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Abstract The food enzyme α‐amylase (1,4‐α‐d‐glucan glucanohydrolase; EC 3.2.1.1) is produced with the genetically modified Bacillus licheniformis strain DP‐Dzb52 by Danisco US Inc. The production strain contains multiple copies of an antimicrobial resistance gene. 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 α‐amylase is intended to be used in starch processing for the production of glucose syrups, brewing processes and distilled alcohol production. Since residual amounts of the food enzyme are removed by the purification steps applied during the production of glucose syrups and distillation, no dietary exposure was calculated. Based on the maximum use levels recommended for the brewing processes and individual data from the EFSA Comprehensive European Food Consumption Database, dietary exposure to the enzyme–total organic solids (TOS) was estimated to be up to 0.145 TOS/kg body weight per day in European populations. The toxicity studies were carried out with another α‐amylase from B. licheniformis strain DP‐Dzb54, considered by the Panel as a suitable substitute. Toxicological tests indicated that there was no concern with respect to genotoxicity or systemic toxicity. A no observed adverse effect level was identified in rats which, compared with the dietary exposure, results in a margin of exposure of at least 750. A search for similarity of the amino acid sequence to known allergens was made and one match was found. The Panel considered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions can be excluded in distilled alcohol production and is considered low when the enzyme is used in starch processing and brewing. 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 The food enzyme endo‐1,3(4)‐β‐glucanase (3(or 4)‐β‐d‐glucan 3(4)‐glucanohydrolase; EC 3.2.1.6) is produced with a genetically modified Bacillus subtilis strain DP‐Ezm28 by Danisco US Inc. The genetic modifications do not give rise to safety concerns. The production strain of the food enzyme contains multiple copies of a known antimicrobial resistance gene. 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 distilled alcohol production and brewing processes. Since residual amounts of total organic solids (TOS) are removed by distillation, dietary exposure was only calculated for brewing processes. Based on the maximum use levels recommended for brewing processes and individual data from the EFSA Comprehensive European Food Database, dietary exposure to the food enzyme–total organic solids was estimated to be up to 0.183 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, results in a margin of exposure of at least 5464. Similarity of the amino acid sequence to those of known allergens was searched and two matches were found. The Panel considered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions upon dietary exposure to this food enzyme cannot be excluded, but the likelihood is considered 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 The food enzyme triacylglycerol lipase (triacylglycerol acylhydrolase EC 3.1.1.3) is produced with the genetically modified Ogataea polymorpha strain DP‐Jzk33 by Danisco US Inc. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. It is intended to be used in baking and cereal‐based processes. Based on the maximum use levels recommended for baking and cereal‐based processes and individual data from the EFSA Comprehensive European Food Database, dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 0.520 mg TOS/kg body weight (bw) per day. Genotoxicity tests did not raise a safety concern. The systemic toxicity was assessed by means of a repeated dose 90‐day oral toxicity study in rats. The Panel identified a no observed adverse effect level of 669 mg TOS/kg bw per day, the highest dose tested. Comparison with the estimated dietary exposure results in a margin of exposure of at least 1,287. A search was made of the similarity of the amino acid sequence of the lipase to those of known allergens and no match was found. The Panel considered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood of such reactions to occur is likely to be low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.

Abstract The food enzyme glucan 1,4‐α‐maltotetraohydrolase (4‐α‐d‐glucan maltotetraohydrolase, EC 3.2.1.60) is produced with a genetically modified Bacillus licheniformis strain DP‐Dzr46 by Danisco US Inc. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. The glucan 1,4‐α‐maltotetraohydrolase food enzyme is intended to be used in baking processes. Based on the maximum use levels, dietary exposure to the food enzyme–Total Organic Solids (TOS) was estimated to be up to 0.405 mg TOS/kg body weight (bw) per day in European populations. The toxicity studies were carried out with another glucan 1,4‐α‐maltotetraohydrolase from B. licheniformis (strain DP‐Dzf24). The Panel considered this food enzyme as a suitable substitute to be used in the toxicological studies, because it derives from the same recipient strain as strain DP‐Dzr46, the location of the inserts is comparable, no partial inserts were present and the production methods are comparable. Genotoxicity tests did not raise a safety concern. The systemic toxicity was assessed by means of a repeated dose 90‐day oral toxicity study in rats. The Panel identified a no observed adverse effect level (NOAEL) at the highest dose of 94 mg TOS/kg bw per day that, compared with the estimated dietary exposure, results in a sufficiently high margin of exposure of at least 232. Similarity of the amino acid sequence to those of known allergens was searched and none was found. The Panel considered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood is considered to be low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.

Abstract The food enzyme endo‐1,4‐β‐xylanase (4‐β‐d‐xylan xylanohydrolase; EC 3.2.1.8) is produced with a genetically modified Bacillus licheniformis (strain NZYM‐CE) by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This xylanase is intended to be used in baking and cereal‐based processes. Based on the maximum use levels recommended for the respective food processes and individual 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 0.012 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate a genotoxic concern. The systemic toxicity was assessed by a repeated dose 90‐day oral toxicity study in rats. The Panel identified a no observed adverse effect level (NOAEL) of at least 1,020 mg TOS/kg bw per day, the highest dose tested. When the NOAEL value is compared to the estimated dietary exposure, this results in a margin of exposure (MoE) of at least 85,000. Similarity of the amino acid sequence to those of known allergens was searched and no match was found. The Panel considered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions upon dietary exposure to this food enzyme cannot be excluded, but the likelihood is considered to be low. Overall, the Panel concluded that based on the data provided and the derived MoE, this food enzyme does not give rise to safety concerns under the intended conditions of use.

Abstract The food enzyme glucose oxidase (β‐d‐glucose:oxygen 1‐oxidoreductase; EC 1.1.3.4) is produced with a genetically modified Aspergillus niger strain ZGL 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 recombinant DNA. The glucose oxidase is intended to be used in baking processes. Based on the maximum use levels, dietary exposure to the food enzyme‐total organic solids (TOS) was estimated to be up to 0.004 mg TOS/kg body weight (bw) per day. The toxicity studies were carried out with an asparaginase from A. niger (strain ASP). The Panel considered this enzyme as a suitable substitute to be used in the toxicological studies, because they derive from the same recipient strain, the location of the inserts are comparable, no partial inserts were present and the production methods are essentially the same. Genotoxicity tests did not raise a safety concern. The systemic toxicity was assessed by means of a repeated dose 90‐day oral toxicity study in rats. The Panel identified a no observed adverse effect level (NOAEL) at the highest dose of 1,038 and 1,194 mg TOS/kg bw per day (for males and females, respectively) that, compared with the estimated dietary exposure, results in a sufficiently high margin of exposure (MoE) (of at least 260,000). Similarity of the amino acid sequence to those of known allergens was searched and one match was found. The Panel considered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood to occur is considered to be low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.

Abstract The food enzyme triacylglycerol lipase (triacylglycerol acylhydrolase, EC 3.1.1.3) is produced with a genetically modified Aspergillus niger strain LFS 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 recombinant DNA. The triacylglycerol lipase food enzyme is intended to be used in baking processes. Based on the maximum use levels, dietary exposure to the food enzyme‐total organic solids (TOS) was estimated to be up to 0.020 mg TOS/kg body weight (bw) per day. The toxicity studies were carried out with an asparaginase from A. niger (strain ASP). The Panel considered this enzyme as a suitable substitute to be used in the toxicological studies, because they derive from the same recipient strain, the location of the inserts are comparable, no partial inserts were present and the production methods are essentially the same. Genotoxicity tests did not raise a safety concern. The systemic toxicity was assessed by means of a repeated dose 90‐day oral toxicity study in rats. The Panel identified a no observed adverse effect level (NOAEL) at the highest dose of 1,038 and 1,194 mg TOS/kg bw per day (for males and females, respectively) that, compared with the estimated dietary exposure, results in a sufficiently high margin of exposure (MoE) (of at least 51,900). Similarity of the amino acid sequence to those of known allergens was searched and no match was found. The Panel considered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood to occur is considered to be low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.

Abstract The food enzyme pullulanase (pullulan 6‐α‐glucanohydrolase; EC 3.2.1.41) is produced with a genetically modified Bacillus licheniformis (strain DP‐Dzp39) by Danisco US Inc. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and its recombinant DNA. This pullulanase is intended to be used in brewing processes, starch processing for glucose syrups production and distilled alcohol production. Residual amounts of total organic solids (TOS) are removed by distillation and by the purification steps applied during the production of glucose syrups, consequently, dietary exposure was not calculated for these food processes. For brewery products, based on the maximum use level recommended for the brewing processes and individual data from the EFSA Comprehensive European Food Consumption Database, dietary exposure to the food enzyme–TOS was estimated to be up to 0.053 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests with the food enzyme did not raise 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 at the highest dose of 500 mg TOS/kg bw per day that, compared to the estimated dietary exposure, results in sufficiently high margin of exposure (at least 9,400). The amino acid sequence of the food enzyme did not match those of known allergens. The Panel considered that, under the intended condition of use, the risk of allergic sensitisation and elicitation reactions upon dietary exposure to this food enzyme cannot be excluded, but the likelihood is considered low. Based on the data provided, the Panel concluded that this food enzyme does not raise safety concerns under the intended conditions of use.

Abstract The EFSA FEEDAP Panel previously (2016) could not conclude on the safety of certain concentrated liquid l‐lysine (base), l‐lysine monohydrochloride (HCl) and l‐lysine sulfate products manufactured using different strains of Corynebacterium glutamicum. New information on the safety of these products was provided by the applicant. The recipient strain C. glutamicum KCTC 12307BP qualifies for qualified presumption of safety (QPS) approach for safety assessment, the genetic modification does not introduce any safety concern and no introduced antibiotic resistance genes remain in its genome. Even if uncertainty remains concerning the absence/presence of the production strain and/or its recombinant DNA in the final products, these would not raise safety concerns. The liquid l‐lysine (base) and l‐lysine HCl produced by C. glutamicum KCTC 12307BP or C. glutamicum KCCM 11117P; and l‐lysine HCl produced by C. glutamicum NRRL B‐50547 are considered safe for the target species, consumers and the environment. Regarding the safety for the user, concentrated liquid l‐lysine (base) and l‐lysine HCl produced by C. glutamicum KCTC 12307BP, C. glutamicum NRRL B‐50547 or C. glutamicum KCCM 11117P are not irritant to skin or eyes and they are not skin sensitisers. l‐Lysine HCl is not hazardous by inhalation. The use of C. glutamicum DSM 24990 in the production of l‐lysine sulfate is considered safe for the target species, consumers, users or the environment. No negative effects are to be expected for the target species within the proposed inclusion levels of 0.5–30 g lysine sulfate/kg complete feed provided that the total S intake complies with the recommendations of established scientific bodies. The use of C. glutamicum KCCM 10227 in the production of l‐lysine sulfate is considered safe for the target species, consumers, users and the environment with regard to antimicrobial resistance. No negative effects are to be expected for the target species within common inclusion levels provided that the total S intake complies with the recommendations of established scientific bodies.

Abstract The European Commission asked EFSA for an opinion on the safety for the target animals, consumer, user and the environment and on the efficacy of a l‐lysine monohydrochloride (HCl, minimum 98.5%) and of a concentrated liquid l‐lysine (base, minimum 50%) produced by a genetically modified strain of Corynebacterium glutamicum (NRRL B‐50775). They are intended to be used in feed or water for drinking for all animal species and categories. Neither the production strain C. glutamicum NRRL B‐50775 nor its recombinant DNA was detected in the final product. Therefore, the product does not pose any safety concern associated with the genetic modification of the production strain. l‐Lysine HCl and concentrated liquid l‐lysine (base) produced by C. glutamicum NRRL B‐50775 are considered safe for the target species, for the consumer and for the environment. l‐Lysine HCl produced by C. glutamicum NRRL B‐50775 is considered not irritant to skin or eyes and not a skin sensitiser. In the absence of data, the FEEDAP Panel cannot conclude on the potential toxicity by inhalation of l‐lysine HCl produced by C. glutamicum NRRL B‐50775. Concentrated liquid l‐lysine (base) produced by C. glutamicum NRRL B‐50775, due to its high pH (11) it is anticipated to be corrosive to skin and eyes and poses a risk by inhalation. l‐Lysine HCl and concentrated liquid l‐lysine (base) produced by C. glutamicum NRRL B‐50775 are considered as efficacious sources of the essential amino acid l‐lysine for non‐ruminant animal species. For the supplemental l‐lysine to be as efficacious in ruminants as in non‐ruminant species, it would require protection against degradation in the rumen.

Abstract The food enzyme is an endo‐1,4‐β‐xylanase (EC 3.2.1.8) produced with a genetically modified strain of Aspergillus oryzae by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This xylanase is intended to be used in baking and cereal‐based processes. Based on the proposed maximum use levels, dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 0.027 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not raise a safety concern. Subchronic toxicity was assessed by means of a repeated dose 90‐day oral toxicity study in rats. In this study, effects were seen in the control group on reproductive parameters (particularly the seminiferous epithelium atrophy in the testes) at incidences that far exceeded the background range. Consequently, a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test, including haematological parameters and the immunology cohort, was conducted. The Panel identified a no observed adverse effect level at the highest dose tested of 1,101.3 mg TOS/kg bw per day. When compared with the dietary exposure, resulted in a sufficiently high margin of exposure (at least 40,000). Similarity of the amino acid sequence to those of known allergens was searched and no match was found. The Panel considered that under the intended conditions of use the risk for allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood is considered low. Based on the data provided, the Panel concluded that this food enzyme does not raise safety concerns under the intended conditions of use.

Abstract The food enzyme acetolactate decarboxylase (α‐acetolactate decarboxylase; EC 4.1.1.5) is produced with a genetically modified Bacillus licheniformis strain NZYM‐JB by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This acetolactate decarboxylase is intended to be used in distilled alcohol production and brewing processes. Residual amounts of total organic solids (TOS) are removed by distillation; consequently, dietary exposure was not calculated for distilled alcohol products. For other brewery products, based on the maximum use level recommended for the brewing processes and individual data from the EFSA Comprehensive European Food Consumption Database, dietary exposure to the food enzyme–TOS was estimated to be up to 0.003 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests with the food enzyme did not indicate a genotoxic 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 at the highest dose of 1,018 mg TOS/kg bw per day. When compared with the dietary exposure, this results in a sufficiently high margin of exposure (at least 300,000). The amino acid sequence of the food enzyme did not match to those of known allergens. The Panel considered that, under the intended condition of use, the risk of allergic sensitisation and elicitation reactions upon dietary exposure to this food enzyme cannot be excluded, but the likelihood is considered low. Based on the data provided, the Panel concluded that this food enzyme does not raise safety concerns under the intended conditions of use.

Abstract The food enzyme glucoamylase (glucan 1,4‐α‐glucosidase; EC 3.2.1.3) is produced with the genetically modified strain of Aspergillus niger by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This glucoamylase is intended to be used in brewing processes and in starch processing for glucose syrups production. Residual amounts of total organic solids (TOS) are removed by the purification steps applied during the production of glucose syrups, consequently dietary exposure was not calculated. For brewing processes, based on the proposed maximum use levels, dietary exposure to the food enzyme–TOS was estimated to be below 3.627 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not raise a safety concern. The systemic toxicity was assessed by means of a repeated dose 90‐day oral toxicity study in rodents. The Panel identified a no‐observed‐adverse‐effect level (NOAEL) at the highest dose of 1,360 mg TOS/kg bw per day. Similarity of the amino acid sequence to those of known allergens was searched and one match was found. The Panel considered that, under the intended condition of use, the risk of allergic sensitisation and elicitation reactions upon dietary exposure to this food enzyme cannot be excluded, but the likelihood of such reactions to occur is considered to be low. Based on the data provided, the removal of TOS during the production of glucose syrups and the derived margin of exposure for brewing processes, the Panel concluded that this food enzyme does not raise safety concerns under the intended conditions of use.

Abstract The food enzyme glucan 1,4‐α‐glucosidase (EC 3.2.1.3) is produced with the genetically modified Aspergillus niger strain NZYM‐BW by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. The glucan 1,4‐α‐glucosidase food enzyme is intended to be used in distilled alcohol production and starch processing for the production of glucose syrups. Residual amounts of total organic solids (TOS) are removed by distillation and by the purification steps applied during the production of glucose syrups (by > 99%). Consequently, dietary exposure was not calculated. Genotoxicity tests did not raise a safety concern. The systemic toxicity was assessed by means of a repeated dose 90‐day oral toxicity study in rodents. The Panel identified a no observed adverse effect level at the highest dose of 1,244 mg TOS/kg body weight (bw) per day. Similarity of the amino acid sequence to those of known allergens was searched and one match was found. The Panel considered that, under the intended condition of use, the risk of allergic sensitisation and elicitation reactions upon dietary exposure to this food enzyme cannot be excluded, but the likelihood of such reactions occurring is considered to be low. Based on the data provided and the removal of TOS during the intended food production processes, the Panel concluded that this food enzyme does not raise safety concerns under the intended conditions of use.

Abstract The product subject of this assessment is l‐threonine produced by fermentation with a genetically modified strain of Escherichia coli (CGMCC 7.232). It is intended to be used in feed and water for drinking for all animal species and categories. The production strain and its recombinant DNA were not detected in the additive. The product l‐threonine, manufactured by fermentation with E. coli CGMCC 7.232, does not raise any safety concern with regard to the genetic modification of the production strain. l‐Threonine produced using E. coli CGMCC 7.232 is considered safe for the target species. The FEEDAP Panel has concerns regarding the safety of the simultaneous administration of l‐threonine via water for drinking and feed. l‐Threonine produced using E. coli CGMCC 7.232 is safe for the consumer. In absence of data, the FEEDAP Panel cannot conclude on the potential of the additive to be irritant to skin and eyes or to be a skin sensitiser. There is a risk from the inhalation exposure to endotoxins for persons handling the additive. l‐Threonine produced using E. coli CGMCC 7.232 is safe for the environment. The product under assessment is considered an efficacious source of the amino acid l‐threonine for all animal species. For l‐threonine to be as efficacious in ruminants as in non‐ruminant species, it requires protection against degradation in the rumen.

Abstract The food enzyme alpha‐amylase (4‐α‐d‐glucan glucanohydrolase; EC 3.2.1.1) is produced with the genetically modified strain of Aspergillus niger by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This α‐amylase is intended to be used in starch processing for glucose syrups production, beverage alcohol (distilling) processes and baking processes. Residual amounts of total organic solids (TOS) are removed by distillation and by the purification steps applied during the production of glucose syrups, consequently dietary exposure was not calculated. For baking processes, based on the proposed maximum use levels, dietary exposure to the food enzyme–TOS was estimated to be up to 3.784 mg TOS/kg body weight per day in European populations. Genotoxicity tests did not raise a safety concern. The systemic toxicity was assessed by means of a repeated dose 90‐day oral toxicity study in rodents. The Panel identified a no observed adverse effect level (NOAEL) at the highest dose of 1,400 mg TOS/kg body weight (bw) per day. Similarity of the amino acid sequence to those of known allergens was searched and two matches were found. The Panel considered that, under the intended condition of use, the risk of allergic sensitisation and elicitation reactions upon dietary exposure to this food enzyme cannot be excluded, but the likelihood of such reactions to occur is considered to be low. Based on the data provided, the removal of TOS during the production of glucose syrups and the derived margin of exposure for baking processes, the Panel concluded that this food enzyme does not raise safety concerns under the intended conditions of use.

Abstract l‐Arginine is considered as a non‐essential amino acid for most adult mammalian species, but it is classified as essential for birds, fish, possibly reptiles and also for strict carnivores. l‐Arginine produced by fermentation with Escherichia coli NITE BP‐02186, genetically modified to enhance the production of l‐arginine, is intended to be used in feed and water for drinking for all animal species and categories. The product under assessment does not give rise to any safety concern with regard to the genetic modification of the production strain. Its use as a nutritional additive is safe for target species when supplemented to diets in appropriate amounts. The use of l‐arginine as a feed flavouring agent is unlikely to pose any concern. No risks are expected for the consumer from the use of the product under assessment as a feed additive. It is not irritant to skin or eyes, nor a skin sensitiser. Although the presence of endotoxin activity is of no concern, the available exposure and toxicological data indicate that the additive may pose a risk to users by inhalation. The use of this additive in animal nutrition does not pose a risk to the environment. The additive is an effective source of arginine for all species. l‐Arginine is considered efficacious when used as a flavouring compound in animal nutrition.

Abstract Fumonisin esterase produced from a genetically modified strain of Komagataella phaffi is intended to degrade fumonisin mycotoxins contaminants in feeds for pigs and poultry. The production strain and its recombinant genes are not present in the final product. The applicant selected 300 U/kg feed to represent a likely upper limit. This concentration showed to be safe for piglets, chickens and turkeys for fattening and laying hens; the additive is thus safe for those categories. This conclusion is extended to all pigs, chickens reared for laying and turkeys reared for breeding and extrapolated to all other poultry species for growing and laying and to minor porcine species. No evidence of mutagenicity or genotoxicity was detected and no evidence of toxicity from a repeated‐dose oral toxicity study; the residue assessment did not identify any concern. The use of the additive is, thus, considered safe for consumers. The additive is not toxic by inhalation and the respiratory exposure is likely to be low; however, a risk of sensitisation via the respiratory route cannot be excluded. The additive is non‐irritant to skin and eyes and is not considered a dermal sensitiser. No risks for the environment are expected following the use of the additive in feeds under the proposed condition of use. The additive has the capacity to degrade fumonisin contaminants in feed of marketable quality when used at the minimum recommended dose of 10 U/kg complete feed, as shown in studies with chickens for fattening, laying hens and weaned piglets. Since the mode of action of the additive can be reasonably assumed to be the same in animal species for which the application is made, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) considers the additive efficacious for all poultry and all pigs.

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 Hemicell® HT/HT‐L is an additive that presents endo‐1,4‐β‐mannanase produced by a genetically modified strain of Paenibacillus lentus. This additive is aimed to be used as a feed additive for chickens for fattening/reared for laying, turkeys for fattening/reared for breeding, weaned piglets, pigs for fattening and minor poultry and porcine species. In a previous assessment, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) established the safety of the additive regarding the production strain, target species, consumer and user. However, limitations on the data regarding the absence of the production strain and its DNA did not permit to conclude on the safety of the additive for the environment. In that assessment, the Panel considered that the additive has a potential to be efficacious in the target species with the exception of pigs for fattening and in minor porcine species. The applicant provided new data to address the limitations identified. New data provided allowed the FEEDAP Panel to conclude that production strain and its recombinant DNA are not detected in the intermediate product used to formulate the additive. Therefore, the Panel concluded that the additive does not pose any environmental safety concern. Regarding the efficacy in pigs for fattening, the applicant provided a new analysis of the trials previously assessed which allowed the Panel to conclude that the additive has a potential to improve the feed to gain ratio at 32,000 U/kg feed. No data was provided regarding the efficacy in minor porcine species. However, considering the data available in major porcine species and that the mode of action of enzymes is well‐known and can be reasonably be considered to be similar among porcine species the Panel extrapolated the conclusion drawn in pigs for fattening to minor porcine species for fattening.

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.

Draft Endorsed by the FEEDAP Panel * 18 May 2017 Submitted for public consultation 15 June 2017 End of public consultation 15 September 2017 Adopted by the FEEDAP Panel 21 February 2018 Implementation date 1 September 2018 * Sections 3.1 and 3.2 were also endorsed by the EFSA Panel on Genetically Modified Organisms (GMO), EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) and EFSA Panel on Food Additives and Nutrient Sources Added to Food (ANS) on 18 May (GMO) and 7 June (CEF and ANS) 2017. Abstract This guidance document is intended to assist the applicant in the preparation and the presentation of an application, as foreseen in Article 7.6 of Regulation (EC) No 1831/2003, for the authorisation of additives for use in animal nutrition. It specifically covers the characterisation of microorganisms used as feed additives or as production organisms.

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 Riboflavin (80%) is a feed additive produced by fermentation of a genetically modified Bacillus subtilis strain. In 2014, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) issued an opinion on the safety and efficacy of riboflavin (80%) based on a dossier supplied by the applicant. The Panel concluded that neither the production strain nor its recombinant DNA was detected in the final product, and therefore, the additive does not give rise to any safety concern with regard to the genetic modification of the production strain. The Community Reference Laboratory on Feed additives, in the context of an official control, reported on the presence of recombinant DNA in samples of the additive. The European Commission asked EFSA to deliver a new opinion on the safety of Vitamin B2 (80%) based on the new data, complementing the former one. The analysed samples contained DNA belonging to the production strain, including the genetic modification. Moreover, one of the samples contained viable cells from the production strain. Because the production strain carries antimicrobial resistance genes introduced by the genetic modification, the FEEDAP Panel considers that Riboflavin (80%) poses a risk for the spread of viable cells and DNA of a genetically modified strain‐harbouring genes coding for resistance to antimicrobials.

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 ENZY CARBOPLUS® is an additive available in liquid and solid forms that contains endo‐1,4‐beta‐xylanase and endo‐1,3(4)‐beta‐glucanase which are produced by two genetically modified strains of Komagataella pastoris. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the production strains are safe and the genetic modifications raise no safety concerns. The Panel also concluded that the additive is safe for the target species at the recommended dosages and that its use as a feed additive raises no concern for consumers. The additive in either form is not a skin or eye irritant nor a dermal sensitiser; however, it is considered as a potential respiratory sensitiser. The production strains and their recombinant DNA were not detectable in the additive; moreover, the active substances of the additive will be degraded/inactivated during passage through the digestive tract of animals or in the environment, consequently, the Panel concluded that the additive poses no concerns to the environment. The Panel concluded that the additive has a potential to be efficacious as a zootechnical additive in chickens for fattening at 4,000 LXU and 375 LGU per kg feed, in turkeys for fattening at 1,400 LXU and 120 LGU per kg feed, and in weaned piglets at 700 LXU and 60 LGU per kg feed. The Panel extended these conclusions to chickens reared for laying and turkeys reared for breeding at the corresponding doses. Since the mode of action of xylanase and glucanase can be reasonably assumed to be the same within avian or within porcine species, the Panel extrapolated the conclusions on the efficacy to all avian species up to the point of lay and to all porcine species. Owing to the lack of data, no conclusions could be drawn on the efficacy of the additive in laying hens.

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

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

Abstract This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids deals with the safety assessment of the recycling process Krones pellet (EU register number RECYC0149). The input to the process is washed and dried poly(ethylene terephthalate) (PET) flakes originating from collected post‐consumer PET containers and containing no more than 5% PET from non‐food consumer applications. In this technology, washed and dried PET flakes are extruded to pellets that are then crystallised and decontaminated in a reactor at high temperature under vacuum. Having examined the results of the challenge test provided, the Panel concluded that two steps, the extrusion (step 2) and the decontamination in the vacuum reactor (step 4), are the critical steps that determine the decontamination efficiency of the process. The operating parameters to control the performance of these critical steps are temperature, residence time and, for the vacuum reactor, also pressure. Under these conditions, it was demonstrated that the recycling process is able to ensure that the level of migration of potential unknown contaminants into food is below the conservatively modelled migration of 0.1 μg/kg food. Therefore, the Panel concluded that the recycled PET obtained from this process when used up to 100% for the manufacture of materials and articles for contact with all types of foodstuffs for long‐term storage at room temperature, with or without hotfill, is not considered of safety concern. Trays made of this recycled PET should not be used in microwave and conventional ovens.

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

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

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

Abstract Beltherm MP/ML is a feed additive that contains endo‐1,4‐beta‐xylanase to be used as a zootechnical additive in poultry species. The production strain of the xylanase is a genetically modified strain of Bacillus subtilis. This species is considered by EFSA to qualify for the qualified presumption of safety (QPS) approach to safety assessment. The strain was unequivocally identified and qualifications were met. The genetic modification along with the results on the investigations regarding the presence? of the production strain and its DNA in the product were evaluated by the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) and raised no safety concerns. The FEEDAP Panel also concluded that the additive is safe for chickens and turkeys for fattening, chickens reared for laying, turkeys reared for breeding, turkeys for breeding purposes and minor poultry species at 100 ADXU/kg feed with a wide margin of safety. The Panel also concluded that no toxicological concerns for the consumer would arise from the use of Beltherm as a feed additive. The additive is considered a potential respiratory sensitiser for users. The Panel concluded that the use of the product as a feed additive raises no safety concerns for the environment. The additive has the potential to improve the performance of chickens for fattening, chickens reared for laying and minor growing poultry species at the dose of 100 ADXU/kg feed. The Panel could not conclude on the efficacy of the product in turkeys for fattening or reared for breeding or in turkeys for breeding purposes.

Abstract This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety evaluation of the recycling process PEGRA‐V (EU register number RECYC0137), which is based on the Starlinger IV+® technology. The input of the process is hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes originating from collected post‐consumer PET containers, containing no more than 5% of PET from non‐food consumer applications. In this technology, washed PET flakes are dried and crystallised in a reactor, then extruded into pellets which are further crystallised in a second reactor. Crystallised pellets are then preheated in a third reactor and fed to the solid‐state polycondensation (SSP) reactor. Having examined the challenge test provided, the Panel concluded that the three steps, drying and crystallisation, extrusion and crystallisation and SSP are the critical steps that determine the decontamination efficiency of the process. The operating parameters that control their performance are well defined and they are the temperature, the gas flow and the residence time for the drying and crystallisation step, and the temperature, the pressure and the residence time for the extrusion and crystallisation step and the SSP step. Under these conditions, it was demonstrated that the recycling process is able to ensure that the level of migration of potential unknown contaminants into food is below a conservatively modelled migration of 0.1 μg/kg food. Therefore, the Panel concluded that the recycled PET obtained from this process intended to be used up to 100% for the manufacture of materials and articles for contact with all types of foodstuffs for long‐term storage at room temperature, with or without hotfill, is not considered of safety concern. Trays made of this recycled PET are not intended to be used, and should not to be used in microwave and conventional ovens.

Abstract The product subject of this assessment is l‐threonine produced by fermentation with a genetically modified strain of Escherichia coli (CGMCC 11473). It is intended to be used in feed and water for drinking for all animal species and categories. It was not possible to characterise the genetic modification with the information provided. Uncertainty remained on the possible presence of cells from the production strain and their recombinant DNA in the product. Therefore, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) could not conclude on the safety of the product l‐threonine, produced by fermentation with Escherichia coli CGMCC 11473 for the target species, consumers and the environment. The FEEDAP Panel has concerns on the safety of the simultaneous oral administration of threonine containing additives via water for drinking and feed. In the absence of data, the FEEDAP Panel cannot conclude on the potential of the additive to be an irritant for skin and eyes or to be a skin sensitiser. There is a risk from the exposure by inhalation to endotoxins for persons handling the additive. The product under assessment is considered an efficacious source of the amino acid l‐threonine for all animal species. For l‐threonine to be as efficacious in ruminants as in non‐ruminant species, it requires protection against degradation in the rumen.

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.