Turck Dominique, Bohn Torsten, Castenmiller Jacqueline, de Henauw Stefaan, Hirsch-Ernst Karen Ildico, Knutsen Helle Katrine, Maciuk Alexandre, Mangelsdorf Inge, McArdle Harry J, Pentieva Kristina, Siani Alfonso, Thies Frank, Tsabouri Sophia, Vinceti Marco, Kass George, Heng Leng, Sofroniou Angeliki, Ververis Ermolaos, Valtueña Martínez Silvia, Naska Androniki
EFSA J. 2024 Sep 30;22(9):e8946. doi: 10.2903/j.efsa.2024.8946. eCollection 2024 Sep.
Following the adoption of Regulation (EU) No 1169/2011 on food information to consumers, the European Commission requested EFSA to update its 'Guidance on safety evaluation of sources of nutrients and bioavailability of the nutrient from the sources' regarding the scientific principles and data requirements for the scientific assessment of all new forms of micronutrients and to derive a conversion factor for new micronutrient sources or forms of micronutrients to be authorised for addition to foods, including food supplements. This guidance outlines the scientific principles that the NDA Panel will consider for the assessment of the safety and the quantification of the relative bioavailability of new sources of micronutrients, which applicants are requested to consider when preparing their applications. It also outlines the data requirements for dossiers. Applicants should integrate the data presented in different sections to provide their overall considerations on how the information provided supports the safety of the new micronutrient source and the quantification of its relative bioavailability compared to a reference source under the proposed conditions of use. As preparatory work for the development of this guidance, EFSA launched an Expert Survey and held an online workshop on 9th March 2023 inviting scientific input from stakeholders and scientific experts, the report of which is now available online in the EFSA's webpage.
在欧盟第1169/2011号《消费者食品信息条例》通过后，欧盟委员会要求欧洲食品安全局更新其“营养素来源安全评估及营养素生物利用度指南”，内容涉及对所有新形式微量营养素进行科学评估的科学原则和数据要求，并为拟批准添加到食品（包括食品补充剂）中的新微量营养素来源或微量营养素形式推导一个转换因子。本指南概述了新食品原料评估小组在评估微量营养素新来源的安全性和相对生物利用度量化时将考虑的科学原则，申请人在准备申请时应予以考虑。它还概述了档案的数据要求。申请人应整合不同部分提供的数据，以全面考虑所提供的信息如何支持新微量营养素来源的安全性以及在拟议使用条件下与参考来源相比其相对生物利用度的量化。作为制定本指南的准备工作，欧洲食品安全局开展了一项专家调查，并于2023年3月9日举办了一次在线研讨会，邀请利益相关者和科学专家提供科学意见，其报告现已在欧洲食品安全局网页上在线发布。
