Safety assessment of the process ‘Jász-Plasztik’, based on vacurema prime technology, used to recycle post-consumer PET into food contact materials

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP Panel) assessed the safety of the recycling process Jász-Plasztik (EU register number RECYC0157). The input are hot caustic 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 applications. They are heated in a batch reactor under vacuum and then heated in a continuous reactor under vacuum before being extruded into pellets. Having examined the results of the challenge test provided, the Panel concluded that the decontamination in the batch reactors (step 2) and in the continuous reactor (step 3) 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, 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 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 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

Re-evaluation of the risks to public health related to the presence of bisphenol A (BPA) in foodstuffs

Publisher Copyright: © 2023 European Food Safety Authority. EFSA Journal published by Wiley-VCH GmbH on behalf of European Food Safety Authority.In 2015, EFSA established a temporary tolerable daily intake (t-TDI) for BPA of 4 μg/kg body weight (bw) per day. In 2016, the European Commission mandated EFSA to re-evaluate the risks to public health from the presence of BPA in foodstuffs and to establish a tolerable daily intake (TDI). For this re-evaluation, a pre-established protocol was used that had undergone public consultation. The CEP Panel concluded that it is Unlikely to Very Unlikely that BPA presents a genotoxic hazard through a direct mechanism. Taking into consideration the evidence from animal data and support from human observational studies, the immune system was identified as most sensitive to BPA exposure. An effect on Th17 cells in mice was identified as the critical effect; these cells are pivotal in cellular immune mechanisms and involved in the development of inflammatory conditions, including autoimmunity and lung inflammation. A reference point (RP) of 8.2 ng/kg bw per day, expressed as human equivalent dose, was identified for the critical effect. Uncertainty analysis assessed a probability of 57–73% that the lowest estimated Benchmark Dose (BMD) for other health effects was below the RP based on Th17 cells. In view of this, the CEP Panel judged that an additional uncertainty factor (UF) of 2 was needed for establishing the TDI. Applying an overall UF of 50 to the RP, a TDI of 0.2 ng BPA/kg bw per day was established. Comparison of this TDI with the dietary exposure estimates from the 2015 EFSA opinion showed that both the mean and the 95th percentile dietary exposures in all age groups exceeded the TDI by two to three orders of magnitude. Even considering the uncertainty in the exposure assessment, the exceedance being so large, the CEP Panel concluded that there is a health concern from dietary BPA exposure.Peer reviewe

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 AMB, based on bandera technology, used to recycle post-consumer PET into food contact materials

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) evaluated the safety of the recycling process AMB (EU register number RECYC154). The input is washed and dried poly(ethylene terephthalate) (PET) flakes originating from collected post-consumer PET containers with no more than 5% PET from non-food applications. It is decontaminated in a reactor at high temperature under vacuum and extruded to sheets. Having examined the challenge test provided, the Panel concluded that two steps, the decontamination in the vacuum reactor (step 2) and the extrusion (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, residence time and pressure for step 2 and temperature, residence time, pressure and screw speed for step 3. 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 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. 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 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 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 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 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 β-galactosidase from the genetically modified Escherichia coli NCIMB 30325

Abstract The food enzyme is a β‐galactosidase (β‐D‐galactoside galactohydrolase; EC 3.2.1.23) produced with the genetically modified Escherichia coli strain NCIMB 30325 by Clasado Ingredients Ltd. The β‐galactosidase encoding gene is introduced into the recipient strain of E. coli using a self‐replicating plasmid which also contains a gene, which confers resistance to an antibiotic listed as a critically important antimicrobial. This gene was detected in the food enzyme. The absence of viable cells of the production strain in the food enzyme was not demonstrated. The food enzyme is intended to be used only for the production of a mixture of galacto‐oligosaccharides (GOS). 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. The Panel identified a no observed adverse effect level at the highest dose tested of 900 mg total organic solids (TOS)/kg body weight (bw) per day. 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. Given the risk associated with the presence of antibiotic resistance gene in the food enzyme and the lack of data showing the absence of viable cells, the Panel concludes that the use of β‐galactosidase produced with the genetically modified E. coli NCIMB 30325 cannot be considered safe