Percorrer por autor "da Silva, Maria"
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- Safety assessment of the process brtCOMBIPET used to recycle post‐consumer PET into food contact materialsPublication . EFSA FCM Panel (EFSA Panel on Food Contact Materials); Lambré, Claude; Crebelli, Riccardo; da Silva, Maria; Grob, Koni; Milana, Maria Rosaria; Pronk, Marja; Rivière, Gilles; Ščetar, Mario; Theodoridis, Georgios; Van Hoeck, Els; Waegeneers, Nadia; Dudler, Vincent; Papaspyrides, Constantine; Tavares Poças, Maria de Fátima; Lioupis, Alexandros; Tsochatzis, Emmanouil; Lampi, EvgeniaThe EFSA Panel on Food Contact Materials (FCM) assessed the safety of the recycling process brtCOMBIPET (EU register number RECYC338). The input is 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 (step 6), melted in an extruder (step 7) and pelletised, dried and crystallised (step 8). The pellets are then preheated, further crystallised, then decontaminated in a solid‐state polymerisation (SSP) reactor (step 9) and cooled down. Having examined the challenge tests provided, the Panel concluded that the extrusion, the preheating and the SSP are critical in determining the decontamination efficiency of the process. The operating parameters to control the performance are the temperature and the pressure for step 7 (extrusion) as well as the temperature, residence time and gas flow rate for step 9 (preheating and SSP). It was demonstrated that this recycling process ensures that the level of migration of potential unknown contaminants into food is below the conservatively modelled migration of 0.0481 or 0.0962 μg/kg food, depending on the molar mass of the contaminant substance. 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 or below, with or without hot‐fill. 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.
- Safety assessment of the process EREMA VACUNITE (EREMA Vacurema Basic and Polymetrix SSP V‐LeaN) used to recycle post‐consumer PET into food contact materialsPublication . EFSA FCM Panel (EFSA Panel on Food Contact Materials); Lambré, Claude; Crebelli, Riccardo; da Silva, Maria; Grob, Koni; Milana, Maria Rosaria; Pronk, Marja; Rivière, Gilles; Ščetar, Mario; Theodoridis, Georgios; Van Hoeck, Els; Waegeneers, Nadia; Dudler, Vincent; Papaspyrides, Constantine; Tavares Poças, Maria de Fátima; Sfika, Vasiliki; Tsochatzis, Emmanouil; Lampi, EvgeniaThe EFSA Panel on Food Contact Materials (FCM) assessed the safety of the recycling process EREMA VACUNITE (EREMA Vacurema Basic and Polymetrix SSP V‐LeaN) (EU register number RECYC332). The input is hot caustic/surfactant‐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 first decontaminated in a ■■■■■ flake reactor under ■■■■■ (step 2), then extruded, pelletised and ■■■■■ (step 3). The ■■■■■ pellets are ■■■■■ (step 4) and submitted to solid‐state polycondensation (SSP) in a ■■■■■ reactor at ■■■■■ under ■■■■■ and ■■■■■ (step 5). Having examined the challenge tests provided, the Panel concluded that steps 2 and 5 are critical for determining the decontamination efficiency of the process. The operating parameters to control the performance of steps 2 and 5 are temperature, pressure and residence time as well as ■■■■■ for step 5. It was demonstrated that this recycling process ensures that the level of migration of potential unknown contaminants into food is below the conservatively modelled migration of 0.0481 or 0.0962 μg/kg food, depending on the molar mass of a contaminant substance. 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 or below, with or without hot‐fill. 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.
- Safety assessment of the process EREMA Vacurema Basic used to recycle post‐consumer PET into food contact materialsPublication . EFSA FCM Panel (EFSA Panel on Food Contact Materials); Lambré, Claude; Crebelli, Riccardo; da Silva, Maria; Grob, Koni; Milana, Maria Rosaria; Pronk, Marja; Rivière, Gilles; Ščetar, Mario; Theodoridis, Georgios; Van Hoeck, Els; Waegeneers, Nadia; Dudler, Vincent; Papaspyrides, Constantine; Tavares Poças, Maria de Fátima; Marano, Remigio; Lampi, EvgeniaThe EFSA Panel on Food Contact Materials (FCM) assessed the safety of the recycling process EREMA Vacurema Basic (EU register number RECYC 336). The input is washed and dried poly(ethylene terephthalate) (PET) flakes mainly originating from collected post‐consumer PET containers, with below 5% PET from non‐food consumer applications. The flakes are heated in a continuous flake reactor (step 2) under vacuum before being extruded. Having examined the challenge test provided, the Panel concluded that step 2 is critical in determining the decontamination efficiency of the process. The operating parameters to control the efficiency are the temperature, the pressure (vacuum) and the residence time. It was demonstrated that this recycling process ensures that the level of migration of potential unknown contaminants into food is below the conservatively modelled migration of 0.0481 or 0.0962 μg/kg food, depending on the molar mass of the contaminant substance. 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, and used for long‐term storage at room temperature or below, with or without hot‐fill. 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.
- Safety assessment of the process Gneuss 5 used to recycle post‐consumer PET into food contact materialsPublication . EFSA FCM Panel (EFSA Panel on Food Contact Materials); Lambré, Claude; Crebelli, Riccardo; da Silva, Maria; Grob, Koni; Milana, Maria Rosaria; Pronk, Marja; Rivière, Gilles; Ščetar, Mario; Theodoridis, Georgios; Van Hoeck, Els; Waegeneers, Nadia; Dudler, Vincent; Papaspyrides, Constantine; Poças, Maria de Fátima Tavares; Comandella, Daniele; Lampi, EvgeniaThe EFSA Panel on Food Contact Materials (FCM) assessed the safety of the recycling process Gneuss 5. 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 melted in an extruder (step 2), decontaminated during a melt‐state polycondensation (MSP) ■■■■■ (step 3) and finally pelletised. Having examined the challenge test provided, the Panel concluded that MSP (step 3) is critical in determining the decontamination efficiency of the process. The operating parameters to control the efficiency of step 3 are the pressure, the temperature, the residence time as well as the geometrical and operational characteristics of the reactor. It was demonstrated by the challenge test that this recycling process ensures that the level of migration of potential unknown contaminants into food is below the conservatively modelled migration of 0.0481 or 0.0962 μg/kg food, depending on the molecular mass of a contaminant substance. 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 or below, with or without hot‐fill. 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.
- Safety assessment of the process Starlinger recoSTAR PET art used to recycle post‐consumer PET into food contact materialsPublication . EFSA FCM Panel (EFSA Panel on Food Contact Materials); Lambré, Claude; Crebelli, Riccardo; da Silva, Maria; Grob, Koni; Milana, Maria Rosaria; Pronk, Marja; Rivière, Gilles; Ščetar, Mario; Theodoridis, Georgios; Van Hoeck, Els; Waegeneers, Nadia; Dudler, Vincent; Papaspyrides, Constantine; Tavares Poças, Maria de Fátima; Marano, Remigio; Lampi, EvgeniaThe EFSA Panel on Food Contact Materials (FCM) assessed the safety of the recycling process Starlinger recoSTAR PET art (EU register number RECYC331). The input is hot 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 (step 2), melted in an extruder (step 3), crystallised (step 4) and treated in a solid‐state polycondensation (SSP) reactor under high temperature and vacuum (step 5). Having examined the challenge test provided, the Panel concluded that all the four steps are critical in determining the decontamination efficiency of the process; the SSP being the most relevant for decontamination. The operating parameters to control the efficiency are: the pressure, the temperature, the residence time and gas flow rate. It was demonstrated that this recycling process ensures that the level of migration of potential unknown contaminants into food is below the conservatively modelled migration of 0.0481 or 0.0962 μg/kg food, depending on the molar mass of a contaminant substance. 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 or below, with or without hot‐fill. 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.
- Safety assessment of the process Starlinger recoSTAR PET iV+ used to recycle post‐consumer PET into food contact materialsPublication . EFSA FCM Panel (EFSA Panel on Food Contact Materials); Lambré, Claude; Crebelli, Riccardo; da Silva, Maria; Grob, Koni; Milana, Maria Rosaria; Pronk, Marja; Rivière, Gilles; Ščetar, Mario; Theodoridis, Georgios; Van Hoeck, Els; Waegeneers, Nadia; Dudler, Vincent; Papaspyrides, Constantine; de Fátima Tavares Poças, Maria; Marano, Remigio; Lamp, EvgeniaThe EFSA Panel on Food Contact Materials (FCM) assessed the safety of the recycling process Starlinger recoSTAR PET iV+ (EU register number RECYC333). The input is hot 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 (step 2), melted in an extruder and crystallised (step 3) and treated in a solid‐state polycondensation (SSP) reactor under high temperature and vacuum (step 4). Having examined the challenge test provided, the Panel concluded that all three steps are critical in determining the decontamination efficiency of the process, the SSP being the most relevant for decontamination. The operating parameters to control the efficiency are the pressure, the temperature, the residence time and the gas flow rate. It was demonstrated that this recycling process ensures that the level of migration of potential unknown contaminants into food is below the conservatively modelled migration of 0.0481 or 0.0962 μg/kg food, depending on the molar mass of a contaminant substance. 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 or below, with or without hot‐fill. 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.
- Safety assessment of the substance N,N′‐(2‐(4‐(2‐aminobenzamido)butyl)pentane‐1,5‐diyl)bis(2‐aminobenzamide) for use in plastic food contact materialsPublication . EFSA FCM Panel (EFSA Panel on Food Contact Materials); Lambré, Claude; Crebelli, Riccardo; da Silva, Maria; Grob, Konrad; Lampi, Evgenia; Milana, Maria Rosaria; Pronk, Marja; Ščetar, Mario; Theodoridis, Georgios; Van Hoeck, Els; Waegeneers, Nadia; Cariou, Ronan; Castle, Laurence; Di Consiglio, Emma; Franz, Roland; Barthélémy, Eric; Marano, Remigio; Rivière, GillesThe EFSA Panel on Food Contact Materials assessed the safety of N,N′‐(2‐(4‐(2‐aminobenzamido)butyl)pentane‐1,5‐diyl)bis(2‐aminobenzamide) to be used at up to 650 mg/kg in polyethylene terephthalate (PET) to scavenge acetaldehyde (AA). Final articles are intended for contact with aqueous, acidic and low‐alcoholic beverages for long‐term storage at room temperature and below. The migration of the substance from PET bottles into 20% ethanol was 0.0038 mg/kg food. The Panel calculated the potential migration of the summed reaction products not to exceed 0.02 mg/kg food. From experimental studies, the Panel excluded genotoxicity concerns for the substance, for 2‐aminobenzamide +1 formaldehyde and 2‐aminobenzamide +1 AA, both with desaturation. In silico predictions, previous EFSA evaluations and the use of the threshold of toxicological concern (TTC) excluded genotoxicity concerns for 15 other impurities/reaction products. A tentatively identified by‐product was predicted as possible DNA‐reactive in vitro mutagen and clastogen, due to its aromatic hydroxylamine group. Its modelled migration would not exceed 0.14 μg/kg food, leading to a potential exposure below the TTC of 0.0025 μg/kg body weight per day. Non‐identified reaction products are expected to be structurally related to the identified ones and, hence, not to raise concern for genotoxicity. The Panel concluded that the substance is not of safety concern for the consumer, if it is used as an additive at up to 650 mg/kg in PET intended for contact with foods simulated by simulants A, B and C, for storage above 6 months at room temperature and below, including hot‐fill conditions and/or heating up to 70°C ≤ T ≤ 100°C for maximum t = 120/2((T−70)/10) minutes. The substance should not be used for infant formula (including water used for reconstitution) and human milk. The migration of the substance should not exceed 0.05 mg/kg food. The substance should not contain aromatic hydroxylamine derivatives at more than 0.15% w/w.
- Safety assessment of the substance phosphorus acid, triphenyl ester, polymer with alpha‐hydro‐omega‐hydroxypoly[oxy(methyl‐1,2‐ethanediyl)], C10‐16 alkyl esters, for use in food contact materialsPublication . EFSA FCM Panel (EFSA Panel on Food Contact Materials); Lambré, Claude; Crebelli, Riccardo; da Silva, Maria; Grob, Konrad; Lampi, Evgenia; Milana, Maria Rosaria; Pronk, Marja; Ščetar, Mario; Theodoridis, Georgios; Van Hoeck, Els; Waegeneers, Nadia; Cariou, Ronan; Castle, Laurence; Di Consiglio, Emma; Franz, Roland; Franz, Roland; Comandella, Daniele; Rivière, GillesThe EFSA Panel on Food Contact Materials (FCM) assessed the safety of phosphorus acid, triphenyl ester, polymer with alpha‐hydro‐omega‐hydroxypoly[oxy(methyl‐1,2‐ethanediyl)], C10‐16 alkyl esters, intended to be used as additive in acrylonitrile‐butadiene‐styrene copolymers (ABS) and high impact polystyrene (HIPS). The substance is a polymer with < 10% w/w low molecular weight fraction (< 1000 Da). The safety of its use in HIPS and ABS was already evaluated by the EFSA CEP Panel in 2019 and 2021, respectively. This opinion assesses the safety of the extension of the use to up to 0.25% w/w for ABS and to the contact with alcoholic and fatty food for HIPS. Migration tests were carried out with food simulants and samples containing the substance at the maximum intended levels. For ABS, the specific migration was below the limit of detection (LoD) of 0.005 mg/kg food (3% acetic acid and 10% ethanol) and up to 0.007 mg/kg food (20% and 50% ethanol). For HIPS, the specific migration was up to 0.020 mg/kg food (20% ethanol) and up to 0.039 mg/kg food (50% ethanol). The assessment of toxicological data was reported in the previous opinions and the corresponding conclusions are considered still valid. The FCM Panel concluded that the substance is not of safety concern for the consumer if its migration does not exceed 0.05 mg/kg food and it is used in ABS at up to 0.25% w/w in contact with aqueous, acidic, alcoholic and oil‐in‐water emulsion foods, and in HIPS at up to 0.2% w/w in contact with all types of food, in both materials for long term storage at room temperature and below, after hot‐fill and/or heating up to 100°C for up to 2 h. The use in contact with human milk and infant formula was excluded and hence was not addressed in this assessment.