Turck Dominique, Bohn Torsten, Castenmiller Jacqueline, De Henauw Stefaan, Hirsch-Ernst Karen Ildico, Maciuk Alexandre, Mangelsdorf Inge, McArdle Harry J, Naska Androniki, Pelaez Carmen, Pentieva Kristina, Siani Alfonso, Thies Frank, Tsabouri Sophia, Vinceti Marco, Cubadda Francesco, Frenzel Thomas, Heinonen Marina, Marchelli Rosangela, Neuhäuser-Berthold Monika, Poulsen Morten, Prieto Maradona Miguel, Schlatter Josef Rudolf, van Loveren Henk, Roldán-Torres Ruth, Knutsen Helle Katrine
EFSA J. 2022 Jun 10;20(6):e07332. doi: 10.2903/j.efsa.2022.7332. eCollection 2022 Jun.
Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on zinc l-carnosine as a novel food (NF) pursuant to Regulation (EU) 2015/2283 and as a source of zinc for use in food supplements. The NF is produced by chemical synthesis and is proposed to be used in food supplements as a source of zinc. The target population proposed by the applicant is individuals above the age of 12, excluding pregnant and lactating women. The NF which is the subject of the application is a chelate-complex, formed between Zn and l-carnosine and is present as a mixture of a monomer and a dimer. The material is a powder with particulate nature and is insoluble in water at neutral pH. No relevant data using an existing zinc source as comparator have been made available by the applicant and the actual bioavailability of the zinc provided by the NF at the proposed use levels remains uncharacterised. Owing to the lack of a correct characterisation of the fraction of small particles, including nanoparticles of the NF, the Panel is not in the position to evaluate specification limits for the size of the constituent particles in the NF. Owing to the lack of information on the size distribution and the physico-chemical properties of the particles constituting the NF, the Panel is not in the position to confirm whether the ADME studies and the toxicological studies provided by the applicant are appropriate to assess the safety of the NF. The Panel concludes that the NF is absorbed and provides zinc, but as it is in an insufficiently characterised particulate form, its safety has not been established and the bioavailability has not been determined.
应欧盟委员会的要求，欧洲食品安全局营养、新型食品和食品过敏原小组（NDA）被要求根据欧盟法规（EU）2015/2283，就L-肌肽锌作为新型食品（NF）以及作为用于食品补充剂的锌源发表意见。该新型食品通过化学合成生产，拟用作食品补充剂中的锌源。申请人提议的目标人群为12岁以上个体，不包括孕妇和哺乳期妇女。申请所涉及的新型食品是一种螯合物，由锌与L-肌肽形成，以单体和二聚体的混合物形式存在。该物质为具有颗粒性质的粉末，在中性pH值下不溶于水。申请人未提供以现有锌源作为对照的相关数据，且在所提议使用水平下该新型食品所提供锌的实际生物利用度仍未得到表征。由于缺乏对包括新型食品纳米颗粒在内的小颗粒部分的正确表征，小组无法评估新型食品中组成颗粒大小的规格限度。由于缺乏关于构成新型食品颗粒的大小分布和物理化学性质的信息，小组无法确认申请人提供的吸收、分布、代谢和排泄（ADME）研究及毒理学研究是否适合评估该新型食品的安全性。小组得出结论，该新型食品可被吸收并提供锌，但由于其颗粒形式的表征不充分，其安全性尚未确立，生物利用度也未确定。
