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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    Guidance on the scientific requirements for health claims related to muscle function and physical performance: (Revision 1)
    (John Wiley and Sons Ltd on behalf of European Food Safety Authority, 2018-10-30) EFSA Panel on Nutrition, Novel Foods and Food Allergens (EFSA NDA Panel); Turck D; Castenmiller J; De Henauw S; Hirsch-Ernst KI; Kearney J; Knutsen HK; Maciuk A; Mangelsdorf I; McArdle HJ; Naska A; Pelaez C; Pentieva K; Thies F; Tsabouri S; Vinceti M; Bresson J-L; Burlingame B; Dean T; Fairweather-Tait S; Heinonen M; Neuhäuser-Berthold M; Nowicka G; Sanz Y; Sjödin A; Stern M; Tomé D; Van Loveren H; Willatts P; Martin A; Strain JJ; Heng L; Martínez SV; Siani A
    EFSA has asked the Panel on Nutrition, Novel Foods and Food Allergens (NDA) to update the guidance on the scientific requirements for health claims related to physical performance published in 2012. The update takes into account the experience gained by the NDA Panel with the evaluation of additional health claim applications, changes introduced to the general scientific guidance for stakeholders for health claims applications and information collected from a grant launched in 2014 which aimed at gathering information in relation to claimed effects, outcome variables and methods of measurement in the context of the scientific substantiation of health claims. The guidance is intended to assist applicants in preparing applications for the authorisation of health claims related to muscle function and physical performance. The draft guidance was subject to public consultation from 16 July to 2 September 2018. This document supersedes the guidance on the scientific requirements for health claims related to physical performance published in 2012. It is intended that the guidance will be further updated as appropriate in the light of experience gained from the evaluation of health claims.
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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.