Browsing by Author "EFSA Panel on Food Contact Materials (FCM)"
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- Safety assessment of the process NGR LSP used to recycle post‐consumer PET into food contact materialsPublication . EFSA Panel on Food Contact Materials (FCM); Lambré, Claude; Crebelli, Riccardo; Silva, Maria de; 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; Comandella, Daniele; Lioupis, Alexandros; Lampi, EvgeniaThe EFSA Panel on Food Contact Materials (FCM) assessed the safety of the recycling process NGR LSP (EU register number RECYC328). 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 (step 2), melted in an extruder (step 3) and decontaminated during a melt‐state polycondensation step under high temperature and vacuum (step 4). In step 5, the material is granulated. Having examined the challenge test provided, the Panel concluded that the melt‐state polycondensation (step 4) is critical in determining the decontamination efficiency of the process. The operating parameters to control the performance of step 4 are the pressure, the temperature, the residence time and the characteristics of the reactor. 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.
- 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.