– by European Food Safety Authority (EFSA) (2014)
Following an application from InQpharm Europe Ltd, submitted for authorization of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of the United Kingdom, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to a standardized aqueous extract from white kidney bean (Phaseolus vulgaris L.) and reduction of body weight. The Panel considers that the food is sufficiently characterized.
A reduction in body weight is a beneficial physiological effect for overweight individuals. The applicant identified a total of four human intervention studies which investigated the effects of the aqueous extract from white kidney bean on body weight as being pertinent to the claim. No conclusions could be drawn from two of these four studies.
In weighing the evidence, the Panel took into account that one human intervention study showed an effect of the standardised aqueous extract from white kidney bean in reducing body weight when consumed for 12 weeks, that the reduction in body weight was mostly through a reduction in body fat and that the effect of the standardized aqueous extract from white kidney bean on body weight was supported by a second study of shorter duration.
However, the Panel also took into account that the first study was at risk of bias, that the supportive study suffered from methodological limitations and that no evidence was provided for a mechanism by which the standardized aqueous extract from white kidney bean could exert the claimed effect. The Panel concludes that the evidence provided is insufficient to establish a cause and effect relationship between the consumption of the standardized aqueous extract from white kidney bean (Phaseolus vulgaris L.) and reduction of body weight.
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– by European Food Safety Authority (EFSA) (2017)
The present opinion deals with the re-evaluation of konjac (E 425), comprising konjac gum (E 425 i) and konjac glucomannan (E 425 ii) when used as food additives. Following the conceptual framework for the risk assessment of certain food additives re-evaluated under Commission Regulation (EU) No 257/2010, the Panel considered that current use of konjac (E 425) was limited in all food categories to maximum permitted level (MPL) of 10 g/kg, and that the calculated indicative refined exposure assessment for all population groups was below 0.1 mg/kg body weight (bw) per day for the general population (mean and high level). Konjac gum and konjac glucomannan were unlikely to be absorbed intact and were significantly fermented by intestinal microbiota. The available database on toxicological studies was considered limited, however, no relevant adverse effects were seen in rats and dogs in 90-day feeding studies according to the SCF, the no-observed-effect level (NOEL) in rats being 1,250 mg konjac glucomannan/kg bw per day. Konjac gum and konjac glucomannan were of no concern with respect to the genotoxicity. After a daily dosage of 3,000 mg in adults for 12 weeks, several individuals experienced abdominal discomfort including diarrhoea or constipation. The Panel concluded that there was no need for a numerical acceptable daily intake (ADI) and that there was no safety concern for the general population at the refined exposure assessment for the reported uses of konjac gum (E 425 i) and konjac glucomannan (E 425 ii) as food additives under the current conditions of use of 10 g/kg. The Panel agreed with the conclusions of the SCF (1997) that the uses of konjac (E 425) as an additive at the levels up to 10 g/kg in food are acceptable, provided that the total intake from all sources stays below 3 g/day.
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– by European Food Safety Authority (EFSA) (2010)
Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to provide a scientific opinion on a list of health claims pursuant to Article 13 of Regulation (EC) No 1924/2006. This opinion addresses the scientific substantiation of health claims in relation to konjac mannan (glucomannan) and reduction of body weight, reduction of post-prandial glycaemic responses, maintenance of normal blood glucose concentrations, maintenance of normal (fasting) blood concentrations of triglycerides, maintenance of normal blood cholesterol concentrations, maintenance of normal bowel function and decreasing potentially pathogenic gastrointestinal microorganisms. The scientific substantiation is based on the information provided by the Member States in the consolidated list of Article 13 health claims and references that EFSA has received from the Member States or directly from stakeholders. The food constituent that is the subject of the health claims is konjac mannan (glucomannan). The Panel considers that konjac mannan (glucomannan) is sufficiently characterized.
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