%, respectively) and potatoes and potato products (12% and 14%, respectively). Detailed data show that adults with the highest estimated intakes are high consumers of mollusks and crustaceans, bread and potatoes. EFSA's TWI of 2.5 mg/kg bw/wk (EFSA, 2009) is exceeded by 0.6% [CI95% 0.3e1.0] of adults and by 14.9% [CI95% 13.0e16.7] of children. The difference between the proportion of subjects exceeding the reference values set for body burden (3.6%) on one hand, and set for food consumption on the other (0.6%), can be explained, leaving aside methodological differences, by the fact that diet accounts for 90% of exposure of non-smokers (UNEP, 2008) and that part of the general population's body burden can be attributed to other contamination vectors (mainly tobacco). Moreover, body burden reflect past exposure, whereas TDS reflects current dietary exposure, and data suggest that cadmium concentrations in foods and chaux et al., 2014). exposure tend to decrease for several years (Be Moreover, dietary exposure data suggest that 1.4% of adults are exposed to more than 90% of the TWI. For these individuals the exposure margin is low if other potential sources of cadmium are taken into account. The results generated by these two approaches concur, emphasizing that a small part of the French adult population is over-exposed to cadmium, largely through dietary intake, and that high consumers of seafood appear to be more exposed than the general population. The level of overexposure remains moderate and it would be helpful to compare it to a future action threshold to decide on the most appropriate reduction measures to be taken. As a small fraction of the French population is overexposed to cadmium and since foods are the main source of contamination
(excluding smoking and occupational exposure), dietary regulations could be an effective way of reducing exposure. Since cadmium is a ubiquitous metal found in a large number of foods, it is important to identify the food groups to be regulated. The present work focuses on the evaluation of strategy that could help decreasing cadmium exposure of adults via foodstuffs. The impact on cadmium dietary exposure of new ML has been assessed as well as the impact on the percentage of individuals exceeding the TWI. 2. Material and methods 2.1. Consumption and exposure profiles Exposure data used in the present work have already been described elsewhere (Arnich et al., 2012). Briefly, total individual exposures were assessed by combining consumption and contamination data. The national and individual food consumption survey (INCA2) was carried out in between December 2005 and May 2007 (Dubuisson et al., 2010). The survey included 2624 adults (aged 18e79), these random sample were drawn using a multistage cluster sampling technique. After exclusion of the under-reporters, the analysis was done with 1918 adults. Food and beverages consumptions were assessed in detail using a 7-day food record. The amounts consumed were estimated by using a photograph manual of portion size or household measures or grams per unit. Individual data such as body weight were also recorded. Contamination data were those from the 2nd French TDS. Briefly, food samples representative of the whole French diet were collected in 2007e2009, prepared as consumed by the population. In all, 1319 composite corresponding to 212 core foods were analyzed for cadmium. The analytical method has already been described (Arnich et al., 2012). In the present work, in order to have a statistically more robust and larger population sample, it was decided to investigate the 5% most exposed adults (95th percentile of exposure, or P95, N ¼ 90) instead of the 0.6% exceeding the TWI (N ¼ 16). Consumption levels of this subgroup were compared to the general population by mean of a t-test. Alpha (two-tailed) was set at 5%. Adjustments were performed to compensate for the multiple t-tests: 0.001 ¼ 0.05/number of tests (n ¼ 43). Data analyses were performed using the Statistical Analysis System statistical software package version 9.1.3 (SAS Institute, Cary, NC, USA). 2.2. Simulations of new ML The contribution of each foodstuff and food group to the total exposure was calculated as the part (%) of the exposure resulting from the consumption of this foodstuff or food group. The major contributors to the exposure have been identified in the general population as well as in the 5% most exposed to choose some foods for which the impact of a new ML could be tested. The simulations finally concerned some of those main contributors, i.e. products based on wheat flour, mollusks and crustaceans, and potatoes. To evaluate the impact of new ML on contamination data and on exposure levels, concentration data from the 2009e2010 French monitoring programs for the selected food groups and 2000e2010 data from the main operators in the cereals industry were used, in order to have a general distribution of the contamination levels per food. The P90 and P95 values for these foodstuffs have been chosen as possible new ML for the simulations, and then the contamination values above those limits were then excluded from the calculations. The impact on the mean concentration of these exclusions was applied to the TDS data in order to calculate the new exposure. For example, if the exclusion of 10 values of oyster samples implied a decrease of 5% in the general cadmium mean concentration, the mean TDS concentration of oysters was also reduced by 5% for the
Please cite this article in press as: Jean, J., et al., Impact of a modification of food regulation on cadmium exposure, Regulatory Toxicology and Pharmacology (2015), http://dx.doi.org/10.1016/j.yrtph.2015.07.027
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exposure calculation. This calculation was directly done for mollusks, crustaceans, and potatoes. For products based on wheat flour, as no data were available directly on those foodstuffs, data on wheat grains and flour were used. The cadmium concentration is on average 73% (IC95%: 40%; 128%) of the concentration in wheat grains in lower bound (LB) approach and 82% (IC95%: 48%; 126%) in upper bound (UB) approach. As this rate is stable with time between 2000 and 2010, it has been considered that the impact of an ML change on wheat flour concentration was the same as for wheat grains. Among the 212 foods analyzed in the TDS, 181 contained wheat or wheat-based ingredients according to ANSES’ internal recipe table, with different rates. In order to estimate the impact of the new ML on the exposure, it was considered that the decrease in the concentration of each wheat-based ingredient was the same as the decrease in the mean of the wheat flour concentration, except for wheat bran, for which data were directly available and used. For soft wheat, the final concentration, after applying the new ML, was calculated according to the following formulae:
Ccor;food ¼ Cinit;food %ing Cinit;ing %decrease;ing %bran Cinit;bran %decrease;bran where, Ccor, food ¼ corrected contamination of food (after applying the new ML) Cinit, food ¼ initial contamination of food %ing ¼ pourcentage of soft wheat-based ingredients (equivalent wheat flour) Cinit,ing ¼ initial mean contamination of wheat flour %decrease,ing ¼ decrease in mean contamination of wheat flour after applying the new ML %bran ¼ percentage of wheat bran in food Cinit, bran ¼ initial mean contamination of bran %decrease, bran ¼ decrease in mean contamination of wheat bran after applying the new ML For durum wheat, as the ingredients are consumed cooked (rehydrated), i.e. durum wheat, semolina and pasta, it has been considered a rehydrated factor of 3. The final concentration, after applying the new ML, was then calculated according to the following formulae:
Ccor;food ¼ Cinit;food %ing Cinit;ing %decrease;ing ¼ Cinit;food %ing Cinit;wheat 1=3 %decrease;ing where, Ccor, food ¼ corrected contamination of food (after applying the new ML) Cinit, food ¼ initial contamination of food %ing ¼ percentage of durum wheat-based ingredients Cinit,ing ¼ initial mean contamination of durum wheat-based ingredients %decrease,ing ¼ decrease in mean contamination of wheat flour after applying the new ML Cinit, wheat ¼ initial contamination of durum wheat Finally, the new exposure to cadmium was recalculated for all subjects, by combining consumption data and contamination data, and dividing by the individual body weight of each subject. For foodstuffs with new ML, the corrected concentrations were used. For other foodstuffs, initial data from TDS2 were used.
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Two different scenarios were tested, with new ML at the P95 and at the P90 of current concentration. 3. Results and discussion The 5% of subjects exceeding the 95th percentile of exposure corresponded to a sample of 90 adults (35 men and 55 women), aged from 18 to 78 years old. Their consumption profile was not significantly different from that of the 0.6% of individuals exceeding the TWI. Their mean exposure (±standard deviation) was 2.24 ± 0.05 mg/kg b.w. per week. Their mean body weight (63 ± 11 kg) and mean body mass index (BMI) (22.2 ± 3.5 kg/m2) were significantly lower than those for the general adult population (70 ± 14 kg and 24.6 ± 4.5 kg/m2, P < 0.0001). This can be due to the fact that the number of women in this group was disproportionately high. The major contributors to exposure, in adults whose exposure exceeded the 95th percentile, were essentially the same as the contributors identified for the general population, i.e. “bread and dried bread products”, “vegetables” and “potatoes”. Mollusks and crustaceans appeared to be the main contributors and alone contributed to 21% in adults exceeding the 95th percentile of exposure compared with the 5% of the exposure in the general population, with an important contribution from scallops, as a result of their high level of contamination when compared to other foods (0.36 mg/kg fw on average). The second main contributor was the “bread and dried bread products” group (22% in both cases), followed by “potatoes” (10% compared to 12% for the population as a whole) and “vegetables” (9% compared to 10% for the population as a whole). The four main contributors identified account for 62% of exposure in the most exposed subjects, compared with 49% for the general population. Although the groups encompassing “offal”, “sweet and savoury biscuits and bars” and “chocolate” are among the groups with the highest levels in the TDS, they did not appear to be major contributors to exposure, due to a generally low consumption. Mean overall food consumption by adults exceeding the 95th percentile of exposure (3.3 ± 0.9 kg) was significantly higher than that by for the rest of the population (2.7 ± 0.8 kg, P < 0.0001). Compared to the rest of the population, adults exceeding the 95th percentile of exposure consumed significantly more crustaceans and mollusks (133 g/week) than the rest of the population (28 g/week) (P < 0.0001). In comparison, the mean consumption of crustaceans and mollusks in French high consumers of seafood (Bemrah et al., 2008) was 198 g/week. Bread and dried bread products were also food items which were more consumed by the adults exceeding the 95th percentile of the exposure (201 g/day on average, compared to 111 g/day, P < 0.0001) whereas other cereal products did not appear to be significantly over-consumed. Finally, potatoes and potato products were also more consumed by this sub population (87 g/day versus 57 g/day, P ¼ 0.0006). Furthermore, no significant difference appeared between the P95 group and the general population regarding consumption of the other main contributors and the foods most highly contaminated with cadmium, with the exception of crustaceans and mollusks. This analysis showed that the principal factors explaining the high levels of exposure (expressed in mg/kg b.w. per week) in adults were a general high consumption, and particularly high consumption of crustaceans/mollusks (five times more), bread (twice as much) and potatoes (1.5 times more), and a lower body weight compared to the general population. It would be possible to propose statutory limits concerning foods contributing the most to exposure in the general population (products based on wheat flour, potatoes and potato products, vegetable) and also mollusks and crustaceans, the most
Please cite this article in press as: Jean, J., et al., Impact of a modification of food regulation on cadmium exposure, Regulatory Toxicology and Pharmacology (2015), http://dx.doi.org/10.1016/j.yrtph.2015.07.027
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Table 1 Distribution of contamination of the main contributors to cadmium exposure e Results from the monitoring programs and from producers. Levels of contamination (mg/kg fw)
Bivalve molluscsmollusks Oysters Mussels Scallops Potatoes Soft wheat bran Soft wheat flour Soft wheat grains Durum wheat
n
mean
P90
P95
max
242 57 138 47 89 478 2861 1644 486
0.165 0.182 0.149 0.184 0.023 0.074 0.031 0.036 0.085
0.340 0.316 0.400 0.366 0.049 0.110 0.050 0.050 0.130
0.431 0.334 0.633 0.376 0.062 0.120 0.050 0.060 0.151
0.787 0.414 0.787 0.390 0.080 0.300 3.020 0.320 0.240
contaminated foods, which contribute little to the exposure of the general population but considerably to that of the most exposed adults. There would be little to be gained by regulating foods that make only a small contribution to exposure. A 10% reduction in the exposure linked with the consumption of a food contributing to 1% of the total exposure would result in a general reduction of 0.1% the total exposure. For example, there seemed little point in reducing cadmium levels in offal, chocolate or biscuits, even though these are among the food items with the highest levels of cadmium, considering that they contribute less than 1% to the total exposure (due to a general low consumption). Reducing exposure via consumption of these foods would therefore have a limited impact. Finally, it was chosen to simulate the impact of new ML on contamination and exposure levels for products based on wheat flour, mollusks and crustaceans, and potatoes. Table 1 sets out the distribution of the levels of contamination in those foodstuffs for which data from monitoring were available. Generally speaking, the contamination levels were below the ML set by the regulations (Regulation EC n 1881/2006). It was noticed that the means from the monitoring programs were slightly over the means from the TDS data (Arnich et al., 2012). That can be explained by different reasons. On one hand, the data form TDS are results from analysis on foods prepared as consumed (i.e. cooked for instance) contrary to the monitoring plan data, and cooking preparation could decrease certain contaminant concentrations (Cubadda et al., 2003). TDS data are then considered to be closer to the reality of exposure of the consumer. Another reason can be that monitoring plan may target some samples suspected to be over the ML, this would artificially increase the mean concentration. Table 2 shows that setting new ML at the 90th and 95th percentiles of the distribution of the contamination of food items would have various impact on the mean of the contaminations. For
instance, under the P90 scenario, the mean contamination of mussels would decrease by 33% whereas a decrease of 4% only is anticipated for oysters. Similarly, the impact on “market withdrawals l” is different depending on the food item. For mussels, only 5% of the current batches would not meet regulatory specifications whereas for durum wheat 10% would not meet current regulations. Setting an ML at P90 logically appeared to be more efficient than the P95 scenario, but results are generally the same for both scenarios (Table 3). According to the simulation results, setting an ML at P90 for all bivalve mollusks (i.e. 0.34 mg/kg, see Table 1) would lead to a dramatic decrease (66%) of the maximum limit compared to the current one (1 mg/kg) (Table 3). For durum wheat, the impact would be less pronounced (35%). In terms of exposure, applying these ML would not lead to a considerable reduction in mean exposure levels for the general adult population. By reducing mean levels in products produced from soft wheat, including bread and dried bread products, through application of an ML set at P90, mean exposure levels would be reduced by 6.2%. For bivalve mollusks, potatoes and durum wheat, which are minor contributors, mean exposure of the general adult population would be lowered by 2.6%, 3.5% and 3.5% respectively, for an ML set at P90. The combined effect of applying ML to these four contributors, which together represent food groups accounting for 62% of exposure, would lead to a reduction of only 6.2% of mean exposure for the general adult population. The impact was more pronounced when considering the 95th percentile of the general population consuming more of these contributors than the general population. The combined effect of the four ML set at P90 of cadmium levels would decrease the exposure by 7.4% for the 95th percentile of the population. In this case, the percentage of individuals overexposed would be 0.5% instead of 0.6% in the present situation. 4. Conclusions The results of the second French total diet study emphasized the need to decrease cadmium exposure in the general population. This appeared in several EU countries (United Kingdom, Ireland …) since the lower health based guidance value was published by EFSA. The main sources of cadmium exposure being food (FSAI, 2011), setting maximum limits in highly contaminated food items could be an efficient way to decrease the general population exposure. In the present work, the impact of setting new ML on the food contributing the most to the general exposure was simulated. Surprisingly, applying new ML set at P90 of the levels of the main contributors of cadmium exposure for the French adult population would not significantly reduce exposure levels. The impact would
Table 2 Simulated impact of setting new ML at P90 and P95 on the mean contamination of food items and on market withdrawals. P90 scenario
Oysters Mussels Scallops Potatoes Soft wheat branb Soft wheat flourb Soft wheat grainsb Durum wheat
P95 scenario
Mean contamination (%age of decrease)
Percentage of market withdrawals
Mean contamination (%age of decrease)
Percentage of market withdrawals
4 33 20 17 7 23 10 10
2 5 9 9 Not calculateda Not calculateda 7 10
0 30 0 13 4 17 6 6
0 4 0 4 Not calculateda Not calculateda 3 5
a
The percentage of market withdrawals for soft wheat bran, soft wheat flour are not calculated since the regulation applies to grains. For soft wheat, left-censored data have been considered under the lower bound approach: non detects have been considered as zero, and detects but non quantified have been considered at the LOD level. b
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Table 3 Impact of ML set at P90 or P95 of contamination on the exposure level of the adult population. Bivalve mollusks
Potatoes
ML value (mg/kg fw) Current ML 1.00 0.10 New MLs (P90/P95 scenarios) 0.34/0.431 0.05/0.062 Difference (P90/P95 scenarios) 66%/56.9% 50%/ Mean total exposure of the general adult population (mg/kg bw/week) With current ML 1.12 1.12 With new MLs (P90/P95 scenarios) 1.09/1.10 1.08/1.08 Difference (P90/P95 scenarios) 2.6%/1.8% 3.5%/3.5% Mean total exposure of the highest exposed adults (mg/kg bw/week) With current ML 1.89 1.89 With new MLs (P90/P95 scenarios) 1.81/1.86 1.83/1.83 Difference (P90/P95 scenarios) 4.2%/1.6% 3.2%/3.2% Percentage of adults whose weekly exposure exceeds the TWI With current ML 0.6% 0.6% With new ML (P90/P95 scenarios) 0.5%/0.6% 0.6%/0.6%
Soft wheat
Durum wheat
Bivalve mollusks, potatoes, and wheat (soft and durum) (P90 scenario only)
0.20 0.13/0.151 35%/25%
e
1.12 1.05/1.05 6.2%/6.2%
1.12 1.05/1.12 6.2%/0%
1.12 1.05 6.2%
1.89 1.75/1.75 7.4%/7.4%
1.89 1.82/1.82 3.7%/3.7%
1.89 1.75 7.4%
0.6% 0.6%/0.6%
0.6% 0.6%/0.6%
0.6% 0.5%
bran 0.20 0.11/0.12 45%/40%
Flour/grain 0.10 0.05/0.05 50%/50%
Values were calculated following the upper bound hypothesis. Differences between the results following the LB or the UB hypothesis were non-significant.
be greater in the most exposed individuals (beyond the 95th percentile) but none of the ML simulated decreased the intake of individuals exceeding the TWI below this TWI. Several reasons could explain the modest efficiency in terms of exposure of ML established at P90 and P95 of contamination levels. First, cadmium is a ubiquitous contaminant found in many foods (Rose et al., 2010). For the general population, the greatest contributing food group contributes no more than 22%, which means that it would be necessary to act on several food groups to lead to a significant impact. Moreover, as depicted above, the consumption profiles of the overexposed population are too heterogeneous. Finally, since regulations imposing ML have been applied since 1997, none of the levels of contamination are excessively high, which explains why eliminating the highest levels of cadmium (P90 and P95) would not lead to a significant reduction in mean levels of the foods affected. To significantly decrease cadmium exposure of the population two main proposals can be listed. First, acting on the level of contamination in environmental sources, especially on intrants (contaminated fertilizers, spreading sludge from sewage treatment plants, etc.) that are at the origin of contamination of soil and, in fine, foods. Identifying at-risk farming practices would be a step towards reducing the cadmium that currently ends up into the soil. Finally, general consumption recommendations towards population having specific dietary habits would help reducing the exposure levels of overexposed individuals. Acknowledgments The authors acknowledge the members of the “physical and chemical contaminants in food” panel for their scientific contribution (J.C. Amiard, A. Periquet, P.M. Badot, A. Baert, V. Camel, M. Clauw, H. Coffigny, C. Feidt, F. Hommet, T. Guerin, B. Le Bizec, A.M. Le Bon, R. Maximilien (chair), J.F. Narbonne, I. Oswald, J. Rose, A.C. Roudot, J. Tulliez, P. Vasseur, J.P. Vernoux). Transparency document Transparency document related to this article can be found online at http://dx.doi.org/10.1016/j.yrtph.2015.07.027. References curite Sanitaire des Aliments, 2009. Etude Afssa (Agence Française de Se gnation par les dioxines des populations vivant d’usines d’impre a proximite
ration d’ordures me nage res e Rapport d’e tude, p. 228. Available. www. d’incine invs.sante.fr. €l, L., Guerin, T., Leblanc, J.C., 2012. Dietary Arnich, N., Sirot, V., Riviere, G., Jean, J., Noe exposure to trace elements and health risk assessment in the second French total diet study. Food Chem. Toxicol. 50 (7), 2432e2449. chaux, C., Bodin, L., Cle mençon, S., Cre pet, A., 2014. PBPK and population Be modelling to interpret urine cadmium concentrations of the French population. Toxicol Appl Pharmacol. 2014 Sep 15;279(3):364-72 Toxicol. Appl. Pharmacol. 279 (3), 364e372. http://dx.doi.org/10.1016/j.taap.2014.06.026. Epub 2014 Jul 3. Becker, K., Schulz, C., Kaus, S., Seiwert, M., Seifert, B., 2003. German environmental survey 1998 (GerES III): environmental pollutants in the urine of the German population. Int. J. Hyg. Environ. Health 206, 15e24. Bemrah, N., Sirot, V., Leblanc, J.C., Volatier, J.L., 2008. Fish and seafood consumption and omega 3 intake in French coastal populations: CALIPSO survey. Public Health Nutr. 12 (5), 599e608. tho, C., Bemrah, N., Vin, K., Sirot, V., Aguilar, F., Ladrat, A.C., Ducasse, C., Gey, J.L., Re re, A., Leblanc, J.C., 2012. Assessment of dietary exposure to annatto Nougade (E160b), nitrites (E249-250), sulphites (E220-228) and tartaric acid (E334) in the French population: the second French total diet study. Food Addit. Contam. Part A 29, 875e885. CDC (Centers for Disease Control and Prevention, 2009. Fourth Report on Human Exposure to Environmental Chemicals. U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, Atlanta, GA. Available. http://www.cdc.gov/exposurereport/. Cubadda, F., Raggi, A., Zanasi, F., Carcea, M., 2003. From durum wheat to pasta: effect of technological processing on the levels of arsenic, cadmium, lead and nickelea pilot study. Food Addit. Contam. 20 (4), 353e360. Dubuisson, C., Lioret, S., Touvier, M., Dufour, A., Calamassi-Tran, G., Volatier, J.L., Lafay, L., 2010. Trends in food and nutritional intakes of French adults from 1999 to 2007: results from the INCA surveys. Br. J. Nutr. 103, 1035e1048. EFSA, 2009. 2009 scientific opinion of the panel on contaminants in the food chain on a request from the European commission on cadmium in food. EFSA J. 980, 1e139. EU, 2006. Commission Regulation (EC) No 1881/2006 of 19 December 2006 Setting Maximum Levels for Certain Contaminants in Foodstuffs. Available at: http:// eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri¼OJ. L:2006:364:0005:0024: EN: PDF. ry, N., Saoudi, A., Garnier, R., Zeghnoun, A., Falq, G., Guldner, L., 2011. Exposition Fre de la population française aux substances chimiques de l’environnement. Institut de veille sanitaire, Saint-Maurice (Fra), p. 154. Available. www.invs. sante.fr. FSAI, 2011. Report on a Total Diet Study Carried Out by the Food Safety Authority of Ireland in the Period 2001 e 2005. Available at: www.fsai.ie. Health Canada, 2010. Report on Human Biomonitoring of Environmental Chemicals in Canada. Results of the Canadian Health Measures Survey Cycle 1 (20072009). Health Canada, p. 292. €l, L., Kadar, A., Chekri, R., Vastel, C., Sirot, V., Leblanc, J.C., Gue rin, T., Millour, S., Noe 2011. Pb, Hg, Cd, As, Sb and Al levels in foodstuffs from the 2nd French total diet study. Food Chem. 126 (4), 1787e1799. NIPH (National Institute of Public Health, 2006. Environmental Health Monitoring System in the Czech Republic. Summary Report-2005. Prague, p. 126. Available. www.szu.cz/chzpa/sumrep.htm. NIPH (National Institute of Public Health, 2010. Environmental Health Monitoring System in the Czech Republic. Summary Report-2009. Prague, p. 94. Available. www.szu.cz/uploads/documents/chzp/souhrnna_zprava/Szu_10.pdf. re, A., Sirot, V., Kadar, A., Fastier, A., Truchot, E., Vergnet, C., Hommet, F., Nougade , J., Gros, P., Leblanc, J.C., 2012. Total diet study on pesticide residues in Bayle France: levels in food as consumed and chronic dietary risk to consumers.
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Environ. Int. 45, 135e150. gional de la Sante PACA, 2011. Evaluation ORS PACA (Observatoire Re des conquences sanitaires et environnementales de la pollution d’origine industrielle se au cadmium autour du site TLM dans le 15e arrondissement de Marseille, p. 146. Available. http://www.orspaca.org/publications/rapports/CADIMIUM/ cadmium.PDF. re, G., Sirot, V., Tard, A., Jean, J., Marchand, P., Veyrand, B., Le Bizec, B., Rivie Leblanc, J.C., 2014. Food risk assessment for perfluoroalkyl acids and brominated flame retardants in the French population: results from the second French total diet study (2014). Sci. Total Environ. 491e492, 176e183. seau national de sante publique, 1997. et Institut national de la sante et de RNSP (Re dicale (INSERM) Surveillance de la population française visla recherche me a-vis du risque saturnin, p. 90. Rose, M., Baxter, M., Brereton, N., Baskaran, C., 2010. Dietary exposure to metals and other elements in the 2006 UK total diet study and some trends over the last 30 years. Food Addit. Contam. Part A 27 (10), 1380e1404.
Sirot, V., Hommet, F., Tard, A., Leblanc, J.C., 2012. Dietary acrylamide exposure of the French population: results of the second French total diet study. Food Chem. Toxicol. 50, 889e894. Sirot, V., Tard, A., Venisseau, A., Brosseaud, A., Marchand, P., Le Bizec, B., Leblanc, J.C., 2012b. Dietary exposure to polychlorinated dibenzo-p-dioxins, polychlorinated dibenzofurans and polychlorinated biphenyls of the French population: results of the second French total diet study. Chemosphere 88, 492e500. nard, C., Dufour, A., Sirot, V., Volatier, J.L., Calamassi-Tran, G., Dubuisson, C., Me Leblanc, J.C., 2009. Core food of the French food supply: second total diet study. Food Addit. Contam. 26, 623e639. Sirot, V., Samieri, C., Volatier, J.L., Leblanc, J.C., 2008. Cadmium dietary intake and biomarker data in French high seafood consumers. J. Expo. Sci. Environ. Epidemiol. 18 (4), 400e409. UNEP (United Nations Environment Programme, 2008. Draft Final Review of Scientific Information on Cadmium. Chemicals Branch, DTIE, p. 188.
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Contents lists available at ScienceDirect
Regulatory Toxicology and Pharmacology journal homepage: www.elsevier.com/locate/yrtph
Impact of a modification of food regulation on cadmium exposure ronique Sirot a, 1, Paule Vasseur b, Jean-François Narbonne c, Julien Jean a, 1, Ve re a, * Jean-Charles Leblanc a, Jean-Luc Volatier a, Gilles Rivie a
Risk Assessment Directorate e French Agency for Food Environmental and Occupational Health and Safety (ANSES), Maisons-Alfort, France CNRS Universit e Paul Verlaine, 57050 Metz, France c Laboratoire de Physico-Toxico Chimie des Syst emes Naturels, Universit e Bordeaux 1, Talence, France b
a r t i c l e i n f o
a b s t r a c t
Article history: Received 5 June 2015 Received in revised form 30 July 2015 Accepted 31 July 2015 Available online xxx
The 2nd French Total Diet Study demonstrated that 0.6% of adults and 14.9% of children exceeded the tolerable weekly intake set by EFSA. The overexposure of several consumers (adults and children) can be partially due to the high consumption of bread and dried bread products, of bivalve mollusks and of potatoes. Except for mollusks, these foods are the main contributors identified for the general population. On this basis, the French agency for food, environmental and occupational health and safety (ANSES) assessed whether a decrease of the European maximum limits in foodstuffs could significantly reduce the level of exposure of French consumers. Applying ML set at P90 of the main contributors would neither significantly reduce exposure levels to cadmium for the general population, nor the percentage of subjects exceeding the TWI. To reduce background consumer exposure to cadmium, actions to be taken include efforts on sources that are at the origin of the soil contamination and the efficacy of consumption recommendations. © 2015 Elsevier Inc. All rights reserved.
Keywords: Cadmium Dietary exposure Maximum limits Regulation
1. Introduction Cadmium (Cd) is a widespread metallic trace element, naturally present in the environment but also found in high concentrations at certain sites as a result of human activities (metalworking, mines and other industries) and is of potential concern as a contaminant in the food chain. Consequently, the European Union has passed and amended a series of Regulations on cadmium. These are based on setting maximum levels (ML) of cadmium in several foodstuffs (EU, 2006) and are, among others, 1 mg/kg fresh weight (fw) for mollusks, 0.2 mg/kg fw for bran and durum wheat and 0.1 mg/kg fw for flour. However, since EFSA lowered the health based guidance value (tolerable weekly intake or TWI) by a factor of almost three in 2009 (From 7 to 2.5 mg/kg bw/week, EFSA, 2009) and since new data became available concerning food contamination and the exposure
Abbreviations: TWI, Tolerable Weekly Intake; EFSA, European Food Safety Authority; ANSES, French agency for food environmental and occupational health and safety; ML, Maximum Limits; NHANES, National Health and Nutrition Examination Survey; TDS, Total Diet Study; BMI, Body Mass Index. * Corresponding author. re). E-mail address: [email protected] (G. Rivie 1 These authors equally contributed to this work.
and body burden of different population groups, the European Commission and the Member States have put in motion a revision of the ML for cadmium in foodstuffs. In the adult population (between 18 and 74 years old) studied in ry et al., 2011) the the French biosurveillance study (ENNS) (Fre mean and median concentrations of urine cadmium in France were both equal to 0.29 mg Cd/g creatinine, and the 95th percentile to 0.91 mg Cd/g creatinine. Those recent data for body burden suggest that 3.6% of French adults exceed the 1 mg Cd/g creatinine threshold of toxicological concern set by EFSA (EFSA, 2009). It is of importance to note that none of the subjects in the study exceeded the action threshold proposed by the German Human Biomonitoring ry et al., 2011). Commission (5 mg Cd/g creatinine, Fre These mean levels are in agreement with those found in France during previous investigations carried out by the French institute of surveillance (InVS) in 1997, 2000 and 2005 in different French cities (about 0.3 mg Cd/g creatinine at Salsigne and its surrounding area; RNSP, 1997) as well as in Marseilles (ORS PACA, 2011) and 0.27 mg Cd/g creatinine in the national study on incineration plants (Afssa, 2009). Mean human urinary cadmium levels measured in the ENNS study were similar to those observed in the National Health and Nutrition Examination Survey (NHANES) carried out in 2003e2004 (CDC, 2009) on a representative sample of the population of the
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United States, in the Canadian Health Measures Survey performed in 2007e2009 (Health Canada, 2010) and in the population of the Czech Republic in 2005 (NIPH, 2006, 2010). On the other hand, the levels observed in Germany in the adult population ten years ago were slightly lower (Becker et al., 2003): 1.5 times lower than the mean in the adult French population and 1.25 times lower at the 95th percentile. In 2006, the French agency for food, environmental and occupational health and safety (ANSES) showed that high consumers of seafood (fish, mollusks and crustaceans) had a higher body burden than the national average, with mean cadmium levels of 0.65 mg Cd/ g creatinine and 1.19 mg Cd/g creatinine at 95th percentile (Sirot et al., 2008). In this study, subjects over the age of 64 years had mean body burden of 0.95 mg Cd/g creatinine and 1.94 mg Cd/g creatinine at P95. Fifteen percent of subjects in the study had body burden exceeding the threshold of concern. On the other hand, none exceeded the level of 5 mg Cd/g creatinine. In 2006, Anses launched the second French total diet study (TDS2) to assess the dietary exposure of the general population to 445 substances of public health interest, including cadmium. The TDS consisted in three major steps: (i) food sampling and sample preparation as consumed by the population, (ii) analysis of the samples, and (iii) dietary exposure assessment by combining the occurrence data with the national consumption data. The food sampling methodology has already been described in details elsewhere (Sirot et al., 2009) as well as results for the substances re et al., 2012; Bemrah et al., 2012; measured in the TDS (Nougade re et al., 2014; Sirot et al., 2012b). The reSirot et al., 2012; Rivie sults for trace elements (including cadmium) can also be found (Millour et al., 2011; Arnich et al., 2012). The French population's mean exposure to cadmium was estimated at 1.12 mg/kg bw/wk in adults (18e79 years old) and 1.68 mg/kg bw/wk in children (3e18 years old). At the 95th percentile, exposure was estimated at 1.89 mg/kg bw/wk in adults and 3.15 mg/kg bw/wk in children. The main contributors to cadmium exposure both in adults and children were bread and dried bread products (22% and 13%, respectively) and potatoes and potato products (12% and 14%, respectively). Detailed data show that adults with the highest estimated intakes are high consumers of mollusks and crustaceans, bread and potatoes. EFSA's TWI of 2.5 mg/kg bw/wk (EFSA, 2009) is exceeded by 0.6% [CI95% 0.3e1.0] of adults and by 14.9% [CI95% 13.0e16.7] of children. The difference between the proportion of subjects exceeding the reference values set for body burden (3.6%) on one hand, and set for food consumption on the other (0.6%), can be explained, leaving aside methodological differences, by the fact that diet accounts for 90% of exposure of non-smokers (UNEP, 2008) and that part of the general population's body burden can be attributed to other contamination vectors (mainly tobacco). Moreover, body burden reflect past exposure, whereas TDS reflects current dietary exposure, and data suggest that cadmium concentrations in foods and chaux et al., 2014). exposure tend to decrease for several years (Be Moreover, dietary exposure data suggest that 1.4% of adults are exposed to more than 90% of the TWI. For these individuals the exposure margin is low if other potential sources of cadmium are taken into account. The results generated by these two approaches concur, emphasizing that a small part of the French adult population is over-exposed to cadmium, largely through dietary intake, and that high consumers of seafood appear to be more exposed than the general population. The level of overexposure remains moderate and it would be helpful to compare it to a future action threshold to decide on the most appropriate reduction measures to be taken. As a small fraction of the French population is overexposed to cadmium and since foods are the main source of contamination
(excluding smoking and occupational exposure), dietary regulations could be an effective way of reducing exposure. Since cadmium is a ubiquitous metal found in a large number of foods, it is important to identify the food groups to be regulated. The present work focuses on the evaluation of strategy that could help decreasing cadmium exposure of adults via foodstuffs. The impact on cadmium dietary exposure of new ML has been assessed as well as the impact on the percentage of individuals exceeding the TWI. 2. Material and methods 2.1. Consumption and exposure profiles Exposure data used in the present work have already been described elsewhere (Arnich et al., 2012). Briefly, total individual exposures were assessed by combining consumption and contamination data. The national and individual food consumption survey (INCA2) was carried out in between December 2005 and May 2007 (Dubuisson et al., 2010). The survey included 2624 adults (aged 18e79), these random sample were drawn using a multistage cluster sampling technique. After exclusion of the under-reporters, the analysis was done with 1918 adults. Food and beverages consumptions were assessed in detail using a 7-day food record. The amounts consumed were estimated by using a photograph manual of portion size or household measures or grams per unit. Individual data such as body weight were also recorded. Contamination data were those from the 2nd French TDS. Briefly, food samples representative of the whole French diet were collected in 2007e2009, prepared as consumed by the population. In all, 1319 composite corresponding to 212 core foods were analyzed for cadmium. The analytical method has already been described (Arnich et al., 2012). In the present work, in order to have a statistically more robust and larger population sample, it was decided to investigate the 5% most exposed adults (95th percentile of exposure, or P95, N ¼ 90) instead of the 0.6% exceeding the TWI (N ¼ 16). Consumption levels of this subgroup were compared to the general population by mean of a t-test. Alpha (two-tailed) was set at 5%. Adjustments were performed to compensate for the multiple t-tests: 0.001 ¼ 0.05/number of tests (n ¼ 43). Data analyses were performed using the Statistical Analysis System statistical software package version 9.1.3 (SAS Institute, Cary, NC, USA). 2.2. Simulations of new ML The contribution of each foodstuff and food group to the total exposure was calculated as the part (%) of the exposure resulting from the consumption of this foodstuff or food group. The major contributors to the exposure have been identified in the general population as well as in the 5% most exposed to choose some foods for which the impact of a new ML could be tested. The simulations finally concerned some of those main contributors, i.e. products based on wheat flour, mollusks and crustaceans, and potatoes. To evaluate the impact of new ML on contamination data and on exposure levels, concentration data from the 2009e2010 French monitoring programs for the selected food groups and 2000e2010 data from the main operators in the cereals industry were used, in order to have a general distribution of the contamination levels per food. The P90 and P95 values for these foodstuffs have been chosen as possible new ML for the simulations, and then the contamination values above those limits were then excluded from the calculations. The impact on the mean concentration of these exclusions was applied to the TDS data in order to calculate the new exposure. For example, if the exclusion of 10 values of oyster samples implied a decrease of 5% in the general cadmium mean concentration, the mean TDS concentration of oysters was also reduced by 5% for the
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exposure calculation. This calculation was directly done for mollusks, crustaceans, and potatoes. For products based on wheat flour, as no data were available directly on those foodstuffs, data on wheat grains and flour were used. The cadmium concentration is on average 73% (IC95%: 40%; 128%) of the concentration in wheat grains in lower bound (LB) approach and 82% (IC95%: 48%; 126%) in upper bound (UB) approach. As this rate is stable with time between 2000 and 2010, it has been considered that the impact of an ML change on wheat flour concentration was the same as for wheat grains. Among the 212 foods analyzed in the TDS, 181 contained wheat or wheat-based ingredients according to ANSES’ internal recipe table, with different rates. In order to estimate the impact of the new ML on the exposure, it was considered that the decrease in the concentration of each wheat-based ingredient was the same as the decrease in the mean of the wheat flour concentration, except for wheat bran, for which data were directly available and used. For soft wheat, the final concentration, after applying the new ML, was calculated according to the following formulae:
Ccor;food ¼ Cinit;food %ing Cinit;ing %decrease;ing %bran Cinit;bran %decrease;bran where, Ccor, food ¼ corrected contamination of food (after applying the new ML) Cinit, food ¼ initial contamination of food %ing ¼ pourcentage of soft wheat-based ingredients (equivalent wheat flour) Cinit,ing ¼ initial mean contamination of wheat flour %decrease,ing ¼ decrease in mean contamination of wheat flour after applying the new ML %bran ¼ percentage of wheat bran in food Cinit, bran ¼ initial mean contamination of bran %decrease, bran ¼ decrease in mean contamination of wheat bran after applying the new ML For durum wheat, as the ingredients are consumed cooked (rehydrated), i.e. durum wheat, semolina and pasta, it has been considered a rehydrated factor of 3. The final concentration, after applying the new ML, was then calculated according to the following formulae:
Ccor;food ¼ Cinit;food %ing Cinit;ing %decrease;ing ¼ Cinit;food %ing Cinit;wheat 1=3 %decrease;ing where, Ccor, food ¼ corrected contamination of food (after applying the new ML) Cinit, food ¼ initial contamination of food %ing ¼ percentage of durum wheat-based ingredients Cinit,ing ¼ initial mean contamination of durum wheat-based ingredients %decrease,ing ¼ decrease in mean contamination of wheat flour after applying the new ML Cinit, wheat ¼ initial contamination of durum wheat Finally, the new exposure to cadmium was recalculated for all subjects, by combining consumption data and contamination data, and dividing by the individual body weight of each subject. For foodstuffs with new ML, the corrected concentrations were used. For other foodstuffs, initial data from TDS2 were used.
3
Two different scenarios were tested, with new ML at the P95 and at the P90 of current concentration. 3. Results and discussion The 5% of subjects exceeding the 95th percentile of exposure corresponded to a sample of 90 adults (35 men and 55 women), aged from 18 to 78 years old. Their consumption profile was not significantly different from that of the 0.6% of individuals exceeding the TWI. Their mean exposure (±standard deviation) was 2.24 ± 0.05 mg/kg b.w. per week. Their mean body weight (63 ± 11 kg) and mean body mass index (BMI) (22.2 ± 3.5 kg/m2) were significantly lower than those for the general adult population (70 ± 14 kg and 24.6 ± 4.5 kg/m2, P < 0.0001). This can be due to the fact that the number of women in this group was disproportionately high. The major contributors to exposure, in adults whose exposure exceeded the 95th percentile, were essentially the same as the contributors identified for the general population, i.e. “bread and dried bread products”, “vegetables” and “potatoes”. Mollusks and crustaceans appeared to be the main contributors and alone contributed to 21% in adults exceeding the 95th percentile of exposure compared with the 5% of the exposure in the general population, with an important contribution from scallops, as a result of their high level of contamination when compared to other foods (0.36 mg/kg fw on average). The second main contributor was the “bread and dried bread products” group (22% in both cases), followed by “potatoes” (10% compared to 12% for the population as a whole) and “vegetables” (9% compared to 10% for the population as a whole). The four main contributors identified account for 62% of exposure in the most exposed subjects, compared with 49% for the general population. Although the groups encompassing “offal”, “sweet and savoury biscuits and bars” and “chocolate” are among the groups with the highest levels in the TDS, they did not appear to be major contributors to exposure, due to a generally low consumption. Mean overall food consumption by adults exceeding the 95th percentile of exposure (3.3 ± 0.9 kg) was significantly higher than that by for the rest of the population (2.7 ± 0.8 kg, P < 0.0001). Compared to the rest of the population, adults exceeding the 95th percentile of exposure consumed significantly more crustaceans and mollusks (133 g/week) than the rest of the population (28 g/week) (P < 0.0001). In comparison, the mean consumption of crustaceans and mollusks in French high consumers of seafood (Bemrah et al., 2008) was 198 g/week. Bread and dried bread products were also food items which were more consumed by the adults exceeding the 95th percentile of the exposure (201 g/day on average, compared to 111 g/day, P < 0.0001) whereas other cereal products did not appear to be significantly over-consumed. Finally, potatoes and potato products were also more consumed by this sub population (87 g/day versus 57 g/day, P ¼ 0.0006). Furthermore, no significant difference appeared between the P95 group and the general population regarding consumption of the other main contributors and the foods most highly contaminated with cadmium, with the exception of crustaceans and mollusks. This analysis showed that the principal factors explaining the high levels of exposure (expressed in mg/kg b.w. per week) in adults were a general high consumption, and particularly high consumption of crustaceans/mollusks (five times more), bread (twice as much) and potatoes (1.5 times more), and a lower body weight compared to the general population. It would be possible to propose statutory limits concerning foods contributing the most to exposure in the general population (products based on wheat flour, potatoes and potato products, vegetable) and also mollusks and crustaceans, the most
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Table 1 Distribution of contamination of the main contributors to cadmium exposure e Results from the monitoring programs and from producers. Levels of contamination (mg/kg fw)
Bivalve molluscsmollusks Oysters Mussels Scallops Potatoes Soft wheat bran Soft wheat flour Soft wheat grains Durum wheat
n
mean
P90
P95
max
242 57 138 47 89 478 2861 1644 486
0.165 0.182 0.149 0.184 0.023 0.074 0.031 0.036 0.085
0.340 0.316 0.400 0.366 0.049 0.110 0.050 0.050 0.130
0.431 0.334 0.633 0.376 0.062 0.120 0.050 0.060 0.151
0.787 0.414 0.787 0.390 0.080 0.300 3.020 0.320 0.240
contaminated foods, which contribute little to the exposure of the general population but considerably to that of the most exposed adults. There would be little to be gained by regulating foods that make only a small contribution to exposure. A 10% reduction in the exposure linked with the consumption of a food contributing to 1% of the total exposure would result in a general reduction of 0.1% the total exposure. For example, there seemed little point in reducing cadmium levels in offal, chocolate or biscuits, even though these are among the food items with the highest levels of cadmium, considering that they contribute less than 1% to the total exposure (due to a general low consumption). Reducing exposure via consumption of these foods would therefore have a limited impact. Finally, it was chosen to simulate the impact of new ML on contamination and exposure levels for products based on wheat flour, mollusks and crustaceans, and potatoes. Table 1 sets out the distribution of the levels of contamination in those foodstuffs for which data from monitoring were available. Generally speaking, the contamination levels were below the ML set by the regulations (Regulation EC n 1881/2006). It was noticed that the means from the monitoring programs were slightly over the means from the TDS data (Arnich et al., 2012). That can be explained by different reasons. On one hand, the data form TDS are results from analysis on foods prepared as consumed (i.e. cooked for instance) contrary to the monitoring plan data, and cooking preparation could decrease certain contaminant concentrations (Cubadda et al., 2003). TDS data are then considered to be closer to the reality of exposure of the consumer. Another reason can be that monitoring plan may target some samples suspected to be over the ML, this would artificially increase the mean concentration. Table 2 shows that setting new ML at the 90th and 95th percentiles of the distribution of the contamination of food items would have various impact on the mean of the contaminations. For
instance, under the P90 scenario, the mean contamination of mussels would decrease by 33% whereas a decrease of 4% only is anticipated for oysters. Similarly, the impact on “market withdrawals l” is different depending on the food item. For mussels, only 5% of the current batches would not meet regulatory specifications whereas for durum wheat 10% would not meet current regulations. Setting an ML at P90 logically appeared to be more efficient than the P95 scenario, but results are generally the same for both scenarios (Table 3). According to the simulation results, setting an ML at P90 for all bivalve mollusks (i.e. 0.34 mg/kg, see Table 1) would lead to a dramatic decrease (66%) of the maximum limit compared to the current one (1 mg/kg) (Table 3). For durum wheat, the impact would be less pronounced (35%). In terms of exposure, applying these ML would not lead to a considerable reduction in mean exposure levels for the general adult population. By reducing mean levels in products produced from soft wheat, including bread and dried bread products, through application of an ML set at P90, mean exposure levels would be reduced by 6.2%. For bivalve mollusks, potatoes and durum wheat, which are minor contributors, mean exposure of the general adult population would be lowered by 2.6%, 3.5% and 3.5% respectively, for an ML set at P90. The combined effect of applying ML to these four contributors, which together represent food groups accounting for 62% of exposure, would lead to a reduction of only 6.2% of mean exposure for the general adult population. The impact was more pronounced when considering the 95th percentile of the general population consuming more of these contributors than the general population. The combined effect of the four ML set at P90 of cadmium levels would decrease the exposure by 7.4% for the 95th percentile of the population. In this case, the percentage of individuals overexposed would be 0.5% instead of 0.6% in the present situation. 4. Conclusions The results of the second French total diet study emphasized the need to decrease cadmium exposure in the general population. This appeared in several EU countries (United Kingdom, Ireland …) since the lower health based guidance value was published by EFSA. The main sources of cadmium exposure being food (FSAI, 2011), setting maximum limits in highly contaminated food items could be an efficient way to decrease the general population exposure. In the present work, the impact of setting new ML on the food contributing the most to the general exposure was simulated. Surprisingly, applying new ML set at P90 of the levels of the main contributors of cadmium exposure for the French adult population would not significantly reduce exposure levels. The impact would
Table 2 Simulated impact of setting new ML at P90 and P95 on the mean contamination of food items and on market withdrawals. P90 scenario
Oysters Mussels Scallops Potatoes Soft wheat branb Soft wheat flourb Soft wheat grainsb Durum wheat
P95 scenario
Mean contamination (%age of decrease)
Percentage of market withdrawals
Mean contamination (%age of decrease)
Percentage of market withdrawals
4 33 20 17 7 23 10 10
2 5 9 9 Not calculateda Not calculateda 7 10
0 30 0 13 4 17 6 6
0 4 0 4 Not calculateda Not calculateda 3 5
a
The percentage of market withdrawals for soft wheat bran, soft wheat flour are not calculated since the regulation applies to grains. For soft wheat, left-censored data have been considered under the lower bound approach: non detects have been considered as zero, and detects but non quantified have been considered at the LOD level. b
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Table 3 Impact of ML set at P90 or P95 of contamination on the exposure level of the adult population. Bivalve mollusks
Potatoes
ML value (mg/kg fw) Current ML 1.00 0.10 New MLs (P90/P95 scenarios) 0.34/0.431 0.05/0.062 Difference (P90/P95 scenarios) 66%/56.9% 50%/ Mean total exposure of the general adult population (mg/kg bw/week) With current ML 1.12 1.12 With new MLs (P90/P95 scenarios) 1.09/1.10 1.08/1.08 Difference (P90/P95 scenarios) 2.6%/1.8% 3.5%/3.5% Mean total exposure of the highest exposed adults (mg/kg bw/week) With current ML 1.89 1.89 With new MLs (P90/P95 scenarios) 1.81/1.86 1.83/1.83 Difference (P90/P95 scenarios) 4.2%/1.6% 3.2%/3.2% Percentage of adults whose weekly exposure exceeds the TWI With current ML 0.6% 0.6% With new ML (P90/P95 scenarios) 0.5%/0.6% 0.6%/0.6%
Soft wheat
Durum wheat
Bivalve mollusks, potatoes, and wheat (soft and durum) (P90 scenario only)
0.20 0.13/0.151 35%/25%
e
1.12 1.05/1.05 6.2%/6.2%
1.12 1.05/1.12 6.2%/0%
1.12 1.05 6.2%
1.89 1.75/1.75 7.4%/7.4%
1.89 1.82/1.82 3.7%/3.7%
1.89 1.75 7.4%
0.6% 0.6%/0.6%
0.6% 0.6%/0.6%
0.6% 0.5%
bran 0.20 0.11/0.12 45%/40%
Flour/grain 0.10 0.05/0.05 50%/50%
Values were calculated following the upper bound hypothesis. Differences between the results following the LB or the UB hypothesis were non-significant.
be greater in the most exposed individuals (beyond the 95th percentile) but none of the ML simulated decreased the intake of individuals exceeding the TWI below this TWI. Several reasons could explain the modest efficiency in terms of exposure of ML established at P90 and P95 of contamination levels. First, cadmium is a ubiquitous contaminant found in many foods (Rose et al., 2010). For the general population, the greatest contributing food group contributes no more than 22%, which means that it would be necessary to act on several food groups to lead to a significant impact. Moreover, as depicted above, the consumption profiles of the overexposed population are too heterogeneous. Finally, since regulations imposing ML have been applied since 1997, none of the levels of contamination are excessively high, which explains why eliminating the highest levels of cadmium (P90 and P95) would not lead to a significant reduction in mean levels of the foods affected. To significantly decrease cadmium exposure of the population two main proposals can be listed. First, acting on the level of contamination in environmental sources, especially on intrants (contaminated fertilizers, spreading sludge from sewage treatment plants, etc.) that are at the origin of contamination of soil and, in fine, foods. Identifying at-risk farming practices would be a step towards reducing the cadmium that currently ends up into the soil. Finally, general consumption recommendations towards population having specific dietary habits would help reducing the exposure levels of overexposed individuals. Acknowledgments The authors acknowledge the members of the “physical and chemical contaminants in food” panel for their scientific contribution (J.C. Amiard, A. Periquet, P.M. Badot, A. Baert, V. Camel, M. Clauw, H. Coffigny, C. Feidt, F. Hommet, T. Guerin, B. Le Bizec, A.M. Le Bon, R. Maximilien (chair), J.F. Narbonne, I. Oswald, J. Rose, A.C. Roudot, J. Tulliez, P. Vasseur, J.P. Vernoux). Transparency document Transparency document related to this article can be found online at http://dx.doi.org/10.1016/j.yrtph.2015.07.027. References curite Sanitaire des Aliments, 2009. Etude Afssa (Agence Française de Se gnation par les dioxines des populations vivant d’usines d’impre a proximite
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