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The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of the recycling process Silver Plastics (EU register number RECYC299), which uses the Reifenhäuser technology. The input material consists of hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes mainly originating from collected post‐consumer PET containers, including no more than 5% PET from non‐food consumer applications. The flakes are extruded under vacuum into sheets. Having examined the challenge test provided, the Panel concluded that the decontamination in the extruder under vacuum degassing (step 2), for which a challenge test was provided, is critical in determining the decontamination efficiency of the process. The operating parameters to control the performance are temperature, pressure and throughput. The Panel concluded that this recycling process is able to ensure a level of exposure to potential unknown contaminants from food below 0.0025 μg/kg bw per day, when such recycled PET is used from 15% to 100% in mixtures with virgin PET, depending on the specific intended application. Therefore, the Panel concluded that the recycled PET obtained from this process is not considered to be of safety concern when used from 15% to 100% in mixtures with virgin PET for the manufacture of materials and articles depending on the specific intended application. Articles made of this recycled PET are not intended to be used in microwave and conventional ovens and such uses are not covered by this evaluation. [ABSTRACT FROM AUTHOR]

The food enzyme subtilisin (serine endopeptidase, EC 3.4.21.62) is produced with the non‐genetically modified Bacillus paralicheniformis strain DP‐Dzx96 by Genencor International B.V. The food enzyme was considered free from viable cells of the production organism. The food enzyme is intended to be used in five food manufacturing processes: production of protein hydrolysates from plants and fungi, production of protein hydrolysates from meat and fish proteins, production of cooked rice, production of modified meat and fish products, and yeast processing. The production strain of the food enzyme contains known antimicrobial resistance genes. Bacitracin, a medically important antimicrobial, was detected in the food enzyme. The presence of bacitracin represents a risk for the development of antimicrobial resistant bacteria. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and three matches with respiratory and two matches with food allergens were found. The Panel considered that, under the intended conditions of use, the risk of allergic reactions upon dietary exposure to this food enzyme, particularly in individuals sensitised to muskmelon or pomegranate, cannot be excluded, but would not exceed the risk of consuming these foods. Due to the presence of bacitracin, the Panel concluded that the food enzyme subtilisin produced with the non‐genetically modified Bacillus paralicheniformis strain DP‐Dzx96 cannot be considered safe. [ABSTRACT FROM AUTHOR]

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of the recycling process Langgeng (EU register number RECYC293), which uses the Starlinger deCON technology. The input material is hot washed and dried poly(ethylene terephthalate) (PET) flakes originating from collected post‐consumer PET containers, e.g. bottles, with no more than 5% PET from non‐food consumer applications. The flakes are preheated before being submitted to solid‐state polycondensation (SSP) in a continuous reactor at high temperature under vacuum and gas flow. Having examined the challenge test provided, the Panel concluded that the preheating (step 2) and the decontamination in the SSP reactor (step 3) are critical in determining the decontamination efficiency of the process. The operating parameters to control the performance of these critical steps are temperature, pressure and residence time for steps 2 and 3, reduced gas flow rate for step 2 and gas volume/PET mass ratio for step 3. It was demonstrated that this recycling process is able to ensure that the level of migration of potential unknown contaminants into food below the conservatively modelled migration of 0.1 μg/kg food. Therefore, the Panel concluded that the recycled PET obtained from this process is not considered to be of safety concern, when used at up to 100% for the manufacture of materials and articles for contact with all types of foodstuffs, including drinking water, for long‐term storage at room temperature or below, with or without hotfill. The final articles made of this recycled PET are not intended to be used in microwave and conventional ovens and such uses are not covered by this evaluation. [ABSTRACT FROM AUTHOR]

The food enzyme α‐amylase (4‐α‐D‐glucan glucanohydrolase; EC 3.2.1.1) is produced with the non‐genetically modified microorganism Bacillus licheniformis strain T74 by Novozymes A/S. The production strain met the qualifications of the qualified presumption of safety (QPS) approach. The food enzyme is intended to be used in eight food manufacturing processes: starch processing for the production of glucose syrups and other starch hydrolysates, distilled alcohol production, refined and unrefined sugar production, brewing processes, cereal‐based processes, fruit and vegetable processing for juice production, fruit and vegetable processing for products other than juices and the production of dairy analogues. Since residual amounts of total organic solids (TOS) are removed during two food processes (starch processing for the production of glucose syrups and other starch hydrolysates, distilled alcohol production), dietary exposure was calculated only for the remaining six food manufacturing processes. It was estimated to be up to 0.291 mg TOS/kg body weight per day in European populations. Since the production strain meets the requirements for the QPS approach and no issues of concern arose from the production process of the food enzyme, the Panel considered that toxicological studies were unnecessary. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and no match was found. The Panel considered that, under the intended conditions of use, the risk of allergic reactions upon dietary exposure to this food enzyme cannot be excluded (except for distilled alcohol production), but the likelihood is low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use. [ABSTRACT FROM AUTHOR]

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of the recycling process RE–PETKunststoffrecycling (EU register number RECYC286), which uses the Gneuss 4 technology. The input consists of washed and dried poly(ethylene terephthalate) (PET) flakes mainly originating from collected post‐consumer PET containers, with no more than 5% PET from non‐food consumer applications. The flakes are melted in an extruder (step 2) and decontaminated during a melt‐state polycondensation step under ■■■■■ and vacuum (step 3) and finally pelletised. Having examined the challenge test provided, the Panel concluded that the melt‐state polycondensation (step 3) is critical in determining the decontamination efficiency of the process. The operating parameters to control the performance of the critical step are the pressure, the temperature, the residence time and the characteristics of the reactor. It was demonstrated by the challenge test that this recycling process is able to ensure that the level of migration of potential unknown contaminants into food is below the conservatively modelled migration of 0.1 μg/kg food. Therefore, the Panel concluded that the recycled PET obtained from this process is not of safety concern when used at up to 100% for the manufacture of materials and articles for contact with all types of foodstuffs, including drinking water, for long‐term storage at room temperature or below, with or without hotfill. The final articles made of this recycled PET are not intended to be used in microwave and conventional ovens and such uses are not covered by this evaluation. [ABSTRACT FROM AUTHOR]

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of the recycling process Plastrec (EU register number RECYC288), which uses the Polymetrix technology. The input material consists of hot washed and dried poly(ethylene terephthalate) (PET) flakes originating from collected post‐consumer PET containers, e.g. bottles, including no more than 5% PET from non‐food consumer applications. The flakes are extruded to pellets, crystallised and subsequently decontaminated in a solid‐state polycondensation (SSP) reactor under high temperature and gas flow. Having examined the challenge tests provided, the Panel concluded that the fourth step, the decontamination in the SSP reactor, is critical in determining the decontamination efficiency of the process. The operating parameters to control the performance of this critical step are temperature, gas velocity and residence time. It was demonstrated that this recycling process is able to ensure a level of migration of potential unknown contaminants into food below the conservatively modelled migration of 0.1 μg/kg food. Therefore, the Panel concluded that the recycled PET obtained from this process is not considered to be of safety concern, when used at up to 100% for the manufacture of materials and articles for contact with all types of foodstuffs, including drinking water, for long‐term storage at room temperature or below, with or without hotfill. The final articles made of this recycled PET are not intended to be used in microwave or conventional ovens and such uses are not covered by this evaluation. [ABSTRACT FROM AUTHOR]

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of the recycling process PCR Ambalaj (EU register number RECYC294), which uses the Starlinger iV+ technology. The input is hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes mainly originating from collected post‐consumer PET containers, with no more than 5% PET from non‐food consumer applications. The flakes are dried and crystallised in a first reactor, then extruded into pellets. These pellets are crystallised, preheated and treated in a solid‐state polycondensation (SSP) reactor. Having examined the challenge test provided, the Panel concluded that the drying and crystallisation (step 2), extrusion and crystallisation (step 3) and SSP (step 4) are critical in determining the decontamination efficiency of the process. The operating parameters to control the performance of these critical steps are temperature, air/PET ratio and residence time for the drying and crystallisation step, and temperature, pressure and residence time for the extrusion and crystallisation step as well as the SSP step. It was demonstrated that this recycling process is able to ensure that the level of migration of potential unknown contaminants into food is below the conservatively modelled migration of 0.1 μg/kg food. Therefore, the Panel concluded that the recycled PET obtained from this process is not of safety concern when used at up to 100% for the manufacture of materials and articles for contact with all types of foodstuffs, including drinking water, for long‐term storage at room temperature, with or without hotfill. The final articles made of this recycled PET are not intended to be used in microwave and conventional ovens and such uses are not covered by this evaluation. [ABSTRACT FROM AUTHOR]

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of the recycling process Loreco Plast Recyclage (EU register number RECYC290), which uses the VACUNITE (EREMA basic and Polymetrix SSP V‐leaN) technology. The input consists of hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes mainly originating from collected post‐consumer PET containers, with no more than 5% PET from non‐food consumer applications. The flakes are pre‐decontaminated in the ■■■■■ at ■■■■■ under ■■■■■ (step 2) before being extruded, pelletised and ■■■■■ (step 3). The ■■■■■ pellets are then ■■■■■ (step 4) and submitted to solid‐state polycondensation (SSP) (step 5) at ■■■■■ and under ■■■■■ and ■■■■■ in two parallel ■■■■■ lines. Having examined the challenge tests provided, the Panel concluded that step 2 as well as steps 4 and 5 are critical for determining the decontamination efficiency of the process. The operating parameters to control the performance are temperature, pressure and residence time for steps 2, 4 and 5 as well as the ■■■■■ for steps 4 and 5. It was demonstrated that this recycling process is able to ensure that the level of migration of potential unknown contaminants into food is below the conservatively modelled migration of 0.1 μg/kg food. Therefore, the Panel concluded that the recycled PET obtained from this process is not of safety concern, when used at up to 100% for the manufacture of materials and articles for contact with all types of foodstuffs, including drinking water, for long‐term storage at room temperature or below, with or without hotfill. The final articles made of this recycled PET are not intended to be used in microwave and conventional ovens and such uses are not covered by this evaluation. [ABSTRACT FROM AUTHOR]

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of the recycling process CPE (EU register number RECYC291), which uses the VACUNITE (EREMA basic and Polymetrix SSP V‐leaN) technology. The input is hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes mainly originating from collected post‐consumer PET containers, with no more than 5% PET from non‐food consumer applications. The flakes are pre‐decontaminated in the flakes reactor at high temperature under ■■■■■ (step 2) before being extruded, pelletised and crystallised (step 3). The crystallised pellets are then preheated (Step 4) and submitted to solid‐state polycondensation (SSP) (step 5) at ■■■■■ and ■■■■■ and ■■■■■ flow. Having examined the challenge tests provided, the Panel concluded that step 2 as well as steps 4 and 5 are critical for determining the decontamination efficiency of the process. The operating parameters to control the performance are temperature, pressure and residence time for steps 2, 4 and 5 as well as the ■■■■■ for steps 4 and 5. It was demonstrated that this recycling process is able to ensure that the level of migration of potential unknown contaminants into food is below the conservatively modelled migration of 0.1 μg/kg food. Therefore, the Panel concluded that the recycled PET obtained from this process is not of safety concern, when used at up to 100% for the manufacture of materials and articles for contact with all types of foodstuffs, including drinking water, for long‐term storage at room temperature or below, with or without hotfill. The final articles made of this recycled PET are not intended to be used in microwave and conventional ovens and such uses are not covered by this evaluation. [ABSTRACT FROM AUTHOR]

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of the recycling process Veolia Huafei Polymer Technology (Zhejiang) (EU register numberRECYC292), which uses the VACUNITE (EREMA basic and Polymetrix SSP V‐leaN) technology. The input consists of hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes, mainly originating from collected post‐consumer PET containers, with no more than 5% PET from non‐food consumer applications. The flakes are pre‐decontaminated in the ■■■■■ at ■■■■■ under ■■■■■ (step 2) before being extruded, pelletised and ■■■■■ (step 3). The ■■■■■ pellets are then ■■■■■ (step 4) and submitted to solid‐state polycondensation (SSP) (step 5) at ■■■■■ and under ■■■■■ and ■■■■■. Having examined the challenge tests provided, the Panel concluded that step 2 as well as steps 4 and 5 are critical for determining the decontamination efficiency of the process. The operating parameters to control the performance are temperature, pressure and residence time for steps 2, 4 and 5 as well as the ■■■■■ for steps 4 and 5. It was demonstrated that this recycling process is able to ensure that the level of migration of potential unknown contaminants into food is below the conservatively modelled migration of 0.1 μg/kg food. Therefore, the Panel concluded that the recycled PET obtained from this process is not of safety concern, when used at up to 100% for the manufacture of materials and articles for contact with all types of foodstuffs, including drinking water, for long‐term storage at room temperature or below, with or without hotfill. Articles made of this recycled PET are not intended to be used in microwave and conventional ovens and such uses are not covered by this evaluation. [ABSTRACT FROM AUTHOR]

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of the recycling process Lerg‐Pet (EU register number RECYC297), which uses the Starlinger iV+ technology. The input is hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes mainly originating from collected post‐consumer PET containers, with no more than 5% PET from non‐food consumer applications. The flakes are dried and crystallised in a first reactor, then extruded into pellets. These pellets are crystallised, preheated and treated in a solid‐state polycondensation (SSP) reactor. Having examined the challenge test provided, the Panel concluded that the drying and crystallisation (step 2), extrusion and crystallisation (step 3) and SSP (step 4) are critical in determining the decontamination efficiency of the process. The operating parameters to control the performance of these critical steps are temperature, air/PET ratio and residence time for the drying and crystallisation step, and temperature, pressure and residence time for the extrusion and crystallisation step as well as the SSP step. It was demonstrated that this recycling process is able to ensure that the level of migration of potential unknown contaminants into food is below the conservatively modelled migration of 0.1 μg/kg food. Therefore, the Panel concluded that the recycled PET obtained from this process is not of safety concern when used at up to 100% for the manufacture of materials and articles for contact with all types of foodstuffs, including drinking water, for long‐term storage at room temperature, with or without hotfill. The final articles made of this recycled PET are not intended to be used in microwave and conventional ovens and such uses are not covered by this evaluation. [ABSTRACT FROM AUTHOR]

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of the recycling process Dialog Diyou PCR (EU register number RECYC296), which uses the Starlinger iV+ technology. The input is hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes mainly originating from collected post‐consumer PET containers, with no more than 5% PET from non‐food consumer applications. The flakes are dried and crystallised in a first reactor, then extruded into pellets. These pellets are crystallised, preheated and treated in a solid‐state polycondensation (SSP) reactor. Having examined the challenge test provided, the Panel concluded that the drying and crystallisation (step 2), extrusion and crystallisation (step 3) and SSP (step 4) are critical in determining the decontamination efficiency of the process. The operating parameters to control the performance of these critical steps are temperature, air/PET ratio and residence time for the drying and crystallisation step, and temperature, pressure and residence time for the extrusion and crystallisation step as well as the SSP step. It was demonstrated that this recycling process is able to ensure that the level of migration of potential unknown contaminants into food is below the conservatively modelled migration of 0.1 μg/kg food. Therefore, the Panel concluded that the recycled PET obtained from this process is not of safety concern when used at up to 100% for the manufacture of materials and articles for contact with all types of foodstuffs, including drinking water, for long‐term storage at room temperature, with or without hotfill. The final articles made of this recycled PET are not intended to be used in microwave and conventional ovens and such uses are not covered by this evaluation. [ABSTRACT FROM AUTHOR]

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of the recycling process Tanrikulu Plastik (EU register number RECYC295), which uses the Starlinger iV+ technology. The input is hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes mainly originating from collected post‐consumer PET containers, with no more than 5% PET from non‐food consumer applications. The flakes are dried and crystallised in a first reactor, then extruded into pellets. These pellets are crystallised, preheated and treated in a solid‐state polycondensation (SSP) reactor. Having examined the challenge test provided, the Panel concluded that the drying and crystallisation (step 2), extrusion and crystallisation (step 3) and SSP (step 4) are critical in determining the decontamination efficiency of the process. The operating parameters to control the performance of these critical steps are temperature, air/PET ratio and residence time for the drying and crystallisation step, and temperature, pressure and residence time for the extrusion and crystallisation step as well as the SSP step. It was demonstrated that this recycling process is able to ensure that the level of migration of potential unknown contaminants into food is below the conservatively modelled migration of 0.1 μg/kg food. Therefore, the Panel concluded that the recycled PET obtained from this process is not of safety concern when used at up to 100% for the manufacture of materials and articles for contact with all types of foodstuffs, including drinking water, for long‐term storage at room temperature, with or without hotfill. The final articles made of this recycled PET are not intended to be used in microwave and conventional ovens and such uses are not covered by this evaluation. [ABSTRACT FROM AUTHOR]

The food enzyme triacylglycerol lipase (triacylglycerol acylhydrolase; EC 3.1.1.3) is produced with the non‐genetically modified Rhizopus arrhizus strain AE‐TL(B) by Amano Enzyme Inc. The food enzyme was considered free from viable cells of the production organism. It is intended to be used in the modification of fats and oils by interesterification and in the manufacture of enzyme‐modified dairy ingredients. Dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 0.057 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate a safety concern. The systemic toxicity was assessed by means of a repeated dose 90‐day oral toxicity study in rats. The Panel identified a no observed adverse effect level of 1,960 mg TOS/kg bw per day, the highest dose tested, which, when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 34,386. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and no match found. The Panel considered that, under the intended conditions of use, the risk of allergic reactions upon dietary exposure cannot be excluded, but the likelihood is low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns, under the intended conditions of use. [ABSTRACT FROM AUTHOR]

The food enzyme α‐amylase (4‐α‐d‐glucan glucanohydrolase; EC 3.2.1.1) is produced with the non‐genetically modified microorganism Bacillus amyloliquefaciens strain BA by HBI Enzymes Inc. The enzyme under assessment is intended to be used in six food processes: baking processes, brewing processes, distilled alcohol production, starch processing for the production of glucose syrups and other starch hydrolysates, production of dairy analogues and production of rice‐based meals. Since residual amounts of total organic solids (TOS) are removed during distillation and during the production of glucose syrups and other starch hydrolysates, dietary exposure was calculated only for the remaining four food manufacturing processes. It was estimated to be up to 4.805 mg TOS/kg body weight (bw) per day in European populations. The applicant did not provide sufficient data to demonstrate that the production strain meets the qualified presumption of safety (QPS) criteria, or proof of absence of viable cells and DNA from the production organism in the food enzyme. Therefore, the Panel was not able to conclude on the safety of the microbial source. A margin of exposure could not be calculated in the absence of toxicological studies. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and two matches with respiratory allergens were found. The Panel considered that, under the intended conditions of use (other than distilled alcohol production), the risk of allergic reactions by dietary exposure cannot be excluded, but the likelihood is low. Based on the data provided, the Panel could not conclude on the safety of this food enzyme, under the intended conditions of use. [ABSTRACT FROM AUTHOR]

The food enzyme ribonuclease P (EC 3.1.26.5) is produced with the non‐genetically modified Penicillium citrinum strain AE‐RP‐4 by Amano Enzyme Inc. It is intended to be used in yeast processing only for the production of yeast extract. Dietary exposure to the food enzyme total organic solids (TOS) was estimated to be up to 0.153 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not raise safety concerns. The systemic toxicity was assessed by means of a repeated dose 90‐day oral toxicity study in rats. The Panel identified a no observed adverse effect level (NOAEL) of 134.7 mg TOS/kg bw per day, which when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 880. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and no match was found. The Panel considered that, under the intended conditions of use, the risk of allergic reactions upon dietary exposure cannot be excluded, but the likelihood is low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use. [ABSTRACT FROM AUTHOR]

The food enzyme pectinesterase (pectin pectylhydrolase; EC 3.1.1.11) is produced with the genetically modified Aspergillus niger strain PME by DSM Food Specialties B.V. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and its recombinant DNA. It is intended to be used in fruit and vegetable processing, for juice production and fruit and vegetable processing for products other than juices. Dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 0.095 mg TOS/kg body weight (bw) per day in European populations. The toxicity studies were carried out with a xylanase obtained from A. niger strain XEA. The Panel considered this food enzyme as a suitable substitute for the pectinesterase to be used in the toxicological studies, because both production strains are derived from the same recipient strain, the location of the inserts is comparable, no partial inserts were present and the production methods are essentially the same. Genotoxicity tests did not indicate a safety concern. The systemic toxicity was assessed by means of a repeated dose 90‐day oral toxicity study in rats. The Panel identified a no observed adverse effect level (NOAEL) of 1,852 mg TOS/kg bw per day, the highest dose tested, resulting in a margin of exposure of at least 19,495. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and two matches with pollen allergens were found. The Panel considered that, under the intended conditions of use, the risk of allergic reactions upon dietary exposure to this food enzyme, particularly in individuals sensitised to pollen allergens, cannot be excluded. The Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use. [ABSTRACT FROM AUTHOR]

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of the recycling process CERSA (EU register number RECYC298), which uses the Starlinger deCON technology. The input material is hot washed and dried poly(ethylene terephthalate) (PET) flakes originating from collected post‐consumer PET containers, e.g. bottles, with no more than 5% PET from non‐food consumer applications. The flakes are preheated before being submitted to solid‐state polycondensation (SSP) in a continuous reactor at high temperature under vacuum and gas flow. Having examined the challenge test provided, the Panel concluded that the preheating (step 2) and the decontamination in the SSP reactor (step 3) are critical in determining the decontamination efficiency of the process. The operating parameters to control the performance of these critical steps are temperature, pressure and residence time for steps 2 and 3, reduced gas flow rate for step 2 and gas volume/PET mass ratio for step 3. It was demonstrated that this recycling process is able to ensure that the level of migration of potential unknown contaminants into food below the conservatively modelled migration of 0.1 μg/kg food. Therefore, the Panel concluded that the recycled PET obtained from this process is not considered to be of safety concern, when used at up to 100% for the manufacture of materials and articles for contact with all types of foodstuffs, including drinking water, for long‐term storage at room temperature or below, with or without hotfill. The final articles made of this recycled PET are not intended to be used in microwave and conventional ovens and such uses are not covered by this evaluation. [ABSTRACT FROM AUTHOR]

The food enzyme glucan‐1,4‐α‐maltohydrolase (4‐α‐d‐glucan α‐maltohydrolase; EC 3.2.1.133) is produced with the genetically modified Bacillus subtilis strain AR‐453 by AB Enzymes GmbH. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and its DNA. It is intended to be used in baking processes. Dietary exposure was estimated to be up to 0.262 mg TOS/kg body weight per day in European populations. As the production strain of B. subtilis strain AR‐453 qualifies for the qualified presumption of safety (QPS) approach to safety assessment and no issue of concern arose from the production process, no toxicological data were required. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and six matches were found. The Panel considered that, under the intended conditions of use, the risk of allergic reactions by dietary exposure cannot be excluded, but the likelihood is low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use. [ABSTRACT FROM AUTHOR]

The food enzyme with the declared activities endo‐polygalacturonase ((1–4)‐α‐D‐galacturonan glycanohydrolase; EC 3.2.1.15) and pectin lyase ((1–4)‐6‐O‐methyl‐α‐D‐galacturonan lyase; EC 4.2.2.10) is produced with the non‐genetically modified Aspergillus tubingensis strain NZYM‐PE by Novozymes A/S. It is intended to be used in four food manufacturing processes: fruit and vegetable processing for juice production, fruit and vegetable processing for products other than juices, refined olive oil production and wine and wine vinegar production. Since residual amounts of total organic solids (TOS) are removed during production, dietary exposure was not calculated for refined olive oil production. For the remaining three food processes, it was estimated to be up to 0.132 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate a safety concern. The systemic toxicity was assessed by means of a repeated dose 90‐day oral toxicity study in rats. The Panel identified a no observed adverse effect level (NOAEL) of 1,430 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, resulted in a margin of exposure above 10,833. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and 13 matches were found, including one food allergen (papaya). The Panel considered that, under the intended conditions of use, the risk of allergic reactions upon dietary exposure to this food enzyme cannot be excluded, in particular for individuals sensitised to papaya, but that the risk will not exceed that of consumption of papaya. In addition, oral allergy reactions cannot be excluded in pollen‐sensitised individuals. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns, under the intended conditions of use. [ABSTRACT FROM AUTHOR]

The food enzyme inulinase (1‐β‐d‐fructan fructanohydrolase; EC 3.2.1.7) is produced with the genetically modified Aspergillus oryzae strain MUCL 44346 by PURATOS NV. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and its DNA. It is intended to be used in the production of fructo‐oligosaccharides (FOS) from inulin extracted from chicory roots. Dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 0.01 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate a safety concern. The systemic toxicity was assessed by means of a repeated dose 90‐day oral toxicity study in rats. The Panel identified a no observed adverse effect level (NOAEL) of 100 mg TOS/kg bw per day, which when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 10,000. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and two matches were found with tomato allergens. The Panel considered that, under the intended conditions of use, the risk of allergic reactions upon dietary exposure to this food enzyme, particularly in individuals sensitised to tomato, cannot be excluded. However, the likelihood of allergic reactions is expected not to exceed the likelihood of allergic reactions to tomato. As the prevalence of allergic reactions to tomato is low, also the likelihood of such reactions to occur to the food enzyme is low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use. [ABSTRACT FROM AUTHOR]

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of the recycling process PT Veolia Indonesia (EU register number RECYC289), which uses the Polymetrix technology. The input material is hot washed and dried poly(ethylene terephthalate) (PET) flakes originating from collected post‐consumer PET containers, e.g. bottles, including no more than 5% PET from non‐food consumer applications. The flakes are extruded to pellets, crystallised and subsequently decontaminated in a solid‐state polycondensation (SSP) reactor under high temperature and gas flow. Having examined the challenge tests provided, the Panel concluded that the fourth step, the decontamination in the SSP reactor, is critical in determining the decontamination efficiency of the process. The operating parameters to control the performance of this critical step are temperature, gas velocity and residence time. It was demonstrated that this recycling process is able to ensure a level of migration of potential unknown contaminants into food below the conservatively modelled migration of 0.1 μg/kg food. Therefore, the Panel concluded that the recycled PET obtained from this process is not considered to be of safety concern, when used at up to 100% for the manufacture of materials and articles for contact with all types of foodstuffs, including drinking water, for long‐term storage at room temperature, with or without hotfill. The final articles made of this recycled PET are not intended to be used in microwave or conventional ovens and such uses are not covered by this evaluation. [ABSTRACT FROM AUTHOR]

Food enzymes are used for technical purposes in the production of food ingredients or foods‐as‐consumed. In the European Union, the safety of a food enzyme is evaluated by EFSA on the basis of a technical dossier provided by an applicant. Dietary exposure is an integral part of the risk assessment of food enzymes. To develop exposure models specific to each food manufacturing process in which food enzymes are used, different input data are required which are then used in tandem with technical conversion factors. This allows the use levels of food enzyme to be related to food consumption data collected in dietary surveys. For each food manufacturing process, EFSA identified a list of food groups (FoodEx1 classification system) and collated technical conversion factors. To ensure a correct and uniform application of these input data in the assessment of food enzyme dossiers, stakeholders were consulted via open calls‐for‐data. In addition to publishing and updating the identified input parameters on an annual basis, single‐process‐specific calculators of the Food Enzyme Intake Models (FEIMs) have been developed. These calculators have been deposited at https://zenodo.org/ since 2018 for open access. By 2023, EFSA had compiled the input data for a total of 40 food manufacturing processes in which food enzymes are employed. In this document, the food manufacturing processes are structured, food groups classified initially in the FoodEx1 system are translated into the FoodEx2 system, and technical factors are adjusted to reflect the more detailed and standardised FoodEx2 nomenclature. The development of an integrated FEIM‐web tool using this collection of input data is carried out for a possible release in 2024. This tool will be able to estimate the exposure to the food enzyme–total organic solids (TOS) when employed in multiple food manufacturing processes. [ABSTRACT FROM AUTHOR]

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of poly(2‐hydroxypropanoic acid), n‐octyl/n‐decyl esters (OLA8), which is intended to be used as a plasticiser into polylactic acid (PLA) in contact with non‐fatty foods. OLA8 is intended to be used at up to 5% and 15% w/w with or without starch, respectively (or with other additives with similar function). The migration for 10 days at 40°C from the film without starch was 0.16 mg/kg in 10% ethanol and 0.01 mg/kg in 3% acetic acid, while from the film with the starch it was well above 0.05 mg/kg food in all simulants. Some of the testing conditions were inconsistently reported. The substance did not induce gene mutations in bacterial cells and did not induce structural chromosomal aberrations or polyploidy in mammalian cells, thus, does not raise concern for genotoxicity. Instead of providing a 90‐day oral toxicity study, a hydrolysis study in ■■■■■ was submitted to read‐across from the authorised starting substances, ■■■■■ and the ■■■■■. However, the data provided did not allow to perform the read‐across, thus no appropriate toxicological data were provided to support migration above 0.05 mg/kg food (including for contact with 10% ethanol and use in combination with starch). The Panel concluded that OLA8 does not raise a safety concern for the consumer if it is used as an additive at up to 15% w/w in the manufacture of PLA articles that do not contain starch (and other additives with similar function), that are intended to be in contact for 10 days at 40°C with foods simulated by 3% acetic acid and from which the migration does not exceed 0.05 mg/kg food. [ABSTRACT FROM AUTHOR]

The food enzyme cellulase (4‐(1,3;1,4)‐β‐d‐glucan‐4‐glucanohydrolase; EC 3.1.2.4) is produced with the non‐genetically modified Aspergillus niger strain 294 by Kerry Ingredients & Flavours Ltd. The food enzyme is considered free from viable cells of the production organism. The enzyme is intended to be used in eight food manufacturing processes: baking processes, cereal‐based processes, brewing processes, grain treatment for the production of starch and gluten fractions, fruit and vegetable processing for juice production, fruit and vegetable processing for products other than juices, distilled alcohol production and wine and wine vinegar production. Since residual amounts of total organic solids (TOS) are removed during distilled alcohol production and grain treatment for the production of starch and gluten fractions, dietary exposure was only calculated for the remaining six food manufacturing processes. It was estimated to be up to 5.706 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate a safety concern. The systemic toxicity was assessed by means of a repeated dose 90‐day oral toxicity study in rats. The Panel identified a no observed adverse effect level of 794 mg TOS/kg bw per day, the highest dose tested. The calculated margin of exposure for each age group was 184 (infants), 146 (toddlers), 139 (children), 219 (adolescents), 305 (adults) and 441 (the elderly). A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and four matches were found. The Panel considered that, under the intended conditions of use (other than distilled alcohol production), the risk of allergic reactions by dietary exposure cannot be excluded, but the likelihood is low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use for adolescents, adults and the elderly. [ABSTRACT FROM AUTHOR]

The food enzyme peroxidase (phenolic donor: hydrogen‐peroxide oxidoreductase, EC 1.11.1.7) is produced with the genetically modified Aspergillus niger strain MOX by DSM Food Specialties B.V. The genetic modifications do not give rise to safety concerns. The food enzyme is considered free from viable cells of the production organism and its DNA. The food enzyme is intended to be used in whey processing. Dietary exposure to the food enzyme total organic solids (TOS) was estimated to be up to 0.635 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate a safety concern. The systemic toxicity was assessed by means of a repeated dose 90‐day oral toxicity study in rats. The Panel identified a no observed adverse effect level of 2,162 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure resulted in a margin of exposure of at least 3,405. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and no match was found. The Panel considered that, under the intended conditions of use, the risk of allergic reactions by dietary exposure cannot be excluded, but the likelihood is low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns, under the intended conditions of use. [ABSTRACT FROM AUTHOR]

The food enzyme triacylglycerol lipase (triacylglycerol acylhydrolase, EC 3.1.1.3) is produced with the genetically modified Saccharomyces cerevisiae strain LALL‐LI by Lallemand Inc. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism, but not from recombinant DNA. It is intended to be used in baking processes. Dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 0.42 mg TOS/kg body weight per day in European populations. The production strain of the food enzyme fulfils the requirements for the qualified presumption of safety (QPS) approach to safety assessment. Therefore, the Panel considered that toxicological tests are not needed for the assessment of this food enzyme. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and no match was found. The Panel considered that, under the intended conditions of use, the risk of allergic reactions by dietary exposure cannot be excluded, but the likelihood is low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use. [ABSTRACT FROM AUTHOR]

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of the recycling process Coca‐Cola HBC (EU register number RECYC285), which uses the NGR technology. The input is washed and dried poly(ethylene terephthalate) (PET) flakes mainly originating from collected post‐consumer PET containers, with no more than 5% PET from non‐food consumer applications. The flakes are dried (step 2), melted in an extruder (step 3) and decontaminated during a melt‐state polycondensation step ■■■■■ (step 4). In step 5, the material is granulated. Having examined the challenge test provided, the Panel concluded that the melt‐state polycondensation (step 4) is critical in determining the decontamination efficiency of the process. The operating parameters to control the performance of the critical step are the pressure, the temperature, the residence time (depending on the mass and throughput of the melt) and the characteristics of the reactor. It was demonstrated that this recycling process is able to ensure that the level of migration of potential unknown contaminants into food is below the conservatively modelled migration of 0.1 μg/kg food. Therefore, the Panel concluded that the recycled PET obtained from this process is not of safety concern when used at up to 100% for the manufacture of materials and articles for contact with all types of foodstuffs, including drinking water, for long‐term storage at room temperature, with or without hotfill. The final articles made of this recycled PET are not intended to be used in microwave and conventional ovens and such uses are not covered by this evaluation. [ABSTRACT FROM AUTHOR]

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of the recycling process CCH CIRCULARPET (EU register number RECYC284), which uses the NGR technology. The input is washed and dried poly(ethylene terephthalate) (PET) flakes mainly originating from collected post‐consumer PET containers, with no more than 5% PET from non‐food consumer applications. The flakes are dried (step 2), melted in an extruder (step 3) and decontaminated during a melt‐state polycondensation step ■■■■■ (step 4). In step 5, the material is granulated. Having examined the challenge test provided, the Panel concluded that the melt‐state polycondensation (step 4) is critical in determining the decontamination efficiency of the process. The operating parameters to control the performance of the critical step are the pressure, the temperature, the residence time (depending on the mass and throughput of the melt) and the characteristics of the reactor. It was demonstrated that this recycling process is able to ensure that the level of migration of potential unknown contaminants into food is below the conservatively modelled migration of 0.1 μg/kg food. Therefore, the Panel concluded that the recycled PET obtained from this process is not of safety concern when used at up to 100% for the manufacture of materials and articles for contact with all types of foodstuffs, including drinking water, for long‐term storage at room temperature, with or without hotfill. The final articles made of this recycled PET are not intended to be used in microwave and conventional ovens and such uses are not covered by this evaluation. [ABSTRACT FROM AUTHOR]

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of the recycling process Cirrec Netherlands BV (EU register number RECYC283), which uses the EREMA Basic technology. The input material is hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes originating from collected post‐consumer PET containers, including less than 5% PET from non‐food consumer applications. The flakes are heated in a continuous reactor under vacuum before being extruded. Having examined the challenge test provided, the Panel concluded that the continuous decontamination (step 2), for which a challenge test was provided, is critical in determining the decontamination efficiency of the process. The operating parameters to control the performance of this step are temperature, pressure and residence time. It was demonstrated that this recycling process is able to ensure a level of migration of potential unknown contaminants into food below the conservatively modelled migration of 0.1 μg/kg food, derived from the exposure scenario for infants when such recycled PET is used at up to 100%. Therefore, the Panel concluded that the recycled PET obtained from this process is not considered to be of safety concern when used at up to 100% for the manufacture of materials and articles for contact with all types of foodstuffs, including drinking water, for long‐term storage at room temperature or below, with or without hotfill. This evaluation does not cover uses of the recycled PET in microwaves or conventional ovens. [ABSTRACT FROM AUTHOR]

The food enzyme endo‐1,4‐β‐xylanase (4‐β‐d‐xylan xylanohydrolase, EC 3.2.1.8) is produced with the non‐genetically modified microorganism Aspergillus tubingensis strain LYX by DSM Food Specialties B.V. The food enzyme was considered free from viable cells of the production organism. It is intended to be used in baking processes and cereal‐based processes. Dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 0.106 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate a safety concern. The systemic toxicity was assessed by means of a repeated dose 90‐day oral toxicity study in rats. The Panel identified a no observed adverse effect level of 227 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 2,142. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and no match was found. The Panel considered that, under the intended conditions of use, the risk of allergic reactions by dietary exposure cannot be excluded, but the likelihood is low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns, under the intended conditions of use. [ABSTRACT FROM AUTHOR]

The food enzyme endo‐1,4‐β‐xylanase (4‐β‐d‐xylan xylanohydrolase, EC 3.2.1.8) is produced with the genetically modified microorganism Bacillus subtilis strain XAN by DSM Food Specialties B.V. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and its DNA. The production strain of the food enzyme contains antimicrobial resistance genes. However, based on the absence of viable cells and DNA from the production organism in the food enzyme, this is not considered to be a risk. The food enzyme is intended to be used in baking processes and cereal‐based processes. Dietary exposure to the food enzyme total organic solids (TOS) was estimated to be up to 0.02 mg TOS/kg body weight (bw) per day in European populations. As no other concerns arising from the microbial source and its subsequent genetic modification or from the manufacturing process have been identified, the Panel considered that toxicological tests are not needed for the assessment of this food enzyme. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made and no match was found. The Panel considered that, under the intended conditions of use, the risk of allergic reactions by dietary exposure cannot be excluded, but the likelihood is low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns, under the intended conditions of use. [ABSTRACT FROM AUTHOR]

The food enzyme containing chymosin (EC 3.4.23.4) and pepsin A (EC 3.4.23.1) is prepared from the abomasum of calves and cows (Bos taurus) by Chr. Hansen. The food enzyme is intended to be used in milk processing for cheese production and in milk processing for the production of fermented milk products. As no concerns arise from the animal source of the food enzyme, from its manufacture, and based on the history of safe use and consumption, the Panel considered that toxicological data were unnecessary and an estimation of dietary exposure was not required. A search for the similarity of the amino acid sequences of the two proteins (chymosin and pepsin A) to those of known allergens was made and one match with pig pepsin, a respiratory allergen, was found. The Panel considered that, under the intended conditions of use, the risk of allergic reactions upon dietary exposure cannot be excluded, but the likelihood is low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use. [ABSTRACT FROM AUTHOR]

The food enzyme α‐amylase (4‐α‐d‐glucan glucanohydrolase; EC 3.2.1.1) is produced with the non‐genetically modified Cellulosimicrobium funkei strain AE‐AMT by Amano Enzyme Inc. In a previous opinion, a safety evaluation of this food enzyme was completed, in which EFSA concluded that this food enzyme did not give rise to safety concerns when used in starch processing for maltodextrin production. The applicant has now provided new data to extend the use of this food enzyme to six additional food manufacturing processes: baking processes, cereal‐based processes, plant processing for the production of dairy analogues, processing of tea, herbal and fruit infusions, brewing processes and the production of non‐wine vinegar. For its use in a total of seven food manufacturing processes, the dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 0.012 mg TOS/kg body weight (bw) per day in European populations. Using the toxicological data provided in the previous opinion, with a NOAEL of 230 mg TOS/kg bw per day (the highest dose tested), the Panel derived a margin of exposure of at least 19,167. Based on the revised exposure calculation and the outcome of the previous evaluation, the Panel concluded that this food enzyme does not give rise to safety concerns under the revised intended conditions of use. [ABSTRACT FROM AUTHOR]

The food enzyme pectinesterase (pectin pectylhydrolase; EC 3.1.1.11) is produced with the genetically modified Trichoderma reesei strain RF6201 by AB Enzymes GmbH. The genetic modifications do not give rise to safety concerns. The food enzyme was considered free from viable cells of the production organism and its DNA. It is intended to be used in five food manufacturing processes: fruit and vegetable processing for juice production, fruit and vegetable processing for products other than juices, production of wine and wine vinegar, coffee demucilation and production of plant extracts as flavouring preparations. Since residual amounts of the total organic solids (TOS) are removed during the coffee demucilation and the production of flavouring extracts, dietary exposure was calculated only for the remaining three food processes. It was estimated to be up to 0.532 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate a safety concern. The systemic toxicity was assessed by means of a repeated dose 90‐day oral toxicity study in rats. The Panel identified a no observed adverse effect level of 1,000 mg TOS/kg bw per day, the highest dose tested, which, when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 1,880. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and two matches were found with pollen allergens. The Panel considered that, under the intended conditions of use, the risk of allergic reactions upon dietary exposure, particularly in individuals sensitised to pollen allergens, cannot be excluded. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use. [ABSTRACT FROM AUTHOR]

The food enzyme endo‐polygalacturonase ((1–4)‐α‐d‐galacturonan glycanohydrolase; EC 3.2.1.15) is produced with the genetically modified Trichoderma reesei strain RF6197 by AB Enzymes GmbH. The genetic modifications do not give rise to safety concerns. The food enzyme was considered free from viable cells of the production organism and its DNA. It is intended to be used in five food manufacturing processes: fruit and vegetable processing for juice production, fruit and vegetable processing for products other than juices, production of wine and wine vinegar, coffee demucilation and production of plant extracts as flavouring preparations. Since residual amounts of the total organic solids (TOS) are removed during the coffee demucilation and the production of flavouring extracts, dietary exposure was calculated only for the remaining three food processes. It was estimated to be up to 0.156 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate a safety concern. The systemic toxicity was assessed by means of a repeated dose 90‐day oral toxicity study in rats. The Panel identified a no observed adverse effect level of 1,000 mg TOS/kg bw per day, the highest dose tested, which, when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 6,410. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and matches were found with a number of pollen allergens. The Panel considered that, under the intended conditions of use, the risk of allergic reactions by dietary exposure, particularly in individuals sensitised to pollen cannot be excluded. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use. [ABSTRACT FROM AUTHOR]

The food enzyme α‐amylase (4‐α‐d‐glucan glucanohydrolase; EC 3.2.1.1) is produced with the non‐genetically modified Aspergillus niger strain AS 29‐286 by Shin Nihon Chemical Co., Ltd. The food enzyme is considered free from viable cells of the production organism. It is intended to be used in seven food manufacturing processes: baking processes, fruit and vegetable processing for juice production, fruit and vegetable processing for products other than juices, distilled alcohol production, starch processing for the production of maltodextrins, brewing processes and non‐wine vinegar production. Since residual amounts of total organic solids (TOS) are removed during distilled alcohol production and starch processing for the production of maltodextrins, dietary exposure was calculated only for the remaining five food manufacturing processes. It was estimated to be up to 2.158 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate a safety concern. The systemic toxicity was assessed by means of a repeated dose 90‐day oral toxicity study in rats. The Panel identified a no observed adverse effect level of 1,774 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 822. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and four matches with respiratory allergens were found. The Panel considered that, under the intended conditions of use, the risk of allergic reactions upon dietary exposure cannot be excluded, but the likelihood is low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use. [ABSTRACT FROM AUTHOR]

The food enzyme subtilisin (serine endopeptidase, EC 3.4.21.62) is produced with the non‐genetically modified microorganism Bacillus paralicheniformis strain LMG S‐30155 by ENMEX SA de CV, now part of Kerry Food Ingredients (Cork) Ltd. The food enzyme is intended to be used in oil production, hydrolysis of vegetable/microbial/animal proteins, yeast processing and production of flavouring preparations. The production strain of the food enzyme contains known antimicrobial resistance genes and genes involved in bacitracin biosynthesis. Consequently, it does not fulfil the requirements for the QPS approach to safety assessment. Bacitracin was detected in the food enzyme and the ■■■■■ The presence of bacitracin, a medically important antimicrobial, in the food enzyme represents a risk for the development of resistance in bacteria. Due to the presence of bacitracin, the Panel concluded that the food enzyme subtilisin produced with the non‐genetically modified Bacillus paralicheniformis strain LMG S‐30155 cannot be considered safe. [ABSTRACT FROM AUTHOR]