SCIENTIFIC OPINION. EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) 2,3

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1 EFSA Journal 2015;13(2):4017 SCIENTIFIC OPINION Scientific Opinion on the safety evaluation of the following processes based on EREMA Advanced technology used to recycle post-consumer PET into food contact materials: Greentech, Alimpet and Polyrecycling 1 ABSTRACT EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) 2,3 European Food Safety Authority (EFSA), Parma, Italy This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety assessment of the recycling processes Greentech, Alimpet and Polyrecycling (EU register numbers RECYC112, RECYC114 and RECYC119, respectively), all of which are based on the same EREMA Advanced technology. The input to these processes is washed and dried polyethylene terephthalate (PET) flakes originating from collected post-consumer PET containers, mainly bottles, containing no more than 5 % PET from non-food consumer applications. In this technology, washed and dried PET flakes are heated successively in two continuous reactors before being extruded into pellets. Having examined the results of the challenge test provided, the Panel concluded that the continuous reactor step (step 3) is the critical step that determines the decontamination efficiency of these processes. The operating parameters which control the performance of this step are well defined and are temperature, pressure and residence time. It was demonstrated that the recycling processes under evaluation are able to ensure that the level of migration of potential unknown contaminants into food is below a conservatively modelled migration of 0.1 μg/kg food, derived from the exposure scenario for infants, and 0.15 μg/kg food, derived from the exposure scenario for toddlers. The Panel concluded that recycled PET obtained from these processes is not of safety concern when used to manufacture articles intended for food contact materials applications if it is produced in compliance with the conditions specified in the conclusion of this opinion. European Food Safety Authority, 2015 KEY WORDS food contact materials, plastic, polyethylene terephthalate (PET), recycling processes, EREMA Advanced, safety assessment 1 On request from the Ministry of Health, Romania, EFSA-Q , the Ministero della Salute, Italy, EFSA-Q , and the Bundesamt für Verbraucherschutz und Lebensmittelsicherheit, Germany, EFSA-Q , adopted on 27 January Panel members: Claudia Bolognesi, Laurence Castle, Jean-Pierre Cravedi, Karl-Heinz Engel, Paul Fowler, Roland Franz, Konrad Grob, Rainer Gürtler, Trine Husøy, Wim Mennes, Maria Rosaria Milana, André Penninks, Vittorio Silano, Andrew Smith, Maria de Fátima Tavares Poças, Christina Tlustos, Fidel Toldrá, Detlef Wölfle and Holger Zorn. One member of the Panel did not participate in the discussion because of potential conflicts of interest identified in accordance with the EFSA policy on declarations of interests. Correspondence: fip@efsa.europa.eu 3 Acknowledgement: The Panel wishes to thank the members of the Working Group on Recycling plastics: Laurence Castle, Vincent Dudler, Nathalie Gontard, Eugenia Lampi, Maria Rosaria Milana, Cristina Nerin, Constantine Papaspyrides and Maria de Fátima Tavares Poças for the preparatory work on this scientific opinion and EFSA staff: Joaquim Maia, for the support provided to this EFSA scientific output. Suggested citation: EFSA CEF Panel (EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids), Scientific Opinion on the safety evaluation of the following processes based on EREMA Advanced technology used to recycle post-consumer PET into food contact materials: Greentech, Alimpet and Polyrecycling. EFSA Journal 2015;13(2):4017, 19 pp. doi: /j.efsa Available online: European Food Safety Authority, 2015

2 SUMMARY According to Commission Regulation (EC) No 282/2008 of 27 March 2008 on recycled plastic materials intended to come into contact with foods, EFSA is requested to evaluate processes for recycling plastic waste. In this context, the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) evaluated the following processes: Greentech, Alimpet and Polyrecycling. The Ministry of Health, Romania, requested the evaluation of the recycling process Greentech. The dossier was submitted on behalf of the company Greentech S.A. This process has been allocated the European Union register number RECYC112. The Ministero della Salute, Italy, requested the evaluation of the recycling process Alimpet. The dossier was submitted on behalf of the company Alimpet S.R.L. This recycling process has been allocated the European Union register number RECYC114. The Bundesamt für Verbraucherschutz und Lebensmittelsicherheit, Germany, requested the evaluation of the recycling process Polyrecycling. The dossier was submitted on behalf of the company Polyrecycling GmbH. This recycling process has been allocated the European Union register number RECYC119. All three processes are deemed to recycle polyethylene terephthalate (PET) materials from PET collected through post-consumer collection systems. According to the applicants, the recycled PET obtained from these processes is intended to be used up to 100 % in the manufacture of (i) bottles intended for contact with all types of foodstuffs and (ii) thermoformed trays and containers intended for contact with all types of foodstuffs except packaged water. All of these materials are intended for long-term storage at room temperature, with or without hotfill. These processes have been grouped into a single opinion as they use the same EREMA Advanced technology and their decontamination efficiencies were evaluated on the basis of the same challenge test. The processes comprise four steps. First, the post-consumer collected PET containers are processed into hot caustic-washed and dried PET flakes, which are used as the input for the EREMA Advanced decontamination technology. Dried flakes are heated in a continuous reactor (step 2) at high temperature and under vacuum, and then heated in a second continuous reactor at a higher temperature under vacuum (step 3) before being extruded (step 4). Detailed specifications for the input materials are provided for each of the submitted recycling processes and the proportion of non-food containers is reported to be below 5 % for each of them. Challenge test was conducted with surrogate contaminants in an industrial-scale plant in step 3 (continuous reactor) of the processes to measure their decontamination efficiencies. Since a mixture of flakes not contaminated with surrogates (white) and flakes spiked with surrogates (green) was used for this challenge test, the Panel calculated the decontamination efficiencies by taking into account the amount possibly transferred to the white flakes as a result of cross-contamination during the challenge test. Step 3 was considered by the Panel to be the critical step for the removal of possible contaminants and should, therefore, be kept under control to guarantee the decontamination performance of these processes. The decontamination efficiencies obtained for each surrogate contaminant from the challenge test, at the different residence times studied, ranging from 92.4 % to 99.2 %, have been used to calculate the residual concentrations of potential unknown contaminants in PET (Cres), in accordance with the evaluation procedure described in the scientific opinion on the criteria to be used for safety evaluation of a mechanical recycling process to produce recycled PET intended to be used for manufacture of materials and articles in contact with food (EFSA CEF Panel, 2011). According to these evaluation principles, the Cres should not be higher than a modelled concentration of contaminants in PET (Cmod) corresponding to a migration, after one year at 25 C, which cannot give EFSA Journal 2015;13(2):4017 2

3 rise to a dietary exposure exceeding μg/kg body weight (bw)/day, the exposure threshold below which the risk to human health would be negligible. For processes that produce PET intended for use in the manufacture of bottles, the default exposure scenario for infants has been applied as a worst case. A maximum dietary exposure of μg/kg bw/day corresponds to a maximum migration of 0.1 μg/kg of a contaminant substance into an infant s food, as calculated by conservative migration modelling. For processes that produce PET intended to be used in the manufacture of trays and containers not used to package water (since water could be used to prepare infant formula), the exposure scenario for toddlers has been applied as a worst case, where a maximum dietary exposure of μg/kg bw/day corresponds to a maximum migration of 0.15 μg/kg of the contaminant into a toddler s food. Therefore, the corresponding migration values of 0.1 μg/kg (scenario for infants) and 0.15 μg/kg (scenario for toddlers) into food have been used to calculate the Cmod. If the pellets produced by a recycling process are used up to 100 % to produce new articles and they do not meet these targets, recycled pellets should be mixed with virgin PET to make sure that the Cres will not be higher than the Cmod. This has been done for the different residence times requested by each applicant. The Panel established the maximum percentages of recycled PET in final articles for which the risk to human health is demonstrated to be negligible. These percentages differed in some cases from the initial request from the applicants. The Panel considered that the processes are well characterised and that the main steps used to recycle PET flakes into decontaminated PET pellets have been identified. Having examined the results of the challenge test provided, the Panel concluded that decontamination in a continuous reactor with high temperature and under vacuum (step 3) is the critical step for the decontamination efficiency of the processes. The operating parameters which control the performance of this step are temperature, pressure and residence time. Therefore, the Panel considered that the recycling processes Greentech, Alimpet and Polyrecycling are able to reduce any foreseeable accidental contamination of the postconsumer food contact PET to a concentration that does not give rise to concern of a risk to human health if: they are operated under conditions that are at least as severe as those applied in the challenge test used to measure the decontamination efficiencies of the processes; the inputs for the processes are washed and dried post-consumer PET flakes originating from materials and articles that have been manufactured in accordance with the Community legislation on food contact materials and contain no more than 5 % PET from non-food consumer applications; the final bottles manufactured from the recycled pellets contain up to 70 % recycled postconsumer PET if produced by Polyrecycling, and up to 100 % recycled post-consumer PET if produced by Alimpet or Greentech; the final thermoformed trays and containers manufactured from the recycled pellets and not used for packaging water contain up to 100 % recycled post-consumer PET if produced by Greentech, Alimpet or Polyrecycling. Therefore, the Panel concluded that the recycled PET obtained from the processes Greentech, Alimpet and Polyrecycling, intended to be used for the manufacture of bottles for contact with all types of foodstuffs and for the manufacture of thermoformed trays and containers for contact with all types of foodstuffs except packaged water, is not considered of safety concern when final articles are manufactured with no more than the percentage of recycled post-consumer PET specified above. The trays are not intended to be used in microwaves or ovens. The Panel recommended that it should be verified periodically, as part of good manufacturing practice, that, as foreseen in Regulation (EC) No 282/2008, Article 4b, the input must originate from plastic materials and articles that have been manufactured in accordance with Community legislation on plastic food contact materials and articles, and that the proportion of PET from non-food consumer EFSA Journal 2015;13(2):4017 3

4 applications in the input to be recycled is no more than 5 %. Critical steps should be monitored and kept under control; supporting documentation describing how it will be ensured that the critical steps are operated under conditions at least as severe as those applied in the challenge test used to measure the decontamination efficiencies of the processes should be available. EFSA Journal 2015;13(2):4017 4

5 TABLE OF CONTENTS Abstract... 1 Summary Introduction Background and Terms of Reference as provided by the legislation Assessment Introduction General information Description of the process General description Characterisation of the input EREMA Advanced technology Description of the main steps Decontamination efficiency of the recycling processes Discussion Conclusions Recommendations Documentation provided to EFSA References Appendices Appendix A. Technical data for the washed flakes as provided by the applicants Appendix B. Relationship between the key parameters for the evaluation scheme (EFSA CEF Panel, 2011) Abbreviations EFSA Journal 2015;13(2):4017 5

6 1. Introduction 1.1. Background and Terms of Reference as provided by the legislation Recycled plastic materials and articles shall only be placed on the market if they contain recycled plastic obtained from an authorised recycling process. Before a recycling process is authorised, EFSA s opinion on its safety is required. This procedure has been established in Article 5 of the Regulation (EC) No 282/ of the Commission of 27 March 2008 on recycled plastic materials intended to come into contact with foods and Articles 8 and 9 of the Regulation (EC) No 1935/ of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food. According to this procedure, the industry submits applications to the Member States competent Authorities which transmit the applications to EFSA for evaluation. Each application is supported by a technical dossier submitted by the industry following the EFSA guidelines for the submission of an application for safety evaluation by the EFSA of a recycling process to produce recycled plastics intended to be used for manufacture of materials and articles in contact with food, prior to its authorization (EFSA, 2008). In this case, EFSA received the following applications for evaluation of PET recycling processes which were grouped in this opinion as they use the same EREMA Advanced technology and their decontamination efficiency was evaluated on the basis of the same challenge test: A. Greentech, EU register number RECYC112, from the Ministry of Health, Romania, B. Alimpet, EU register number RECYC114, from the Ministero della Salute, Italy, C. Polyrecycling, EU register number RECYC119, from the Bundesamt für Verbraucherschutz und Lebensmittelsicherheit, Germany. EFSA is required by Article 5 of Regulation (EC) No 282/2008 of the Commission of 27 March 2008 on recycled plastic materials intended to come into contact with foods to carry out risk assessments on the risks originating from the migration of substances from recycled food contact plastic materials and articles into food and deliver a scientific opinion on the recycling processes examined. According to Article 4 of Regulation (EC) No 282/2008, EFSA will evaluate whether it has been demonstrated in a challenge test, or by other appropriate scientific evidence that the recycling processes Greentech, Alimpet and Polyrecycling are able to reduce any contamination of the plastic input to a concentration that does not pose a risk to human health. The PET materials and articles used as input of the processes as well as the conditions of use of the recycled PET make part of this evaluation. 2. Assessment 2.1. Introduction The European Food Safety Authority was asked to evaluate the safety of recycling processes as follows: 4 Regulation (EC) No 282/2008 of the European Parliament and of the Council of 27 March 2008 on recycled plastic materials and articles intended to come into contact with foods and amending Regulation (EC) No 2023/2006. OJ L 86, , p Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC. OJ L 338, , p EFSA Journal 2015;13(2):4017 6

7 The Ministry of Health, Romania, requested that EFSA evaluate the safety of the recycling process Greentech with the EU register number RECYC112. The request was registered in the EFSA s register of questions under the number EFSA-Q The dossier was submitted on behalf of Greentech S.A., Romania. The Ministero della Salute, Italy, requested that EFSA evaluate the safety of the recycling process Alimpet with the EU register number RECYC114. The request was registered in the EFSA s register of questions under the number EFSA-Q The dossier was submitted on behalf of Alimpet S.R.L., Italy. The Bundesamt für Verbraucherschutz und Lebensmittelsicherheit, Germany, requested that EFSA evaluate the safety of the recycling process Polyrecycling with the EU register number RECY119. The request was registered in the EFSA s register of questions under the number EFSA-Q The dossier was submitted on behalf of Polyrecycling GmbH, Switzerland. The dossiers submitted for evaluation followed the EFSA guidelines for the submission of an application for safety evaluation by EFSA of a recycling process to produce recycled plastics intended to be used for manufacture of materials and articles in contact with food, prior to its authorisation (EFSA, 2008) General information According to the applicants, the recycling processes (Greentech, Alimpet and Polyrecycling) are intended to recycle post-consumer polyethylene terephthalate (PET) articles to produce recycled PET pellets using EREMA Advanced technology. Depending on the recycling processes and operating parameters, the recycled pellets are intended to be used up to 100 % in the manufacture of final materials and articles intended to be used in direct contact with all kinds of foodstuffs for long-term storage at room temperature, with or without hotfill Description of the process General description The recycling processes Greentech, Alimpet and Polyrecycling produce recycled PET pellets from PET bottles, coming from post-consumer collection systems (kerbside and deposit collection systems). The recycling processes comprise the four steps described below. Step 1: input In step 1, post-consumer PET containers are ground and processed into washed and dried flakes, which are used as the input for the next steps. The washed flakes used for the recycling process are produced in-house for Alimpet and Greentech, and in-house or by a third party for Polyrecycling. Steps 2, 3 and 4: decontamination and production of recycled PET material In step 2, the flakes are treated in a continuous reactor at high temperature and under vacuum. In step 3, after the first reactor, the flakes are decontaminated in a second continuous reactor at a higher temperature and under vacuum. In step 4, the decontaminated flakes from the previous step are extruded at high temperature and under vacuum to produce pellets. EFSA Journal 2015;13(2):4017 7

8 Recycled pellets, the final product of the processes, are checked against technical requirements on intrinsic viscosity, colour, black spots, etc. According to the applicants, recycled pellets are intended to be converted by other companies into recycled articles used for long-term storage at room temperature, with or without hotfill conditions, such as bottles for mineral water, soft drinks, juices and beer. The recycled pellets may also be used for sheets which are thermoformed to make food trays. The trays are not intended to be used in microwaves or ovens. The operating conditions of the processes have been provided to EFSA Characterisation of the input According to the applicants, the input for the recycling processes Greentech, Alimpet and Polyrecycling are hot caustic-washed flakes obtained from PET bottles previously used for food packaging, obtained from post-consumer collection systems (kerbside and deposit collection systems). However, a small fraction may originate from non-food applications such as soap bottles, mouth wash bottles, kitchen cleaning product bottles, etc. According to the applicants, the fraction of non-food containers depends on the re-collection system. On the basis of European market share data, the applicants estimated this fraction to be below 5 %. Technical data for the hot caustic-washed and dried flakes are provided for each of the submitted recycling processes, such as information on the residual content of poly(vinyl chloride) (PVC), glue, polyolefins, cellulose, metals, polyamides and physical properties (see Appendix A) EREMA Advanced technology Description of the main steps The PET recycling processes Greentech, Alimpet and Polyrecycling use EREMA Advanced technology, which is described below and for which the general scheme provided by the applicants is reported in Figure 1. Hot caustic-washed and dried flakes from step 1 are used as the input for subsequent steps, which are: Pre-decontamination in a continuous reactor (step 2): In this step, the flakes are introduced into a continuous reactor with a bottom-mounted rotating mixing device in which a high temperature and vacuum are applied for a predefined residence time. Decontamination in a continuous reactor (step 3): The flakes from the previous reactor are fed into another continuous reactor running under higher temperature and vacuum for a pre-defined residence time. These process conditions favour the vaporisation of possible contaminants and the crystallisation of PET flakes. There are significant differences, which characterise the different processes, in the residence times reactors used in step 3. Re-extrusion of the decontaminated flakes (step 4): The flakes continuously coming from the previous reactor are melted in the extruder under vacuum through a double venting zone. In all of the recycling processes, residual solid particles (e.g. paper, aluminium, etc.) are filtered out of the extruded plastic before the final pellets are produced. EFSA Journal 2015;13(2):4017 8

9 Figure 1: General scheme of EREMA Advanced technology The processes are operated under defined operating parameters of temperature, pressure and residence time Decontamination efficiency of the recycling processes To demonstrate the decontamination efficiency of the recycling processes Greentech, Alimpet and Polyrecycling, a challenge test on EREMA Advanced technology was submitted to EFSA. PET flakes were contaminated with selected chemicals, toluene, chlorobenzene, chloroform, methyl salicylate, phenylcyclohexane, benzophenone and methyl stearate, which were used as surrogate contaminants. The surrogates were chosen in agreement with EFSA guidelines and in accordance with the recommendations of the US Food and Drug Administration. The surrogates include chemicals with different molecular weights and polarities to cover the possible chemical classes of contaminants of concern, and have been demonstrated to be suitable to monitor the behaviour of PET during recycling (EFSA, 2008). For the preparation of the contaminated PET flakes, conventionally recycled 6 post-consumer PET flakes of green colour were soaked in a mixture containing the surrogates and stored for seven days at 50 C. The contaminated flakes were washed and rinsed in a batch process in a pilot-scale plant. The concentration of surrogates in this material was determined. Only the reactor used for step 3 of the EREMA Advanced technology was challenged, using an industrial-scale plant. To process a sufficiently large amount of material, compatible with the high capacity of the continuous industrial plant, the reactor was initially fed with non-contaminated flakes and, after process conditions were stabilised, with a defined amount of contaminated flakes (green) and then with a much larger quantity of non-contaminated flakes (white). The flakes were continuously fed into the reactor. Samples were taken at the outlet of the reactor at regular intervals. The green flakes were separated from the white flakes and the evolution of the fraction of green flakes 6 Conventional recycling includes commonly sorting, grinding, washing and drying steps and produces washed and dried flakes. EFSA Journal 2015;13(2):4017 9

10 over time (residence time distribution curve) was determined by weighing. The green flakes were then analysed for the residual concentrations of the applied surrogates. The Panel noted that decontamination efficiencies, calculated only on the basis of residual surrogates in contaminated (green) flakes, could be overestimated. In fact, cross-contamination by transfer of contaminants from green to white flakes may occur. 7 Therefore, to take this potential cross-contamination into account, and in the absence of specific data provided by the applicants, some assumptions and considerations were made as follows: The mass fraction of green to white flakes at each residence time was derived from the data provided. A best-fit residence time distribution curve was derived from the experimental figures and was used to calculate the percentage of green and white flakes at different residence times. The residual concentrations of surrogates in the green flakes after decontamination were derived from the data provided. A best-fit curve was used to interpolate the residual concentrations in green flakes at different residence times. The Panel made the assumption that cross-contamination of surrogates from green to white flakes in the reactor occurred to the extent of 10 % of the residual concentration measured in the green flakes. This percentage reflects experience gained from previous evaluations. To take into account the cross-contamination between green and white flakes, the evolution of the total residual surrogate content at the outlet of the continuous reactor (step 3) as a function of (residence) time was calculated by adding the residual surrogate amount in green flakes to the residual surrogate amount in white flakes. The residual surrogate amount in green flakes was calculated from the mass fraction of green flakes multiplied by the residual concentration of surrogates in the green flakes. The residual surrogate amount in white flakes was calculated from the mass fraction of white flakes multiplied by the residual concentration of surrogates in the white flakes (assumption of 10 % of the concentration measured in the green flakes). The calculated total residual surrogate amounts were compared with the initial contamination level of green flakes at the inlet of the reactor to derive the decontamination efficiencies. This was done for the different residence times in the step 3 reactor specified by the applicants for each commercial process. 7 Cross-contamination, as meant in the scientific opinion on the criteria to be used for safety evaluation of a mechanical recycling process to produce recycled PET intended to be used for manufacture of materials and articles in contact with food, is the transfer of surrogate contaminants from the initially contaminated to the initially not contaminated material (EFSA CEF Panel, 2011). EFSA Journal 2015;13(2):

11 Table 1: Efficiencies of the decontamination of the continuous reactor step (step 3) depending on different residence times (t1-t3) Surrogates Concentration of surrogates before step 3 (mg/kg PET) Concentration of surrogates after step 3 (mg/kg PET) t1 (a) Decontamination efficiency (%) t1 (a) Concentration of surrogates after step 3 (mg/kg PET) t2 (b) Decontamination efficiency (%) t2 (b) Concentration of surrogates after step 3 (mg/kg PET) t3 (c) Decontamination efficiency (%) t3 (c) Toluene Chlorobenzene Chloroform Methyl salicylate Phenylcyclohexane Benzophenone Methyl stearate (a) t1: (b) t2: (c) t3: Polyrecycling. Alimpet. Greentech. EFSA Journal 2015;13(2):

12 The decontamination efficiencies, as presented in Table 1, were calculated at the time(s) of exit from the continuous decontamination reactor (step 3) in the challenge test. The overall decontamination efficiencies of the processes is expected to be higher, as further decontamination will occur during the pre-decontamination in the continuous reactor in step 2 and in the extrusion step (step 4) Discussion Considering the high temperatures used during the processes, the possibility of contamination by microorganisms can be discounted. Therefore, this evaluation focuses on the chemical safety of the final product. Technical data, such as information on the residual content of PVC, glue, polyolefins, cellulose, metals and polyamides, and physical properties are provided for the input materials, hot causticwashed and dried flakes (step 1), for each of the submitted recycling processes. The input materials are produced from PET containers previously used for food packaging, collected through post-consumer collection systems. However, a small fraction of the input may originate from non-food applications, such as soap bottles, mouth wash bottles, kitchen cleaning product bottles, etc. According to the applicants, the fraction of non-food containers depends on the collection systems and, on the basis of market share data, it is below 5 %, as recommended by the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) in its scientific opinion on the criteria to be used for safety evaluation of a mechanical recycling process to produce recycled PET intended to be used for manufacture of materials and articles in contact with food (EFSA CEF Panel, 2011). The processes are well described. The production of washed and dried flakes from collected containers (step 1) is carried out in different ways depending on the plant, but, according to the applicants, they are under control. The following steps are those of the EREMA Advanced technology used to recycle the PET flakes into decontaminated PET pellets: first continuous reactor (step 2), second continuous reactor (step 3) and extrusion (step 4). The operating parameters of temperature, pressure and residence time for steps 2 to 4 have been provided to EFSA. A challenge test on step 3 (continuous decontamination reactor) of each process was carried out in an industrial-scale plant to measure the decontamination efficiency. In this challenge test, the continuous decontamination reactor was operated under pressure and temperature conditions equivalent to those used for the commercial processes. The challenge test was performed in accordance with EFSA guidelines (EFSA, 2008). Since a mixture of not contaminated flakes (white) and flakes spiked with surrogates (green) was collected at the outlet of the reactor used for this challenge test, the Panel calculated the decontamination efficiency taking into account the amount of surrogates possibly transferred to the white flakes as a result of cross-contamination during the challenge test. The Panel considered that decontamination in the continuous reactor (step 3) is the critical step for the decontamination efficiency of the processes. Consequently, the temperature, pressure and residence time parameters of step 3 should be controlled to guarantee the performance of decontamination. These parameters have been provided to EFSA. The decontamination efficiencies obtained for each surrogate contaminant from the challenge test, at the different residence times, ranging from 92.4 % to 99.2 %, have been used to calculate Cres values, in accordance with the evaluation procedure described in the scientific opinion on the criteria to be used for safety evaluation of a mechanical recycling process to produce recycled PET (EFSA CEF Panel, 2011; Appendix B). By applying the decontamination efficiency percentages to the reference contamination level of 3 mg/kg PET, the Cres values for the different surrogates are obtained (see Tables 2 and 3). According to the evaluation principles (EFSA CEF Panel, 2011), the Cres value should not be higher than a Cmod value corresponding to a migration, after one year at 25 C, which cannot give rise to a dietary exposure exceeding μg/kg bw/day, the exposure threshold below which the risk to EFSA Journal 2015;13(2):

13 human health would be negligible. 8 For processes that produce PET intended to be used in the manufacture of bottles, the default exposure scenario for infants has been applied as a worst case. A maximum dietary exposure of μg/kg bw/day corresponds to a maximum migration of 0.1 μg/kg of a contaminant substance into an infant s food, as calculated by conservative migration modelling. For processes that produce PET intended to be used in the manufacture of trays and containers not used to package water (since water could be used to prepare infant formula), the exposure scenario for toddlers has been applied as a worst case, where a maximum dietary exposure of μg/kg bw/day corresponds to a maximum migration of 0.15 μg/kg of the contaminant into a toddler s food. Therefore, the corresponding migrations of 0.1 μg/kg (scenario for infants) and 0.15 μg/kg (scenario for toddlers) into food have been used to calculate the Cmod value (EFSA CEF Panel, 2011). If the pellets produced by a recycling process are used up to 100 % to produce new articles and they do not meet these targets, recycled pellets should be mixed with virgin PET to make sure that the Cres value does not exceed the Cmod value. This has been done for the different residence times requested by each applicant. These percentages are reported in Tables 2 and 3 for the scenarios for infants and toddlers, respectively. The percentages of recycled PET reported in Tables 2 and 3 are, therefore, the maximum percentages for which the risk to human health is demonstrated to be negligible and may differ from the initial request from the applicants. The relationship between the key parameters for the evaluation scheme is reported in Appendix B μg/kg bw/day is the human exposure threshold value for chemicals with structural alerts raising concern for potential genotoxicity, below which the risk to human health would be negligible (EFSA CEF Panel, 2011). EFSA Journal 2015;13(2):

14 Table 2: Scenario for bottles Surrogates Cmod (mg/kg PET) Decontamination efficiency (%) t1 (a) Cres (mg/kg PET) for 70 % rpet t1 (a) Decontamination efficiency (%) t2 (b) Cres (mg/kg PET) for 100 % rpet t2 (b) Decontamination efficiency (%) t3 (c) Cres (mg/kg PET) for 100 % rpet t3 (c) Toluene Chlorobenzene Chloroform Methyl salicylate Phenylcyclohexane Benzophenone Methyl stearate (a) t1: Polyrecycling. (b) t2: Alimpet. (c) t3: Greentech. Calculated Cmod corresponding to a modelled migration of 0.1 µg/kg food after one year at 25 C. Decontamination efficiencies from the challenge test depending on different residence time and Cres of surrogate contaminants in recycled PET (rpet). Table 3: Scenario for trays Surrogates Cmod (mg/kg PET) Decontamination efficiency (%) t1 (a) Cres (mg/kg PET) for 70 % rpet t1 (a) Decontamination efficiency (%) t2 (b) Cres (mg/kg PET) for 100 % rpet t2 (b) Decontamination efficiency (%) t3 (c) Cres (mg/kg PET) for 100 % rpet t3 (c) Toluene Chlorobenzene Chloroform Methyl salicylate Phenylcyclohexane Benzophenone Methyl stearate (a) t1: Polyrecycling. (b) t2: Alimpet. (c) t3: Greentech. Calculated Cmod corresponding to a modelled migration of 0.1 µg/kg food after one year at 25 C. Decontamination efficiencies from the challenge test depending on different residence time and Cres of surrogate contaminants in recycled PET (rpet). EFSA Journal 2015;13(2):

15 On the basis of the data provided from the challenge test and the applied conservative assumptions, the Panel considered that the recycling processes under evaluation using EREMA Advanced technology are able to ensure that the level of migration of unknown contaminants from the recycled PET into food is below the conservatively modelled migration of 0.1 μg/kg food (derived from the exposure scenario for infants), when the recycled pellets are used for bottles intended for contact with all types of foodstuffs, and 0.15 μg/kg food (scenario for toddlers), when the recycled pellets are used for trays and containers intended for contact with all types of foodstuffs except packaged water, and the recycled pellets from the different recycling processes are used up to the percentages indicated in Table 4 below, which depend on the residence time and scenario. Table 4: Maximum percentages of recycled PET in final articles Scenario for infants (bottles) Scenario for toddlers (trays and containers) Greentech 100 % 100 % Alimpet 100 % 100 % Polyrecycling 70 % 100 % 3. Conclusions The Panel considered that all processes are well characterised and the main steps used to recycle PET flakes into decontaminated PET pellets have been identified. Having examined the challenge test provided, the Panel concluded that the decontamination in the continuous reactor of step 3 is the critical step for the decontamination efficiency of the processes. The operating parameters which control performance are temperature, pressure and residence time. Therefore, the Panel considered that the recycling processes Greentech, Alimpet and Polyrecycling are able to reduce any foreseeable accidental contamination of the post-consumer food contact PET to a concentration that does not give rise to any concern regarding a risk to human health if: they are operated under conditions that are at least as severe as those obtained from the challenge test used to measure the decontamination efficiency of the processes; the input is washed and dried post-consumer PET flakes originating from materials and articles that have been manufactured in accordance with the Community legislation on food contact materials containing no more than 5 % of PET from non-food consumer applications; the final bottles manufactured from the recycled pellets contain up to 70 % recycled postconsumer PET if produced by Polyrecycling and up to 100 % recycled post-consumer PET if produced by Alimpet or Greentech; the final thermoformed trays and containers manufactured from the recycled pellets and not used for packaging water contain up to 100 % recycled post-consumer PET if produced by Greentech, Alimpet or Polyrecycling. Therefore, the Panel concluded that the recycled PET obtained from the processes Greentech, Alimpet and Polyrecycling, intended to be used for the manufacture of bottles for contact with all types of foodstuffs and for the manufacture of thermoformed trays and containers for contact with all types of foodstuffs except packaged water, is not considered of safety concern when final articles are manufactured with no more than the percentage of recycled post-consumer PET specified above. The trays are not intended to be used in microwaves or ovens. 4. Recommendations The Panel recommends that it should be verified periodically, as part of the good manufacturing practice, that, as foreseen in Regulation (EC) No 282/2008, Article 4b, the input originates from plastic materials and articles that have been manufactured in accordance with Community legislation on plastic food contact materials and articles, and that the proportion of PET from non-food consumer EFSA Journal 2015;13(2):

16 applications is no more than 5 % of the input to be recycled. Critical steps should follow Community legislation on food contact materials and the proportion of PET should be monitored and kept under control; supporting documentation describing how it will be ensured that the critical steps are operated under conditions at least as severe as those obtained from the challenge test used to measure the decontamination efficiency of the processes should be available. DOCUMENTATION PROVIDED TO EFSA 1. Dossier Greenfiber, newly Greentech. Dated May Submitted on behalf of Greenfiber International S.A, newly Greentech S.A. 2. Additional data for Dossier Greentech, formerly Greenfiber. Dated October Submitted on behalf of Greentech S.A., formerly Greenfiber International S.A. 3. Dossier Alimpet. Dated June Submitted on behalf of Alimpet S.R.L. 4. Additional data for Dossier Alimpet. Dated October Submitted on behalf of Alimpet S.R.L. 5. Dossier Polyrecycling. Dated August Submitted on behalf of Polyrecycling GmbH. 6. Additional data for Dossier Polyrecycling. Dated October Submitted on behalf of Polyrecycling GmbH. REFERENCES EFSA (European Food Safety Authority), Guidelines for the submission of an application for safety evaluation by the EFSA of a recycling process to produce recycled plastics intended to be used for manufacture of materials and articles in contact with food, prior to its authorisation. The EFSA Journal 2008, 717, EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF), Scientific Opinion on the criteria to be used for safety evaluation of a mechanical recycling process to produce recycled PET intended to be used for manufacture of materials and articles in contact with food. EFSA Journal 2011;9(7):2184, 25 pp. doi: /j.efsa EFSA Journal 2015;13(2):

17 APPENDICES Appendix A. Technical data for the washed flakes as provided by the applicants Washed and dried flakes used for the Greentech recycling process Parameter Value Moisture max. 1.0 % Moisture variation ± 0.3 %/h Bulk density 350 kg/m 3 Bulk density variation ± 50 kg/m 3 /h 1 Material temperature C PVC max. 10 ppm Glue max. 20 ppm Polyolefins max. 20 ppm Cellulose (paper, wood) 20 ppm Metals max. 20 ppm Polyamide max. 20 ppm Washed and dried flakes used for the Alimpet recycling process Parameter Value Moisture max. 1.5 % Moisture variation ± 0.3 %/h Bulk density kg/m 3 Bulk density variation ± 150 kg/m 3 /h 1 Material temperature C PVC max. 500 ppm Glue max. 500 ppm Polyolefins max. 500 ppm Cellulose (paper, wood) 500 ppm Aluminium max ppm PET dust max. 1 % Washed and dried flakes used for the Polyrecycling recycling process Parameter Value Moisture max. 1.5 % Moisture variation ± 0.3 %/h Bulk density kg/m 3 Bulk density variation ± 150 kg/m 3 /h 1 Material temperature C PVC max. 100 ppm Glue max. 500 ppm Polyolefins max. 500 ppm Other thermoplastics 300 ppm Polyamide 1000 ppm Cellulose (paper, wood) 500 ppm Aluminium max. 400 ppm PET dust max. 1 % EFSA Journal 2015;13(2):

18 Appendix B. Panel, 2011) Relationship between the key parameters for the evaluation scheme (EFSA CEF PLASTIC INPUT Assumption of reference contamination level 3 mg/kg PET RECYCLING PROCESS WITH DECONTAMINATION TECHNOLOGY Decontamination efficiency measured using a challenge test Eff (%) MIGRATION IN FOOD 0.1 µg/kg food* calculated by conservative migration modelling related to a maximum potential intake of µg/kg bw/day PLASTIC OUPUT Residual contamination in the recycled PET Cres = 3 (mg/kg PET) * (1 Eff %) PLASTIC IN CONTACT Cmod modelled residual contamination in the recycled PET Yes Cres < Cmod No No safety concern Further considerations *Default scenario (infant). For adults and toddlers, the migration criterion will be 0.75 and 0.15 µg/kg food respectively. EFSA Journal 2015;13(2):

19 ABBREVIATIONS bw body weight CEF Food Contact Materials, Enzymes, Flavourings and Processing Aids Cmod modelled concentration in PET Cres EC residual concentrations in PET European Commission EFSA European Food Safety Authority PET PVC polyethylene terephthalate poly(vinyl chloride) EFSA Journal 2015;13(2):