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The food enzyme triacylglycerol lipase (triacylglycerol acylhydrolase EC 3.1.1.3) is produced with the genetically modified Ogataea polymorpha strain DP-Jzk33 by Danisco US Inc. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. It is intended to be used in baking and cereal-based processes. Based on the maximum use levels recommended for baking and cereal-based processes and individual data from the EFSA Comprehensive European Food Database, dietary exposure to the food enzyme-total organic solids (TOS) was estimated to be up to 0.520 mg TOS/kg body weight (bw) per day. Genotoxicity tests did not raise a safety concern. The systemic toxicity was assessed by means of a repeated dose 90-day oral toxicity study in rats. The Panel identified a no observed adverse effect level of 669 mg TOS/kg bw per day, the highest dose tested. Comparison with the estimated dietary exposure results in a margin of exposure of at least 1,287. A search was made of the similarity of the amino acid sequence of the lipase to those of known allergens and no match was found. Cyclopamine purchase The Panel considered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood of such reactions to occur is likely to be low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of N,N-bis(2-hydroxyethyl)stearylamine partially esterified with saturated C16/C18 fatty acids (SABOFOG F1), FCM No 1081, which is intended to be used as an antistatic and anti-fog agent in all types of polymers at up to 2% w/w. It was requested for use in contact with dry food, acidic foods and alcoholic beverages (represented by simulants E, B and C, respectively) with storage up to 6 months at ambient temperature. The migration data provided did not enable the assessment of the safety of applications intended for contact with foods represented by simulants B and C. In the migrate into simulant E, the non-esterified N,N-bis(2-hydroxyethyl)stearylamine was the main constituent. Its mono- and di-esters migrated to a lower extent. According to the data provided, the Panel concluded that the substance does not raise concern for genotoxicity and accumulation in humans. Based on the results of 28-day oral toxicity study with SABOFOG F1 and on the 90-day oral toxicity study with the read-across substance bis(2-hydroxyethyl)oleylamine, the Panel considered the current SML(T) of 1.2 mg/kg food provided a margin sufficiently large to accommodate the uncertainties related to the read-across approach. Overall, the CEP Panel concluded that N,N-bis(2-hydroxyethyl)stearylamine, of which at least ■■■■■ is partially or fully esterified with saturated C16/C18 fatty acids is not of safety concern for the consumer when used at up to 2% (w/w) in all polymers intended for contact with foods represented by simulant E for up to 6 months at room temperature. Additionally, the migration of the sum of N,N-bis(2-hydroxyethyl)stearylamine and its mono- and di-ester, calculated as N,N-bis(2-hydroxyethyl)stearylamine, should not exceed 1.2 mg/kg, i.e. the SML(T) for FCM substances 19 and 20, in which also the migration of the mono- and di-ester of N,N-bis(2-hydroxyethyl)stearylamine should be included.The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of the recycling process Ltd. PolyER (EU register number RECYC175), which uses the Starlinger deCON technology. The input material is hot washed and dried poly(ethylene terephthalate) (PET) flakes originating from collected post-consumer PET containers, mainly bottles, with less than 5% PET from non-food consumer applications. The flakes are preheated before being submitted to solid-state polycondensation (SSP) in a continuous reactor at high temperature under vacuum and gas flow. Having examined the challenge test provided, the Panel concluded that the preheating (step 2) and the decontamination in the continuous SSP reactor (step 3) are the critical steps that determine the decontamination efficiency of the process. The operating parameters to control the performance of these critical steps are temperature, pressure, residence time and gas flow rate. It was demonstrated that this recycling process is able to ensure that the level of migration of potential unknown contaminants into food is below the conservatively modelled migration of 0.1 μg/kg food. Therefore, the Panel concluded that the recycled PET obtained from this process is not considered of safety concern, when used at up to 100% for the manufacture of materials and articles for contact with all types of foodstuffs for long-term storage at room temperature, with or without hotfill. Trays 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.The food enzyme α-amylase (4-a-d-glucan glucanohydrolase; EC 3.2.1.1) is produced with the genetically modified Pseudomonas fluorescens strain BD15754 by BASF Enzymes LLC1. The food enzyme is free from viable cells of the production organism and recombinant DNA. The α-amylase is intended to be used in distilled alcohol production and starch processing for the production of glucose syrups. Residual amounts of total organic solids (TOS) are removed by distillation and by the purification steps applied during the production of glucose syrups, consequently, dietary exposure was not calculated. Genotoxicity tests did not raise a safety concern. The systemic toxicity was assessed by means of a repeated dose 90-day oral toxicity study in rats. The Panel identified a no observed adverse effect level (NOAEL) at the highest dose of 887 mg TOS/kg body weight (bw) per day. Similarity of the amino acid sequence to those of known allergens was searched and no match was found. The Panel considered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood of such reactions to occur is considered to be low.