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Scientific Opinion on the safety evaluation of the process “Holfeld Diamat” used to recycle post-consumer PET into food contact materials

EFSA Journal 2013;11(3):3118[15 pp.]. doi:10.2903/j.efsa.2013.3118
  EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) Panel Members 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, Wim Mennes, Maria Rosaria Milana, Fatima Poças, Iona Pratt, Kettil Svensson, Fidel Toldrá and Detlef Wölfle. Acknowledgment 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, Constantine Papaspyrides and Karla Pfaff 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 cef@efsa.europa.eu
Type: Opinion of the Scientific Committee/Scientific Panel On request from: the Food Safety Authority of Ireland Question number: EFSA-Q-2011-00936 Adopted: 20 February 2013 Published: 05 March 2013 Affiliation: European Food Safety Authority (EFSA), Parma, Italy
Abstract

This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids deals with the safety evaluation of the recycling process Holfeld Diamat (EC register number RECYC076) which is based on the Diamat ® technology. The input of the process is washed and dried PET flakes originating from collected post-consumer PET containers, mainly bottles, containing no more than 5 % of PET from non-food consumer applications. Through this process, post-consumer washed and dried PET flakes are mixed up to 50 % with virgin PET flakes before being heated in a crystallisation reactor (step 2) and extruded under vacuum into sheets (step 3). After having examined the challenge tests provided, the Panel concluded that the decontamination in the two consecutive extruders step 3 is the critical step for the decontamination efficiency of the process. The operating parameters to control its performance are well defined and are the temperature, the pressure and the residence time. The operating parameters of these steps in the process are at least as severe as those obtained from the challenge test. Under these conditions, it was demonstrated that the recycling process is able to ensure that the level of migration of potential unknown contaminants into food is below a conservatively modelled migration of 0.15 μg/kg food derived from the exposure scenario for toddlers. Therefore, the recycled PET obtained from the process Holfeld Diamat intended for the manufacture of recycled thermoformed trays and containers made with up to 50 % recycled post-consumer PET and intended for contact for long term storage at room temperature with all types of foodstuffs except packaged water is not considered of safety concern.

© European Food Safety Authority,2013

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, EFSA is requested to evaluate recycling processes of plastic waste. In this context, the CEF Panel evaluated the process “Holfeld Diamat”.

The Food Safety Authority of Ireland requested the evaluation of the recycling process Holfeld Diamat submitted on behalf of Holfeld Plastics Ltd. The recycling process has been allocated the European Commission register number RECYC076. It is deemed to recycle poly(ethylene terephthalate) (PET) sheets containing up to 50 % recycled PET from containers, mainly bottles, collected through post-consumer collection systems. The recycled sheets are intended to be converted into thermoformed articles such as trays and containers containing up to 50 % recycled PET. These recycled materials and articles are used in direct contact with all kind of foodstuffs in majority for storage under chilled conditions or below.

The process is composed of three steps. First the post-consumer collected PET containers, mainly bottles, are processed into washed and dried flakes then mixed up to 50 % with virgin flakes before being used as input of the Diamat ® decontamination technology. Mixed flakes are crystallised in a reactor (step 2) and then extruded under multiple vacuum degassing into sheets (step 3).
Detailed specifications for the input materials are provided for the submitted recycling process and the amount of non-food containers is reported to be below 5 %.

To measure the decontamination efficiency, two challenge tests were conducted in a pilot plant with 50 % and 100 % contaminated flakes on the process steps 2 and 3 (crystallisation reactor and extrusion). Because surrogates were not removed from the surface before being subjected to step 2 and 3, which is expected to over-estimate the decontamination efficiency, the decontamination efficiency was calculated for the step 3 (extrusion) alone which is considered to be the most critical step for the elimination of contaminants.

The decontamination efficiencies obtained for each surrogate contaminant from the two challenge tests carried out with 50 and 100 % contaminated flakes, ranging from 87.8 % to above 99.9 %, have been used to calculate the residual concentrations of potential unknown contaminants in recycled PET article made of 50 % of post-consumer PET mixed with 50 % of virgin PET (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 Scientific Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF), 2011). According to these criteria and the intended uses (not for water bottles), the recycling process under evaluation using a Diamat ® technology 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 0.15 μg/kg food (derived from the exposure scenario for toddlers).

  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 of the process 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 and,
  3. the final recycled thermoformed trays and containers manufactured with the recycled sheets do not contain more than 50 % recycled post-consumer PET and are not used for packaging water.

Therefore, the recycled PET obtained from the process Holfeld Diamat intended for the manufacture of recycled thermoformed trays and containers made with up to 50 % recycled post-consumer PET and intended for contact for long term storage at room temperature with all types of foodstuffs except packaged water 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

Food contact materials; Plastic; Poly(ethylene terephthalate) PET; Recycling; Process; Holfeld Diamat; Safety evaluation