Safety assessment of the process KGL, based on the EREMA Basic technology, used to recycle post‐consumer PET into food contact materials

TL;DR

This paper evaluates the safety of a recycling process for post-consumer PET used in food contact materials.

Contribution

The study confirms the safety of the KGL recycling process for food contact materials under specified conditions.

Findings

The KGL process ensures migration of contaminants below safety thresholds for infant and toddler exposure scenarios.

The decontamination step is critical and controlled by temperature, pressure, and residence time.

Recycled PET is safe for long-term storage at room temperature but not for microwave or oven use.

Abstract

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of the recycling process KGL (EU register number RECYC326), which uses the EREMA Basic technology. The input material is hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes originating from collected post‐consumer PET containers, including no more than 5% PET from non‐food consumer applications. The flakes are heated in a ■■■■■ reactor under vacuum before being extruded. Having examined the challenge test provided, the Panel concluded that the ■■■■■ decontamination (step 2), for which a challenge test was provided, is critical in determining the decontamination efficiency of the process. The operating parameters to control the performance of this step are temperature, pressure and residence time. It was demonstrated that this recycling process is able to ensure a level of migration of potential unknown contaminants into food below the conservatively modelled migrations of 0.1 and 0.15 μg/kg food, derived from the exposure scenarios for infants and toddlers, when such recycled PET is used at up to 100%. Therefore, the Panel concluded that the recycled PET obtained from this process is not of safety concern when used at up to 100% for the manufacture of materials and articles for contact with all types of foodstuffs, including drinking water, for long‐term storage at room temperature or below, with or without hotfill. Articles made of this recycled PET are not intended to be used in microwave or conventional ovens and such uses are not covered by this evaluation.

Figures

General scheme of the EREMA Basic technology (provided by the applicant).

Tables

TABLE 1. Efficiency of the decontamination of the reactor (step 2) in the challenge test.

Surrogates	Concentration a of surrogates before step 2 (mg/kg PET)	Concentration b of surrogates after step 2 (mg/kg PET)	Decontamination efficiency c (%)
Toluene	202	0.18	99.1
Chlorobenzene	361	0.36	99.0
Chloroform	291	0.23	99.2
Methyl salicylate	143	0.47	96.6
Phenylcyclohexane	364	1.35	96.2
Benzophenone	480	2.40	94.9
Methyl stearate	360	1.03	97.1

TABLE 2. Decontamination efficiency from the challenge test, residual concentrations of the surrogates (C res) related to the reference contamination level and calculated concentrations of the surrogates in PET (C mod) corresponding to a modelled migration of 0.10 and 0.15 μg/kg food after 1 year at 25°C.

Surrogates	Decontamination efficiency (%)	C res for 100% rPET (mg/kg PET)	C mod (mg/kg PET); infant scenario	C mod (mg/kg PET); toddler scenario
Toluene	99.1	0.03	0.09	0.13
Chlorobenzene	99.0	0.03	0.09	0.15
Chloroform	99.2	0.03	0.10	0.15
Methyl salicylate	96.6	0.10	0.13	0.20
Phenylcyclohexane	96.2	0.11	0.14	0.21
Benzophenone	94.9	0.15	0.16	0.24
Methyl stearate	97.1	0.09	0.32	0.47

Full text

INTRODUCTION

1

Background and terms of reference as provided by the requestor

1.1

Recycled plastic materials and articles shall only be placed on the market if the recycled plastic is from an authorised recycling process. Before a recycling process is authorised, the European Food Safety Authority (EFSA)'s opinion on its safety is required. This procedure has been established in Article 5 of Regulation (EC) No 282/20081 ^,^ 2 on recycled plastic materials intended to come into contact with foods and Articles 8 and 9 of Regulation (EC) No 1935/20043 on materials and articles intended to come into contact with food.

According to this procedure, the industry submits applications to the competent authorities of Member States, which transmit the applications to EFSA for evaluation.

In this case, EFSA received from the Polish competent authority (Chief Sanitary Inspectorate), an application for evaluation of the recycling process KGL, European Union (EU) register No RECYC326. The request has been registered in EFSA's register of received questions under the number EFSA‐Q‐2022‐00837. The dossier was submitted on behalf of Korporacja KGL S.A., Mościska, ul. Postępu 20, 05‐080 Izabelin, Poland (see ‘Section 7’).

Terms of Reference

1.2

The Polish competent authority (Chief Sanitary Inspectorate) requested the safety evaluation of the recycling process KGL, in accordance with Article 5 of Regulation (EC) No 282/2008.

Interpretation of the Terms of Reference

1.3

According to Article 5 of Regulation (EC) No 282/2008 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 is able to reduce the 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 are part of this evaluation.

DATA AND METHODOLOGIES

2

Data

2.1

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) and the ‘Administrative guidance for the preparation of applications on recycling processes to produce recycled plastics intended to be used for manufacture of materials and articles in contact with food’ (EFSA, 2021). In accordance with Art. 38 of the Commission Regulation (EC) No 178/20024 and taking into account the protection of confidential information and of personal data in accordance with Articles 39 to 39e of the same Regulation and of the Decision of the EFSA's Executive Director laying down practical arrangements concerning transparency and confidentiality,5 the non‐confidential version of the dossier is published on Open.EFSA.6

According to Art. 32c (2) of Regulation (EC) No 178/2002 and to the Decision of EFSA's Executive Director laying down the practical arrangements on pre‐submission phase and public consultations,7 EFSA carried out a public consultation on the non‐confidential version of the application from 17 May 2024 to 07 June 2024, for which no comments were received.

Additional information was provided by the applicant during the assessment process in response to a request from EFSA sent on 16 January 2024 (see ‘Section 7’).

The following information on the recycling process was provided by the applicant and used for the evaluation:

• 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.

Methodologies

2.2

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 (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 (C res) is compared with a modelled concentration of the surrogate contaminants in PET (C mod). This C mod is calculated using generally recognised conservative migration models so that the related migration does not give rise to a dietary exposure exceeding 0.0025 μg/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 C res is not higher than the C mod, the recycled PET manufactured by such recycling process is not considered to be 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.

ASSESSMENT

3

General information

8

3.1

According to the applicant, the recycling process KGL is intended to recycle food grade PET containers using the EREMA Basic technology. The recycled PET is intended to be used at up to 100% for thermoformed trays/containers, e.g. for fruits, vegetables, cooked and uncooked meats, dairy products and desserts, for long‐term food storage at room temperature or below, with or without hotfill. The final articles are not intended to be used in microwave or conventional ovens.

Description of the process

3.2

General description

9

3.2.1

The recycling process KGL produces recycled PET pellets from PET containers from post‐consumer collection systems (kerbside and deposit systems).

It comprises the three steps below.

Input

• In step 1, the post‐consumer PET containers are processed into hot caustic washed and dried flakes. This step is performed by ■■■■■.

Decontamination and production of recycled PET material

• In step 2, the flakes are crystallised and decontaminated under high temperature and vacuum.
• In step 3, the decontaminated flakes are extruded to produce pellets.

The operating conditions of the process have been provided to EFSA.

Characterisation of the input

10

3.2.2

According to the applicant, the input material for the recycling process KGL consists of hot washed and dried flakes obtained from PET containers previously used for food packaging, from post‐consumer collection systems (kerbside and deposit systems). A small fraction may originate from non‐food applications. According to the applicant, the proportion will be no more than 5%.

Technical data on the hot washed and dried flakes are provided, such as on physical properties and residual contents of moisture, poly(vinyl chloride) (PVC), adhesives, wood, paper and metals (see Appendix A).

EREMA Basic technology

3.3

Description of the main steps

11

3.3.1

The general scheme of the EREMA Basic technology, as provided by the applicant, is reported in Figure 1. The steps are:

• Decontamination in a ■■■■■ reactor (step 2): The flakes are ■■■■■ fed into a reactor ■■■■■ running under high temperature and vacuum for a predefined residence time.
• Extrusion of the decontaminated flakes (step 3): The flakes, ■■■■■ introduced from the previous reactor, are molten in the extruder. ■■■■■ the melt is converted to pellets.

General scheme of the EREMA Basic technology (provided by the applicant).

The process is run under defined operating parameters12 of temperature, pressure and residence time.

Decontamination efficiency of the recycling process

13

3.3.2

To demonstrate the decontamination efficiency of the recycling process KGL, a challenge test on step 2 was submitted to the EFSA.

PET flakes were contaminated with toluene, chlorobenzene, chloroform, methyl salicylate, phenylcyclohexane, benzophenone and methyl stearate, selected as surrogate contaminants in agreement with the EFSA guidelines (EFSA CEF Panel, 2011) and in accordance with the recommendations of the US Food and Drug Administration (FDA, 2006). The surrogates include different molecular masses 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).

Solid surrogates (benzophenone and methyl stearate) were mixed with liquid surrogates (toluene, chlorobenzene, chloroform, methyl salicylate and phenyl cyclohexane) and added to 5 kg of conventionally recycled14 post‐consumer PET flakes. This masterbatch was added to approximately 50 kg PET flakes and stored for 7 days at 50°C with periodical agitation. The contaminated flakes were washed and rinsed in a batch process at pilot plant scale. The concentration of surrogates in this material was determined.

■■■■■

■■■■■■■■■■ ■■■■■■■■■■■■■■■

■■■■■

• ■■■■■
• ■■■■■
• ■■■■■

■■■■■ concentrations of the surrogates were compared with their initial concentrations in green flakes at the inlet of the reactor to derive the decontamination efficiencies (see Table 1).

The decontamination efficiencies presented in Table 1 were calculated for the average residence time in the ■■■■■ reactor (step 2) in the challenge test.

The decontamination efficiency ranged from 94.9% for benzophenone up to 99.2% for chloroform.

DISCUSSION

4

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 on physical properties and residual contents of PVC, adhesives, wood, paper and metals, were provided for the input materials (i.e. hot caustic washed and dried flakes, step 1). The flakes are produced from PET containers previously used for food packaging, collected through post‐consumer collection systems. However, a small fraction may originate from non‐food applications, such as bottles for soap, mouth wash or kitchen hygiene agents. According to the applicant, the collection system and the process are managed in such a way that this fraction will be no more than 5% in the input stream, as recommended by the EFSA 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 process is adequately described. The washing and drying of the flakes from the collected PET containers (step 1) is conducted by third parties and, according to the applicant, this step is under control. The EREMA Basic technology comprises the ■■■■■ decontamination (step 2) and the extrusion (step 3). The operating parameters of temperature, pressure and residence time for these steps have been provided to EFSA.

A challenge test to measure the decontamination efficiency was conducted at ■■■■■ on step 2. The reactor was operated under pressure and temperature conditions as well as residence time equivalent to or less severe than those of the commercial process. ■■■■■ The Panel considered that this challenge test was performed correctly according to the recommendations of the EFSA guidelines (EFSA, 2008) and concluded that step 2 was critical for the decontamination efficiency of the process. Consequently, temperature, pressure and residence time of step 2 should be controlled to guarantee the performance of the decontamination. These parameters have been provided to EFSA (Appendix C).

The decontamination efficiencies obtained from the challenge test on step 2, ranging from 94.9% to 99.2%, have been used to calculate the residual concentrations of potential unknown contaminants in PET (C res) according to 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 percentages to the reference contamination level of 3 mg/kg PET, the C res for the different surrogates was obtained (Table 2).

TABLE 2: Decontamination efficiency from the challenge test, residual concentrations of the surrogates (C res) related to the reference contamination level and calculated concentrations of the surrogates in PET (C mod) corresponding to a modelled migration of 0.10 and 0.15 μg/kg food after 1 year at 25°C.

According to the evaluation principles (EFSA CEF Panel, 2011), the dietary exposure must not exceed 0.0025 μg/kg bw per day, below which the risk to human health is considered negligible. The C res value should not exceed the modelled concentration in PET (C mod) that, after 1 year at 25°C, results in a migration giving rise to a dietary exposure of 0.0025 μg/kg bw per day. Because the recycled PET is intended for sheets to manufacture trays and containers not intended to pack water, the exposure scenario for toddlers has been applied. A maximum dietary exposure of 0.0025 μg/kg bw per day corresponds to a maximum migration of 0.15 μg/kg of the contaminant into the toddler's food and has been used to calculate C mod (EFSA CEF Panel, 2011). The calculated percentages are reported in Table 2. C res reported in Table 2 (scenario for toddlers) is calculated for 100% recycled PET, for which the risk to human health is demonstrated to be negligible. The Panel noted that the process results in a decontamination efficiency that allows for applying the exposure scenario for infants, corresponding to a maximum migration of 0.1 μg/kg food, for 100% recycled PET (Table 2).The relationship between the key parameters for the evaluation scheme is reported in Appendix B.

On the basis of the provided data from the challenge test and the applied conservative assumptions, the Panel considered that under the given operating conditions, the recycling process KGL using the EREMA Basic technology is able to ensure that the level of migration of unknown contaminants from the recycled PET into food is below the conservatively modelled migrations of 0.10 and 0.15 μg/kg food. At this level, the risk to human health is considered negligible when the recycled PET is used at up to 100% to produce materials and articles intended for contact with all types of foodstuffs including drinking water for long‐term storage at room temperature or below, with or without hotfill.

CONCLUSIONS

5

The Panel considered that the KGL recycling process using the EREMA Basic technology is adequately characterised and that the critical step to decontaminate the PET is identified. Having examined the challenge test provided, the Panel concluded that the temperature, the pressure and the residence time in the ■■■■■ reactor of step 2 are critical for the decontamination efficiency of the process. Therefore, these are the operating parameters to be controlled.

The Panel concluded that the recycling process KGL is able to reduce foreseeable accidental contamination of 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 applied in the challenge test used to measure the decontamination efficiency of the process;
• the input material 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 and contain no more than 5% of PET from non‐food consumer applications;
• the recycled PET is used at up to 100% for the manufacture of materials and articles intended for contact with all types of foodstuffs, including drinking water, for long‐term storage at room temperature or below, with or without hotfill.

Articles made of this recycled PET are not intended to be used in microwave and conventional ovens and such uses are not covered by this evaluation.

RECOMMENDATION

6

The Panel recommended periodic verification that the input material 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

7

Dossier ‘KGL’, August 2023. Submitted on behalf of Korporacja KGL S.A., Poland.

Additional information, April 2024. Submitted on behalf of Korporacja KGL S.A., Poland.

Abbreviationsbwbody weightCEF PanelPanel on Food Contact Materials, Enzymes, Flavourings and Processing AidsCEP PanelPanel on Food Contact Materials, Enzymes and Processing Aids C mod modelled concentration in PET C res residual concentration in PETPETpoly(ethylene terephthalate)PVCpoly(vinyl chloride)rPETrecycled poly(ethylene terephthalate)

CONFLICT OF INTEREST

If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact interestmanagement@efsa.europa.eu.

REQUESTOR

Polish competent authority (Chief Sanitary Inspectorate)

QUESTION NUMBER

EFSA‐Q‐2022‐00837

COPYRIGHT FOR NON‐EFSA CONTENT

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PANEL MEMBERS

José Manuel Barat Baviera, Claudia Bolognesi, Andrew Chesson, Pier Sandro Cocconcelli, Riccardo Crebelli, David Michael Gott, Konrad Grob, Claude Lambré, Evgenia Lampi, Marcel Mengelers, Alicja Mortensen, Gilles Rivière, Vittorio Silano (until 21 December 2020 †), Inger‐Lise Steffensen, Christina Tlustos, Henk Van Loveren, Laurence Vernis, and Holger Zorn.

WAIVER

In accordance with Article 21 of the Decision of the Executive Director on Competing Interest Management a waiver was granted to an expert of the Working Group. Pursuant to Article 21(6) of the aforementioned Decision, the concerned expert was allowed to take part in the preparation and discussion of the scientific output but was not allowed to take up the role of rapporteur within that time frame. Any competing interests are recorded in the respective minutes of the meetings of the CEP Panel Working Group on Recycling Plastics.

LEGAL NOTICE

Relevant information or parts of this scientific output have been blackened in accordance with the confidentiality requests formulated by the applicant pending a decision thereon by EFSA. The full output has been shared with the European Commission, EU Member States (if applicable) and the applicant. The blackening may be subject to review once the decision on the confidentiality requests is adopted by EFSA and in case it rejects some of the confidentiality requests.