A simple chromatographic method was developed for the simultaneous determination of butyland octyltin compounds in two aqueous-based food simulants, water and 3% (w/v) acetic acid. The procedure is based on one-step derivatization/extraction with sodium tetraethylborate directly in the aqueous phase in the presence of 1 ml of 0.05% (w/v) tropolone in hexane. Derivatization parameters such as extraction solvent, pH, reaction time and amount of the reagent were optimized. The corresponding ethylated compounds were analysed by GC-MS using tripropyltin (TPrT) and diheptyltin (DHT) as internal standards for butyl-and octyltin compounds, respectively. This new method was validated and evaluated for linearity, trueness and precision in both simulants. The detection limits were in the range 1.9 (MBT) to 8.8 (TBT) µg l −1 (as organic-metallic cation) in both simulants. The stability of the organotin compounds under migration conditions (10 days at 40 • C) was also tested. The tested organotins presented no significant losses under the migration conditions. The developed method was applied to some PVC food packaging materials from the market. Few organotins were detected at levels near the limit of quantitation.
The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids ( CEP ) was requested by the European Commission to review the substances for which a Specific Migration Limit ( SML ) is not assigned in Regulation ( EU ) No 10/2011. These substances had been covered by the Generic SML of 60 mg/kg food, but with Regulation ( EU ) 2016/1416 it was removed, necessitating their re‐examination. EFSA was requested to identify those substances requiring an SML to ensure the authorisation is sufficiently protective to health, grouping them in high, medium and low priority to serve as the basis for future re‐evaluations of individual substances. The CEP Panel established a stepwise procedure. This took into account existing hazard assessments for each substance on carcinogenicity/mutagenicity/reprotoxicity ( CMR ), bioaccumulation and endocrine disruptor ( ED ) properties along with the use of in silico generated predictions on genotoxicity. Molecular weights and boiling points were considered with regard to their effect on potential consumer exposure. This prioritisation procedure was applied to a total of 451 substances, from which 78 substances were eliminated at the outset, as they had previously been evaluated by EFSA as food contact substances. For 89 substances, the Panel concluded that a migration limit should not be needed. These are in the lists 0 and 1 of the Scientific Committee for Food ( SCF ), defined as substances for which an Acceptable Daily Intake ( ADI ) does not need to be established, along with substances that are controlled by existing restrictions and/or generic limits. Of the remaining 284 substances, 179 were placed into the low priority group, 102 were placed into the medium priority group and 3 were placed into the high priority group, i.e. salicylic acid ( FCM No 121), styrene ( FCM No 193) and lauric acid, vinyl ester ( FCM No 436).
The 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 lg/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.
The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of the recycling process RE‐PET (EU register number RECYC178) which uses the EREMA Basic technology. The input material is hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes originating from collected post‐consumer PET containers including no more than 5% PET from non‐food consumer applications. The flakes are heated in a continuous reactor under vacuum before being extruded. The Panel concluded that the continuous reactor (step 2, for which a challenge test was provided) is critical in determining the decontamination efficiency of the process. The operating parameters to control the performance of this step are temperature, pressure and residence time. It was demonstrated that this recycling process is able to ensure a level of migration of potential unknown contaminants into food below the conservatively modelled migration of 0.1 μg/kg food derived from the exposure scenario for infants when such recycled PET is used at up to 70% in mixtures with virgin PET and of 0.15 μg/kg food derived from the exposure scenario for toddlers when used at up to 100%. Therefore, the Panel concluded that the recycled PET obtained from this process is not of safety concern when used at up to 70% in mixtures with virgin PET for manufacturing bottles for drinking water and at up to 100% for the manufacture of other materials and articles for contact with all types of foodstuffs, for long‐term storage at room temperature, with or without hotfill. 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.
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