Younes Maged, Aquilina Gabriele, Castle Laurence, Degen Gisela, Engel Karl-Heinz, Fowler Paul, Frutos Fernandez Maria Jose, Gundert-Remy Ursula, Gürtler Rainer, Husøy Trine, Manco Melania, Mennes Wim, Moldeus Peter, Passamonti Sabina, Shah Romina, Waalkens-Berendsen Ine, Wright Matthew, Cheyns Karlien, Mirat Manuela, Rincon Ana Maria, Tard Alexandra, Zakidou Panagiota, Fürst Peter
EFSA J. 2024 Feb 6;22(2):e8563. doi: 10.2903/j.efsa.2024.8563. eCollection 2024 Feb.
Quillaia extract (E 999) was re-evaluated in 2019 by the EFSA Panel on Food Additives and Flavourings (FAF). EFSA derived an acceptable daily intake (ADI) of 3 mg saponins/kg bw per day for E 999. Following a European Commission call for data to submit data to fill the data gaps, the present follow-up opinion assesses data provided by interested business operators (IBOs) to support an amendment of the EU specifications for E 999. Additionally, this opinion deals with the assessment of the proposed extension of use for E 999 in food supplements supplied in a solid and liquid form, excluding food supplements for infants and young children and, as a carrier in botanical nutrients. The Panel concluded that the proposed extension of use, if authorised, could result in an exceedance of the ADI at the maximum of the ranges of the mean for children, adolescents and the elderly, and for all populations at the 95th percentile. An additional proposed extension of use for E 999 to be used as a carrier for glazing agents on entire fresh fruits and vegetables has been received. Since no information on the proposed use levels of E 999 on a saponins content basis has been provided by this applicant, the Panel was not able to evaluate the safety of this extension of use. Considering the technical data submitted, the Panel recommended some modifications of the existing EU specifications for E 999, mainly to lower the limits for lead, mercury and arsenic and to include a maximum limit for cadmium and for calcium oxalate. The Panel also recommended that the limits would be expressed on a saponins basis. The Panel proposed to revise the definition of E 999 to better describe the composition in a qualitative way.
2019年，欧洲食品安全局食品添加剂和调味剂专家委员会（FAF）对皂树提取物（E 999）进行了重新评估。欧洲食品安全局得出E 999的每日允许摄入量（ADI）为3毫克皂苷/千克体重/天。应欧盟委员会要求提供数据以填补数据空白，本次后续意见评估了相关商业经营者（IBOs）提供的数据，以支持修订E 999的欧盟规范。此外，本意见还涉及对E 999在固体和液体形式的食品补充剂中（不包括婴幼儿食品补充剂）以及作为植物性营养素载体的拟议用途扩展的评估。专家委员会得出结论，如果拟议的用途扩展获得批准，可能会导致儿童、青少年和老年人的平均摄入量范围上限以及所有人群第95百分位数的摄入量超过每日允许摄入量。已收到关于E 999用作整个新鲜水果和蔬菜上的包衣剂载体的另一拟议用途扩展。由于该申请人未提供基于皂苷含量的E 999拟议使用水平的信息，专家委员会无法评估此用途扩展的安全性。考虑到提交的技术数据，专家委员会建议对E 999的现有欧盟规范进行一些修改，主要是降低铅、汞和砷的限量，并纳入镉和草酸钙的最大限量。专家委员会还建议这些限量应以皂苷为基础表示。专家委员会提议修订E 999的定义，以便更定性地描述其成分。
