Younes Maged, Aquilina Gabriele, Castle Laurence, Engel Karl-Heinz, Fowler Paul, Frutos Fernandez Maria Jose, Fürst Peter, Gürtler Rainer, Husøy Trine, Manco Melania, Mennes Wim, Moldeus Peter, Passamonti Sabina, Shah Romina, Waalkens-Berendsen Ine, Wölfle Detlef, Wright Matthew, Dusemund Birgit, Mortensen Alicja, Turck Dominique, Barmaz Stefania, Tard Alexandra, Vianello Giorgia, Gundert-Remy Ursula
EFSA J. 2021 Jan 29;19(1):e06387. doi: 10.2903/j.efsa.2021.6387. eCollection 2021 Jan.
Pectin (E 440i) and amidated pectin (E 440ii) were re-evaluated in 2017 by the former EFSA Panel on Food Additives and Nutrient sources added to Food (ANS). As a follow-up to this assessment, the Panel on Food Additives and Flavourings (FAF) was requested to assess the safety of pectins (E 440i,ii) for their uses as food additives in food for infants below 16 weeks of age. In addition, the FAF Panel was requested to address the issues already identified during the re-evaluation of the same food additive. The process involved the publication of a call for data to allow the interested business operators to provide the requested information to complete the risk assessment. Based on the information submitted in response to the call for data, the FAF Panel considered it feasible to amend the current specifications, in particular for the toxic elements arsenic, lead, cadmium, mercury and for sulfur dioxide and to introduce new specifications for aluminium and microbiological criteria. Studies on neonatal piglets, clinical studies and post-marketing data were made available during the call for data. Due to the low internal validity of the clinical studies, the Panel concluded that a reference point could not be derived from them, but the results of the adequate piglet study could serve to derive a reference point. When calculating the margin of safety for pectins exposure, this was below 1 for some scenarios. At the maximum permitted levels (MPLs), an internal methanol dose would be produced that could lead to adverse health effects in infants below 16 weeks of age. The FAF Panel recommended a reduction of the MPL of pectin (E 440i) and amidated pectin (E 440ii) in food categories 13.1.5.1 and 13.1.5.2, in order to reduce the exposure to both the additives themselves and to methanol.
2017年，前欧洲食品安全局食品添加剂和添加到食品中的营养源专家委员会（ANS）对果胶（E 440i）和酰胺化果胶（E 440ii）进行了重新评估。作为此次评估的后续行动，食品添加剂和调味剂专家委员会（FAF）被要求评估果胶（E 440i、ii）作为食品添加剂在16周龄以下婴儿食品中的安全性。此外，FAF专家委员会被要求解决在对同一种食品添加剂重新评估期间已经确定的问题。该过程包括发布数据征集通知，以便感兴趣的企业经营者提供所需信息以完成风险评估。根据针对数据征集通知提交的信息，FAF专家委员会认为修订现行规范是可行的，特别是对于有毒元素砷、铅、镉、汞以及二氧化硫，并引入铝和微生物标准的新规范。在数据征集期间提供了关于新生仔猪的研究、临床研究和上市后数据。由于临床研究的内部效度较低，专家委员会得出结论，无法从中得出参考点，但充分的仔猪研究结果可用于得出参考点。在计算果胶暴露的安全边际时，在某些情况下该值低于1。在最大允许水平（MPL）下，会产生内部甲醇剂量，这可能对16周龄以下婴儿产生不良健康影响。FAF专家委员会建议降低食品类别13.1.5.1和13.1.5.2中果胶（E 440i）和酰胺化果胶（E 440ii）的MPL，以减少对添加剂本身和甲醇的暴露。
