Open Access Grey Literature

Risk Assessments of Cyclamate, Saccharin, Neohesperidine DC, Steviol Glycosides and Neotamefrom Soft Drinks, “Saft” and Nectar

Inger-Lise Steffensen, Jan Alexander, Mona-Lise Binderup, Knut Helkås Dahl, Berit Granum, Ragna Bogen Hetland, Trine Husøy, Jan Erik Paulsen, Vibeke Thrane

European Journal of Nutrition & Food Safety, Page 72-74
DOI: 10.9734/EJNFS/2015/14816

The Norwegian Scientific Committee for Food Safety (Vitenskapskomiteen for mattrygghet, VKM), Panel on Food Additives, Flavourings, Processing Aids, Materials in Contact with Food and Cosmetics, has at the request of the Norwegian Food Safety Authority (Mattilsynet) conducted a risk assessment of the intense sweeteners cyclamate, saccharin, neohesperidine DC, steviol glycosides and neotame in soft drinks, “saft” and nectar. The risk assessment includes exposure assessments and the calculated exposures are compared to the acceptable daily intake (ADI) for the respective sweeteners. VKM was also requested to compare the current calculated intake of saccharin and cyclamate to the calculated intake reported by VKM in 2007 (the VKM report «Impact on health when sugar is replaced with intense sweeteners in soft drinks, “saft” and nectar») when possible (VKM, 2007).

Six different intake scenarios with varying concentrations of added sweeteners (either the average concentration or the highest reported concentration for the respective sweetener) and varying consumption of beverages with sweeteners (either the actual reported consumption of beverages added sweetener or the assumption that all reported beverages were added sweeteners) were used for the exposure calculations.

• Scenario 1 gives the best estimate of the current situation in the population (average content of sweeteners, actual reported consumption).
• Scenario 2 is based on the average content of sweeteners and that all consumed beverages contain sweeteners.
• Scenario 3 is based on the highest reported content of sweeteners and the actual reported consumption.
• Scenario 4 is based on the highest reported content of sweeteners and that all consumed beverages contain sweeteners.

Scenarios 5 and 6 are based on the maximum allowed amounts of sweeteners within a category in accordance with the Regulation on food additives, within the categories soft drinks, “saft” and nectar in Norway (Regulation No 668 of 6 June 2011 on food additives, 2011).

• In scenario 5 the consumption of beverages with added sweeteners or sugar reported in dietary surveys were used for the calculations.
• In scenario 6 it was assumed that all consumed soft drinks, “saft” and nectar contained sweeteners (no sugar).

In the current risk assessment, the intake of the sweeteners was calculated for 2-year-old children and 18-70 year old men and women. Due to lack of new dietary surveys, the other age groups of children and adolescents were not included.

For all age groups in all scenarios, the intake of the sweeteners cyclamate, saccharin, neohesperidine DC, steviol glycosides and neotame was below their respective established ADI values. Due to possible differences in the calculation, it was not possible to compare the current calculated intake of saccharin and cyclamate to the calculated intake reported by VKM in 2007.

VKM concludes that there is no major health concern related to the intake of the sweeteners cyclamate, saccharin, neohesperidine DC, steviol glycosides and neotame from the beverage categories included in this risk assessment per today.

VKM further concludes that among young women who are high consumers of beverages with cyclamate, and 2-year-old children who are high consumers of beverages with steviol glycosides, the estimated intake approaches the ADI values. The high intakes approaching ADI are considered conservative estimates, as the highest reported content of sweetener or the maximum allowed amounts is used. Thus, these estimates are only relevant for the part of the population that are both loyal to beverages with sweeteners and a particular brand of sweetened beverage. It should be noted that intake of sweeteners from other foods or from tabletop sweeteners is not included in the intake estimates, and that a considerable contribution from these sources cannot be excluded.

Open Access Grey Literature

Assessment of Infant Formula and Follow-on Formula Supplemented with Lactobacillus fermentum CECT5716

Jørgen Lassen, Siamak Yazdankhah, Judith Narvhus

European Journal of Nutrition & Food Safety, Page 88-89
DOI: 10.9734/EJNFS/2015/14817

The Norwegian Scientific Commitee for Food Safety (VKM) has appointed a working group of experts to answer a request from the Norwegian Food Safety Authority regarding risk assessment of Lactobacillus fermentum CECT5716 in infant formula intended for use from birth (0 month) and in infant formulae and follow-on formulae intended for children after the age of 6 month.

The mandate of this risk assessment was not to evaluate the health claims related to the products as such health claims are assessed by EFSA. However, in the EFSA opinions so far (November 2009), a cause and effect relationship has not been established between the consumption of L. fermentum CECT5716 containing products and the claimed effects.

In the assessment of L. fermentum CECT5716 by the expert committee in EFSA, the panel considered that the strain is sufficiently characterized.

We are not aware of any data indicating that this strain has been the cause of human disease. Its potential toxicity and ability to translocate has been studied in adult mice after oral administration of doses 10 000 times greater than those normally consumed by humans without observing any bacteremia or translocation to spleen or liver. However, strains of Lactobacillus have from time to time been isolated from human blood cultures and may therefore, although seldom, translocate.

L. fermentum CECT5716 is fully susceptible to all antibiotics that are recommended by the Panel on additive and products or substances used in animal feed (FEEDAP) of EFSA and is considered safe with respect to absence of antimicrobial resistance genes. DNA-sequence data do not imply the presence of any gene(s) coding for toxin production, but confirming in vitro-studies are missing.

The FBO refers to two randomized clinical studies in healthy infants of 1-6months of age with respect to possible safety aspects, concluding that the L. fermentum CECT5716 was well tolerated and safe for the groups examined. However, data concerning safety aspects specifically concerned with new-borns, or for immunocompromised infants are lacking. The FBO has submitted some data regarding possible long-term adverse effects of giving the strain daily as a “monoculture” over a prolonged period of time. These data are not sufficient to draw any conclusion regarding long-term safety of the strain.

It is supposed that the early composition of the human gastro-intestinal tract microbiota can have long-lasting functional effects. If that is the case, a daily supply of a “monoculture” of a single, specific strain such as L. fermentum CECT 5716, in large quantities over a prolonged period of time to age groups where the intestinal flora is still developing may therefore have unknown, but possible long-lasting adverse effects.

Open Access Original Research Article

Customers Purchasing Organic Food - Do They Live Healthier? Results of the German National Nutrition Survey II

Marianne Eisinger-Watzl, Friederike Wittig, Thorsten Heuer, Ingrid Hoffmann

European Journal of Nutrition & Food Safety, Page 59-71
DOI: 10.9734/EJNFS/2015/12734

Aims: Using national food consumption data this paper addresses issues whether buyers of organic food make healthier food choices and pursue a healthy lifestyle concerning smoking, physical exercise and body weight compared to non-buyers.
Study Design: The German National Nutrition Survey II (NVS II) is a nationwide food consumption study providing additional information on social demographics, health, and lifestyle aspects as well as anthropo¬metric measurements. Using data of several assessment tools, a comparison was conducted between buyers and non-buyers of organic food.
Place and Duration of the Study: From November 2005 to November 2006, data collection took place in about 500 randomly chosen sample points across Germany.
Methodology: 13,074 participants aged 18-80 years were divided into groups of buyers (44.9%) and non-buyers (55.1%) of organic food. According to their purchase frequency, the organic food buyers were further differentiated into intensive, occasional or infrequent purchase groups. A diet history method was applied to assess food consumption, trained staff measured BMI while questionnaires were used for social demographic description and healthy lifestyle factors.
Results: Buyers of organic food consumed 17% more fruit and 23% more vegetables as well as less meat/sausages (25%) and soft drinks (58%) than non-buyers did (P< .001, resp.). These results are more pronounced for women and for intensive buyers. Additionally, buyers of organic food exhibit healthier lifestyle characteristics in respect to smoking behaviour, physical activity, and body weight compared to non-buyers. 
Conclusion: German buyers of organic food demonstrate health behaviours complying better with the recommendations for a healthy lifestyle compared with non-buyers. Independent of the discussion whether organically produced food exerts additional health effects, buyers of organic food make healthier food choices than non-buyers, thereby benefiting for their overall health.

Open Access Original Research Article

The Application of Magnetic Resonance Spectroscopy to Investigate the Effect of a Commercial Energy Drink

Tracy L. Burrows, Kirrilly M. Pursey, Peter Stanwell

European Journal of Nutrition & Food Safety, Page 75-87
DOI: 10.9734/EJNFS/2015/9229

Aims: Proton magnetic resonance spectroscopy (MRS) is an imaging technique that provides non-invasive, in-vivo measurement of brain biochemistry. The objective of this study was to explore the effects of a commercial energy drink (ED) on brain metabolites in adult males using MRS. 
Methods: Ten males (18 to 30 years), of mean body mass index 23.8±2.2 kg/m2 [range 21.4-27.8 kg/m2] were recruited and randomized to either the intervention group (n=5) or control group (n=5). The intervention group were asked to consume two 250ml cans of Red Bull and the control group consumed no drink. One dimensional MRS on a 1.5T Achieva MRI scanner was obtained of bi-occipital gray matter. Subjects were placed in the scanner and a spectrum acquired every 5.75 minutes for 60 minutes. Linear mixed models were generated to determine the main effects due to differences between groups and times and the interaction. 
Results: There was a significant group by time effect for N-acetylaspartate (NAA) (P= .02, d= 0.7) and a statistical trend for macromolecule 20 (MM20) (P= .06 d= 0.1) with the control group having higher concentrations than that of the intervention. Mean differences from baseline to 45 minutes for NAA in the intervention group were -0.8 mM (-12%) compared with 0.15 mM (<1%) for control and for MM20 -0.12 mM (<1%) in the intervention group compared with 0.03 mM (<1%) for control. 
Conclusions: Consumption of two cans of ED was found to produce few changes in brain metabolites with moderate effect sizes. Changes detected in this study demonstrate the sensitivity of the MRS method to explore nutrition related variables with 1.5T clinical MRI unit. The study provides some insight into an understudied, topical area of research.

Open Access Review Article

Review and Perspective on the Composition and Safety of Green Tea Extracts

Jeffrey B. Blumberg, Bradley W. Bolling, C. Y. Oliver Chen, Hang Xiao

European Journal of Nutrition & Food Safety, Page 1-31
DOI: 10.9734/EJNFS/2015/12712

The growing body of evidence regarding the putative health benefits of green tea (Camellia sinensis), including reduced risk of cancer and cardiovascular disease, has led to an increase in the consumption of brewed green tea and the formulation of green tea extracts (GTE) into a variety of food and beverage products and food supplements. The principal bioactive ingredients in green tea beverages and GTE are polyphenols, particularly the flavan-3-ols, which have been shown to act on antioxidant, anti-inflammatory, glucoregulatory, and cell signaling pathways. Some experimental evidence and case reports suggest the use of green tea and GTE is associated with the potential for inducing liver injury. The ability to extrapolate findings from in vitro and animal model studies is always limited and the available results on green tea- and GTE-induced liver injury in humans have presented clinical and regulatory challenges due to the difficulty of demonstrating a causal relationship between intake and harm. Attention to the risk for hepatotoxicity has largely been focused on GTE. Existing data are insufficient to identify the causative agent in the preparation or composition of GTE or its dose or duration of use as well as nutrigenetic, medical, and other factors that may contribute to the risk of hepatotoxicity. Responses by different government regulatory agencies regarding the safety of GTE are inconsistent with one another, including the dosage and derivation of its bioactives from aqueous versus hydro-alcoholic extracts. Restrictions on the production of GTE limit the application of innovative extraction technologies that may improve the efficiency, quality, and cost-effectiveness of production and minimize the presence of endogenous or contaminant heavy metals as well as mycotoxins, pesticides, and other unwanted constituents. The objective of this review is to characterize the phytochemical profile of green tea and GTE, provide an updated description of the methods that could be used to extract green tea constituents, and discuss recent considerations on the potential for harm from consumption of GTE and products containing GTE.

Open Access Review Article

Public Health Risk-benefit Assessment Associated with Food Consumption–A Review

Géraldine Boué, Sandrine Guillou, Jean-Philippe Antignac, Bruno Le Bizec, Jeanne-Marie Membré

European Journal of Nutrition & Food Safety, Page 32-58
DOI: 10.9734/EJNFS/2015/12285

Background: In the food safety field, risk assessment, including microbial and chemical components, has been applied for many years. However, a whole and integrated public health assessment also depends on the nutritional composition of food. While the fact that foods and diets can be a source of both risks and benefits now appears undisputed, carrying out a risk-benefit assessment (RBA) is still an emerging and challenging scientific subject.
Aims: The purpose of the present review was to synthesize RBA studies associated with food consumption and to summarize the current methodological options and/or tendencies carried out in this field.
Methods: The different data sources explored included around 20 accessible databases using the main terms “risk”, “benefit” and “food” as keyword enquiries in article title and full-text. The initial research process led to 3293 screened papers, 160 of which were examined in detail.
Results: There were 126 articles dealing with RBA studies and 34 with the RBA methodological framework. Most of the available papers dealt with the comparison of nutritional beneficial effects and chemical adverse effects related to fish consumption. The majority of studies undertook a comparison of consumer exposure to risks and benefits with regard to reference safety values. However, more varied studies have emerged during the last 15 years, contributing to the diversification and the development of this issue.
Conclusion: RBA appears to be a promising scientific discipline and should be the next step in assessing the overall impact of food on health.