Percorrer por autor "Grob, Konrad"
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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.
- Safety assessment of the process KREYENBORG IR Clean+ (universal) 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 João; Grob, Konrad; 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; Lampi, EvgeniaThe EFSA Panel on Food Contact Materials (FCM) assessed the safety of the recycling process KREYENBORG IR Clean+ (universal) (EU register number RECYC329). 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 heated in a continuous infrared (IR) dryer (step 2) before being processed in a finisher reactor (step 3). Having examined the challenge test provided, the Panel concluded that both steps are critical in determining the decontamination efficiency of the process. The operating parameters to control the efficiency of these critical steps are temperature, air/PET ratio and 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 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.
- Update of the safety assessment of N,N‐bis(2‐hydroxyethyl)alkyl(C8‐C18)amines (FCM No 19) and N,N‐bis(2‐hydroxyethyl)alkyl(C8‐C18)amine hydrochlorides (FCM No 20) for their use in plastic materials and articles intended to come into contact with foodPublication . EFSA Panel on Food Contact Materials (FCM); Lambré, Claude; Crebelli, Riccardo; Silva, Maria de; Grob, Konrad; Lampi, Evgenia; Milana, Maria Rosaria; Pronk, Marja; Ščetar, Mario; Theodoridis, Georgios; Van Hoeck, Els; Waegeneers, Nadia; Bolognesi, Claudia; Cariou, Ronan; Castle, Laurence; Di Consiglio, Emma; Franz, Roland; Wölfle, Detlef; Al Harraq, Zainab; Barthélémy, Eric; Comandella, Daniele; Vela, Julia Fontán; Halamoda, Blanka; Rivière, GillesThe European Commission asked EFSA to review whether the authorisation of N,N‐bis(2‐hydroxyethyl)alkyl(C8‐C18)amine (FCM No 19) and N,N‐bis(2‐hydroxyethyl)alkyl(C8‐C18)amine hydrochlorides (FCM No 20) is still in accordance with Regulation (EC) No 1935/2004, as provided for in Article 12(3). The FCM Panel concluded that some uses of the substance N,N‐bis(2‐hydroxyethyl)alkyl(C8‐C18)amine (FCM No 19) are not in accordance with this Regulation, since the migration is likely to exceed the current SML(T) of 1.2 mg/kg food under certain conditions of use. Based on the provided data, the FCM Panel concluded that the FCM substance No 19, N,N‐bis(2‐hydroxyethyl)alkyl(C8‐C18)amine, is not of safety concern for the consumer if (i) the substance is used at up to 0.1% w/w as polymer production aid and as processing aid to manufacture polyolefin materials and articles of thickness up to 1 mm that are intended for contact with all types of food except infant foods. This exception for infant foods and the restriction for maximum thickness do not apply to caps of bottles; (ii) the migration does not exceed 5 mg/kg food; (iii) the source of the alkyl group is either from hydrogenated vegetable oil or synthetic from ethylene oligomers with a high degree of linear structure and (iv) the impurities do not exceed 5% w/w. As they bear unsaturation, PFAEO‐coco, PFAEO‐oleyl, PFAEO‐HT, PFAEO‐T and PFAO‐C18 do not fall within the scope of the FCM substance No 19. The information related to these substances was only considered supportive for FCM substance No 19. If they were intended to be used to manufacture FCMs, a proper application following the EFSA Guidance documents should be submitted. No uses of the FCM substance No 20, N,N‐bis(2‐hydroxyethyl)alkyl(C8‐C18)amine hydrochlorides, were claimed and no information was provided to support that the current authorisation is in accordance with the Regulation (EC) No 1935/2004.
- Update of the safety assessment of N,N‐bis(2‐hydroxyethyl)alkyl(C8‐C18)amines (FCM No 19) and N,N‐bis(2‐hydroxyethyl)alkyl(C8‐C18)amine hydrochlorides (FCM No 20) for their use in plastic materials and articles intended to come into contact with foodPublication . EFSA Panel on Food Contact Materials (FCM); Lambré, Claude; Crebelli, Riccardo; Silva, Maria Joao; Grob, Konrad; Lampi, Evgenia; Milana, Maria Rosaria; Pronk, Marja; Ščetar, Mario; Theodoridis, Georgios; Van Hoeck, Els; Waegeneers, Nadia; Bolognesi, Claudia; Cariou, Ronan; Castle, Laurence; Di Consiglio, Emma; Franz, Roland; Wölfle, Detlef; Al Harraq, Zainab; Barthélémy, Eric; Comandella, Daniele; Fontán-Vela, Julia; Halamoda, Blanka; Rivière, GillesThe European Commission asked EFSA to review whether the authorisation of N,N‐bis(2‐hydroxyethyl)alkyl(C8‐C18)amine (FCM No 19) and N,N‐bis(2‐hydroxyethyl)alkyl(C8‐C18)amine hydrochlorides (FCM No 20) is still in accordance with Regulation (EC) No 1935/2004, as provided for in Article 12(3). The FCM Panel concluded that some uses of the substance N,N‐bis(2‐hydroxyethyl)alkyl(C8‐C18)amine (FCM No 19) are not in accordance with this Regulation, since the migration is likely to exceed the current SML(T) of 1.2 mg/kg food under certain conditions of use. Based on the provided data, the FCM Panel concluded that the FCM substance No 19, N,N‐bis(2‐hydroxyethyl)alkyl(C8‐C18)amine, is not of safety concern for the consumer if (i) the substance is used at up to 0.1% w/w as polymer production aid and as processing aid to manufacture polyolefin materials and articles of thickness up to 1 mm that are intended for contact with all types of food except infant foods. This exception for infant foods and the restriction for maximum thickness do not apply to caps of bottles; (ii) the migration does not exceed 5 mg/kg food; (iii) the source of the alkyl group is either from hydrogenated vegetable oil or synthetic from ethylene oligomers with a high degree of linear structure and (iv) the impurities do not exceed 5% w/w. As they bear unsaturation, PFAEO‐coco, PFAEO‐oleyl, PFAEO‐HT, PFAEO‐T and PFAO‐C18 do not fall within the scope of the FCM substance No 19. The information related to these substances was only considered supportive for FCM substance No 19. If they were intended to be used to manufacture FCMs, a proper application following the EFSA Guidance documents should be submitted. No uses of the FCM substance No 20, N,N‐bis(2‐hydroxyethyl)alkyl(C8‐C18)amine hydrochlorides, were claimed and no information was provided to support that the current authorisation is in accordance with the Regulation (EC) No 1935/2004.