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SCIENTIFIC OPINION ADOPTED: 15 September 2016 doi: 10.2903/j.efsa.2016.4583

Safety assessment of the process ‘Pokas Arcadian Recycle Ltd’ used to recycle polypropylene (PP) and high-density polyethylene (HDPE) articles for use as food contact material 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 deals with the safety assessment of the recycling process ‘Pokas Arcadian Recycle Ltd’ (EU register No RECYC130). According to the applicant, the input to the process is polypropylene (PP) or high-density polyethylene (HDPE) used or intended to be used for the packaging of food. In this process, PP or HDPE pieces are sorted, ground into flakes, washed and dried before being extruded into granules. The recycled plastics are intended for a wide variety of food contact applications. Having examined the information provided, the Panel concluded that the process ‘Pokas Arcadian Recycle Ltd’ is not sufficiently characterised. Based on the information submitted to EFSA, the applicant has not demonstrated in a challenge test or by other appropriate evidence, that the recycling process ‘Pokas Arcadian Recycle Ltd’ is able to reduce any contamination of the PP and HDPE input to a concentration that does not pose a risk to human health. © 2016 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.

Keywords: Pokas Arcadian Recycle Ltd, food contact materials, plastic, polypropylene (PP), high-density polyethylene (HDPE), recycling, process, safety assessment

Requestor: Greece Competent Authority (Hellenic Republic Ministry of Finance) Question number: EFSA-Q-2015-00444 Correspondence: fi[email protected]

www.efsa.europa.eu/efsajournal

EFSA Journal 2016;14(10):4583

Recycling process Pokas Arcadian Recycle Ltd

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 ‘Pokas Arcadian Recycle Ltd’ used to recycle polypropylene (PP) and high-density polyethylene (HDPE) articles for use as food contact material. EFSA Journal 2016;14(10):4583, 9 pp. doi:10.2903/j.efsa.2016.4583 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. Description of the recycling steps of the Pokas Arcadian Recycle Ltd process ........................................ 3.3.1. Description of the main steps ............................................................................................................ 3.3.2. Decontamination efficiency of the recycling process ............................................................................ 3.4. Discussion ....................................................................................................................................... 3.5. Conclusions...................................................................................................................................... Documentation provided to EFSA ............................................................................................................... References................................................................................................................................................ Abbreviations ............................................................................................................................................ Appendix A – Technical data of the recycled PP or HDPE granulates (after step 2), as provided by the applicant ..................................................................................................................................................


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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 in 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 (Hellenic Republic Ministry of Finance), Greece, an application for evaluation of the recycling process Pokas Arcadian Recycle Ltd, EU register No RECYC130. The request has been registered in EFSA’s register of received questions under the number EFSA-Q-2015-00444. The dossier was submitted on behalf of Pokas Arcadian Recycle Ltd, 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 in 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 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 process Pokas Arcadian Recycle Ltd is able to reduce any contamination of the plastic input to a concentration that does not pose a risk to human health. The polypropylene (PP) and high-density polyethylene (HDPE) materials and articles used as input of the process as well as the conditions of use of the recycled PP and HDPE 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 up for the evaluation are described here. The risks associated with 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). In 2011, EFSA published an opinion on the safety evaluation of a mechanical recycling process to produce recycled polyethylene terephthalate (PET) (EFSA CEF Panel, 2011). The principle presented in this opinion is applicable to any plastic. However, some of the criteria used in the evaluation procedure are specific to PET and, therefore, cannot be applied directly to PP or HDPE. The Panel has discussed the considerations on the safety evaluation of recycled polyolefins within a closed loop system where the quality of the incoming material can be assured to some extent (EFSA CEF Panel, 2015). For non-closed loop systems, the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) has discussed the special considerations to the safety evaluation of recycled polyethylene in an opinion on the recycling of HDPE bottles (EFSA CEF panel, 2015). Three aspects specific to polyethylene are considered: (i) the reference contamination of conventionally recycled post-consumer material, (ii) the modelling to calculate migration from polyethylene material, and (iii) the surrogates to be used in the challenge test. These considerations can be adapted to different polyolefin materials and be used for the evaluation procedure. 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 Pokas Arcadian Recycle Ltd is intended to recycle PP and HDPE articles which have been used in contact with food. PP and HDPE materials are collected and treated separately. Through this process, used PP or HDPE crates for the packaging of whole fruits and vegetables, and PP or HDPE articles for the primary packaging of food are collected from packaging and/or food manufacturers and/or from different selected suppliers. Incoming material is sorted in three categories: (1) scrap material from production and used crates or (2) primary packaging material from agreed collection systems, from food packaging industry as well from food processing industry and (3) all other material coming from an ‘approved Packaging Management Recycling System’. Material is ground into flakes, washed, dried and extruded into granules. Recycled granules (with or without blending with virgin material) are used to produce (1) new crates or (2) containers for the packaging of whole fruits and vegetables at room temperature or lower and (3) crates for the secondary packaging of food at room temperature or chilled, and (4) food packaging articles to be used with a functional barrier between the packaging material and the food itself.

3.2.

Description of the process

3.2.1.

General description

The input material for the recycling process is PP or HDPE used or intended to be used for the packaging of food. HDPE and PP materials are collected and treated separately. Collected material is inspected, sorted and shredded into pieces on-site. After sorting, the PP or HDPE parts are submitted to the following steps:

• •

Step 1: The PP or HDPE pieces are prewashed in water, ground into flakes, washed in acidic water, rinsed, centrifuged and dried. Step 2: The dried flakes are extruded under vacuum into granules.

Recycled granules are checked for content of volatile compounds, non-volatile-compounds or semi-volatile polar compounds (see Appendix A).


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Recycled granules from step 2 are used as such (100% of recycled material) or mixed with virgin PP or HDPE material to manufacture (1) crates for the packaging of whole fruits and vegetables to be stored at room or lower temperature, (2) containers and vessels for the packaging of whole fruits and vegetables at room temperature or lower, (3) crates for the secondary packaging of food stored at room or lower temperature, and (4) food packaging intended to be used with a functional barrier between the packaging material and the food. Incomplete information on the operation conditions of the process (step 1 and 2) has been provided to EFSA.

3.2.2.

Characterisation of the input

The input material of the recycling process consists of PP or HDPE materials and articles intended for or used by the food industry. Incoming material (bundles) purchased from agreed suppliers is first inspected and sorted. PP and HDPE material is sorted and processed separately. Incoming material is sorted and grouped in three categories based on their origin:

• • •

used PP or HDPE crates and scrap material from production; primary packaging material from agreed collection systems, from food packaging industry as well from food processing industry; all other material coming from an ‘approved Packaging Management Recycling System’.

The output is then shredded into pieces and foreign material, such as metallic objects, is further removed before entering the recycling process.

3.3.

Description of the recycling steps of the Pokas Arcadian Recycle Ltd process

3.3.1.

Description of the main steps

According to the applicant, to process the PP or HDPE articles, Pokas Arcadian Recycle Ltd uses a batch process, which the main steps are described below:

• •

Grinding, washing and drying (step 1): In this step, the input material is first prewashed with water, ground into flakes and washed with acidified water (acetic acid). The flakes are then rinsed with water and dried. Granulation (step 2): The flakes are extruded under vacuum and granules are produced.

According to the applicant, in subsequent steps, the granules may be mixed with virgin material, extruded under vacuum and thermoformed to produce articles such as trays. The process is operated under defined operating parameters of residence time, temperature and pressure. Incomplete information on these parameters has been provided to EFSA.

3.3.2.

Decontamination efficiency of the recycling process

To demonstrate the decontamination efficiency of the recycling process Pokas Arcadian Recycle Ltd, a challenge test was submitted to EFSA. PP flakes were contaminated with selected chemicals, toluene, chloroform, zinc stearate, benzophenone and lindane, used as surrogate contaminants. The surrogates include different molecular weights and polarities to cover possible chemical classes of contaminants of concern. PP and HDPE are materials with similar physical properties in terms of decontamination (i.e. similar diffusion coefficients). Moreover, according to the applicant, both materials are recycled under identical conditions in the Pokas Arcadian process. Therefore, the challenge test was performed only on PP material. For the preparation of the contaminated material, 70 kg of PP flakes were soaked in a heptane/ isopropanol solution containing the surrogates and stored for 15 days under agitation at 40°C. The surrogates’ solution was decanted and PP flakes were rinsed with acidified water (acetic acid) and air-dried during 3 days. These contaminated flakes were then washed and extruded according to the recycling process. The concentration of surrogates in the PP flakes was determined at each step of the process. Results are given in Table 1 below.


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Table 1:

Decontamination efficiency (DE) of the process (washing and extrusion) of the recycling process Pokas Arcadian Recycle Ltd Concentration of surrogates before washing (mg/Kg)

Surrogates

Chloroform

Concentration of surrogates after washing (mg/kg)

Decontamination efficiency (%) of washing step

0.32

Decontamination efficiency (%) total

96.0

0.12

62.5

98.5

Toluene Benzophenone

463 2,700

18.7 31.6

96.0 98.8

1.86 1.43

90.1 95.5

99.6 99.9

Lindane

1,950

12.3

99.4

n.d.(a)

> 98.4

100.0

20.5

33.7

2.9

35.6

Zinc stearate

8.11

Concentration of Decontamination surrogates after efficiency (%) of extrusion extrusion step (mg/Kg)

(b)

30.9

19.9

(a): Limit of detection: 0.2 mg/kg. (b): Measured as Zn. Data are corrected with the initial concentration of zinc measured in the material (18 mg/kg).

As shown above, the decontamination efficiency (DE) for the washing step ranges from 33.7% (zinc stearate) to 99.4% (lindane), and for the extrusion step it ranges from 2.9% (zinc stearate) to 100% (lindane). The Panel noted that there are inconsistencies in the behaviour of surrogates, being the more volatile surrogates, chloroform and toluene, removed less efficiently than benzophenone and lindane. Also the removal of the hydrophobic lindane in the washing step is unexpectedly high.

3.4.

Discussion

The Panel considered that the extrusion is part of the recycling process. Considering the high temperatures (up to 230°C) used in the extrusion of the flakes, the possibility of contamination by micro-organisms can be discounted. Therefore, this evaluation focuses on the chemical safety of the final product. The process and the challenge test presented by the applicant were not well characterised. There were inconsistencies and discrepancies in the information provided and the Panel raised fundamental issues, in particular: Collection and quality of the input material: The characteristics of the collected materials and the different types of suppliers were insufficiently described. It was not possible to ensure that the input material was collected only from industries (packaging of food) or also from consumers. It was also not possible to determine what type of material was obtained from the different selected suppliers mentioned in the dossier (see Section 3.2.2). Based on the information provided, it was not possible to identify if the process is operated in a product loop as intended in the Regulation 282/2008/EC art. 4 (c). Intended use of the recycled material: The intended use of the recycled PP and HDPE materials is not well defined. It is not clear if the recycled material is intended for logistic use only (e.g. transport and short-term storage) or intended to be used at the retail stage (e.g. display crates, trays) or destined to be bought by the consumer together with the food. Process: A discrepancy is noted regarding the washing agent used in step 1. Information on the operational parameters of the extrusion in step 2 is incomplete. Challenge test: Some cleaning efficiencies reported in the challenge test are inconsistent with the expected efficiencies based on the physicochemical properties of the surrogates and observed in similar technologies. Indeed, it is not comprehensible how hydrophobic lindane can be so efficiently removed by a washing step and how chloroform and toluene are removed less efficiently than benzophenone and lindane in an extrusion process under vacuum. Information is not provided to demonstrate the applicability of the challenge test and data were not provided to support the reliability of the analytical results. Overall, the dossier does not satisfy the requirements of the EFSA guidelines because the data provided by the applicant do not provide information on the quality of the input, do not provide a proper description of the process, do not prove the representativeness of the challenge test, and do not allow identification of the critical parameters and evaluation of the cleaning efficiency of the process. Without this information, a proper safety evaluation cannot be concluded.


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Information on these points was requested to the applicant but this was not provided and the applicant requested the CEF Panel to proceed with its evaluation on the basis of the information provided.

3.5.

Conclusions

The Panel considered that the process ‘Pokas Arcadian Recycle Ltd’ is not adequately characterised. Based on the information submitted to EFSA, the applicant has not demonstrated in a challenge test or by other appropriate evidence that the recycling process ‘Pokas Arcadian Recycle Ltd’ is able to reduce any contamination of the PP and HDPE input to a concentration that does not pose a risk to human health.

Documentation provided to EFSA 1) Technical dossier ‘POKAS Arcadian Recycle Ltd’. September 2015. Submitted on behalf of POKAS Arcadian Recycle Ltd. 2) Technical dossier Annex 1. September 2015. Submitted on behalf of POKAS Arcadian Recycle Ltd. 3) Technical dossier Annex 2. September 2015. Submitted on behalf of POKAS Arcadian Recycle Ltd. 4) Technical dossier Annex 3. September 2015. Submitted on behalf of POKAS Arcadian Recycle Ltd. 5) Technical dossier Annex 3c. September 2015. Submitted on behalf of POKAS Arcadian Recycle Ltd. 6) Technical dossier Annex 4. September 2015. Submitted on behalf of POKAS Arcadian Recycle Ltd. 7) Technical dossier Annex 5. September 2015. Submitted on behalf of POKAS Arcadian Recycle Ltd. 8) Technical dossier Annex 6. September 2015. Submitted on behalf of POKAS Arcadian Recycle Ltd.

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, 12pp. 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 EFSA CEF Panel (EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF), 2015. Scientific opinion on the safety assessment of the processes ‘Biffa Polymers’ and ‘CLRrHDPE’ used to recycle high-density polyethylene bottles for use as food contact material. EFSA Journal 2015;13(2):4016, 25 pp. doi: 10.2903/j.efsa.2015.4016

Abbreviations CEF Panel DE HDPE PET PP

EFSA Food Contact Materials, Enzymes, Flavourings and Processing Aids Panel decontamination efficiency high-density polyethylene polyethylene terephthalate polypropylene


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Appendix A – Technical data of the recycled PP or HDPE granulates (after step 2), as provided by the applicant Level (mg/kg) Volatile, non-volatile and semivolatile contents (semiquantitative determination)(a) Limonene Medium-chain aliphatic hydrocarbon

5.1 0.47–4.55

Isopropyl myristate Squalene

0.62 0.88

Terephthalic acid, 2-ethylhexyl octyl ester

1.45

Terephthalic acid, diethyl ester

4.84

(a): The identified compounds are subjected to an expert opinion before releasing the analysed batch.


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