Safety assessment of the process Bangladesh Petrochemical Company, based on the Vacurema Prime technology, used to recycle post-consumer PET into food contact materials

[EN] The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP Panel) assessed the safety of the recycling process Bangladesh Petrochemical Company (EU register number RECYC246), which uses the Vacurema Prime technology. The input material is hot caustic washed and dried poly (ethylene terephthalate) (PET) flakes originating from collected post-consumer PET containers, including no more than 5% PET from non-food applications. The flakes are heated in a batch reactor (step 2) and then heated in a continuous reactor (step 3) before being extruded into pellets. Having examined the challenge test provided, the Panel concluded that step 2 and step 3 are critical in determining the decontamination efficiency of the process. The operating parameters to control the performance of these steps are temperature, pressure and residence time. The Panel concluded 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 mu g/kg food. Therefore, 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. The final articles made of this recycled PET are not intended to be used in microwave and conventional ovens and such uses are not covered by this evaluation.Lambré, C.; Barat Baviera, JM.; Bolognesi, C.; Chesson, A.; Cocconcelli, PS.; Crebelli, R.; Gott, DM.... (2022). Safety assessment of the process Bangladesh Petrochemical Company, based on the Vacurema Prime technology, used to recycle post-consumer PET into food contact materials. EFSA Journal. 20(6):1-14. https://doi.org/10.2903/j.efsa.2022.736011420

Evaluation of the safety and efficacy of lactic acid to reduce microbiological surface contamination on carcases from kangaroos, wild pigs, goats and sheep

[EN] Studies evaluating the safety and efficacy of lactic acid to reduce microbiological surface contamination from carcases of wild game (i.e. kangaroos and wild pigs) and small stock (i.e. goats and sheep) before chilling at the slaughterhouse were assessed. Wild pig and kangaroo hide-on carcases may have been chilled before they arrive at the slaughterhouse and are treated after removal of the hides. Lactic acid solutions (2-5%) are applied to the carcases at temperatures of up to 55 degrees C by spraying or misting. The treatment lasts 6-7 s per carcass side. The Panel concluded that: [1] the treatment is of no safety concern, provided that the lactic acid complies with the European Union specifications for food additives; [2] based on the available evidence, it was not possible to conclude on the efficacy of spraying or misting lactic acid on kangaroo, wild pig, goats and sheep carcases; [3] treatment of the above-mentioned carcases with lactic acid may induce reduced susceptibility to the same substance, but this can be minimised; there is currently no evidence that prior exposure of food-borne pathogens to lactic acid leads to the occurrence of resistance levels that compromise antimicrobial therapy; and [4] the release of lactic acid is not of concern for the environment, assuming that wastewaters released by the slaughterhouses are treated on-site, if necessary, to counter the potentially low pH caused by lactic acid, in compliance with local rules.The CEP Panel wishes to thank the members of the Panel on Biological Hazards (BIOHAZ): Ana Allende, Avelino Alvarez-Ordonez, Marianne Chemaly, Robert Davies, Alessandra De Cesare, Lieve Herman, Friederike Hilbert, Konstantinos Koutsoumanis, Roland Lindqvist, Maarten Nauta, Giuseppe Ru, Marion Simmons and Elisabetta Suffredini for the preparatory work on this scientific opinion. In addition, the CEP Panel wishes to thank the following for the support provided to this scientific output: Nikolaos Giannoulis (EFSA trainee).Lambré, C.; Barat Baviera, JM.; Bolognesi, C.; Chesson, A.; Cocconcelli, PS.; Crebelli, R.; Gott, DM.... (2022). Evaluation of the safety and efficacy of lactic acid to reduce microbiological surface contamination on carcases from kangaroos, wild pigs, goats and sheep. EFSA Journal. 20(5):1-31. https://doi.org/10.2903/j.efsa.2022.726513120

Safety assessment of the process Cajas y Palets en una Economia Circular (CAPEC), used to recycle high-density polyethylene and polypropylene crates for use as food contact materials

[EN] The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of the recycling process Cajas y Palets en una Economia Circular (CAPEC) (EU register number RECYC242). The input consists of crates made of high-density polyethylene (HDPE) or polypropylene (PP) originating from closed and controlled product loops for the packaging of whole fruits and vegetables. Flakes or pellets are produced that will be used by manufacturers of 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 CAPEC originates from product loops which are in closed and controlled chains designed to ensure that only materials and articles that have been intended for food contact are used and that contamination can be ruled out when run under the conditions described by the applicant. The recycling process CAPEC is therefore suitable to produce recycled HDPE and PP crates intended to be used in contact with fruits and vegetables.Lambré, C.; Barat Baviera, JM.; Bolognesi, C.; Chesson, A.; Cocconcelli, PS.; Crebelli, R.; Gott, DM.... (2022). Safety assessment of the process Cajas y Palets en una Economia Circular (CAPEC), used to recycle high-density polyethylene and polypropylene crates for use as food contact materials. EFSA Journal. 20(6):1-9. https://doi.org/10.2903/j.efsa.2022.73841920

Safety assessment of the process Enkador, based on the Vacurema Prime technology, used to recycle post-consumer PET into food contact materials

[EN] The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP Panel) assessed the safety of the recycling process Enkador (EU register number RECYC206), which uses the Vacurema Prime technology. The input material is hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes originating from collected post-consumer PET containers, including no more than 5% PET from non-food applications. The flakes are heated in a batch reactor (step 2) and then heated in a continuous reactor (step 3) before being extruded into pellets. Having examined the challenge test provided, the Panel concluded that step 2 and step 3 are critical in determining the decontamination efficiency of the process. The operating parameters to control the performance of these steps 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 0.1 lg/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. The final articles made of this recycled PET are not intended to be used in microwave and conventional ovens and such uses are not covered by this evaluation.The CEP Panel of EFSA wishes to thank the following for the support provided to this scientific output: Stavroula Sampani. The Panel wishes to acknowledge all European competent institutions, Member State bodies and other organisations that provided data for this scientific output.Lambré, C.; Barat Baviera, JM.; Bolognesi, C.; Chesson, A.; Cocconcelli, PS.; Crebelli, R.; Gott, DM.... (2022). Safety assessment of the process Enkador, based on the Vacurema Prime technology, used to recycle post-consumer PET into food contact materials. EFSA Journal. 20(3):1-13. https://doi.org/10.2903/j.efsa.2022.718811320

Safety evaluation of the food enzyme beta-galactosidase from the non-genetically modified Aspergillus sp. strain GD-FAL

[EN] The food enzyme beta-galactosidase (EC 3.2.1.23) is produced with the non-genetically modified Aspergillus sp. strain GD-FAL by Godo Shusei Co., Ltd. The food enzyme is intended to be used in milk processing for the hydrolysis of lactose. The absence of viable cells of the production organism in the food enzyme was not demonstrated. Based on the assumption that all milk/dairy products are enzymatically treated, dietary exposure to the food enzyme-total organic solids (TOS) was estimated to be up to 0.301 mg TOS/kg body weight per day in European populations. The data provided did not allow concerns of genotoxicity of the food enzyme to be excluded. The systemic toxicity could not be assessed in the absence of an appropriate repeated dose 90-day oral toxicity study. Consequently, a margin of exposure was not calculated. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and no match was found. The Panel considered that, under the intended conditions of use, the risk of allergic reactions by dietary exposure cannot be excluded, but the likelihood for this to occur is low. Based on the remaining concerns on genotoxicity, the inadequacies of the 90-day repeated dose oral toxicity study in rats and the missing data regarding the absence of viable cells of the production strain in the food enzyme, the Panel could not conclude on the safety of this food enzyme.The Panel wishes to thank the following for the support provided to this scientific output: Davide Arcella, Erik Boinowitz, Daniele Cavanna and Giulio di Piazza. The Panel wishes to acknowledge all European competent institutions, Member State bodies and other organisations that provided data for this scientific output.Lambré, C.; Barat Baviera, JM.; Bolognesi, C.; Cocconcelli, PS.; Crebelli, R.; Gott, DM.; Grob, K.... (2022). Safety evaluation of the food enzyme beta-galactosidase from the non-genetically modified Aspergillus sp. strain GD-FAL. EFSA Journal. 20(12):1-16. https://doi.org/10.2903/j.efsa.2022.7677116201

Safety evaluation of the native and thermolabile forms of the food enzyme mucorpepsin from Rhizomucor miehei strain MMR 164

[EN] The food enzyme mucorpepsin (aspartic endopeptidase, EC 3.4.23.23) is produced with the non-genetically modified microorganism Rhizomucor miehei strain MMR 164 by Takabio. The enzyme is chemically modified to produce a thermolabile form. The food enzyme is free from viable cells of the production organism. It is intended to be used in milk processing for cheese production. The dietary exposure to the food enzyme-total organic solids (TOS) was estimated to be up to 0.98 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 rats. The Panel identified a no observed adverse effect level of 1,320 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 1,300. Similarity of the amino acid sequence of the food enzyme to those of known allergens was searched and five 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 is considered low except for individuals sensitised to mustard proteins, but this risk will not exceed that of mustard consumption. 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.The Panel wishes to thank the following for the support provided to this scientific output: Ana Gomes, Simone Lunardi, Ivana Nikodinoska.Lambré, C.; Barat Baviera, JM.; Bolognesi, C.; Cocconcelli, PS.; Crebelli, R.; Gott, DM.; Grob, K.... (2022). Safety evaluation of the native and thermolabile forms of the food enzyme mucorpepsin from Rhizomucor miehei strain MMR 164. EFSA Journal. 20(8):1-17. https://doi.org/10.2903/j.efsa.2022.745911720

Safety assessment of the process Société Générale de Recyclage (SGR), based on the VACUNITE (EREMA basic and Polymetrix SSP V-leaN) technology, used to recycle post-consumer PET into food contact materials

[EN] The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of the recycling process Societe Generale de Recyclage (SGR) (EU register number RECYC201), which uses the VACUNITE (EREMA basic and Polymetrix SSP V-leaN) technology. The input material is hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes mainly originating from collected post-consumer PET containers, including no more than 5% PET from non-food consumer applications. The flakes are heated in a continuous reactor under vacuum before being extruded and pelletised. The crystallised pellets are then preheated and 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 continuous reactor (step 3) and the SSP reactor (step 5) are critical in determining the decontamination efficiency of the process. The operating parameters to control the performance are temperature, pressure and residence time for steps 3 and 5 as well as velocity of inert gas for step 5. It was demonstrated that this recycling process is able to ensure that the level of migration of potential unknown contaminants into food is below the conservatively modelled migration of 0.1 mu g/kg food. Therefore, the Panel concluded that the recycled PET obtained from this process is not of safety concern, when used at up to 100% for the manufacture of materials and articles for contact with all types of foodstuffs, including drinking water, for long-term storage at room temperature, with or without hotfill. The final articles made of this recycled PET are not intended to be used in microwave and conventional ovens and such uses are not covered by this evaluation.Lambré, C.; Barat Baviera, JM.; Bolognesi, C.; Chesson, A.; Cocconcelli, PS.; Crebelli, R.; Gott, DM.... (2022). Safety assessment of the process Société Générale de Recyclage (SGR), based on the VACUNITE (EREMA basic and Polymetrix SSP V-leaN) technology, used to recycle post-consumer PET into food contact materials. EFSA Journal. 20(5):1-13. https://doi.org/10.2903/j.efsa.2022.727011320

Safety evaluation of the food enzyme glucan 1,4-alpha-glucosidase from the genetically modified Aspergillus niger strain NZYM-BE

[EN] The food enzyme glucan 1,4-alpha-glucosidase (4-alpha-D-glucan glucohydrolase EC 3.2.1.3) is produced with the genetically modified Aspergillus niger strain NZYM-BE by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme was free from viable cells of the production organism and its DNA. The food enzyme is intended to be used in six food manufacturing processes, namely starch processing for the production of glucose syrups and other starch hydrolysates, distilled alcohol production, brewing processes, baking processes, cereal-based processes, and fruit and vegetable processing for juice production. Since residual amounts of total organic solids (TOS) are removed by distillation and by the purification steps applied to produce glucose syrups, dietary exposure was not calculated for these two food processes. For the remaining four processes, dietary exposure to the food enzyme-TOS was estimated to be up to 7.7 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 rats. The Panel identified a no observed adverse effect level of 3,795 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, results in a margin of exposure above 490. Similarity of the amino acid sequence of the food enzyme to those of known allergens was searched for and one match found. The Panel considered that, under the intended conditions of use (other than distilled alcohol production) the risk of allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood for this 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.Lambré, C.; Barat Baviera, JM.; Bolognesi, C.; Cocconcelli, PS.; Crebelli, R.; Gott, DM.; Grob, K.... (2022). Safety evaluation of the food enzyme glucan 1,4-alpha-glucosidase from the genetically modified Aspergillus niger strain NZYM-BE. EFSA Journal. 20(6):1-17. https://doi.org/10.2903/j.efsa.2022.737411720

Safety evaluation of the food enzyme alpha-amylase from Cellulosimicrobium funkei strain AE-AMT

[EN] The food enzyme alpha-amylase (4-alpha-d-glucan glucanohydrolase; EC 3.2.1.1) is produced with the non-genetically modified Cellulosimicrobium funkei strain AE-AMT by Amano Enzyme Inc. The food enzyme is free from viable cells of the production organism. It is intended to be used in starch processing for maltotriose production. Since residual amounts of total organic solids (TOS) are removed by purification steps applied during starch processing, the estimation of a dietary exposure is considered unnecessary. 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 at the highest dose of 230 mg TOS/kg body weight (bw) per day. Similarity of the amino acid sequence of the food enzyme to those of known allergens was searched and nine matches were 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 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.Lambré, C.; Barat Baviera, JM.; Bolognesi, C.; Cocconcelli, PS.; Crebelli, R.; Gott, DM.; Grob, K.... (2022). Safety evaluation of the food enzyme alpha-amylase from Cellulosimicrobium funkei strain AE-AMT. EFSA Journal. 20(8):1-12. https://doi.org/10.2903/j.efsa.2022.746311220

Safety assessment of bleached cellulose pulp for use in plastic food contact materials

[EN] The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids assessed the safety of the substance bleached cellulose pulp, consisting of cellulose fibres (70-92%) and hemicellulose (8-30%) obtained from pine and spruce wood. The substance is intended to be used in polyethylene and polypropylene food contact materials. The final articles are intended to be used for all food types and for long-term storage at room temperature, with or without a short time at higher temperature, including hot-fill. Low-density polyethylene samples containing of the substance were subjected to a broad set of migration tests with food simulants and extraction tests with dichloromethane. The limits of detection ranged from (when specified). The Panel noted that they do not ensure the detection of genotoxic substances at a concentration leading to a human exposure above the Threshold of Toxicological Concern. Moreover, not all possibly migrating substances were identified or amenable to the analytical methods applied. No toxicological data were provided for the substance itself, as its migration into food is not expected. The safety of the potentially migrating substances of low molecular mass detected was addressed individually and was considered adequate. However, the Panel considered this approach insufficient owing to a substantial fraction of unidentified components. The Panel concluded that the information provided by the applicant does not allow the safety assessment of the substances below 1,000 Da from bleached cellulose pulp from pine and spruce wood used in plastic food contact materials potentially migrating into food. Therefore, the Panel could not conclude on the safety of the use of bleached cellulose pulp from pine and spruce wood as a plastic additive.The Panel wishes to acknowledge all European competent institutions, Member State bodies and other organisations that provided data for this scientific opinion.Lambré, C.; Barat Baviera, JM.; Bolognesi, C.; Chesson, A.; Cocconcelli, PS.; Crebelli, R.; Gott, DM.... (2022). Safety assessment of bleached cellulose pulp for use in plastic food contact materials. EFSA Journal. 20(3):1-9. https://doi.org/10.2903/j.efsa.2022.71711920