Browsing by Author "EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF)"
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- Safety assessment of the active substances carboxymethylcellulose, acetylated distarch phosphate, bentonite, boric acid and aluminium sulfate, for use in active food contact materialsPublication . EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF); Poças, Maria de Fátima TavaresThis 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.
- Safety assessment of the process ‘BTB PET DIRECT IV* +’, used to recycle post-consumer PET into food contact materialsPublication . EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF); Poças, Maria de Fátima TavaresThis 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.
- Safety assessment of the process ‘Gneuss 1’, based on Gneuss technology, used to recycle post-consumer PET into food contact materialsPublication . EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF); Poças, Maria de Fátima TavaresThis scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids deals with the safety evaluation of the recycling process Gneuss 1 (EU register No RECYC0143). The input is 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. They are extruded under vacuum into pellets or sheets. Having examined the challenge test provided, the Panel concluded that the decontamination in the extruder under vacuum degassing is the critical step for the decontamination efficiency of the process. The operating parameters to control its performance are well defined and are temperature, pressure, residence time, throughput rate, rotor speed and satellite screws speed. The operating parameters of this step are at least as severe as those obtained from the challenge test. It was demonstrated that this 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 recycled PET obtained from the process Gneuss 1 intended for the manufacture of articles made with up to 100% recycled post-consumer PET and intended for contact for long-term storage at room temperature with all types of foodstuffs 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.
- Safety assessment of the process ‘Gneuss 2’, based on Gneuss technology, used to recycle post-consumer PET into food contact materialsPublication . EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF); Poças, Maria de Fátima TavaresThis scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids deals with the safety evaluation of the recycling process Gneuss 2 (EU register No RECYC0144). The input is 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. They are extruded under vacuum into pellets or sheets. Having examined the challenge test provided, the Panel concluded that the decontamination in the extruder under vacuum degassing is the critical step for the decontamination efficiency of the process. The operating parameters to control its performance are well defined and are temperature, pressure, residence time, throughput rate, the rotor speed and the satellite screws speed. The operating parameters of this step are at least as severe as those obtained from the challenge test. It was demonstrated that this 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 recycled PET obtained from the process Gneuss 2 intended for the manufacture of articles made with up to 90% recycled post-consumer PET and intended for contact for long-term storage at room temperature with all types of foodstuffs 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.
- Safety assessment of the process ‘Linpac’, based on Linpac super clean technology, used to recycle post-consumer PET into food contact materialsPublication . EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF); Poças, Maria de Fátima TavaresThis scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety assessment of the Linpac recycling process (EU register number RECYC0148), which is based on the Linpac super clean technology. The input to this process is hot washed and dried poly(ethylene terephthalate) (PET) flakes originating from collected post-consumer PET containers, containing no more than 5% PET from non-food consumer applications. In this technology post-consumer washed and dried PET flakes are heated in continuous driers under gas flow before being extruded. Having examined the results of the challenge test provided, the Panel concluded that the decontamination in the driers (steps 2 and 3) are the critical steps that determine the decontamination efficiency of the process. The operating parameters controlling its performance are well defined and are residence time, ‘air flow per mass of flakes’ and temperature in the driers. It was demonstrated that, depending on the operating conditions, the recycling process under evaluation is able to ensure that the level of migration of potential unknown contaminants into food is below a conservatively modelled migration of 0.15 μg/kg food, derived from the exposure scenario for toddlers. The Panel concluded that recycled PET obtained from the process is not of safety concern when used at up to 100% to make articles intended for contact with all types of foodstuffs, except packaged water. These articles should be used at conditions covered by migration testing of 10 days at 20°C. The articles are not intended to be used, and should not be used, in microwave and conventional ovens.
- Safety evaluation of food enzyme xylanase from a genetically modified Bacillus subtilis (strain LMG S-27588)Publication . EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF); Poças, Maria de Fátima Tavares Tavares; Gomes, AnaThe 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.
- Safety evaluation of the food enzyme alpha-amylase from a genetically modified bacillus licheniformis (strain NZYM-AN)Publication . EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF); Poças, Maria de Fátima TavaresThe food enzyme is an α-amylase (4-α-d-glucan glucanohydrolase; EC 3.2.1.1) produced with a genetically modified Bacillus licheniformis strain NZYM-AN by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme does not contain the production organism or recombinant DNA; therefore, there is no safety concern for the environment. The α-amylase is intended to be used in starch processing for the production of glucose syrups 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 (by > 99%). Consequently, dietary exposure was not calculated. Genotoxicity tests with the food enzyme did not raise a safety concern. 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 microbial source, the genetic modifications, the manufacturing process, the compositional and biochemical data, the removal of TOS during the intended food production processes and the findings in the genotoxicity studies, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.
- Safety evaluation of the food enzyme aqualysin 1 from a genetically modified Bacillus subtilis (strain LMGS 25520)Publication . EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF); Poças, Maria de Fátima TavaresThe 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.
- Safety evaluation of the food enzyme endo-1,4-β-xylanase from a genetically modified Aspergillus niger (strain XEA)Publication . EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF); Poças, Maria de Fátima TavaresThe 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.
- Safety evaluation of the food enzyme glucose oxidase from a genetically modified Aspergillus oryzae (strain NZYM-KP)Publication . EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF); Poças, Maria de Fátima TavaresThe 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.