SIV(SM)/HIV-2 Vpx proteins promote retroviral escape from a proteasome-dependent restriction pathway present in human dendritic cells

BACKGROUND: Vpx is a non-structural protein coded by members of the SIV(SM)/HIV-2 lineage that is believed to have originated by duplication of the common vpr gene present in primate lentiviruses. Vpx is incorporated into virion particles and is thus present during the early steps of viral infection, where it is thought to drive nuclear import of viral nucleoprotein complexes. We have previously shown that Vpx is required for SIV(MAC)-derived lentiviral vectors (LVs) infection of human monocyte-derived dendritic cells (DCs). However, since the requirement for Vpx is specific for DCs and not for other non-dividing cell types, this suggests that Vpx may play a role other than nuclear import. RESULTS: Here, we show that the function of Vpx in the infection of DCs is conserved exclusively within the SIV(SM)/HIV-2 lineage. At a molecular level, Vpx acts by promoting the accumulation of full length viral DNA. Furthermore, when supplied in target cells prior to infection, Vpx exerts a similar effect following infection of DCs with retroviruses as divergent as primate and feline lentiviruses and gammaretroviruses. Lastly, the effect of Vpx overlaps with that of the proteasome inhibitor MG132 in DCs. CONCLUSION: Overall, our results support the notion that Vpx modifies the intracellular milieu of target DCs to facilitate lentiviral infection. The data suggest that this is achieved by promoting viral escape from a proteasome-dependent pathway especially detrimental to viral infection in DCs

Safety assessment of the process DY Polymer, based on PET direct iV+ 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 DY Polymer (EU register number RECYC197), which uses the Starlinger PET direct iV+ technology. The input is hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes mainly originating from collected post-consumer PET containers, with no more than 5% PET from non-food consumer applications. The flakes are extruded to pellets, which are then crystallised, preheated and treated in a solid-state polycondensation (SSP) reactor. Having examined the challenge test provided, the Panel concluded that the three steps, extrusion, crystallisation and SSP, are critical in determining the decontamination efficiency of the process. The operating parameters to control the performance of these critical steps are temperature, gas flow, pressure and residence time. The challenge test 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 ¿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 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.... (2021). Safety assessment of the process DY Polymer, based on PET direct iV+ technology, used to recycle post-consumer PET into food contact materials. EFSA Journal. 19(8):1-13. https://doi.org/10.2903/j.efsa.2021.6797S11319

Safety assessment of the process Marmara PET Levha, based on Starlinger deCON 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 Marmara PET Levha (EU register number RECYC222), which uses the Starlinger deCON technology. The input material is hot washed and dried poly(ethylene terephthalate) (PET) flakes originating from collected post-consumer PET containers, e.g. bottles, including no more than 5% PET from non-food consumer applications. The flakes are preheated before being submitted to solid-state polycondensation (SSP) in a continuous reactor at high temperature under vacuum and. Having examined the challenge test provided, the Panel concluded that the preheating (step 2) and the decontamination in the SSP reactor (step 3) are critical in determining the decontamination efficiency of the process. The operating parameters to control the performance of these critical steps are temperature, pressure, residence time and. It was demonstrated that this recycling process is able to ensure a level of migration of potential unknown contaminants into food below the conservatively modelled migration of 0.1 lg/kg food. Therefore, the Panel concluded that the recycled PET obtained from this process is not considered to be of safety concern, when used at up to 100% for the manufacture of materials and articles for contact with all types of foodstuffs for long-term storage at room temperature, with or without hotfill. The final articles made of this recycled PET are not intended to be used in microwave or conventional ovens and such uses are not covered by this evaluation. (C) 2021 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.Lambré, C.; Barat Baviera, JM.; Bolognesi, C.; Chesson, A.; Cocconcelli, PS.; Crebelli, R.; Gott, DM.... (2021). Safety assessment of the process Marmara PET Levha, based on Starlinger deCON technology, used to recycle post-consumer PET into food contact materials. EFSA Journal. 19(10):1-12. https://doi.org/10.2903/j.efsa.2021.6868S112191

Safety assessment of the process Omorika Recycling, based on PET direct iV+ 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 Omorika Recycling (EU register number RECYC224), which uses the Starlinger PET direct iV+ technology. The input is hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes mainly originating from collected post-consumer PET containers, with no more than 5% PET from non-food consumer applications. The flakes are extruded to pellets, which are then crystallised, preheated and treated in a solid-state polycondensation (SSP) reactor. Having examined the challenge test provided, the Panel concluded that the three steps, extrusion, crystallisation and SSP are critical in determining the decontamination efficiency of the process. The operating parameters to control the performance of these critical steps are temperature, gas flow, pressure and residence time. The challenge test 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 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. (C) 2021 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.Lambré, C.; Barat Baviera, JM.; Bolognesi, C.; Chesson, A.; Cocconcelli, PS.; Crebelli, R.; Gott, DM.... (2021). Safety assessment of the process Omorika Recycling, based on PET direct iV+ technology, used to recycle post-consumer PET into food contact materials. EFSA Journal. 19(10):1-13. https://doi.org/10.2903/j.efsa.2021.6872S113191

Updated safety evaluation of the food enzyme isoamylase from the Dyella sp. strain MU 1174

[EN] The food enzyme isoamylase (glycogen ¿-1,6-glucanohydrolase, EC 3.2.1.68) is produced with Dyella sp. strain MU 1174 by Hayashibara Co. Ltd. In a previous opinion, the Panel on Food Contact Materials, Enzymes and Processing Aids of EFSA could not conclude on the safety of this food enzyme due to uncertainties about the presence of a gene conferring resistance to antimicrobials in the genome of the production strain and its potential transfer to the food enzyme. New whole genome sequence data provided by the applicant showed that the production strain Dyella sp. MU 1174 does not contain antimicrobial resistance genes of concern. Based on the new data provided and the evaluation of the data previously submitted, the Panel concludes that this food enzyme does not give rise to safety concerns under the intended conditions of use.Lambre, C.; Barat Baviera, JM.; Bolognesi, C.; Cocconcelli, PS.; Crebelli, R.; Gott, DM.; Grob, K.... (2021). Updated safety evaluation of the food enzyme isoamylase from the Dyella sp. strain MU 1174. EFSA Journal. 19(10):1-7. https://doi.org/10.2903/j.efsa.2021.6871S17191

Safety evaluation of the food enzyme α-amylase from the genetically modified Bacillus licheniformis strain DP-Dzb52

[EN] The food enzyme alpha-amylase (1,4-alpha-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 alpha-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 alpha-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. (C) 2021 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.Claude Lambré; Barat Baviera, JM.; Claudia Bolognesi; Pier Sandro Cocconcelli; Riccardo Crebelli; David M Gott; Konrad Grob... (2021). Safety evaluation of the food enzyme α-amylase from the genetically modified Bacillus licheniformis strain DP-Dzb52. EFSA Journal. 19(4):1-17. https://doi.org/10.2903/j.efsa.2021.6564S11719

Safety assessment of the process Kunststof Recycling Nederland (KRN), used to recycle high density polyethylene box pallets 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 Kunststof Recycling Nederland (KRN) (EU register number RECYC251). The input consists of box pallets made of high-density polyethylene (HDPE) originating from a closed and controlled product loop for packaging of meat. Flakes are used to produce new box pallets for food contact. The Panel considered that the management system put in place to provide full traceability from the input to the final product and to ensure compliance of the origin of the input with Commission Regulation (EC) No 282/2008 is critical. According to the applicant, the input of the process KRN originates from a product loop which is in closed and controlled chain, 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 Panel concluded that the recycling process KRN is suitable to produce recycled HDPE box pallets intended to be used in contact with refrigerated or frozen, packed or unpacked meat.Lambré, C.; Barat Baviera, JM.; Bolognesi, C.; Chesson, A.; Cocconcelli, PS.; Crebelli, R.; Gott, DM.... (2022). Safety assessment of the process Kunststof Recycling Nederland (KRN), used to recycle high density polyethylene box pallets for use as food contact materials. EFSA Journal. 20(6):1-7. https://doi.org/10.2903/j.efsa.2022.73621720

Safety assessment of the process Viridor Waste Management, based on Starlinger iV+ 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 Viridor Waste Management (EU register number RECYC184), which uses the Starlinger iV+ technology. The input is hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes mainly originating from collected post-consumer PET containers, with no more than 5% PET from non-food consumer applications. The flakes are dried and crystallised in a first reactor, then extruded into pellets. These pellets are crystallised, preheated and treated in a solid-state polycondensation (SSP) reactor. Having examined the challenge test provided, the Panel concluded that the drying and crystallisation (step 2), extrusion and crystallisation (step 3) and SSP (step 4) are critical in determining the decontamination efficiency of the process. The operating parameters to control the performance of these critical steps are temperature, air flow and residence time for the drying and crystallisation step, and temperature, pressure and residence time for the extrusion and crystallisation step as well as the SSP step. It was demonstrated that this recycling process is able to ensure that the level of migration of potential unknown contaminants into food is below the conservatively modelled migration of 0.1 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 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. (C) 2021 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.Lambré, C.; Barat Baviera, JM.; Bolognesi, C.; Chesson, A.; Cocconcelli, PS.; Crebelli, R.; Gott, DM.... (2021). Safety assessment of the process Viridor Waste Management, based on Starlinger iV+ technology, used to recycle post-consumer PET into food contact materials. EFSA Journal. 19(8):1-13. https://doi.org/10.2903/j.efsa.2021.6788S11319

Safety assessment of the process Sulpet Plásticos, based on Starlinger deCON 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 Sulpet Plasticos (EU register number RECYC221), which uses the Starlinger deCON technology. The input material is hot washed and dried poly(ethylene terephthalate) (PET) flakes originating from collected post-consumer PET containers, e.g. bottles, including no more than 5% PET from non-food consumer applications. The flakes are preheated before being submitted to solid-state polycondensation (SSP) in a continuous reactor at high temperature under vacuum and. Having examined the challenge test provided, the Panel concluded that the preheating (step 2) and the decontamination in the SSP reactor (step 3) are critical in determining the decontamination efficiency of the process. The operating parameters to control the performance of these critical steps are temperature, pressure, residence time and. It was demonstrated that this recycling process is able to ensure a level of migration of potential unknown contaminants into food below the conservatively modelled migration of 0.1 lg/kg food. Therefore, the Panel concluded that the recycled PET obtained from this process is not considered to be of safety concern, when used at up to 100% for the manufacture of materials and articles for contact with all types of foodstuffs for long-term storage at room temperature, with or without hotfill. The final articles made of this recycled PET are not intended to be used in microwave or conventional ovens and such uses are not covered by this evaluation. (C) 2021 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.Lambré, C.; Barat Baviera, JM.; Bolognesi, C.; Chesson, A.; Cocconcelli, PS.; Crebelli, R.; Gott, DM.... (2021). Safety assessment of the process Sulpet Plásticos, based on Starlinger deCON technology, used to recycle post-consumer PET into food contact materials. EFSA Journal. 19(10):1-12. https://doi.org/10.2903/j.efsa.2021.6867S112191

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