Risk Assessment of Furan Exposure in the Norwegian Population

The Norwegian Scientific Committee for Food Safety (Vitenskapskomiteen for mattrygghet, VKM) has on request of The Norwegian Food Safety Authority performed a risk assessment of furan intake in the Norwegian population based on the most recent national food consumption surveys. National occurrence data of furan concentrations in food were preferentially used in the risk assessment. When national data were lacking, VKM has used occurrence data of furan from other countries. The assessment has been performed by the VKM Panel on Food Additives, Flavourings, Processing Aids, Materials in Contact with Food and Cosmetics and the VKM Panel on Contaminants. Furan is a volatile and lipophilic compound formed in a variety of heat-treated commercial foods and contributes to the sensory properties of the product. The substance has been found in a number of foods such as coffee, canned and jarred foods including baby food containing meat and various vegetables. High concentrations of furan have been found in coffee and the presence of furan in jarred baby food and infant formulae has received much attention since such products may be the sole diet for many infants. The occurrence of furan in a variety of foods suggests that there are multiple routes of furan formation rather than a single mechanism. The Norwegian Food Safety Authority has in 2008 and 2009 collected data on furan concentrations in different food products sold on the Norwegian market (Norwegian Food Safety Authority, 2008). In 2011, the Norwegian Food Safety Authority also decided to analyse commercial porridges for infants and children sold on the Norwegian market, to see if furan could be detected in such products. The calculated furan exposures from food and beverages are based on data from the nationally representative food consumption surveys; Spedkost, Småbarnskost, Ungkost and Norkost. The consumption for each relevant food or food category in the dietary surveys were multiplied with the corresponding mean furan concentrations and totalled for each individual. The liver is the main target organ for furan toxicity both in mice and rats, but the rat is the most sensitive species. A dose-dependent increase in hepatocellular adenomas and carcinomas was observed in mice and rats, and an increase in the incidence of cholangiocarcinomas was observed in rat liver. Cholangiocarcinomas in male and female rats were the most sensitive toxicological end point observed in rodents. On the basis of the available data, VKM considers that rat cholangiocarcinomas may be relevant for assessing human risk from furan. Available in vivo data with furan indicate that a reactive metabolite, most likely cis-2-butene1,4-dial (BDA), is formed and that this metabolite can react with DNA and induce mutations. To VKM’s knowledge, no in vivo studies on genotoxicity of BDA have been performed, but BDA was found to be genotoxic in several in vitro tests. VKM therefore considers that a genotoxic mechanism in furan-induced carcinogenesis cannot be excluded and the substance was assessed as a genotoxic carcinogen. VKM used the Margin of Exposure (MOE) approach in this risk assessment. The suitability of different studies on cholangiocarcinomas for dose-response modelling was considered. The 9-month interim evaluation of a 2-year study from NTP (1993) was chosen because it demonstrates a dose-response relationship. From this study, a point of departure of 0.02 mg/kg bw/day was chosen, based on a benchmark dose lower bound (BMDL10) of 0.14 mg furan/kg bw/day and a correction factor of 7 for shorter than full life-time (2 years) study duration. For 6-, 12- and 24-month-old children, the main source of furan exposure is jarred baby food. For 4-, 9- and 13-year-old children, the major food source to the furan exposure is breakfast cereals. In adults, the major contribution to the furan exposure is coffee. The highest furan exposure was calculated for 12-month-old infants and ranged from 0.62-1.51 µg/kg bw/day. In adults the furan exposure ranged from 0.27-0.82 µg/kg bw/day. For mean exposure among infants, children and adolescents, the MOE-values ranged from 29 in 12-month-infants to 2000 in the 13-year-old adolescents. Among high consumers in these groups, the MOE-values ranged from 13 to 400. In adults, the corresponding MOE-values ranged from 59 to 74 for mean furan exposure and from 24 to 26 for high exposure. It should be noted that this risk assessment of furan contains notable uncertainties and limitations. The use of the 9-month interim study in rats including a correction factor of 7 to derive a point of departure, instead of a full life-time study (2-year) study, likely overestimates the hazard of furan. A possible over-diagnosis of the cholangiocarcinomas, due to the similarities in histopathology between cholangiofibrosis and cholangiocarcinomas in rats, may overestimate the hazard. There are also limitations in assessing food consumption and furan content in foods, leading to uncertainties in estimation of furan exposure. VKM considers that the current exposure to furan in all age groups, particularly among infants and children, is of health concern.

Risk Assessment of Lead Exposure from Cervid Meat in Norwegian Consumers and in Hunting Dogs

The Norwegian Food Safety Authority requested the Norwegian Scientific Committee for Food Safety (VKM) to assess the risk of lead exposure to the Norwegian population by consumption of cervid meat, including any subpopulations with an increased risk. Further, VKM was asked to describe the distribution of lead from ammunition in the carcass and to estimate the tissue area associated with the wound channel that has to be removed in order to reduce the risk. VKM was also asked to present, if any, other appropriate measures in addition to removing tissue in order to limit the content of lead residues from ammunition in cervid meat. Finally, VKM was asked to assess the significance of lead exposure to the health of dogs if they were fed with trimmings from the wound channel. Consumption of cervid meat in Norway: Lead exposure from cervid meat can be seen as an addition to the exposure from other food sources. According to a recent exposure assessment by EFSA, grains and grain products, milk and dairy products, non-alcoholic beverages, vegetables and vegetable products are the major dietary lead sources in the general population. According to the most recent (2012) representative national dietary survey in Norway, mean game (including cervid) meat consumption was low, approximately 5-7 meals per year. However, in other Norwegian population studies including hunters, a large proportion (70%) of the participants consumed cervid meat at least once a month or more often. No information on cervid meat consumption among Norwegian children has been found. However, it can be expected that children eat cervid meat equally often as the rest of the family. Negative health effects associated with lead exposure: Lead concentration in blood is considered to be a good indicator of lead exposure. Lead exposure in Europe has decreased dramatically over the last three decades. In Norwegian studies, the mean or median concentrations of lead in blood were from 11 to 27 µg/L, which is in the same range as studies in most European countries the last 10 years. Blood lead concentrations were lower in pregnant women than in other adult population groups in Norway. No information on blood lead levels in Norwegian children has been found. Neurodevelopmental effects and increased blood pressure in adults were critical effects of lead exposure identified by both EFSA and JECFA. Children are more sensitive than adults to the effects of lead because their brain is under development. Increased blood pressure is not an adverse outcome by itself, but it is associated with increased risk of cardiovascular mortality. In addition, EFSA pointed out chronic kidney disease as a sensitive endpoint in adults. Overview of reference values for blood lead concentrations associated with increased blood pressure and increased prevalence of chronic kidney disease in adults, and neurodevelopmental effects in children: Lead exposure in cervid meat consumers: Associations between game meat consumption and blood lead concentration have been studied in four population studies in Norway. In the three studies performed in the years 2003-2005, a significant association between game meat consumption and higher blood lead concentration was only seen in the subgroup of male participants in one of the studies (the Norwegian Fish and Game study). In the fourth study, the Norwegian Game and Lead study conducted in 2012, the median blood lead concentration was in the lower range of medians measured in most European and Norwegian studies over the past 10 years. This study also showed association between cervid meat consumption and concentrations of lead in blood. Those with frequent (monthly or more often) cervid meat consumption had about 30% higher average levels of lead in blood than those with less frequent consumption. However, there was a wide range, and many participants with high or long-lasting game meat intake had low blood lead concentrations. The increase in blood lead concentrations seemed to be associated with consumption of minced cervid meat, particularly purchased minced meat. Blood lead concentration was significantly higher in participants who reported self-assembling of lead-containing bullets. Risk characterization: The blood lead concentrations measured in participants in the Norwegian population studies are in the range of, and partly exceeding, the reference values for increased risk of high blood pressure and increased prevalence of chronic kidney disease in adults, and for neurodevelopmental effects in children. The additional lead exposure from cervid meat in frequent (monthly or more often) consumers of such meat is therefore of concern. At the individual level, the risk for adverse effect is likely to be small. At present lead levels, adults with for example normal blood pressure will most likely not experience any clinical symptoms by a small increase, although it may add to the burden of those individuals who are at risk of experiencing cardiovascular disease. A small reduction in the intelligence of children will not be notable at the individual level, but at the population level it can for instance increase the proportion not able to graduate from school. Lead exposure was declining in the population on which the reference value for increased prevalence of chronic kidney disease was based. EFSA noted that this reference value (15 µg/L) is likely to be numerically lower than necessary. The implications of having a concurrent blood lead concentration above the reference value cannot fully be interpreted, since it is not known when and at which level of lead exposure the kidney disease was initiated. However, an eventual increased risk of chronic kidney disease would be higher among those who consume cervid meat regularly or often than those who rarely consume such meat. For these reasons, continued effort is needed in order to reduce lead exposure in the population. Exposure reducing measurements: Removal of meat around the wound channel reduces the lead exposure from cervid meat consumption. Lead fragmenting and distribution is dependent on several variables, and there are no available studies in moose. The available studies do not allow a firm conclusion on the amount of meat needed to be trimmed around the wound channel in order to remove lead originating from the ammunition. Other possible measures to reduce lead exposure from cervid meat would be to use lead based ammunition with low fragmentation or ammunition without lead. Risk of negative health effects in dogs: In dogs, metallic lead fragments most often pass through the gastrointestinal tract unretained. If larger lead fragments or particles are retained in the gastrointestinal tract for prolonged periods of time, this can result in a continual exposure and toxicity. A daily dose around 1 mg lead acetate/kg bw is shown to increase the blood pressure in dogs after a few days of exposure, and is considered as a Lowest Observed Effect Level (LOEL). This corresponds to a lead acetate concentration of 10-20 mg/kg in fresh meat or offal when fed daily to dogs. The uptake of lead from small metallic lead fragments in contaminated cervid products is probably lower than that of lead acetate. However, high metallic lead concentrations are expected to be present in meat trimmed from the wound channel. Even when a lower absorption of metallic lead than of lead acetate is taken into consideration, the risk for chronic health effects in dogs fed on trimmings of meat/offal from the wound channel from lead killed cervids can be considered as high. On the other hand, the risk for adverse effects after a single exposure of lead contaminated meat must be considered as low.

Risk Assessment of Dietary Exposure to Acrylamide in the Norwegian Population

Request from the Norwegian Food Safety Authority The Norwegian Food Safety Authority (NFSA) requested the Norwegian Scientific Committee for Food Safety (VKM) to assess whether Norwegians in general or subgroups in the population could be expected to have different dietary exposure to acrylamide than reported for other European population groups, and if found to be different to calculate their exposure. Furthermore, VKM was asked to identify food categories with a high potential to increase acrylamide exposure; both for the whole population and for specific groups. Finally, VKM was asked to characterise the risk of acrylamide exposure to the Norwegian population compared to the rest of the European population. The Norwegian Food Safety Authority intends to use this risk assessment as a basis for the Norwegian contribution to the ongoing legislative work in the EU and to consider the necessity to adjust the existing national dietary advices or to issue new ones. How VKM has addressed the request VKM appointed a working group consisting of members of the Panel on Contaminants to answer the request. The Panel on Contaminants has reviewed and revised the draft prepared by the working group and finally approved the risk assessment on dietary acrylamide exposure in the Norwegian population. What acrylamide is and its toxicity to humans Acrylamide is a water-soluble organic chemical formed in carbohydrate-rich foods from naturally present carbohydrates and amino acids during cooking or other heat processing at temperatures above 120°C. Acrylamide is a widely used industrial chemical and is also formed in tobacco smoke. Acrylamide is known to be neurotoxic in humans and is classified as a probable human carcinogen. Concerns about exposure to acrylamide in the general population arose in 2002 when it was discovered in heat-treated foods. Dietary acrylamide exposure in Europe and Norway Dietary acrylamide exposure has been assessed by combining food consumption data and acrylamide concentration data and by biological markers of exposure both in Norway and different European countries. In the EFSA 2015 Scientific Opinion on acrylamide in food, chronic dietary exposure was calculated for 61,338 individuals from 28 surveys and 17 different European countries covering the following age groups: infants (<1 year old), toddlers (≥1 year to <3 years old), other children (≥3 years to <10 years old), adolescents (≥10 years to <18 years old), adults (≥18 years to <65 years old), elderly (≥65 years to <75 years old) and very elderly (≥75 years old). The estimation of human exposure to acrylamide revealed that infants, toddlers and other children were the most exposed groups, but EFSA concluded that dietary acrylamide represents a health concern for all age groups. In previous Norwegian studies reporting dietary acrylamide exposure, the mean and median exposure in adolescents and adults were in the range of 0.3-0.5 μg/kg bw per day. These estimates are in the same range as the mean daily exposures estimated by EFSA for adolescents (0.4-0.9 μg/kg bw) and adults (0.4-0.5 μg/kg bw). Taking into consideration the results from previous exposure estimates and knowledge about food consumption patterns in recent consumption surveys in Norway, VKM concludes that Norwegian adults, adolescents and children older than three years of age are not likely to have a different exposure to acrylamide than corresponding age groups in other European countries. VKM therefore decided not to perform a new exposure assessment in these age groups. No previous studies in Norway have assessed acrylamide exposure in infants and children less than three years of age. Information from national and European dietary surveys shows that Norwegian 1-year-olds, but not 2-year-olds, have higher consumption of infant porridge than other European toddlers. VKM therefore decided to conduct a full exposure estimate in 1-year-old toddlers. The comparison of data on acrylamide occurrence in food reported by EFSA (2015) and in foods sampled in Norway showed that acrylamide concentrations in the main food categories do not differ essentially, with the exception of three categories. The category “Potato crisps and snacks” has higher acrylamide concentrations in Norwegian samples than in those reported by EFSA, while the categories “Baby foods, other than cereal-based” and “Processed cereal-based baby food” (i.e. infant porridge) have lower concentrations in Norwegian samples than in those reported by EFSA. VKM considered that Norwegian analytical values were sufficient for exposure calculations if the concentrations were analysed in 16 samples or more. Infant porridge had 52 analysed samples and VKM considered that the brands sampled are representative for infant porridge on the Norwegian market. VKM calculated acrylamide exposure based on food consumption in Norwegian 1-year-olds by two approaches: one using EFSA concentration data only; and the other using Norwegian concentration data for food categories including 16 samples or more, and EFSA data for the remaining categories. Both approaches resulted in acrylamide exposures within the exposure range for toddlers reported by EFSA (2015). When using EFSA concentration data only the calculated daily exposure (mean: 1.6 μg/kg bw and P95: 3.2 μg/kg bw) is in the upper range calculated by EFSA for toddlers (mean range: 0.9-1.9 μg/kg bw, P95 range: 1.2-3.4 μg/kg bw). When using Norwegian concentration data for food categories including 16 Norwegian samples or more and EFSA data for the remaining categories, the calculated daily exposure (mean: 0.9 μg/kg bw, P95: 1.6 μg/kg bw) is in the lower range of what EFSA has calculated for toddlers. The dietary exposure for acrylamide in Norwegian 1-year-olds is within the same range as reported by EFSA for European toddlers. Although the acrylamide-concentration was lower in infant porridge (i.e. “Processed cereal-based baby food”) sampled in Norway than in those reported by EFSA, Norwegian 1-year-olds have higher consumption of infant porridge than European toddlers. In addition to infant porridge, soft bread is a major source of acrylamide in Norwegian 1-year-olds. Food categories with high potential to increase acrylamide exposure Baby food and soft bread contributed most to acrylamide exposure in the 1-year-olds, while food items contributing the most to acrylamide exposure in adults are fried potato products, coffee, biscuits, crackers and crisp breads, and soft bread. Previous Norwegian studies and EFSA (2015) showed that in all populations groups except toddlers, ‘fried potato products’ is a food group with high potential to increase acrylamide exposure. Acrylamide is also contributed by food items commonly consumed such as coffee and bread, and this is of concern in Norway as well as in the rest of Europe. The EFSA risk assessment included exposure scenarios addressing the potential impact of home-cooking habits, locations of consumption, and preferences for particular food products. These scenarios showed that food preparation, and particularly conditions of potato frying, resulted in large variations and a possible increase of acrylamide exposure by as much as 80%. VKM considers that these scenarios carried out by EFSA are equally relevant for the Norwegian population. The temperature and browning of fried potato products will have a considerable impact on the exposure to acrylamide. VKM calculated three simplified scenarios to illustrate the influence of consumption of particular food items on acrylamide exposure. These scenarios confirmed that potato crisps, French Fries and coffee are food items with high potential to increase acrylamide exposure. Risk characterisation of dietary acrylamide exposure in Norway VKM used the same reference points as EFSA (2015), and calculated Margin of Exposures (MOEs) for assessing health risk. MOE is the ratio between a reference value and the estimated dietary exposure. The MOE approach provides an indication of the level of safety but it does not quantify the risk as such. For non-neoplastic effects, EFSA used a BMDL10 value of 0.43 mg/kg bw/day as the reference point based on animal studies of neurotoxicity, and considered a substance-specific MOE of 125 or above as a sufficient safety margin for no health concern. For neoplastic effects, EFSA used a BMDL10 value of 0.17 mg/kg bw/day as the reference point based on animal studies, and taking into account overall uncertainties in the interpretation, EFSA concluded that a MOE of 10 000 or higher would be of low concern for public health. The EFSA risk assessment concluded that the MOEs for non-neoplastic effects were above 125 for all age groups indicating no health concern, whereas the MOEs for non-neoplastic effects were substantially lower than 10 000, indicating a health concern for all age groups. The dietary acrylamide exposure in Norwegian adolescent and adults reported in previous studies were within the range calculated by EFSA for these age groups. VKM therefore concludes that the resulting MOEs for non-neoplastic and neoplastic effects of acrylamide for adolescent and adults will be similar to those calculated by EFSA. VKM calculated acrylamide exposure based on food consumption in Norwegian 1-year-olds by two approaches: one using EFSA concentration data only; and the other using Norwegian concentration data for food categories including 16 samples or more, and EFSA data for the remaining categories. Both approaches resulted in comparable MOEs. For both non-neoplastic and neoplastic effects, MOEs for 1-year-olds were similar to those reported in EFSA 2015. For non-neoplastic effects of dietary acrylamide exposure, VKM reached the same conclusion as EFSA, which is that the MOEs across all age groups indicate no health concern. For neoplastic effects of dietary acrylamide exposure, VKM reached the same conclusion as EFSA, whi

Dietary Exposure to Inorganic Arsenic in the Norwegian Population

Request from the Norwegian Food Safety Authority: The Norwegian Food Safety Authority (NFSA) requested a statement from the Norwegian Scientific Committee for Food Safety (VKM) on the dietary exposure to inorganic arsenic in the Norwegian population. VKM was asked to comment on the following; 1.) Why the European Food Safety Authority (EFSA) assessment from 2009 found that the Norwegian population had higher dietary exposure to total arsenic than other European populations, 2.) Whether the Norwegian population or special groups of the population have food consumption patterns which could lead to a different dietary exposure to inorganic arsenic than what is reported for the European population, and 3.) Whether the consumption rice and rice products, such as rice cakes, and in Hijiki seaweed could pose additional health risks for children and adults. How VKM has addressed the request: VKM has appointed a working group consisting of members of the Panel on Contaminants and from the VKM secretariat to answer the request. The Panel on Contaminants has reviewed and revised the draft prepared by the working group and finally approved the assessment on dietary exposure to inorganic arsenic in the Norwegian population. What arsenic is and its toxicity to humans: Arsenic is a metalloid occurring in many different chemical forms in the environment. In the terrestrial environment, arsenic is mainly found as inorganic arsenic, i.e. arsenite and arsenate. In the aquatic environment, more than a 100 arsenic species have been identified. The organic form arsenobetaine is the major form in fish and other seafood. Humans are mainly exposed to arsenic through food and drinking water. Food is the major source for most people, but for people living in regions with naturally elevated concentrations of arsenic in groundwater, drinking water is the major source. The toxicity of arsenic species depends on the chemical form, with inorganic arsenic (arsenite and arsenate) being more toxic than organic arsenic compounds. Inorganic arsenic is carcinogenic, but not genotoxic, and is classified as a human carcinogen. Dietary total arsenic exposure in Europe and Norway: The dietary exposure to total arsenic for the Norwegian population was estimated by EFSA (2009). The Norwegian exposure levels were the highest among the European populations. A high exposure to total arsenic for Norwegian adults was also estimated in the Norwegian Fish and Game study (Birgisdottir et al., 2013). Fish and seafood is the main contributor to the dietary exposure to total arsenic, and a high consumption of fish and seafood leads to a high dietary exposure to total arsenic. Dietary inorganic arsenic exposure in Europe and Norway: There was little variation in the estimated dietary exposures to inorganic arsenic for the European populations (EFSA, 2014). The dietary exposure to inorganic arsenic has earlier been estimated for the Norwegian adult population based on a study including participants with high consumption of fish and other seafood and game meat, and participants representing the general population (Birgisdottir et al., 2013). The estimates for inorganic arsenic exposure were within the ranges reported by EFSA (2014), suggesting that Norwegian adults do not have specific eating patterns leading to a different dietary exposure to inorganic arsenic than other European adult populations. In the European populations, the main contributors to dietary exposure of inorganic arsenic were the food groups “grain-based processed products (non rice-based)”, “rice”, “milk and dairy products” and “drinking water” (EFSA, 2014). There is no information regarding specific dietary patterns of Norwegian sub-populations possibly leading to a higher exposure to inorganic arsenic. Fish and other seafood generally contain high levels of total arsenic, but the level of inorganic arsenic is very low. Exposure to inorganic arsenic through consumption of rice and rice products, and Hijiki seaweed The dietary exposures to inorganic arsenic in the European populations are within the range of the BMDL01 values and therefore possible health risks cannot be excluded (EFSA, 2009; EFSA, 2014). The estimated dietary exposure to inorganic arsenic in the Norwegian adult population (Birgisdottir et al., 2013) is also within the range of the BMDL01 values. Rice was identified as one of the main contributors to the dietary exposure to inorganic arsenic in Europe (EFSA, 2014). Rice and rice products contain higher levels of inorganic arsenic than other food groups and individuals with a high consumption of rice and rice products may have a higher exposure to inorganic arsenic than the rest of the population, resulting in an added health risk. For infants and toddlers, rice and rice products are not an important source of inorganic arsenic (EFSA, 2014). According to EFSA (2014) the main contributor to exposure to inorganic arsenic in infants and toddlers was “milk and dairy products”, then “drinking water”, “grain-based processed products (non rice-based)” and “Foods for infants and young children”. However, the dietary exposure to inorganic arsenic in toddlers and children is higher than in adults because of their higher food consumption relative to body weight (EFSA, 2014). Rice cakes are a product, which may contain particularly high levels of inorganic arsenic, and consumption of rice cakes by children will increase their exposure to inorganic arsenic (Livsmeddelsverket 2015, DTU Food 2013). Thus, Norwegian infants and toddlers with a high consumption of rice and rice products, such as rice cakes, may have a higher exposure to inorganic arsenic than other infants and toddlers, resulting in an added health risk. The edible seaweed Hijiki generally contains high levels of inorganic arsenic, whereas other seaweeds contain low levels of inorganic arsenic. Any consumption of Hikiji seaweed will lead to an additional exposure of inorganic arsenic, resulting in an added health risk.

Benefit-risk Assessment of Fish and Fish Products in the Norwegian Diet – An Update.

Request from the Norwegian Food Safety Authority (NFSA) In September 2013, the Norwegian Food Safety Authority requested VKM to update relevant parts of the benefit-risk assessment of fish in the Norwegian diet published by VKM in 2006. The background for the request was new knowledge and data on the content of some nutrients and contaminants both for wild and farmed fish since 2006. The proportion of vegetable ingredients used in farmed fish feed has in recent years increased, and new national dietary surveys for adults and children have been conducted. The Norwegian Food Safety Authority referred to VKM’s report from 2006, which pointed out that the positive impact of fish consumption on public health was especially due to the content of polyunsaturated fatty acids and vitamin D in fish. Further, VKM concluded that the contaminants that could pose a potential risk to public health through fish consumption mainly were methylmercury, dioxins and dioxin-like PCBs (dl-PCBs). The request included a reassessment of fish consumption in Norway with focus on specific nutrients; n-3 fatty acids (eicosapentaenoic acid (EPA), docosapentaenoic acid (DPA), docosahexaenoic acid (DHA), vitamin D, and the minerals iodine and selenium, and on specific contaminants; mercury, dioxins and dl-PCBs. VKM was asked to address the main changes in the use of raw materials in farmed fish feed and how these affect the levels of nutrients, mercury, dioxins and dl-PCBs and in fish feed. Further, VKM was asked to address to what extent levels of nutrients and contaminants in fish have changed since 2006, to describe these changes and estimate the human intake of the substances in question on the basis of recent dietary data. VKM was also requested to consider the benefits of eating fish with regard to the intake of nutrients and the risks associated with the intake of mercury, dioxins and dl-PCBs and comment on whether this change the conclusions from the report in 2006. Additionally, on the basis of updated knowledge, VKM was asked to comment whether other substances, like pesticide and residues of veterinary medicinal products, could affect the conclusions with regard to the impact on public health. The Norwegian Food Safety Authority and the Directorate of Health will use the updated assessment as a basis for public recommendations concerning the consumption of fish and fish products. How VKM has Addressed the Request The VKM appointed a working group consisting of VKM members and external experts to answer the request. Several of the scientific panels of VKM reviewed the report during its preparation. The Scientific Steering Committee of VKM has given their final assessment and approval of the current report. In the current report, VKM has mainly used data from national surveillance and monitoring programs for nutrient and contaminant concentrations in fish feed, farmed fish and wild caught fish, but occurrence data have also been derived from peer reviewed articles. VKM has estimated fish consumption in three population groups (2-year-olds, adults and pregnant women). The estimated fish consumption was compared to national dietary guidelines. To assess health effects of fish consumption, the current estimated fish intakes were also compared with assessments done by recognised international bodies and results from epidemiological studies addressing possible associations between fish consumption and specific health outcomes. Literature searches were done to identify relevant epidemiological studies. VKM has not systematically assessed reviews or meta-analyses nor individual studies for weight of evidence, but merely summarised the studies retrieved from the literature search. It was considered being beyond the scope of this assessment to review individual studies included in reviews or meta-analyses. Furthermore, based on current fish consumption in the various population groups, intake of nutrients and exposure to contaminants from fish were estimated. For benefit characterisation of the specific nutrients the estimated nutrient intake was compared with national recommendations of nutrients intake and for EPA and DHA a comparison was also done with European recommendations. For risk characterization of contaminant exposure from fish, VKM used health based guidance values set by international risk assessment bodies (WHO, EFSA). VKM noted that the request from NFSA was restricted to fish, whereas the VKM report in 2006 included both fish and other seafood. VKM focused on specific nutrients and contaminants as requested by the NFSA. In addition, VKM also commented on other substances that could affect the risk assessment, such as residues of veterinary medicinal products including residues of antibiotics, new contaminants from fish feed like the pesticide endosulfan, polycyclic aromatic hydrocarbons (PAHs), mycotoxins, the synthetic antioxidants ethoxyquin, butylhydroxyanisole (BHA) and butylhydroxytoluene (BHT), as well as environmental contaminants like brominated flame retardants and perfluorated organic compounds Background In the Norwegian diet fish is important source of well-balanced proteins, and important nutrients such as EPA and DHA, vitamin D, iodine and selenium. On the other hand, fish is also a source of exposure to chemical contaminants like dioxins, PCBs and mercury. Over the last 10 years there has been a great change in raw materials used in fish feeds, and in 2013 terrestrial plant proteins and vegetable oils accounted for 70% of the feed. The changes in concentrations of nutrients and contaminants in fish feed for farmed Atlantic salmon and trout are reflected in changed concentrations and compositions of the same nutrients and contaminants in the farmed fish fillet. The current national dietary guideline is to eat fish as dinner meals 2-3 times per week for all age groups, representing 300-450 g fish per week for adults, including at least 200 g fatty fish, such as salmon, trout, mackerel and herring. Fish is also recommended as bread spread. Further, a daily supplement of vitamin D to infants from 4 weeks of age is recommended, and if this supplement is taken as cod liver oil it will in addition ensure an adequate supply of EPA and DHA. The present benefit-risk assessment is comprised of three elements, i.e. benefit assessment, risk assessment and benefit-risk comparison. This methodology is in accordance with the guidance given by EFSA in 2010. Fish Consumption in Norway and Comparison with National Dietary Guidelines VKM has used information about fish consumption from more recent national dietary surveys among 2-year-olds (Småbarnskost 2007) and adults at 18-70 years of age (Norkost 3, 2010/2011), as well as information for pregnant women who answered the Norwegian Mother and Child Cohort Study (MoBa2, 2002-2008) food frequency questionnaire. The national food consumption survey Ungkost 2000, which covers the age groups 4-, 9-, and 13-year-old children, was considered too old to be used and it is therefore not known if their fish consumption patterns have changed, neither in amount consumed nor type of fish consumed. Even though there are methodological differences between the dietary surveys used in 2006 and 2014, the amount of fish consumed appears to be unchanged for all population groups. Furthermore, in 2014, lean fish and fatty fish contribute with about 60 and 40 percent, respectively, of the total fish consumption, which is similar to 2006. Given a portion size of 150 g fish, the average adult eats fish equivalent to 2-3 dinner servings per week and the average pregnant woman eats fish equivalent to 1-2 dinner servings per week, while the average two-year-old eats fish equivalent to 1-2 dinner servings per week given a portion size of 75 g. The table below describes fish intake in the selected populations. Fish consumption (expressed as raw fish), mean grams (g) per week in 2-year-olds (Småbarnskost 2007, n=1674), adults (Norkost 3, n=1787) and pregnant women (MoBa, n=86277) Population groups Mean fish consumption g/week Fish roe Fish, total Lean fish (≤ 5% fat) Fatty fish (> 5% fat) and liver 2-year-olds 112 70 35 7 Adults 364 210 147 7 Pregnant women 217 126 77 14 VKM concludes that of the different population groups, only adults (18-70 years of age) with an average or higher fish consumption reach the national food based dietary guidelines for total fish consumption. Mean total fish consumption and fatty fish consumption in children (2-year-olds) and pregnant women, as well as the mean fatty fish consumption in adults are lower than recommended. In pregnant women and 2-year-olds, fish consumption is too low to meet the food based dietary guidelines Health Effects of Fish Consumption VKM is of the opinion that according to epidemiological studies, the net effects of the present average fish consumption in Norway for adults including pregnant women is beneficial for specific cardiovascular diseases (particularly cardiac mortality, but also with regard to ischaemic stroke, non-fatal coronary heart disease events, congestive heart failure and atrial fibrillation), as well as for optimal neurodevelopment of foetus and infants. Furthermore, VKM is of the opinion that those with fish consumption less than one dinner serving per week may miss these beneficial effects. The health benefit of fish consumption is reported from 1-2 dinner servings per week and up to 3-4 dinner servings per week. For higher fish intake per week, the limited number of consumers in epidemiological studies does not allow for drawing firm conclusions about the actual balance of risk and benefit. More knowledge is needed to reveal the beneficial mechanisms of fish consumption. Benefit Characterisation of Nutrients in Fish VKM is of the opinion that there has been minor or no changes of the composition and concentrations of nutrients in wild caught fish since 2006. Due to replacement of fish oil and fish protein with plant prote