Percorrer por autor "Crebelli, Riccardo"
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- Re‐assessment of the risks to public health related to the genotoxicity of styrene present in plastic food contact materialsPublication . EFSA Panel on Food Contact Materials (FCM); Claude, Lambré; Crebelli, Riccardo; Silva, Maria Da; Grob, Konrad; Lampi, Evgenia; Milana, Maria Rosaria; Pronk, Marja; Ščetar, Mario; Theodoridis, Georgios; Van Hoeck, Els; Waegeneers, Nadia; Bolognesi, Claudia; Consiglio, Emma Di; Mengelers, Marcel; Al Harraq, Zainab; Pilar, Irene Muñoz; Rainieri, Sandra; Rivière, GillesThe EFSA Panel on Food Contact Materials (FCM) was requested by the European Commission to re‐evaluate the potential genotoxicity of styrene after oral exposure and its safety for use in plastic FCM with a specific migration limit (SML) of 40 μg/kg food. A rigorous assessment of the in vivo genotoxicity studies (i) provided by third parties, (ii) identified by a targeted literature search and (iii) reported in the 2019 IARC Monograph was performed. All studies were assessed for reliability and relevance and the results integrated in the weight of evidence. The results provided by reliable in vivo oral genotoxicity studies, covering different genetic endpoints and target tissues, including liver, the primary site of metabolism, demonstrated that the oral administration of styrene in mice and rats up to the maximum tolerated dose (300 and 500 mg/kg body weight (bw), respectively) did not induce genotoxic effects. The Panel concluded that there was no evidence that styrene is genotoxic following oral exposure. For substances demonstrated to be non‐genotoxic, according to the EFSA Note for Guidance for FCM, an SML up to 50 μg/kg food would not be of safety concern. Consequently, the use of styrene in the manufacture of FCM respecting the SML of 40 μg/kg food proposed by the European Commission is not of safety concern.
- Re‐evaluation of acesulfame K (E 950) as food additivePublication . EFSA Panel on Food Additives and Flavourings (FAF); Castle, Laurence; Andreassen, Monica; Aquilina, Gabriele; Bastos, Maria Lourdes; Boon, Polly; Fallico, Biagio; FitzGerald, Reginald; Frutos-Fernandez, Maria Jose; Grasl-Kraupp, Bettina; Gundert-Remy, Ursula; Gürtler, Rainer; Houdeau, Eric; Kurek, Marcin; Louro, Henriqueta; Morales, Patricia; Passamonti, Sabina; Batke, Monika; Bruzell, Ellen; Chipman, James; Cheyns, Karlien; Crebelli, Riccardo; Fortes, Cristina; Fürst, Peter; Halldorsson, Thorhallur; Leblanc, Jean-Charles; Mirat, Manuela; Lindtner, Oliver; Mortensen, Alicja; Barmaz, Stefania; Wright, Matthew; Civitella, Consuelo; Le Gall, Pauline; Mazzoli, Elena; Rasinger, Josef Daniel; Rincon, Ana; Tard, Alexandra; Lodi, FedericaThe present opinion deals with the re‐evaluation of acesulfame K (E 950) as a food additive. Acesulfame K (E 950) is the chemically manufactured compound 6‐methyl‐1,2,3‐oxathiazin‐4(3H)‐one‐2,2‐dioxide potassium salt. It is authorised for use in the European Union (EU) in accordance with Regulation (EC) No 1333/2008. The assessment involved a comprehensive review of existing authorisations, evaluations and new scientific data. Acesulfame K (E 950) was found to be stable under various conditions; at pH lower than 3 with increasing temperatures, it is degraded to a certain amount. Based on the available data, no safety concerns arise for genotoxicity of acesulfame K (E 950) and its degradation products. For the potential impurities, based on in silico data, a concern for genotoxicity was identified for 5‐chloro‐acesulfame; a maximum limit of 0.1 mg/kg, or alternatively, a request for appropriate genotoxicity data was recommended. Based on the synthesis of systematically appraised evidence of human and animal studies, the Panel concluded that there are no new studies suitable for identification of a reference point (RP) on adverse effects. Consequently, the Panel established an acceptable daily intake (ADI) of 15 mg/kg body weight (bw) per day based on the highest dose tested without adverse effects in a chronic toxicity and carcinogenicity study in rats; a study considered of moderate risk of bias and one of two key studies from the previous evaluations by the Scientific Committee on Food (SCF) and the Joint FAO/WHO Expert Committee on Food Additives (JECFA). This revised ADI replaces the ADI of 9 mg/kg bw per day established by the SCF. The Panel noted that the highest estimate of exposure to acesulfame K (E 950) was generally below the ADI in all population groups. The Panel recommended the European Commission to consider the revision of the EU specifications of acesulfame K (E 950).
- Re‐evaluation of neotame (E 961) as food additivePublication . EFSA Panel on Food Additives and Flavourings (FAF); Castle, Laurence; Andreassen, Monica; Aquilina, Gabriele; Bastos, Maria Lourdes; Boon, Polly; Fallico, Biagio; FitzGerald, Reginald; Frutos-Fernandez, Maria Jose; Grasl‐Kraupp, Bettina; Gundert‐Remy, Ursula; Gürtler, Rainer; Houdeau, Eric; Kurek, Marcin; Louro, Henriqueta; Morales, Patricia; Passamonti, Sabina; Batke, Monika; Bruzell, Ellen; Chipman, James; Crebelli, Riccardo; Fortes, Cristina; Fürst, Peter; Gaffet, Eric; Karlien, Cheyns; Halldorsson, Thorhallur; Leblanc, Jean‐Charles; Lindtner, Oliver; Loeschner, Katrin; Mast, Jan; Mirat, Manuela; Mortensen, Alicja; Undas, Anna; Wright, Matthew; Barmaz, Stefania; Civitella, Consuelo; Abrahantes, Jose Cortiñas; Le Gall, Pauline; Mazzoli, Elena; Mech, Agnieszka; Rasinger, Josef Daniel; Rincon, Ana; Riolo, Francesca; Smeraldi, Camilla; Tard, Alexandra; Zakidou, Panagiota; Lodi, FedericaThe present opinion deals with the re‐evaluation of neotame (E 961) as a food additive. Neotame is the chemically manufactured compound N‐[N‐(3,3‐dimethylbutyl)‐l‐α‐aspartyl]‐l‐phenylalanine 1‐methyl ester. The main impurity of neotame (E 961) is also a degradation product (de‐esterified form), N‐[N‐(3,3‐dimethylbutyl)‐l‐α‐aspartyl]‐l‐phenylalanine (NC‐00751) and the primary metabolite. No new data were received following the call for biological and toxicological data. A summary of the toxicological studies available in the EFSA opinion of 2007 is presented and studies gathered from the literature are summarised. Neotame is rapidly absorbed and pre‐systemically metabolised, systemic intact neotame is likely to be excreted in the urine with its metabolites. The potential aneugenic effects at the site of contact are not expected to occur; overall, there is no concern for genotoxicity of neotame (E 961) at the maximum permitted levels or reported use levels. A review of the other endpoints from the already available toxicological database did not indicate an adverse effect for neotame at the highest doses tested. The Panel established an acceptable daily intake (ADI) of 10 mg/kg bw per day for neotame based on the no observed adverse effect level (NOAEL) of 1000 mg/kg bw per day from a 52‐week chronic and 104‐week carcinogenicity studies in rats. This ADI replaces the ADI of 2 mg/kg bw per day established by EFSA in 2007. The resulting exposure to methanol and its metabolite formaldehyde from the use of neotame at the ADI of 10 mg/kg bw per day does not raise a concern. The dietary exposure estimates of neotame (E 961) for the different population groups of all exposure scenarios did not exceed the ADI. The Panel concluded that there is no safety concern for neotame (E 961) at the currently permitted and reported uses and use levels. The Panel recommended the European Commission to consider revising the EU specifications of neotame (E 961).
- Re‐evaluation of saccharin and its sodium, potassium and calcium salts (E 954) as food additivesPublication . Castle, Laurence; Andreassen, Monica; Aquilina, Gabriele; Bastos, Maria Lourdes; Boon, Polly; Fallico, Biagio; FitzGerald, Reginald; Frutos Fernandez, Maria Jose; Grasl‐Kraupp, Bettina; Gundert‐Remy, Ursula; Gürtler, Rainer; Houdeau, Eric; Kurek, Marcin; Louro, Henriqueta; Morales, Patricia; Passamonti, Sabina; Batke, Monika; Bruzell, Ellen; Chipman, James; Cheyns, Karlien; Crebelli, Riccardo; Fortes, Cristina; Fürst, Peter; Halldorsson, Thorhallur; LeBlanc, Jean‐Charles; Mirat, Manuela; Lindtner, Oliver; Mortensen, Alicja; Ntzani, Evangelia; Shah, Romina; Wallace, Heather; Wright, Matthew; Barmaz, Stefania; Civitella, Consuelo; Georgelova, Petra; Lodi, Federica; Mazzoli, Elena; Rasinger, Josef; Maria Rincon, Ana; Tard, Alexandra; Zakidou, Panagiota; Younes, Maged; EFSA Panel on Food Additives and Flavourings (FAF)This opinion deals with the re-evaluation of saccharin and its sodium, potassium and calcium salts (E 954) as food additives. Saccharin is the chemically manufactured compound 1,2-benzisothiazol-3(2H)-one-1,1-dioxide. Along with its sodium (Na), potassium (K) and calcium (Ca) salts, they are authorised as sweeteners (E 954). E 954 can be produced by two manufacturing methods i.e. Remsen-Fahlberg and Maumee. No analytical data on potential impurities were provided for products manufactured with the Maumee process; therefore, the Panel could only evaluate saccharins (E 954) manufactured with the Remsen-Fahlberg process. The Panel concluded that the newly available studies do not raise a concern for genotoxicity of E 954 and the saccharins impurities associated with the Remsen-Fahlberg manufacturing process. For the potential impurities associated with the Maumee process, a concern for genotoxicity was identified. The data set evaluated consisted of animals and human studies. The Panel considered appropriate to set a numerical acceptable daily intake (ADI) and considered the decrease in body weight in animal studies as the relevant endpoint for the derivation of a reference point. An ADI of 9 mg/kg body weight (bw) per day, expressed as free imide, was derived for saccharins (E 954). This ADI replaces the ADI of 5 mg /kg bw per day (expressed as sodium saccharin, corresponding to 3.8 mg /kg bw per day saccharin as free imide) established by the Scientific Committee on Food. The Panel considered the refined brand-loyal exposure assessment scenario the most appropriate exposure scenario for the risk assessment. The Panel noted that the P95 exposure estimates for chronic exposure to saccharins (E 954) were below the ADI. The Panel recommended the European Commission to consider the revision of the EU specifications of saccharin and its sodium, potassium and calcium salts (E 954).
- 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 Diamat SC used to recycle post‐consumer PET into food contact materialsPublication . EFSA FCM Panel (EFSA Panel on Food Contact Materials); Lambré, Claude; Crebelli, Riccardo; Silva, Maria da; 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; Lioupis, Alexandros; Lampi, EvgeniaThe EFSA Panel on Food Contact Materials (FCM) assessed the safety of the recycling process Diamat SC (EU register number RECYC334). 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 crystallised (step 2), dried (step 3) and extruded into sheets (step 4). Having examined the challenge test provided, the Panel concluded that the crystallisation, drying and extrusion steps (steps 2–4) are critical in determining the decontamination efficiency of the process. The operating parameters to control the efficiency of the process are the temperature and the residence time for all steps (steps 2–4), the air flow rate for step 3, the pressure and the characteristics of the extruder (step 4). 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 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 EREMA Vacurema Basic_Sheet used to recycle post‐consumer PET into food contact materialsPublication . EFSA Panel on Food Contact Materials (FCM); Lambré, Claude; Crebelli, Riccardo; Silva, Maria da; 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_Sheet (EU register number RECYC 337). 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 the 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 0.156 or 0.312 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 foodstuffs, excluding drinking water, reconstituted infant formula and human milk, 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.