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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 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 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.

Abstract The EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids 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 four flavouring substances consisting of isopulegone and three other substances evaluated by JECFA at the 55th meeting. This revision is made due to additional toxicity data available for (1R,2S,5R)‐isopulegol [FL‐no: 02.067]. The substances were evaluated through a stepwise approach that integrates information on structure–activity relationships, intake from current uses, toxicological threshold of concern, and available data on metabolism and toxicity. p‐Mentha‐1,4(8)‐dien‐3‐one [FL‐no: 07.127] is no longer supported by the flavour industry and was not evaluated. In agreement with JECFA, the Panel evaluated the candidate substances in this Flavouring Group Evaluation (FGE) via the B‐side of the Procedure. Based on a no observed adverse effect level (NOAEL) from a 90‐day oral toxicity study on [FL‐no: 02.067], adequate margins of safety for the three candidate substances could be calculated. Therefore, 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 considered and found adequate. For the three substances evaluated in this FGE, use levels have become available and the modified theoretical added maximum daily intakes (mTAMDIs) were estimated. For [FL‐no: 02.067 and 07.067], the mTAMDI exceeds the toxicological threshold of concern for their structural classes and need more refined exposure assessment to finalise the evaluation.

Abstract The EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids was requested to evaluate N‐(2‐methylcyclohexyl)‐2,3,4,5,6‐pentafluoro‐benzamide [FL‐no: 16.119] in the Flavouring Group Evaluation 302, using the Procedure in Commission Regulation (EC) No 1565/2000. The substance is intended to be used as a flavour modifier and the current evaluation is only applicable to this use. Information on the ratios of diastereoisomers of the substance has been provided (cis 20–40% and trans 60–80%). Information on the ratio of enantiomers is lacking. The available data on genotoxicity do not preclude the evaluation of the candidate substance [FL‐no: 16.119] through the Procedure. The substance was evaluated through the B‐side of the Procedure. A ‘No Observed Adverse Effect Level’ (NOAEL) of 55 mg/kg body weight (bw) per day could be derived for [FL‐no: 16.119] from a 90‐day subchronic toxicity study in rats. This NOAEL provides an adequate margin of safety of 1.4 × 106, based on the ‘Maximised Survey‐Derived Daily Intake’ (MSDI) of 2.4 μg/capita per day. Based on the ‘modified Theoretical Added Maximum Daily Intake’ (mTAMDI) approach, the Panel concluded that more information is needed on use and use levels. Besides the safety assessment of this flavouring substance, the specifications for the material of commerce have also been considered. Additional information on the stereoisomeric composition of the flavouring substance is required.

Abstract The EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) was requested to deliver a scientific opinion on the implications for human health of the flavouring substance 4‐amino‐5‐(3‐(isopropylamino)‐2,2‐dimethyl‐3‐oxopropoxy)‐2‐methylquinoline‐3‐carboxylic acid [FL‐no: 16.130], in the Flavouring Group Evaluation 407 (FGE.407), according to Regulation (EC) No 1331/2008 of the European Parliament and of the Council. The substance has not been reported to occur in natural source materials of botanical or animal origin. It is intended to be used as both the parent compound and its hemisulfate monohydrate salt as a flavouring substance with modifying properties in specific categories of food. The chronic dietary exposure to the substance estimated using the added portions exposure technique (APET), is calculated to be 882 μg/person per day for a 60‐kg adult and 547 μg/person per day for a 15‐kg 3‐year‐old child. There is no concern with respect to genotoxicity. A 90‐day dietary administration study in rats showed no adverse effects for doses up to 100 mg/kg body weight (bw) per day, providing an adequate margin of safety. Developmental toxicity was not observed in a study with rats at the dose levels up to 1,000 mg/kg bw per day. The Panel concluded that [FL‐no: 16.130] and its hemisulfate monohydrate salt are not expected to be of safety concern at the estimated levels of dietary exposure calculated using the APET approach. This conclusion applies only to the use of the substance as a flavour modifier as requested and when used at the levels as specified for foods from different food categories.

Abstract In preparation of receiving dossiers on food enzymes, in 2009, the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids published guidance on data requirements and methodologies foreseen in the risk assessment of food enzymes. Based on experiences gained in assessing submitted dossiers, the Panel noted that the Budget method, an approach originally designed to assess food additives, was not appropriate for the purpose of assessing food enzymes. Consequently, the Panel undertook the task of developing an alternative assessment methodology. The Panel recommends the use of actual food consumption data for the assessment of dietary exposure to food enzymes. Consequently, individual data reported in the EFSA Comprehensive European Food Consumption Database will be used in the evaluation of food enzyme dossiers. It is envisaged that, during the evaluation of dossiers, a process‐based tool, based on summary statistics reported in the EFSA Comprehensive European Food Consumption Database, will be developed. As each process will require information on several input parameters, it is foreseen that the tool will be rolled out process‐by‐process over a period of time in collaboration with stakeholders.

Abstract This opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety assessment of basic copper (II) carbonate, CAS No 12069‐69‐1, for use as intelligent substance in the ink of a freshness indicator applied in labels inside trays of fresh poultry meat at temperatures from 2°C to 10°C and for a period of up to 12 days. Being a salt of carbonic acid, basic copper (II) carbonate is authorised and listed under Regulation (EU) No 10/2011 (food contact material (FCM) substance No 21: carbonic acid, salts) as, according to Article 6 of Regulation (EU) No 10/2011, salts of copper are authorised even if they are not included in the Union list. The residual amount of solvents in the printed label was determined and assuming total mass transfer from a 0.02 dm2 label into 400 g food would give a worst‐case migration in the order of ■■■■■. No migration of copper is expected taking into account the nature of the application with no direct contact between the substance and the food. However, even complete transfer in case of incidental direct contact would remain several orders of magnitude lower than the migration limit applicable at the date of the assessment (5 mg/kg). The CEF Panel, having considered the above‐mentioned data, concluded that the use of the substance basic copper (II) carbonate as a freshness indicator for packed poultry meat does not raise a safety concern to the consumer if the migration limit of copper is met.

Abstract The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) of EFSA was requested to deliver a scientific opinion on the implications for human health of the flavouring substance 3‐(1‐((3,5‐dimethylisoxazol‐4‐yl)methyl)‐1H‐pyrazol‐4‐yl)‐1‐(3‐hydroxybenzyl)imidazolidine‐2,4‐dione [FL‐no: 16.127], in the Flavouring Group Evaluation 400 (FGE.400), according to Regulation (EC) No 1331/2008 of the European Parliament and of the Council. The substance has not been reported to occur in natural source materials of botanical or animal origin. It is intended to be used as a flavour modifier in specific categories of food. There is no safety concern with respect to genotoxicity. A 90‐day dietary administration study in rats showed no adverse effects for doses up to 100 mg/kg body weight (bw) per day, providing an adequate margin of safety. Developmental toxicity was not observed in a study with rats at dose levels up to 1,000 mg/kg bw per day. The Panel concluded that [FL‐no: 16.127] is 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 and when used at levels up to those specified for various foods in different food categories.

Abstract The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of EFSA was requested to evaluate three flavouring substances, 2,5‐dimethyl‐4‐ethoxyfuran‐3(2H)‐one [FL‐no: 13.117], 2,5‐dimethylfuran‐3(2H)‐one [FL‐no: 13.119] and 4‐Acetyl‐2,5‐dimethylfuran‐3(2H)‐one [FL‐no: 13.175] in the Flavouring Group Evaluation 313 (FGE.313), using the Procedure in Commission Regulation (EC) No 1565/2000. The substances were considered in FGE.220, and revisions hereof, not to have genotoxic potential. They were evaluated through a stepwise approach that integrates information on the structure–activity relationships, intake from current uses, toxicological threshold of concern, and available data on metabolism and toxicity. The Panel concluded that the two flavouring substances [FL‐no: 13.117, 13.119] do not give rise to safety concerns at their level of dietary intake, estimated on the basis of the Maximised Survey‐derived Daily Intake (MSDI) approach. For the flavouring substance [FL‐no: 13.175], toxicity data are required. Besides the safety assessment of the flavouring substance, the specifications for the materials of commerce have also been considered. Adequate specifications including complete purity criteria and identity for the materials of commerce have been provided for the three flavouring substances. The Panel concluded that for 2,5‐dimethyl‐4‐ethoxyfuran‐3(2H)‐one [FL‐no: 13.117], 2,5‐dimethylfuran‐3(2H)‐one [FL‐no: 13.119] and 4‐acetyl‐2,5‐dimethylfuran‐3(2H)‐one [FL‐no: 13.175] for which the Modified Theoretical Added Maximum Daily Intakes (mTAMDIs) are above the thresholds for their structural class, more reliable exposure data are required for a re‐evaluation.

Abstract This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) deals with the safety evaluation of the recycling process Polisan Hellas S.A. (EU register No RECYC128), which is based on the Polymetrix (formerly Buhler) technology. 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. Through this process, washed and dried PET flakes are extruded into pellets, crystallised and subsequently decontaminated in a continuous countercurrent reactor under high temperature and inert gas flow. The recovered PET is mixed with at least 67% by mass of virgin PET before the main decontamination step. Having examined the challenge test provided, the Panel concluded that the third step, the decontamination in continuous countercurrent reactor for solid‐state polycondensation (SSP), is the critical step that determines the decontamination efficiency of the process. The operating parameters that control its performance are well defined and are temperature, residence time and gas flow. The operating parameters of this step in the process are at least as severe as those used in the challenge tests. Under these conditions, 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. Therefore, the Panel concluded that the PET obtained from this process (containing at least 67% virgin PET input), 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 This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) deals with the safety evaluation of the substance diethyl[[3,5‐bis(1,1‐dimethylethyl)‐4‐hydroxyphenyl]methyl]phosphonate. The substance with the CAS no 976‐56‐7 and the food contact materials (FCM) substance no 1007 is intended to be used in the polymerisation reaction to make poly(ethyleneterephthalate) (PET) plastic. The substance is intended to become a component of the backbone of the polymer and function as an antioxidant, providing thermal stability to the polyester during heat processing. The applications intended are contact with all types of food under any condition of time and temperature. A PET sample made with 0.2% w/w of the substance (i.e. twice the maximum intended) was subjected to a comprehensive set of migration tests. Migration of the substance was not detectable, with detection limits in the range of 3–6 μg/kg for the different simulants used. Using the results provided from a range of extraction and migration tests conducted on the PET sample, the Panel concluded that the potential migration into food of any impurities and possible reaction products coming from the substance was well below 2 μg/kg. Based on negative results from four in vitro genotoxicity tests, the Panel concluded that there is no evidence of genotoxicity of the substance. The substance is an organophosphorus compound but due to its low migration, there is no concern for neurotoxicity. Considering the structures and the low migration of the impurities and reaction products, the Panel concluded that they do not give rise to safety concern. The CEF Panel concluded therefore that the substance diethyl[[3,5‐bis(1,1‐dimethylethyl)‐4‐hydroxyphenyl]methyl]phosphonate does not raise a safety concern for the consumer if used up to 0.2% w/w (based on the weight of the polymer) in the polymerisation to make PET intended for contact with all types of foods under any contact conditions.

Abstract This opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety assessment of ground sunflower seed hulls, food contact material (FCM) substance No 1060, for use as an additive at up to 50% w/w in plastics such as polypropylene. The plastics are processed at up to 240°C and are intended for contact with dry foods only at room temperature or below. No migration data were provided for the additive as no migration is foreseeable. Concerning the possible presence and migration of impurities, as well as reaction and degradation products, a multistep investigation was used involving analysis of the plastic itself and then migration testing using modified polyphenylene oxide (MPPO) and test conditions of 10 days at 40 or 60°C. The highest migration, up to 54 mg/kg, was for the sum of four natural fatty acids. All other substances were either not detectable (

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 2,4,4′‐trifluorobenzophenone (TFB), Chemical Abstracts Service (CAS) No 80512‐44‐3, Food Contact Materials (FCM) substance No 1061, for use as a co‐monomer to manufacture polyether ether ketone (PEEK) plastics. The final articles made of PEEK are intended for repeated use in contact with all types of foods for short‐term duration, including at high temperatures. In tests for migration from PEEK under exaggerated test conditions compared to the intended uses, TFB was not detected using a method with a limit of detection of ■■■■■ food simulant. No TFB‐related impurities, oligomers or reaction products were detected in the same set of migration tests. No oligomeric fraction below 1,000 Da was found in PEEK samples made without and with TFB used as a co‐monomer. The substance was tested in three genotoxicity tests and was considered not to raise a concern for genotoxicity. Therefore, the CEF Panel concluded that TFB is not of safety concern for the consumer if used as co‐monomer up to ■■■■■ (the highest tested concentration based on the final material) in the manufacture of PEEK plastics.

Abstract The EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) was requested to consider in the Flavouring Group Evaluation 205 (FGE.205), the additional data on genotoxicity submitted by the Industry on two representative substances, oct‐1‐en‐3‐one [FL‐no: 07.081] and pent‐1‐en‐3‐one [FL‐no: 07.102], from subgroup 1.2.2 of FGE.19. The Panel concluded that both substances were weakly genotoxic in bacteria with pent‐1‐en‐3‐one being the most potent (previously available data). In these assays, the representative substances were highly cytotoxic with a steep toxicity curve and with a very narrow concentration range resulting in mutagenicity. Both substances were also tested in mammalian cells for gene mutations at the hprt locus and for structural and numerical chromosomal aberrations in the micronucleus assay. Also in mammalian cells, the test substances were highly cytotoxic. The Panel considered that the positive effects in the bacterial mutagenicity assays of the two representative substances cannot be overruled by the one negative and one equivocal gene mutation test in mammalian cells. Therefore, the Panel recommended to test the most potent of the representative substances, pent‐1‐en‐3‐one, in an in vivo Comet assay on the first site of contact (e.g. the stomach or duodenum) and on the liver. The Industry has now submitted new data, a combined micronucleus and Comet assay for pent‐1‐en‐3‐one, with scoring in the liver and duodenum, and an Ames test and a Comet assay with scoring in the liver for oct‐1‐en‐3‐one. Based on these new data, the Panel concluded that the concern for a genotoxic potential could be ruled out for the two representative substances and accordingly for the remaining 11 substances in FGE.205Rev1. The 13 substances in FGE.205Rev1 can therefore be evaluated via the Procedure.