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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 ‘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 active substance polyacrylic acid, sodium salt, cross-linked, for use in active food contact materialsPublication . EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP); Poças, Maria de Fátima TavaresThe 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.
- Safety assessment of the process ‘RecyPET Hungária’, based on RecyPET Hungária technology, used to recycle post-consumer PET into food contact materialsPublication . EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP); Poças, Maria de Fátima TavaresThe 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.
- Safety assessment of the process ‘Jász-Plasztik’, based on vacurema prime technology, used to recycle post-consumer PET into food contact materialsPublication . EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (EFSA CEP Panel); Poças, Maria de Fátima TavaresThe 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.
- Safety assessment of the process poly recycling, based on starlinger iV+ technology, used to recycle post-consumer PET into food contact materialsPublication . EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP); Poças, Maria de Fátima TavaresThe 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.
- 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 assessment of the process quinn packaging, based on erema basic technology, used to recycle post-consumer PET into food contact materialsPublication . EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP); Poças, Maria de Fátima TavaresThe 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.
- Assessment of baby Bibs. GC-MS screening, migration into saliva and insight of toxicity with QSAR toolsPublication . Rajbux, Chandisree; Pereira, Joel; Selbourne, Maria do Céu; Costa-Pinto, Ana Rita; Poças, FátimaPlastic baby Bibs are, according to the European legislation, food contact materials. Therefore, compositional and migration limits applicable to plastics should be observed. This work aimed at identifying potential migrants in Bibs from European market and determining the migration into artificial saliva. Bibs were subjected to screening analyses (GC-MS). Thirty substances non-authorised in European or Swiss legislation were detected: phthalates, light stabilizers, flame retardants and photoinitiators. Irgacure 184, Cyclohexanone, Tinuvin 770, Isophorone and 9-Octadecenamide, (Z)- were detected in saliva after contact with selected Bibs. The migration values render two samples noncompliant although results should be interpreted with caution given the experimental conditions. In order to gain insight on the toxicity of migrants, QSAR tools were applied. Substances non-evaluated or not-listed were analysed with free software regarding their Cramer class (ToxTree and their predicted mutagenicity, carcinogenicity and developmental toxicity (VEGA). Results indicate that surveillance is required: monitoring Bibs'compliance, application of GMPs and traceability.
- 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.