Open Access Grey Literature

Risk Assessment of "Other Substances" – Curcumin

Inger-Lise Steffensen, Ellen Bruzell, Berit Granum, Ragna Bogen Hetland, Trine Husøy, Jens Rohloff, Trude Wicklund

European Journal of Nutrition & Food Safety, Page 139-141
DOI: 10.9734/EJNFS/2018/42114

The Norwegian Scientific Committee for Food Safety (Vitenskapskomiteen for mattrygghet, VKM) has, at the request of the Norwegian Food Safety Authority (Mattilsynet; NFSA), assessed the risk of "other substances" in food supplements and energy drinks purchased in Norway. VKM has assessed the risk of doses in food supplements and concentrations in energy drinks given by NFSA. These risk assessments will provide NFSA with the scientific basis while regulating the addition of “other substances” to food supplements and other foods.

 

"Other substances" are described in the food supplement directive 2002/46/EC as substances other than vitamins or minerals that ha ve a nutritional and/or physiological effect. It is added mainly to food supplements, but also to energy drinks and other foods. VKM has not in this series of risk assessments of "other substances" evaluated any claimed beneficial effects from these substances, only possible adverse effects.

 

The present report is a risk assessment of curcumin, and it is based on previous risk assessments and articles retrieved from literature searches.

 

According to information from NFSA, curcumin is an ingredient in food supplements purchased in Norway. NFSA has requested a risk assessment of 300, 600 and 900 mg/day of curcumin in food supplements. The intake of curcumin was estimated for the age groups children (10 to <14 years), adolescents (14 to <18 years) and adults (≥18 years). Other sources of curcumin, such as foods and cosmetics, have not been included in the present risk assessment.

 

Curcumin is the main ingredient in the spice turmeric, which is derived from the ground rhizomes of the plant Curcuma longa Linn. Other curcuminoids in turmeric are demethoxycurcumin and bis -demethoxycurcumin (EFSA, 2010). Curcumin is used as a food additive (E100) and is a spice component, such as in turmeric and curry. The absorption of curcumin is low, and the absorbed curcumin is efficiently metabolised by the liver and excreted into the biliary system. The curcumin plasma levels peak within 2 hours of administration, and complete clearance occurs within a few hours thereafter (Heger et al., 2014).

 

Maximum curcumin intake from food as food additive and spice combined has been reported to be 2.3 and 1.6-7.6 mg/kg bw per day for adults and children (1-10 years in the case of food additive; 5-12 years in the case of spices), respectively (EFSA, 2010).

 

An acceptable daily intake (ADI) of 0-3 mg/kg bw per day was allocated by JECFA (2004), based on the NOAEL from a multigeneration reproductive toxicity study in rats (Ganiger, 2002; Ganiger et al., 2007). Based on the same study, EFSA established an ADI of 3 mg/kg bw per day (EFSA, 2010).

 

For children (10 to <14 years), the estimated daily intakes of curcumin were 6.9, 13.8 and 20.7 mg/kg bw per day from daily doses of 300, 600 and 900 mg curcumin, respectively, from food supplements.

 

For adolescents (14 to <18 years), the estimated daily intakes were 4.9, 9.8 and 14.7 mg/kg bw per day from daily doses of 300, 600 and 900 mg curcumin, respectively, from food supplements.

 

For adults (≥18 years), the estimated intakes were 4.3, 8.6 and 12.9 mg/kg bw per day from a daily intake of 300, 600 and 900 mg curcumin, respectively, from food supplements.

 

The intake from all three doses of curcumin exceeded the ADI value of 3 mg/kg bw per day for all age groups.

 

VKM concludes that a daily intake of 300, 600 or 900 mg of curcumin in food supplements may represent a risk of adverse health effects in children (10 to <14 years), adolescents (14 to <18 years) and adults (≥18 years).

Open Access Grey Literature

Risk Assessment of "Other Substances" – Lycopene

Trude Wicklund, Gro Haarklou Mathisen, Trine Husøy, Ellen Bruzell, Berit Granum, Ragna Bogen Hetland, Jens Rohloff, Inger-Lise Steffensen

European Journal of Nutrition & Food Safety, Page 142-144
DOI: 10.9734/EJNFS/2018/42115

The Norwegian Scientific Committee for Food Safety (Vitenskapskomiteen for mattrygghet, VKM) has, at the request of the Norwegian Food Safety Authority (Mattilsynet; NFSA), assessed the risk of "other substances" in food supplements and energy drinks sold in Norway. VKM has assessed the risk of doses in food supplements and concentrations in energy drinks given by NFSA. These risk assessments will provide NFSA with the scientific basis while regulating the addition of “other substances” to food supplements and other foods.

 

"Other substances" are described in the food supplement directive 2002/46/EC as substances other than vitamins or minerals that have a nutritional and/or ph ysiological effect. It is added mainly to food supplements, but also to energy drinks and other foods. VKM has not in this series of risk assessments of "other substances" evaluated any claimed beneficial effects from these substances, only possible adverse effects.

The present report is a risk assessment of lycopene, and it is based on previous risk assessments and articles retrieved from a literature search.

 

According to information from NFSA, lycopene is an ingredient in food supplements sold in Norway. NFSA has requested a risk assessment of 10 mg/day of lycopene in food supplements. The intake of lycopene was estimated for the age groups children (10 to <14 years), adolescents (14 to <18 years) and adults (≥18 years).

 

Other sources of lycopene, such as foods and cosmetics, have not been included in the present risk assessment.

 

Lycopene belongs to a large group of naturally-occurring pigments known as carotenoids, and is known to have antioxidant properties. Lycopene is a natural constituent of red fruits and vegetables and of certain algae and fungi. The major sources of natural lycopene in the human diet are tomatoes and tomato-based products. Fruits like pink grapefruit, water melon, rosehip, papaya and guava are also sources of lycopene.

 

Lycopene can be obtained by solvent extraction of the natural strains of red tomatoes (Lycopersicon esculentum L.) with subsequent removal of the solvent. Synthetic lycopene can be produced by the Wittig condensation of synthetic intermediates commonly used in the production of other carotenoids used in food. Lycopene biosynthesis by the fungus B. trispora follows the same pathway as the synthesis of lycopene in tomatoes.

 

There are case reports of yellow-orange skin discoloration and/or gastrointestinal discomfort after prolonged high intakes of lycopene-rich food and supplements, those effects being reversible upon cessation of lycopene ingestion. The results from one study indicated that lycopene increased the incidence of the preterm labor and low birthweight babies. However, due to weaknesses in the reporting, VKM cannot use the results from this study in the risk characterisation.

 

An ADI of 0.5 mg/kg bw per day was established by EFSA in 2008. The ADI was derived from the NOAEL of 50 mg/kg bw per day from a 52-week toxicity study in rats, based on a partly reversible increased level of the liver enzyme alanine transaminase (ALT). An ADI is set to cover the general population, including children. This ADI-value was used for comparison with the estimated exposure in the risk characterization.

 

From a daily dose of 10 mg lycopene, the daily exposure is 0.23 mg/kg bw for children (10 to <14 years), 0.16 mg/kg bw for adolescents (14 to <18 years), and 0.14 mg/kg bw for adults (Table 3.1-1). Thus, the intakes are below the ADI of 0.5 mg/bw per day for all age groups. 

 

VKM concludes that it is unlikely that a daily dose of 10 mg lycopene from food supplements causes adverse health effects in children (10 to <14 years), adolescents (14 to <18 years) and adults (≥18 years).

Open Access Grey Literature

Risk Assessment of "Other Substances" – Piperine

Jens Rohloff, Trine Husøy, Ellen Bruzell, Berit Granum, Ragna Bogen Hetland, Trude Wicklund, Inger-Lise Steffensen

European Journal of Nutrition & Food Safety, Page 145-147
DOI: 10.9734/EJNFS/2018/42116

The Norwegian Scientific Committee for Food Safety (Vitenskapskomiteen for mattrygghet, VKM) has, at the request of the Norwegian Food Safety Authority (Mattilsynet, NFSA), assessed the risk of "other substances" in food supplements and energy drinks sold in Norway. VKM has assessed the risk of doses given by NFSA. These risk assessments will provide NFSA with the                 scientific basis while regulating the addition of “other substances” to food supplements and other foods.

 

"Other substances" are described in the food supplement directive 2002/46/EC as substances other than vitamins or minerals that have a nutritional or physiological effect . It is added mainly to food supplements, but also to energy drinks and other foods. In this series of risk assessments of "other substances", VKM has not evaluated any claimed beneficial effects from these substances, only possible adverse effects.

 

The present report is a risk assessment of piperine, and it is based on previous risk assessments and articles retrieved from a literature search.

 

According to information from NFSA, piperine, derived from black pepper, is an ingredient in food supplements sold in Norway. NFSA has requested a risk assessment of the dose 1.5 mg/day of piperine in food supplements.

 

The total exposure to piperine from other sources than food supplements, such as foods or cosmetics, is not included in the risk assessment.

 

Piperine (( E , E )-piperine) is a naturally occurring alkaloid which is the major pungent compound found in spices like black pepper ( Piper nigrum L.) and long pepper ( Piper longum L.), but it also occurs in Grains of Paradise ( Aframomum melegueta K. Schum.). ( E,E ) piperine is the isomeric form which is used in food supplements. Several isomers structurally related to ( E,E )-piperine are found in pepper with less hot taste, including isopiperine, chavicine and isochavicine. In the European/Western cuisine, black pepper is the major source of piperine in the human diet. Other sources in the diet are piperine (pepper)flavoured finished food products, including beverages and spirits. Piperine  is also used in cosmetics as a perfuming agent (CosIng, 2016).

 

The range of doses reported to cause interactions with drugs and phytochemicals when studied in vivo , 5 to 20 mg/kg bw per day in humans and 10 to 50 mg/kg bw per day in animals (Chinta et al., 2015; Srinivasan, 2007; Srinivasan, 2013), exceeded estimated daily intake levels of piperine. Provided that the ingestion of piperine via pepper (food flavouring) or intake of dietary supplements containing P. nigrum or P. longum does not exceed common dietary levels, the risk of adverse piperine-drug and piperine-phytochemical interactions is minimal.

 

Based on a 90-day toxicity study in rats, a no observed adverse effect level (NOAEL) of 5 mg/kg bw per day was set in 2015 by the European Food Safety Authority (EFSA). In the present risk assessment, VKM has used this NOAEL of 5 mg/kg bw per day for the risk characterisation. 

 

The risk characterisation is based on the margin of exposure (MOE) approach; the ratio of the NOAEL to the exposure. An acceptable MOE value for a NOAEL-based assessment of piperine based on an animal study is ≥100, which includes a factor 10 for extrapolation from animals to humans and a factor 10 for interindividual human variation.

 

From a daily dose of 1.5 mg piperine, the calculated intake levels are 34.6, 24.5, and 21.4 µg/kg bw per day for children (10 to <14 years), adolescents (14 to <18 years) and adults (³18 years), respectively. Using the MOE approach, for a daily intake of 1.5 mg piperine from food supplements and a NOAEL of 5 mg/kg bw per day, the MOE values are 145, 204 and 234 for children (10 to <14 years), adolescents (14 to <18 years) and adults (≥18 years), respectively. Thus, for a daily intake of 1.5 mg piperine, the MOE values are above 100 for all age groups.

 

VKM concludes that it is unlikely that a daily dose of 1.5 mg piperine from food supplements causes adverse health effects in children (10 to <14 years), adolescents (14 to <18 years) and adults (≥18 years).

Open Access Grey Literature

Assessment of Selenium Intake in Relation to Tolerable Upper Intake Levels

Tor A. Strand, Inger Therese L. Lillegaard, Livar Frøyland, Margaretha Haugen, Sigrun Henjum, Martinus Løvik, Tonje Holte Stea, Kristin Holvik

European Journal of Nutrition & Food Safety, Page 155-156
DOI: 10.9734/EJNFS/2018/42536

The Norwegian Scientific Committee for Food Safety (Vitenskapskomiteen for mattrygghet, VKM) has, at the request of the Norwegian Food Safety Authority (Mattilsynet; NFSA), evaluated the intake of selenium in the Norwegian population. VKM has also conducted scenario calculations to illustrate the consequences of amending maximum limits for selenium to 50, 150 or 200 μg/day in food supplements. The existing maximum limit is 100 μg/day.

 

Selenium is a cofactor for enzymes and proteins with vital importance in antioxidant defence, thyroid hormone and insulin function and regulation of cell growth.

 

We reviewed four risk assessments undertaken by the Institute of Medicine (IOM), Scientific Committee on Food (SCF), Expert Committee on Vitamins and Minerals (EVM), and the Nordic Nutrition Recommendations (NNR). Because of limited evidence from human studies and due to the selection of a high uncertainty factor (UF), we decided to use the tolerable upper intake levels (ULs) set by the SCF (2000) and later adopted by NNR (2012).

 

Early signs of selenium toxicity are a garlic breath and a metallic taste. Severe selenosis results in fast hair loss and brittle nails, as well as other gastrointestinal symptoms such as nausea, vomiting, diarrhea, fatigue, irritability, and rash. Acute selenium intoxication and chronical overexposure may affect the nervous system and result in nerve damage.

 

The SCF established a UL for selenium at 300 μg/day for adults, including pregnant and lactating women. This UL was based on a no observed adverse effect level (NOAEL) of 850 μg/day for clinical selenosis applying a UF of 3, and was supported by three studies reporting no adverse effects for selenium intake between about 200 and 500 μg/day.

 

As there were no data to derive specific ULs for children, the SCF (2000) extrapolated the UL from adults to children based on reference body weights. The proposed UL values for children and adolescents ranged from 60 μg/day (1–3 years) to 250 μg selenium/day (15–17 years).

 

According to the scenario estimations in adults, the dietary selenium intake at the 95th percentile and additionally 150 μg selenium from food supplements will be below the UL while 200 μg selenium from food supplements will lead to exceedance of the UL for adults. For 13- and 9-year-olds, supplemental doses of 100 and 50 μg selenium per day, respectively, do not lead to exceedance of the ULs in these age groups. For 2- and 4-year-olds, all the suggested doses in food supplements will lead to exceedance of the ULs.

Open Access Grey Literature

Risk Assessment of Dietary Cadmium Exposure in the Norwegian Population

Helle Katrin Knutsen, Heidi Amlund, Anne Lise Brantsæter, Dagrun Engeset, Christiane Kruse Fæste, Edel Holene, Anders Ruus, Inger Therese L. Lillegaard, Gunnar Sundstøl Eriksen, Helen Engelstad Kvalem, Christopher Owen Miles, Hedvig Marie Egeland Nordeng, Irma Caroline Oskam, Cathrine Thomsen, Janneche Utne Skåre

European Journal of Nutrition & Food Safety, Page 157-161
DOI: 10.9734/EJNFS/2018/42537

Request from the Norwegian Food Safety Authority (NFSA):

 

The Norwegian Food Safety Authority requested the Norwegian Scientific Committee for Food Safety (VKM) to evaluate whether Norwegians in general or subgroups in the population could be expected to have different dietary exposure to cadmium than reported for other European population groups. Furthermore, VKM was asked to assess the potential health risk of cadmium exposure from brown meat of crabs and to identify how much crab can be eaten by children and adults without exceedance of the tolerable intake for cadmium. Finally, VKM was asked to identify other particular food items which would lead to an added cadmium exposure in Norway. The Norwegian Food Safety Authority intends to use the 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 cadmium intake in the Norwegian population.

 

What Cadmium is and Its Toxicity to Humans:

 

Cadmium (Cd) is a heavy metal found as an environmental contaminant, both through natural occurrence and from industrial and agricultural sources.

 

Humans are exposed to cadmium by food, water and air, with food as the most important source in non-smokers. Cadmium accumulates especially in the kidneys and in liver. The amount of cadmium in the body increases continuously during life until the age of about 6070 years, from which it levels off. The most well characterised chronic toxic effects resulting from cadmium exposure are on kidneys and bones.

 

The tolerable weekly intake (TWI) of cadmium was in 2009 reduced by EFSA from 7 to 2.5 μg /kg body weight (bw). The new TWI established was based on human studies on the dose-response relationship between concentration of cadmium in urine and kidney function. Severe cadmium-induced damage in cells in the proximal kidney tubules is considered to be irreversible and results in the progressive deterioration of renal function, even after cessation of exposure. Long-term exceedance of the TWI is of concern as it can increase the risk of developing kidney disease in the population. Keeping the exposure below the TWI will ensure that the cadmium concentrations in the kidneys will not reach a critical level for reduced kidney function.

 

Dietary Intakes in Europe and Norway, and Major Dietary Cadmium Sources:

 

In 2012, EFSA estimated that the mean cadmium exposure from food in Europe was close to the TWI and exceeded the TWI in some population groups, like toddlers and other children.

 

Previous exposure assessments in Europe and Scandinavia, including Norway, clearly show that cereal based food and root vegetables, particular potatoes, are the major dietary cadmium sources in the general population. These are, however, not the food groups with the highest cadmium concentrations. The highest concentrations have been found in offal, bivalve molluscs and crustaceans (e.g. crabs), and previous exposure assessments have shown that high consumption of such food can be associated with high cadmium exposure at the individual level. There is large variation at the individual level regarding consumption of particular food items (e.g. crab brown meat) that can be important contributors to cadmium exposure in addition to the exposure from the regular diet.

 

VKM has compiled the available Norwegian data on cadmium concentrations in food, mainly from 2006 and onwards. Comparison of Norwegian and European occurrence data shows that the cadmium concentrations for the food categories and items in the two datasets are within a similar range. The exceptions are fish filet and fish products (dishes based on minced fish meat), in which the mean cadmium concentrations were higher in products on the European market than in fish from Norway.

VKM has evaluated if there are national factors (geological factors, self-sufficiency rate, national occurrence data and food consumption habits) that would indicate that exposure in Norway is different from the rest of Europe. VKM has also evaluated available national and European data on concentrations of cadmium in blood and urine in relation to estimated dietary intakes.

 

VKM concludes that it can be expected that cadmium exposure among adults in Norway is within the range previously identified by EFSA, and close to the exposure estimated for Sweden. VKM is of the opinion that long-term cadmium exposure above the TWI as result from the regular diet in adults is unlikely in Norway, but that exceedance might occur from the additional consumption of food items with high cadmium concentrations, in particular brown meat of crabs. In dietary exposure estimates from EFSA, toddlers and other children have mean cadmium exposure exceeding the TWI, due to their higher food consumption relative to the body weight. Based on this, VKM expects that the mean dietary cadmium exposure in toddlers and children may exceed the TWI also in Norway.

 

Risk from Cadmium Intake from Particular Foods in Norway:

 

Based on the mean concentrations of cadmium, VKM identified fish liver, bivalve molluscs and offal in addition to brown crab meat as particular food items that potentially can lead to added cadmium exposure in Norway.

 

Since these particular food items are mainly eaten on a seasonal or non-regular basis, it was stipulated that the associated cadmium exposure would come in addition to the mean exposure from regularly eaten food. In scenario exposure assessments, VKM calculated how much crabs/fish liver that could be consumed by adults and adolescents in addition to the regular diet without exceeding the TWI. The mean dietary exposures in adults and adolescents calculated by EFSA in 2012 were used as the mean exposures from regularly eaten food.

 

Since cadmium accumulates in the kidneys over time (decades), VKM is of the opinion that a short-term exceedance of the TWI (for some weeks or a few months) will not lead to adverse effects in the kidneys as long as the long-term exposure (for several months and years) is below the TWI. VKM therefore considers that the cadmium exposure from particular food items can be averaged over longer time-periods (for months and up to one year) than a week.

 

Crabs and fish liver: The edible crab Cancer pagurus is found all along the Norwegian coast up to Vesterålen, whereas further north the occurrence is infrequent. Brown meat from crabs contains much higher concentrations of cadmium than any other food item commonly consumed in Norway, and has approximately 14 to 20-fold higher concentration of cadmium than white crab meat. The cadmium concentration in fish liver is about two-fold higher than in white meat from crabs caught south of Saltenfjorden. A large part of the Norwegian adult population report consumption of crabs or fish liver at least a few times a year, while a small fraction consume these particular food items more frequently. Consumption of brown meat from crabs and fish liver is, however, not common in most European regions and therefore not covered by the exposure estimates performed by EFSA. The dietary assessment method used in the recent Norwegian national food consumption survey in adults (two times 24h dietary recall) does not supply reliable information about consumption of foods that are not eaten on a daily basis. In order to estimate cadmium exposure from rarely eaten foods, VKM has calculated scenarios for the exposure to cadmium from consumption of crabs and fish liver.

 

Scallops, oysters and offal: The cadmium concentrations in scallops and oysters are 2-3 fold higher than in white meat from crabs caught south of Saltenfjorden. Offal, in particular offal from game and sheep, contains much higher cadmium concentrations than the meat from the same species. However, consumption of offal, including offal from game, and bivalve molluscs is generally low in Norway, although high consumption in some population groups cannot be excluded. In contrast to Norway, consumption of offal and bivalve molluscs is more common in some European regions, and is therefore covered by the exposure estimates performed by EFSA.

 

Scenarios for Cadmium Exposure from Crab or Fish Liver Consumption:

 

Crabs and filled crab shells: Because of high cadmium levels in edible crabs (Cancer pagurus) north of Saltenfjorden up to Vesterålen, Norwegian Food Safety Authority has issued advice to avoid consumption of all parts of crabs caught in this area. The scenarios presented below are valid only for meat of crabs caught south of Saltenfjorden.

 

Whole crabs contain a higher percentage of brown meat than commercially available filled crab shells, and this was taken into account in the scenarios.

 

Scenarios of cadmium exposure from crab consumption indicate that adults can eat approximately one whole crab or two filled crab shells per month in addition to regular food without exceeding the TWI. Averaged over a year, this corresponds to 13.5 whole crabs or approximately 25 filled crab shells. If adults only eat white crab meat, they can consume white meat from approximately nine crabs per week, which corresponds to white meat from approximately 468 crabs per year.

 

Adolescents can eat as little as approximately 0.3 whole crabs or 0.6 filled crab shells per month in addition to regular food without exceeding the TWI. Averaged over a year, this corresponds to 3-4 whole crabs per year or approximately 7 filled crab shells. If adolescents only eat white crab meat, they can consume white meat from about 2.5 crabs per week, which corresponds to white meat from approximately 129 crabs per year.

 

Since a higher crab consumption than the acceptable range calculated in the scenarios has been reported in Norwegian dietary surveys, VKM concludes that high consumers of crab brown meat are at high risk of exceeding the TWI. VKM concludes that cadmium exposure from white crab meat is not of concern in Norway.

 

Fish liver: The scenarios for fish liver consumption performed by VKM indicated that adults can in average consume 224 g saithe liver or 273 g cod liver from the North-Eastern Arctic Sea (Barents Sea) or 737 g cod liver from the North Sea per week in addition to regular food without exceeding the TWI. Because of their lower body weight, adolescents can consume less fish liver than adults in addition to regular food without exceeding the TWI. The scenarios indicated that adolescents can in average consume 60 g saithe liver or 73 g cod liver from the North-East Arctic Sea (Barents Sea) or 196 g cod liver from the North Sea per week in addition to regular food without exceeding the TWI.

 

The available Norwegian data on the consumption of fish liver indicate that such high fish liver consumption over a longer period (months and years) is unlikely, and consequently VKM concludes that cadmium exposure from fish liver consumption is not of concern in adults and adolescents.

 

Cadmium Exposure from Particular Food Items was not Addressed for Toddlers and Children:

 

Exposure scenarios were not calculated for children because there are no Norwegian data on the consumption of crabs or fish liver for toddlers and children. It was, however, anticipated by VKM based on common knowledge regarding children’s food habits that crab brown meat and fish liver are rarely consumed by children. However, if consumed by children, crabs and fish liver would contribute more to the exposure in children than in adolescents and adults because of the low body weight in children and their high energy requirement relative to the body weight. Furthermore, they already have a mean cadmium exposure above the TWI from the regular diet as estimated by EFSA.

 

Uncertainties:

 

VKM considers the uncertainties in the outcome of the present risk assessment as moderate. The highest uncertainty is associated with the amount of cadmium that can be allocated to particular food items, such as brown meat of crabs, before TWI is exceeded, since there is a high individual variation in cadmium exposure from regularly eaten food. The scenarios for exposure to cadmium from consumption of crabs and fish liver are VKM’s best estimate for the maximum possible amounts of these particular food items that can be eaten without exceeding the TWI for cadmium.

 

Data Gaps and Recommendations:

 

During the work with this risk assessment, VKM identified a need for updated consumption information for rarely consumed food in adults and children, as well as for more occurrence data on cadmium in food. There is a lack of information about cadmium levels in organically produced vegetables including those grown in alum shale areas. Furthermore, there is a need for systematic human biomonitoring studies (e.g. blood and urine) and Norwegian participation in European collaborative biomarker studies. A Total Diet Study would be helpful to reduce the uncertainty in the estimates of the mean dietary cadmium exposure in Norway.

Open Access Grey Literature

Risk Assessment of Dietary Exposure to Acrylamide in the Norwegian Population

Anne Lise Brantsæter, Helle Katrine Knutsen, Inger Therese L. Lillegaard, Heidi Amlund, Gunnar Sundstøl Eriksen, Christiane Kruse Fæste, Helen Engelstad Kvalem, Christopher Owen Miles, Irma Oskam, Anders Ruus, Cathrine Thomsen, Janneche Utne Skåre

European Journal of Nutrition & Food Safety, Page 162-166
DOI: 10.9734/EJNFS/2018/42538

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, which is that the MOEs across all age groups were substantially lower than 10 000, indicating a health concern.

 

VKM is of the opinion that the conclusion reached by EFSA's risk assessment of acrylamide, which states that acrylamide in food potentially increases the risk of developing cancer for consumers in all age groups, also applies to Norwegians.

 

Uncertainties and data gaps

 

There is uncertainty in the calculation of dietary acrylamide exposure. One of the reasons is that none of the existing dietary methods are able to capture the “true” long-term food consumption in individuals. Another reason is that the large variation in acrylamide concentrations in food items, even within the same food category. Acrylamide concentrations in food depend on how food is being processed and cooking practises both at home and in restaurants. Cooking practices and preferences, in especially the degree of browning, represent particular uncertainties when estimating dietary acrylamide exposure. More knowledge about this is needed in order to provide a better basis for up-to-date exposure estimates in Norway.

Open Access Grey Literature

Risk Assessment of "Other Substances" – Coenzyme Q10

Bente Brokstad Herlofsen, Gro Haarklou Mathisen, Ellen Merete Bruzell, Berit Granum, Ragna Bogen Hetland, Trine Husøy, Jens Rohloff, Trude Wicklund, Inger-Lise Steffensen

European Journal of Nutrition & Food Safety, Page 167-169
DOI: 10.9734/EJNFS/2018/42539

The Norwegian Scientific Committee for Food Safety (Vitenskapskomiteen for mattrygghet, VKM) has, at the request of the Norwegian Food Safety Authority (Mattilsynet; NFSA), assessed the risk of "other substances" in food supplements and energy drinks sold in Norway. VKM has assessed the risk of doses given by NFSA. These risk assessments will provide NFSA with the scientific basis while regulating the addition of “other substances” to food supplements and other foods.

 

"Other substances" are described in the food supplement directive 2002/46/EC as substances other than vitamins or minerals t hat have a nutritional and/or physiological effect. It is added mainly to food supplements, but also to energy drinks and other foods. In this series of risk assessments of "other substances", VKM has not evaluated any potential beneficial effects from these substances, only possible adverse effects.

 

The present risk assessment of coenzyme Q10 (CoQ10) is based on previous risk assessments and articles retrieved from a literature search.

 

According to information from NFSA, CoQ10 is an ingredient in food supplements sold in Norway. NFSA has requested a risk assessment of intake of 100 mg/day of CoQ10 in food supplements.

 

CoQ10 (CAS no. 303-98-0) is a naturally-occurring, lipid-soluble compound present in all tissues in humans. Ubiquinone is the totally oxidized form (CoQ10), whereas ubiquinol (CoQ10H2) is the totally reduced form. Meat and fish are the food sources richest in CoQ10. CoQ10 intake from the diet ranges between 3 and 6 mg/day in developed countries. The total body pool of CoQ10 is estimated to be approximately 0.5–1.5 g in an adult.

 

Several studies of CoQ10 (both oxidized and reduced form) have been performed in healthy humans (adults) and animals, showing fairly similar results. The adverse effects reported in a small number of human subjects were generally limited to mild gastrointestinal symptoms such as nausea and stomach upset. In humans, orally ingested CoQ10 was well tolerated at doses up to 900 mg/day (corresponding to 12.9 mg/kg bw per day in a 70 kg adult) over periods up to one month. With regard to animal studies, the lack of adverse effects of CoQ10 doses up to 1200 mg/kg per day in long-term toxicity studies supported and extended the results from the human studies. No studies on children (10 to <14 years) and adolescents (14 to <18 years) were identified. Based on the included literature there was no evidence indicating that age affects tolerance for CoQ10. Therefore, in this risk characterisation the same tolerance as for adults was assumed for these age groups (adjusted for body weight).

 

From a daily dose of 100 mg CoQ10, the daily exposure is 2.3 mg/kg bw for children (10 to <14 years), 1.6 mg/kg bw for adolescents (14 to <18 years), and 1.4 mg/kg bw for adults (≥18 years). For the risk characterization, the values used for comparison with the estimated exposure are 900 mg/day (corresponding to 12.9 mg/kg bw per day in a 70 kg adult) based on human studies (4 weeks) and the no observed adverse effect level (NOAEL) of 1200 mg/kg bw per day based on a long-term toxicity study in rats (52 weeks).

 

The margin of exposure (MOE) approach is used for the rat study; that is the ratio of the NOAEL to the exposure. An acceptable MOE value for a NOAEL-based assessment of CoQ10 based on an animal study is ≥100, which includes a factor 10 for extrapolation from animals to humans, and a factor 10 for interindividual human variation. Comparing the NOAEL from a long-term toxicity study in rats with the estimated exposure for the different age groups, it is unlikely that a daily dose of 100 mg/day of CoQ10 causes adverse health effects in children above 10 years, adolescents and adults. 

 

Comparing the dose reported to be well tolerated for healthy adults directly with the estimated exposure, it is unlikely that a daily dose of 100 mg/day of CoQ10 causes adverse health effects in children above 10 years, adolescents and adults.

 

VKM concludes that it is unlikely that a daily dose of 100 mg of CoQ10 from food supplements causes adverse health effects in children (10 to <14 years), adolescents (14 to <18 years) and adults (≥18 years).

Open Access Grey Literature

Risk Assessment of "Other Substances" – Taurine

Berit Granum, Ellen Merete Bruzell, Ragna Bogen Hetland, Trine Husøy, Jens Rohloff, Trude Wicklund, Inger-Lise Steffensen

European Journal of Nutrition & Food Safety, Page 170-173
DOI: 10.9734/EJNFS/2018/42541

The Norwegian Scientific Committee for Food Safety (Vitenskapskomiteen for mattrygghet, VKM) has, at the request of the Norwegian Food Safety Authority (Mattilsynet; NFSA), assessed the risk of "other substances" in food supplements and energy drinks sold in Norway. VKM has assessed the risk of doses in food supplements and concentrations in energy drinks given by NFSA. These risk assessments will provide NFSA with the scientific basis while regulating the addition of “other substances” to food supplements and other foods.

 

"Other substances" are described in the food supplement directive 2002/46/EC as s ubstances other than vitamins or minerals that have a nutritional and/or physiological effect . It is added mainly to food supplements, but also to energy drinks and other foods. VKM has not in this series of risk assessments of "other substances" evaluated any claimed beneficial effects from these substances, only possible adverse effects.

 

The present report is a risk assessment of taurine, and it is based on previous risk assessments and articles retrieved from a literature search.

According to information from NFSA, taurine is an ingredient in food supplements and energy drinks sold in Norway. NFSA has requested a risk assessment of 750, 800, 900, 1000 and 2000 mg/day of taurine in food supplements, and of 300, 350 and 400 mg/100 ml of taurine in energy drinks. Drinking patterns reflecting a high acute intake, a mean chronic intake and a high chronic intake were assessed. For food supplements, the intake of taurine was estimated for the age groups children (10 to <14 years), adolescents (14 to <18 years) and adults (>18 years), whereas for energy drinks the age group children (3 to <10 years) was also included.

 

Other sources of taurine, such as foods and cosmetics, have not been included in the present risk assessment.

 

Taurine (CAS No. 107-35-7) is synthesised endogenously (average 50-125 mg per day), and participates in the formation of bile salts and is involved in a number of crucial physiological processes, including modulation of calcium flux and neuronal excitability, osmoregulation and membrane stabilisation. Taurine occurs naturally in food, especially in meat and seafood. The mean daily intake of taurine from the diet has been estimated to vary between 40 and 400 mg/day.

There are indications that taurine may have cardiovascular and neurological effects in humans. However, based on the human studies, an intake of approximately 21 mg/kg bw per day is considered unlikely to cause adverse health effects.

 

Based on a 13-week neurotoxicity study in rats, a no observed adverse effect level (NOAEL) of 1000 mg/kg bw per day for pathological changes was set in 2009 by the European Food Safety Authority (EFSA). In the present risk assessment, VKM has used this NOAEL of 1000 mg/kg bw per day from rats.

 

The human studies available were not of sufficient quality (due to low number of participants, non-healthy populations, short duration) to be used as the sole basis for the risk characterisation. The risk characterisation is based on the margin of exposure (MOE) approach; the ratio of the NOAEL to the exposure. An acceptable MOE value for a NOAELbased assessment of taurine based on an animal study is ≥100, which includes a factor 10 for extrapolation from animals to humans and a factor 10 for interindividual human variation. However, since the NOAEL set by EFSA was based on the highest tested dose and there is a possibility that the actual NOAEL is higher than 1000 mg/kg bw per day, the intake that was considered unlikely to cause adverse health effects based on human studies (21 mg/kg bw per day) was also taken into consideration in the risk characterisation.

 

Food supplements:

 

For children (10 to <14 years), the estimated daily intakes of taurine were 17.3, 18.4, 20.7, 23.0 and 46.1 mg/kg bw per day from daily doses of 750, 800, 900, 1000 and 2000 mg taurine, respectively, from food supplements. The margin of exposure (MOE) values was in the range of 22-58 for the various taurine doses, i.e. all below 100. However, from a daily intake of 750, 800 or 900 mg taurine from food supplements, the estimated intakes were below 21 mg/kg bw per day (the intake considered unlikely to cause adverse health effects based on human studies). VKM therefore concludes that it is unlikely that a daily intake of 750, 800 or 900 mg taurine from food supplements causes adverse health effects in children (10 to <14 years). The estimated exposure from a daily intake of 1000 or 2000 mg taurine was above 21 mg/kg bw per day. Thus, VKM concludes that a daily intake of 1000 or 2000 mg taurine from food supplements may represent a health risk in children (10 to <14 years).

 

For adolescents (14 to <18 years), the estimated daily intakes were 12.2, 13.1, 14.7, 16.3 and 32.6 mg/kg bw per day from daily doses of 750, 800, 900, 1000 and 2000 mg taurine, respectively, from food supplements. For adults (≥18 years), the estimated intakes were 10.7, 11.4, 12.9, 14.3 and 28.6 mg/kg bw per day from a daily intake of 750, 800, 900, 1000 and 2000 mg taurine, respectively, from food supplements.

 

For adolescents (14 to <18 years) and adults (≥18 years), the MOE values were in the range of 31-82 and 35-93, respectively, i.e. all below 100. However, from a daily intake of 750, 800, 900 or 1000 mg taurine from food supplements the estimated intakes were below 21 mg/kg bw per day (the intake considered unlikely to cause adverse health effects based on human studies) for both age groups. Thus, VKM concludes that it is unlikely that a daily intake of 750, 800, 900 or 1000 mg of taurine causes adverse health effects in adolescents (14 to <18 years) and adults (≥18 years).

 

For adolescents (14 to <18 years) and adults (≥18 years) the estimated MOE values were 31 and 35, respectively, i.e. below 100, after a daily intake of 2000 mg taurine from food supplements. In addition, the estimated intakes were above the intake level of 21 mg/kg bw per day (the intake considered unlikely to cause adverse health effects based on human studies) for both age groups. Thus, VKM concludes that a daily intake of 2000 mg of taurine may represent a risk of adverse health effects in adolescents (14 to <18 years) and adults (≥18 years).

 

Energy drinks:

 

High acute drinking pattern, all age groups:

 

For the high acute drinking pattern, the estimated consumption of energy drinks was 1000, 1500, 2000 and 2000 ml/day for children (3 to <10 years), children (10 to <14 years), adolescents (14 to <18 years) and adults (≥18 years), respectively. For the concentrations of 300, 350 and 400 mg taurine/100 ml energy drink, the intake levels of taurine after a high acute consumption of energy drinks (in mg/kg bw per day) were 130, 152 and 173; 104, 121 and 138; 97.9, 114 and 131; and 85.7, 100 and 114, for children (3 to <10 years), children (10 to <14 years), adolescents (14 to <18 years) and adults (≥18 years), respectively.

 

Due to lack of an acute reference dose or other data for acute toxicity of taurine, it was not possible to characterise the risk related to an acute intake of taurine for any of the age groups.

 

Mean chronic drinking pattern, all age groups:

 

For the mean chronic drinking pattern, the estimated consumption of energy drinks was 58, 65, 64 and 71 ml/day for children (3 to <10 years), children (10 to <14 years), adolescents (14 to <18 years) and adults (≥18 years), respectively. For the concentrations of 300, 350 and 400 mg taurine/100 ml energy drink, the intake levels of taurine after a mean chronic drinking pattern (in mg/kg bw per day) were 7.5, 8.8 and 10.0; 4.5, 5.2 and 6.0; 3.1, 3.7 and 4.2; and 3.0, 3.6 and 4.1, for children (3 to <10 years), children (10 to <14 years), adolescents (14 to <18 years) and adults (≥18 years), respectively.

 

In all age groups, the estimated MOE values were 100-333, i.e. 100 or above, for all three taurine concentrations. In addition, the estimated intakes were all below 21 mg/kg bw per day (the intake considered unlikely to cause adverse health effects based on human studies) for all age groups. Thus, VKM concludes that it is unlikely that the mean chronic intake of all three concentrations of taurine causes adverse health effects in children (3 to <10 years), children (10 to <14 years), adolescents (14 to <18 years) and adults (≥18 years).

 

High chronic drinking pattern, all age groups:

 

For the high chronic drinking pattern, the estimated consumption of energy drinks was 163, 180, 211 and 320 ml/day for children (3 to <10 years), children (10 to <14 years), adolescents (14 to <18 years) and adults (≥18 years), respectively. For the concentrations of 300, 350 and 400 mg taurine/100 ml energy drink, the intake levels of taurine after a high chronic drinking pattern (in mg/kg bw per day) were 21.2, 24.7 and 28.2; 12.4, 14.5 and 16.6; 10.3, 12.0 and 13.8; and 13.7, 16.0 and 18.3 mg/kg bw per day for children (3 to <10 years), children (10 to <14 years), adolescents (14 to <18 years) and adults (≥18 years), respectively.

 

For children (3 to <10 years), the estimated MOE values were 47, 40 and 35, for the three taurine concentrations of 300, 350 and 400 mg/ml, respectively, i.e. all below 100. In addition, the estimated intakes were all above 21 mg/kg bw per day (the intake considered unlikely to cause adverse health effects based on human studies) for all three taurine concentrations. Thus, VKM concludes that a high chronic intake of all three concentrations of taurine from energy drinks may represent a health risk in children (3 to <10 years).

 

For children (10 to <14 years), adolescents (14 to <18 years) and adults (≥18 years), the estimated MOE values were in the range of 55-97, i.e. all below 100 for all three taurine concentrations. However, the estimated intakes were all below the intake level of 21 mg/kg bw per day (the intake considered unlikely to cause adverse health effects based on human studies) for all three taurine concentrations in all age groups. Thus, VKM concludes that it is unlikely that a high chronic intake of any of the three concentrations of taurine from energy drinks causes adverse health effects in children (10 to <14 years), adolescents (14 to <18 years) and adults (≥18 years).

Open Access Grey Literature

Risk Assessment of "Other Substances" – L-Carnitine and L-Carnitine-L-tartrate

Ellen Merete Bruzell, Berit Granum, Ragna Bogen Hetland, Trine Husøy, Jens Rohloff, Trude Wicklund, Inger-Lise Steffensen

European Journal of Nutrition & Food Safety, Page 174-176
DOI: 10.9734/EJNFS/2018/42545

The Norwegian Scientific Committee for Food Safety (Vitenskapskomiteen for mattrygghet, VKM) has, at the request of the Norwegian Food Safety Authority (Mattilsynet; NFSA), assessed the risk of "other substances" in food supplements and energy drinks sold in Norway. VKM has assessed the risk of doses given by NFSA. These risk assessments will provide NFSA with the scientific basis while regulating the addition of other substances to food supplements and other foods.

 

"Other substances" are described in the food supplement directive 2002/46/EC as substances other than vitam ins or minerals that have a nutritional and/or physiological effect. It is added mainly to food supplements, but also to energy drinks and other foods. In this series of risk assessments of "other substances", VKM has not evaluated any claimed beneficial effects from these substances, only possible adverse effects.

 

The present report is a risk assessment of L-carnitine and L-carnitine-L-tartrate, and it is based on previous risk assessments and/or articles retrieved from a literature search.

According to information from NFSA, L-carnitine and L-carnitine-L-tartrate are ingredients in food supplements sold in Norway. NFSA has requested a risk assessment of 1500 mg/day (21.4 mg/kg bw per day) of L-carnitine and 2250 mg/day (32.1 mg/kg bw per day) of Lcarnitine-L-tartrate in food supplements.

 

Other sources of L-carnitine and L-carnitine-L-tartrate, such as e.g. cosmetics, have not been included in the present risk assessment.

 

L-carnitine is a quaternary ammonium salt naturally occurring in all animals and bacteria. It is essential in the fatty acid metabolism. L-carnitine-L-tartrate is the salt of the L-carnitine base with tartaric acid, and is synthesised commercially.

 

L-carnitine occurs naturally in foods, and the richest source is red meat. L-carnitine-L-tartrate does not occur naturally in foods. L-carnitine-L-tartrate dissociates into L-carnitine and Ltartaric acid in the gastrointestinal tract. L-carnitine is endogenously synthesised from lysine and methionine.

 

L-carnitine is widely distributed in all mammalian tissues and is abundant in muscular tissue. After ingestion, L-carnitine is absorbed in the small intestine, and the bioavailability declines with increasing dose. L-carnitine is excreted mainly via the kidneys with a highly efficient tubular reabsorption; only 2% of the ingested L-carnitine is excreted in the faeces. The amount of L-carnitine absorbed into the systemic circulation is similar whether L-carnitine-Ltartrate or L-carnitine is administered.

 

Neonates, infants and young children can be exposed to L-carnitine and L-carnitine-L-tartrate through foods for particular nutritional uses (including infant formulae and various baby foods). L-carnitine and L-carnitine-L-tartrate are used as supplements in animal food, and they are listed as ingredients in various cosmetic products. L-tartaric acid occurs naturally in fruits and wine, and L-tartaric acid and its salts are approved as food additives (E 334).

 

Adverse effects of L-carnitine (-L-tartrate) are occasionally observed in vulnerable groups such as in patients with kidney disease and persons with high plasma values of trimethylamine (TMA) and trimethylamine-N-oxide (TMAO). High plasma L-carnitine levels in subjects with concurrently high TMAO levels have been associated with cardiovascular disease and adverse cardiac events in patients undergoing cardiac evaluation. Adverse effects are suspected in patients with inborn errors of metabolism. Further, interactions with certain types of drugs have been reported.

 

One study of L-carnitine on children (6-13 year old boys diagnosed with attention deficit hyperactivity disorder (ADHD), but otherwise healthy) was identified, which did not indicate that children were more sensitive to L-carnitine than adults. No studies were found on adverse effects of L-carnitine-L-tartrate or tartaric acid specifically in children. No studies were found on adverse effects of L-carnitine, L-carnitine-L-tartrate or tartaric acid specifically in adolescents. Based on the included literature there was no evidence indicating that age affects sensitivity towards L-carnitine, L-carnitine-L-tartrate or tartaric acid. Therefore, in this risk characterisation the same tolerance level as for adults was assumed for children and adolescents (adjusted for body weight). 

 

EFSA established a human tolerance level of L-carnitine-L-tartrate up to 3 g/day (43 mg/kg bw per day), equivalent to 2 g/day (29 mg/kg bw per day) L-carnitine in healthy adults. A safety factor for interindividual variation was not included in the established value. Further, this value was based on few studies of which all but one was unavailable to VKM. Intake of 3 g of L-carnitine-L-tartrate would yield 1 g of tartaric acid (14 mg/kg bw per day) (values in parentheses apply to a 70 kg adult). An acceptable daily intake (ADI) based on animal studies is set for tartaric acid of 0-30 mg/kg bw per day. These values (29 mg/kg bw per day  L-carnitine, 43 mg/kg bw per day L-carnitine-L-tartrate and 30 mg/kg bw per day tartaric acid) were compared with the estimated exposure in the risk characterisation.

 

Based on the daily intake of 1500 mg L-carnitine (equivalent to 2250 mg L-carnitine-Ltartrate) and the default body weights determined by EFSA, the estimated exposure is 34.6, 24.5 and 21.4 mg/kg bw per day for the age groups children (10 to <14 years), adolescents (14 to <18 years) and adults (≥18 years), respectively.

 

VKM concludes that a dose of 1500 mg of L-carnitine per day, which is equivalent to a dose of 2250 mg of L-carnitine-L-tartrate per day, is unlikely to cause adverse health effects in adolescents (14 to <18 years) and adults (≥18 years), whereas intake at this level in children (10 to <14 years) may represent a risk of adverse health effects. The tartaric acid exposure from this dose of L-carnitine-L-tartrate is unlikely to cause adverse health effects.

Open Access Grey Literature

Assessment of Intake of Nicotinic Acid and Nicotinamide in Relation to Tolerable Upper Intake Levels

Tonje Holte Stea, Inger Therese L. Lillegaard, Livar Frøyland, Margaretha Haugen, Sigrun Henjum, Martinus Løvik, Tor A. Strand, Kristin Holvik

European Journal of Nutrition & Food Safety, Page 177-179
DOI: 10.9734/EJNFS/2018/42535

The Norwegian Scientific Committee for Food Safety (Vitenskapskomiteen for mattrygghet, VKM) has, at the request of the Norwegian Food Safety Authority (Mattilsynet; NFSA), assessed the intake of niacin in the Norwegian population. NFSA has also requested that VKM conduct scenario calculations to illustrate the consequences of establishing separate maximum limits for nicotinic acid (1, 4, 8 or 10 mg/day) and nicotinamide (100, 500, 700 or 900 mg/day) in food supplements, by assessing these scenarios against existing tolerable upper intake levels (ULs). The current maximum limit for niacin added to food supplements is 32 mg/day, including nicotinic acid, nicotinamide and inositol hexanicotinate.

 

The term niacin (vitamin B3) comprises the two main water-soluble forms nicotinic acid and nicotinamide (niacinamide). The human body can get niacin from the diet or synthesise it from the essential amino acid tryptophan. Dietary intakes are expressed as milligram niacin equivalents (NEs), which correspond to 1 mg of pure niacin or 60 mg of tryptophan.

 

In the body, niacin primarily functions as a component of the coenzymes NAD (nicotinamide adenine dinucleotide) and NADP (nicotinamide adenine dinucleotide phosphate) which are present in all cells. These coenzymes play essential roles for the functioning of a wide range of enzymes involved in the metabolism of carbohydrates, amino acids and fat. In addition to its function in coenzymes, niacin is involved in DNA repair and gene stability. Niacin has a half-life of 20-40 minutes in the human body.

 

Late symptoms of severe niacin deficiency (pellagra) include fatigue, headache, apathy, depression, memory loss, dementia, pigmented skin rash after sun exposure, bright red tongue, vomiting, diarrhoea, and constipation.

 

Flushing (burning and itching of the face, arms and chest) and stomach irritation are the main side effects of moderately high supplemental intake of nicotinic acid (>35 mg/day). Long-term use of high doses (≥3000 mg/day) of nicotinic acid as a cholesterol-lowering drug can also be toxic to the liver. Nicotinamide, however, does not have these effects. In general, the risk of nicotinamide toxicity appears to be quite low.

 

VKM proposes to adopt the ULs of nicotinic acid and nicotinamide set by the Scientific Committee for Food Safety (SCF) in 2002, which are based on one human dose-response study (nicotinic acid) and several human dose-response studies (nicotinamide), respectively. Hence, the UL for supplemental nicotinic acid is suggested to 10 mg/day for adults and the UL for supplemental nicotinamide to 900 mg/day for adults. The ULs for children and adolescents have been derived on the basis of their body weights.

 

The ULs set for nicotinic acid and nicotinamide concern only intake from supplements since intake of nicotinic acid and nicotinamide from regular foods is considered to be without risk of negative health effects. Therefore, VKM has not conducted or evaluated scenarios with intake from both diet and the separated new maximum limits for nicotinic acid and nicotinamide in food supplements suggested by NFSA.

 

Dietary calculations, however, have been performed for niacin intakes (includes both nicotinic acid and nicotinamide) in various percentiles (P5, P25, mean, P50, P75 and P95) in children (2-, 4- and 9-year-olds), adolescents (13-year-olds) and adults as background information.

 

Mean and median intakes of niacin from the diet alone are above or at the recommended intakes for all age groups.

 

Because UL for supplemental nicotinic acid is 10 mg/day for adults, none of the suggested maximum limits in food supplements (1, 4, 8, or 10 mg/day) will lead to exceedance of this UL in adults. In 13-year-olds and 9-year-olds, supplements with 8 mg nicotinic acid per day will lead to exceedance of UL, and in 4-year-olds and 2-year-olds supplementation of 4 mg nicotinic acid per day will lead to exceedance of the UL for nicotinic acid.

 

Because UL for supplemental nicotinamide is 900 mg/day for adults, none of the suggested maximum limits in food supplements (100, 500, 700 or 900 mg/day) will lead to exceedance of UL in adults. In 13-year-olds, supplements with 700 mg nicotinamide per day will lead to exceedance of UL. In 9-year-olds, 4-year-olds and 2-year-olds, supplementation of 500 mg nicotinamide per day will lead to exceedance of the UL for nicotinic acid.

Open Access Grey Literature

Risk Assessment of "Other Substances" – Inositol

Jens Rohloff, Ellen Merete Bruzell, Berit Granum, Ragna Bogen Hetland, Trine Husøy, Trude Wicklund, Inger-Lise Steffensen

European Journal of Nutrition & Food Safety, Page 180-182
DOI: 10.9734/EJNFS/2018/42540

The Norwegian Scientific Committee for Food Safety (Vitenskapskomiteen for mattrygghet, VKM) has, at the request of the Norwegian Food Safety Authority (Mattilsynet; NFSA), assessed the risk of "other substances" in food supplements and energy drinks sold in Norway. VKM has assessed the risk of doses given by NFSA. These risk assessments will provide NFSA with the scientific basis while regulating the addition of “other substances” to food supplements and other foods.

 

"Other substances" are described in the food supplement directive 2002/46/EC as substances other than vitamins or minerals that have a nutritional and/ or physiological effect. It is added mainly to food supplements, but also to energy drinks and other foods. In this series of risk assessments of "other substances", VKM has not evaluated any potential beneficial effects from these substances, only possible adverse effects.

 

The present risk assessment is based on previous risk assessments of inositol and articles retrieved from a literature search.

 

According to information from NFSA, inositol is an ingredient in energy drinks sold in Norway. NFSA has requested a risk assessment of 10 mg/100 ml inositol in energy drinks. Drinking patterns reflecting a high acute intake, a mean chronic intake and a high chronic intake were assessed.

 

Inositol (CAS no. 6917-35-7) is a sugar alcohol. Among the nine possible stereoisomers, myo inositol (CAS no. 87-89-8) is the most abundant. The name inositol is frequently used as a synonym for myo -inositol. Inositol occurs naturally in all organisms including humans, and is an important component in all human cells. Inositol-containing lipids and phosphates are required for various structural and functional processes, including membrane formation, signalling, membrane trafficking and osmoregulation. Endogenous production of inositol in humans amounts to about 4 g/day (about 57 mg/kg bw per day in a 70 kg adult) (EFSA, 2014). The total dietary intake of inositol in adults is estimated to range between 500 to 1000 mg/day (about 7-14 mg/kg bw per day).

 

Inositol added to energy drinks in Norway denotes the compound myo -inositol, according to information from NFSA.

 

M yo -inositol is a water-soluble compound naturally occurring in the cells of all living organisms including humans, animals, plants and microorganisms.

 

Certain plant (fruits and vegetables) and foods from animals contain inositol, and seeds of cereals and legumes show high levels of the inositol storage form, phytic acid (inositol hexaphosphate).

 

With regard to hazard identification and characterisation of inositol, most of the adverse effects observed in several human studies were related to gastrointestinal symptoms such as nausea, flatulence, loose stools and diarrhoea.

 

Drinking patterns reflecting a high acute intake, a mean chronic intake and a high chronic intake were assessed for energy drinks containing 10 mg inositol per 100 ml, for the age groups children (3 to <10 years and 10 to <14 years), adolescents (14 to <18 years) and adults (≥18 years).

 

For the high acute drinking pattern, the intake was estimated to be 1000, 1500, 2000 and  2000 ml/day for children (3 to <10 years), children (10 to <14 years), adolescents (14 to <18 years) and adults (>18 years), respectively. For the mean chronic drinking pattern, the intake was estimated to be 58, 65, 64 and 71 ml/day for children (3 to <10 years), children (10 to <14 years), adolescents (14 to <18 years) and adults (≥18 years), respectively. For the high chronic drinking pattern, the intake was estimated to be 163, 180, 210 and 320 ml/day for children (3 to <10 years), children (10 to <14 years), adolescents (14 to <18 years) and adults (≥18 years), respectively.

 

The data on toxicity of inositol was very limited. The human study with the longest exposure at highest doses (3 months treatment at maximum tolerated dose) that was available for risk assessment was a clinical study of 40-74 year old smokers with bronchial dysplasia, from which a NOAEL of 18 g/day of myo -inositol was established (Lam et al. 2006). VKM estimated the margins of exposure (MOE) based on the NOAEL established in this study.

 

The MOE is the ratio of the NOAEL value to the exposure. An acceptable MOE value for a NOAEL-based assessment of inositol based on a human study is ≥10, taking into account a factor 10 for the interindividual variation between humans in toxicokinetics and toxicodynamics. Due to the uncertainty regarding the relevance of the study by Lam et al. (2006) for the general healthy population, an additional safety factor of 3 was used. Therefore, an acceptable MOE value was 30.

For all age groups, the MOE values were in the range of 857 to 2570 for mean chronic intake and in the range of 367 to 857 for high chronic intake of energy drinks, respectively, i.e. far above the acceptable MOE value of 30.

 

Since neither the sub-optimal human study by Lam et al. (2006) or the animal studies in rodent models of chronic diseases available were on healthy subjects, as a supplement to the MOE values calculated from the human study, comparisons with endogenous production and amounts in food of inositol were also performed.

 

No studies specifically on children (3 to <10 years and 10 to <14 years) and adolescents (14 to <18 years) were identified. Based on the included literature there was no evidence indicating that age affects tolerance or endogenous production of inositol. Therefore, in this risk characterisation a tolerance and an endogenous production of inositol as for adults, based on body weight, was assumed for these age groups.

 

For the high acute drinking pattern, and for the mean chronic and the high chronic drinking patterns all estimated intakes of inositol from energy drinks containing 10 mg/100 ml were far below the endogenous production (57 mg/kg bw per day), and also below the dietary intake (7-14 mg/kg bw per day).

 

VKM concludes that it is unlikely that the exposure to inositol from the high acute, the mean chronic or the high chronic drinking patterns causes adverse health effects in children (3 to <10 years and 10 to <14 years), adolescents (14 to <18 years) and adults (≥18 years).

Open Access Grey Literature

Risk Assessment of "Other Substances" – Caffeine

Trine Husøy, Gro Haarklou Mathisen, Ellen Merete Bruzell, Berit Granum, Ragna Bogen Hetland, Jens Rohloff, Trude Wicklund, Inger-Lise Steffensen

European Journal of Nutrition & Food Safety, Page 183-186
DOI: 10.9734/EJNFS/2018/42542

The Norwegian Scientific Committee for Food Safety (Vitenskapskomiteen for mattrygghet, VKM) has, at the request of the Norwegian Food Safety Authority (Mattilsynet, NFSA), assessed the risk of "other substances" in food supplements and energy drinks sold in Norway. VKM has assessed the risk of doses given by NFSA. These risk assessments will provide NFSA with the scientific basis while regulating the addition of “other substances” to food supplements and other foods.

 

"Other substances" are described in the food supplement directive 2002/46/EC as substances other than vitamins or minerals that have a nutritional or physiological effect. It is added mainly to food supplements, but also to energy drinks and other foods. In this series of risk assessments of "other substances", VKM has not evaluated any claimed beneficial effects from these substances, only possible adverse effects.

 

The present risk assessment of caffeine is based on previous risk assessments and articles retrieved from a literature search.

 

According to information from NFSA, caffeine is an ingredient in food supplements and energy drinks sold in Norway. NFSA has requested a risk assessment of 100 and 300 mg/day of caffeine in food supplements, and of 32 mg/100 ml of caffeine in energy drinks. Drinking patterns reflecting a high acute intake, a mean chronic intake and a high chronic intake were assessed.

 

The total exposure to caffeine from other sources than energy drinks, such as foods and cosmetic products, is not included in the risk assessment.

 

The main sources of caffeine in the diet include coffee, tea, caffeinated soft drinks (including energy drinks) and chocolate. The means and 95th percentiles of daily caffeine intake from all sources for adults (from 16 EU Member States) calculated by the European Food Safety Authority (EFSA) ranged from 37 to 319 mg and from 109 to 742 mg, respectively. The median daily caffeine intake from different sources among pregnant Norwegian women, selfreported at gestational weeks 17 and 30, was 126 mg/day pre-pregnancy, 44 mg/day at gestational week 17, and 62 mg/day at gestational week 30.

 

Caffeine is rapidly and completely absorbed after oral intake, and the peak plasma concentration can be reached within 30-120 minutes. Caffeine crosses the blood–brain barrier, the placental barrier and the blood–testicular barrier, and is excreted in breast milk.

 

Several studies and assessments addressing safety or risk of caffeine have been performed. With regard to caffeine intake and adverse birth weight-related outcomes, these outcomes were observed at all levels of caffeine intake, with no threshold below which this relationship was not observed (EFSA, 2015). In the risk characterization, VKM has applied the intake levels considered unlikely to cause adverse health effects in the new and comprehensive risk assessment by EFSA (EFSA, 2015), also taking into account previous risk assessments and newer literature. The intake levels of caffeine for different population groups (children, adolescents, pregnant women and fetus, lactating women and the breastfed infant and adults) unlikely to cause adverse effects have been identified.

 

For the general adult population (not including pregnant women), these levels are:

 

      • Single intake of caffeine up to 200 mg (about 3 mg/kg bw for a 70-kg adult) do not give rise to safety concerns.

     • Intakes up to 400 mg per day (about 5.7 mg/kg bw per day for a 70-kg adult) consumed throughout the day, do not give rise to safety concerns for adults in the general population, except for pregnant women (see below).

      • Caffeine intake of about 1.4 mg/kg bw may increase sleep latency and reduce sleep duration in adults.

 

For children and adolescents, these levels are:

 

      • A daily intake of 3 mg/kg bw per day do not give rise to safety concerns.

     • Caffeine doses of about 1.4 mg/kg bw may increase sleep latency and reduce sleep duration in some children and adolescents.

 

For pregnant women and the fetus, these levels are:

 

     • 200 mg per day (about 3 mg/kg bw for a 70-kg adult) consumed throughout the day do not give rise to safety concerns. 
    • With regard to caffeine intake and adverse birth weight-related outcomes, it was concluded that these outcomes were observed at all levels of caffeine intake, with no threshold below which this relationship was not observed. It was considered that the risk becomes clinically relevant at total daily doses of about 200 mg of caffeine from all sources. Sengpiel et al. (2013) reported that caffeine intake from different sources was associated with lower birth weight, and that caffeine intake of 200 to 300 mg/day increased the odds for the baby being small for gestational age compared to 0 to 50 mg/day.

 

For lactating women and the breastfed infant, these levels are:

 

    • Single doses of caffeine up to 200 mg (about 3 mg/kg bw) and habitual caffeine consumption at doses of 200 mg per day do not give rise to safety concerns.

 

Food supplements:

 

From a daily dose of 100 mg caffeine, the calculated intake levels are 2.3, 1.6 and 1.4 mg/kg bw per day for children (10 to <14 years), adolescents (14 to <18 years) and adults (≥18 years), respectively. From a daily dose of 300 mg caffeine, the calculated intake levels are 6.9, 4.9 and 4.3 mg/kg bw per day for the same age groups, respectively.

 

VKM concludes that it is unlikely that a dose of 100 mg of caffeine per day from food supplements causes adverse health effects in children (10 years and above), adolescents (14 to <18 years), pregnant women and the fetus, lactating women and the breastfed infant and adults (≥18 years). However, for children and adolescents, a dose of 100 mg per day is above the intake that may increase sleep latency and reduce sleep duration. For adults, a dose of 100 mg per day is equal to the intake that may increase sleep latency and reduce sleep duration.

 

VKM concludes that a dose of 300 mg of caffeine per day from food supplements may represent a risk of adverse health effects in children (10 years and above), adolescents (14 to <18 years), pregnant women and the fetus and lactating women and the breastfed infant. Consumed as a single dose, 300 mg of caffeine from food supplement may represent a risk of adverse health effects in adults (≥18 years). Consumed throughout the day, it is unlikely that a dose of 300 mg of caffeine per day from food supplements causes adverse health effects in adults. A dose of 300 mg per day is above the intake that may increase sleep latency and reduce sleep duration.

 

Energy drinks:

 

The estimated exposure to caffeine from a drinking pattern reflecting a high acute intake of caffeine from energy drinks (containing 32 mg caffeine/100 ml) is 13.9 mg/kg bw per day for children (3 to <10 years), 11.1 mg/kg bw per day for children (10 to <14 years), 10.4 mg/kg bw per day for adolescents (14 to <18 years) and 9.1 mg/kg bw per day for adults (≥18 years).

 

VKM concludes that a drinking pattern reflecting a high acute intake of caffeine from energy drinks (containing 32 mg caffeine/100 ml) may represent a risk of adverse health effects in children (3 years and above), adolescents (14 to <18 years), pregnant women and the fetus, lactating women and the breastfed infant and adults (≥18 years). In addition, the intake is above the intake that may increase sleep latency and reduce sleep duration.

 

The estimated exposure to caffeine from a drinking pattern reflecting a mean chronic intake of caffeine from energy drinks (containing 32 mg caffeine/100 ml) is 0.8 mg/kg bw per day for children (3 to <10 years), 0.5 mg/kg bw per day for children (10 to <14 years), 0.3 mg/kg bw per day for adolescents (14 to <18 years) and 0.3 mg/kg bw per day for adults (≥18 years).

 

VKM concludes that it is unlikely that a drinking pattern reflecting a mean chronic intake of caffeine from energy drinks (containing 32 mg caffeine/100 ml) causes adverse health effects in children (3 years and above), adolescents (14 to <18 years), pregnant women and the fetus, lactating women and the breastfed infant and adults (≥18 years). In addition, the intake is below the intake that may increase sleep latency and reduce sleep duration.

 

The estimated exposure to caffeine from a drinking pattern reflecting a high chronic intake of caffeine from energy drinks (containing 32 mg caffeine/100 ml) is 2.3 mg/kg bw per day for children (3 to <10 years), 1.3 mg/kg bw per day for children (10 to <14 years), 1.1 mg/kg bw per day for adolescents (14 to <18 years) and 1.5 mg/kg bw per day for adults (≥18 years).

 

VKM concludes that it is unlikely that a drinking pattern reflecting a high chronic intake of caffeine from energy drinks (containing 32 mg caffeine/100 ml) causes adverse health effects in children (3 years and above), adolescents (14 to <18 years), pregnant women and the fetus, lactating women and the breastfed infant and adults (≥18 years). For children (3 to <10 years) and adults (≥18 years), the intake is above the intake that may increase sleep  latency and reduce sleep duration. For children (10 to <14 years) and adolescents (14 to <18 years), the intake is below the intake that may increase sleep latency and reduce sleep duration.

Open Access Grey Literature

Risk Assessment of "Other Substances" – D-Ribose

Ragna Bogen Hetland, Ellen Bruzell, Berit Granum, Trine Husøy, Jens Rohloff, Trude Wicklund, Inger-Lise Steffensen

European Journal of Nutrition & Food Safety, Page 187-189
DOI: 10.9734/EJNFS/2018/42543

The Norwegian Scientific Committee for Food Safety (NFSA) [Vitenskapskomiteen (VKM) for mattrygghet] has, at the request of the Norwegian Food Safety Authority (Mattilsynet; NFSA), assessed the risk of "other substances" in food supplements and energy drinks sold in Norway. VKM has assessed the risk of doses in food supplements and concentrations in energy drinks given by NFSA. These risk assessments will provide NFSA with the scientific basis while regulating the addition of “other substances” to food supplements and other foods.

 

"Other substances" are described in the food supplement directive 2002/46/EC as substances other than vitamins or minerals that have a nutritional and/or physiological effect. It is added mainly to food supplements, but also to energy drinks and other foods. VKM has not in this series of risk assessments of "other substances" evaluated any claimed beneficial effects from these substances, only possible adverse effects.

 

The present report is a risk assessment of D-ribose, and it is based on previous risk assessments and articles retrieved from a literature search.

 

According to information from NFSA, D-ribose is an ingredient in food supplements sold in Norway. NFSA has requested a risk assessment of 3100 and 6200 mg/day of D-ribose in food supplements for the age groups children (10 to <14 years), adolescents (14 to <18 years) and adults (>18 years).

 

Other sources of D-ribose, such as foods and cosmetics, have not been included in the present risk assessment.

 

D-ribose is a component of the genetic material RNA and is synthesized in all living cells via the pentose phosphate pathway. D-ribose is also a structural component of adenosine triphosphate (ATP), the primary source of cellular energy and a key component of riboflavin (e.g. vitamin B2). The estimated endogen synthesis of D-ribose is referred to be from 2.7 g per day (women) to 16.5 g per day (men). D-ribose is available in small amounts in the diet via ripe fruits and vegetables. It is also an ingredient in food supplements, some so-called energy drinks and in cosmetics as skin conditioner and humectant.

 

Orally administered D-ribose is absorbed in the small intestine by passive diffusion. Absorption rates after oral ingestion of doses up to 200 mg/kg bw per hour (administered for 5 hours) has been shown to range from 87.8 to 99.8% in humans.

 

No serious adverse health effects were identified at doses up to 20 g per day as reported in the human studies included in this opinion.

 

Based on a subchronic oral toxicity study in rats, no observed adverse effect levels (NOAELs) of 3.6 and 4.4 g/kg bw per day in males and females were derived. The NOAELs were based on a statistically significant decrease in body weight. In another study in rats, the NOAELs for embryo toxicity/teratogenicity of D-ribose were 3.6 and 4.6 g/kg bw per day based on individual females. This NOAELs were primarily based on a statistically significantly higher incidence of one or multiple wavy ribs in the mid- and high-dose groups compared to control animals.

 

No studies on children (10 to <14 years) and adolescents (14 to <18 years) were identified. Based on the included literature there was no evidence indicating that age affects tolerance for D-ribose. Therefore, in this risk characterisation a tolerance as for adults, based on body weight, were assumed for these age groups.

 

The values used for comparison with the estimated exposure in the risk characterization are 20 g per day (corresponding to 286 mg/kg bw per day in a 70 kg adult) considered to be without appreciable health risk for most healthy adults and the NOAEL of 3.6 g/kg bw per day from the subchronic toxicity and embryotoxicity/teratogenicity studies in rats.

 

From a daily dose of 3100 mg or 6200 mg of D-ribose, the intake levels are 71.4, 50.6 and 44.3 mg/kg bw per day and 142.6, 101.1 and 88.6 mg/kg bw per day for for children (10 to <14 years), adolescents (14 to <18 years) and adults (³18 years), respectively.

 

The calculated MOE values from the rat study for a daily intake of 3100 mg per day were 50.4, 71.1 and 81.3 for children (10 to <14 years), adolescents (14 to <18 years) and adults (³18 years), respectively. The calculated MOE values for a daily intake of 6200 mg per day were 25.2, 35.6 and 40.6 for children (10 to <14 years), adolescents (14 to <18 years) and adults (³18 years), respectively. In this case, MOE values below 100 are regarded as acceptable since D-ribose is present in all cells in the body and the daily doses from food supplements are in the same order as the endogenous production, which ranges from 2.7 g per day (women) to 16.5 g per day (men) (Bioenergy Life Science Inc., 2008).

 

VKM concludes that it is unlikely that daily doses of 3100 mg or 6200 mg D-ribose in food supplements causes adverse effects in children (10 to <14 years), adolescents (14 to <18 years) and adults (above18 years).

Open Access Grey Literature

Risk Assessment of "Other Substances" – Inulin

Ragna Bogen Hetland, Ellen Bruzell, Berit Granum, Trine Husøy, Jens Rohloff, Trude Wicklund, Inger-Lise Steffensen

European Journal of Nutrition & Food Safety, Page 190-192
DOI: 10.9734/EJNFS/2018/42544

The Norwegian Scientific Committee for Food Safety (Vitenskapskomiteen for mattrygghet, VKM) has, at the request of the Norwegian Food Safety Authority (Mattilsynet, NFSA), assessed the risk of "other substances" in food supplements and energy drinks sold in Norway. VKM has assessed the risk of doses given by NFSA. These risk assessments will provide NFSA with the scientific basis while regulating the addition of “other substances” to food supplements and other foods.

 

"Other substances" are described in the food supplement directive 2002/46/EC as substances other than vitamins or minerals that have a nutritional or ph ysiological effect. It is added mainly to food supplements, but also to energy drinks and other foods. In this series of risk assessments of "other substances", VKM has not evaluated any claimed beneficial effects from these substances, only possible adverse effects.

 

The present report is a risk assessment of inulin, and it is based on previous risk assessments and articles retrieved from a literature search.

 

According to information from NFSA, inulin is an ingredient in food supplements sold in Norway. NSFA has requested a risk assessment of the dose 3 g/day of inulin in food supplements.

The total exposure to inulin from other sources than food supplements and cosmetics, such as foods, is not included in the risk assessment.

 

Inulin is a naturally occurring carbohydrate found in a variety of vegetables and fruits such as onions, leeks, garlic, asparagus, artichokes, bananas and wheat. Chicory root is the most common source of industrially produced inulin. Inulin belongs to the nondigestible polysaccharides which are carbohydrates that resist digestion in the small intestine but are fermented by bacteria in the colon.

 

No serious adverse health effects were identified in the human studies included in this opinion. The reported negative health effects of inulin-type fibres are generally mild gastrointestinal symptoms and include diarrhea, abdominal rumbling, bloating, cramping and excessive flatulence. Such effects occur over a wide range of doses and may also depend on the source of inulin. Chain length influences the negative gastrointestinal effects, which will be less with long-chained inulin molecules. As a pragmatic approach, the intake of 5 g/day of inulin from agave and Jerusalem artichoke and 10 g/day of inulin from chicory root and globe artichoke were chosen as the values for comparison with the exposure to inulin from food supplements in the risk characterization. These doses were without serious adverse health effects, even though mild gastrointestinal effects may occur in some/sensitive individuals. These doses are in the same range as the estimated average consumption of inulin from food in Europe (3 – 11 g/day). Data indicates that also doses up to 20 g/day may be well tolerated by most people. However, there is a wide interpersonal variability in the doses at which gastrointestinal effects associated with the colonic fermentation will appear.

 

No studies on children (10 to <14 years) and adolescents (14 to <18 years) were identified. Based on the included literature there was no evidence indicating that age affects tolerance for inulin. Therefore, in this risk assessment the same tolerance as for adults was assumed for these age groups (adjusted for body weight).

 

From a daily dose of 3 g inulin, the calculated intake levels are 69.1, 48.9 and 42.9 mg/kg bw per day for children (10 to <14 years), adolescents (14 to <18 years) and adults (³18 years), respectively. In the risk characterisation, the values used for comparisons with the exposure from food supplements is 5 g/day of inulin from agave and Jerusalem artichoke and 10 g/day of inulin from chicory root and globe artichoke (corresponding to 71 and 143 mg/kg bw per day, respectively, in a 70 kg adult).

 

Comparing the exposure of a daily dose of 3 g/day of inulin from food supplements with the inulin doses of 5 g/day and 10 g/day considered to be without appreciable risk for most healthy adults, it is unlikely that this dose in food supplements causes any adverse health effects in children above 10 years, adolescents and adults.

 

VKM concludes that it is unlikely that a daily dose of 3 g of inulin from food supplements causes adverse health effects in children (10 to <14 years), adolescents (14 to <18 years) and adults (≥18 years).

Open Access Grey Literature

Assessment of Copper Intake in Relation to Tolerable Upper Intake Levels

Tor A. Strand, Inger Therese L. Lillegaard, Livar Frøyland, Margaretha Haugen, Sigrun Henjum, Martinus Løvik, Tonje Holte Stea, Kristin Holvik

European Journal of Nutrition & Food Safety, Page 193-194
DOI: 10.9734/EJNFS/2018/42531

The Norwegian Scientific Committee for Food Safety (Vitenskapskomiteen for mattrygghet, VKM) has, at the request of the Norwegian Food Safety Authority (Mattilsynet; NFSA), evaluated the intake of copper in the Norwegian population in relation to tolerable upper intake levels (ULs). VKM has also conducted scenario calculations to illustrate the consequences of amending maximum limits for copper to 1, 2, or 3, mg/day in food supplements. The existing maximum limit is 4 mg/day.

Copper is a micronutrient essential for energy utilisation, brain function (neurotransmitter regulation), soft tissue and bone (collagen synthesis), nutrient metabolism (especially iron) and antioxidant defence against free radicals. Foods account for 90% or more of copper intake in adults when the copper content in drinking water is low (< 0.1 mg/L). If the copper content is higher (> 1-2 mg/L), water may account for up to 50% of total intake (EFSA, 2015).

 

We reviewed four risk assessments undertaken by the Institute of Medicine (IOM), Scientific Committee on Food (SCF), Expert Committee on Vitamins and Minerals (EVM), and the Nordic Nutrition Recommendations (NNR). Liver damage was selected as a critical endpoint from which to derive a UL because it was judged to be the most reliable marker and consequence of a long-term chronic high copper intake. However, copper-related liver damage is observed almost exclusively in patients with genetic predispositions of copper accumulation.

 

VKM suggest to use the UL at 5 mg/day (NNR Project Group, 2012; SCF, 2003). This UL was derived from human studies.In the light of the evidence, SCF decided that an uncertainty factor (UF) of 2 was adequate to allow for potential variability within the normal population, whereas the Institute of Medicine (IOM) applied a UF of 1. VKM find the higher UF suitable because human data is limited, the uncertainty of the copper content of drinking water and the potential severe and irreversible adverse effects.

 

According to the scenario calculations, adults and 13-year-olds with high copper intakes from regular foods (95 th percentile) will exceed the ULs with supplemental copper at doses of 3 mg/day or higher. 9-year-old children will exceed the UL with use of 2 mg supplemental copper per day. For younger children the ULs will be exceeded in more than 5% without adding supplemental copper.

 

In our calculations, copper from drinking water is not included. Copper concentrations in annual samples from waterworks are in general below 0.1 mg/L (Nordheim et al., 2016).

Open Access Grey Literature

Assessment of Dietary Intake of Chromium (III) in Relation to Tolerable Upper Intake Level

Martinus Løvik, Livar Frøyland, Margaretha Haugen, Sigrun Henjum, Tonje Holte Stea, Tor A. Strand, Christine Louise Parr, Kristin Holvik

European Journal of Nutrition & Food Safety, Page 195-197
DOI: 10.9734/EJNFS/2018/42532

The Norwegian Scientific Committee for Food and Environment (Vitenskapskomiteen for mat og miljø, VKM) has, at the request of the Norwegian Food Safety Authority (Mattilsynet; NFSA), evaluated the intake of chromium. VKM has also conducted scenario calculations to illustrate the consequences of establishing maximum limit for chromium at 50, 125, 200 or 300 μg/day in food supplements. The former maximum limit for chromium of 125 μg/day in food supplements was revoked 30 May 2017.

 

Chromium is present in food and supplements mainly as trivalent chromium, Cr(III), whereas in drinking water, chromium is present mainly as Cr(VI). Trivalent chromium has been reported to be an essential trace element in that it has been postulated to be necessary for the efficacy of insulin in regulation of the metabolism of carbohydrates, lipids and proteins. However, no mechanisms for these roles have been identified. Absorption of Cr(III) from food has been estimated to range from 0.4 to 2.5%, depending among other factors on the chemical properties of the ingested source and the presence of other dietary components. Absorption efficiency of supplemental Cr(III) has been reported to be between 0.1 and 5.2%, and to vary between the chromium complex ingested.

In general, Cr(III) has very low toxicity by the oral route (ATSDR, 2012), and there are hardly any well-documented observations of toxicity after peroral intake in humans. In a series of animal repeat dose toxicity studies, the no observed adverse effect level (NOAEL) for general toxicity was consistently the highest dose tested (EFSA, 2014b).

 

Chromium is ubiquitous in foods, and rich sources include meat and meat products, oils and fats, breads and cereals, fish, pulses and spices.

 

There are no Norwegian recommendations for intake of chromium. The Nordic Nutrition Recommendations and the European Food Safety Authority (EFSA) concluded that no recommendations could be given for chromium due to lack of sufficient evidence (EFSA, 2014a; NNR Project Group, 2012). Furthermore, no tolerable upper intake levels (UL) have been established for chromium. However, the EFSA Panel on Contaminants in the Food Chain (CONTAM Panel) suggested a tolerable daily intake (TDI) at 300 μg trivalent chromium per kg bodyweight per day based on a NOAEL in a rat study and an uncertainty factor at 1000. Due to uncertainty in the available data on developmental and reproduction toxicity, the EFSA Panel applied an uncertainty factor of 10 in addition to the default uncertainty factor of 100 for the extrapolations from rodents to humans and for human variability.

 

The chromium intake in Norway is not known, since Norwegian food composition data are not available. VKM has therefore based this evaluation upon intake data from EFSA. Values from EFSA are likely to be valid also for Norway. Median dietary chromium intakes were 28.6 -44.0 μg/day (medians of lower and upper bound) in the category toddlers (1 to < 3 years), 55.4-76.2 μg/day in other children (3 to < 10 years), 52.1-69.4 μg/day in adolescents (≥10 to <14 years), 73.6-98.1 in adolescents (≥14 to <18 years) and 63.0-84.0 μg/day in adults (18-65 years) (EFSA, 2014b). These values are 80-300 times lower than the suggested tolerable daily intake (TDI).

 

To illustrate the consequences of amending maximum limits for chromium to 50, 125, 200 or 300 μg per daily dose in food supplements, VKM has compared these levels and various intakes from food to the TDI at 300 μg/kg bw per day.

 

Even with the highest level of supplemental intake and additional median levels as well as the 95 percentile intakes from food, the estimated exposure will be 16-48 times lower than the TDI of 300 μg/kg bw per day in all age groups except for the 95 th percentile intake in toddlers, where it will be about nine times lower.

 

VKM emphasises that the current assessment of maximum limits for Cr(III) in food supplements is merely based on published reports concerning upper levels from the WHO (1996), IOM (2001, USA), SCF (2003, EU), EVM (2003, UK) , NNR (2012, Nordic countries), and EFSA (2014b). VKM has not conducted any systematic review of the literature for the current opinion, as this was outside the scope of the terms of reference from NFSA.

Open Access Grey Literature

Assessment of Dietary Intake of Phosphorus in Relation to Tolerable Upper Intake Levels

Margaretha Haugen, Inger Therese L. Lillegaard, Livar Frøyland, Sigrun Henjum, Martinus Løvik, Tonje Holte Stea, Tor A. Strand, Kristin Holvik

European Journal of Nutrition & Food Safety, Page 198-200
DOI: 10.9734/EJNFS/2018/42533

The Norwegian Scientific Committee for Food Safety (Vitenskapskomiteen for mattrygghet, VKM) has, at the request of the Norwegian Food Safety Authority (Mattilsynet; NFSA), evaluated the intake of phosphorus in the Norwegian population. VKM has also conducted scenario calculations to illustrate the consequences of amending maximum limits for phosphorus (to 1000, 2000 or 2500 mg/day) in food supplements.

 

Phosphorus is an essential nutrient and is involved in many physiological processes, such as in the cell’s energy cycle, in regulation of the body’s acid-base balance, as a component of the cell structure, in cell regulation and signalling, and in the mineralisation of bones and teeth. In the human body, phosphorus is present in different forms. Serum contains mainly inorganic phosphates (Pi) (dihydrogen and monohydrogen phosphate), bone contains phosphorus largely in the form of hydroxyapatite, whereas the soft tissues and extracellular fluids contain organic phosphates in complex with carbohydrates, lipids and proteins. Phosphorus is the main mineral constituent of bones. About 85% of the body’s phosphorus is in bones and teeth, and together with calcium account for around 80-90% of bone composition. The remaining 15% of the body’s phosphorus is essential in functions ranging from the transfer of genetic information to energy utilisation. Phosphorus is a structural component of the nucleic acids DNA and RNA and thus involved in the storage and transmission of genetic material. It is an essential component of phospholipids (e.g. phosphatidylcholine) that form all membrane bilayers throughout the body. Phosphorus is also an essential component of adenosine triphosphate (ATP), the body’s key energy source.

 

Currently there is no reliable biomarker of phosphorus status, and serum phosphorus increases for a short period after ingestion of a meal and then decreases and remains within a relatively narrow range as a result of homeostatic mechanisms.

 

The EFSA recommendations (2015) for adequate intake (AI) of phosphorus is 550 mg/day for adults, both sexes, whereas the recommended intake (RI) in the Nordic Nutrition Recommendations (2012) is 600 mg/day. Adolescents have a higher requirement of phosphorous because of bone accretion (640 mg/day EFSA and 700 mg/day NNR).

 

EFSA (2005) concluded that the available data were not sufficient to establish a tolerable upper level for phosphorus, however, data indicate that normal healthy individuals can tolerate phosphorus intakes up to 3000 mg/day. EFSA advised supplemental intake not to exceed 750 mg/day, because mild gastrointestinal symptoms have been reported when this dose was increased. EFSA gave no UL suggestions for children, lactating or pregnant women, while Institute of Medicine set a UL for total intake of phosphorous for children at 3000 mg/day and 4000 mg/day for adolescents and adults and 3500 mg/day for lactating women.

 

In accordance with EFSA (2005), VKM suggests to use 3000 mg/day as a provisional UL for total intake of phosphorous for adults, and suggests 750 mg/day as an upper level for supplements. Because of lack of data no provisional ULs are set for adolescents or children.

Accordingly, all the suggested doses from NFSA (1000, 2000 and 2500 mg/day) in supplements exceed 750 mg/day, the suggested UL for supplemental phosphorus for adults.

Open Access Grey Literature

Assessment of Dietary Intake of Potassium in Relation to Upper Guidance Level

Margaretha Haugen, Inger Therese L. Lillegaard, Livar Frøyland, Sigrun Henjum, Martinus Løvik, Tonje Holte Stea, Tor A. Strand, Kristin Holvik

European Journal of Nutrition & Food Safety, Page 201-203
DOI: 10.9734/EJNFS/2018/42534

The Norwegian Scientific Committee for Food Safety (Vitenskapskomiteen for mattrygghet, VKM) has, at the request of the Norwegian Food Safety Authority (Mattilsynet; NFSA), evaluated the intake of potassium in the Norwegian population. VKM has also evaluated the consequences of amending the existing maximum limit for potassium at 1000 mg/day to 300, 2000 or 3000 mg/day in food supplements.

 

Potassium is an essential mineral to humans and is important as the osmotically active element inside the cells, whereas sodium and chloride are the main elements outside the cells. The enzyme Na+/K+ -ATPase pumps potassium ions into the cells and sodium ions out of the cells and helps keep the intracellular potassium concentration about 30 times higher than that of plasma and interstitial fluids.

 

The plasma potassium concentration is maintained within narrow limits (3.5 to 5.0 mmol/L) by multiple mechanisms making up the potassium homeostasis. The strict regulation is essential for a broad array of important physiological processes, like the resting cellular membrane potential and the transmission action in neuronal, muscular and cardiac tissue. Potassium is also important for hormone secretion, vascular tone, systemic blood pressure control, gastrointestinal motility, acid-base balance, glucose and insulin metabolism, mineralocorticoid action, renal concentration ability and fluid and electrolyte balance. Both hypo- and hyperkalaemia result in increased mortality.

 

The EFSA recommendations (2016) for adequate intake (AI) of potassium is 3500 mg/day for adults, both sexes, whereas the recommended intake (RI) in the Nordic Nutrition recommendations (2012) is 3500 mg/day for men and 3100 mg/day for women.

 

Tolerable upper intake levels have not been established for potassium from food, because intake from food has not caused adverse health effects in the healthy population. In children the renal function rapidly reaches the normal adult level in early childhood and no concern about high intake of potassium from food has been put forward.

 

Potassium chloride supplement has, however, resulted in hyperkalaemia and case reports have described heart failure and cardiac arrest at plasma concentrations above 5.5 mmol/L and doses over 6.5 - 6.8 g supplementary potassium per day.

 

VKM proposes to use 3000 mg/day of potassium as an upper guidance level for daily dose of supplemental potassium in adults since this dose has not been shown to cause hyperkalaemia or heart failure, and has not resulted in gastrointestinal lesions.

 

The proposed upper guidance level for adults extrapolated for body weights corresponds to 2630 mg/day for adolescents 14 to <18 years, 1860 mg/day for children 10 to < 14 years and 990 mg/day for children 3 to 10 years.

 

For vulnerable groups all doses of potassium supplementation could lead to hyperkalaemia. Vulnerable groups such as persons with impaired kidney function and elderly have been estimated to comprise 15-20% of the population of Norway. However, most of the vulnerable individuals will be aware of the condition and be under medical supervision.

 

Accordingly, all the evaluated doses from NFSA (300, 1000, 2000 and 3000 mg/day of potassium in food supplements are at or below the suggested upper guidance level for supplemental potassium for adults (>18 years). In adolescents 14 to <18 years, the supplemental doses of 300, 1000 and 2000 mg/day are below the suggested upper guidance level. For the younger age groups, only 300 mg/day is below the suggested upper guidance level for supplemental potassium.

Open Access Grey Literature

Assessment of Dietary Intake of Vitamin C and Calcium in the Norwegian Population

Margaretha Haugen, Inger Therese L. Lillegaard, Livar Frøyland, Kristin Holvik, Martinus Løvik, Tor A. Strand, Grethe S. Tell, Per Ole Iversen

European Journal of Nutrition & Food Safety, Page 233-236
DOI: 10.9734/EJNFS/2018/43855

The Norwegian Scientific Committee for Food Safety (Vitenskapskomiteen for mattrygghet, VKM) has, at the request of the Norwegian Food Safety Authority (Mattilsynet; NFSA), evaluated the intake of vitamin C and calcium in the Norwegian population. VKM has also conducted scenario estimations to illustrate the consequences of amending maximum limits for vitamin C (to 100, 300, 500, 600, 800 or 1000 mg/day) and calcium (to 800, 1200 or 2000 mg/day) in food supplements.

 

Vitamin C:

 

Vitamin C refers to both ascorbic acid and dehydroascorbic acid. Scurvy is the manifestation of vitamin C deficiency which is preventable by a daily intake of 5-10 mg/day. Fruits, berries and vegetables are important food sources of vitamin C and especially citrus fruit are important contributors. The Norwegian recommendation for dietary intake of vitamin C is 75 mg/day for adults (Helsedirektoratet, 2014).

 

Vitamin C is absorbed from the intestine by an active process that is dose dependent. The bioavailability is at least 80% for doses up to 100 mg, 70% for doses of 200-500 mg and less than 50% for doses exceeding 1000 mg.

 

Intestinal discomfort and diarrhea have been reported by persons using large doses (>1000 mg/day) of vitamin C supplementation. In 2000 the Institute of Medicine (IOM) in the USA proposed a tolerable upper intake level (UL) for vitamin C intake from food and supplements of 2000 mg/day for adults. ULs for children and adolescents were extrapolated based on body weight; 400 mg for children 1-3 years, 650 mg/day for children 4-8 years, 1200 mg/day for 9-13 years old adolescents, 1800 mg/day for 14-18 years old (IOM, 2000).

 

In the assessment of vitamin C, VKM uses the Norwegian recommendations for intakes (Helsedirektoratet, 2014), and the acceptable dose for supplemental vitamin C from EFSA (2004) for adults and the tolerable upper intake levels established by the IOM (2000) for children and adolescents. Daily intakes of vitamin C from diet and supplements are estimated from nationwide dietary surveys performed in selected age groups: Adults 18-70 years, adolescents aged 13 years, and children aged 2, 4, and 9 years.

 

Not all age-groups in the Norwegian population reach the recommended intake of vitamin C. At the 5th percentile, only 13-year-olds have an intake of vitamin C from food alone above the recommendations. At the 25th percentile, all age groups except adults have a vitamin C intake from food alone at or above the recommendations. At the 40th percentile, adults reach the recommended intake of vitamin C.

 

The whole population would reach the recommended dietary intake with supplementation of 100 mg vitamin C per day.

 

All the alternative maximum limits for vitamin C in food supplements listed in the terms of reference from NFSA (100, 300, 500, 600, 800 or 1000 mg/day) will be within the acceptable dose for supplemental vitamin C suggested by EFSA (2004) for adults. None of the alternative maximum limits for vitamin C in food supplements listed in the terms of reference (100, 300, 500, 600, 800 or 1000 mg/day) leads to exceedance of the tolerable upper intake levels established by IOM in adults, 13- year-olds or 9-year-olds, even with intakes from food at the 95th percentile.

 

However, the tolerable upper intake level proposed by the IOM will be exceeded for 4-year-old children at supplemental doses above 500 mg vitamin C per day, and for 2-year-old children at doses higher than 100 mg/day.

 

Calcium:

 

Calcium is the most abundant mineral in the body and constitutes approximately 1200 g and 1400 g in adult women and men, respectively. More than 99% of the calcium in the body is bound to hydroxyapatite in bone and tooth enamel. Calcium is crucial for many bodily functions such as cell signalling, coagulation, muscular contraction, and neural transmission as well as skeletal integrity. Milk and dairy products are the main dietary sources of calcium, but foods such as fish, pulses, nuts, seeds (especially millet) and green vegetables may contribute to the total intake. The Norwegian recommendation for dietary intake of calcium is 800 mg/day for adults.

 

The bioavailability of calcium is dependent on the amount of calcium ingested as well as the individual’s vitamin D status and physiological needs, like e.g. growth and pregnancy.

 

Adverse effects of excessive calcium intake include symptoms of hypercalcaemia such as e.g. anorexia, weight loss, polyuria, heart arrhythmias, fatigue and soft tissue calcification (Jones, 2008 in IOM, 2011), deterioration of kidney function, kidney stone formation, the milk-alkali syndrome and vascular calcification.

In 2012 the European Food Safety Authority (EFSA) established a tolerable upper intake level (UL) for calcium at 2500 mg/day from food and supplements for adults. No UL was set for children and adolescents.

 

In 2011, IOM established a UL for 1-8 years old children to 2500 mg/day and 3000 mg/day for 9-18 years old children and adolescents (IOM, 2011). VKM however suggests that the UL established for adults by EFSA (2012) is used for the purpose of this VKM opinion also for children and adolescents, as the ULs from IOM for children and adolescents are considered to be high.

 

In the assessment of calcium, VKM uses the Norwegian recommendations for intakes (Helsedirektoratet, 2014) and the tolerable upper intake levels established by the European Food Safety Authority for adults (includes both foods and supplements) (EFSA, 2012). Daily intakes of calcium from diet and supplements are estimated from nationwide dietary surveys performed in selected age groups: Adults 18-70 years, adolescents aged 13 years, and children aged 2, 4, and 9 years.

 

Not all age groups in the Norwegian population reach the recommended intake of calcium. At the 5th percentile, no age groups fulfil the recommended daily intakes of calcium from food alone, and in the 50th percentile the 13-year-olds did not reach the recommended intake for calcium from food alone. At approximately the 65th percentile, the 13-year-olds reach the recommended intake for calcium.

 

The whole population would reach the recommended dietary intake with supplementation of 800 mg calcium per day.

 

For calcium, three alternative maximum limits were listed in the terms of reference (800, 1200 and 2000 mg/day). In the scenarios for high intakes of calcium, a dietary calcium intake at the 95th percentile and additionally 800 mg calcium from food supplements, will lead to an intake close to the tolerable upper intake level established by EFSA for the adult population, and supplements with 1200 or 2000 mg calcium per day will lead to exceedance of the tolerable upper intake level in adults.

 

Children and adolescents with a dietary intake at the 95th percentile and additionally 2000 mg calcium from food supplements, will all exceed the UL suggested for adults by EFSA in 2012. All age groups except 4-year-olds will also exceed the UL with 1200 mg supplemental calcium. With 800 mg supplemental calcium 13-year-old adolescents, 9-year-old, 4 year-old and 2-year-old children will not exceed the suggested UL.

Open Access Grey Literature

Assessment of Antimicrobial Resistance in the Food Chains in Norway

Siamak Yazdankhah, Danica Grahek-Ogden, Brit Hjeltnes, Solveig Langsrud, Jørgen Lassen, Madelaine Norström, Marianne Sunde, Karl Eckner, Georg Kapperud, Judith Narvhus, Truls Nesbakken, Lucy Robertson, Jan Thomas Rosnes, Olaug Taran Skjerdal, Eystein Skjerve, Line Vold, Yngvild Wasteson

European Journal of Nutrition & Food Safety, Page 237-239
DOI: 10.9734/EJNFS/2018/43854

The Norwegian Food Safety Authority (NFSA) asked the Norwegian Scientific Committee for Food Safety (Vitenskapskomiteen for mattrygghet, VKM) for an assessment of antimicrobial resistance (AMR) in the food chains in Norway, with focus on each of the following food chains: pigs and pork products; poultry, eggs and poultry products; cattle and bovine products; aquaculture and aquaculture products; fresh produce (fruit, berries, and vegetables); and drinking water.

 

AMR in imported food has not been assessed in this report. AMR in Norwegian food chains has been assessed in terms of probability of exposure to humans. Due to data constraints, it has not been possible to assess the consequences of this exposure for human health.

 

VKM appointed a working group consisting of three members of the Panel on Biological Hazards, one member of Panel on Animal Health and Welfare, and four external experts to prepare a draft Opinion document and the answer the questions. The Panel on Biological Hazards has reviewed and revised the draft prepared by the working group and approved the Opinion document «Assessment of antimicrobial resistance in the food chains in Norway”.

 

AMR can be described as the ability of a bacterium to withstand the effects of an antimicrobial. The clinical antimicrobial resistance crisis has focused attention on all uses of antimicrobial agents, including their use in human medicine, veterinary medicine, and in agriculture and aquaculture. AMR is considered the greatest challenge to face health care in 21st century, and there is increasing concern and debate about which roles the food production chains play as reservoirs and disseminators of AMR.

 

This assessment addresses several food chains. The report does not characterise all forms of AMR that may occur in these chains, but puts emphasis on the resistant bacteria and resistance determinants that have emerged at the animal-human interface in recent decades. VKM’s choice is based on zoonotic potential and the limited alternatives available for treatment of infections. In order for a comprehensive and detailed assessment to be conducted, these particular resistance forms need to be characterised and assessed separately.

 

At an overall level, the hazard regarding exposure of humans to antimicrobial resistant bacteria from cattle, milk/milk products, fish/fish products/seafood, fresh produce, water, and food processing in Norway is considered by VKM to be negligible.

 

Current data regarding possible pathways for transmission of LA-MRSA via contaminated food/meat to the broader human population fail to implicate LA-MRSA from pigs as a foodborne pathogen. Compared with other animal products, poultry and poultry products are regarded as the most important reservoirs of ESBL/AmpC-producing Enterobacteriaceae, quinolone-resistant E. coli (QREC), and their corresponding resistance determinants. The probability of human exposure of ESBL/AmpC-producing Enterobacteriaceae and QREC via poultry is assessed as being non-negligible.

 

Probability of AMR Transfer Associated with Food and Uncertainties:

 

In this assessment, the probability of transmission of AMR from food chains to humans has been either categorized as negligible or non-negligible according to the following definitions:

 

Negligible – the probability of transfer of AMR is extremely low. Negligible probability should be considered insignificant.
Non-negligible – the probability of transfer of AMR is greater than negligible. Non-negligible probability should be considered significant, but the available data are currently insufficient to enable discrimination between the different levels.

 

Lack of data has made it difficult to reach any firm conclusions regarding the probability of AMR transmission from food to humans in Norway. Similarly, ranking the probabilities with regard to relative importance is largely not possible with the data available.

 

The probability of transfer of AMR from cattle, milk/milk products, fish, seafood, and drinking water has been assessed to be negligible.

 

The probability of transfer of LA-MRSA from live pigs to humans is considered to be non-negligible, while the probability of transfer from pork to humans has been assessed to be negligible.

 

The probability of transfer of ESBL/AmpC-producing Enterobacteriaceae, quinolone-resistant E. coli, and their respective corresponding genes from live poultry and poultry meat is considered as non-negligible.

 

Processing of food, such as cooking or preservation, can reduce the number of bacteria in the products and thus decrease the transmission of antimicrobial resistant bacteria from food to humans.

It should be noted that both categories of probabilities (negligible and non-negligible) in this assessment are associated with a number of uncertainties. Bacteria are living organisms that are under continuous evolution, and are able to adapt rapidly to changing living conditions. This report is an assessment of the current situation with regards to development and dissemination of antibiotic resistant bacteria and their resistance genes in the food chain. This situation may change as the bacteria continue to adapt to the selection pressures exerted by the worldwide use of antimicrobials. Such bacterial changes, sometimes occurring VKM Report 2015:29 9 in “quantum leaps” due to horizontal gene transfer (HGT), may also rapidly change the probability of transfer of resistance to specific antimicrobials.

 

Data Gaps:

 

There is a lack of knowledge regarding the vast reservoir of AMR in the environmental, animal, and food reservoirs. Furthermore, there is lack of data regarding the routes and frequencies of transmission of AMR from live, food-producing animals and foodstuffs of different origins to humans and vice versa.

Open Access Grey Literature

Criteria for Safe Use of Plant Ingredients in Diets for Aquacultured Fish

Gro-Ingunn Hemre, Heidi Amlund, Marit Aursand, Anne Marie Bakke, Rolf Erik Olsen, Einar Ringø, Birger Svihus, Birger Svihus, Aksel Bernhoft, Bjørn M. Jenssen, Trond Møretrø, Live Lingaas Nesse, Ole Torrissen

European Journal of Nutrition & Food Safety, Page 240-242
DOI: 10.9734/EJNFS/2018/43861

The Norwegian Food Safety Authority (Mattilsynet) asked the Norwegian Scientific Committee for Food Safety (Vitenskapskomiteen for mattrygghet) to assess if the criteria for safe use of plant ingredients in diets for aquacultured fish fulfil the Feed regulative §7 to “not induce negative health effects in the animal”, and in this context aquacultured fish. The use of feed ingredients of both plant and animal origin is set by the regulation “Forskrift 7. November 2002 nr 1290”, and amendments. The objective of the regulation is to protect animals, consumers and the environment. For animals, the feed shall not pose a risk, or danger, to their health.

 

Aspects to be assessed were whether the changes in fish diet ingredient composition seen in

recent years with high levels of plant ingredients, plus additions of immunostimulants, would in any manner challenge fish health and if any ingredient should be limited due to its negative effect, or induce any long-term negative effect. “Long-term” here extends beyond normal production time for consumption, e.g. when substances that might affect fish health are included in broodstock diets. Atlantic salmon (Salmo salar), rainbow trout (Onchorhyncus mykiss), Atlantic halibut (Hippoglossus hippoglossus) and Atlantic cod (Gadus morhua) should especially be addressed. However, since all life stages should be included, especially broodstock, and also possible long-term effects, and literature on these for the requested species is scarce, the assessment mentions studies on other species when relevant.

 

With the exception of full-fat and extracted soybean meal for salmonids, substituting at least part of the fishmeal fraction of aquafeeds with individual plant ingredients is promising, at least in the short to medium term. Indeed in some cases, diets containing up to 20% inclusion level of high-quality plant protein sources have resulted in better nutrient digestibility and growth parameters than the fishmeal-based control diets. When substituting fishmeal with plant ingredients, however, it is necessary to balance the diets regarding limiting amino acids and minerals. Adding plant proteins to fish diets result in the introduction of anti-nutritional factors. There is an urgent need to investigate consequences of various anti-nutritional factors, individually and in combinations, to nutrient digestibility, utilization and metabolism as well as to intestinal function, structure, defence mechanisms and microbiota. Long-term effects also merit investigation. This will aid in the ability to predict how a newly introduced plant ingredient as well as combinations of plant ingredients may affect the fish and identify steps needed to avoid adverse health effects.

 

As many of the potential disadvantages of using plant oils in salmonid diets are related to either very high levels of n-6 PUFA (most available oils) or very high levels of linseed oil, it would be recommended that mixtures of plant oils should be used as feed inclusions. By adjusting the ratio of n-6 and n-3 the level of eicosanoids can be controlled. By including palm oil, potential problems in lipid digestibility and transport can be controlled. A standard inclusion of soybean lecithin may also be advisory. These and other variants of mixtures of oil sources have been explored in recent years with some success in salmonid fish. Such mixtures do not seem to be necessary for marine fish.

 

Modern finfish aquaculture faces problems such as bone and skeletal deformities, cataracts, heart disorders, unspecific ulceration and various digestive disorders including intestinal colic in Atlantic cod, gastric dilatation (bloat) in rainbow trout, and intestinal tumours, at low incidence, in Atlantic salmon broodstock. Most of the mentioned problems have been related to malnutrition, feed, intensive growth and/or unfavourable environmental conditions. The disorders are often not lethal, but may imply a fish welfare problem and increase the susceptibility to secondary disorders and infectious diseases. Major changes in feed composition and feed ingredients may increase the risk for such production-related disorders in intensive fish farming. Care should be taken when choosing plant alternatives, both types and qualities, to prevent nutrition-related diseases such as skeletal deformities, cataracts, heart conditions, and other, unspecific symptoms.

 

The change from marine- to plant-based diet ingredients, results in changed profile and content of undesirable substances. The list of undesirable substances included in the feed legislation is, in general, sufficient, but it should be considered to include pesticides in use today and more of the mycotoxins. Currently only aflatoxin B1 is included, while only recommendations exist for other mycotoxins. Studies of dietary exposure to undesirable substances, e.g. pesticides and mycotoxins, and their toxic effects and toxicokinetics in fish are scarce.

 

To date, the application of pre- and probiotics for the improvement of aquatic environmental quality and for disease control in aquaculture seems promising; however, the information is limited and sometimes contradictory. Currently there are numerous gaps in existing knowledge about exogenous nucleotide application to fish including various aspects of digestion, absorption, metabolism, and influences on various physiological responses, especially expression of immunogenes and modulation of immunoglobulin production. As limited information is available about the effect of immunostimulants, prebiotics and nucleotides on gut morphology, this topic should be given high priority in future studies.

Heat processing of raw materials and of the complete fish diets may potentially alter nutritional properties of plant materials. However, the negative effects appear to be modest under practical conditions.

Open Access Grey Literature

Assessment of Zinc Intake in Relation to Tolerable Upper Intake Levels

Tor A. Strand, Inger Therese L. Lillegaard, Livar Frøyland, Margaretha Haugen, Sigrun Henjum, Kristin Holvik, Martinus Løvik, Bjørn Steen Skålhegg, Tonje Holte Stea, Per Ole Iversen

European Journal of Nutrition & Food Safety, Page 243-244
DOI: 10.9734/EJNFS/2018/43860

The Norwegian Food Safety Authority (NFSA, Mattilsynet) has requested the Norwegian Scientific Committee for Food Safety (VKM) to assess the intake of iron zinc in the Norwegian population in relation to tolerable upper intake levels (ULs). The existing maximum limit for zinc in food supplements is 25 mg/day.

 

VKM has also conducted scenario calculations to illustrate the consequences of amending the maximum limit to 1, 2, 5, 10, 15 or 20 mg/day.

 

Zinc is an essential trace element required for RNA, DNA and protein synthesis, cellular division, differentiation and growth (Mac Donald, 2000). Zinc is required for catalytic function in several enzymes and participates in all major biochemical pathways in the body. The function of the immune system depends on the ability of its cells to proliferate and differentiate, which is impaired in individuals with suboptimal zinc status (Barton et al. 2000). Due to its role in cell division and differentiation, adequate zinc nutrition is particularly important in children, and the requirements per kg body weight are highest in early life. The endogenous intestinal losses can vary from 7 mmol/day (0.5 mg/day) to more than 45 mmol/day (3 mg/day), depending on zinc intake (King and Turnlund, 1989).

 

The requirements for zinc vary according to age and bioavailability. Several bioactive compounds in food such as tannins and phytic acids interact with zinc absorption and increase zinc requirements. The requirements vary twenty-fold according to life stage and diet. 

 

Zinc supplements, even at or slightly above the recommended intakes, can cause nausea and vomiting. The main concern with chronic zinc excess is, however, copper deficiency which is associated with several chronical illnesses. However, copper deficiency is uncommon due to the ubiquitous presence of copper in the diet.

 

VKM proposes to use the ULs set by IOM (2001) as they provide values also for children and adolescents. The tolerable upper intake level set for adults is 40 mg zinc per day from food (and water) and supplements.

 

Based on the scenario estimations, a dietary zinc intake at the 95th percentile and additionally 20 mg zinc from food supplements will lead to an intake close to the tolerable upper intake level established by IOM for adults. For adolescents and child populations the maximum amounts are 15 and 5 mg for 13- and 9-year-olds, respectively. For 2 and 4-yearolds, P95 from intake of zinc from food alone exceeds the UL.

Open Access Grey Literature

Risk Assessment of Bacillus coagulans Used as "Other Substances"

Danica Grahek-Ogden, Karl Eckner, Georg Kapperud, Jørgen Lassen, Judith Narvhus, Truls Nesbakken, Lucy Robertson, Jan Thomas Rosnes, Olaug Taran Skjerdal, Eystein Skjerve, Line Vold, Siamak Yazdankhah, Yngvild Wasteson

European Journal of Nutrition & Food Safety, Page 245-246
DOI: 10.9734/EJNFS/2018/43863

The Norwegian Scientific Committee for Food Safety (Vitenskapskomiteen for mattrygghet, VKM) has, at the request of the Norwegian Food Safety Authority (Mattilsynet; NFSA), assessed the risk of "other substances" in food supplements sold in Norway. These risk assessments will provide NFSA with the scientific basis while regulating the addition of “other substances” to food supplements and other foods.

 

"Other substances" are described in the food supplement directive 2002/46/EC as substances other than vitamins or minerals that have a nutritional and/or physiological effect. It is added mainly to food supplements, but also to other foods. VKM has not in this series of risk assessments of "other substances" evaluated any claimed beneficial effects from these substances, only possible adverse effects.

 

The present report is a risk assessment of Bacillus coagulans, and it is based on previous risk assessments and articles retrieved from a literature search.

 

The risk of B. coagulans was assessed for the general population. However, in previous assessments of “probiotics” published by VKM, concerns have been identified for specific groups. Therefore, the risk was assessed for the age group with immature gastro-intestinal microbiota (age group 0-36 months), population with mature gastro-intestinal microbiota (>3 years) and vulnerable groups independent of age. VKM has also assessed the risk of B. coagulans in food supplements independent of the dose and have assessed exposure in general terms.

 

Other sources of B. coagulans, such as foods, have not been included in the present risk assessment.

 

VKM concludes that it is unlikely that B. coagulans causes adverse health effects in the general healthy population with mature gastro-intestinal tract. Acquired resistance genes have been detected in this species and the assessment of susceptibility to antibiotics for each single strain is required.

 

However, no data on long-term adverse effects on infants and young children were identified. As evidence is accruing that the early microbial composition of the neonatal gut is important for the development of the gut microbiota and the immune system of the growing child, it is not possible to exclude that a daily supply of a single particular bacterial strain over a prolonged period of time to an immature gastro-intestinal tract may have long-term, although still unknown, adverse effects on that development.

Open Access Grey Literature

Assessment of Vitamin E Intake in Relation to Tolerable Upper Intake Levels

Margaretha Haugen, Inger Therese L. Lillegaard, Livar Frøyland, Sigrun Henjum, Kristin Holvik, Martinus Løvik, Bjørn Steen Skålhegg, Tonje Holte Stea, Tor A. Strand

European Journal of Nutrition & Food Safety, Page 247-249
DOI: 10.9734/EJNFS/2018/43859

The Norwegian Scientific Committee for Food Safety (Vitenskapskomiteen for mattrygghet, VKM) has, at the request of the Norwegian Food Safety Authority (Mattilsynet; NFSA), assessed the intake of vitamin E (alpha-tocopherol) in the Norwegian population in relation to tolerable upper intake levels (ULs). The existing maximum limit for vitamin E in food supplements is 30 mg/day. VKM was also requested to conduct scenario calculations to illustrate the consequences of amending the maximum limit for alpha-tocopherol to 15, 50, 100, 150, 200 and 300 mg/day. 

 

Naturally vitamin E is a fat soluble compound synthesised by plants and consists of eight different tocopherols (α-, β-, γ- and δ- tocopherols and α-, β-, γ- and δ- tocotrienols) with varying vitamin E antioxidant activity. α-Tocopherol is recognised to meet human vitamin E requirements and accounts for 90% of the activity in human tissue. Vitamin E activity in food is expressed as α-tocopherol equivalents (α-TE) and 1 α-TE is defined as 1 mg d-αtocopherol.

 

The physiological role of vitamin E is to react with free radicals in cell membranes and other lipid milieu, thereby preventing polyunsaturated fatty acids (PUFA) from being damaged by lipid peroxidation. This antioxidant activity is important to maintain membrane integrity and takes place in all cells in the body.

 

Vitamin E deficiency symptoms include peripheral neuropathy, ataxia, myopathy and retinopathy. Vitamin E is dependent on lipid and lipoprotein metabolism and it takes decades for body depletion. The Norwegian recommended intakes for vitamin E for adults are 10 αTE/day for men and 8 α-TE/day for women.

 

There is no evidence of adverse effects from the consumption of vitamin E naturally occurring in foods. Animal studies have shown that α-tocopherol is not mutagenic, carcinogenic or teratogenic. However, high doses of α-tocopherol supplements can cause haemorrhage and interrupt blood coagulation. 

 

VKM propose to adopt the tolerable upper intake level set by the Scientific Committee for Food Safety (SCF) which is based on one human dose-response study. Hence, the upper level for supplemental vitamin E is suggested to 300 mg/day for adults. The upper level for children and adolescents is derived from scaling the adult upper level based on body surface area (body weight 0.75).

 

The tolerable upper intake levels set for vitamin E concern only intake from supplements, since intake of vitamin E from the diet is considered safe. VKM has therefore not conducted or evaluated scenarios with intake from both diet and supplements.

 

Dietary calculations have, however, been performed for intake in various percentiles (P) P5, P25, mean, P50, P75 and P95 in children (2- 4- and 9-year-olds), adolescents (13-year-olds) and in adult men and women as background information. 

 

Mean and median intakes of vitamin E are above the recommended intakes for all age groups. No age group reaches the recommended intake at P5, and 9- and 13-year-old boys and 9-year-old girls do not reach the recommended intake at P25 from diet alone. 

 

Because the tolerable upper intake level for supplemental vitamin E for adults is 300 mg/day, none of the suggested amendments of the maximum limit in food supplements (to 15, 50, 100, 150, 200 and 300 mg/day) will lead to exceedance of this upper level in adults. In 13year-olds supplements with 300 mg/day vitamin E will lead to exceedance of the upper level. In 9-year-olds supplements with 200 mg/day vitamin E will lead to exceedance of the upper level. In 4- and 2-year-olds supplements with 150 mg/day vitamin E will lead to exceedance of the upper level. Vitamin E intake from fortified products is not included in the calculations, but are however, evaluated to be very low.

Open Access Grey Literature

Human Pathogens in Marine Mammal Meat

Morten Tryland, Bjørn-Tore Lunestad, Truls Nesbakken, Lucy Robertson, Eystein Skjerve, Danica Grahek-Ogden, Karl Eckner, Georg Kapperud, Karin Nygård, Michael Tranulis, Jørgen Lassen

European Journal of Nutrition & Food Safety, Page 250-251
DOI: 10.9734/EJNFS/2018/43862

Background:

 

Norway conducts commercial hunts for seals and whales, and since marine mammal meat and products are distributed to the public, these products are covered by the general hygiene control regulations. The control of meat from marine mammals is based primarily on organoleptic and microbiological spot tests.

 

There is a general lack of knowledge available on the presence of potential zoonotic pathogens in marine mammal meat and products and on the potential risk for humans. The Norwegian Scientific Committee for Food Safety (Vitenskapskomiteen; VKM), Panel of Biological Hazards (Faggruppe hygiene og smittestoffer) took the initiative to develop this risk assessment in order to identify possible risks associated with human consumption of meat and products from seals and whales. The risk assessment is based on scientific publications and reports, and documents that have been used for training of veterinary personnel in meat control. Animal welfare is not within the scope of this assessment.

Main Conclusions:

 

It is documented in this assessment that marine mammals may harbour several pathogens with the potential of giving disease in humans, and there are some reports on the transfer of such agents via meat from seals and whales.

 

The Panel of Biological Hazards has not been able to document that human consumption of meat from seals and whales is associated to a risk of exposure to human pathogens in Norway, but the data on which this conclusion is build, is scarce and are too limited to draw firm conclusions. There are almost no data documenting the microbiological status of seal and whale meat that is distributed for human consumption and the control is ad hoc, based on spot tests and few animals.

 

The general trend of increased consumption of raw or lightly cooked food may increase the risk for transmission of pathogens to humans. Considered suboptimal conditions for hygienic treatment of meat on board, as compared to abattoir conditions, as well as a long storage time in a non-frozen state (whale meat), it is crucial to secure the hygienic quality of the meat.

 

The training of personnel in slaughter hygiene should be strengthened, and if meat is not frozen, an unbroken cold-chain should be documented through the production line from the slaughter to the retail level.

 

A more systematic meat control practice (routine control) should be established. Broad-scale research projects, focusing on human pathogens in seals and whales, as well as monitoring and collating of data on contamination, are needed to further explore the risks of transmission of human pathogens from marine mammal meat.

Open Access Grey Literature

Assessment of Vitamin B6 Intake in Relation to Tolerable Upper Intake Levels

Margaretha Haugen, Inger Therese L. Lillegaard, Livar Frøyland, Sigrun Henjum, Kristin Holvik, Martinus Løvik, Bjørn Steen Skålhegg, Tonje Holte Stea, Tor A. Strand, Per Ole Iversen

European Journal of Nutrition & Food Safety, Page 252-254
DOI: 10.9734/EJNFS/2018/43858

The Norwegian Scientific Committee for Food Safety (Vitenskapskomiteen for mattrygghet, VKM) has, at the request of the Norwegian Food Safety Authority (Mattilsynet; NFSA), assessed the intake of vitamin B6 (pyridoxine) in the Norwegian population in relation to tolerable upper intake levels (ULs). The existing maximum limit for vitamin B6 in food supplements is 4.2 mg/day. VKM has also conducted scenario calculations to illustrate the consequences of amending the maximum limitto 2, 6, 8, 10, 20 or 25 mg/day.

 

Vitamin B6 is water soluble and comprises six compounds with vitamin B6 activity; pyridoxine (PN, an alcohol), pyridoxal (PL, an aldehyde) and pyridoxamine (PM, the amine) and their corresponding phosphates; pyridoxine 5’-phosphate (PNP), pyridoxal 5’ -phosphate (PLP) and pyridoaxamin 5’ –phosphate (PMP). These six forms of vitamin B6 are all present in food in addition to the glycosylated form, pyridoxine-5’-β-δ-glucoside (PNG), in some plants. In food supplements the most common vitamin B6 form is pyridoxine hydrochloride. 

 

Eighty to ninety percent of vitamin B6 in the body is found in muscles and estimated body stores in adults amount to about 170 mg with a half-life of 25-33 days. Vitamin B6 deficiency is mostly seen in combination with deficiency of other B vitamins. Symptoms of vitamin B6 deficiency are anaemia and neurological abnormalities (EFSA, 2016). 

 

Intakes of vitamin B6 from the diet alone have not been reported to cause adverse effects. Sensory neuropathy has been reported to be the most sensitive adverse health effect of vitamin B6 supplementation. VKM proposes to adopt the tolerable upper intake level (UL) set by the Scientific Committee for Food (SCF) in 2000 at 25 mg/day for vitamin B6, which was based on a lowest observed adverse effect level (LOAEL) of 100 mg/day found in one randomised controlled trial. VKM recognises that there are no well-designed dose-response studies of long-term use available. However, for adults, no adverse effects have been reported at doses with vitamin B6 up to 25 mg/day. 

 

Dietary calculations have been performed for mean intakes and in various percentiles (P5, P25, P50, P75 and P95) in children (2-, 4- and 9-year-olds), adolescents (13-year-olds) and in adults.

 

To illustrate the consequences of amending the maximum limit for vitamin B6 in food supplements to 2, 6, 8, 10, 20 or 25 mg/day in the different age groups, VKM has used the scenarios with P95 from food and added the alternative amounts of supplements. VKM has compared these scenarios with the tolerable upper intake levels set by the Scientific Committee for Food in 2000 for adults, adolescents and children. In these scenarios, the 2- and 4-year-old children will exceed the tolerable upper intake level with use of 6 mg/day or higher vitamin B6 in supplements. The 9-year-old children will exceed the tolerable upper intake level with supplemental use of 10 mg/day. The 13-year-old adolescents will exceed the tolerable upper intake level with 20 mg/day of vitamin B6 in supplements. Adults will exceed the tolerable upper intake level with use of 25 mg/day of vitamin B6/pyridoxine in supplements.

Open Access Grey Literature

Assessment of Iron Intake in Relation to Tolerable Upper Intake Levels

Tor A. Strand, Inger Therese L. Lillegaard, Livar Frøyland, Margaretha Haugen, Sigrun Henjum, Kristin Holvik, Martinus Løvik, Bjørn Steen Skålhegg, Tonje Holte Stea, Per Ole Iversen

European Journal of Nutrition & Food Safety, Page 255-256
DOI: 10.9734/EJNFS/2018/43856

The Norwegian Scientific Committee for Food Safety (Vitenskapskomiteen for mattrygghet, VKM) has, at the request of the Norwegian Food Safety Authority (Mattilsynet; NFSA), assessed the intake of iron in the Norwegian population in relation to tolerable upper intake levels (ULs). The existing maximum limit for iron in food supplements is 27 mg/day. VKM has also conducted scenario calculations to illustrate the consequences of amending the maximum limit to 5, 10, 20, 30, 40 or 50 mg/day.

 

Iron deficiency is one of the most common nutritional disorders in the world. Individuals with increased iron demand such as growing children and pregnant women, those who experience blood loss such as menstruating women are particularly at risk for the consequences or iron deficiency. Iron deficiency can lead to fatigue and anaemia. 

 

The most common adverse effects of iron supplementation are reversible gastrointestinal symptoms. Chronic iron excess can lead to iron overload which is associated with several irreversible severe health outcomes such as cancers and cardiovascular diseases. Up to 1% of the population have a genetic trait that leads to accumulation of iron and renders them more vulnerable to iron excess. 

 

An adult needs approximately 10 mg iron per day to overcome daily loss. The tolerable upper intake level (UL) for iron in adults range from 45 to 60 mg/day. However, all previous reports acknowledge the challenges in defining upper levels. The Expert Group on Vitamins and minerals (EVM), UK report provided a guidance level (GL) of 17 instead of a UL and the Nordic Nutrition Recommendations (NNR) (2012) suggested an UL of 60 mg/day, but did not suggest any clear upper levels for children. Institute of Medicine (IOM), US (2001) gives the most substantiated tolerable upper intake levels based on gastrointestinal effects, which is 40 mg/day for infants and children, regardless of age, and 45 mg/day for adolescents and adults. The Joint FAO/WHO Expert Committee on Food Additives 2003 (JECFA) also took the potential serious effects of iron overload into account and suggested a GL of 50 mg/day in adults or 0.8 mg/kg per day in children and adolescents. 

 

Because the risks and consequences from overload are significant and potentially serious, VKM suggests that the GL from JECFA (2003) is used.

 

Using the GL from JECFA (2003), none of the suggested doses can be given to 2 or 4-yearold children, 9 year olds can add 5 mg iron from supplements, 13 year olds 20, and adults 30 mg without exceeding the guidance levels.

Open Access Grey Literature

Risk Assessment of Lactobacillus paracasei 8700:2 Used as "Other Substances"

Danica Grahek-Ogden, Karl Eckner, Georg Kapperud, Jørgen Lassen, Judith Narvhus, Truls Nesbakken, Lucy Robertson, Jan Thomas Rosnes, Olaug Taran Skjerdal, Eystein Skjerve, Line Vold, Siamak Yazdankhah, Yngvild Wasteson

European Journal of Nutrition & Food Safety, Page 324-325
DOI: 10.9734/EJNFS/2018/44964

The Norwegian Scientific Committee for Food Safety (Vitenskapskomiteen for mattrygghet, VKM) has, at the request of the Norwegian Food Safety Authority (Mattilsynet; NFSA), assessed the risk of "other substances" in food supplements sold in Norway. These risk assessments will provide NFSA with the scientific basis while regulating the addition of “other substances” to food supplements and other foods.

"Other substances" are described in the food supplement directive 2002/46/EC as substances other than vitamins or minerals that have a nutritional and/or physiological effect. It is added mainly to food supplements, but also to other foods. VKM has not in this series of risk assessments of "other substances" evaluated any claimed beneficial effects from these substances, only possible adverse effects.

The present report is a risk assessment of Lactobacillus paracasei 8700:2, and it is based on previous risk assessments and articles retrieved from a literature search.

The risk of L. paracasei 8700:2 was assessed for the general population. However, in previous assessments of “probiotics” published by VKM, concerns have been identified for specific groups. Therefore, the risk was assessed for the age group with immature gastro-intestinal flora (age group 0-36 months), population with mature gastro-intestinal flora (>3 years) and vulnerable groups independent of age. VKM has also assessed the risk of L. paracasei 8700:2 in food supplements independent of the dose and have assessed exposure in general terms.

Other sources of L. paracasei 8700:2, such as foods, have not been included in the present risk assessment.

VKM concludes that it is unlikely that L. paracasei 8700:2 causes adverse health effects in the general healthy population with mature gastro-intestinal tract.

However, no data on long-term adverse effects on infants and young children were identified. As evidence is accruing that the early microbial composition of the neonatal gut is important for the development of the gut flora and the immune system of the growing child, it is not possible to exclude that a daily supply of a single particular bacterial strain over a prolonged period of time to an immature gastro-intestinal tract may have long-term, although still unknown, adverse effects on that development.

Open Access Grey Literature

Risk Assessment of Lactobacillus salivarius W24 Used as "Other Substances"

Danica Grahek-Ogden, Karl Eckner, Georg Kapperud, Jørgen Lassen, Judith Narvhus, Truls Nesbakken, Lucy Robertson, Jan Thomas Rosnes, Olaug Taran Skjerdal, Eystein Skjerve, Line Vold, Siamak Yazdankhah, Yngvild Wasteson

European Journal of Nutrition & Food Safety, Page 326-327
DOI: 10.9734/EJNFS/2018/44965

The Norwegian Scientific Committee for Food Safety (Vitenskapskomiteen for mattrygghet, VKM) has, at the request of the Norwegian Food Safety Authority (Mattilsynet; NFSA), assessed the risk of "other substances" in food supplements sold in Norway. These risk assessments will provide NFSA with the scientific basis while regulating the addition of “other substances” to food supplements and other foods.

"Other substances" are described in the food supplement directive 2002/46/EC as substances other than vitamins or minerals that have a nutritional and/or physiological effect. It is added mainly to food supplements, but also to other foods. VKM has not in this series of risk assessments of "other substances" evaluated any claimed beneficial effects from these substances, only possible adverse effects.

The present report is a risk assessment of Lactobacillus salivarius W24, and it is based on previous risk assessments and articles retrieved from a literature search.

The risk of L. salivarius W24 was assessed for the general population. However, in previous assessments of “probiotics” published by VKM, concerns have been identified for specific groups. Therefore, the risk was assessed for the age group with immature gastro-intestinal microbiota (age group 0-36 months), population with mature gastro-intestinal microbiota (>3 years) and vulnerable groups independent of age. VKM has also assessed the risk of L. salivarius W24 in food supplements independent of the dose and have assessed exposure in general terms.

Other sources of L. salivarius W24, such as foods, have not been included in the present risk assessment.

VKM concludes that it is unlikely that L. salivarius W24 causes adverse health effects in the general healthy population with mature gastro-intestinal tract.

However, no data on long-term adverse effects on infants and young children were identified. As evidence is accruing that the early microbial composition of the neonatal gut is important for the development of the gut microbiota and the immune system of the growing child, it is not possible to exclude that a daily supply of a single particular bacterial strain over a prolonged period of time to an immature gastro-intestinal tract may have long-term, although still unknown, adverse effects on that development.

Open Access Grey Literature

Risk Assessment of Lactococcus lactis W58 Used as "Other Substances"

Siamak Yazdankhah, Danica Grahek-Ogden, Karl Eckner, Georg Kapperud, Jørgen Lassen, Judith Narvhus, Truls Nesbakken, Lucy Robertson, Jan Thomas Rosnes, Olaug Taran Skjerdal, Eystein Skjerve, Line Vold, Yngvild Wasteson

European Journal of Nutrition & Food Safety, Page 328-329
DOI: 10.9734/EJNFS/2018/44966

The Norwegian Scientific Committee for Food Safety (Vitenskapskomiteen for mattrygghet, VKM) has, at the request of the Norwegian Food Safety Authority (Mattilsynet; NFSA), assessed the risk of "other substances" in food supplements sold in Norway. These risk assessments will provide NFSA with the scientific basis while regulating the addition of “other substances” to food supplements and other foods.

"Other substances" are described in the food supplement directive 2002/46/EC as substances other than vitamins or minerals that have a nutritional and/or physiological effect. It is added mainly to food supplements, but also to other foods. VKM has not in this series of risk assessments of "other substances" evaluated any claimed beneficial effects from these substances, only possible adverse effects.

The present report is a risk assessment of Lactococcus lactis W58, and it is based on previous risk assessments and articles retrieved from a literature search.

The risk of L. lactis W58 was assessed for the general population. However, in previous assessments of “probiotics” published by VKM, concerns have been identified for specific groups. Therefore, the risk was assessed for the age group with immature gastro-intestinal microbiota (age group 0-36 months), population with mature gastro-intestinal microbiota (>3 years) and vulnerable groups independent of age. VKM has also assessed the risk of L. lactis W58 in food supplements independent of the dose and have assessed exposure in general terms.

Other sources of L. lactis W58, such as foods, have not been included in the present risk assessment.

VKM concludes that it is unlikely that L. lactis W58 causes adverse health effects in the general healthy population with mature gastro-intestinal tract.

However, no data on long-term adverse effects on infants and young children were identified. As evidence is accruing that the early microbial composition of the neonatal gut is important for the development of the gut microbiota and the immune system of the growing child, it is not possible to exclude that a daily supply of a single particular bacterial strain over a prolonged period of time to an immature gastro-intestinal tract may have long-term, although still unknown, adverse effects on that development.

Open Access Grey Literature

Risk Assessment of "Other Substances" – L-alanine

Kristin Holvik, Livar Frøyland, Margaretha Haugen, Sigrun Henjum, Martinus Løvik, Tonje Holte Stea, Tor A. Strand

European Journal of Nutrition & Food Safety, Page 330-332
DOI: 10.9734/EJNFS/2018/44968

The Norwegian Scientific Committee for Food Safety (Vitenskapskomiteen for mattrygghet, VKM) has, at the request of the Norwegian Food Safety Authority (Mattilsynet; NFSA), assessed the risk of "other substances" in food supplements and energy drinks sold in Norway. VKM has assessed the risk of doses given by NFSA. These risk assessments will provide NFSA with the scientific basis while regulating "other substances" in food supplements.

"Other substances" are described in the food supplement directive 2002/46/EC as substances other than vitamins or minerals that have a nutritional and/ or physiological e ffect . It is added mainly to food supplements, but also to energy drinks and other foods. In this series of risk assessments of "other substances" the VKM has not evaluated any claimed beneficial effects from these substances, only possible adverse effects.

For the current report VKM has studied previous risk assessments and performed two systematic literature searches for any published studies assessing negative health effects of L-alanine in humans or animals.

According to information from NFSA, L-alanine is an ingredient in food supplements sold in Norway. NSFA has requested a risk assessment of L-alanine: 3500, 3750, 4000, 4250 and 4500 mg/day. Foods rich in alanine are generally protein rich foods such as meat, dairy products, legumes, fish, nuts, seeds, eggs and whole grains. Based on NHANES III (19881994), the overall mean intake of L-alanine from food and food supplements in the United States was 3.6 g/day.

L-alanine is a naturally occurring non-essential α-amino acid belonging to the group of the 20 amino acids that are normal components of food proteins.

L-alanine acts as an intermediary between protein catabolism and carbohydrate synthesis. It can be easily synthesised from the alpha keto acid pyruvate and has close links to several metabolic pathways including glycolysis, gluconeogenesis, and the citric acid cycle. Together with lactate it is capable of generating glucose from muscle protein through gluconeogenesis in the liver. Alanine thus plays a central role in the metabolism of muscle protein and is a key factor in nitrogen metabolism. 

Previous reports from the US Institute of Medicine (IOM) 2005, the French Food Safety Agency (AFSSA) 2007 and the Spanish Agency for Food Safety and Nutrition (AESAN) 2012 did not conclude regarding safe doses of L-alanine, but stated that data on adverse effects of L-alanine intake from supplements were not sufficient for a dose-response assessment and establishment of a tolerable upper intake level. 

Few studies have assessed health effects of L-alanine supplementation in humans, and these were generally not designed to evaluate potential harmful effects of L-alanine. Most human experimental studies gave single doses (up to 50 g) or short-term loading doses (e.g. 25 to 45 g/hour during exercise) to study metabolic responses such as ergogenic effects during exercise or prevention of ketosis after fasting. Adverse health effects were not reported except for abdominal discomfort and stomach cramps, nausea and diarrhea after consuming high doses. No studies assessed long-term effects of L-alanine supplementation, and no studies gave doses comparable to the doses under consideration in the present report. 

Only one dose-reponse toxicity study in rodents has been found (Chow et al., 1976). In that study, growing Wistar rats were fed up to 20% DL-alanine (a racemic mixture of D- and Lalanine) in their basal diet for 26 weeks, with no effect on liver and kidney weight and no pathological changes in any organs. The study was taken into account due to the otherwise scarce literature on L-alanine toxicity, and could be used since there were no adverse effects at the highest dose tested. The no observed adverse effect level (NOAEL) in mg L-alanine per kg body weight per day was not stated. VKM has therefore estimated the NOAEL using information about average reported feed consumption and average body weights of the animals, and divided by 2 to obtain a NOAEL for L-alanine, arriving at approximately 6450 mg/kg bw/day in male rats and 9700 mg/kg bw/day in female rats. A standard toxicological approach dividing by an uncertainty factor (UF) of 10 for between-species variation and an additional UF of 10 for within-species variation gives the value of 64.5 mg/kg bw per day in females and 97.0 mg/kg bw per day in males, corresponding to approximately 4500 mg/day and 6800 mg/day for a 70 kg man and woman, respectively. 

VKM also calculated the margins of exposure (MOE) between the estimated NOAEL and the estimated daily exposures from the five supplement doses given by the NFSA (based on default average body weights for the age groups). MOE were 100 or higher for all five doses in adults. For adolescents 14 to <18 years, the MOE was 88 for the highest dose under consideration. For children 10 to <14 years, MOE ranged from 62 for the highest dose to 80 for the lowest dose.

The VKM considers that these margins are relatively high and are acceptable based on the following considerations: The highest dose tested in growing rats did not cause adverse effects, implying that the “true” NOAEL is unknown and could be considerably higher. Furthermore, L-alanine is a nutrient participating in normal energy metabolism as a substrate for glucose. It is consumed in the magnitude of 3 to 4 g/day on average in the habitual diet, and it has not been associated with harmful effects in humans beyond gastrointestinal effects when consuming very high single doses (50 g, or at a consumption rate of 30 to 45 grams per hour during exercise).

VKM concludes that:

  • In adults (≥18 years), the specified doses 3500, 3750, 4000, 4250 and 4500 mg/day L-alanine in food supplements are unlikely to cause adverse health effects.
  • In adolescents (14 to <18 years), the specified doses 3500, 3750, 4000, 4250 and 4500 mg/day L-alanine in food supplements are unlikely to cause adverse health effects.
  • In children (10 to <14 years), the specified doses 3500, 3750, 4000, 4250 and 4500 mg/day L-alanine in food supplements are unlikely to cause adverse health effects.

Children younger than 10 years were not within the scope of the present risk assessment.

Open Access Grey Literature

Risk Assessment of "Other Substances" – L-leucine, L-isoleucine and L-valine, the Branched Chain Amino Acids (BCAA)

Bjørn Steen Skålhegg, Livar Frøyland, Margaretha Haugen, Kristin Holvik, Martinus Løvik, Tonje Holte Stea, Tor A. Strand, Grethe S. Tell, Per Ole Iversen

European Journal of Nutrition & Food Safety, Page 333-335
DOI: 10.9734/EJNFS/2018/44969

The Norwegian Scientific Committee for Food Safety (Vitenskapskomiteen for mattrygghet, VKM) has, at the request of the Norwegian Food Safety Authority (Mattilsynet; NFSA), assessed the risk of "other substances" in food supplements and energy drinks sold in Norway. VKM has assessed the risk of doses given by NFSA. The risk assessments are the scientific basis for NFSA in its efforts to regulate the use of "other substances" to food supplements.

"Other substances" are described in the food supplement directive 2002/46/EC as substances other than vitamins or minerals that have a nutritional and/or physiological effect. It is added mainly to food supplements, but also to energy drinks and other foods. VKM has not in this series of risk assessments of "other substances" evaluated any claimed beneficial effects from these substances, only possible adverse effects.

The present report is a risk assessment of L-leucine, L-isoleucine and L-valine and it is based on previous risk assessments and articles retrieved from a literature search. In this report Lleucine, L-isoleucine and L-valine may occasionally be termed merely leucine, isoleucine or valine.

L-leucine, L-isoleucine and L-valine are essential amino acids. L-leucine, L-isoleucine and Lvaline are commonly known as Branched Chain Amino Acids (BCAAs), and are found in food items containing proteins and in particular, in protein-rich foods such as dairy products, meats,  eggs, nuts, whole grains, seeds, avocadoes and edible seaweed.

According to information from NFSA, L-leucine, L-isoleucine and L-valine are ingredients in food supplements sold in Norway. NFSA has requested a risk assessment of the following doses of L-leucine, L-isoleucine and L-valine in food supplements for adults, adolescents and children 10 years and above: L-leucine: 2500, 3000, 4000, 5000 and 5250 mg/day, Lisoleucine: 1500, 1750, 2000 and 2500 mg/day and L-valine: 1500, 1750, 2000, 2250 and 2500 mg/day. Usual dietary intakes of these amino acids in Norway are not known. Based on data from the 1988–1994 NHANES III, mean daily intakes in adults of leucine, isoleucine and valine from food and supplements are 6.1, 3.6 and 4.0 g/day, respectively (IOM, 2005).

Most studies on BCAAs have focused on the three amino acids taken as single amino acids or together combined in food supplements. It has been shown that BCAAs are not metabolized in the liver as is common for most other amino acids but taken up by most peripheral tissues (in particular muscle) where they are either used in protein synthesis or as precursors for nitrogen and/or a number of carbon containing molecules.

There is a lack of relevant well-designed supplementation studies with L-leucine, L-isoleucine and L-valine in humans designed to address adverse effects and dose-response relationships as primary outcome. 

However, daily doses of as much as 30 g BCAA per day given to athletes have been investigated and reported to improve performance. In these reports adverse effects were not addressed and not reported. L-leucine has been administered orally in single doses for one day of up to 50 g without showing any adverse effects. There are no published studies on the effects of longitudinal supplementation with either L-isoleucine or L-valine.

Thus, there are no published studies that can be used for suggesting a "value for comparison", and there is no scientific data in the literature suitable for assessing the specific doses in the terms of reference.

WHO (2007) recommendations for BCAAs are: Leucine 2730 mg/day, isoleucine 1400 mg/day and valine 1820 mg/day. For a 70 kg person, this corresponds to 39 mg leucine/kg body weight (bw) per day, 20 mg isoleucine/kg bw per day and 26 mg valine/kg bw per day.

The acute upper tolerable metabolic limit of L-leucine for men between 20 and 35 years was determined by administration of single doses of 550-700 mg/kg bw over one day. This corresponded to 39 to 50 g/day for a person of 70 kg. Furthermore, based on several studies investigating L-leucine, L-isoleucine and L-valine supplemented as single doses ranging from 10 to 30 g/day without any reported adverse effects. The uncertainties for this consideration are described in chapter 5.

VKM concludes that:

Due to lack of studies addressing adverse effects for the specified doses 2500, 3000, 4000, 5000 and 5250 mg/day L-leucine, 1500, 1750, 2000 and 2500 mg/day L-isoleucine and 1500, 1750, 2000, 2250 and 2500 mg/day L-valine in food supplements, no conclusions can be made for adults (≥ 18 years), adolescents (≥ 10 and < 18 years) or children (< 10 years).

Open Access Grey Literature

Risk Assessment of "Other Substances"-Beta-Alanine

Martinus Løvik, Livar Frøyland, Margaretha Haugen, Sigrun Henjum, Tonje Holte Stea, Tor A. Strand, Kristin Holvik

European Journal of Nutrition & Food Safety, Page 336-338
DOI: 10.9734/EJNFS/2018/44970

The Norwegian Scientific Committee for Food Safety (Vitenskapskomiteen for mattrygghet, VKM) has, at the request of the Norwegian Food Safety Authority (Mattilsynet; NFSA), assessed the risk of "other substances" in food supplements and energy drinks sold in Norway. VKM has assessed the risk of doses given by NFSA. These risk assessments will provide NFSA with the scientific basis while regulating "other substances" in food supplements.

"Other substances" are described in the food supplement directive 2002/46/EC as substances other than vitamins or minerals that have a nutritional and/or physiological effect. It is added mainly to food supplements, but also to energy drinks and other foods. In this series of risk assessments of "other substances" the VKM has not evaluated any claimed beneficial effects from these substances, only possible adverse effects.

The present report is a risk assessment of specified doses of beta-alanine in food supplements, and it is based on previous risk assessments and articles retrieved from literature searches.

According to information from NFSA, beta-alanine is an ingredient in food supplements sold in Norway. NSFA has requested a risk assessment of beta-alanine: 1000, 1500 and 2000 mg/day from food supplements.

Beta-alanine is a non-essential, non-proteogenic naturally occurring beta amino acid. Beta-alanine is a component of the naturally occurring peptides carnosine, anserine and balenine. Supplementation with beta-alanine leads to an increased production of the peptide carnosine, which is found in high concentrations in the skeletal muscle of both vertebrates and non-vertebrates. Data suggest that beta-alanine functions as a small molecule neurotransmitter and should join the ranks of the other amino acid neurotransmitters.

The only observed adverse effect from beta-alanin supplementation in humans is transient (1-2 hours) paraesthesia and flushing. Paraesthesia is characterised by a stinging or prickling sensation in the skin. There is no evidence that the paraesthesia in the skin is harmful in any way. Long-term studies in humans were not found. Four small human clinical studies have been included in this risk assessment. The occurrence of paraesthesia apparently is dependent on the magnitude of the individual doses that the daily dose is split into. Single doses of beta-alanine of 10 mg/kg bw (700 mg in a 70 kg person) or more provoked transient paraesthesia. Symptom occurrence and severity increased with the dose. Repeated intakes of 5 mg beta-alanine/kg bw or less taken with >2 hours intervals did not induce paraesthesia. Haematology and plasma clinical chemistry was found normal after daily doses of 2.8 g and 3.2 g for 4 weeks in healthy adults. Apart from occasional paraesthesia, a daily dose of 6.4 g for up to seven weeks did not induce any adverse clinical effects in healthy adults of 80 kg, corresponding to a dose of 5.6 g per day in a 70-kg person.

We are not aware of any data indicating that children and adolescents are more vulnerable than adults for supplementation with beta-alanine on a per kg bw basis.

No relevant animal studies were identified.

VKM concludes that:

  • In adults (≥18 years), the specified doses 1000, 1500 and 2000 mg/day of beta-alanine in food supplements are unlikely to cause adverse health effects provided that beta-alanine is consumed with maximum 5 mg/kg bw per intake and a minimum of 2 hours between the intakes.
  • In adolescents (14 to <18 years) and children (10 to <14 years) the specified doses 1000, 1500 and 2000 mg/day of beta-alanine in food supplements are unlikely to cause adverse health effects provided that beta-alanine is consumed with maximum 5 mg/kg bw per intake and a minimum of 2 hours between the intakes.

Children younger than 10 years were not within the scope of the present risk assessment.

Open Access Grey Literature

Risk Assessment of Lactobacillus casei W56 Used as "Other Substances"

Danica Grahek-Ogden, Karl Eckner, Georg Kapperud, Jørgen Lassen, Judith Narvhus, Truls Nesbakken, Lucy Robertson, Jan Thomas Rosnes, Olaug Taran Skjerdal, Eystein Skjerve, Line Vold, Siamak Yazdankhah, Yngvild Wasteson

European Journal of Nutrition & Food Safety, Page 339-340
DOI: 10.9734/EJNFS/2018/44961

The Norwegian Scientific Committee for Food Safety (Vitenskapskomiteen for mattrygghet, VKM) has, at the request of the Norwegian Food Safety Authority (Mattilsynet; NFSA), assessed the risk of "other substances" in food supplements sold in Norway. These risk assessments will provide NFSA with the scientific basis while regulating the addition of “other substances” to food supplements and other foods.

"Other substances" are described in the food supplement directive 2002/46/EC as substances other than vitamins or minerals that have a nutritional and/or physiological effect. It is added mainly to food supplements, but also to other foods. VKM has not in this series of risk assessments of "other substances" evaluated any claimed beneficial effects from these substances, only possible adverse effects.

The present report is a risk assessment of Lactobacillus casei W56, and it is based on previous risk assessments and articles retrieved from a literature search.

The risk of L. casei W56 was assessed for the general population. However, in previous assessments of “probiotics” published by VKM, concerns have been identified for specific groups. Therefore, the risk was assessed for the age group with immature gastro-intestinal microbiota (age group 0-36 months), population with mature gastro-intestinal microbiota (>3 years) and vulnerable groups independent of age. VKM has also assessed the risk of L. casei W56 in food supplements independent of the dose and have assessed exposure in general terms.

Other sources of L. casei W56, such as foods, have not been included in the present risk assessment.

VKM concludes that it is unlikely that L. casei W56 causes adverse health effects in the general healthy population with mature gastro-intestinal tract.

However, no data on long-term adverse effects on infants and young children were identified. As evidence is accruing that the early microbial composition of the neonatal gut is important for the development of the gut microbiota and the immune system of the growing child, it is not possible to exclude that a daily supply of a single particular bacterial strain over a prolonged period of time to an immature gastro-intestinal tract may have long-term, although still unknown, adverse effects on that development.

Open Access Grey Literature

Risk Assessment of Lactobacillus delbrueckii subsp. bulgaricus Used as "Other Substances"

Danica Grahek-Ogden, Karl Eckner, Georg Kapperud, Jørgen Lassen, Judith Narvhus, Truls Nesbakken, Lucy Robertson, Jan Thomas Rosnes, Olaug Taran Skjerdal, Eystein Skjerve, Line Vold, Siamak Yazdankhah, Yngvild Wasteson

European Journal of Nutrition & Food Safety, Page 341-342
DOI: 10.9734/EJNFS/2018/44962

The Norwegian Scientific Committee for Food Safety (Vitenskapskomiteen for mattrygghet, VKM) has, at the request of the Norwegian Food Safety Authority (Mattilsynet; NFSA), assessed the risk of "other substances" in food supplements sold in Norway. These risk assessments will provide NFSA with the scientific basis while regulating the addition of “other substances” to food supplements and other foods.

"Other substances" are described in the food supplement directive 2002/46/EC as substances other than vitamins or minerals that have a nutritional and/or physiological effect. It is added mainly to food supplements, but also to other foods. VKM has not in this series of risk assessments of "other substances" evaluated any claimed beneficial effects from these substances, only possible adverse effects.

The present report is a risk assessment of Lactobacillus delbrueckii subsp. bulgaricus, and it is based on previous risk assessments and articles retrieved from a literature search.

The risk of L. delbrueckii subsp. bulgaricus was assessed for the general population. However, in previous assessments of “probiotics” published by VKM, concerns have been identified for specific groups. Therefore, the risk was assessed for the age group with immature gastro-intestinal microbiota (age group 0-36 months), population with mature gastro-intestinal microbiota (>3 years) and vulnerable groups independent of age. VKM has also assessed the risk of L. delbrueckii subsp. bulgaricus in food supplements independent of the dose and have assessed exposure in general terms.

Other sources of L. delbrueckii subsp. bulgaricus, such as foods, have not been included in the present risk assessment.

VKM concludes that it is unlikely that L. delbrueckii subsp. bulgaricus causes adverse health effects in the general healthy population with mature gastro-intestinal tract.

However, no data on long-term adverse effects on infants and young children were identified. As evidence is accruing that the early microbial composition of the neonatal gut is important for the development of the gut microbiota and the immune system of the growing child, it is not possible to exclude that a daily supply of a single particular bacterial strain over a prolonged period of time to an immature gastro-intestinal tract may have long-term, although still unknown, adverse effects on that development.

Open Access Grey Literature

Risk Assessment of Lactobacillus helveticus Rosell-52 ND Used as "Other Substances"

Danica Grahek-Ogden, Karl Eckner, Georg Kapperud, Jørgen Lassen, Judith Narvhus, Truls Nesbakken, Lucy Robertson, Jan Thomas Rosnes, Olaug Taran Skjerdal, Eystein Skjerve, Line Vold, Siamak Yazdankhah, Yngvild Wasteson

European Journal of Nutrition & Food Safety, Page 343-344
DOI: 10.9734/EJNFS/2018/44963

The Norwegian Scientific Committee for Food Safety (Vitenskapskomiteen for mattrygghet, VKM) has, at the request of the Norwegian Food Safety Authority (Mattilsynet; NFSA), assessed the risk of "other substances" in food supplements sold in Norway. These risk assessments will provide NFSA with the scientific basis while regulating the addition of “other substances” to food supplements and other foods.

"Other substances" are described in the food supplement directive 2002/46/EC as substances other than vitamins or minerals that have a nutritional and/or physiological effect. It is added mainly to food supplements, but also to other foods. VKM has not in this series of risk assessments of "other substances" evaluated any claimed beneficial effects from these substances, only possible adverse effects.

The present report is a risk assessment of Lactobacillus helveticus Rosell-52 ND, and it is based on previous risk assessments and articles retrieved from a literature search.

The risk of L. helveticus Rosell-52 ND was assessed for the general population. However, in previous assessments of “probiotics” published by VKM, concerns have been identified for specific groups. Therefore, the risk was assessed for the age group with immature gastro-intestinal microbiota (age group 0-36 months), population with mature gastro-intestinal microbiota (>3 years) and vulnerable groups independent of age. VKM has also assessed the risk of L. helveticus Rosell-52 ND in food supplements independent of the dose and have assessed exposure in general terms.

Other sources of L. helveticus Rosell-52 ND, such as foods, have not been included in the present risk assessment.

VKM concludes that it is unlikely that L. helveticus Rosell-52 ND causes adverse health effects in the general healthy population with mature gastro-intestinal tract.

However, no data on long-term adverse effects on infants and young children were identified. As evidence is accruing that the early microbial composition of the neonatal gut is important for the development of the gut microbiota and the immune system of the growing child, it is not possible to exclude that a daily supply of a single particular bacterial strain over a prolonged period of time to an immature gastro-intestinal tract may have long-term, although still unknown, adverse effects on that development.

Open Access Grey Literature

Risk Assessment of Magnesium in Food Supplements

Margaretha Haugen, Inger Therese L. Lillegaard, Tor A. Strand, Livar Frøyland, Kristin Holvik, Martinus Løvik, Grethe S. Tell, Per Ole Iversen

European Journal of Nutrition & Food Safety, Page 345-347
DOI: 10.9734/EJNFS/2018/44967

The Norwegian Scientific Committee for Food Safety (Vitenskapskomiteen for mattrygghet, VKM) has, at the request of the Norwegian Food Safety Authority (Mattilsynet; NFSA), assessed the risk associated with magnesium in food supplements. VKM is requested to evaluate upper tolerable intake levels for magnesium and high and low intakes in the Norwegian population. Pending establishment of common maximum limits in the EU, the NFSA is evaluating the national maximum limits for vitamins and minerals in food supplements. This risk assessment is the scientific basis for NFSA's evaluation of national limits for magnesium.

Directive 2002/46/EC on food supplements was implemented in Norwegian law in 2004 in Regulation 20 May 2004 No. 755 on food supplements. Common maximum and minimum levels of vitamins and minerals in food supplements shall be set in the EU. Until common limits are established in the EU, the national limits apply.

The present report is a risk assessment of magnesium in food supplements. It is based on published articles retrieved from literature searches and previous risk assessments of magnesium.

Magnesium is an essential alkaline mineral and occurs as free cation Mg2+ in aqueous solution, or as the mineral part of a large variety of compounds such as chlorides, carbonates and hydroxides.

Dietary sources of magnesium include green leafy vegetables, legumes, whole grain cereals, dark chocolate, nuts, fish and seafood, banana and coffee. NFSA has especially requested VKM to consider water as a source of magnesium. A few waterworks reported magnesium concentrations at 10 mg/L. Consumption of water from these waterworks may contribute up to 10% of recommended magnesium intake. However, most waterworks reported negligible magnesium concentrations.

Magnesium has multiple functions in the body; it is a required cofactor for more than 300 enzyme systems in the body; for energy-dependent membrane transport, for gene regulation, and for sustained electrical potential in excitable cells. Magnesium also plays a major role in bone and mineral homeostasis.

No tolerable upper intake level (UL) has been established for magnesium intake from food sources for the reason that no adverse effects have been recognised in healthy populations.

Magnesium salts in food supplements may cause osmotic diarrhoea which is the most frequently reported adverse effect. However, these effects are considered relatively mild.

Previous reports have arrived on UL or guidance levels (GLs) for supplemental magnesium ranging from 250 mg/day in the EU (Scientific Committee for Food (SCF, 2001)) through 350 mg/day in the USA (Institute of Medicine (IOM, 1997)) and up to 400 mg per day in the UK (Expert group on Vitamins and Minerals (EVM, 2003)).

The UL from SCF (2001) is below the recommended daily dietary intakes for adults. Since the critical endpoint (gastrointestinal symptoms) is mild, rapidly reversible and no NOAEL could be identified, VKM finds it appropriate to base the UL for magnesium salts in food supplements on the LOAEL from IOM (1997). For the same reason, an uncertainty factor of 1 may be applicable for establishing a UL for magnesium salts in food supplements. VKM therefore proposes an amendment of the ULs suggested by SCF (2001) for magnesium in supplements.

The IOM (1997) suggestion of a UL at 350 mg supplementary magnesium per day for adults was based on a LOAEL for mild diarrhea. VKM found no results to support an alteration of this UL.

VKM therefore suggests a UL of 350 mg magnesium in food supplements per day in adults which is in accordance with the UL suggested by (IOM, 1997). This UL will also cover the recommended intakes for the adult population.

VKM suggests that the ULs for children equal the recommended intakes for each age group:

 Age group

 ULs (mg/day)

 Children 1-3 years

 85

 Children 3-10 years

 120-200

 Children (10-<14 years)

 280

 Adolescents (14-<18 years)

 280

 Adults (≥18 years)

 350

 

According to the habitual dietary intakes of magnesium estimated from nationwide dietary surveys in Norway, about 25% of adults have intakes of magnesium below the recommendations from food and supplements. Almost the same percentage was below the recommended intakes among 9-year-old children, while approximately 70% of 13-year-olds had an intake of magnesium below the recommendations. It should be noted that the intakes have been estimated with use of different dietary survey methods for the different age categories and a comparison of estimates across age groups can be misleading and has a high degree of uncertainty.

Concentration of magnesium in water is low and about 60% of the waterworks reporting to the Norwegian Waterworks Registry had a magnesium concentration below 2 mg/L, indicating water as a negligible source of magnesium for the majority of the population.

Open Access Original Research Article

Detection of Oxytetracycline Residues in Table Eggs in Khartoum State, Sudan

E. A. Hind, K. M. Osman, Ishraga, G. Ibrahim, Y. A. Sabiel

European Journal of Nutrition & Food Safety, Page 148-154
DOI: 10.9734/EJNFS/2018/39827

Aims: This study was conducted to detect the presence of oxytetracycline residues in table eggs in Khartoum State and to compare its level with the international acceptable maximum residue limits (MRLs).

Study Design: One hundred and eighty table egg samples were randomly collected from 18 sale points in the three localities of Khartoum State, Sudan, (60 eggs from Omdurman, 60 eggs from Khartoum and 60 eggs from Khartoum North).

Place and Duration of Study: Samples collected from Khartoum State during August and September, 2015.

Methodology: Microbiological inhibition assay was used to screen the presence of antibiotic residues using Bacillus subtilis seeded in nutrient agar.  Ninety positive egg samples from the microbiological inhibition assay were analyzed to detect the presence and quantity of oxytetracycline residues using HPLC.

Results: Microbiological inhibition assay showed that 50% of the tested samples were positive for antibiotic residues in Omdurman, Khartoum and Khartoum North with 34(18.9%), 28(15.6%), and 28(15.6%) of the antibiotics respectively. HPLC results showed that 63(70%) were positive for oxytetracycline residues 19(10.5%) from Omdurman, 21(11.6%) from Khartoum and 23(12.7%) from Khartoum North.

Conclusion: It was concluded that high percentage of table eggs contained oxytetracycline residues above the MRLs (0.2 ppm) that indicated the widespread misuse of oxytetracycline in poultry farms that may cause health hazards to consumers in Khartoum State. Therefore the study recommends compliance of drug withdrawal periods in poultry farms could reduce the incidence of antibiotic residues in consumed eggs.

Open Access Original Research Article

Cyanide Toxicity of Freshly Prepared Smoothies and Juices Frequently Consumed

A. Baker, M. C. Garner, K. W. Kimberley, D. B. Sims, J. H. Stordock, R. P. Taggart, D. J. Walton

European Journal of Nutrition & Food Safety, Page 215-224
DOI: 10.9734/EJNFS/2018/44004

Aims: This study was conducted to detect the presence of cyanide in popular fruit and vegetable smoothies and juices marketed as raw and natural.

Study Design: Eleven (11) popular varieties of drinks were analyzed for total cyanide (TCN).   Drinks contained raw vegetables and fruits, flax seeds, whole apples with seeds, raw almond milk, and pasteurized almond milk as ingredients.

Place and Study Duration: Samples were collected from health food eateries located within Las Vegas, Nevada (USA) during the summer of 2017.

Methodology: Fifty milliliters (mL) of a homogenized smoothie and juice drink and 1 gram of flax seeds were subjected to the above-referenced methods for sample preparation per USEPA Methods 9012B (digestion) followed by USEPA method 9014 (colorimetry). 

Results: The highest TCN was detected in drinks containing raw flax seed followed by unpasteurized raw almond milk, then fresh whole apple juice.  No TCN was observed in drinks that contained none of the above mentioned items (e.g. flax seed, raw almond milk) or those utilizing pasteurized ingredients.

Conclusion: This study observed that TCN is present in smoothies and juices containing raw flax seeds, fresh whole apples, and/or unpasteurized almond milk. Concentrations were detected as high as 341 μg L-1 in commercially available smoothies containing vegetables, raw flax seeds, almond milk and fruits. Smoothies with vegetables, fruits, unpasteurized almond milk, and no flax seeds contained 41 ug L-1 TCN, while similar smoothies with pasteurized almond milk contained negligible to 9.6 ug L-1 CN-. Unpasteurized almond milk and raw flax seeds were the major sources of TCN in drinks.  With the increased demand for raw and natural foods, there is a potential sublethal exposure of TCN by consumers.

Open Access Original Research Article

Retrospective Study on the Association between Maternal Macronutrient Intake and Urogenital Infections during Pregnancy in a Swiss Cohort

Agusta Viola Snophan, Katharina C. Quack Lötscher

European Journal of Nutrition & Food Safety, Page 225-232
DOI: 10.9734/EJNFS/2018/42904

Aims: Urogenital infections during pregnancy have been linked to adverse pregnancy outcomes. The objective of this study was to test the hypothesis that macronutrient intake and relative macronutrient contribution to diet is related to the risk of developing urogenital infections during pregnancy.

Study Design: This is a retrospective single center cohort study.

Place and Duration of Study: Outpatient Clinic of Obstetrics at the University Hospital Zurich, Switzerland; between January 2009 and December 2010.

Methodology: We included 774 pregnant women of ages ranging from 16 to 47 years with data on urogenital infections and diet history. A diet history of these pregnant women based on food intake during the last seven days was collected in a nutritional counselling program. Diet information of these same women was matched with vaginal/urinary/cervical specimens collected within 90 days (range) prior to the nutrition assessment. The pathogens analyzed included Gram-negative rods, Gram-positive rods, Gram-positive cocci (including group B Streptococcus), Gardnerella vaginalis, Chlamydia trachomatis, and Candida spp. The covariates were maternal age, body mass index (BMI), origin, and parity. Crude and adjusted odds ratios (ORs) were determined by logistic regression.

Results: Among the 774 pregnant women, 47.7% had some kind of infection. High fat intake was positively associated with Gardnerella vaginalis (adjusted OR=3.6; 95% confidence interval (CI)=1.3–10; p=0.01). No association was seen between macronutrients or their distribution and other pathogens. However, significant associations were found between infections and covariates.

Conclusions: Findings suggested that increased dietary fat intake is associated with vaginal infections, thereby predisposing women to adverse pregnancy outcomes. This signified the importance of appropriate diet during pregnancy.

Open Access Original Research Article

Fermentation of Cassava Leaves Improves Provitamin A Carotenoid Bioefficacy in Mongolian gerbils (Meriones unguculatus)

Lessoy Zoué, Christopher Davis, Sébastien Niamké, Sherry Tanumihardjo

European Journal of Nutrition & Food Safety, Page 257-265
DOI: 10.9734/EJNFS/2018/43881

Aims: The aim of this study was to evaluate the effect of fermented cassava leaves used as diet on provitamin A carotenoid bioefficacy.

Study Design: Carotenoid analysis of fermented (F) and non-fermented (NF) cassava leaves, feeding Mongolian gerbils with F and NF leaves and β-carotene bioconversion evaluation.

Place and Duration of Study: Felix Houphouet-Boigny University, Abidjan (March to August 2015) and University of Wisconsin-Madison, USA (March to June 2016).

Methodology: Fermented cassava leaves were fed to Mongolian gerbils (Meriones unguculatus) and compared with non-fermented leaves and controls. Gerbils (32 days old, n = 46) were vitamin A (VA)-depleted for 3 weeks. After depletion, baseline gerbils (n = 6) were killed and remaining gerbils (n = 40) were weight-matched to 4 groups (n = 10/group) in the following treatments: VA-free feed (VA-); non-fermented leaves (NF); fermented leaves (F); and VA-free feed with daily oral doses of retinyl acetate dissolved in oil (VA+). The feeds were prepared using F and NF leaves at 3.53 and 4.27%, respectively, to equalise daily theoretical VA intake at 35 nmol β-carotene/g feed. Serum and livers were analysed using UPLC®.

Results: The daily feed intake from the F and NF groups did not differ (4.38 ± 0.40 g). Serum retinol concentrations did not differ among groups, but the VA+ group had higher liver retinol (1.39 ± 0.32 μmol/liver) than the F and NF groups (P < 0.05). The calculated bioconversion factors were 13 and 37 µg β-carotene equivalents to 1 µg retinol for the F and NF groups, respectively.

Conclusion: This study showed that the provitamin A carotenoids from small quantities of F and NF leaves were effective at maintaining VA status of gerbils when assessed by liver stores.

Open Access Original Research Article

Bio-preservative Activities of Partially Purified Bacteriocin Extracts of Lactobacillus mindensis TMW and Lactobacillus tucceti CECT 5920 Isolated from Nigerian Fermented Foods

C. N. Obi, O. K. Achi, E. Nwachukwu

European Journal of Nutrition & Food Safety, Page 266-283
DOI: 10.9734/EJNFS/2018/44097

The preservative potentials of lactic acid bacteria (LAB) recovered from some Nigerian traditional fermented foods were assessed by inoculating 0.1 ml aliquots of suitable dilutions of the food samples on De Man Rogosa Sharpe (MRS) agar fortified with 50mg of nystatin. The isolates were assessed for their ability to produce bacteriocin using Agar Well Diffusion assay method.  By using (GTG)5-PCR and 16s rDNA sequencing tools, two bacteriocin-producing LAB namely Lactobacillus tucceti CECT 5920 and Lactobacillus mindensis TMW were identified. Both LAB isolates had equal level of bacteriocin activity. Studies on inhibitory activity of partially purified bacteriocin extracts showed that temperature of 35°C had maximum effect on bacteriocin antimicrobial activity of L. tucceti CECT 5920 against Staphylococcus aureus NCTC 8325 and Escherichia coli 0157:H7, while pH had same effects on both LAB isolates against the test bacteria. Maximum tolerance of acidic medium was exhibited by both LAB isolates at pH 3-8.  Bacteriocin inhibitory activity was best against both test bacteria at 0.2% concentration of NaCl. Combination of ginger with partially purified bacteriocin sample from both LAB isolates had reduction effect on both test pathogens for both Lactic acid bacteria isolates. When stored for 14 days, bacteriocin activity was optimum for the first day against both test pathogens, but decreased progressively with increased in storage time. The two LAB isolates had similar inhibitory activity against both test pathogens. L. tucceti CECT 5920 gave greater reduction result (90.03%) on S. aureus NCTC 8325 in fish sample and 78.07% against E. coli 0157:H7 in meat sample while L mindensis TMW had highest significant reduction effect (90.12%) in fish sample against S. aureus NCTC 8325 and 77.80% against E. coli 0157:H7 in fish sample. Both LAB isolates will perform well as preservative agents in food preservation as they showed production of bacteriocin which has antimicrobial activity and rapid acidification in growth medium.

Open Access Original Research Article

Microbial Diversity and Heavy Metals Concentration of Wood Smoked Fish from Edonwhii Fishing Settlement in Akwa Ibom State, Nigeria

U. S. Fred, O. D. Akan, J. P. Essien, S. I. Umana

European Journal of Nutrition & Food Safety, Page 284-290
DOI: 10.9734/EJNFS/2018/43454

The microbial diversity and heavy metal concentrations of wood smoked fishes (Clarias gariepinus and Pseudotolithus elongatus) from Edonwhii fishing settlement in Akwa Ibom State, Nigeria were investigated using standard microbiological protocols and analytical procedures, to ascertain the level of fish contamination. The study revealed variations in the densities of the different microbial groups. The fresh fish samples of Clarias gariepinus and Pseudotolithus elongates had Total heterotrophic bacterial count of 7.1 x 105 and 4.1 x 107 cfu/g respectively as compared to the smoke-dried fish which had 4.8 x102 and 6.7 x 102 cfu/g respectively obtained 16 hours after smoke dying. The study reveals a rich microbial assemblage of the fish samples. Streptococcus sp, Salmonella sp, Shigella sp, Escherichia coli, Vibrio cholerae and Bacillus sp. were the different bacteria isolates encountered in the study while Absidia sp., Candida sp., Penicillium sp., Cladosporium sp., Aspergillus sp., Trichophyton sp., Torula sp., Saccharomyces sp., Verticillium sp. and Mucor sp were the fungal isolates identified. The metal analysis result showed that Zn was found to be the most abundant metal. However, Cd levels in Clarias gariepinus (0.23 mg/kg) was relatively higher than the value recorded for Pseudotolithus elongatus (0.16 mg/kg) but all were within the FAO/WHO permissible level of (0.5 mg/kg) of Cd in sea food. Similarly, the Pb levels were within the FAO/WHO permissible level of 0.3 mg/kg, indicating that the smoked fish samples were still suitable for human consumption.

Open Access Original Research Article

Evaluation of Nutritional and Sensory Quality of Complementary Food from Selected Spices, Soy and Maize Blends

A. A. Folorunso, G. F. Ayetigbo, W. A. O. Afolabi

European Journal of Nutrition & Food Safety, Page 291-299
DOI: 10.9734/EJNFS/2018/44588

Aims: This study examined the nutritional composition and consumer acceptability of complementary food produced using selected spices and soy-maize blends.

Study Design: The produce formulated complementary food using different proportions of maize, soybeans, turmeric and ginger powders and to evaluate the blends for their nutritive and Sensory qualities.

Place and Duration: The Processing and preparations were done in the Department of Family Nutrition and Consumer Sciences kitchen. All analyses were done at the Central Laboratory, Obafemi Awolowo University, Ile-Ife, Nigeria. The experiment was conducted between March and July 2018.

Methodology: The blends were formulated by mixing maize flour, soybeans flour and ginger powder in the ratio of 85:10:5 and 70:20:10 respectively, and with turmeric powder in the same ratio. These blends were evaluated for their nutritive value using standard methods. Sensory evaluation was also carried out to assess the acceptability of the blends. Results obtained were subjected to statistical analysis.

Results: The proximate analysis showed that samples 85:10:5  and 70:20:10 (Maize-soybeans-ginger) contained protein (18.9 and 34.7)%, fat (4.7 and 10.6)%, crude fibre (1.6 and 1.49)%, ash (2.9 and 3.5)% while sample 85:10:5 and 70:20:10  (Maize- soybeans- turmeric) contained protein (21.5 and 29.0)%, fat (8.6 and 19.7)%, crude fibre (1.3 and 2.8)% and ash (3.9 and 5.6)% respectively. Sensory evaluation showed that blend 85:10:5 (Maize-soybeans-ginger) was more preferred in terms of taste, flavour, and general acceptability while sample 70:20:10 (Maize- soybeans- turmeric) was generally more acceptable in terms of colour and texture.

Conclusion: The study has shown that nutrient dense complementary food can be produced from blends of turmeric, ginger, soybeans and maize, which are locally available and will help reduce the cost of the products and also minimise the outlay of foreign currency, which is an important economic consideration for developing countries like Nigeria. 

Open Access Original Research Article

Sodium and Saturated Fat Levels in Meat Products in the Netherlands: An Evaluation Based on Label Information

Suzan J. C. M. Janssen, Kelly J. J. Neessen, Elizabeth Dunford, Hans Verhagen, Annet J. C. Roodenburg

European Journal of Nutrition & Food Safety, Page 300-323
DOI: 10.9734/EJNFS/2018/43306

Aim: To collate and analyse label information on nutrients for meat products (used as sandwich fillings) in the Netherlands, using a standardised methodology established by the Global Food Monitoring Group. The objective was to compare levels of saturated fat (in g/100 grams) and sodium (in mg/100 grams) from 2011-2015 and to evaluate reformulation targets for sodium and saturated fat levels that were due to be met by January 1, 2015.

Study Design: Data collection study.

Place and Duration: Data collection in two supermarkets in the Netherlands for one month.

Methodology: Data were collected by photographing the Nutrition Information Panels (NIPs), front-of-pack communications (Guideline Daily Amounts, health logos) and other back-of-pack information from product labels of processed foods in-store using smartphone technology. Photos were uploaded to a central database where data were entered and checked and cleaned manually. Levels of sodium and saturated fat were calculated and compared with data available from reformulation monitoring reports and with the reformulation targets of the meat sector.

Results: Data were collected for 911 processed meat products, with data available for 863 meat products after data cleaning, and 86% (n=745) displaying a NIP. Sodium levels in 2015 were similar compared to concentrations observed in previous years for all subcategories of meat products. For saturated fat, combined heated meat products' saturated fat content was 8 g/100g (SD=3) based on label information in 2015 compared with 10 g/100g (SD=3) based on the label and chemical analyses information of 2014: P<0.001. The percentages of products (2015) which complied with the reformulation targets ranged per product category from 14%-93% for sodium levels and 25%-88% for saturated fat levels. Only a small percentage of meats displayed a health logo (2%) or Guideline Daily Amounts (15%) on the label.

Conclusion: Based on the comparison we observed no progress with sodium reductions and little progress with saturated fat reductions in the Netherlands between 2011 and 2015 in processed meat products. In light of the Netherlands’ reformulation covenant of 2014, focus on nutrient levels of meat products could contribute to help meet the national commitment to reduce sodium and saturated fat levels. This method of evaluation could also be used for other product categories to monitor progress and to ultimately decrease the burden of nutrition-associated diseases in the country.

Open Access Original Research Article

Prevalence and Correlates of Nutritional Anaemia among Adolescent Girls of Distt. U.S. Nagar, Uttarakhand

Deepa Joshi, Archana Kushwaha

European Journal of Nutrition & Food Safety, Page 348-360
DOI: 10.9734/EJNFS/2018/42883

Aim: Present study was carried out to determine the prevalence and epidemiological correlates of anaemia among adolescent girls (AGs) of district U. S. Nagar, Uttarakhand (India).             

Methodology: A cross sectional study was conducted between March-November 2017 among 880 AGs (10-19 years) in 88 anganwadi (AWC) centers covering three blocks one each from rural, urban and tribal blocks of district U.S. Nagar. A pre-structured questionnaire was used to collect socio-demographic, dietary and menstrual health data on AGs along with their anthropometric and heamoglobin (Hb) measurements. Univariate logistic regression analysis was performed using R software between independent variables categorised under socio-demographic characteristics, anthropometric, menstrual health and dietary characters versus the presence of anaemia. Independent variables which were found to be significantly associated with the presence of anaemia, in univariate analysis were further analysed through multiple regression analysis to find predictors of anaemia.

Results: The mean age of the study population was 15.4 years. Prevalence of anaemia was found to be 83.18% among AGs with mean Hb value of 10.62±1.5g/dl. In univariate analysis, consumption of iron folic acid supplement (IFA), age, current school status, exposure to nutrition education on anaemia, mother’s literacy status, number of children in the family, abdominal obesity, behavior of skipping meals, number of meals per day, duration of menstrual flow and type of menstrual flow were significantly associated with anaemia in AGs. While multiple regression analysis revealed that the strongest predictors of anaemia were non-exposure to nutrition education on anaemia AOR (95%CI) 1.76 (1.36, 3.12); mother’s illiteracy AOR (95%CI) 1.56(1.17,1.96) and long duration (>5 days) of menstrual flow AOR (95%CI) 1.45(1.25, 1.65), and these were significantly associated with increased odds of  nutritional anaemia while consumption of IFA AOR(95%CI) 0.329(-0.04-0.71), scanty menstrual flow AOR (95%CI) 0.692(-0.45,0.95) and  late adolescent age  AOR (95%CI) 0.45(-0.03,0.94) showed a protective effect.

Open Access Review Article

Moringa olifera: Nutrient Dense Food Source and World’s Most Useful Plant to Ensure Nutritional Security, Good Health and Eradication of Malnutrition

Vijai Pratap Singh, Amit Arulanantham, Victor Parisipogula, Sian Arulanantham, Arnab Biswas

European Journal of Nutrition & Food Safety, Page 204-214
DOI: 10.9734/EJNFS/2018/42468

Moringa (Moringa olifera Lam.), belonging to the family Moringaceae, is a plant native to the Indian sub-continent and has become naturalised in tropical and sub-tropical areas around the world. Traditionally, the leaves, fruits, flowers, and immature pods of this tree are eaten in many countries. It is an economically important, multipurpose tree with immense nutritional value, containing all essential vitamins and minerals.

In view of the high nutritional and nutraceutical values the aim of this study was to compile a comprehensive review on the functional nutrients of Moringa with their respective health benefits and its significant potential to address malnutrition.

The majority of the research articles reviewed showed that Moringa leaves have very dense nutritional values, with highest number of antioxidants, and is rich in vitamins A, B, C, D, E and K. Apart from vitamins, the plant is also very rich in mineral content and contains Calcium, Iron, Potassium, Magnesium, Manganese and Zinc. Every part of Moringa tree is nutritious. Taking Moringa leaf as a vegetable, juice or in the form of dried powder can help in curing a number of deficiencies and diseases. Regular consumption of its leaf, in various forms, can control blood pressure, blood sugar and anemia, enhance mental alertness and bone strength. Further studies on recommended daily intake and scientific consensus on therapeutic benefits are needed.