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- Scientific opinion on the safety of a proposed amendment of the conditions of use of the food additive sorbitan monostearate (E 491) in enzyme preparationsPublication . EFSA Panel on Food Additives and Flavourings (FAF); Castle, Laurence; Andreassen, Monica; Aquilina, Gabriele; Bastos, Maria Lourdes; Boon, Polly; Fallico, Biagio; FitzGerald, Reginald; Frutos-Fernandez, Maria Jose; Grasl-Kraupp, Bettina; Gundert-Remy, Ursula; Gürtler, Rainer; Houdeau, Eric; Kurek, Marcin; Louro, Henriqueta; Morales, Patricia; Passamonti, Sabina; Barat Baviera, José Manuel; Leblanc, Jean-Charles; Smeraldi, Camilla; Tard, Alexandra; Ruggeri, LauraThe EFSA Panel on Food Additives and Flavourings (FAF Panel) provides a scientific opinion on the safety evaluation of a proposed amendment of the conditions of use of the food additive sorbitan monostearate (E 491) in accordance with Annex III, Part 3 to Regulation (EC) No 1333/2008, with respect to the intended use as a food additive in preparations of the food enzyme asparaginase (also known as acrylamide reducing yeast, or ARY). The group of sorbitan esters (E 491–495) was re‐evaluated by the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS Panel) in 2017. The ANS Panel established a group ADI of 10 mg sorbitan/kg body weight (bw) per day applicable to the food additives E 491–495. In the present opinion the Panel calculated an updated dietary exposure estimate of sorbitan resulting from the current authorised uses of the group of sorbitan esters (E 491–495), and from the proposed amendment of the conditions of use of sorbitan monostearate (E 491) in enzyme preparations. In updating the dietary exposure with the latest dietary surveys available, the group ADI of 10 mg sorbitan/kg bw per day was exceeded in toddlers and children at the 95th percentile in the refined non‐brand loyal scenario for a limited number of dietary surveys. This observation holds true either considering the proposed amendment of the conditions of use of the food additive E 491 or only the currently permitted uses in the exposure calculations. The same conclusions apply to the dietary exposure estimates for consumers of food supplements, for which the ADI is exceeded in children at the 95th percentile. The Panel however concluded that the conservative assumptions made in the refined scenarios have resulted in a clear overestimation of the dietary exposure and therefore that the calculated exceedance of the acceptable daily intake (ADI) is not of safety concern. The Panel concluded that the proposed amendment of the conditions of use of sorbitan monostearate (E 491) in preparations of the food enzyme ARY has little impact on the current dietary exposure to sorbitan resulting from the already permitted uses and reported use levels of sorbitan esters (E 491–495) and would not be of safety concern.
- Safety assessment of the process KREYENBORG IR Clean+ (universal) used to recycle post‐consumer PET into food contact materialsPublication . EFSA FCM Panel (EFSA Panel on Food Contact Materials); Lambré, Claude; Crebelli, Riccardo; da Silva, Maria João; Grob, Konrad; Milana, Maria Rosaria; Pronk, Marja; Rivière, Gilles; Ščetar, Mario; Theodoridis, Georgios; Van Hoeck, Els; Waegeneers, Nadia; Dudler, Vincent; Papaspyrides, Constantine; Tavares Poças, Maria de Fátima; Sfika, Vasiliki; Lampi, EvgeniaThe EFSA Panel on Food Contact Materials (FCM) assessed the safety of the recycling process KREYENBORG IR Clean+ (universal) (EU register number RECYC329). The input is hot washed and dried poly(ethylene terephthalate) (PET) flakes mainly originating from collected post‐consumer PET containers, with no more than 5% PET from non‐food consumer applications. The flakes are heated in a continuous infrared (IR) dryer (step 2) before being processed in a finisher reactor (step 3). Having examined the challenge test provided, the Panel concluded that both steps are critical in determining the decontamination efficiency of the process. The operating parameters to control the efficiency of these critical steps are temperature, air/PET ratio and residence time. It was demonstrated that this recycling process ensures that the level of migration of potential unknown contaminants into food is below the conservatively modelled migration of 0.0481 or 0.0962 μg/kg food, depending on the molar mass of a contaminant substance. Therefore, the Panel concluded that the recycled PET obtained from this process is not of safety concern, when used at up to 100% for the manufacture of materials and articles for contact with all types of foodstuffs, including drinking water, for long‐term storage at room temperature or below, with or without hot‐fill. Articles made of this recycled PET are not intended to be used in microwave and conventional ovens and such uses are not covered by this evaluation.