Younes Maged, Aquilina Gabriele, Castle Laurence, Engel Karl-Heinz, Fowler Paul, Frutos Fernandez Maria Jose, Fürst Peter, Gürtler Rainer, Gundert-Remy Ursula, Husøy Trine, Mennes Wim, Moldeus Peter, Oskarsson Agneta, Shah Romina, Wölfle Detlef, Lambré Claude, Christodoulidou Anna, Waalkens-Berendsen Ine
EFSA J. 2019 Mar 1;17(3):e05625. doi: 10.2903/j.efsa.2019.5625. eCollection 2019 Mar.
In this opinion, the EFSA Panel on Food Additives and Flavourings (FAF Panel) was requested by the European Commission to carry out a scientific evaluation of an extended one-generation reproductive toxicity study (EOGRTS) to determine whether it would allow reconsideration of the temporary group acceptable daily intake (ADI) for sorbic acid (E 200) and potassium sorbate (E 202), established by the Panel on Food Additives and Nutrient Sources added to Food (ANS Panel) in 2015. From the EOGTRS, the FAF Panel identified a lower confidence limit of the benchmark dose (BMDL) of 1,110 mg sorbic acid/kg body weight (bw) per day. By applying a default uncertainty factor of 100, the Panel established a group ADI expressed as 11 mg sorbic acid/kg bw per day for sorbic acid (E 200) and its potassium salt (E 202). In addition, European Commission asked EFSA to review a report on the 'Stability of sorbic acid (E 200) and its potassium salt (E 202) during food processing and storage' provided by industry. No new information was provided in this report, and therefore, in this opinion, there was no re-assessment of the EFSA ANS opinion conclusions from 2015 regarding the stability of sorbates in food.
在此意见中,欧盟委员会要求欧洲食品安全局食品添加剂和调味剂小组(FAF小组)对一项扩展的一代生殖毒性研究(EOGRTS)进行科学评估,以确定是否可以重新考虑食品添加剂和营养源添加到食品小组(ANS小组)于2015年确定的山梨酸(E 200)和山梨酸钾(E 202)的临时群体每日允许摄入量(ADI)。根据EOGRTS,FAF小组确定山梨酸的基准剂量下限(BMDL)为每天1110毫克/千克体重(bw)。通过应用默认的不确定系数100,该小组确定山梨酸(E 200)及其钾盐(E 202)的群体ADI为每天11毫克山梨酸/千克体重。此外,欧盟委员会要求欧洲食品安全局审查一份由行业提供的关于“山梨酸(E 200)及其钾盐(E 202)在食品加工和储存过程中的稳定性”的报告。该报告未提供新信息,因此,在此意见中,未对欧洲食品安全局ANS小组2015年关于山梨酸盐在食品中稳定性的意见结论进行重新评估。