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SCIENTIFIC OPINION ADOPTED: 21 June 2016 doi: 10.2903/j.efsa.2016.4463

Safety assessment of the process ‘Polisan Hellas S.A.’, based on Polymetrix (formerly Buhler) technology, used to recycle post-consumer PET into food contact materials EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) Abstract This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) deals with the safety evaluation of the recycling process Polisan Hellas S.A. (EU register No RECYC128), which is based on the Polymetrix (formerly Buhler) technology. The input of this process is hot washed and dried poly(ethylene terephthalate) (PET) flakes originating from collected postconsumer PET containers, mainly bottles, containing no more than 5% of PET from non-food consumer applications. Through this process, washed and dried PET flakes are extruded into pellets, crystallised and subsequently decontaminated in a continuous countercurrent reactor under high temperature and inert gas flow. The recovered PET is mixed with at least 67% by mass of virgin PET before the main decontamination step. Having examined the challenge test provided, the Panel concluded that the third step, the decontamination in continuous countercurrent reactor for solid-state polycondensation (SSP), is the critical step that determines the decontamination efficiency of the process. The operating parameters that control its performance are well defined and are temperature, residence time and gas flow. The operating parameters of this step in the process are at least as severe as those used in the challenge tests. Under these conditions, it was demonstrated that the recycling process under evaluation is able to ensure that the level of migration of potential unknown contaminants into food is below a conservatively modelled migration of 0.1 lg/kg food. Therefore, the Panel concluded that the PET obtained from this process (containing at least 67% virgin PET input), intended to be used up to 100% for the manufacture of materials and articles for contact with all types of foodstuffs for long-term storage at room temperature, with or without hotfill, is not considered of safety concern. Trays made of this PET are not intended to be used, and should not to be used in microwave and conventional ovens. © 2016 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.

Keywords: Polymetrix (formerly Buhler), Polisan Hellas S.A., food contact materials, plastic, poly (ethylene terephthalate) (PET), recycling process, safety assessment

Requestor: Greece Competent Authority, Greece Question number: EFSA-Q-2015-00404 Correspondence: fi[email protected]

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Panel members: Claudia Bolognesi, Laurence Castle, Jean-Pierre Cravedi, Karl-Heinz Engel, Paul €renlampi, Wim Mennes, Maria €rtler, Trine Husøy, Sirpa Ka Fowler, Roland Franz, Konrad Grob, Rainer Gu  Penninks, Vittorio Silano, Andrew Smith, Maria de Fa tima Tavares Pocßas, Rosaria Milana, Andre €lfle, Holger Zorn and Corina-Aurelia Zugravu Christina Tlustos, Detlef Wo Competing interests: In line with EFSA’s policy on declarations of interest, Roland Franz did not participate in the development and adoption of this scientific opinion. Acknowledgements: 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, tima Tavares Pocßas for the preparatory work Cristina Nerin, Constantine Papaspyrides and Maria de Fa on this scientific opinion and EFSA staff member Cristina Croera for the support provided to this scientific opinion. Suggested citation: EFSA CEF Panel (EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids), 2016. Scientific opinion on the safety assessment of the process ‘Polisan Hellas S.A.’, based on Polymetrix (formerly Buhler) technology, used to recycle post-consumer PET into food contact materials. EFSA Journal 2016;14(7):4463, 13 pp. doi:10.2903/j.efsa.2015.4463 ISSN: 1831-4732 © 2016 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority. This is an open access article under the terms of the Creative Commons Attribution-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited and no modifications or adaptations are made. The EFSA Journal is a publication of the European Food Safety Authority, an agency of the European Union.

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Table of contents Abstract................................................................................................................................................... 1. Introduction................................................................................................................................... 1.1. Background and Terms of Reference as provided by the requestor..................................................... 2. Data and methodologies ................................................................................................................. 2.1. Data.............................................................................................................................................. 2.2. Methodologies................................................................................................................................ 3. Assessment.................................................................................................................................... 3.1. General information ........................................................................................................................ 3.2. Description of the process............................................................................................................... 3.2.1. General description......................................................................................................................... 3.2.2. Characterisation of the input ........................................................................................................... 3.3. Polymetrix technology..................................................................................................................... 3.3.1 Description of the main steps .......................................................................................................... 3.3.2. Decontamination efficiency of the recycling process .......................................................................... 3.4. Discussion ..................................................................................................................................... 4. Conclusions.................................................................................................................................... 5. Recommendations .......................................................................................................................... Documentation provided to EFSA .............................................................................................................. References............................................................................................................................................... Abbreviations ........................................................................................................................................... Appendix A – Technical data of the washed flakes as provided by the applicant ............................................ Appendix B – Relationship between the key parameters for the evaluation scheme (EFSA CEF Panel, 2011)....

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1 4 4 4 4 5 5 5 5 5 6 6 6 7 9 10 11 11 11 11 12 13

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1.

Introduction

1.1.

Background and Terms of Reference as provided by the requestor

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 Regulation (EC) No 282/20081 of the Commission of 27 March 2008 on recycled plastic materials intended to come into contact with foods and Articles 8 and 9 of Regulation (EC) No 1935/20042 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 the European Food Safety Authority (EFSA) for evaluation. In this case, EFSA received, from the Greece Competent Authority, an application for evaluation of the recycling process Polisan Hellas S.A., EU register No RECYC128. The request has been registered in EFSA’s register of received questions under the number EFSA-Q-2015-00404. The dossier was submitted on behalf of Polisan Hellas S.A., Greece. According to 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, EFSA is required 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 process 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 process Polisan Hellas S.A. is able to reduce any contamination of the plastic input to a concentration that does not pose a risk to human health. The poly(ethylene terephthalate) (PET) materials and articles used as input of the process as well as the conditions of use of the recycled PET make part of this evaluation.

2.

Data and methodologies

2.1.

Data

The applicant has submitted a dossier following the ‘EFSA guidelines for the submission of an application for the safety evaluation of a recycling process to produce recycled plastics intended to be used for the manufacture of materials and articles in contact with food, prior to its authorisation’ (EFSA, 2008). Applications shall be submitted in accordance with Article 5 of the Regulation (EC) No 282/2008. The following information on the recycling process was provided by the applicant and used for the evaluation:

• •

1

2

General information:

– –

general description, existing authorisations.

Specific information:

– – – – – – – –

recycling process, characterisation of the input, determination of the decontamination efficiency of the recycling process, characterisation of the recycled plastic, intended application in contact with food, compliance with the relevant provisions on food contact materials and articles, process analysis and evaluation, operating parameters.

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, 28.3.2008, p. 9–18. 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, 13.11.2004, p. 4–17.

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2.2.

Methodologies

The principles followed for the evaluation are described here. The risks associated to the use of recycled plastic materials and articles in contact with food come from the possible migration of chemicals into the food in amounts that would endanger human health. The quality of the input, the efficiency of the recycling process to remove contaminants, as well as the intended use of the recycled plastic, are crucial points for the risk assessment (see Guidelines on recycling plastics; EFSA, 2008). The criteria for the safety evaluation of a mechanical recycling process to produce recycled PET intended to be used for the manufacture of materials and articles in contact with food are described in the scientific opinion developed by the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (EFSA CEF Panel, 2011). The principle of the evaluation is to apply the decontamination efficiency of a recycling technology or process, obtained from a challenge test with surrogate contaminants, to a reference contamination level for post-consumer PET, conservatively set at 3 mg/kg PET for contaminants resulting from possible misuse. The resulting residual concentration of each surrogate contaminant in recycled PET (Cres) is compared with a modelled concentration of the surrogate contaminants in PET (Cmod). This Cmod is calculated using generally recognised conservative migration models so that the related migration does not give rise to a dietary exposure exceeding 0.0025 lg/kg body weight (bw) per day (i.e. the human exposure threshold value for chemicals with structural alerts for genotoxicity), below which the risk to human health would be negligible. If the Cres is not higher than the Cmod, the recycled PET manufactured by such recycling process is not considered of safety concern for the defined conditions of use (EFSA CEF Panel, 2011). The assessment was conducted in line with the principles described in the EFSA Guidance on transparency in the scientific aspects of risk assessment (EFSA, 2009) and considering the relevant guidance from the EFSA Scientific Committee.

3.

Assessment

3.1.

General information

According to the applicant, the recycling process Polisan Hellas S.A. is intended to recycle food grade PET containers to produce PET pellets using the Polymetrix (formerly Buhler) technology. The pellets (made of up to 33% recyclate and at least 67% virgin PET) are intended to be used in a mass fraction up to 100% to manufacture new food packaging, typically bottles and thermoformed sheets. These final materials and articles are intended to be used in direct contact with all kinds of foodstuffs for long-term storage at room temperature, with or without hotfill.

3.2.

Description of the process

3.2.1.

General description

The recycling process Polisan Hellas S.A. produces PET pellets from PET containers, mainly bottles, coming from post-consumer collection systems (kerbside and deposit systems). The recycling process is composed of the three steps below. Step 1 is performed by third parties. Input

• •

In step 1, post-consumer PET containers, mainly bottles, are processed into hot caustic washed and dried flakes. In step 2, washed and dried flakes are extruded into pellets and mixed with virgin PET. The process has two options (2a or 2b) depending on how the recovered PET is then mixed with virgin PET:

– –

Step 2a: During the extrusion process, the melt from the washed and dried flakes (i.e. from step 1) is melt-mixed with at least 67% by mass of virgin PET. Subsequently, the mixed PET is pelletised, then crystallised and heated to the decontamination temperature. Step 2b: The washed and dried flakes (from step 1) are melted and extruded into pellets. These are then mixed with at least 67% by mass of virgin PET pellets. This mixture of pellets is then crystallised and heated to the decontamination temperature.

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Decontamination and production of recycled PET material

•

In step 3, the crystallised pellets are decontaminated during solid-state polycondensation (SSP) in a continuous countercurrent reactor under high temperature and inert gas flow.

The operating conditions of the process have been provided to EFSA. The final pellets are checked against technical requirements on intrinsic viscosity, colour, black spots, etc. Pellets are intended to be converted by other companies into articles, such as bottles, for contact with all kinds of foodstuffs, used for hot fill and/or long-term storage at room temperature. These pellets may also be used for sheets, which are thermoformed to make food trays. Trays made of this PET are not intended to be used in microwave and conventional ovens.

3.2.2.

Characterisation of the input

According to the applicant, the input material for the recycling process Polisan Hellas S.A. is hot washed and dried flakes obtained from PET containers, mainly bottles, previously used for food packaging, from post-consumer collection systems (kerbside and deposit systems). A small fraction may originate from non-food applications such as soap bottles, mouth wash bottles, kitchen hygiene bottles, etc. According to information from the applicant, the amount of this non-food container fraction depends on the recollection system and will be between (nearly) 0% and about 5%. Depending on the amount of non-food bottles in the PET input bales, the material is fed into the grinding step together with material with less non-food bottles. Therefore, the amount of non-food PET bottles in the input stream of the recycling process is significantly lower than 5%. Technical data for the hot washed and dried flakes are provided, such as information on residual content of poly(vinyl chloride) (PVC), glue, polyolefins, cellulose, metals, polyamides and physical properties (see Appendix A).

3.3.

Polymetrix technology

3.3.1.

Description of the main steps

To decontaminate post-consumer PET, the recycling process that Polisan Hellas S.A. uses is the Polymetrix (formerly Buhler) technology as described below and for which the general scheme is reported in Figure 1. In step 1, not reported in the scheme, post-consumer PET containers, mainly bottles, are processed into hot caustic washed and dried flakes by third parties.

•

Step 2: According to the applicant, either step 2a or 2b is applied:

–

–

•

Step 2a (extrusion including melt mixing, pelletising and crystallisation): The washed and dried flakes are processed in the extruder and melted. Then, the melt is continuously filtered to remove solid particles (e.g. paper, aluminium, etc.) and mixed with ≥ 67% of virgin PET (melt mixing). Subsequently, the mixed melt is pelletised, and the pellets are fed to a continuous reactor in which they are crystallised and heated up to the temperature of the SSP reactor. Step 2b (extrusion, pelletising, pellet mixing and crystallisation): The washed and dried flakes are processed in the extruder and melted. Then, the melt is continuously filtered to remove solid particles (e.g. paper, aluminium, etc.) and subsequently pelletised. Then, these pellets are mixed with ≥ 67% of virgin PET pellets and fed to a continuous reactor in which they are crystallised and heated up to the temperature of the SSP reactor.

Step 3 (SSP): The crystallised and preheated pellets are continuously fed to a countercurrent reactor running under high temperature and inert gas flow for a predefined residence time. This step increases the intrinsic viscosity of the material and decontaminates the PET pellets.

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Step 2a: Extrusion (melt mixing)

Crystallisation and heating

SSP Step 2b: Extrusion

Pellet mixing

Crystallisation and heating

STEP 2

STEP 3

Figure 1: General scheme of the technology The process is operated under defined operating parameters (temperature, pressure, inert gas flow and residence time) for steps 2 and 3.

3.3.2.

Decontamination efficiency of the recycling process

To demonstrate the decontamination efficiency of the recycling process Polisan Hellas S.A., two challenge tests on the Polymetrix (formerly Buhler) technology were submitted to the EFSA. According to the applicant, the challenge tests were performed at the Polymetrix (formerly Buhler) facilities at a pilot-plant scale. In both the cases, PET flakes were contaminated with toluene, chlorobenzene, phenylcyclohexane, benzophenone and methyl stearate, selected 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 different molecular weights and polarities to cover possible chemical classes of contaminants of concern and were demonstrated to be suitable to monitor the behaviour of PET during recycling (EFSA, 2008). For the preparation of the contaminated flakes, virgin clear (i.e. without added colour) flakes were spiked with a liquid mixture containing the surrogates in a pilot-plant twin-screw extruder, without degassing, favouring a homogenous and deep contamination of the obtained pellets. To prevent possible agglomeration during the challenge test, the amorphous pellets were crystallised according to step 2, without addition of virgin PET. The concentrations of surrogates in this material, used as the starting material for the challenge tests, were determined. The two challenge tests were performed directly on the SSP (step 3) in batch mode using a pilot plant at two different decontamination temperatures T1 and T2 (T1 < T2) and different residence times (residence time at T1 > residence time at T2). For each challenge test, the contaminated PET pellets, which were clear (without added colour), were mixed with blue, non-contaminated pellets (3-kg clear contaminated and 50-kg blue non-contaminated) in order to provide the quantity of material needed for the pilot plant. In the samples drawn after the SSP (step 3), the initially contaminated pellets (clear) were separated from the blue pellets. Only the initially clear contaminated pellets were analysed for their residual concentrations of the applied surrogates. When not detected, the limit of detection was considered for the calculation of the decontamination efficiency. The results are summarised in Tables 1 and 2. Of note, in the early stage (step 2) of the industrial process, the post-consumer PET is mixed with virgin PET (ratio: maximum 33% post-consumer PET, minimum 67% virgin PET). Therefore, in the final calculation of the decontamination efficiencies to be applied to calculate Cres, this dilution effect was considered (Tables 1 and 2).

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Table 1:

Efficiency of the decontamination of the SSP reactor at T1 decontamination temperature in the challenge test Concentration Concentration Concentration of surrogates Decontamination efficiency of surrogates of surrogates Decontamination after step 3 considering before step 3 after step 3 efficiency (%) considering dilution(b) (%) (mg/kg PET) (mg/kg PET) dilution(b) (mg/kg PET)

Surrogates

5.4  0.4

< 0.1(a)

Chlorobenzene Phenylcyclohexane

64.3  0.4 600.7  31.2

1.3 58.2

98.0 90.3

0.4 19.2

99.4 96.8

Benzophenone

591.3  50.3

38.2

93.5

12.6

97.9

Methyl stearate

704.1  49.9

26.0

96.3

8.6

98.8

Toluene

> 98.1

< 0.03(a)

> 99.4

SSP: solid-state polycondensation; PET: poly(ethylene terephthalate). (a): Not detected at the limit of detection given. (b): Calculated taking into account the dilution factor due to use of 33% post-consumer PET with respect 67% virgin PET.

Table 2:

Efficiency of the decontamination of the SSP reactor at T2 decontamination temperature in the challenge test

Surrogates

Concentration of surrogates Decontamination Concentration Concentration efficiency of surrogates of surrogates Decontamination after step 3 considering efficiency (%) after step 3 considering before step 3 dilution(b) dilution(b) (%) (mg/kg PET) (mg/kg PET) (mg/kg PET) > 98.1

< 0.03(a)

> 99.4

5.4  0.4

< 0.1(a)

Chlorobenzene Phenylcyclohexane

64.3  0.4 600.7  31.2

1.4 45.7

97.8 92.4

0.5 15.1

99.3 97.5

Benzophenone

591.3  50.3

30.4

94.9

10

98.3

Methyl stearate

704.1  49.9

19.0

94.6

Toluene

6.3

99.1

SSP: solid-state polycondensation; PET: poly(ethylene terephthalate). (a): Not detected at the limit of detection given. (b): Calculated taking into account the dilution factor due to use of 33% post-consumer PET with respect 67% virgin PET.

As shown in Tables 1 and 2, the decontamination efficiency depended on the temperature and the associated residence times applied in the challenge tests and ranged from 90.3% for phenylcyclohexane up to more than 98.1% for toluene. When considering the dilution effect due to the use of 33% postconsumer PET mixed with 67% virgin PET, the resulting decontamination efficiency (relating the concentrations in the contaminated PET before step 3 to the concentrations in the final output) ranged from 96.8% for phenylcyclohexane up to more than 99.4% for toluene. As the challenge tests were performed with both contaminated and non-contaminated pellets, cross-contamination3 may occur. However, the applicant demonstrated that any potential crosscontamination is expected to have a negligible impact on the calculation of the final decontamination efficiency. The Panel noted that these challenge tests performed on the SSP, step 3, using physically mixed pellets, are applicable to calculate the decontamination efficiency for both the options of the industrial process (step 2a extrusion with melt mixing or step 2b extrusion with pellet mixing) that feed into the SSP. In fact, potential inhomogeneity of contaminants in the input materials was already taken into account in setting the default reference contamination (EFSA CEF Panel, 2011). Any decontamination occurring during the extrusion and crystallisation (step 2), may contribute further to the overall decontamination but is not taken into account as only step 3 was challenged. Therefore, the overall decontamination efficiency of the full process is expected to be higher. 3

‘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).

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3.4.

Discussion

Considering the high temperatures used during the process, 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 residual content of PVC, glue, polyolefins, cellulose, metals, polyamides and physical properties, are provided for the input materials (washed and dried flakes (step 1)) for the submitted recycling process. The input materials are produced from PET containers, mainly bottles, 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 hygiene bottles, etc. According to the applicant, the amount of this nonfood container fraction depends on the collection system and the process is managed in such a way that in the input stream of the recycling process this amount will be lower than 5%, as recommended (EFSA CEF Panel, 2011). The process is well described. The production of hot caustic washed and dried flakes from collected containers, mainly bottles (step 1) is conducted by third parties. The recycled pellets (made of maximum 33% recyclate and minimum 67% virgin) are intended to be used in a mass fraction up to 100% to manufacture new food contact articles. The following steps are those of the Polymetrix (formerly Buhler) technology used to recycle the PET flakes into decontaminated PET pellets: extrusion and mixing with virgin PET (in the melt or after pelletising), crystallisation and heating (step 2), and SSP in a continuous countercurrent reactor (step 3). The operating parameters of temperature, pressure and residence time for step 2, and the temperature, inert gas flow and residence time for step 3 are provided to EFSA. Two challenge tests at two different temperatures and residence times (T1, t1 and T2, t2 with T2 > T1 and t2 < t1) were conducted at a pilot-plant (batch mode) process step 3 (reactor for SSP, which is the main decontamination reactor), to measure the decontamination efficiency. In the challenge tests, only step 3 was challenged. Cleaning efficiencies of the other steps were not considered. The decontamination efficiency was determined from the contaminated pellets before and after the SSP reactor. The challenge tests were performed according to the recommendations in the EFSA Guidelines (EFSA, 2008). As the challenges tests were conducted on the SSP step, excluding the steps of extrusion and mixing with virgin PET, crystallisation/heating (step 2), the Panel concluded that in operation the decontamination efficiency of the whole recycling process would be higher than the experimentally determined values. A potential cross-contamination between clear (contaminated) and blue (non-contaminated used in the challenge test) pellets is expected to have negligible impact on the final decontamination efficiency calculated. The Panel considered that the SSP reactor (step 3) is the critical step for the decontamination efficiency of the process. Consequently, temperature, inert gas flow and residence time, parameters of step 3 of the process should be controlled to guarantee the performance of the decontamination. These parameters have been provided to EFSA. The decontamination efficiencies obtained for each surrogate contaminant from the challenge tests have been used to calculate the residual concentrations of potential unknown contaminants in pellets (Cres), according to the evaluation procedure described (EFSA CEF Panel, 2011; Appendix B). By applying the decontamination efficiency percentage to the reference contamination level of 3 mg/kg PET, the Cres for the different surrogates in the two challenge tests are obtained (Tables 3 and 4). According to the evaluation principles (EFSA CEF Panel, 2011), the Cres value should not be higher than a modelled concentration in PET (Cmod) corresponding to a migration, after 1 year at 25°C, which cannot give rise to a dietary exposure exceeding 0.0025 lg/kg bw per day, the exposure threshold below which the risk to human health would be negligible.4 Because PET is intended for general use for the manufacturing of articles, the most conservative default scenario for infants has been applied. Therefore, the migration of 0.1 lg/kg into food has been used to calculate Cmod (EFSA CEF Panel, 2011). The results of these calculations are shown in Table 3 and 4. The relationship between the key parameters for the evaluation scheme is reported in Appendix B.

4

0.0025 lg/kg bw per 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).

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Table 3:

Decontamination efficiency from challenge test at T1, residual concentration of surrogate contaminants in recycled PET (Cres) and calculated concentration of surrogate contaminants in PET (Cmod) corresponding to a modelled migration of 0.1 lg/kg food after 1 year at 25°C Decontamination efficiency (%)(a)

Surrogates

Cres (mg/kg PET)

Cmod (mg/kg PET)

> 99.4

0.02

0.09

Chlorobenzene Phenylcyclohexane

99.3 96.8

0.02 0.10

0.10 0.14

Benzophenone

97.9

0.06

0.16

Methyl stearate

98.8

0.04

0.32

Toluene

PET: poly(ethylene terephthalate). (a): Calculated taking into account the dilution factor due to use of 33% post-consumer PET with respect 67% virgin PET.

Table 4:

Decontamination efficiency from challenge test at T2, residual concentration of surrogate contaminants in recycled PET (Cres) and calculated concentration of surrogate contaminants in PET (Cmod) corresponding to a modelled migration of 0.1 lg/kg food after 1 year at 25°C Decontamination efficiency (%)(a)

Cres (mg/kg PET)

Cmod (mg/kg PET)

> 99.4

0.02

0.09

Chlorobenzene Phenylcyclohexane

99.3 97.5

0.02 0.08

0.10 0.14

Benzophenone

98.3

0.05

0.16

Methyl stearate

99.1

0.03

0.32

Surrogates Toluene

PET: poly(ethylene terephthalate). (a): Calculated taking into account the dilution factor due to use of 33% post-consumer PET with respect 67% virgin PET.

According to the applicant, in the industrial process, the continuous countercurrent reactor for SSP (step 3) may be run at either of the temperature/residence time combinations used in the two challenge tests. Under both the conditions, the residual concentrations of all surrogates in PET after the decontamination (Cres) are lower than the corresponding modelled concentrations in PET (Cmod). Therefore, the Panel considered the recycling process under evaluation, using Polymetrix technology, is 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 lg/kg food at which the risk to human health would be negligible. The Panel noted that this evaluation takes into account the dilution factor coming from the present application, mixing 33% post-consumer PET together with 67% virgin PET during the recycling process applied. The evaluation would come to the same conclusion if the PET produced from the post-consumer input was mixed with virgin PET not during but after the recycling process, as the same dilution factor would apply.

4.

Conclusions

The Panel considered that the process is well characterised and the main steps used to recycle the PET flakes into decontaminated PET pellets have been identified. Having examined the challenge tests provided, the Panel concluded that step 3, the continuous countercurrent SSP reactor, is the critical step for the decontamination efficiency of the process. The operating parameters to control its performance are temperature, residence time and gas flow. Therefore, the Panel considered that the recycling process Polisan Hellas S.A. is able to reduce any foreseeable accidental contamination of the post-consumer food contact PET to a concentration that does not give rise to concern for a risk to human health if:

• •

it is operated under conditions that are at least as severe as those obtained from the challenge tests used to measure the decontamination efficiency of the process; the input of the process is washed and dried post-consumer PET flakes originating from materials and articles that have been manufactured in accordance with the EU legislation on food contact materials containing no more than 5% of PET from non-food consumer applications;

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•

PET obtained from the process and used for food contact applications, contains at least 67% w/w of virgin PET, added during or after the recycling process steps applied.

Therefore, PET obtained from the process Polisan Hellas S.A. intended to be used up to 100% for the manufacture of materials and articles for contact with all types of foodstuffs for long-term storage at room temperature, with or without hotfill, is not considered of safety concern. Trays made of this PET are not intended to be used, and should not be used in microwave and conventional ovens.

5.

Recommendations

The Panel recommended periodic verification that the input to be recycled originates from materials and articles that have been manufactured in accordance with the EU legislation on food contact materials and that the proportion of PET from non-food consumer applications is no more than 5%. This adheres to good manufacturing practice and the Regulation (EC) No 282/2008, Art. 4b. Critical steps in recycling should be monitored and kept under control. In addition, supporting documentation should be available on how it is ensured that the critical steps are operated under conditions at least as severe as those in the challenge test used to measure the decontamination efficiency of the process.

Documentation provided to EFSA 1) Dossier ‘Polisan Hellas S.A.’. July 2015. Submitted on behalf of Polisan Hellas S.A., Greece. 2) Additional data. December 2015. Submitted on behalf of Polisan Hellas S.A., Greece.

References EFSA (European Food Safety Authority), 2008. 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. EFSA Journal 2008;6(7):717, 12 pp. doi:10.2903/j.efsa.2008.717 EFSA (European Food Safety Authority), 2009. Guidance of the Scientific Committee on transparency in the scientific aspects of risk assessments carried out by EFSA. Part 2: general principles. EFSA Journal 2009; 7(5):1051, 22 pp. doi:10.2903/j.efsa.2009.1051 EFSA CEF Panel (EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF)), 2011. 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:10.2903/j.efsa.2011.2184

Abbreviations bw CEF Panel Cmod Cres PET PVC SSP

body weight EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids modelled concentration in PET residual concentrations in PET poly(ethylene terephthalate) poly(vinyl chloride) solid-state polycondensation

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PET recycling process Polisan Hellas S.A.

Appendix A – Technical data of the washed flakes as provided by the applicant Parameter

Value

Moisture max.

1.5  0.3%/h

Bulk density Material temperature

200–500 kg/m3 10–60°C

PVC max. Glue max.

50 ppm 50 ppm

Polyolefins max. Cellulose (paper, wood)

50 ppm 50 ppm

Metal max.

50 ppm

Polyamide max.

2,000 ppm

PVC: poly(vinyl chloride).

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Appendix B – Relationship between the key parameters for the evaluation scheme (EFSA CEF Panel, 2011) PLASTIC INPUT Assumption of reference contamination level 3 mg/kg PET

RECYCLING PROCESS WITH DECONTAMINATION

MIGRATION IN FOOD

TECHNOLOGY

0.1 µg/kg food* calculated by conservative migration modelling related to a maximum potential intake of 0.0025 µg/kg bw per day

Decontamination efficiency measured using a challenge test Eff (%)

PLASTIC OUTPUT

PLASTIC IN CONTACT

Residual contamination in the recycled PET

C m od modelled residual contamination in the recycled PET

C res = 3 (mg/kg PET) *(1–Eff%)

Yes

No

C res < C m od

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.

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