Safety assessment of the process texplast, based on starlinger iV+ technology, used to recycle post-consumer PET into food contact materials

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of the recycling process Texplast (EU register number RECYC170). The input is hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes 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 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 drying and crystallisation (step 2), extrusion and crystallisation (step 3) and SSP (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, gas flow and residence time for the drying and crystallisation step; temperature, pressure and residence time for the extrusion and crystallisation step as well as for 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 for long-term storage at room temperature, with or without hotfill. Articles made of this recycled PET are not intended to be used in microwave and conventional ovens and such use is not covered by this evaluation.info:eu-repo/semantics/publishedVersio

Safety assessment of the substance Ln 1,4-benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials

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

Safety assessment of the process ‘RecyPET Hungária’, based on RecyPET Hungária technology, used to recycle post-consumer PET into food contact materials

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of the recycling process RecyPET Hungária (EU register number RECYC0146). The input 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 applications. The flakes are dried and extruded. The output of the extrusion step is cut into pellets in an underwater chamber and then recrystallised. The crystallised pellets may then be fed into a solid-state polycondensation (SSP) reactor. The recycled plastic is intended for manufacture of bottles for soft drinks or water. The applicant provided a challenge test, but the flakes contaminated with the surrogates and the pellets obtained after extrusion and crystallisation were extracted with n-hexane without showing sufficient recovery. The Panel considered the extraction as unreliable and could therefore not conclude on the efficiency of the decontamination process. Furthermore, the flow charts provided by the applicant did not enable a clear identification of the steps relevant for the decontamination efficiency, and no sufficiently clear overview of the operational parameters of the steps of the process and the challenge test was provided. Without this information, a proper safety evaluation could not be performed. The Panel concluded that the process RecyPET Hungária is not sufficiently characterised and the applicant has not demonstrated in an adequately performed challenge test or by other appropriate evidence that the recycling process RecyPET Hungária is able to reduce contamination of the PET input to a concentration that does not pose a risk to human health.info:eu-repo/semantics/publishedVersio

Safety assessment of the active substance polyacrylic acid, sodium salt, cross-linked, for use in active food contact materials

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

Safety assessment of the process quinn packaging, based on erema basic technology, used to recycle post-consumer PET into food contact materials

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of the recycling process Quinn Packaging (EU register number RECYC172). The input is hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes originating from collected post-consumer PET containers, with no more than 5% PET from non-food consumer applications. They are heated in a continuous reactor under vacuum before being extruded. Having examined the challenge test provided, the Panel concluded that the continuous reactor step (step 2) is the critical step that determines the decontamination efficiency of the process. The operating parameters to control the performance of this critical step are temperature, pressure and residence time. 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 0.15 μg/kg food, derived from the exposure scenario for toddlers. Therefore, the Panel concluded that the recycled PET obtained from this process is not of safety concern when the final thermoformed trays and containers manufactured with the recycled sheets and not used for packaging water contain up to 100% recycled post-consumer PET. Trays made of this recycled PET are not intended to be used in microwave and conventional ovens and such use is not covered by this evaluation.info:eu-repo/semantics/publishedVersio

Safety evaluation of food enzyme xylanase from a genetically modified Bacillus subtilis (strain LMG S-27588)

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.info:eu-repo/semantics/publishedVersio

Safety assessment of the process poly recycling, based on starlinger iV+ technology, used to recycle post-consumer PET into food contact materials

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of the recycling process Poly Recycling (EU register number RECYC171). The input is hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes 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 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 drying and crystallisation (step 2), extrusion and crystallisation (step 3) and SSP (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, gas flow and residence time for the drying and crystallisation step; temperature, pressure and residence time for the extrusion and crystallisation step as well as for 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 for long-term storage at room temperature, with or without hotfill. Trays made of this recycled PET are not intended to be used in microwave and conventional ovens and such use is not covered by this evaluation.info:eu-repo/semantics/publishedVersio

Safety evaluation of the food enzyme glucose oxidase from a genetically modified Aspergillus oryzae (strain NZYM-KP)

The food enzyme is a glucose oxidase (beta-d-glucose:oxygen 1-oxidoreductase; EC 1.1.3.4) produced with a genetically modified strain of Aspergillus oryzae strain NZYM-KP by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme does not contain the production organism or DNA; therefore, there is no safety concern for the environment. The glucose oxidase 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 0.156 mg TOS/kg body weight (bw) per day in European populations. The food enzyme did not induce gene mutations in bacteria or chromosome 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 was derived (341 mg TOS/kg bw per day), which compared with the estimated 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 and one match with a fungal contact allergen was found. The Panel considered that, under the intended condition of use, the risk of allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood is considered low. Based on the microbial source, the genetic modifications, the manufacturing process, the compositional and biochemical data, the estimated dietary exposure and the findings in the toxicological studies, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.info:eu-repo/semantics/publishedVersio

Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM-SM)

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.info:eu-repo/semantics/publishedVersio

Safety evaluation of the food enzyme endo-1,4-β-xylanase from a genetically modified Aspergillus niger (strain XEA)

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.info:eu-repo/semantics/publishedVersio