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Scientific Opinion on the safety evaluation of the following processes based on BUHLER C technology used to recycle post-consumer PET into food contact materials “Buhler C” and “FENC”
This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids deals with the safety evaluation of the recycling processes ‘’Buhler C’’ and “FENC’’ (EC register numbers RECYC037 and RECYC083 respectively) which are based on the same BUHLER C technology. The decontamination efficiency of these processes was demonstrated using the same challenge tests. The input of the BUHLER C technology is washed and dried PET flakes originating from collected post-consumer PET containers containing no more than 5% of PET from non-food consumer applications. Through this technology, washed and dried flakes are dried and extruded in a ring extruder into pellets which are further crystallised in a reactor then fed into the Solid State Polymerisation (SSP) reactor. After having examined the challenge tests provided, the Panel concluded that the two steps, the drying and crystallisation step and the SSP step are the most critical steps that determine the decontamination efficiency of the processes. The operating parameters to control the performance of these critical steps are well defined and are the temperature and the residence time for the drying and crystallisation, and the temperature, the gas flow and the residence time for SSP. The operating parameters of these steps in the processes are at least as severe as those obtained from the challenge tests. Under these conditions, it was demonstrated that the recycling processes are able to ensure that the level of migration of potential unknown contaminants into food is below a conservatively modelled migration of 0.1μg/kg food. Therefore the Panel concluded that the recycled PET obtained from these processes 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.
© European Food Safety Authority,2012
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 “Buhler C” and “FENC”.
The Bundesamt für Verbraucherschutz und Lebensmittelsicherheit, Germany and the Ministère de l’Economie de l’Industrie et de l’Emploi (DGCCRF), France, requested the evaluation of the recycling processes Buhler C and FENC respectively. The dossiers were submitted on behalf of Buhler AG and Far Eastern New Century Corporation (FENC) companies. These recycling processes have been allocated the European Commission register numbers RECYC037 and RECYC083, respectively. They are deemed to produce recycled poly(ethylene terephthalate) (PET) pellets from PET containers collected through post-consumer collection systems. The recycled pellets are intended to be used 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 kinds 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 BUHLER C technology and their decontamination efficiency was evaluated on the basis of the same challenge tests.
The recycling processes are composed of four steps. In the Step 1, PET containers are processed by sorting-grinding-milling-washing-drying to provide flakes of recycled PET. In the step 2, PET flakes are further dried and extruded in a ring extruder with vacuum ports. In the step 3, the pellets are crystallised at high temperature in a gastight fluidbed. The fourth step involves a solid state polymerisation (SSP) process under inert gas flow at high temperature and long residence time to increase the molecular weight and the viscosity, obtaining pellets of recycled PET that are the final product.
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.
Four challenge tests were performed on the process steps 2 to 4 (extrusion, drying and crystallisation and SSP) with contaminated flakes at three different nominal surrogate concentrations (100, 500 and 1000 ppm) either in pilot plant and/or at laboratory scale and under the same operating parameters in order to measure the decontamination efficiency.
Because surrogates were not removed from the surface of contaminated flakes before being subjected to steps 2 to 4, what is expected to over-estimate the decontamination efficiency, the decontamination efficiency was calculated for the drying and crystallisation step 3 and the SSP step 4. The Panel noted that the drying and extrusion step 2 is expected to contribute to the general decontamination.
The decontamination efficiencies obtained for each surrogate contaminant from the challenge tests, ranging from 97.3% to more than 99.7%, 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 Scientific Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF), 2011). According to these criteria, the recycling processes under evaluation using a BUHLER C 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 tests provided, the Panel concluded that the two steps, drying and crystallisation and SSP are the critical steps for the decontamination efficiency of the processes. The operating parameters to control their performance are the temperature and the residence time for the drying and crystallisation (step 3) and the temperature, the gas flow and the residence time for the SSP (step 4). Therefore, the Panel considered that the recycling processes Buhler C and FENC 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:
- 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,
- 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 not higher than 5% of PET from non-food consumer applications.
The Panel concluded that the recycled PET obtained from the processes Buhler C and FENC 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 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 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.
Food contact materials; Plastic; Poly(ethylene terephthalate) PET; Recycling; Process; BUHLER C; Safety evaluation