Opinion on the re‐evaluation of pectin (E 440i) and amidated pectin (E 440ii) as food additives in foods for infants below 16 weeks of age and follow‐up of their re‐evaluation as food additives for uses in foods for all population groups

摘要

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.