Scientific Opinion on the safety evaluation of the following processes based on VACUREMA Prime ® technology used to recycle post-consumer PET into food contact materials “Lux PET”, “Jayplas”, “PolyQuest” and “CIER”

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Article
Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids
EFSA Journal
EFSA Journal 2012;10(8):2827 [18 pp.].
doi
10.2903/j.efsa.2012.2827
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 and 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 Nerin, 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
Ministère de la Santé, Luxembourg; Food Standards Agency, United Kingdom; Bundesamt für Verbraucherschutz und Lebensmittelsicherheit, Germany; Ministero della Salute, Italy
Question Number
EFSA-Q-2009-00773
EFSA-Q-2010-00003
EFSA-Q-2010-00022
EFSA-Q-2010-0048
Adopted
5 July 2012
Published
2 August 2012
Last Updated
21 November 2013. This version replaces the previous one/s.
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
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Abstract

This scientific opinion of EFSA deals with the safety evaluation of the recycling processes LuxPET, Jayplas, PolyQuest and CIER (EC register numbers RECYC008, RECYC024, RECYC025 and RECYC027 respectively) which are all based on the same VACUREMA Prime ® technology. The decontamination efficiency of all these processes was demonstrated using the same challenge test. Collected post-consumer PET bottles are processed into washed and dried flakes which are used as input of the VACUREMA Prime ® technology. Through this technology, washed and dried PET flakes are heated in a batch reactor under vacuum and then heated in a continuous reactor under vacuum before being extruded into pellets. After having examined the challenge test provided, the Panel concluded that the two steps, the decontamination in batch reactors and the decontamination in continuous reactor are the critical steps that determine the decontamination efficiency of the processes. The operating parameters to control the performance of these critical steps are the temperature, the pressure and the residence time. It was demonstrated by means of the challenge test that the recycling processes under evaluation using a VACUREMA Prime ® technology are 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 processes LuxPET, Jayplas, PolyQuest and CIER are 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. they are 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 processes LuxPET, Jayplas, PolyQuest and CIER 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 processes “LuxPET”, “Jayplas”, “PolyQuest” and “CIER”.

The Ministère de la Santé, Luxembourg, the Food Standards Agency, United Kingdom, the Bundesamt für Verbraucherschutz und Lebensmittelsicherheit, Germany and the Ministero della Salute, Italy, requested the evaluation of the recycling processes LuxPET, Jayplas, PolyQuest and CIER respectively. The dossiers were submitted on behalf of LuxPET AG/SA, Jayplas Ltd, PolyQuest Inc and CIER Vomano companies. These recycling processes have been allocated the European Commission register numbers RECYC008, RECYC024, RECYC025 and RECYC027 respectively. They are deemed to recycle poly(ethylene terephthalate) (PET) pellets from PET bottles collected through post-consumer collection systems. The recycled pellets are intended to be used at up to 100% for the manufacture of food contact materials and articles. These recycled materials and articles are intended to be used in direct contact with all kind of foodstuffs for long term storage at room temperature, with or without hotfill. 

These processes are grouped into a single opinion as they use the same VACUREMA Prime ® technology and their decontamination efficiency was evaluated on the basis of the same challenge test.

The processes are composed of four steps. First the post-consumer collected PET bottles are processed into washed and dried flakes which are used as input of the VACUREMA Prime ® decontamination technology. Dried flakes are heated in a batch reactor under vacuum (step 2) and then heated in a continuous reactor under vacuum (step 3) before being extruded (step 4).

Detailed specifications for the input materials are provided for each of the submitted recycling processes and the amount of non-food containers is claimed to be below 5% for all of them.

A challenge test was conducted with surrogate contaminants in a small production plant on the process steps from 2 to 4 (batch reactor, continuous reactor and extrusion respectively) to measure the decontamination efficiency.

The steps 2 and 3 were considered by the Panel as the critical steps for the removal of possible contaminants and should be kept under control to guarantee the performance of the decontamination of these processes. The operating parameters to control the performance of these critical steps are the temperature, the pressure and the residence time.

The decontamination efficiencies obtained for each surrogate contaminant from the challenge test, ranging from 98.3 % to 99.9%, 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 processes under evaluation using a VACUREMA Prime ® technology are 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 all processes are 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 two steps, the decontamination in batch reactors (step 2) and the decontamination in continuous reactor (step 3) are the critical steps for the decontamination efficiency of the processes. The operating parameters to control their performance are the temperature, the pressure and the residence time   Therefore, the Panel considered that the recycling processes LuxPET, Jayplas, PolyQuest and CIER are 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. they are 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 processes LuxPET, Jayplas, PolyQuest and CIER 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. Critical steps should be monitored and kept under control; supporting documentation on how it is ensured that the critical steps are operated under conditions at least as severe as those obtained from the challenge test used to measure the decontamination efficiency of the processes should be available.

Keywords
LuxPET; Jayplas; PolyQuest; CIER; VACUREMA Prime; RECYC008; RECYC024; RECYC025; RECYC027; Food contact materials; Plastic; Poly(ethylene terephthalate); PET; Recycling; Process; Safety evaluation
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Number of Pages
18