Scientific Opinion on the safety evaluation of the process “PETUK SSP” for production of recycled post-consumer PET for use in food contact materials

Tabs

Article
Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids
EFSA Journal
EFSA Journal 2012;10(8):2826 [16 pp.].
doi
10.2903/j.efsa.2012.2826
Panel members at the time of adoption
Ulla Beckman Sundh, Mona-Lise Binderup, Leon Brimer, Laurence Castle, Karl-Heinz Engel, Roland Franz, Nathalie Gontard, Rainer Gürtler, Trine Husøy, Klaus-Dieter Jany, Catherine Leclercq, Jean-Claude Lhuguenot, Wim Mennes, Maria Rosaria Milana, Maria de Fatima Pocas, Iona Pratt, Kettil Svensson, Fidel Toldrá, Detlef Wölfle.
Acknowledgements

The European Food Safety Authority wishes to thank the members of the Working Group on Recycling processes, Laurence Castle, Vincent Dudler, Nathalie Gontard, Eugenia Lampi, Maria Rosaria Milana, Cristina Nérin, Costas Papaspyrides and Karla Pfaff for their contribution to the draft opinion.

Possible conflict of interest
One member of the Panel did not participate in the discussion because of potential conflicts of interest identified in accordance with the EFSA policy on declarations of interests.
Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On request from
Food Standards Agency, United Kingdom
Question Number
EFSA-Q-2009-00706
Adopted
5 July 2012
Published
2 August 2012
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Download Article (264.45 KB)
Abstract

This scientific opinion of EFSA deals with the safety evaluation of the recycling process PETUK SSP, EC register number RECYC004. Through this process, washed PET flakes are dried, extruded into pellets then fed to a solid state polymerisation (SSP) reactor where high temperature and long residence time are applied under vacuum. After having examined the challenge test provided, the Panel concluded that the SSP is the critical step that determines the decontamination efficiency of the process. The operating parameters to control the performance of this critical step are the temperature, the pressure and the residence time. It was demonstrated, by means of the challenge test, that the recycling process under evaluation is able to ensure that the level of migration of potential unknown contaminants into food is below a conservatively modelled migration of 0.1 μg/kg food. Therefore, the Panel considered that the recycling process PETUK SSP is able to reduce any foreseeable accidental contamination of the post-consumer food contact PET to a concentration that does not give rise to concern for a risk to human health if:

  1. it is operated under conditions that are at least as severe as those obtained from the challenge test used to measure the decontamination efficiency of the processes and
  2. the input is washed and dried post-consumer PET flakes originating from materials and articles that have been manufactured in accordance with the Community legislation on food contact materials containing no more than 5% of PET from non-food consumer applications.

The Panel concluded that the recycled PET obtained from the process PETUK SSP intended 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 is not considered of safety concern.

Summary

According to the Commission Regulation (EC) No 282/2008 of 27 March 2008 on recycled plastic materials intended to come into contact with foods and amending Regulation (EC) No 2023/2006, the EFSA is requested to evaluate recycling processes of plastic waste. In this context, the CEF Panel evaluated the following process “PETUK SSP”.

The Food Standards Agency, United Kingdom, requested the evaluation of the recycling process PETUK SSP submitted by PET Processors UK L.L.C. This recycling process has been allocated the European Commission register number RECYC004. It is deemed to recycle poly(ethylene terephthalate) (PET) pellets from PET materials and articles (bottles, trays) collected though post-consumer collection systems.The recycled pellets are intended to be used up to 100% for the manufacture of either bottles for mineral water, soft drinks and beer or sheet that is thermoformed to make food trays. These recycled materials and articles are intended to be used in direct contact with foodstuffs for long term storage at room temperature, with or without hotfill.

The process is composed of three steps. The first step aims to process materials and articles (bottles, trays) of post-consumer PET into hot caustic-washed PET flakes. Washed flakes are further dried and extruded in the step 2 then solid state polymerised (SSP) in the step 3.

Detailed specifications for the input materials are provided. The applicant selects only suppliers who certify that the flakes are coming from previous food use application. The Panel underlined that the proportion of PET from non-food consumer applications should be no more than 5% in the input to be recycled as recommended 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, 2011).

A challenge test was conducted with surrogate contaminants at the production plant on the steps 2 and 3 of the PETUK SSP process operated under the same conditions of temperature, pressure and residence time as the recycling process to measure the decontamination efficiency.

Because surrogates were not removed from the surface before being subjected to steps 2 and 3 (drying and extrusion, solid state polymerisation), which is expected to over-estimate the decontamination efficiency, the decontamination efficiency was calculated for the SSP step alone which is considered to be the most critical step for the elimination of contaminants and should be kept under control to guarantee the performance of the decontamination of the process. The operating parameters to control the performance of this critical step are the temperature, the pressure and the residence time. The Panel noted that the drying and extrusion step 2 may contribute to the general decontamination.

The decontamination efficiencies obtained for each surrogate contaminant from the challenge test, ranging from 95.1 to 99.4%, have been used to calculate the residual concentrations of potential unknown contaminants in pellets (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 intended to be used for manufacture of materials and articles in contact with food” (EFSA, 2011). According to these criteria, the recycling process PETUK SSP under evaluation is able to ensure that the level of unknown contaminants in recycled PET is below a calculated concentration (Cmod) corresponding to a modelled migration of 0.1 μg/kg food.

The Panel considered that the process is well characterised and the main steps used to recycle the PET flakes into decontaminated PET pellets are identified. After having examined the challenge test provided, the Panel concluded that the SSP is the critical step for the decontamination efficiency of the process. The operating parameters to control its performance are the temperature, the pressure and the residence time. Therefore,  the Panel considered that the recycling process PETUK SSP  is able to reduce any foreseeable accidental contamination of the post-consumer food contact PET to a concentration that does not give rise to concern for a risk to human health if:

  1.  it is operated under conditions that are at least as severe as those obtained from the challenge test used to measure the decontamination efficiency of the process and
  2.  the input is washed post-consumer PET flakes originating from materials and articles that have been manufactured in accordance with the Community legislation on food contact materials containing no more than 5% of PET from non-food consumer applications.

The Panel concluded that the recycled PET obtained from the process PETUK SSP intended 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 is not considered of safety concern.

The Panel recommended thatit should be verified periodically, as part of the good manufacturing practice (GMP), that as foreseen in the Regulation (EC) No 282/2008, art. 4b, the input originates from materials and articles that have been manufactured in accordance with the Community legislation on food contact materials and that the proportion of PET from non-food consumer applications is no more than 5% in the input to be recycled. The critical step should be monitored and kept under control; supporting documentation on how it is ensured that the critical step is operated under conditions at least as severe as those obtained from the challenge test used to measure the decontamination efficiency of the process should be available.

Keywords
PETUK SSP; RECYC004; Food contact materials; Plastic; Poly(ethylene terephthalate); PET; Recycling; Process; Safety evaluation
Print on demand
Number of Pages
16