Scientific Guidance on the criteria for the evaluation and on the preparation of applications for the safety assessment of post-consumer mechanical PET recycling processes intended to be used for manufacture of materials and articles in contact with food.

In the context of entry into force of Regulation (EU) 2022/1616, EFSA updated the scientific guidance to assist applicants in the preparation of applications for the authorisation or for the modification of an existing authorisation of a 'post-consumer mechanical PET' recycling process (as defined in Annex I of Regulation (EU) 2022/1616) intended to be used for manufacturing materials and articles intended to come into contact with food. This Guidance describes the evaluation criteria and the scientific evaluation approach that EFSA will apply to assess the decontamination capability of recycling processes, as well as the information required to be included in an application dossier. The principle of the scientific evaluation approach is to apply the decontamination efficiency of a recycling process, obtained from a challenge test with surrogate contaminants, to a reference contamination level for post-consumer PET, set at 3 mg/kg PET for a contaminant resulting from possible misuse. The resulting residual concentration of each surrogate in recycled PET is then compared to a modelled concentration in PET that is calculated using generally recognised conservative migration models, such that the related migration does not give rise to a dietary exposure exceeding 0.0025 µg/kg body weight (bw) per day. This is the lowest threshold for toxicological concern (TTC) value, i.e. for potential genotoxicity, below which the risk to human health would be negligible. The information to be provided in the applications relates to: the recycling process (i.e. collection and pre-processing of the input, decontamination process, post-processing and intended use); the determination of the decontamination efficiency by the challenge test; the self-evaluation of the recycling process. On the basis of the submitted data, EFSA will assess the safety of the mechanical PET recycling process.

Safety assessment of the process Lietpak, based on the EREMA MPR technology, used to recycle post-consumer PET into food contact materials.

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of the recycling process Lietpak (EU register number RECYC319), which uses the EREMA MPR 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 ■■■■■ under vacuum (step 2). Having examined the challenge test provided, the Panel concluded that this step 2, for which the 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 0.15 µg/kg food, derived from the exposure scenario for toddlers, when such recycled PET is used at up to 100%. Therefore, the Panel concluded that the recycled PET obtained from this process is not considered to be of safety concern when used at up to 100% for the manufacture of materials and articles for contact with all types of foodstuffs, except 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 or conventional ovens and such uses are not covered by this evaluation.

Safety assessment of the process CeltiPak, based on the Kreyenborg IR Clean+ technology, used to recycle post-consumer PET into food contact materials.

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of the recycling process CeltiPak (EU register number RECYC318), which uses the Kreyenborg IR Clean+ technology. The input material is hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes originating from collected post-consumer PET containers, for example, bottles, with no more than 5% PET from non-food consumer applications. The flakes are heated in a continuous IR dryer (step 2) before being processed in a finisher reactor (step 3). Having examined the challenge test provided, the Panel concluded that step 2 and step 3 are critical in determining the decontamination efficiency of the process. The operating parameters to control the performance of these critical steps are temperature, air/PET ratio 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 0.10 and 0.15 µg/kg food, derived from the exposure scenario for infants and toddlers, respectively, when such recycled PET is used at up to 100%. Therefore, the Panel concluded that the recycled PET obtained from this process is not considered to be 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 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.

Safety assessment of the process ENPLATER, based on the Kreyenborg IR clean+ technology, used to recycle post-consumer PET into food contact materials.

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of the recycling process ENPLATER (EU register number RECYC316), which uses the Kreyenborg IR Clean+ technology. The input material is hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes originating from collected post-consumer PET containers, e.g. bottles, with no more than 5% PET from non-food consumer applications. The flakes are heated in a continuous IR dryer (step 2) before being processed in a finisher reactor (step 3). Having examined the challenge test provided, the Panel concluded that step 2 and step 3 are critical in determining the decontamination efficiency of the process. The operating parameters to control the performance of these critical steps are temperature, air/PET ratio 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 0.10 and 0.15 µg/kg food, derived from the exposure scenario for infants and toddlers, respectively, when such recycled PET is used at up to 100%. Therefore, the Panel concluded that the recycled PET obtained from this process is not considered to be 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 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.

Safety assessment of the process GTX Hanex, based on the Kreyenborg IR Clean+ technology, used to recycle post-consumer PET into food contact materials.

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of the recycling process GTX Hanex (EU register number RECYC317), which uses the Kreyenborg IR Clean+ technology. The input material is hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes originating from collected post-consumer PET containers, e.g. bottles, with no more than 5% PET from non-food consumer applications. The flakes are heated in a continuous IR dryer (step 2) before being processed in a finisher reactor (step 3). Having examined the challenge test provided, the Panel concluded that step 2 and step 3 are critical in determining the decontamination efficiency of the process. The operating parameters to control the performance of these critical steps are temperature, air/PET ratio 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 0.10 and 0.15 µg/kg food, derived from the exposure scenario for infants and toddlers, respectively, when such recycled PET is used at up to 100%. Therefore, the Panel concluded that the recycled PET obtained from this process is not considered to be 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 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.

Safety assessment of the process ENVICCO, based on EREMA basic and Polymetrix SSP leaN technology, used to recycle post-consumer PET into food contact materials.

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of the recycling process ENVICCO (EU register number RECYC301), which uses the EREMA basic and Polymetrix SSP leaN technology. The input consists of 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 pre-decontaminated in the EREMA reactor at high temperature under vacuum (step 2) before being extruded, pelletised and crystallised (step 3). The crystallised pellets are then preheated (step 4) and submitted to solid-state polycondensation (SSP) (step 5) at ■■■■■ temperature and under nitrogen flow. Having examined the challenge tests provided, the Panel concluded that step 2 as well as steps 4 and 5 are critical for determining the decontamination efficiency of the process. The operating parameters to control the performance of these critical steps are temperature, pressure and residence time for step 2 and temperature, residence time and gas velocity for steps 4 and 5. 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 0.1 µg/kg food. 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 hotfill. The final 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 PT Veolia Indonesia, based on the Polymetrix technology, used to recycle post-consumer PET into food contact materials.

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of the recycling process PT Veolia Indonesia (EU register number RECYC289), which uses the Polymetrix technology. The input material is hot washed and dried poly(ethylene terephthalate) (PET) flakes originating from collected post-consumer PET containers, e.g. bottles, including no more than 5% PET from non-food consumer applications. The flakes are extruded to pellets, crystallised and subsequently decontaminated in a solid-state polycondensation (SSP) reactor under high temperature and gas flow. Having examined the challenge tests provided, the Panel concluded that the fourth step, the decontamination in the SSP reactor, is critical in determining the decontamination efficiency of the process. The operating parameters to control the performance of this critical step are temperature, gas velocity 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. Therefore, the Panel concluded that the recycled PET obtained from this process is not considered to be 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, with or without hotfill. The final articles made of this recycled PET are not intended to be used in microwave or conventional ovens and such uses are not covered by this evaluation.

Ultraviolet light and ultrasound as non-thermal treatments for the inactivation of microorganisms in fresh ready-to-eat foods.

The effects of two non thermal disinfection processes, Ultraviolet light (UV 254 nm) and Ultrasound (US) on the inactivation of bacteria and color in two freshly cut produces (lettuce and strawberry) were investigated. The main scope of this work was to study the efficacy of UV and US on the decontamination of inoculated lettuce and strawberries with a cocktail of four bacteria, Escherichia coli, Listeria innocua, Salmonella Enteritidis and Staphylococcus aureus. Treatment of lettuce with UV reduced significantly the population of E. coli, L. innocua, S. Enteritidis and S. aureus by 1.75, 1.27, 1.39 and 1.21 log CFU/g, respectively. Furthermore, more than a 2-log CFU/g reduction of E. coli and S. Enteritidis was achieved with US. In strawberries, UV treatment reduced bacteria only by 1-1.4 log CFU/g. The maximum reductions of microorganisms, observed in strawberries after treatment with US, were 3.04, 2.41, 5.52 and 6.12 log CFU/g for E. coli, S. aureus, S. Enteritidis and L. innocua, respectively. Treatment with UV and US, for time periods (up to 45 min) did not significantly (p>0.05) change the color of lettuce or strawberry. Treatment with UV and US reduced the numbers of selected inoculated bacteria on lettuce and strawberries, which could be good alternatives to other traditional and commonly used technologies such as chlorine and hydrogen peroxide solutions for fresh produce industry. These results suggest that UV and US might be promising, non-thermal and environmental friendly disinfection technologies for freshly cut produce.