Journal Articles

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    Guidance on the preparation and submission of the notification and application for authorisation of traditional foods from third countries in the context of Regulation (EU) 2015/2283 (Revision 1)
    (John Wiley and Sons Ltd on behalf of the European Food Safety Authority, 2021-03-26) 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 J; Gelbmann W; de Sesmaisons-Lecarré A; Verhagen H; van Loveren H
    Following the adoption of Regulation (EU) 2015/2283 on Novel Foods, the European Commission requested EFSA to develop a scientific and technical guidance for the preparation and submission of notifications for traditional foods from third countries. This guidance presents a common format for the organisation of the information to be presented by applicant for the preparation of a well-structured dossier. The safety of a traditional food should be substantiated by reliable data on its composition, its experience of continued use and its proposed conditions of use. Its normal consumption should not be nutritionally disadvantageous. This guidance is also intended to support applicants in providing the type and quality of information EU Member States and EFSA need for the assessments of traditional foods from third countries. The applicant should integrate the information on the composition and the experience of continued use and provide a concise overall consideration on how this substantiates the history of safe use of the traditional food and how this relates to the proposed conditions of use for the EU. Where potential health hazards have been identified on the basis of the composition and/or data from the experience of continued use, they should be discussed. On the basis of the information provided, EFSA will assess the safety related to the consumption of the traditional food under the proposed conditions of use. This guidance was originally adopted by the NDA Panel in 2016. It has been revised in 2020 to inform applicants of the new provisions introduced by Regulation (EC) No 178/2002, as amended by Regulation (EU) 2019/1381 on the transparency and sustainability of the EU risk assessment in the food chain.It is applicable to allnotifications and applications submitted as of 27 March 2021. The 2016 version remains applicable to notifications and applications submitted before 27 March 2021.
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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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    Guidance on the preparation and submission of an application for authorisation of a novel food in the context of Regulation (EU) 2015/2283 (Revision 1)2
    (John Wiley and Sons Ltd on behalf of European Food Safety Authority, 2021-03-26) EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) Products; 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; Salminen S; Schlatter J; Arcella D; Gelbmann W; de Sesmaisons-Lecarré A; Verhagen H; van Loveren H
    Following the adoption of Regulation (EU) 2015/2283 on novel foods, the European Commission requested EFSA develop scientific and technical guidance for the preparation and submission of applications for authorisation of novel foods. This guidance presents a common format for the organisation of the information to be presented by the applicant when preparing a well-structured application to demonstrate the safety of the novel food. It outlines the data needed for the safety assessments of novel foods. Requirements relate to the description of the novel food, production process, compositional data, specification, proposed uses and use levels, and anticipated intake of the novel food. Further sections on the history of use of the novel food and/or its source, absorption, distribution, metabolism, excretion, nutritional information, toxicological information and allergenicity should be considered by the applicant by default. If not covered in the application, this should be justified. The applicant should integrate the data presented in the different sections to provide their overall considerations on how the information supports the safety of the novel food under the proposed conditions of use. Where potential health hazards have been identified, they should be discussed in relation to the anticipated intakes of the novel food and the proposed target populations. On the basis of the information provided, EFSA will assess the safety of the novel food under the proposed conditions of use. This guidance was originally adopted in 2016.It has been revised to inform applicants of the new provisions introduced by Regulation (EC) No 178/2002, as amended by Regulation (EU) 2019/1381 on the transparency and sustainability of the EU risk assessment in the food chain. This revised guidance applies to all dossiers submitted as of 27 March 2021. The 2016 version of this guidance remains applicable to applications submitted before 27 March 2021.
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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.