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Abstract The European Commission asked EFSA for a scientific evaluation on the risks to human health related to the presence of perfluoroalkyl substances (PFASs) in food. Based on several similar effects in animals, toxicokinetics and observed concentrations in human blood, the CONTAM Panel decided to perform the assessment for the sum of four PFASs: PFOA, PFNA, PFHxS and PFOS. These made up half of the lower bound (LB) exposure to those PFASs with available occurrence data, the remaining contribution being primarily from PFASs with short half‐lives. Equal potencies were assumed for the four PFASs included in the assessment. The mean LB exposure in adolescents and adult age groups ranged from 3 to 22, the 95th percentile from 9 to 70 ng/kg body weight (bw) per week. Toddlers and ‘other children’ showed a twofold higher exposure. Upper bound exposure was 4‐ to 49‐fold higher than LB levels, but the latter were considered more reliable. ‘Fish meat’, ‘Fruit and fruit products’ and ‘Eggs and egg products’ contributed most to the exposure. Based on available studies in animals and humans, effects on the immune system were considered the most critical for the risk assessment. From a human study, a lowest BMDL10 of 17.5 ng/mL for the sum of the four PFASs in serum was identified for 1‐year‐old children. Using PBPK modelling, this serum level of 17.5 ng/mL in children was estimated to correspond to long‐term maternal exposure of 0.63 ng/kg bw per day. Since accumulation over time is important, a tolerable weekly intake (TWI) of 4.4 ng/kg bw per week was established. This TWI also protects against other potential adverse effects observed in humans. Based on the estimated LB exposure, but also reported serum levels, the CONTAM Panel concluded that parts of the European population exceed this TWI, which is of concern.

Abstract The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP Panel) was asked by the European Commission to update its 2005 risk assessments of di‐butylphthalate (DBP), butyl‐benzyl‐phthalate (BBP), bis(2‐ethylhexyl)phthalate (DEHP), di‐isononylphthalate (DINP) and di‐isodecylphthalate (DIDP), which are authorised for use in plastic food contact material (FCM). Dietary exposure estimates (mean and high (P95)) were obtained by combining literature occurrence data with consumption data from the EFSA Comprehensive Database. The highest exposure was found for DINP, ranging from 0.2 to 4.3 and from 0.4 to 7.0 μg/kg body weight (bw) per day for mean and high consumers, respectively. There was not enough information to draw conclusions on how much migration from plastic FCM contributes to dietary exposure to phthalates. The review of the toxicological data focused mainly on reproductive effects. The CEP Panel derived the same critical effects and individual tolerable daily intakes (TDIs) (mg/kg bw per day) as in 2005 for all the phthalates, i.e. reproductive effects for DBP (0.01), BBP (0.5), DEHP (0.05), and liver effects for DINP and DIDP (0.15 each). Based on a plausible common mechanism (i.e. reduction in fetal testosterone) underlying the reproductive effects of DEHP, DBP and BBP, the Panel considered it appropriate to establish a group‐TDI for these phthalates, taking DEHP as index compound as a basis for introducing relative potency factors. The Panel noted that DINP also affected fetal testosterone levels at doses around threefold higher than liver effects and therefore considered it conservative to include it within the group‐TDI which was established to be 50 μg/kg bw per day, expressed as DEHP equivalents. The aggregated dietary exposure for DBP, BBP, DEHP and DINP was estimated to be 0.9–7.2 and 1.6–11.7 μg/kg bw per day for mean and high consumers, respectively, thus contributing up to 23% of the group‐TDI in the worst‐case scenario. For DIDP, not included in the group‐TDI, dietary exposure was estimated to be always below 0.1 μg/kg bw per day and therefore far below the TDI of 150 μg/kg bw per day. This assessment covers European consumers of any age, including the most sensitive groups. Based on the limited scope of the mandate and the uncertainties identified, the Panel considered that the current assessment of the five phthalates, individually and collectively, should be on a temporary basis.

Abstract This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes and Processing aids (CEP Panel) is on the safety assessment of trimellitic acid, tris(2‐ethylhexyl) ester, intended to be used as a plasticiser in the manufacture of soft poly(vinyl chloride) (PVC) materials and articles, such as wrap films (single uses) and tubing (repeated uses) at up to approximately 10% and 40%, respectively. Under the tested conditions, the substance migrated up to 165 μg/kg food from wrap films and was not detected in food simulant in contact with tubing. Based on the three reported in vitro genotoxicity studies, the Panel concluded that the substance does not raise concern for genotoxicity. The lowest no observed adverse effect level (NOAEL), derived from a 90‐day oral toxicity study, was 225 mg/kg body weight (bw) per day. Based on data on toxicokinetic and metabolism, the substance does not give rise to concern for accumulation in humans. The substance does not cause developmental effects as induced by phthalic acid, bis(2‐ethylhexyl) ester (DEHP). Assuming that impurities migrate pro‐rata to a migration of the substance up to 5 mg/kg food, their estimated migration does not raise a safety concern. The Panel concluded that the substance does not raise safety concern for the consumer when used in the manufacture of soft PVC under the conditions requested by the applicant for (i) single use wrap films in contact with food for which simulants A, B and D1 are assigned, as well as (ii) tubing for repeated contacts with food for which simulants A and B are assigned. Overall, the use of the substance does not raise a safety concern if its migration does not exceed 5 mg/kg food. Due to the additional contribution from other sources of exposures, the application of an allocation factor should be considered.

Abstract This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP Panel) is a safety assessment of the additive titanium dioxide surface treated with fluoride‐modified alumina, a defined mixture of particles of which ■■■■■% in number have a diameter in the range of 1–100 nm. It is intended to be used as filler and colourant up to 25% w/w in potentially all polymer types. Materials and articles containing the additive are intended to be in contact with all food types for any time and temperature conditions. The data provided demonstrate that the additive particles stay embedded even in swollen polar polymers such as polyamide, and do not migrate. Moreover, the additive particles resisted release by abrasion and did not transfer into a simulant for solid/dry foods. Thus, the additive particles do not give rise to exposure via food and to toxicological concern. Migration of solubilised ionic fluoride and aluminium occurs from the surface of the additive particles and particularly from swollen plastic. The Panel concluded that the substance does not raise safety concern for the consumer if used as an additive up to 25% w/w in polymers in contact with all food types for any time and temperature conditions. However, uses in polar polymers swelling in contact with foodstuffs simulated by 3% acetic acid should be limited to conditions simulated by contact up to 4 h at 100°C. This is due to the fact that when used at 25%, and contact was followed by 10 days at 60°C, the migration of aluminium and fluoride largely exceeded the specific migration limit (SML) of 1 and 0.15 mg/kg food, respectively. The Panel emphasises that the existing SMLs for aluminium and fluoride should not be exceeded in any case.

Abstract The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of montmorillonite clay modified with hexadecyltrimethylammonium bromide (HDTA) when used as an additive at up to ■■■■■ in polylactic acid (PLA) bottles intended for contact with water for long‐term storage at ambient temperature or below. The modified clay, which 90% w/w of the particles have a dimension of 33.1 μm or less and the average size is 9 μm, has a layered structure with layers of a thickness below 100 nm. When incorporated in PLA, nanosized layers can be dispersed in the matrix, but are not expected to migrate. Thermal degradation is not expected at the maximum manufacturing temperature. No loss of integrity of the PLA surface due to interaction with bottled water was observed. The overall migration was very low. No migration of HDTA was detected at the limit of detection ■■■■■. Migration of aluminium was below or at the limit of detection ■■■■■, which would conservatively correspond to approximately ■■■■■. Comparative analysis of bottled water with and without the modified clay did not reveal additional peaks corresponding to impurities identified in the modifier and/or in the modified clay. Moreover, ■■■■■, and the modifier HDTA have been evaluated and authorised. Therefore, the CEP Panel concluded that the substance montmorillonite clay modified with HDTA bromide is not of safety concern for the consumer if the substance is used as an additive at up to ■■■■■ in PLA plastic bottles and other containers intended for long‐term storage of water at ambient temperature or below, as requested by the applicant.

Abstract The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP Panel) assessed the safety of poly((R)‐3‐hydroxybutyrate‐co‐(R)‐3‐hydroxyhexanoate) (PHBH), CAS No 147398‐31‐0 and food contact material (FCM) substance No 1059. This biodegradable copolymer is produced by fermentation of palm oil using a genetically modified microorganism (Cupriavidus necator). Overall migration was up to 5.4 mg/kg. Oligomers are hydroxyl‐terminated or with crotyl‐ and hexenyl end‐groups from dehydration of hydroxyl end‐groups. In the absence of calibration standards, the total oligomer migration was set at the overall migration values. Other degradation products are crotonic acid and (E)‐2‐hexenoic acid. Crotonic acid is authorised for use in FCMs with a specific migration limit (SML) of 0.05 mg/kg food. For (E)‐2‐hexenoic acid, no indication for genotoxicity was identified by the EFSA CEF Panel in its group evaluation of flavouring substances in FGE.05Rev2 (EFSA CEF Panel, ). The other migrating substances detected, ■■■■■, are from the authorised substance ‘palm oil and/or palm fatty acid distillate’ (FCM substance No 9) used as a carbon source for the fermentation and do not give rise to safety concern. A PHBH oligomer mixture was synthesized to simulate that migrating. It did not give rise to concern for genotoxicity. From the repeated dose 90‐day oral toxicity study in rats, the Panel identified the no‐observed‐adverse‐effect level (NOAEL) at the highest dose tested in males, 1,364 mg/kg body weight (bw) per day. The Panel concluded that the potential for bioaccumulation of oligomers is low. Overall, the CEP Panel concluded that the substance PHBH is not of safety concern for the consumer if it is used alone or blended with other polymers in contact with all kinds of food during more than 6 months at room temperature or below, including hot‐fill or a short heating up phase. The specific migration of all oligomers

Abstract The European Commission asked EFSA for a scientific evaluation on the risks to human health related to the presence of perfluorooctane sulfonic acid (PFOS) and perfluorooctanoic acid (PFOA) in food. Regarding PFOS and PFOA occurrence, the final data set available for dietary exposure assessment contained a total of 20,019 analytical results (PFOS n = 10,191 and PFOA n = 9,828). There were large differences between upper and lower bound exposure due to analytical methods with insufficient sensitivity. The CONTAM Panel considered the lower bound estimates to be closer to true exposure levels. Important contributors to the lower bound mean chronic exposure were ‘Fish and other seafood’, ‘Meat and meat products’ and ‘Eggs and egg products’, for PFOS, and ‘Milk and dairy products’, ‘Drinking water’ and ‘Fish and other seafood’ for PFOA. PFOS and PFOA are readily absorbed in the gastrointestinal tract, excreted in urine and faeces, and do not undergo metabolism. Estimated human half‐lives for PFOS and PFOA are about 5 years and 2–4 years, respectively. The derivation of a health‐based guidance value was based on human epidemiological studies. For PFOS, the increase in serum total cholesterol in adults, and the decrease in antibody response at vaccination in children were identified as the critical effects. For PFOA, the increase in serum total cholesterol was the critical effect. Also reduced birth weight (for both compounds) and increased prevalence of high serum levels of the liver enzyme alanine aminotransferase (ALT) (for PFOA) were considered. After benchmark modelling of serum levels of PFOS and PFOA, and estimating the corresponding daily intakes, the CONTAM Panel established a tolerable weekly intake (TWI) of 13 ng/kg body weight (bw) per week for PFOS and 6 ng/kg bw per week for PFOA. For both compounds, exposure of a considerable proportion of the population exceeds the proposed TWIs.

Abstract The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of polyacrylic acid, sodium salt, cross‐linked, FCM substance No 1015, which is intended to be used as a liquid absorber in the packaging of fresh or frozen foods such as meat, poultry and seafood as well as fresh fruits and vegetables. Specific migration tests were not performed due to the high absorption of liquids by the substance. The Panel noted that if polyacrylic acid, sodium salt, cross‐linked is used not in direct contact with food and placed in a pad under conditions where its absorption capacity is not exceeded, then no migration is to be expected and therefore no exposure from the consumption of the packed food is expected. The Panel also considered that the non‐cross‐linked polymer and the cross‐linkers do not raise a concern for genotoxicity. The CEP Panel concluded that the use of this polyacrylic acid, sodium salt, cross‐linked, does not raise a safety concern when used in absorbent pads in the packaging of fresh or frozen foods. The absorbent pads must be used only under conditions in which the absorption capacity of the active substance is not exceeded and direct contact with food is excluded.

Abstract The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP Panel) assessed the safety of the additive Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials. It is a family of mixtures combining the four lanthanides lanthanum (La), europium (Eu), gadolinium (Gd) and/or terbium (Tb) in different proportions as their 1,4‐benzene dicarboxylate complexes, used as a taggant in plastics for authentication and traceability purposes. The powdered additive, not in nano form, is intended to be used at up to 100 mg/kg in polyethylene, polypropylene and polybutene. Materials and articles made of these plastics are intended for contact with all foods types at up to 4 h/100°C or for long‐term storage at ambient temperature. In tests with food simulants, migration of each Ln was below 5 μg/kg. The Panel considered that irrespective of the composition of the lanthanides, these would dissociate completely from the terephthalic acid salt under aqueous conditions. Evaluation of the genotoxicity studies provided on the individual complexes (La, Eu, Gd and Tb) and on their mixture, taken together with data available in the scientific literature, allows ruling out concern for genotoxicity. Consequently, the CEP Panel concluded that the substance Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) does not raise a safety concern for the consumer under the proposed conditions of use and if the migration of the sum of the four lanthanides in ionic form does not exceed 50 μg/kg food.

Abstract The food enzyme considered in this opinion is a glucan 1,4‐α‐maltohydrolase (maltogenic α‐amylase; EC 3.2.1.133) produced with the genetically modified Bacillus subtilis strain MAM by the company DSM Food Specialties B. V. The food enzyme contains neither the production microorganism nor recombinant DNA; therefore, no environmental risk assessment is required. However, the Panel emphasises that this conclusion only covers the food enzyme recovered via filter press. The glucan 1,4‐α‐maltohydrolase is intended for use in baking processes. Based on the maximum use levels recommended and individual consumption data from the EFSA Comprehensive European Food Consumption Database, dietary exposure to the food enzyme‐total organic solids (TOS) was estimated to be up to 0.175 mg TOS/kg body weight (bw) per day in European populations. The systemic toxicity was assessed by means of a repeated dose 90‐day oral toxicity study in rodents. A no observed adverse effect level (NOAEL) was derived (986 mg TOS/kg bw per day for both males and females), which, compared with the dietary exposure, results in a sufficiently high margin of exposure. The allergenicity was evaluated by comparing the amino acid sequence to those of known allergens; one match was found. However, the Panel considered that there are no indications for food allergic reactions to this glucan 1,4‐α‐maltohydrolase by dietary exposure. No safety concerns were identified in relation to the genetic modifications, the manufacturing process, the compositional data provided, as well as the exposure, allergenicity and systemic toxicity assessments. However, owing to the incompleteness of the genotoxicity data, the Panel is not able to conclude on the safety of the food enzyme.

Abstract The food enzyme considered in this opinion is an endo‐1,4‐β‐xylanase (4‐β‐d‐xylan xylanohydrolase; EC 3.2.1.8) produced from the genetically modified Bacillus subtilis strain LMG S‐27588 by the company Puratos N. V. The production strain was not detected in the food enzyme. The endo‐1,4‐β‐xylanase is intended to be used in baking processes. Based on the maximum use levels recommended and individual consumption data from the EFSA Comprehensive European Food Consumption Database, dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 0.325 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests with the food enzyme indicated no genotoxic concern. The systemic toxicity was assessed by means of a repeated dose 90‐day oral toxicity study in rodents. A no observed adverse effect level (NOAEL) was derived (443 mg TOS/kg bw per day), which, compared with the dietary exposure, results in a sufficiently high margin of exposure. The allergenicity was evaluated by comparing the amino acid sequence to those of known allergens; no match was found. The Panel considered that there are no indications for food allergic reactions to this endo‐1,4‐β‐xylanase by dietary exposure. Based on the genetic modifications, the manufacturing process, the compositional and biochemical data, the dietary exposure assessment, the findings in the toxicological studies and allergenicity assessment, the Panel concludes that this food enzyme does not give rise to safety concerns under the intended conditions of use. The Panel noted that recombinant DNA was present in all batches of the food enzyme tested.

Abstract The food enzyme considered in this opinion is aqualysin 1 (EC 3.4.21.111), produced from the genetically modified strain Bacillus subtilis LMGS 25520 by Puratos NV. The production strain was not detected in the food enzyme. Aqualysin 1 is intended to be used in baking processes. Based on the maximum use level recommended and individual consumption data from the EFSA Comprehensive European Food Consumption Database, dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 2.13 mg TOS/kg body weight per day in European populations. Genotoxicity tests indicated no genotoxic concerns. The allergenicity was evaluated by searching for similarity of the amino acid sequence to those of known allergens and 23 matches were found (20 respiratory and 3 dermal allergens). However, the Panel considered that there are no indications for food allergic reactions to the food enzyme. The genetic modifications performed, the manufacturing process, the compositional and biochemical data, the allergenicity and the genotoxicity assessment did not raise safety concerns. The Panel considered the margin of exposure (MOE) calculated from the no observed adverse effect level (NOAEL) determined from the repeated dose 90‐day oral toxicity study and the estimated dietary exposure as insufficient to conclude that there is no safety concern for this food enzyme under the intended conditions of use. The Panel noted that recombinant DNA was present in all batches of the food enzyme tested.

Abstract The food enzyme considered is a maltogenic amylase (glucan 1,4‐α‐maltohydrolase; EC 3.2.1.133) produced with the genetically modified Bacillus subtilis strain NZYM‐SM by Novozymes A/S. The food enzyme contains neither the production organism nor recombinant DNA. The maltogenic amylase is intended for use in baking processes and starch processing for glucose syrups production. Based on the maximum use levels recommended for the food processes and individual consumption data from the EFSA Comprehensive European Food Consumption Database, dietary exposure to the food enzyme–Total Organic Solids (TOS) was estimated to be up to 0.168 mg TOS/kg body weight (bw) per day in European populations. The food enzyme did not induce gene mutations in bacteria or chromosomal aberrations in human lymphocytes. The subchronic toxicity was assessed by means of a repeated dose 90‐day oral toxicity study in rodents. A no observed adverse effect level (NOAEL) was derived (320 mg TOS/kg bw per day), which, compared with the dietary exposure, results in a sufficiently high margin of exposure. The allergenicity was evaluated by searching for similarity of the amino acid sequence to those of known allergens. Three matches to occupational respiratory allergens were found, however, the Panel considered that there are no indications for food allergic reactions to the food enzyme. Based on the genetic modifications performed, the manufacturing process, the compositional and biochemical data provided, the dietary exposure assessment, the findings in the toxicological studies and allergenicity assessment, the Panel concluded that the food enzyme maltogenic amylase from Bacillus subtilis strain NZYM‐SM does not give rise to safety concerns under the intended conditions of use.

Abstract This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety evaluation of the recycling process BTB PET direct IV+ (EU register number RECYC0152). The input of the process is hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes originating from collected post‐consumer food contact PET containing no more than 5% of PET from non‐food consumer applications. In this technology, washed PET flakes are extruded into pellets which are further crystallised. Crystallised pellets are then preheated and fed to the solid‐state polycondensation (SSP) reactor. Having examined the challenge test provided, the Panel concluded that extrusion, crystallisation and SSP are the critical steps that determine the decontamination efficiency of the process. The operating parameters that control their performance are well defined and they are temperature, pressure and residence time. Under these conditions, it was demonstrated that the 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, intended to be used 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, is not considered of safety concern. Trays made of this recycled PET are not intended to be used, and should not be used, in microwave and conventional ovens.

Abstract The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the EFSA was requested to consider evaluations of flavouring substances assessed since 2000 by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) and to decide whether further evaluation is necessary, as laid down in Commission Regulation (EC) No 1565/2000. The present consideration concerns a group of 22 pyridine, pyrrole and quinoline derivatives evaluated by JECFA (63rd meeting). The revision of this consideration is made since additional genotoxicity data have become available for 6‐methylquinoline [FL‐no: 14.042]. The genotoxicity data available rule out the concern with respect to genotoxicity and accordingly the substance is evaluated through the Procedure. For all 22 substances [FL‐no: 13.134, 14.001, 14.004, 14.007, 14.030, 14.038, 14.039, 14.041, 14.042, 14.045, 14.046, 14.047, 14.058, 14.059, 14.060, 14.061, 14.065, 14.066, 14.068, 14.071, 14.072 and 14.164] considered in this Flavouring Group Evaluation (FGE), the Panel agrees with the JECFA conclusion, ‘No safety concern at estimated levels of intake as flavouring substances’ based on the Maximised Survey‐derived Daily Intake (MSDI) approach. Besides the safety assessment of these flavouring substances, the specifications for the materials of commerce have also been evaluated, and the information is considered adequate for all the substances. For the following substances [FL‐no: 13.134, 14.001, 14.030, 14.041, 14.042, 14.058, 14.072], the Industry has submitted use levels for normal and maximum use. For the remaining 15 substances, use levels are needed to calculate the modified Theoretical Added Maximum Daily Intakes (mTAMDIs) in order to identify those flavouring substances that need more refined exposure assessment and to finalise the evaluation.

Abstract The food enzyme is an endo‐1,4‐β‐xylanase (EC 3.2.1.8) produced with a genetically modified strain of Aspergillus niger (strain XEA), by DSM Food Specialities B.V. The food enzyme is intended to be used in baking and brewing processes. Based on maximum use levels recommended for the food processes and individual consumption data from the EFSA Comprehensive European Food Consumption Database, dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 0.310 mg TOS/kg body weight per day in European populations. Genotoxicity tests with the food enzyme did not indicate a genotoxic concern. A repeated dose 90‐day oral toxicity study in rodents, carried out with this endo‐1,4‐β‐xylanase, showed no concern with respect to systemic toxicity. The allergenicity was evaluated by searching for similarity of the amino acid sequence to those of known allergens; no match was found. The Panel considers that there are no indications for allergic sensitisation and elicitation reactions by dietary exposure to the food enzyme endo‐1,4‐β‐xylanase. Based on the microbial source, the genetic modifications performed, the manufacturing process, the compositional and biochemical data provided, the dietary exposure assessment, the findings in the toxicological studies and the allergenicity assessment, the Panel concludes that this food enzyme does not give rise to safety concerns under the intended conditions of use.

Abstract The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to consider evaluations of flavouring substances assessed since 2000 by the Joint FAO/WHO Expert Committee on Food Additives (JECFA), and to decide whether further evaluation is necessary, as laid down in Commission Regulation (EC) No 1565/2000. The present revision of this FGE is on the assessment of recently submitted toxicity data on methyl propyl trisulfide [FL‐no: 12.020], being the representative for a group of seven additional flavouring substances: diallyl trisulfide [FL‐no: 12.009], dimethyl trisulfide [FL‐no: 12.013], dipropyl trisulfide [FL‐no: 12.023], methyl allyl trisulfide [FL‐no: 12.045], diallyl polysulfides [FL‐no: 12.074], methyl ethyl trisulfide [FL‐no: 12.155] and diisopropyl trisulphide [FL‐no: 12.280]. Specifications have been provided for all substances. The Panel decided that the 90‐day study submitted for [FL‐no: 12.020] can be considered only once it is clearly demonstrated that the material tested is representative of the material of commerce and that potential reaction products of the components are not of safety concern. Therefore, no conclusion on the safety of the eight flavouring substances [FL‐no: 12.009, 12.013, 12.020, 12.023, 12.045, 12.074, 12.155 and 12.280] can be reached. For 2‐methyl‐4‐oxopentane‐2‐thiol [FL‐no: 12.169] and 2‐mercapto‐2‐methylpentan‐1‐ol [FL‐no: 12.241], additional subchronic toxicity data are required. The remaining nine substances [FL‐no: 12.088, 12.179, 12.198, 12.212, 12.238, 12.239, 12.255, 12.257 and 12.291] in this FGE are not considered of safety concern under the intended conditions of use.

Abstract The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) of EFSA was requested to deliver a scientific opinion on the safety of the use of the substance (S)‐1‐(3‐(((4‐amino‐2,2‐dioxido‐1H‐benzo[c][1,2,6]thiadiazin‐5‐yl)oxy)methyl)piperidin‐1‐yl)‐3‐methylbutan‐1‐one [FL‐no: 16.129], as a flavouring substance. The substance is intended to be used in the form of its sodium salt as a flavour modifier in beverages. The Panel concluded that [FL‐no: 16.129] would not raise a concern with respect to genotoxicity under conditions where it remains stable and does not undergo photodegradation. However, the data provided do not rule out genotoxicity for the degradation products. A 90‐day toxicity study with [FL‐no: 16.129] in rats showed no adverse effects at exposure up to 100 mg/kg body weight (bw) per day. No developmental toxicity was observed in rats at dose levels up to 1,000 mg/kg bw per day. An adequate margin of safety was calculated for [FL‐no: 16.129]. The Panel concluded that [FL‐no: 16.129] and its sodium salt are not expected to be of safety concern at the estimated levels of intake. This conclusion applies only to the use of the substance as a flavour modifier at levels up to those specified in beverages, but not to the degradation products that may be formed upon exposure to ultraviolet‐A (UV‐A) light. The conditions protecting [FL‐no: 16.129] from photodegradation have not been adequately investigated. It is also unclear if degradation occurs in the absence of UV light. Based on the data provided, the Panel cannot conclude on the safety of [FL‐no: 16.129] when used as a flavour modifier.

Abstract This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety evaluation of the active substances carboxymethylcellulose, acetylated distarch phosphate (FCM substance No 1071), bentonite, boric acid and aluminium sulfate (FCM substance No 1072). The mixture is intended to be used as a liquid absorber in the packaging of perishable foods to extend their shelf‐life. All substances have been evaluated and approved for use as additives in plastic food contact materials and/or as food additives. Migration of boron into foods was up to 0.7 mg/kg food. Migration of aluminium was not detected (limit of detection (LOD) of 0.001 mg/kg). The CEF Panel concludes that the substances carboxymethylcellulose, acetylated distarch phosphate, bentonite, boric acid and aluminium sulfate are not of safety concern for the consumer when used as active components in moisture and liquid absorbers. The absorbent pads must be used under conditions in which direct contact between the active mixture and the food is avoided and the fluid absorption capacity of the absorber is not exceeded.

Abstract This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety evaluation of the recycling process EstPak Plastik (EU register No RECYC150), which is based on the Starlinger Decon technology. The decontamination efficiency of the process was demonstrated by a challenge test. The input of this process is hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes originating from collected post‐consumer PET containers, mainly bottles, containing no more than 5% of PET from non‐food consumer applications. In this technology, washed and dried PET flakes are preheated before being submitted to solid‐state polycondensation (SSP) in a continuous reactor (one single reactor or several reactors in parallel) 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 that control the performance of the process are well defined and are temperature, pressure, residence time and gas flow for steps 2 and 3. Under these conditions, it was demonstrated that the recycling process under evaluation, using the Starlinger Decon technology, is able to ensure that the level of migration of potential unknown contaminants into food is below a conservatively modelled migration of 0.1 μg/kg food. Therefore, the Panel concluded that the recycled PET obtained from this process intended to be used 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, is not considered of safety concern. Trays made of this PET are not intended to be used, and should not be used, in microwave and conventional ovens.

Abstract This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety evaluation of the recycling process Concept Plastic Packaging (EU register No RECYC151), which is based on the Starlinger Decon technology. The decontamination efficiency of the process was demonstrated by a challenge test. The input of this process is hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes originating from collected post‐consumer PET containers, mainly bottles, containing no more than 5% of PET from non‐food consumer applications. In this technology, washed and dried PET flakes are preheated before being submitted to solid‐state polycondensation (SSP) in a continuous reactor (one single reactor or several reactors in parallel) 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 that control the performance of the process are well defined and are temperature, pressure, residence time and gas flow for steps 2 and 3. Under these conditions, it was demonstrated that the recycling process under evaluation, using the Starlinger Decon technology, is able to ensure that the level of migration of potential unknown contaminants into food is below a conservatively modelled migration of 0.1 μg/kg food. Therefore, the Panel concluded that the recycled PET obtained from this process intended to be used 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, is not considered of safety concern. Trays made of this PET are not intended to be used, and should not be used, in microwave and conventional ovens.

Abstract This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety evaluation of the recycling process ‘Morssinkhof Plastics’, EU register No RECYC0142. The input consists of crates, boxes, trays, pallets and containers, hereafter termed ‘crates’, used in food contact, made of high‐density polyethylene (HDPE) or polypropylene (PP). It comprises unused damaged crates, prewashed used crates and parts of crates originating from closed and controlled product loops. The process separates crates by material type and food type (fruit, vegetables and prepacked meat vs unpacked meat). Flakes from recycled HDPE or PP are produced that will be used by customers to manufacture new crates for food contact. The Panel considered that the management system put in place to ensure compliance of the origin of the input with Commission Regulation (EC) No 282/2008 and to provide full traceability from input to final product is the critical process step. It concluded that the input of the process ‘Morssinkhof Plastics’ originates from product loops which are in closed and controlled chains designed to ensure that only materials and articles which have been intended for food contact are used and that any contamination can be ruled out when run under the conditions described by the applicant. The recycling process ‘Morssinkhof Plastics’ is, therefore, able to produce recycled HDPE and PP suitable for manufacturing HDPE and PP crates intended to be used in contact with dry food, fruits and vegetables, prepacked and unpacked meat. The use of regrind from ‘external’ recyclers only based on private agreements, does not give reassurance to fall under the scope of Art. 4 c (i) of Commission Regulation (EC) No 282/2008 and is excluded from the present evaluation.

Abstract The substance isobutane is intended to be used as a foaming agent at max 4.5% to produce expanded polystyrene (EPS) to be used for packaging foods, such as fruits, vegetables, meat, fish and cheese, at room temperature or lower. Isobutane is approved in Europe as a food additive (E 943b) to be used quantum satis as a gas propellant only in vegetable oil pan spray (for professional use only) and water‐based emulsion spray according to Regulation (EC) No 1333/2008. The purity requirements for the use of isobutane as a food additive are described in Commission Regulation (EU) No 231/2012. The substance is a gas at room temperature. It is a saturated hydrocarbon, obtained with a high level of purity, and is not expected to react under the processing conditions used to make foamed polystyrene materials and articles. Data on migration of isobutane from trays at 20°C for 10 days ranged from 0.2 to 0.4 mg/kg food. Considering the intended applications, estimated exposure is extremely low based on migration data. In the absence of genotoxicity alerts and given the very low toxicity following repeated exposure with no observed adverse effect concentration (NOAEC) of several thousands of mg/m3 by inhalation, it was considered that the use of isobutane as a foaming agent, at the expected exposure from food, does not raise a safety concern.

Abstract This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) deals with the safety assessment of selenium nanoparticles, FCM substance No 1070, which is intended to be used as an antioxidant. Selenium nanoparticles are incorporated into the adhesive middle layer of multilayer laminates with an outside polyethylene terephthalate (PET) layer and an inner polyolefin (food contact) layer. The final materials are intended to be used for contact with all food types that are susceptible to oxidation. The specific migration of total selenium was tested using multilayer pouches containing selenium nanoparticles at 0.002 mg/dm2 and filled with 3% acetic acid and 20%, 50% or 95% ethanol for 10 days at 60°C. In all tests, migration of selenium was not detectable. Taking into account current knowledge on the diffusional properties of nanoparticles in polymers, the CEF Panel concluded that there is no safety concern for the consumer if selenium nanoparticles are used in multilayer films and separated from the food by a polyolefin food contact layer for any type of food and under any food contact conditions.

Abstract This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety evaluation of the recycling process Envases Ureña (EU register No RECYC0147), which is based on the Starlinger Decon technology. The decontamination efficiency of the process was demonstrated by a challenge test. The input of this process is hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes originating from collected post‐consumer PET containers, mainly bottles, containing no more than 5% of PET from non‐food consumer applications. In this technology, washed and dried PET flakes are preheated before being submitted to solid‐state polycondensation (SSP) in a continuous reactor (one single reactor or several reactors in parallel) 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 that control the performance of the process are well defined and are temperature, pressure, residence time and gas flow for steps 2 and 3. Under these conditions, it was demonstrated that the recycling process under evaluation, using the Starlinger Decon technology, is able to ensure that the level of migration of potential unknown contaminants into food is below a conservatively modelled migration of 0.1 μg/kg food. Therefore, the Panel concluded that the recycled PET obtained from this process intended to be used 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, is not considered of safety concern. Trays made of this PET are not intended to be used and should not to be used in microwave and conventional ovens.

Abstract The food enzyme considered in this opinion is an endo‐1,4‐β‐xylanase (EC 3.2.1.8) produced with a genetically modified Bacillus subtilis strain from Puratos N.V. (Belgium). The genetic modifications do not raise safety concerns. The food enzyme contains neither the production organism nor recombinant DNA. The endo‐1,4‐β‐xylanase is intended to be used in baking processes. Based on the maximum use levels recommended for the baking processes, dietary exposure to the food enzyme–total organic solids (TOS) was estimated on the basis of individual data from the EFSA Comprehensive European Food Consumption Database. This exposure estimate is up to 0.008 mg TOS/kg body weight per day in European populations. The food enzyme did not induce gene mutations in bacteria nor clastogenic activity in human lymphocytes. Therefore, there is no concern with respect to genotoxicity. The subchronic toxicity was assessed by means of a repeated dose 90‐day oral toxicity study in rodents. A no observed adverse effect level was derived, which, compared with the dietary exposure, results in a sufficiently high margin of exposure. The allergenicity was evaluated by searching for similarity of the amino acid sequence to those of known allergens; no matches were found. The Panel considered that there are no indications for food allergic reactions to this xylanase. Based on the microbial source, genetic modifications performed, the manufacturing process, the compositional and biochemical data provided, the findings in the toxicological studies and allergenicity assessment, this food enzyme does not give rise to safety concerns under the intended conditions of use.

Abstract The food enzyme considered in this opinion is a peroxidase (hydrogen‐peroxide oxidoreductase; EC 1.11.1.7) obtained from hulls of soybeans (Glycine max) by the company Kerry Ingredients & Flavours. The compositional data provided were considered sufficient. The manufacturing process did not raise safety concerns. The enzyme is intended to be used in baking processes. Based on the maximum recommended use level, dietary exposure to the food enzyme total organic solids (TOS) was estimated on the basis of individual data from the EFSA Comprehensive European Food Consumption Database. This exposure estimate is lower than the exposure to the fraction of soybean comparable to the food enzyme TOS resulting from the consumption of whole soybean‐derived foods by roughly an order of magnitude. As the food enzyme is derived from edible parts of soybean, in line with the requirements of the guidance document on food enzyme assessment, the Panel concluded that the provision of toxicological data was unnecessary. The potential allergenicity was evaluated by searching for similarity between the amino acid sequence of soybean peroxidase retrieved from the database Uniprot and the sequences of known food allergens; no match was found. Peroxidase from soybean hulls is not listed as an allergen in allergen databases. However, several soybean‐ and soybean hull proteins are known to be respiratory or food allergens. Based on the origin of the food enzyme from edible parts of soybean, the enzyme manufacturing process, the compositional and biochemical data provided, and the dietary exposure assessment, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use. However, the Panel noted that this food enzyme may contain allergenic soybean proteins, thus, adverse reactions in susceptible soybean‐allergic individuals cannot be ruled out.

Abstract This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety evaluation of [3‐(2,3‐epoxypropoxy)propyl]trimethoxy silane as a component for sizing glass fibres used for manufacturing glass‐fibre‐reinforced plastics. The substance is typically applied at up to around 0.2% related to the final plastic. The resulting food contact materials are intended for various scenarios of use, i.e. long‐term contact at ambient temperature (e.g. storage tanks) or short‐term contact at elevated temperatures (e.g. kitchen utensils). In extracts of treated fibres, neither the substance was detectable at 10 μg/kg fibre nor its hydrolysis product and oligomers at 60 μg/kg fibre. Based on the detection limits, modelling for the plastics and scenarios of intended use resulted in maximum migrations of 0.05 μg/kg food for the substance and 0.15 μg/kg food for the sum of the reaction products. The Panel concludes that the substance has a genotoxic potential. This may also apply to some of its reaction products which contain the epoxy function. However, due to the very low exposure, if any, [3‐(2,3‐epoxypropoxy)propyl]trimethoxy silane does not raise safety concern if used as a component of sizing agents to treat glass fibres imbedded into low diffusivity plastics (polyethylene terephthalate, polycarbonate, polybutylene terephthalate, thermoset polyesters and epoxy bisphenol vinylester) in contact with all foodstuffs. In addition, the residues in the treated glass fibres must not be detectable at 10 μg/kg for the substance and 60 μg/kg for each of the reaction products (hydrolysed monomers and epoxy‐containing cyclic dimer, trimer and tetramer).

Abstract This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids deals with the safety assessment of the recycling process Krones pellet (EU register number RECYC0149). The input to the process is washed and dried poly(ethylene terephthalate) (PET) flakes originating from collected post‐consumer PET containers and containing no more than 5% PET from non‐food consumer applications. In this technology, washed and dried PET flakes are extruded to pellets that are then crystallised and decontaminated in a reactor at high temperature under vacuum. Having examined the results of the challenge test provided, the Panel concluded that two steps, the extrusion (step 2) and the decontamination in the vacuum reactor (step 4), 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, residence time and, for the vacuum reactor, also pressure. Under these conditions, it was demonstrated that the 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 when used 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, is not considered of safety concern. Trays made of this recycled PET should not be used in microwave and conventional ovens.

Abstract The food enzyme considered in this opinion is a pullulanase (pullulan 6‐α‐glucanohydrolase; EC 3.2.1.41) produced with a non‐genetically modified Pullulanibacillus naganoensis (strain AE‐PL) by Amano Enzyme Inc. (Japan). The pullulanase food enzyme is intended to be used in starch processing for the production of glucose syrups. Since residual amounts of total organic solid (TOS) in glucose syrups are removed by filtration and purification during starch processing, dietary exposure assessment was not performed. Genotoxicity tests made with the food enzyme indicated no genotoxic potential. A repeated dose 90‐day oral toxicity study in rodents, carried out with the food enzyme, showed minor effects that were considered to be of no biological relevance. The allergenicity was evaluated by comparing the amino acid sequence to those of known allergens and no match was found. The Panel considered that there are no indications for food allergic reactions to dietary intake of this food enzyme. Based on the removal of residual amounts of TOS from glucose syrups, consumer exposure is not expected. In addition, the safety of the manufacturing process, the compositional and biochemical data lead the Panel to conclude that the food enzyme pullulanase from P. naganoensis (strain AE‐PL) does not give rise to safety concerns under the intended conditions of use.

Abstract This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety evaluation of the recycling process Veroniki Ecogrup SRL (EU register No RECYC0145), which is based on the Starlinger Decon technology. The decontamination efficiency of the process was demonstrated by a challenge test. The input of this process is hot washed and dried poly(ethylene terephthalate) (PET) flakes originating from collected post‐consumer PET containers, mainly bottles, containing no more than 5% of PET from non‐food consumer applications. In this technology, washed and dried PET 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 that control their performance are well defined and are temperature, pressure, residence time and gas flow for step 2 and 3. Under these conditions, it was demonstrated that the recycling process under evaluation, using the Starlinger Decon technology, is able to ensure that the level of migration of potential unknown contaminants into food is below a conservatively modelled migration of 0.1 μg/kg food. Therefore, the Panel concluded that the recycled PET obtained from this process and intended to be used up to 100% for the manufacture of materials and articles for contact with all types of foodstuffs for long‐term storage at room temperature is not considered of safety concern. Trays made of this PET are not intended to be used, and should not to be used in microwave and conventional ovens.

Abstract This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety assessment of the recycling process Märkische Faser (EU register number RECYC0135), which is based on the Next Generation Group (NGR) technology. The input to this process is hot washed and dried poly(ethylene terephthalate) (PET) flakes originating from collected post‐consumer PET containers, containing no more than 5% PET from non‐food consumer applications. In this technology, post‐consumer washed and dried PET flakes are melted and degassed in an extruder under vacuum (step 2) and decontaminated during a melt‐state polycondensation under high temperature and vacuum (step 3). In step 4, the melt material is homogenised, extruded under vacuum and subsequently pelletised. Having examined the results of the challenge test provided, the Panel concluded that the steps 2, 3 and 4, are the critical steps for the decontamination efficiency of the process. The operating parameters which control the performance of these steps are well defined and are the temperature and pressure in all steps and the exposed surface area of the melt and its residence time of step 3. It was demonstrated that the recycling process under evaluation is able to ensure that the level of migration of potential unknown contaminants into food is below a conservatively modelled migration of 0.1 μg/kg food. The Panel concluded that recycled PET obtained from the process Märkische Faser is not of safety concern when used up to 100% for the manufacture of materials and articles for contact with all types of foodstuffs for long‐term storage at room temperature. Thermoforming trays are not intended to be used and should not be used in microwave and conventional ovens.

Abstract This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety evaluation of the recycling process PEGRA‐V (EU register number RECYC0137), which is based on the Starlinger IV+® technology. The input of the process is hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes originating from collected post‐consumer PET containers, containing no more than 5% of PET from non‐food consumer applications. In this technology, washed PET flakes are dried and crystallised in a reactor, then extruded into pellets which are further crystallised in a second reactor. Crystallised pellets are then preheated in a third reactor and fed to the solid‐state polycondensation (SSP) reactor. Having examined the challenge test provided, the Panel concluded that the three steps, drying and crystallisation, extrusion and crystallisation and SSP are the critical steps that determine the decontamination efficiency of the process. The operating parameters that control their performance are well defined and they are the temperature, the gas flow and the residence time for the drying and crystallisation step, and the temperature, the pressure and the residence time for the extrusion and crystallisation step and the SSP step. Under these conditions, it was demonstrated that the recycling process is able to ensure that the level of migration of potential unknown contaminants into food is below a conservatively modelled migration of 0.1 μg/kg food. Therefore, the Panel concluded that the recycled PET obtained from this process intended to be used 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, is not considered of safety concern. Trays made of this recycled PET are not intended to be used, and should not to be used in microwave and conventional ovens.

Abstract This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety assessment of dimethyl carbonate used as monomer for making a polycarbonate prepolymer with 1,6‐hexanediol and then reacted with 4,4′‐methylenediphenyldiisocyanate (MDI) and diols, such as polypropylene glycol and 1,4‐butanediol, to form a thermoplastic polyurethane containing 29% of the polycarbonate prepolymer. This polymer is intended for repeated use articles with short‐term contact (≤ 30 min) at room temperature for types of food, simulated by 10% ethanol and 3% acetic acid. In the third migration test performed at 40°C during 30 min, overall migration was below 2 mg/dm2. Complete migration of the residual dimethyl carbonate would have amounted to less than 1.5 μg/kg food. The migration of two cyclic hexanediol carbonate oligomers was below 50 μg/kg food when determined by the third migration test; that of all others was below 1 μg/kg food. Three in vitro genotoxicity studies performed in accordance with OECD Guidelines and covering the three endpoints gene mutation, structural and numerical aberrations were provided and were considered negative by the CEF Panel. The oligomers detected by the migration tests are formed from dimethyl carbonate and 1,6‐hexanediol (FCM ref No 1067) do not give rise to concern for genotoxicity. The CEF Panel concluded that the use of dimethyl carbonate does not raise safety concern in the application described above. It is aware that dimethyl carbonate may be used for other polycarbonates and/or under other conditions. These are likely to result in different migrates which need to be evaluated by the business operators. In such cases, the migration of dimethyl carbonate and the total polycarbonate oligomers below 1,000 Da is of no safety concern, if each of them does not exceed 0.05 mg/kg food.

Abstract This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety assessment of the EREMA recycling process (the EREMA Multi‐Purpose Reactor (MPR), EREMA Basic and EREMA Advanced technologies), with EU register number RECYC0134. The input to this process is hot washed and dried poly(ethylene terephthalate) (PET) flakes originating from collected post‐consumer PET containers, containing no more than 5% PET from non‐food consumer applications. In the MPR technology, post‐consumer washed and dried PET flakes are heated in a continuous reactor under vacuum. The EREMA MPR decontamination technology can be combined with an extrusion line for pellets or sheet (EREMA Basic) or with an additional reactor (EREMA Advanced). The decontamination efficiency of the main continuous reactor (EREMA MPR technology) was determined by the challenge test. The Panel noted that this reactor is the critical step that determines the decontamination efficiency of these three EREMA technologies. The operating parameters controlling its performance are well defined and are temperature, pressure and residence time. It was demonstrated that, depending on the operating conditions, the recycling process under evaluation is able to ensure that the level of migration of potential unknown contaminants into food is below a conservatively modelled migration of 0.1 μg/kg food, derived from the exposure scenario for infants, and 0.15 μg/kg food, derived from the exposure scenario for toddlers, when recycled PET is used at up to 100%. The Panel concluded that recycled PET obtained from the process is not of safety concern when used to manufacture articles intended for food contact applications if it is produced in compliance with the conditions and the percentage of recycled PET added to virgin PET specified in this opinion.

Abstract This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety assessment of the recycling process Alimpet (EU register number RECYC0136), which is based on the EREMA Multi‐Purpose Reactor (MPR) technology. The input to this process is hot washed and dried poly(ethylene terephthalate) (PET) flakes originating from collected post‐consumer PET containers, containing no more than 5% PET from non‐food consumer applications. In this technology, post‐consumer washed and dried PET flakes are heated in a continuous reactor under vacuum. Having examined the results of the challenge test provided, the Panel concluded that the continuous reactor step (step 2) is the critical step that determines the decontamination efficiency of the process. The operating parameters controlling its performance are well defined and are temperature, pressure and residence time. It was demonstrated that, depending on the operating conditions, the recycling process under evaluation is able to ensure that the level of migration of potential unknown contaminants into food is below a conservatively modelled migration of 0.15 μg/kg food derived from the exposure scenario for toddlers. The Panel concluded that recycled PET obtained from the process is not of safety concern when used in extruded PET sheet for thermoforming trays and containers made with up to 100% recycled post‐consumer PET, and used for contact with all types of foodstuff except packaged water, for long‐term storage at room temperature. Thermoformed trays are not intended to be used and should not be used in microwave and conventional ovens.

Abstract This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety assessment of the Coexpan Deutschland recycling process (EU register number RECYC0140), which is based on the EREMA Basic technology. The input to this process is hot washed and dried poly(ethylene terephthalate) (PET) flakes originating from collected post‐consumer PET containers, containing no more than 5% PET from non‐food consumer applications. In this technology, post‐consumer washed and dried PET flakes are heated in a continuous reactor under vacuum before being extruded. Having examined the results of the challenge test provided, the Panel concluded that the continuous reactor step (step 2) is the critical step that determines the decontamination efficiency of the process. The operating parameters controlling its performance are well defined and are temperature, pressure and residence time. It was demonstrated that, depending on the operating conditions, the recycling process under evaluation is able to ensure that the level of migration of potential unknown contaminants into food is below a conservatively modelled migration of 0.15 μg/kg food, derived from the exposure scenario for toddlers. The Panel concluded that recycled PET obtained from the process is not of safety concern when the final thermoformed trays and containers manufactured with the recycled sheets and not used for packaging water contain up to 100% recycled post‐consumer PET. Thermoformed trays are not intended to be used and should not be used in microwave and conventional ovens.

Abstract This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety assessment of the Plastienvase recycling process (EU register number RECYC0138), which is based on the EREMA Basic technology. The input to this process is hot washed and dried poly(ethylene terephthalate) (PET) flakes originating from collected post‐consumer PET containers, containing no more than 5% PET from non‐food consumer applications. In this technology, post‐consumer washed and dried PET flakes are heated in a continuous reactor under vacuum before being extruded. Having examined the results of the challenge test provided, the Panel concluded that the continuous reactor step (step 2) is the critical step that determines the decontamination efficiency of the process. The operating parameters controlling its performance are well defined and are temperature, pressure and residence time. It was demonstrated that, depending on the operating conditions, the recycling process under evaluation is able to ensure that the level of migration of potential unknown contaminants into food is below a conservatively modelled migration of 0.15 μg/kg food, derived from the exposure scenario for toddlers. The Panel concluded that recycled PET obtained from the process is not of safety concern when the final thermoformed trays and containers manufactured with the recycled sheets and not used for packaging water contain up to 100% recycled post‐consumer PET. These thermoformed trays are not intended to be used and should not be used in microwave and conventional ovens.

Abstract This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety assessment of the 4PET recycling process (EU register number RECYC0139), which is based on the EREMA Basic technology. The input to this process is hot washed and dried poly(ethylene terephthalate) (PET) flakes originating from collected post‐consumer PET containers, containing no more than 5% PET from non‐food consumer applications. In this technology, post‐consumer washed and dried PET flakes are heated in a continuous reactor under vacuum before being extruded. Having examined the results of the challenge test provided, the Panel concluded that the continuous reactor step (step 2) is the critical step that determines the decontamination efficiency of the process. The operating parameters controlling its performance are well defined and are temperature, pressure and residence time. It was demonstrated that, depending on the operating conditions, the recycling process under evaluation is able to ensure that the level of migration of potential unknown contaminants into food is below a conservatively modelled migration of 0.15 μg/kg food, derived from the exposure scenario for toddlers. The Panel concluded that recycled PET obtained from the process is not of safety concern when the final thermoformed trays and containers and PET beverage bottles manufactured with the recycled pellets and not used for packaging water or ready‐to‐feed liquid infant formulae contain up to 90% recycled post‐consumer PET. These thermoformed trays are not intended to be used and should not be used in microwave and conventional ovens.

Abstract This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids deals with the safety evaluation of the recycling process Coexpan Montonate (EU register No RECYC0141), which is based on the Starlinger Decon technology. The decontamination efficiency of the process was demonstrated by a challenge test. The input of this process is washed and dried poly(ethylene terephthalate) (PET) flakes originating from collected post‐consumer PET containers, mainly bottles, containing no more than 5% of PET from non‐food consumer applications. In this technology, washed and dried PET 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 that control their performance are well defined and are temperature, pressure, residence time and gas flow for step 2 and 3. Under these conditions, it was demonstrated that the recycling process under evaluation, using the Starlinger Decon technology, is able to ensure that the level of migration of potential unknown contaminants into food is below a conservatively modelled migration of 0.1 μg/kg food. Therefore, the Panel concluded that the recycled PET obtained from this process intended to be used 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, is not considered of safety concern. Trays made of this PET are not intended to be used, and should not to be used in microwave and conventional ovens.

Abstract The food enzyme considered in this opinion is a 4‐α‐d‐glucan maltohydrolase (EC 3.2.1.2) obtained from grain of barley (Hordeum vulgare), by the companies Genencor International B.V. and Senson Oy. This β‐amylase is intended to be used in several food‐manufacturing processes: baking and brewing processes, distilled alcohol production, and starch processing for the production of glucose syrups. The compositional data provided for the food enzyme were considered sufficient. The manufacturing process did not raise safety concerns. Based on the maximum use levels recommended for the respective food processes, dietary exposure to the food enzyme–total organic solids (TOS) was estimated on the basis of individual data from the EFSA Comprehensive European Food Consumption Database. This exposure estimate is similar to or lower than the exposure to a fraction of barley comparable to the food enzyme–TOS, resulting from the consumption of barley‐derived foods. As the food enzyme is derived from edible parts of barley, in line with the requirements of the guidance document on food enzyme assessment, the Panel accepted that there was no need for the provision of toxicological data for this food enzyme and the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use. Considering the potential for allergenicity, the gluten content of the food enzyme was below the detection limit of the analytical method, which is well below the level of 20 mg/kg for ‘gluten‐free’ products. The amino acid sequence of the β‐amylase was compared to those of known allergens and no match was found. The food enzyme β‐amylase from barley is an occupational respiratory allergen and may contain low levels of other allergenic barley proteins that may trigger adverse reactions upon oral challenges in individuals with an oral sensitisation to cereals. The Panel considers that dietary exposure to the food enzyme β‐amylase from barley may result in incidental cases of food allergic reactions.

Abstract The food enzyme considered in this opinion is a β‐amylase (EC 3.2.1.2) from soybean submitted by Nagase (Europa) GmbH. This β‐amylase is intended to be used in the starch processing for maltose syrup production and the manufacture of a Japanese rice cake type. Based on the maximum use levels recommended for the respective food processes, dietary exposure to the food enzyme–total organic solids (TOS) was estimated on the basis of Japanese consumption data. Conservative average infant formula consumption, as reported in the EFSA Draft Guidance on risk assessment of substances present in food intended for infants below 16 weeks of age, was used to estimate the exposure to a fraction of soybean comparable to the food enzyme–TOS, resulting from the consumption of soybean‐derived foods. The exposure estimate to the food enzyme–TOS was found to be lower than the comparable fraction from the source material. Potential allergenicity of the β‐amylase was evaluated by searching for similarity of the amino acid sequence to those of known allergens, and no match was found. The β‐amylase is produced from soybean, which is a known allergenic food. Japanese rice cake, consequently, may contain traces of soybean allergens, which may give rise to safety concerns in soybean‐allergic consumers. Based on the origin of the food enzyme from edible parts of soybean, the manufacturing process, the compositional and biochemical data provided and the dietary intake estimates, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use, except that Japanese rice cake produced with this food enzyme may contain traces of soybean allergens.

Abstract The EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) was requested to evaluate the genotoxic potential of flavouring substances from subgroup 2.2 of FGE.19 in the Flavouring Group Evaluation 208 Revision 2 (FGE.208Rev2). In FGE.208Rev1, the CEF Panel evaluated genotoxicity studies on p‐mentha‐1,8‐dien‐7‐al [FL‐no: 05.117], the representative substance for FGE.19 subgroup 2.2. The Comet assay performed in liver showed a positive result, and therefore, the Panel concluded that p‐mentha‐1,8‐dien‐7‐al [FL‐no: 05.117] is genotoxic in vivo and that, accordingly, there is a safety concern for its use as flavouring substance. Since p‐mentha‐1,8‐dien‐7‐al [FL‐no: 05.117] is representative for the nine remaining substances of subgroup 2.2 (p‐mentha‐1,8‐dien‐7‐ol [FL‐no: 02.060], myrtenol [FL‐no: 02.091], myrtenal [FL‐no: 05.106], 2,6,6‐trimethyl‐1‐cyclohexen‐1‐carboxaldehyde [FL‐no: 05.121], myrtenyl formate [FL‐no: 09.272], p‐mentha‐1,8‐dien‐7‐yl acetate [FL‐no: 09.278], myrtenyl acetate [FL‐no: 09.302], myrtenyl‐2‐methylbutyrate [FL‐no: 09.899] and myrtenyl‐3‐methylbutyrate [FL‐no: 09.900]), the Panel concluded in the previous revision of FGE.208 (FGE.208Rev1) that there is a potential safety concern for these substances. Subsequently, the industry has submitted genotoxicity studies on five substances of FGE.19 subgroup 2.2: p‐mentha‐1,8‐dien‐7‐ol [FL‐no: 02.060], myrtenol [FL‐no: 02.091], myrtenal [FL‐no: 05.106], p‐mentha‐1,8‐dien‐7‐yl acetate [FL‐no: 09.278] and myrtenyl acetate [FL‐no: 09.302], which are evaluated in the present revision of FGE.208 (FGE.208Rev2). The Panel concluded that the concern for genotoxicity could be ruled out for p‐mentha‐1,8‐dien‐7‐ol [FL‐no: 02.060], myrtenol [FL‐no: 02.091], p‐mentha‐1,8‐dien‐7‐yl acetate [FL‐no: 09.278] and myrtenyl acetate [FL‐no: 09.302], which will be evaluated through the Procedure. Genotoxicity data on myrtenal [FL‐no: 05.106] were considered equivocal, therefore, it cannot be evaluated through the Procedure, presently. p‐Mentha‐1,8‐dien‐7‐al [FL‐no: 05.117] and four substances not supported by industry (2,6,6‐trimethyl‐1‐cyclohexen‐1‐carboxaldehyde [FL‐no: 05.121], myrtenyl formate [FL‐no: 09.272], myrtenyl‐2‐methylbutyrate [FL‐no: 09.899] and myrtenyl‐3‐methylbutyrate [FL‐no: 09.900]) have been deleted from the Union List.

Abstract The food enzyme considered in this opinion is an endo‐1,4‐β‐xylanase (EC 3.2.1.8) produced with a genetically modified strain of Aspergillus niger. The genetic modifications do not give rise to safety concerns. The food enzyme contains neither the production organism nor recombinant DNA. The endo‐1,4‐β‐xylanase is intended to be used in baking processes. Based on the maximum use levels recommended for the respective food process, dietary exposure to the food enzyme–total organic solids (TOS) was estimated on the basis of individual data from the EFSA Comprehensive European Food Consumption Database. This exposure estimate is below 0.013 mg TOS/kg body weight (bw) per day in European populations. No safety concerns were identified in relation to the genetic modifications performed, the manufacturing process, the compositional and biochemical data provided, allergenicity and exposure assessments. The allergenicity was evaluated by comparing the amino acid sequence to those of known allergens; no match was found. The Panel considered that the likelihood of allergic reactions to dietary intake of endo‐1,4‐β‐xylanase is low and, therefore, does not give rise to safety concerns. The systemic toxicity was assessed by means of a repeated dose 90‐day oral toxicity study in rodents. A no observed adverse effect level was derived (4,095 and 4,457 mg TOS/kg bw per day for males and females, respectively), which, compared with the dietary exposure, results in a sufficiently high margin of exposure. However, the genotoxicity data were incomplete. Due to the absence of the recommended combination of microbial strains used in the Ames test (i.e. lack of Salmonella Typhimurium TA102 and Escherichia coli WP2), no conclusions can be drawn on potential DNA oxidising or cross‐linking mechanisms giving rise to gene mutations. Consequently, no final conclusions can be drawn on genotoxicity.

Abstract This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing aids (CEF Panel) deals with the safety assessment of 1,2,3,4‐tetrahydronaphthalene‐2,6‐dicarboxylic acid, dimethyl ester (TDCM) for use as a co‐monomer to manufacture polyester layers. The polyester layer is not intended to be in direct contact with food. The finished multilayer articles are intended for packaging aqueous, acidic and low alcoholic foodstuffs. Contact conditions include sterilisation followed by long‐term storage at room temperature. No thermal degradation of TDCM is expected during the manufacture of the middle polyester layer and of the multilayer articles. Total mass transfer of the substance from a polyester monolayer was calculated to be up to 0.032 mg/kg food. Based on three in vitro genotoxicity tests, the CEF Panel considered that the substance does not raise concern for genotoxicity. When tested behind a polypropylene layer, migrating TDCM‐related oligomers, their oxidation products and other related reaction products were identified. The major components were TDCM dimers. When tested behind a cyclo‐olefin polymer layer, none of the TDCM‐related substances were found to migrate. Based on the lack of genotoxicity of the co‐monomer, the ester nature of the oligomers and on (quantitative) structure–activity relationship ((Q)SAR) analysis, the CEF Panel considered that there is no indication of genotoxicity for the oligomers, their oxidation products and other TDCM‐related reaction products. The CEF Panel concluded that the substance is not of safety concern for the consumer if used as a co‐monomer for the manufacture of a polyester layer intended to be used as an inner (non‐food contact) layer of a multilayer material for contact with foods simulated by simulants A, B, C, D1 (as set in Regulation (EU) 10/2011). The migration of the sum of the substance and the dimers (cyclic and open chain) should not exceed 0.05 mg/kg food.

Abstract The food enzyme considered in this opinion is a β‐amylase (EC 3.2.1.2), obtained from the grain of wheat (Triticum spp.) by Roquette (France). The β‐amylase is intended to be used in starch processing for production of glucose syrups containing maltose to be used as a food ingredient. Since the presence of residual amounts of total organic solids (TOS) in glucose syrups after filtration and purification during starch processing is negligible, no dietary exposure was calculated. As the food enzyme is derived from edible parts of wheat, no toxicological tests are required. Wheat is known as a gluten‐containing cereal. However, the gluten content of the food enzyme was shown to be below the limit of quantification of the applied analytical method and well below the threshold value of 20 mg/kg for ‘gluten‐free’ products. Furthermore, the potential allergenicity was evaluated by searching for similarity between the amino acid sequence of the β‐amylase and the sequences of known food allergens; no match was found. Although β‐amylase from wheat is described as a potential occupational respiratory allergen, and oral wheat challenges in wheat allergic patients may result in clinical symptoms, the enzyme and the low levels of other wheat proteins will be removed from the final food ingredients through a downstream purification process. Based on the origin of the food enzyme from edible parts of grain, the manufacturing process, and the compositional and biochemical data provided, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.

Abstract The EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids was requested to evaluate the genotoxic potential of one flavouring substance from subgroup 1.1.1(b) of FGE.19 in the Flavouring Group Evaluation 226 (FGE.226). The flavour industry provided genotoxicity studies for the substance 4,5‐epoxydec‐2(trans)‐enal [FL‐no: 16.071]. Based on these data, the Panel concluded in FGE.226 that 4,5‐epoxydec‐2(trans)‐enal did not induce gene mutations in bacterial cells but was positive in an in vitro micronucleus assay, so, 4,5‐epoxydec‐2(trans)‐enal is considered an in vitro genotoxic agent. The negative results obtained in an in vivo micronucleus assay cannot overrule the positive results of the in vitro micronucleus assay with and without S9‐mix due to the lack of demonstration of bone marrow exposure. Following this, the flavour industry has provided plasma analysis of a satellite group of rats treated with 4,5‐epoxydec‐2(trans)‐enal in order to investigate the systemic exposure of animals in the in vivo micronucleus assay. However, the plasma analysis did not provide enough evidence of target tissue exposure. An in vivo Comet assay in rodents was recommended in FGE.226, in order to investigate possible genotoxic effects at the first site of contact (e.g. stomach/duodenum cells) and in the liver. An in vivo Comet assay in liver and duodenum was provided that suggests that 4,5‐epoxydec‐2(trans)‐enal [FL‐no: 16.071] did not induce DNA damage in the duodenum of rats. However, the genotoxic effect observed in vitro was confirmed in the in vivo Comet assay in the liver of rats. The Panel concluded that 4,5‐epoxydec‐2(trans)‐enal [FL‐no: 16.071] does raise a safety concern with respect to genotoxicity and, therefore, it cannot be evaluated according to the Procedure.

Abstract This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety assessment of the substance phosphorous acid, mixed 2,4‐bis(1,1‐dimethylpropyl)phenyl and 4‐(1,1‐dimethylpropyl)phenyl triesters. The substance was evaluated by the CEF Panel in 2011 and 2,4‐di‐tert‐amylphenol, an impurity and hydrolysis product was re‐evaluated by the CEF Panel in 2015. In this application, the applicant requested an increase of the specific migration limit of the substance, currently established at 5 mg/kg food, to 10 mg/kg food, and provided new toxicological studies. Findings from three new in vitro mutagenicity assays on the oxidation products support the conclusion from 2011 that the substance and its oxidation products are not genotoxic. A new toxicokinetic study on the substance supports the consideration from the evaluation in 2011 that the substance does not raise concern for accumulation. The outcome of a new delayed neurotoxicity study on a structurally related substance, phosphorous acid, tris (2,4‐di‐tert‐butylphenyl) ester, which was considered not to cause neurotoxicity in hens, strengthens the conclusion of the Panel in 2011 that the substance does not represent a concern for neurotoxicity. From a new two‐generation reproduction toxicity study and a prenatal developmental toxicity study on the substance, a new subchronic toxicity study on its oxidation products that completes the one submitted in 2011 on the substance itself, and a 2‐year oral toxicity study on the structurally related substance, the lowest NOAEL was 58–147 mg/kg bw per day (from the 2‐year oral toxicity study). Compared to the requested increase of the migration limit, this gives an acceptable margin of safety of 348. Therefore, the CEF Panel concluded that an increase of the specific migration limit of the substance from 5 to 10 mg/kg food is not a safety concern for the consumer.

Abstract Following a request from the European Commission, the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) was requested to deliver a scientific opinion on the safety assessment of the flavouring substances caffeine [FL‐no: 16.016] and theobromine [FL‐no: 16.032] in the Flavouring Group Evaluation 49, Revision 1. Consequent to the 2015 scientific opinion from the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) on the safety of caffeine from all dietary sources, the CEF Panel considered it inappropriate to evaluate the two substances through the Procedure. For caffeine, the Panel based its assessment on the safety threshold of 5.7 mg/kg body weight (bw) per day for adults, except pregnant/lactating women, and 3 mg/kg bw per day for children, adolescents, pregnant and lactating women, as established by the NDA Panel. The safety evaluation of theobromine takes into account that approximately 11% of an oral dose of caffeine is metabolised to theobromine and that both substances have a similar pharmacological profile. For the exposure assessment, a brand loyalty model was chosen. In this model, it was assumed that a consumer is exposed on a long‐term basis to a specific category of food (i.e. non‐alcoholic beverages), containing caffeine or theobromine at their respective maximum use levels. For the rest of the categories, normal use levels applied. Daily dietary exposure to caffeine and theobromine (excluding systemic exposure) added as a chemically defined flavouring substance ranged 0–2.3 and 0–0.4 mg/kg bw, respectively, across all population groups. The Panel concluded that caffeine [FL‐no: 16.016] and theobromine [FL‐no: 16.032] would not be expected to present safety concern based on their estimated levels of intake from their use as flavouring substances.

Abstract The EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids was requested to evaluate 53 flavouring substances attributed to the Flavouring Group Evaluation 07, including four new substances but‐3‐en‐2‐ol, non‐1‐en‐e‐ol, hex‐1‐en‐3‐one and 1‐nonene‐3‐one [FL‐nos: 02.131, 02.187, 07.161 and 07.210] in this Revision 5, using the Procedure in Commission Regulation (EC) No 1565/2000. None of the 53 substances was considered to have genotoxic potential. The substances were evaluated through a stepwise approach that integrates information on the structure–activity relationships, intake from current uses, toxicological threshold of concern (TTC), and available data on metabolism and toxicity. The Panel concluded that all 53 substances do not give rise to safety concerns at their levels of dietary intake, estimated on the basis of the ‘Maximised Survey‐derived Daily Intake’ (MSDI) approach. Besides the safety assessment of the flavouring substances, the specifications for the materials of commerce have also been considered and found adequate. For 50 substances, further information is required based on comparison of the ‘modified Theoretical Added Maximum Daily Intakes’ (mTAMDIs) with the TTCs. This would include more reliable intake data and then, if required, additional toxicological data.