Scientific Opinion on the safety assessment of the following processes based on Starlinger Decon technology used to recycle post-consumer PET into food contact materials “Re-PET”, “Etimex”, “Dannemann”,“Dentis”, “PRT”, “Tec-Folien”, “Linpac”, “Fellinger A flakes”,“TDX” and “HVZ”

Tabs

Article
Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids
EFSA Journal
EFSA Journal 2013;11(10):3397 [22 pp.].
doi
10.2903/j.efsa.2013.3397
Panel members at the time of adoption
Ulla Beckman Sundh, Mona-Lise Binderup, Claudia Bolognesi, Leon Brimer, Laurence Castle, Alessandro Di Domenico, Karl-Heinz Engel, Roland Franz, Nathalie Gontard, Rainer Gürtler, Trine Husøy, Klaus-Dieter Jany, Martine Kolf-Clauw, Catherine Leclercq (until July 2013), Jean-Claude Lhuguenot (until November 2012), Wim Mennes, Maria Rosaria Milana, Maria de Fátima Poças, Iona Pratt, Kettil Svensson, Fidel Toldrá and Detlef Wölfle.
Acknowledgements

The Panel 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 and Constantine Papaspyrides for the preparatory work on this scientific opinion.

Possible conflict of interest
One member of the Panel did not participate in the discussion on the subject referred to above 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
Bundesamt für Verbraucherschutz und Lebensmittelsicherheit, Germany; Bundesministerium für Gesundheit, Austria; Ministero della Salute, Italy; Food Standards Agency, United Kingdom; Ministry of Health, Welfare and Sport, The Netherlands
Question Number
EFSA-Q-2010-00061
EFSA-Q-2010-00062
EFSA-Q-2010-00121
EFSA-Q-2010-00046
EFSA-Q-2010-00025
EFSA-Q-2010-00019
EFSA-Q-2010-00122
EFSA-Q-2010- 01064
EFSA-Q-2013-00200
EFSA-Q-2013-00364
Adopted
26 September 2013
Published
17 October 2013
Corrected
26 May 2014. 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 the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids deals with the safety assessment of the recycling processes Re-PET, Etimex, Dannemann, Dentis, PRT, Tec-Folien, Fellinger A_flakes, Linpac, TDX and HVZ (EU register numbers RECYC031, RECYC032, RECYC045, RECYC046, RECYC048, RECYC049, RECYC059, RECYC077, RECYC100 and RECYC103 respectively) which are all based on the same Starlinger Decon technology. The decontamination efficiency of all these processes was demonstrated using the same challenge test. The input of all the processes is hot caustic washed and dried PET flakes originating from collected post-consumer PET containers, mainly bottles and trays, containing no more than 5 % of PET from non-food consumer applications. Through this technology washed and dried PET flakes are pre-heated before being solid state polymerised (SSP) in a continuous reactor at high temperature under vacuum and gas flow. Having examined the challenge test provided, the Panel concluded that the pre-heating (step 2) and the decontamination in the continuous SSP reactor (step 3) are the critical steps that determine the decontamination efficiency of the processes. The operating parameters to control their performance are well defined and are the temperature, the pressure, the residence time and the gas flow. Under these conditions it was demonstrated that the recycling processes under evaluation, using the Starlinger Decon 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 concluded that the recycled PET obtained from these processes intended to be 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 is not considered of safety concern.

Summary

According to the Commission Regulation (EC) No 282/20085 of 27 March 2008 on recycled plastic materials intended to come into contact with foods and amending Regulation (EC) No 2023/20066 , EFSA is requested to evaluate recycling processes in which plastic waste is recycled pursuant to the definition of recycling in point 7 of Article 3 of Directive 94/62/EC on packaging and packaging waste. In this context, the CEF Panel evaluated the following processes “Re-PET”, “Etimex”, “Dannemann”, “Dentis”, “PRT”, “Tec-Folien”, “Fellinger A flakes”, “Linpac”, “TDX” and “HVZ”.

The Bundesamt für Verbraucherschutz und Lebensmittelsicherheit, Germany, the Bundesamt für Verbraucherschutz und Lebensmittelsicherheit, Germany, the Bundesministerium für Gesundheit, Austria, the Ministero della Salute, Italy, the Bundesministerium für Gesundheit, Austria, the Bundesamt für Verbraucherschutz und Lebensmittelsicherheit, Germany, the Bundesministerium für Gesundheit, Austria, the Bundesamt für Verbraucherschutz und Lebensmittelsicherheit Germany , the Food Standards Agency, United Kingdom and the Ministry of Health, Welfare and Sport, The Netherlands requested the evaluation of the recycling processes Re-PET, Etimex, Dannemann, Dentis, PRT, Tec-Folien, Fellinger A flakes, Linpac, TDX and HVZ respectively. The dossiers were submitted on behalf of Re-PET Flaschenrecycling GmbH, Etimex Primary Packaging GmbH, Dannemann Global Extrusion GmbH, Dentis SRL PET Recycling Team GmbH and Tec-Folien-Allgäu GmbH, by Markus Fellinger and on behalf of LINPAC Group Holdings Limited, TDX Ltd and Hordijk Verpakkingsindustrie Zaandam B.V companies. These recycling processes have been allocated the European Union register numbers RECYC031, RECYC032, RECYC045, RECYC046, RECYC048, RECYC049, RECYC059, RECYC077, RECYC100 and RECYC103 respectively. They are deemed to recycle poly(ethylene terephthalate) (PET) flakes from PET containers collected through post-consumer collection systems. The recycled PET is 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 Starlinger Decon technology and their decontamination efficiency was evaluated on the basis of the same challenge test.

The processes are composed of three steps. First post-consumer PET containers, mainly bottles and trays, are processed into hot caustic washed and dried flakes which are used as input of the Starlinger Decon technology. Washed flakes are pre-heated in the step 2 then solid-state polymerised in the step 3(SSP).

Detailed specifications for the input materials are provided for each of the submitted recycling processes and the amount of non-food containers is reported to be no more than 5 % for all of them.

A challenge test was conducted at pilot plant level on the process steps 2 and 3 (pre-heating and continuous SSP reactor) to measure the decontamination efficiency. The decontamination efficiencies obtained for each surrogate contaminant from the challenge test, ranging from 96.3 % to 99.5 %, have been used to calculate the residual concentrations of potential unknown contaminants in flakes (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 CEF Panel, 2011). According to these criteria the recycling processes under evaluation using a Starlinger Decon 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 flakes are identified. Having examined the challenge test provided, the Panel concluded that pre-heating (step 2) and the decontamination in the continuous SSP reactor (step 3) are the critical step for the decontamination efficiency of the processes. The operating parameters to control their performance are the temperature, the residence time, the pressure, and the gas flow. Therefore, the Panel considered that the recycling processes Re-PET, Etimex, Dannemann, Dentis, PRT, Tec-Folien, Fellinger A flakes, Linpac, TDX and HVZ 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 of the processes is washed and dried post-consumer PET flakes originating from materials and articles that have been manufactured in accordance with the European Union 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 Re-PET, Etimex, Dannemann, Dentis, PRT, Tec-Folien, Fellinger A flakes, Linpac, TDX and HVZ intended be 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 is not considered of safety concern.

The Panel recommended that it 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 European Union 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
Starlinger Decon; Food contact materials; Plastic; Poly(ethylene terephthalate) (PET); Recycling; Process; Safety assessment
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Number of Pages
22