SCIENTIFIC OPINIONADOPTED: 16 September 2021
doi: 10.2903/j.efsa.2021.6869

Safety assessment of the process UTSUMI RECYCLESYSTEMS, based on Starlinger deCON technology, used torecycle post-consumer PET into food contact materials
EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP),
, Jose Manuel Barat Baviera, Claudia Bolognesi, Andrew Chesson,
Claude Lambre
Pier Sandro Cocconcelli, Riccardo Crebelli, David Michael Gott, Konrad Grob,re, Inger-Lise Steffensen, Christina Tlustos,Marcel Mengelers, Alicja Mortensen, Gilles Rivie
Henk Van Loveren, Laurence Vernis, Holger Zorn, Vincent Dudler, Maria Rosaria Milana,tima Tavares Pocßas, Alexandros Lioupis andConstantine Papaspyrides, Maria de Fa
Evgenia Lampi

Abstract
The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of
the recycling process UTSUMI RECYCLE SYSTEMS (EU register number RECYC223), which uses theStarlinger deCON technology. The input material is hot washed and dried poly(ethylene terephthalate)(PET) ﬂakes originating from collected post-consumer PET containers, e.g. bottles, including no morethan 5% PET from non-food consumer applications. The ﬂakes are preheated before being submitted
to solid-state polycondensation (SSP) in a continuous reactor at high temperature under vacuum and. Having examined the challenge test provided, the Panel concluded that the preheating (step2) and the decontamination in the
SSP reactor (step 3) are critical in determining thedecontamination efﬁciency of the process. The operating parameters to control the performance of
these critical steps are temperature, pressure, residence time and. 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 migration of 0.1 lg/kg food. Therefore, thePanel concluded that the recycled PET obtained from this process is not considered to be of safetyconcern, when 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 hotﬁll. The ﬁnal articles
made of this recycled PET are not intended to be used in microwave or conventional ovens and suchuses are not covered by this evaluation.
© 2021 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalfof European Food Safety Authority.

Keywords: Starlinger deCON, UTSUMI RECYCLE SYSTEMS INC., food contact materials, plastic, poly
(ethylene terephthalate) (PET), recycling process, safety assessment€r Verbraucherschutz und Lebensmittelsicherheit, Germany
Requestor: Bundesamt fu
Question number: EFSA-Q-2021-00161
Correspondence: ﬁp@efsa.europa.eu

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PET recycling process UTSUMI RECYCLE SYSTEMS (Starlinger deCON)

 Manuel Barat Baviera, Claudia Bolognesi, Andrew Chesson, Pier Sandro
Panel members: Jose, Evgenia Lampi, Marcel
Cocconcelli, Riccardo Crebelli, David Michael Gott, Konrad Grob, Claude Lambrere, Vittorio Silano (until 21 December 2020 †), Inger-Lise
Mengelers, Alicja Mortensen, Gilles Rivie
Steffensen, Christina Tlustos, Henk Van Loveren, Laurence Vernis and Holger Zorn.
Note: The full opinion will be published in accordance with Article 10(6) of Regulation (EC) No 1935/2004
once the decision on conﬁdentiality, in line with Article 20(3) of the Regulation, will be received from theEuropean Commission. Technical details on recycling steps 2 and 3, details of the performed challenge
test (Section 3.3.2) and the text and table on the operational parameters (Appendix C) have been
provided under conﬁdentiality and they are redacted awaiting the decision of the Commission.
Declarations of interest: The declarations of interest of all scientiﬁc experts active in EFSA’s work
are available at https://ess.efsa.europa.eu/doi/doiweb/doisearch.
Acknowledgements: The Panel wishes to thank Marcello Laganaro for the support provided to thisscientiﬁc output.
Suggested citation: EFSA CEP Panel (EFSA Panel on Food Contact Materials, Enzymes and C, Barat Baviera JM, Bolognesi C, Chesson A, Cocconcelli PS, Crebelli R, Gott
Processing Aids), Lambrere G, Steffensen I-L, Tlustos C, Van Loveren H, Vernis L,
DM, Grob K, Mengelers M, Mortensen A, Rivie
Zorn H, Dudler V, Milana MR, Papaspyrides C, Tavares Pocßas MF, Lioupis A and Lampi E, 2021.
Scientiﬁc Opinion on the safety assessment of the process UTSUMI RECYCLE SYSTEMS, based onStarlinger deCON technology, used to recycle post-consumer PET into food contact materials. EFSA
Journal 2021;19(10):6869, 12 pp. https://doi.org/10.2903/j.efsa.2021.6869
ISSN: 1831-4732© 2021 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalfof 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, a European agency funded by the European Union.

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Table of contents
Abstract................................................................................................................................................... 1
1.
Introduction................................................................................................................................... 4
1.1. Background and Terms of Reference as provided by the requestor..................................................... 4
2.
Data and methodologies ................................................................................................................. 4
2.1. Data.............................................................................................................................................. 4
2.2. Methodologies................................................................................................................................ 5
3.
Assessment.................................................................................................................................... 5
3.1. General information ........................................................................................................................ 5
3.2. Description of the process............................................................................................................... 5
3.2.1. General description......................................................................................................................... 5
3.2.2. Characterisation of the input ........................................................................................................... 6
3.3. Starlinger deCON technology........................................................................................................... 6
3.3.1. Description of the main steps .......................................................................................................... 6
3.3.2. Decontamination efﬁciency of the recycling process .......................................................................... 7
3.4. Discussion ..................................................................................................................................... 7
4.
Conclusions.................................................................................................................................... 8
5.
Recommendations .......................................................................................................................... 9
References............................................................................................................................................... 9Abbreviations ........................................................................................................................................... 9
Appendix A – Technical data of the washed ﬂakes as provided by the applicant ............................................ 10
Appendix B – Relationship between the key parameters for the evaluation scheme (EFSA CEF Panel, 2011).... 11
Appendix C – Table of operational parameters (Conﬁdential Information)...................................................... 12

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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 the recycled plastic isfrom 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 ofMember States, which transmit the applications to EFSA for evaluation.
€r Verbraucherschutz und Lebensmittelsicherheit,
In this case, EFSA received, from the Bundesamt fu
Germany, an application for evaluation of the recycling process UTSUMI RECYCLE SYSTEMS, European
Union (EU) register No RECYC223. The request has been registered in EFSA’s register of received
questions under the number EFSA-Q-2021-00161. The dossier was submitted on behalf of UTSUMIRECYCLE SYSTEMS INC., Japan.
According to Article 5 of Regulation (EC) No 282/2008 on recycled plastic materials intended tocome into contact with foods, EFSA is required to carry out risk assessments on the risks originatingfrom the migration of substances from recycled food contact plastic materials and articles into foodand 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 tohuman health. The poly(ethylene terephthalate) (PET) materials and articles used as input of theprocess 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 theevaluation:••

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.

1

Commission Regulation (EC) No 282/2008 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.
2
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 risks associated with the use of recycled plastic materials and articles in contact with foodcome from the possible migration of chemicals into the food in amounts that would endanger humanhealth. The quality of the input, the efﬁciency of the recycling process to remove contaminants as wellas 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 thedecontamination efﬁciency of a recycling technology or process, obtained from a challenge test withsurrogate 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 concentrationof each surrogate contaminant in recycled PET (Cres) is compared with a modelled concentration of thesurrogate 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 withstructural 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 notconsidered 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 ontransparency 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 UTSUMI RECYCLE SYSTEMS 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% for the manufacture of materials and articles for direct contact with all kinds offoodstuffs for long-term storage at room temperature, with or without hotﬁll, such as bottles formineral water, soft drinks and beer. The recycled ﬂakes may also be used for sheets, which arethermoformed to make food trays. The ﬁnal articles are not intended to be used in microwave or
conventional ovens.

3.2.

Description of the process

3.2.1.

General description4

The recycling process UTSUMI RECYCLE SYSTEMS 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.
In step 3, the preheated ﬂakes are submitted to solid-state polycondensation (SSP) in areactor at high temperature using a combination of vacuum and.

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 thecontent of poly(vinyl chloride) (PVC), other plastics and glues as well as intrinsic viscosity.
3
4

Technical dossier, Section 2.1.
Technical dossier, Section 2.1.1.

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3.2.2.

Characterisation of the input5

According to the applicant, the input material for the recycling process UTSUMI RECYCLE SYSTEMS
consists of hot washed and dried ﬂakes obtained from PET containers, e.g. bottles, previously used forfood 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, theproportion will be no more than 5%.
Technical data for the hot washed and dried ﬂakes are provided, such as information on physicalproperties and on residual contents of moisture, PVC, glues, other plastics than PET, wood, paper andmetals (see Appendix A).

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 Figure 1. The steps are:••Preheating (step 2): The ﬂakes are preheated in a batch reactor
up to thetemperature 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. The SSP
reactor remains under vacuum.

Figure 1: General scheme of the technology (provided by the applicant)
The process is run under deﬁned operating parameters7 of temperature, pressure, gas ﬂow rate
and residence time.
5

Technical dossier, Section 2.2.2 and Appendix 3.
Technical dossier, Section 2.2.1.
7
In accordance with Art. 9 and 20 of Regulation (EC) No 1935/2004, the parameters were provided to EFSA by the applicant
and made available to the Member States and the European Commission (see Appendix C).
6

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3.3.2.

Decontamination efﬁciency of the recycling process8

To demonstrate the decontamination efﬁciency of the recycling process UTSUMI RECYCLESYSTEMS, a challenge test performed atscale was submitted to EFSA.
PET ﬂakes were contaminated with toluene, chlorobenzene, phenylcyclohexane, chloroform, methyl
salicylate, 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 andpolarities to cover possible chemical classes of contaminants of concern and were demonstrated to besuitable to monitor the behaviour of PET during recycling (EFSA, 2008).
The concentration of thesurrogates in these ﬂakes was determined.
The preheater reactor was ﬁlled withcontaminated ﬂakes (step 2). The
preheated ﬂakes were then fed into the SSP reactor (step 3). The ﬂakes were analysed after each stepfor their residual concentrations of the applied surrogates.
The decontamination efﬁciency of the process was calculated from the concentrations of thesurrogates measured in the washed contaminated ﬂakes before the preheating (before step 2) andafter SSP (step 3). The results are summarised in Table 1.
Table 1:

Efﬁciency of the decontamination of the Starlinger deCON technology in the challenge test

Surrogates

Concentration of surrogates Concentration of surrogates Decontamination
before step 2 (mg/kg PET) after step 3 (mg/kg PET)
efﬁciency (%)

Toluene

206.9

1.1

99.5

Chlorobenzene
Chloroform

393.1
120.2

2.1
3.4

99.5
97.2

Methyl salicylate
Phenylcyclohexane

369.0
404.0

4.1
6.9

98.9
98.3

Benzophenone

594.4

22.1

96.3

Methyl stearate

743.4

27.1

96.4

PET: poly(ethylene terephthalate).

As shown in Table 1, the decontamination efﬁciency ranged from 96.3% for benzophenone to99.5% 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, glues,
plastics other than PET, wood, paper and metals, were provided for the input materials (i.e. washedand dried ﬂakes, step 1). These are produced from PET containers, e.g. bottles, previously used forfood 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 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 in different ways depending on the plant and, according to theapplicant, this step is under control. The Starlinger deCON technology comprises the batch preheating(step 2) andSSP (step 3). The operating parameters of temperature, residence time,pressure and gas ﬂow rate for both steps have been provided to EFSA.
8
9

Technical dossier, Section 2.2.3 and Appendix 2.
Conventional recycling commonly includes sorting, grinding, washing and drying steps and produces washed and dried ﬂakes.

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A challenge test to measure the decontamination efﬁciency was conducted atscale onprocess steps 2 and 3. The Panel considered that this challenge test was performed correctly
according to the recommendations of the EFSA guidelines (EFSA, 2008). The Panel considered thatsteps 2 and 3 were critical for the decontamination efﬁciency of the process. Consequently,
temperature, residence time, pressure andparameters of steps 2 and 3 should becontrolled to guarantee the performance of the decontamination (Appendix C).
The decontamination efﬁciencies obtained for each surrogate, ranging from 96.3% to 99.5%, havebeen 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 forsafety evaluation of a mechanical recycling process to produce recycled PET’ (EFSA CEF Panel, 2011;
Appendix B). By applying the decontamination efﬁciency percentage to the reference contaminationlevel of 3 mg/kg PET, the Cres for the different surrogates was obtained (Table 2).
According to the evaluation principles (EFSA CEF Panel, 2011), the dietary exposure must notexceed 0.0025 lg/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 lg/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 lg/kg into food has
been used to calculate Cmod (EFSA CEF Panel, 2011). The results of these calculations are shown in
Table 2. The relationship between the key parameters for the evaluation scheme is reported inAppendix B.
Table 2:

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

Cres for 100% rPET
(mg/kg PET)

Cmod (mg/kg PET)

Toluene

99.5

0.02

0.09

Chlorobenzene
Chloroform

99.5
97.2

0.02
0.08

0.10
0.10

Methyl salicylate
Phenylcyclohexane

98.9
98.3

0.03
0.05

0.13
0.14

Benzophenone

96.3

0.11

0.16

Methyl stearate

96.4

0.11

0.32

Surrogates

PET: poly(ethylene terephthalate); rPET: recycled poly(ethylene terephthalate).

As Cres values are lower than the corresponding modelled concentrations in PET (Cmod), thePanel considered that under the given operating conditions the recycling process UTSUMI RECYCLESYSTEMS 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 migrationof 0.1 lg/kg food, at which the risk to human health would be negligible.
The Panel noted that the input of the process originates from Japan. In the absence of data on
misuse contamination of this input, the Panel used the reference contamination of 3 mg/kg PET (EFSA
CEF Panel, 2011) that was derived from experimental data from an EU survey. Accordingly, therecycling process under evaluation using a Starlinger deCON technology is able to ensure that the levelof unknown contaminants in recycled PET is below a calculated concentration (Cmod) corresponding toa modelled migration of 0.1 lg/kg food.

4.

Conclusions

The Panel considered that the process UTSUMI RECYCLE SYSTEMS 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, thePanel concluded that temperature, residence time, pressure andof the preheating (step2) and the decontamination in the
SSP reactor (step 3), which were included in thechallenge test, are critical for the decontamination efﬁciency.

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The Panel concluded that the recycling process UTSUMI RECYCLE SYSTEMS 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:i)

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;ii) the input material of the process is washed and dried post-consumer PET ﬂakes originatingfrom 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-foodconsumer applications.
iii) the recycled PET obtained from the process UTSUMI RECYCLE SYSTEMS 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 hotﬁll.
The ﬁnal 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.

5.

Recommendations

The Panel recommended periodic veriﬁcation that the input material to be recycled originates frommaterials and articles that have been manufactured in accordance with the EU legislation on foodcontact 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. Criticalsteps 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.

6.

Documentation provided to EFSA
1) Dossier ‘UTSUMI RECYCLE SYSTEMS’. March 2021. Submitted on behalf of UTSUMI RECYCLESYSTEMS INC., Japan.

References
EFSA (European Food Safety Authority), 2008. Guidelines for the submission of an application for safety evaluationby the EFSA of a recycling process to produce recycled plastics intended to be used for manufacture ofmaterials and articles in contact with food, prior to its authorisation. EFSA Journal 2008,6(7):717, 12 pp.
https://doi.org/10.2903/j.efsa.2008.717
EFSA (European Food Safety Authority), 2009. Guidance of the Scientiﬁc Committee on transparency in thescientiﬁc aspects of risk assessments carried out by EFSA. Part2: general principles. EFSA Journal 2009;7(5):1051, 22 pp. https://doi.org/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. https://doi.org/10.2903/j.efsa.2011.2184
FDA (Food and Drug Administration), 2006. Guidance for Industry: Use of Recycled Plastics in Food Packaging:Chemistry Considerations. Available online: https://www.fda.gov/regulatory-information/search-fda-guidancedocuments/guidance-industry-use-recycled-plastics-food-packaging-chemistry-considerations

Abbreviations
bw
CEF Panel
CEP Panel
Cmod
Cres
PET
PVC
rPET
SSP

body weight
Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids
Panel on Food Contact Materials, Enzymes and Processing Aids
modelled concentration in PET
residual concentrations in PET
poly(ethylene terephthalate)poly(vinyl chloride)
recycled poly(ethylene terephthalate)solid-state polycondensationwww.efsa.europa.eu/efsajournal

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Appendix A – Technical data of the washed ﬂakes as provided by theapplicant10
Parameter

Value

Moisture< 2%

Particle size
Bulk density

1–15 mm
250–750 kg/m3

Thickness
Other materials than PET

50–1,200 lm< 500 mg/kg

Flakes with adhesive
Wood, paper< 4,000 mg/kg< 100 mg/kg

Metal content
PVC content< 500 mg/kg< 100 mg/kg

Contamination other than water< 2,000 mg/kg

PET from non-food applications≤ 5%

PVC: poly(vinyl chloride); PET: poly(ethylene terephthalate).

10

Technical dossier, Appendix 3.

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

RECYCLING PROCESS WITH DECONTAMINATIONMIGRATION IN FOODTECHNOLOGY

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

Decontamination efficiency measured using achallenge test
Eff (%)PLASTIC OUTPUT

PLASTIC IN CONTACT

Residual contamination in the recycled PET

Cmod modelled residual contamination in
the recycled PETCres = 3 (mg/kg PET) × (1–Eff %)No

YesCres < Cmod

No safety concern

Further considerations*Default scenario (infant). For adults and toddlers, the migraon criterion will be 0.75 and 0.15 μg/kg
food, respecvely. The ﬁgures are derived from the applicaon of the human exposure thresholdvalue of 0.0025 μg/kg bw per day applying a factor of 5 related to the overesmaon of modelling.

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Appendix C – Table of operational parameters (Conﬁdential Information)11

11

Technical report, Section 2.2.3 and Appendix 2.

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