SCIENTIFIC OPINIONADOPTED: 22 March 2022
doi: 10.2903/j.efsa.2022.7278

Safety assessment of the process Utsumi, based on the
EREMA Basic technology, used to recycle 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, Marcel Mengelers,re, Inger-Lise Steffensen, Christina Tlustos, Henk Van Loveren,
Alicja Mortensen, Gilles Rivie
Laurence Vernis, Holger Zorn, Vincent Dudler, Maria Rosaria Milana, Constantine Papaspyrides,
tima Tavares Pocßas, Alexandros Lioupis and Evgenia Lampi
Maria de Fa

Abstract
The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of
the recycling process Utsumi (EU register number RECYC232), which uses the EREMA Basictechnology. 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 fromnon-food consumer applications. The ﬂakes are heated in a continuous reactor under vacuum before
being extruded. Having examined the challenge test provided, the Panel concluded that the continuous
reactor (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 aretemperature, pressure and residence time. It was demonstrated that this recycling process is able toensure a level of migration of potential unknown contaminants into food below the conservatively
modelled migration of 0.1 lg/kg food, derived from the exposure scenario for infants when such
recycled PET is used at up to 100%. Therefore, the Panel concluded that the recycled PET obtained
from this process is not considered to be 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. 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.
© 2022 Wiley-VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.
Keywords: EREMA Basic, 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-2020-00624
Correspondence: ﬁp@efsa.europa.eu

www.efsa.europa.eu/efsajournal

EFSA Journal 2022;20(5):7278

PET recycling process Utsumi (EREMA Basic)

 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
Mengelers, Alicja Mortensen, Gilles Riviere, Vittorio Silano (until 21 December 2020 †), Inger-Lise
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 the European Commission. Technical details on recycling step 3 (Section 3.3.1), details of theperformed 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.
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, 2022.
Scientiﬁc opinion on the safety assessment of the process Utsumi, based on the EREMA Basictechnology, used to recycle post-consumer PET into food contact materials. EFSA Journal 2022;20(5):7278, 13 pp. https://doi.org/10.2903/j.efsa.2022.7278
ISSN: 1831-4732© 2022 Wiley-VCH Verlag GmbH & Co. KgaA on behalf of the 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.
† Deceased.
www.efsa.europa.eu/efsajournal

2

EFSA Journal 2022;20(5):7278

PET recycling process Utsumi (EREMA Basic)

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. EREMA Basic technology ................................................................................................................. 6
3.3.1. Description of the main steps .......................................................................................................... 6
3.3.2. Decontamination efﬁciency of the recycling process .......................................................................... 6
3.4. Discussion ..................................................................................................................................... 7
4.
Conclusions.................................................................................................................................... 95.
Recommendation ........................................................................................................................... 9
6.
Documentation provided to EFSA .................................................................................................... 9
References............................................................................................................................................... 9Abbreviations ........................................................................................................................................... 10
Appendix A – Technical speciﬁcations of the washed ﬂakes as provided by the applicant................................ 11
Appendix B – Relationship between the key parameters for the evaluation scheme (EFSA CEF Panel, 2011).... 12
Appendix C – Table of operational parameters (Conﬁdential Information)...................................................... 13

www.efsa.europa.eu/efsajournal

3

EFSA Journal 2022;20(5):7278

PET recycling process Utsumi (EREMA Basic)

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, European Union (EU) register
No RECYC232. The request has been registered in EFSA’s register of received questions under thenumber EFSA-Q-2020-00624. The dossier was submitted on behalf of Utsumi recycle 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).
Additional information was provided by the applicant during the assessment process in response torequests from EFSA sent on 5 May 2021, 11 October 2021 and 22 December 2021 (see‘Documentation provided to EFSA’).
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.
www.efsa.europa.eu/efsajournal

4

EFSA Journal 2022;20(5):7278

PET recycling process Utsumi (EREMA Basic)

2.2.

Methodologies

The principles followed for the evaluation are described here. The risks associated with the use ofrecycled plastic materials and articles in contact with food come from the possible migration ofchemicals into the food in amounts that would endanger human health. The quality of the input, theefﬁciency of the recycling process to remove contaminants as well as the intended use of the recycledplastic 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 µg/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 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 the manufacture of materials and articles to be used in direct contact with all kinds of foodstuffs,
such as bottles for mineral water, soft drink and beer as well as sheet/thermoforming applications forfood containers, for long-term storage at room temperature, with or without hotﬁll. The ﬁnal articles
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 Utsumi produces recycled PET pellets from PET containers from postconsumer collection systems (kerbside and deposit systems).
The recycling process 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 the applicant.

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.
Pellets, the ﬁnal product of the process, are checked against technical requirements, such as
intrinsic viscosity, colour and black spots.

3
4

Technical dossier, Section 3.1.1.
Technical dossier, Sections 3.1.1, 3.2.1, 3.2.4.

www.efsa.europa.eu/efsajournal

5

EFSA Journal 2022;20(5):7278

PET recycling process Utsumi (EREMA Basic)

3.2.2.

Characterisation of the input5

According to the applicant, the input material for the recycling process Utsumi consists of hot
washed and dried ﬂakes obtained from PET containers, e.g. bottles, previously used for foodpackaging, 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 morethan 5%.
Technical speciﬁcations on the hot washed and dried ﬂakes were provided, such as information on
physical properties and on residual contents of moisture, poly(vinyl chloride) (PVC), glue, polyoleﬁns,
cellulose and metals (see Appendix A).

3.3.

EREMA Basic technology

3.3.1.

Description of the main steps6

The general scheme of the EREMA Basic technology, as provided by the applicant, is reported in
Figure 1. The steps are:•Decontamination in a continuous reactor (step 2):

The ﬂakes are continuously fed into a reactor equipped with a rotating device, running under hightemperature and vacuum for a pre-deﬁned minimum residence time.

•

Extrusion of the decontaminated ﬂakes (step 3):

The ﬂakes, continuously introduced from the previous reactor, are molten in the extruder.

Figure 1: General scheme of the technology (provided by the applicant)
The process is run under deﬁned operating parameters7 of temperature, pressure and residencetime.

3.3.2.

Decontamination efﬁciency of the recycling process8

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

5

Technical dossier, Section 3.2.2.
Technical dossier, Section 3.2.1.
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).
8Technical dossier, Section 3.2.3 and Appendix E.
6www.efsa.europa.eu/efsajournal

6

EFSA Journal 2022;20(5):7278

PET recycling process Utsumi (EREMA Basic)

PET ﬂakes were contaminated with toluene, chlorobenzene, chloroform, methyl salicylate,phenylcyclohexane, benzophenone and methyl stearate, selected as surrogate contaminants inagreement with the EFSA guidelines (EFSA CEF Panel, 2011) and in accordance with therecommendations of the US Food and Drug Administration (FDA, 2006). The surrogates include
different molecular masses and polarities to cover possible chemical classes of contaminants ofconcern and were demonstrated to be suitable to monitor the behaviour of PET during recycling(EFSA, 2008).
Solid surrogates (benzophenone and methyl stearate) and liquid surrogates (toluene,
chlorobenzene, chloroform, methyl salicylate and phenyl cyclohexane) were added to 25 kg ofconventionally recycled9 post-consumer PET ﬂakes. Sixteen such barrels were prepared and stored for
7 days at 50°C with periodical agitation. Afterwards, the contaminated ﬂakes were rinsed with 10%
ethanol. For each batch, the concentrations of the surrogates in the ﬂakes were determined. The
barrels were shipped to the EREMA facilities, where they were merged into two batches of 200 kg
each.
Step 2 of the EREMA Basic technology was challenged at industrial scale. The contaminated ﬂakes(200 kg) were fed into the decontamination reactor. Samples were taken at the inlet and outlet of thereactor, then analysed for their concentrations of the applied surrogates.
Instead of being operated continuously (as it would be in the industrial process), the challenge test
was run inmode. The Panel considered that the reactor ran at the same temperature andpressure as foreseen for the industrial process. In order to prove the representativeness of theresidence time of the ﬂakes in the challenge test, an additional challenge test running in continuousmode was provided. In this test, a mixture of green (contaminated) and clear (non-contaminated)
ﬂakes was challenged. At different residence times, the ratio of green and clear ﬂakes exiting thereactor was determined. Based on the results, the Panel concluded that the residence time in thechallenge test
reactor corresponded to the minimum residence time in the industrial continuous
reactor.
The decontamination efﬁciency of the process was calculated from the concentrations of thesurrogates measured in the washed contaminated ﬂakes introduced and those exiting the EREMA Basicreactor (step 2). The results are summarised in Table 1.
Table 1:

Efﬁciency of the decontamination of the continuous reactor (step 2) in the challenge test
Concentration of surrogates
before step 2 (mg/kg PET)

Concentration of surrogates
after step 2 (mg/kg PET)

Decontamination
efﬁciency (%)

Toluene

391.3

0.9

99.8

Chlorobenzene
Chloroform

699.5
166.7

3.0
4.2

99.6
97.5

Methyl salicylate
Phenylcyclohexane

982.6
625.3

6.4
15.4

99.3
97.5

Benzophenone

927.1

22.4

97.6

Methyl stearate

1,599.1

15.8

99.0

Surrogates

PET: poly(ethylene terephthalate).

The decontamination efﬁciency ranged from 97.5% for chloroform and phenylcyclohexane up to
99.8% for toluene.

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 speciﬁcations, such as information on physical properties and residual contents of PVC,
glue, polyoleﬁns and metals, were provided for the input materials (i.e. hot caustic washed and dried
ﬂakes, step 1). These are produced from PET containers, e.g. bottles, previously used for foodpackaging, 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.
9

Conventional recycling commonly includes sorting, grinding, washing and drying steps and produces washed and dried ﬂakes.

www.efsa.europa.eu/efsajournal

7

EFSA Journal 2022;20(5):7278

PET recycling process Utsumi (EREMA Basic)

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-house and, according to the applicant, this step is under control.
The EREMA Basic technology comprises the continuous decontamination reactor (step 2) and extrusion(step 3). The operating parameters of temperature, pressure and residence time have been provided
to EFSA.
A challenge test to measure the decontamination efﬁciency was conducted at industrial plant scaleon the process step 2 (decontamination reactor). The reactor was operated under pressure andtemperature conditions as well as residence time equivalent to those of the commercial process. Since
step 2 was conducted with only contaminated ﬂakes, cross-contamination could not occur. The
Panel considered that this challenge test was performed correctly according to the recommendationsof the EFSA guidelines (EFSA, 2008) and that step 2 was critical for the decontamination efﬁciency ofthe process. Consequently, temperature, pressure and residence time of step 2 of the process should
be controlled to guarantee the performance of the decontamination (Appendix C).
The decontamination efﬁciencies obtained for each surrogate, ranging from 97.5% to 99.8%, 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 percentages to the reference contamination level 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 could result, after 1 year
at 25°C, 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 manufacture of containers (also for drinking water), the exposure
scenario for infants has been applied, (water could be used to prepare infant formula). A maximum
dietary exposure of 0.0025 lg/kg bw per day corresponds to a maximum migration of 0.1 lg/kg of thecontaminant into the infant’s food and has been used to calculate Cmod (EFSA CEF Panel, 2011). Cres
reported in Table 2 is calculated for 100% recycled PET, for which the risk to human health isdemonstrated to be negligible. The relationship between the key parameters for the evaluation scheme
is reported in Appendix 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 µg/kg food after 1 year at 25°C

Surrogates

Cres for 100% rPET
(mg/kg PET)

Decontamination
efﬁciency (%)

Cmod(mg/kg PET)

Toluene

99.8

0.01

0.09

Chlorobenzene
Chloroform

99.6
97.5

0.01
0.08

0.09
0.10

Methyl salicylate
Phenylcyclohexane

99.3
97.5

0.02
0.08

0.13
0.14

Benzophenone

97.6

0.07

0.16

Methyl stearate

99.0

0.03

0.32

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

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
Utsumi 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 migration of
0.1 lg/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 offoodstuffs including drinking water.
www.efsa.europa.eu/efsajournal

8

EFSA Journal 2022;20(5):7278

PET recycling process Utsumi (EREMA Basic)

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 the EREMA Basic 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 Utsumi recycling process using the EREMA Basic technology isadequately characterised and that the critical step to decontaminate the PET is identiﬁed. Having
examined the challenge test provided, the Panel concluded that temperature, pressure and residence
time in the continuous reactor of step 2 are critical for the decontamination efﬁciency.
The Panel concluded that the recycling process Utsumi is able to reduce foreseeable accidental
contamination of post-consumer food contact PET to a concentration that does not give rise toconcern for a risk to human health if:
i)
ii)

iii)

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 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 is from non-foodconsumer applications;the recycled PET is used at up to 100% for the manufacture of materials and articles forcontact with all types of foodstuff, for long-term storage at room temperature, including
drinking water, with or without hotﬁll.

The ﬁnal articles made of this recycled PET are not intended to be used in microwave andconventional ovens and such uses are not covered by this evaluation.

5.

Recommendation

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.
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 underconditions at least as severe as those in the challenge test used to measure the decontamination
efﬁciency of the process.

6.

Documentation provided to EFSA
Dossier ‘Utsumi’. September 2020. Submitted on behalf of Utsumi recycle Systems Inc, Japan.
Additional information, August 2021. Submitted on behalf of Utsumi recycle Systems Inc, Japan.
Additional information, October 2021. Submitted on behalf of Utsumi recycle Systems Inc, Japan.
Additional information, January 2022. Submitted on behalf of Utsumi recycle Systems 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

www.efsa.europa.eu/efsajournal

9

EFSA Journal 2022;20(5):7278

PET recycling process Utsumi (EREMA Basic)

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

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 concentration in PET
poly(ethylene terephthalate)poly(vinyl chloride)
recycled poly(ethylene terephthalate)www.efsa.europa.eu/efsajournal

10

EFSA Journal 2022;20(5):7278

PET recycling process Utsumi (EREMA Basic)

Appendix A – Technical speciﬁcations of the washed ﬂakes as provided by
the applicant10
Parameter

Value

Moisture max.
Moisture variation

1.5%
 1.5%/h

Bulk density
Material temperature

300–450 kg/m3
10–35°C

PVC max.
Glue max.

25 mg/kg
1,000 mg/kg

Polyoleﬁns max.
Cellulose (paper, wood)

50 mg/kg
100 mg/kg

Metals max.

100 mg/kg

PET dust max.

0.5%

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

10

Technical report, Sections 3.2.1 and 3.10 (Appendix F).

www.efsa.europa.eu/efsajournal

11

EFSA Journal 2022;20(5):7278

PET recycling process Utsumi (EREMA Basic)

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 0.0025 µg/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) x (1–Eff %)YesCres < Cmod

No safety concern

No

Further considerations*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 thresholdvalue of 0.0025 lg/kg bw per day applying a factor of 5 related to the overestimation of modelling.

www.efsa.europa.eu/efsajournal

12

EFSA Journal 2022;20(5):7278

PET recycling process Utsumi (EREMA Basic)

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

11

Technical report, Sections 3.2.1. and 3.10 (Appendix F).

www.efsa.europa.eu/efsajournal

13

EFSA Journal 2022;20(5):7278