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 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 on recycled plastic materials intended to come into contact with foods and Articles 8 and 9 of Regulation (EC) No 1935/20042 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 German Competent Authority (BVL), an application for evaluation of the recycling process WIP, European Union (EU) register No RECYC187. The request has been registered in EFSA's register of received questions under the number EFSA-Q-2019-00758. The dossier was submitted on behalf of WIP Sp. z o.o. Spółka komandytowa, Poland.
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 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.
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).
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.
2.2 Methodologies
The principles followed 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 (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 Panelon 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 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 Cres is not higher than the Cmod, 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.
3 Assessment
3.1 General information3
According to the applicant, the recycling process WIP is intended to recycle food grade PET containers using the Starlinger deCON technology. The recycled PET is intended to be used at up to 100% by converters for the manufacture of materials and articles for direct contact with all kinds of foodstuffs for long-term storage at room temperature, with or without hot-fill, such as bottles for mineral water, soft drinks and beer. The recycled flakes may also be used for sheets, which are thermoformed to make food trays. They are not intended to be used in microwave and conventional ovens.
3.2 Description of the process
3.2.1 General description4
The recycling process WIP produces recycled PET flakes from PET containers from post-consumer collection systems (kerbside, deposit systems and mixed waste collection).
The recycling process comprises the three steps below.
Input
- In step 1, the post-consumer PET containers are processed into washed and dried flakes. This step may be performed by a third party or by the applicant.
Decontamination and production of recycled PET material
- In step 2, the flakes are preheated in batch reactors by a flow of hot gas.
- In step 3, the preheated flakes are submitted to solid-state polycondensation (SSP) in a continuous reactor at high temperature using a combination of vacuum and gas flow.
The operating conditions of the process have been provided to EFSA.
Flakes, the final product of the process, are checked against technical requirements, such as the content in poly(vinyl chloride) (PVC), other plastics and glue as well as intrinsic viscosity.
3.2.2 Characterisation of the input5
According to the applicant, the input material for the recycling process WIP consists of hot washed and dried flakes obtained from PET containers, e.g. bottles, previously used for food packaging, from post-consumer collection systems (kerbside, deposit systems and mixed waste collection). A small fraction may originate from non-food applications. According to the applicant, the proportion will be no more than 5%.
Technical data for the hot washed and dried flakes are provided, such as information on physical properties and on residual contents of moisture, PVC, glue, other plastics than PET, wood, paper and metals (see AppendixA).
3.3 Starlinger deCON technology
3.3.1 Description of the main steps6
The general scheme of the Starlinger deCON technology, as provided by the applicant, is reported in Figure1. The steps are:
- Preheating (step 2): The flakes are preheated in a batch reactor by a flow of hot gas up to the temperature of the next step, the SSP reactor. Several preheaters can be used alternately.
- SSP (step 3): The preheated flakes are fed into the SSP reactor running continuously. The SSP reactor remains under vacuum while a gas flow is periodically applied to support the removal of the contaminants from the flakes. This step increases the intrinsic viscosity of the material and further decontaminates the PET flakes.
The process is run under defined operating parameters7 of temperature, pressure, inert gas flow rate and residence time.
3.3.2 Decontamination efficiency of the recycling process8
To demonstrate the decontamination efficiency of the recycling process WIP a challenge test performed at pilot plant scale was submitted to EFSA.
PET flakes were contaminated with toluene, chlorobenzene, phenylcyclohexane, chloroform, methyl salicylate, benzophenone and methylstearate, 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).
Conventionally recycled9 post-consumer PET flakes were soaked in a mixture of surrogates and stored for 7 days at 50°C with daily agitation. Then they were washed. The concentration of the surrogates in these flakes was determined.
The preheater reactor was filled with washed and dried contaminated flakes (step 2). The preheated flakes were then fed into the SSP reactor (step 3). The flakes were analysed after each step for their residual concentrations of the applied surrogates.
The decontamination efficiency of the process was calculated from the concentrations of the surrogates measured in the washed contaminated flakes before the preheating (before step 2) and after SSP (step 3). The results are summarised in Table1.
| Surrogates | Concentration of surrogates before step 2 (mg/kg PET) | Concentration of surrogates after step 3 (mg/kg PET) | Decontamination efficiency (%) |
|---|---|---|---|
| Toluene | 206.9 | 1.1 | 99.5 |
| Chlorobenzene | 393.1 | 2.1 | 99.5 |
| Chloroform | 120.2 | 3.4 | 97.2 |
| Methyl salicylate | 369 | 4.1 | 98.9 |
| Phenylcyclohexane | 404 | 6.9 | 98.3 |
| Benzophenone | 594.4 | 22.1 | 96.3 |
| Methyl stearate | 743.4 | 27.1 | 96.4 |
- PET: poly(ethylene terephthalate).
As shown in Table1, the decontamination efficiency ranged from 96.3% for benzophenone to 99.5% for toluene and chlorobenzene.
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 physical properties and residual contents of PVC, glue, plastics other than PET, wood, paper and metals, were provided for the input materials, i.e. washed and dried flakes, step 1). These are produced from PET containers, e.g. bottles, 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 in the input stream, this fraction will be no more than 5%, as recommended by the EFSA CEF Panelin 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 in different ways depending on the plant and, according to the applicant, this step is under control. The Starlinger deCON technology comprises the batch preheating (step 2) and continuous SSP (step 3). The operating parameters of temperature, residence time, pressure and gas flow rate for both steps have been provided to EFSA.
A challenge test to measure the decontamination efficiency was conducted at pilot plant scale on process steps 2 and 3. The Panelconsidered that this challenge test was performed correctly according to the recommendations of the EFSA guidelines (EFSA, 2008). The Panelconsidered that steps 2 and 3 were critical for the decontamination efficiency of the process. Consequently, temperature, residence time, pressure and gas flow rate parameters of steps 2 and 3 should be controlled to guarantee the performance of the decontamination (AppendixC).
The decontamination efficiencies obtained for each surrogate, ranging from 96.3% to 99.5%, have been used to calculate the residual concentrations of potential unknown contaminants in PET (Cres) 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; AppendixB). By applying the decontamination efficiency percentage to the reference contamination level of 3 mg/kg PET, the Cres for the different surrogates was obtained (Table2).
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 Cres value should not exceed the modelled concentration in PET (Cmod) that, after 1 year at 25°C, could result in a migration giving rise to a dietary exposure exceeding 0.0025 μg/kg bw per day. Because the recycled PET is intended for the manufacturing of articles containing up to 100% recycled PET, the scenario for infants has been applied. Therefore, the migration of 0.1 μg/kg into food has been used to calculate Cmod (EFSA CEF Panel, 2011). The results of these calculations are shown in Table2. The relationship between the key parameters for the evaluation scheme is reported in AppendixB.
| Surrogates | Decontamination efficiency (%) | Cres for 100% rPET (mg/kg PET) | Cmod (mg/kg PET) |
|---|---|---|---|
| Toluene | 99.5 | 0.02 | 0.09 |
| Chlorobenzene | 99.5 | 0.02 | 0.10 |
| Chloroform | 97.2 | 0.08 | 0.10 |
| Methyl salicylate | 98.9 | 0.03 | 0.13 |
| Phenylcyclohexane | 98.3 | 0.05 | 0.14 |
| Benzophenone | 96.3 | 0.11 | 0.16 |
| Methyl stearate | 96.4 | 0.11 | 0.32 |
- PET: poly(ethylene terephthalate);rPET: recycled poly(ethylene terephthalate).
As Cres values are lower than the corresponding modelled concentrations in PET (Cmod), the Panelconsidered that the recycling process under evaluation using the Starlinger deCON 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 μg/kg food, at which the risk to human health would be negligible.
4 Conclusions
The Panelconsidered that the process WIP using the Starlinger deCON technology is adequately characterised and that the main steps used to recycle the PET flakes into decontaminated PET flakes have been identified. Having examined the challenge test provided, the Panelconcluded that temperature, residence time, pressure and gas flow rate of the preheating (step 2) and the decontamination in the continuous SSP reactor (step 3), which were included in the challenge test, are critical for the decontamination efficiency.
The Panelconsidered that the recycling process WIP 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 obtained from the process WIP is used at 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 hot-fill.
Trays 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.
5 Recommendations
The Panelrecommended 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
- Dossier ‘WIP’. November 2019. Submitted on behalf of WIP Sp. z o.o. Spółka komandytowa, Poland.
Notes
References
Abbreviations
-
- bw
-
- body weight
-
- CEF Panel
-
- Panelon Food Contact Materials, Enzymes, Flavourings and Processing Aids
-
- CEP Panel
-
- Panelon Food Contact Materials, Enzymes and Processing Aids
-
- Cmod
-
- modelled concentration in PET
-
- Cres
-
- residual concentrations in PET
-
- PET
-
- poly(ethylene terephthalate)
-
- PVC
-
- poly(vinyl chloride)
-
- rPET
-
- recycled poly(ethylene terephthalate)
-
- SSP
-
- solid-state polycondensation
Appendix A – Technical data of the washed flakes as provided by the applicant10
| Parameter | Value |
|---|---|
| Moisture | < 2% |
| PVC content | < 100 mg/kg |
| Other plastic than PET | < 500 mg/kg |
| Flakes with glue | < 4,000 mg/kg |
| Wood, paper content | < 100 mg/kg |
| Metal content | < 500 mg/kg |
| Total contamination other than water | < 2,000 mg/kg |
| Bulk density | 250–750 kg/m3 |
| Flakes size | 1–15 mm |
| Flakes thickness | 50–1,200 μm |
| Proportion of PET from non-food consumer applications in the input for recycling | ≤ 5% |
Appendix B – Relationship between the key parameters for the evaluation scheme (EFSA CEF Panel, 2011)
*Default scenario (infant). For adults and toddlers, the migration criterion will be 0.75 and 0.15 μg/kg food, respectively. The figures are derived from the application of the human exposure threshold value of 0.0025 μg/kg bw per day applying a factor of 5 related to the overestimation of modelling.
Appendix C – Tableon operational parameters (Confidential Information)11
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