Browsing by Author "EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)"

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    Black tea and improvement of attention: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006
    (John Wiley and Sons Ltd on behalf of European Food Safety Authority, 2018-05-24) EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Turck D; Bresson J-L; Burlingame B; Dean T; Fairweather-Tait S; Heinonen M; Hirsch-Ernst KI; Mangelsdorf I; McArdle HJ; Naska A; Neuhäuser-Berthold M; Nowicka G; Pentieva K; Sanz Y; Sjödin A; Stern M; Tomé D; Van Loveren H; Vinceti M; Willatts P; Martin A; Strain SJJ; Siani A
    Following an application from Unilever NV, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Ireland, 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 black tea and improvement of attention. The scope of the application was proposed to fall under a health claim based on newly developed scientific evidence. The food proposed by the applicant as the subject of the health claim is black tea. The Panel considers that black tea characterised by its content of tea solids, caffeine and l-theanine, which is the subject of the health claim, is sufficiently characterised in relation to the claimed effect. The claimed effect proposed by the applicant is 'improves attention'. The Panel considers that improvement of attention is a beneficial physiological effect. Three human intervention studies provided by the applicant show an effect of black tea on attention under the conditions of used proposed by the applicant. The applicant proposed that the claimed effect depends on the concerted action of two substances, caffeine and l-theanine, both of which are present in black tea. The Panel considers that the effect of black tea on attention observed in the three human intervention studies provided by the applicant can be explained by its caffeine content. The Panel concludes that a cause and effect relationship has been established between the consumption of black tea and improvement of attention. The Panel considers that the effect of black tea on attention can be explained by its caffeine content. The following wording reflects the scientific evidence: 'Owing to its caffeine content, black tea improves attention'. In order to obtain the claimed effect, 2-3 servings of black tea providing at least 75 mg of caffeine in total should be consumed within 90 min.
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    Safety of d-ribose as a novel food pursuant to Regulation (EU) 2015/2283
    (ohn Wiley and Sons Ltd on behalf of European Food Safety Authority, 2018-05-31) EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Turck D; Bresson J-L; Burlingame B; Dean T; Fairweather-Tait S; Heinonen M; Hirsch-Ernst KI; Mangelsdorf I; McArdle H; Naska A; Neuhäuser-Berthold M; Nowicka G; Pentieva K; Sanz Y; Siani A; Sjödin A; Stern M; Tomé D; Vinceti M; Willatts P; Engel K-H; Marchelli R; Pöting A; Poulsen M; Schlatter JR; Germini A; Van Loveren H
    Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on D-ribose as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The applicant intends to market the NF as ingredient in a variety of foods, food supplements and in certain foods for specific groups. The NF is produced by fermentation using a transketolase-deficient strain of Bacillus subtilis and marketed as Bioenergy Ribose™. The information provided on the batch-to-batch variability, specifications, stability, production process and history of the organism used as a source of the NF is sufficient and does not raise safety concerns. The Panel considers that the effects observed in a subchronic toxicity study in rats could be the consequence of nutritional imbalances, but toxicological effects could not be ruled out; from this study, the Panel derived a No observed adverse effect level (NOAEL) of 3.6 g/kg body weight (bw) per day. From the human studies indicating a potential decrease in glucose levels and/or the occurrence of transient symptomatic hypoglycaemia at intakes of 10 g of d-ribose, the Panel defined 70 mg/kg bw per day as the NOAEL with respect to hypoglycaemia that can be considered applicable for adults. For children, the Panel acknowledges the lack of human data directly relevant for this population group. Based on the NOAEL derived from the subchronic toxicity study in rats, an acceptable level of intake of 36 mg/kg bw per day was defined that would also take into account the potentially increased sensitivity of certain population groups to hypoglycaemia. The Panel concludes that the NF is safe for the general population at intake levels up to 36 mg/kg bw per day and considers that the safety of the NF at the intended uses and use levels as proposed by the applicant has not been established.
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    Safety of xylo-oligosaccharides (XOS) as a novel food pursuant to Regulation (EU) 2015/2283
    (John Wiley and Sons Ltd on behalf of European Food Safety Authority, 2018-07-23) EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Turck D; Bresson J-L; Burlingame B; Dean T; Fairweather-Tait S; Heinonen M; Hirsch-Ernst KI; Mangelsdorf I; McArdle HJ; Naska A; Neuhäuser-Berthold M; Nowicka G; Pentieva K; Sanz Y; Siani A; Sjödin A; Stern M; Tomé D; Vinceti M; Willatts P; Engel K-H; Marchelli R; Pöting A; Poulsen M; Schlatter JR; Turla E; van Loveren H
    Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver a scientific opinion on a mixture of xylo-oligosaccharides (XOS) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is obtained from corncobs (Zea mays subsp. mays) via enzyme-catalysed hydrolysis and subsequent purification. The main components of the NF, the oligosaccharides, are resistant to human digestive enzymes and are fermented by colonic bacteria. The intention is to add the NF to a variety of foods such as bakery and dairy products, fruit jelly, chocolates and soy-drinks. The information provided on composition, specifications, production process and stability of the NF, does not raise safety concerns. There were effects observed in the animal studies with the NF or with other XOS which were considered by the Panel to be expected from the intake of non-digestible carbohydrates. The Panel notes that the acute and transient gastrointestinal observed in human intervention studies with the NF or with other XOS have also been associated with the consumption of other non-digestible carbohydrates. The Panel concludes that the NF, a mixture of XOS, is safe under the proposed uses and use levels. The target population is the general population.
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    Xanthohumol in XERME®, a xanthohumol-enriched roasted malt extract, and protection of DNA from oxidative damage: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006
    (John Wiley and Sons Ltd on behalf of European Food Safety Authority, 2018-03-13) EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Turck D; Bresson J-L; Burlingame B; Dean T; Fairweather-Tait S; Heinonen M; Hirsch-Ernst KI; Mangelsdorf I; McArdle HJ; Naska A; Neuhäuser-Berthold M; Nowicka G; Pentieva K; Sanz Y; Sjödin A; Stern M; Tomé D; Van Loveren H; Vinceti M; Willatts P; Martin A; Strain SJJ; Siani A
    Following an application from TA-XAN AG, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Germany, 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 xanthohumol in XERME ®, a xanthohumol-enriched roasted malt extract, and protection of DNA from oxidative damage. The scope of the application was proposed to fall under a health claim based on newly developed scientific evidence. The food proposed by the applicant as the subject of the health claim is xanthohumol in XERME ®, a xanthohumol-enriched roasted malt extract. The Panel considers that xanthohumol in XERME ®, a xanthohumol-enriched roasted malt extract, is sufficiently characterised. The claimed effect proposed by the applicant is 'helps to maintain the integrity of DNA and protects against oxidative damage in the cells of the body'. The Panel considers that protection of DNA from oxidative damage is a beneficial physiological effect. The only human study from which conclusions can be drawn for the scientific substantiation of the claim did not show an effect of xanthohumol in XERME ® on the protection of DNA from oxidative damage. In the absence of evidence for an effect of xanthohumol in XERME ® on the protection of DNA from oxidative damage, the studies provided by the applicant on the proposed mechanisms by which the food/constituent could exert the claimed effect were not considered by the Panel for the scientific substantiation of the claim. The Panel concludes that a cause and effect relationship has not been established between the consumption of xanthohumol in XERME ®, a xanthohumol-enriched roasted malt extract, and protection of DNA from oxidative damage.