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


Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids
EFSA Journal
EFSA Journal 2011;9(7):2184 [25 pp.].
Possible conflict of interest
One member of the Panel, Roland Franz declared an interest as his Institute has submitted applications for the evaluation of recycling processes. This was considered as a conflict of interest and he was requested to leave the room during discussion and adoption of the opinion.
Panel members at the time of adoption
Arturo Anadón, Mona-Lise Binderup, Wilfried Bursch, Laurence Castle, Riccardo Crebelli, Karl-Heinz Engel, Roland Franz, Nathalie Gontard, Thomas Haertlé, Trine Husøy, Klaus-Dieter Jany, Catherine Leclercq, Jean-Claude Lhuguenot, Wim Mennes, Maria Rosaria Milana, Karla Pfaff, Kettil Svensson, Fidel Toldrá, Rosemary Waring, Detlef Wölfle

The Panel wishes to thank the members of the Working Group on Recycling process for the preparation of this opinion: Laurence Castle, Vincent Dudler, R. Franz, Nathalie Gontard, Eugenia Lampi, Maria Rosaria Milana, Cristina Nérin, Constantine Papaspyrides, Karla Pfaff, and EFSA’s staff members Eric Barthelemy and Dimitrios Spyropoulos for the support provided to this EFSA scientific output. R. Franz participated as hearing expert to answer to questions and to provide comments on the draft opinion.

Opinion of the Scientific Committee/Scientific Panel
On request from
CEF Panel
Question Number
6 July 2011
Published in the EFSA Journal
20 July 2011
European Food Safety Authority (EFSA), Parma, Italy

This scientific opinion of EFSA deals with the criteria to be used for safety evaluation of a recycling process to produce recycled PET intended to be used for manufacture of materials and articles in contact with food.
The principle of the evaluation is to apply the cleaning efficiency of a recycling technology or process, obtained from a challenge test with surrogate contaminants, to a reference contamination level for post consumer PET, conservatively set a 3 mg/kg PET for a contaminant resulting from possible misuse. The resulting residual concentration of each contaminant in recycled PET (Cres) is then compared to a modelled concentration in PET (Cmod). This Cmod is calculated using generally recognized conservative migration models such that the related migration does not give rise to a dietary exposure exceeding 0.0025 μg/kg bw/day, the human exposure threshold value for chemicals with structural alerts raising concern for potential genotoxicity, below which the risk to human health would be negligible.
The default scenario, when the recycled PET is intended for general use, is that of an infant weighing 5 kg and consuming every day 0.75 l of water coming from a water bottle manufactured from 100% recycled PET. According to this scenario, it can be derived that the highest concentration of a substance in water that would ensure that the dietary exposure of 0.0025 µg/kg bw/day is not exceeded, is 0.017 μg/kg food. Taking into account that generally agreed diffusion modelling overestimates migration by at least 5 times, a calculated migration less than 0.1 µg/kg in food would satisfy the above criterion for the default exposure scenario. In the case of the other exposure scenarios for adults and toddlers, the relevant migration criterion will accordingly be 0.75 and 0.15 µg/kg food.
Therefore if a recycling process is able to reduce an input reference contamination of 3 mg/kg PET to a Cres not higher than a Cmod corresponding to the relevant migration criterion, the potential dietary exposure cannot be higher than 0.0025 µg/kg bw/day and recycled PET manufactured with such recycling process is not considered of safety concern.
The Panel considered appropriate that the proportion of PET from non-food consumer applications should be no more than 5% in the input to be recycled.

Food contact materials, Plastics, Poly(ethylene terephthalate), PET, Recycling process, Evaluation, Safety
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