==== Front EFSA J EFSA J 10.1002/(ISSN)1831-4732 EFS2 EFSA Journal 1831-4732 John Wiley and Sons Inc. Hoboken 10.2903/j.efsa.2023.8087 EFS28087 Scientific Opinion Scientific Opinion Safety assessment of the process CCH CIRCULARPET, based on the NGR technology, used to recycle post‐consumer PET into food contact materials PET recycling process: CCH CIRCULARPET (NGR technology) EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP)fip@efsa.europa.eu Lambré Claude Barat Baviera José Manuel Bolognesi Claudia Chesson Andrew Cocconcelli Pier Sandro Crebelli Riccardo Gott David Michael Grob Konrad Mengelers Marcel Mortensen Alicja Rivière Gilles Steffensen Inger‐Lise Tlustos Christina Van Loveren Henk Vernis Laurence Zorn Holger Dudler Vincent Milana Maria Rosaria Papaspyrides Constantine Tavares Poças Maria de Fátima Comandella Daniele Lampi Evgenia * Correspondence: fip@efsa.europa.eu 03 7 2023 7 2023 21 7 10.1002/efs2.v21.7 e08087© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority. https://creativecommons.org/licenses/by-nd/4.0/ This is an open access article under the terms of the http://creativecommons.org/licenses/by-nd/4.0/ License, which permits use and distribution in any medium, provided the original work is properly cited and no modifications or adaptations are made. Abstract The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of the recycling process CCH CIRCULARPET (EU register number RECYC284), which uses the NGR technology. The input is washed and dried poly(ethylene terephthalate) (PET) flakes mainly originating from collected post‐consumer PET containers, with no more than 5% PET from non‐food consumer applications. The flakes are dried (step 2), melted in an extruder (step 3) and decontaminated during a melt‐state polycondensation step ■■■■■ (step 4). In step 5, the material is granulated. Having examined the challenge test provided, the Panel concluded that the melt‐state polycondensation (step 4) is critical in determining the decontamination efficiency of the process. The operating parameters to control the performance of the critical step are the pressure, the temperature, the residence time (depending on the mass and throughput of the melt) and the characteristics of the reactor. It was demonstrated that this recycling process is able to ensure that the level of migration of potential unknown contaminants into food is below the conservatively modelled migration of 0.1 μg/kg food. Therefore, the Panel concluded that the recycled PET obtained from this process is not of safety concern when used at up to 100% for the manufacture of materials and articles for contact with all types of foodstuffs, including drinking water, for long‐term storage at room temperature, with or without hotfill. The final articles made of this recycled PET are not intended to be used in microwave and conventional ovens and such uses are not covered by this evaluation. NGR CCH CIRCULARPET S.R.L melt‐state polycondensation food contact materials plastic poly(ethylene terephthalate) (PET) recycling process source-schema-version-number2.0 cover-dateJuly 2023 details-of-publishers-convertorConverter:WILEY_ML3GV2_TO_JATSPMC version:6.3.0 mode:remove_FC converted:03.07.2023 Suggested citation: EFSA CEP Panel (EFSA Panel on Food Contact Materials, Enzymes and Processing Aids) , Lambré C , Barat Baviera JM , Bolognesi C , Chesson A , Cocconcelli PS , Crebelli R , Gott DM , Grob K , Mengelers M , Mortensen A , Rivière G , Steffensen I‐L , Tlustos C , Van Loveren H , Vernis L , Zorn H , Dudler V , Milana MR , Papaspyrides C , Tavares Poças MF , Comandella D and Lampi E , 2023. Scientific Opinion on the safety assessment of the process CCH CIRCULARPET, based on the NGR technology, used to recycle post‐consumer PET into food contact materials. EFSA Journal 2023;21 (7 ):8087, 14 pp. 10.2903/j.efsa.2023.8087 Requestor: Austrian competent authority (Federal Ministry of Social Affairs, Health, Care and Consumer Protection) Question number: EFSA‐Q‐2021‐00567 Panel members: José Manuel Barat Baviera, Claudia Bolognesi, Andrew Chesson, Pier Sandro Cocconcelli, Riccardo Crebelli, David Michael Gott, Konrad Grob, Claude Lambré, Evgenia Lampi, Marcel Mengelers, Alicja Mortensen, Gilles Rivière, Vittorio Silano (until 21 December 2020†), Inger‐Lise Steffensen, Christina Tlustos, Henk Van Loveren, Laurence Vernis and Holger Zorn. Legal notice: The scientific output published implements EFSA's decision on the confidentiality requests submitted on specific items. As certain items have been awarded confidential status by EFSA, they are consequently withheld from public disclosure by redaction. Declarations of interest: If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact interestmanagement@efsa.europa.eu. EFSA may include images or other content for which it does not hold copyright. In such cases, EFSA indicates the copyright holder and users should seek permission to reproduce the content from the original source. † Deceased. Adopted: 7 June 2023 ==== Body pmc1 Introduction 1.1 Background and terms of reference 1.1.1 Background Recycled plastic materials and articles shall only be placed on the market if the recycled plastic is from an authorised recycling process. Before a recycling process is authorised, the European Food Safety Authority (EFSA)'s opinion on its safety is required. This procedure has been established in Article 5 of Regulation (EC) No 282/2008 1 , 2 on recycled plastic materials intended to come into contact with foods and Articles 8 and 9 of Regulation (EC) No 1935/2004 3 on materials and articles intended to come into contact with food. According to this procedure, the industry submits applications to the competent authorities of Member States, which transmit the applications to EFSA for evaluation. In this case, EFSA received an application from the Austrian competent authority (Federal Ministry of Social Affairs, Health, Care and Consumer Protection) for the evaluation of the recycling process CCH CIRCULARPET, European Union (EU) register No RECYC284. The request has been registered in EFSA's register of received questions under the number EFSA‐Q‐2021‐00567. The dossier was submitted on behalf of CCH CIRCULARPET S.R.L, Via Cavour, 103 13894, Gaglianico (BI), Italy (see Section 6). 1.1.2 Terms of reference The Austrian competent authority (Federal Ministry of Social Affairs, Health, Care and Consumer Protection) requested the safety evaluation of the recycling process CCH CIRCULARPET, in accordance with Article 5 of Regulation (EC) No 282/2008. 1.2 Interpretation of the terms of reference According to Article 5 of Regulation (EC) No 282/2008 on recycled plastic materials intended to come into contact with foods, EFSA is required to carry out risk assessments on the risks originating from the migration of substances from recycled food contact plastic materials and articles into food and deliver a scientific opinion on the recycling process examined. According to Article 4 of Regulation (EC) No 282/2008, EFSA will evaluate whether it has been demonstrated in a challenge test, or by other appropriate scientific evidence, that the recycling process CCH CIRCULARPET is able to reduce the contamination of the plastic input to a concentration that does not pose a risk to human health. The poly(ethylene terephthalate) (PET) materials and articles used as input of the process as well as the conditions of use of the recycled PET are part of this evaluation. 2 Data and methodologies 2.1 Data The applicant has submitted a confidential and a non‐confidential version of a dossier following the ‘EFSA guidelines for the submission of an application for the safety evaluation of a recycling process to produce recycled plastics intended to be used for the manufacture of materials and articles in contact with food, prior to its authorisation’ (EFSA, 2008) and the ‘Administrative guidance for the preparation of applications on recycling processes to produce recycled plastics intended to be used for manufacture of materials and articles in contact with food’ (EFSA, 2021). Additional information was sought from the applicant during the assessment process in response to requests from EFSA sent on 15 July 2022 and was subsequently provided (see Section 6). In accordance with Art. 38 of the Regulation (EC) No 178/2002 4 and taking into account the protection of confidential information and of personal data in accordance with Articles 39 to 39e of the same Regulation, and of the Decision of EFSA's Executive Director laying down practical arrangements concerning transparency and confidentiality, 5 the non‐confidential version of the dossier has been published on Open.EFSA. 6 According to Art. 32c(2) of Regulation (EC) No 178/2002 and to the Decision of EFSA's Executive Director laying down the practical arrangements on pre‐submission phase and public consultations, 7 EFSA carried out a public consultation on the non‐confidential version of the application from 11 May to 1 June 2023 for which no comments were received. The following information on the recycling process was provided by the applicant and used for the evaluation:General information: – general description, – existing authorisations. Specific information: – recycling process, – characterisation of the input, – determination of the decontamination efficiency of the recycling process, – characterisation of the recycled plastic, – intended application in contact with food, – compliance with the relevant provisions on food contact materials and articles, – process analysis and evaluation, – operating parameters. 2.2 Methodologies The risks associated with the use of recycled plastic materials and articles in contact with food come from the possible migration of chemicals into the food in amounts that would endanger human health. The quality of the input, the efficiency of the recycling process to remove contaminants as well as the intended use of the recycled plastic are crucial points for the risk assessment (EFSA, 2008). The criteria for the safety evaluation of a mechanical recycling process to produce recycled PET intended to be used for the manufacture of materials and articles in contact with food are described in the scientific opinion developed by the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (EFSA CEF Panel, 2011). The principle of the evaluation is to apply the decontamination 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 at 3 mg/kg PET for contaminants resulting from possible misuse. The resulting residual concentration of each surrogate contaminant in recycled PET (Cres) is compared with a modelled concentration of the surrogate contaminants in PET (Cmod). This Cmod is calculated using generally recognised conservative migration models so that the related migration does not give rise to a dietary exposure exceeding 0.0025 μg/kg body weight (bw) per day (i.e. the human exposure threshold value for chemicals with structural alerts for genotoxicity), below which the risk to human health would be negligible. If the Cres is not higher than the Cmod, the recycled PET manufactured by such recycling process is not considered to be of safety concern for the defined conditions of use (EFSA CEF Panel, 2011). The assessment was conducted in line with the principles described in the EFSA Guidance on transparency in the scientific aspects of risk assessment (EFSA, 2009) and considering the relevant guidance from the EFSA Scientific Committee. 3 Assessment 3.1 General information 8 According to the applicant, the recycling process CCH CIRCULARPET is intended to recycle food grade PET containers using the NGR technology. The recycled PET is intended to be used at up to 100% for the manufacture of materials and articles for direct contact with all kinds of foodstuffs for long‐term storage at room temperature, with or without hotfill. The final articles are not intended to be used in microwave or conventional ovens. 3.2 Description of the process 3.2.1 General description 9 The recycling process CCH CIRCULARPET produces recycled PET pellets from PET containers (e.g. bottles), coming from post‐consumer collection systems (kerbside and deposit systems). The recycling process comprises the five steps below. Input In step 1, the post‐consumer PET containers are processed into washed and dried flakes. This step is performed by third parties. Decontamination and production of recycled PET material In step 2, the flakes are dried ■■■■■. In step 3, the flakes are extruded. In step 4, the material is decontaminated in a melt‐state polycondensation process. In step 5, the melt is cooled down and granulated. The operating conditions of the process have been provided to EFSA. Pellets, the final product of the process, are checked against technical requirements, such as intrinsic viscosity, colour and selected contaminants. 3.2.2 Characterisation of the input 10 According to the applicant, the input material for the recycling process CCH CIRCULARPET consists of ■■■■■ washed and dried flakes obtained from PET containers, e.g. bottles, previously used for food packaging, from post‐consumer collection systems (kerbside and deposit systems). A small fraction may originate from non‐food applications. According to the applicant, the proportion will be no more than 5%. Technical data for the ■■■■■ washed and dried flakes are provided, such as on physical properties and residual contents of moisture, poly(vinyl chloride) (PVC), polyolefins, glue, wood, paper and metals (see Appendix A). 3.3 NGR technology 3.3.1 Description of the main steps 11 The general scheme of the NGR technology, as provided by the applicant, is reported in Figure 1. The steps are: Drying (step 2): The flakes are dried ■■■■■. Extrusion (step 3): The flakes from the previous step are melted in an extruder, filtered and pumped to the top of the reactor of step 4. Melt‐state polycondensation (step 4): The material is decontaminated during a melt‐state polycondensation ■■■■■ In this reactor, the molten polymer is exposed with a ■■■■■ surface to the vacuum applied. The reactor consists of two parts: within the vertical part, ■■■■■ The horizontal part consists of a ■■■■■ chamber. ■■■■■ Granulation (step 5): The melt material is cooled down and pelletised. Figure 1 General scheme of the NGR technology (provided by the applicant) The process is run under defined operating parameters 12 of temperature, pressure, gas flow and residence time. 3.3.2 Decontamination efficiency of the recycling process 13 To demonstrate the decontamination efficiency of the recycling process CCH CIRCULARPET, a challenge test performed at pilot plant scale was submitted to EFSA. PET was contaminated with toluene, chlorobenzene, phenylcyclohexane, benzophenone and methyl stearate, selected as surrogates in agreement with the EFSA guidelines (EFSA CEF Panel, 2011) and in accordance with the recommendations of the US Food and Drug Administration (FDA, 2006). The surrogates include different molecular masses and polarities to cover possible chemical classes of contaminants of concern and were demonstrated to be suitable to monitor the behaviour of PET during recycling (EFSA, 2008). The mixture of these surrogates was spiked into the dried PET flakes entering the extruder (before step 3). The NGR technology was challenged at the NGR facilities at pilot plant scale. The decontamination efficiency was then calculated from the concentration difference before the melt‐state polycondensation (step 4) and after pelletisation (step 5). When surrogates were not detected, the limit of detection was considered for the calculation of the decontamination efficiency. The results are summarised in Table 1. Table 1 Efficiency of the decontamination of the NGR technology in the challenge test Surrogates Concentration of surrogates before step 4 (mg/kg PET) Concentration of surrogates after step 5 (mg/kg PET) Decontamination efficiency (%) Toluene 69.7 < 0.1 (a) > 99.9 Chlorobenzene 153.5 < 0.1 (a) > 99.9 Phenylcyclohexane 249.1 0.3 99.9 Benzophenone 292.1 10.3 96.5 Methyl stearate 122.3 0.3 99.8 PET: poly(ethylene terephthalate). (a) Not detected at the limits of detection given. As shown in Table 1, the decontamination efficiency ranged from 96.5% for benzophenone to above 99.9% for toluene and chlorobenzene. Contrary to the recommendations of the EFSA guidelines (EFSA, 2008), the contaminated flakes were not rinsed before being introduced in the recycling process. As the flakes were contaminated at the entry of the extrusion process, before the material is subjected to vacuum, the Panel agreed that the surrogate substances were homogeneously distributed in the PET material before the decontamination started. Therefore, the results from the challenge test can be used to calculate the decontamination efficiency. 3.4 Discussion Considering the high temperatures used during the process, the possibility of contamination by microorganisms can be discounted. Therefore, this evaluation focuses on the chemical safety of the final product. Technical data, such as on physical properties and residual contents of PVC, glues, polyolefins, wood, paper and metals, were provided for the input materials (i.e. washed and dried flakes, step 1). These are mainly produced from PET containers, e.g. bottles, previously used for food packaging, collected through post‐consumer collection systems. However, a small fraction may originate from non‐food applications, such as bottles for soap, mouth wash or kitchen hygiene agents. According to the applicant, the collection system and the process are managed in such a way that this fraction will be no more than 5% in the input stream, as recommended by the EFSA CEF Panel in its ‘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). The process is adequately described. The washing and drying of the flakes from the collected PET containers (step 1) is conducted by third parties. According to the applicant, this step is under control. The NGR technology comprises drying (step 2), extrusion (step 3), melt‐state polycondensation (step 4) and granulation (step 5). The operating parameters of temperature, residence time, pressure and gas flow have been provided to EFSA. A challenge test to measure the decontamination efficiency was conducted at pilot plant scale on process steps 4 and 5. The Panel considered that this challenge test was performed correctly according to the recommendations of the EFSA guidelines (EFSA, 2008). The decontamination of the material in a vacuum reactor by melt‐state polycondensation (step 4) is critical and depends on the surface area of the melt exposed to the vacuum, the residence time and the temperature. ■■■■■ Consequently, the pressure, the temperature, the residence time (depending on the mass and throughput of the melt) and the characteristics of the reactor specified in Appendix C should be controlled to guarantee the performance of the decontamination. The decontamination efficiencies obtained for each surrogate, ranging from 96.5% to more than 99.9%, have been used to calculate the residual concentrations of potential unknown contaminants in 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’ (EFSA CEF Panel, 2011; Appendix B). By applying the decontamination efficiency percentage to the reference contamination level of 3 mg/kg PET, the Cres for the different surrogates was obtained (Table 2). Table 2 Decontamination efficiency from the challenge test, residual concentrations of the surrogates (Cres) related to the reference contamination level and calculated concentrations of the surrogates in PET (Cmod) corresponding to a modelled migration of 0.1 μg/kg food after 1 year at 25°C Surrogates Decontamination efficiency (%) Cres for 100% rPET (mg/kg PET) Cmod (mg/kg PET) Toluene > 99.9 < 0.004 0.09 Chlorobenzene > 99.9 < 0.002 0.09 Phenylcyclohexane 99.9 0.004 0.14 Benzophenone 96.5 0.106 0.16 Methyl stearate 99.8 0.007 0.32 PET: poly(ethylene terephthalate). rPET: recycled poly(ethylene terephthalate). According to the evaluation principles (EFSA CEF Panel, 2011), the dietary exposure must not exceed 0.0025 μg/kg bw per day, below which the risk to human health is considered negligible. The Cres value should not exceed the modelled concentration in PET (Cmod) that, after 1 year at 25°C, results in a migration giving rise to a dietary exposure of 0.0025 μg/kg bw per day. Because the recycled PET is intended for the manufacturing of articles (e.g. bottles) to be used in direct contact with drinking water, the exposure scenario for infants has been applied (water could be used to prepare infant formula).Therefore, the migration of 0.1 μg/kg into food has been used to calculate Cmod (EFSA CEF Panel, 2011). The results of these calculations are shown in Table 2. The relationship between the key parameters for the evaluation scheme is reported in Appendix B. As Cres values are lower than the corresponding modelled concentrations in PET (Cmod), the Panel considered that under the given operating conditions, the recycling process CCH CIRCULARPET using the NGR technology is able to ensure that the level of migration of unknown contaminants from the recycled PET into food is below the conservatively modelled migration of 0.1 μg/kg food. At this level, the risk to human health is considered negligible when the recycled PET is used at up to 100% to produce materials and articles intended for contact with all types of foodstuffs for long‐term storage at room temperature, with or without hotfill. 4 Conclusions The Panel considered that the process CCH CIRCULARPET using the NGR technology is adequately characterised and that the main steps used to recycle the PET flakes into decontaminated PET pellets have been identified. Having examined the challenge test provided, the Panel concluded that the melt‐state polycondensation (step 4) is critical for the decontamination efficiency. The operating parameters to control its performance are the pressure, the temperature, the residence time (depending on the mass and throughput of the melt) and the characteristics of the reactor specified in Appendix C. The Panel considered that the recycling process CCH CIRCULARPET is able to reduce foreseeable accidental contamination of post‐consumer food contact PET to a concentration that does not give rise to concern for a risk to human health if:it is operated under conditions that are at least as severe as those applied in the challenge test used to measure the decontamination efficiency of the process; the input material of the process is washed and dried post‐consumer PET flakes originating from materials and articles that have been manufactured in accordance with the EU legislation on food contact materials and contain no more than 5% of PET from non‐food consumer applications; the recycled PET obtained from the process CCH CIRCULARPET is used at up to 100% for the manufacture of materials and articles for contact with all types of foodstuffs, including drinking water, for long‐term storage at room temperature, with or without hotfill. The final articles made of this recycled PET are not intended to be used in microwave or conventional ovens and such uses are not covered by this evaluation. 5 Recommendations The Panel recommended periodic verification that the input material to be recycled originates from materials and articles that have been manufactured in accordance with the EU legislation on food contact materials and that the proportion of PET from non‐food consumer applications is no more than 5%. This adheres to good manufacturing practice and the Regulation (EC) No 282/2008, Art. 4b. Critical steps in recycling should be monitored and kept under control. In addition, supporting documentation should be available on how it is ensured that the critical steps are operated under conditions at least as severe as those in the challenge test used to measure the decontamination efficiency of the process. 6 Documentation provided to EFSA Dossier ‘CCH CIRCULARPET’, June 2022. Submitted on behalf of CCH CIRCULARPET S.R.L, Italy. Additional information, August 2022. Submitted on behalf of CCH CIRCULARPET S.R.L, Italy. Abbreviations bw body weight CEF Panel Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids CEP Panel Panel on Food Contact Materials, Enzymes and Processing Aids Cmod modelled concentration in PET Cres residual concentrations in PET PET poly(ethylene terephthalate) PVC poly(vinyl chloride) rPET recycled poly(ethylene terephthalate) Appendix A – Technical data of the washed flakes as provided by the applicant 10 1 Parameter Value Moisture < 1% Bulk density 350–400 kg m−3 Intrinsic viscosity 0.75–0.8 dL/g PVC < 50 mg/kg Glue < 20 mg/kg Polyolefins < 50 mg/kg Metals < 20 mg/kg Paper < 20 mg/kg Wood < 40 mg/kg PVC: poly(vinyl chloride). Appendix B – Relationship between the key parameters for the evaluation scheme (EFSA CEF Panel, 2011) 1 *: Default scenario (infant). For adults and toddlers, the migration criterion will be 0.75 and 0.15 μg/kg food, respectively. The figures are derived from the application of the human exposure threshold value of 0.0025 μg/kg bw per day applying a factor of 5 related to the overestimation of modelling. Appendix C – Table on operational parameters 14 1 ■■■■■ ■■■■■ ■■■■■ Process CCH CIRCULARPET (RECYC284) based on the NGR technology Step 2 (drying) Step 3 (Extrusion) Step 4 (Decontamination)* Step 5 (Granulation) t (min) P (mbar) Flow (m3/h) T (°C) t (sec) P (mbar) T (°C) t (min) P (mbar) T (°C) t (min) P (mbar) T (°C) Challenge test (PA/4499a/20) ■■■■■ ■■■■■ ■■■■■ ■■■■■ ■■■■■ ■■■■■ ■■■■■ ■■■■■ ■■■■■ ■■■■■ Process ■■■■■ ■■■■■ ■■■■■ ■■■■■ ■■■■■ ■■■■■ ■■■■■ ■■■■■ ■■■■■ ■■■■■ ■■■■■ ■■■■■ ■■■■■ ■■■■■ ■■■■■ ■■■■■ ■■■■■ *: Characteristics of the reactor in the challenge test and the industrial process. ■■■■■ (challenge test) ■■■■■ (industrial process) General ■■■■■ ■■■■■ ■■■■■ ■■■■■ ■■■■■ ■■■■■ Vertical part ■■■■■ ■■■■■ ■■■■■ ■■■■■ ■■■■■ ■■■■■ ■■■■■ ■■■■■ ■■■■■ Horizontal part ■■■■■ ■■■■■ ■■■■■ ■■■■■ ■■■■■ ■■■■■ ■■■■■ ■■■■■ ■■■■■ ■■■■■ ■■■■■ ■■■■■ ■■■■■ ■■■■■ ■■■■■ ■■■■■ Notes 1 Regulation (EC) No 282/2008 of 27 March 2008 on recycled plastic materials and articles intended to come into contact with foods and amending Regulation (EC) No 2023/2006. OJ L 86, 28.3.2008, p. 9–18. 2 Commission Regulation (EC) No 282/2008 was repealed by Commission Regulation (EU) 2022/1616 of 15 September 2022 on recycled plastic materials and articles intended to come into contact with foods, and repealing Regulation (EC) No 282/2008 (OJ L 243 20.9.2022, p. 3) which entered into force on 10 October 2022. Applications submitted to EU Member State competent authorities before the date of entry into force of Commission Regulation (EU) 2022/1616 are evaluated by EFSA in accordance with Commission Regulation (EC) No 282/2008. 3 Regulation (EC) No 1935/2004 of the European parliament and of the council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC. OJ L 338, 13.11.2004, p. 4–17. 4 Commission Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety. OJ L 31, 1.2.2002, p.1–48. 5 Decision available at: https://www.efsa.europa.eu/en/corporate-pubs/transparency-regulation-practical-arrangements 6 The non‐confidential version of the dossier has been published on Open.EFSA and is available at the following link: https://open.efsa.europa.eu/dossier/FCM-2021-1408 7 Decision available online: https://www.efsa.europa.eu/sites/default/files/corporate_publications/files/210111-PAs-pre-submission-phase-and-public-consultations.pdf 8 Technical dossier, sections ‘Recycling process’ and ‘Intended application in contact with food’. 9 Technical dossier, ‘Recycling process’, ‘Characterisation of the input’ and ‘Characterisation of the recycled plastic’. 10 Technical dossier, section ‘Characterisation of the input’. 11 Technical dossier, section ‘Recycling process’ and ‘Determination of the decontamination efficiency of the recycling process’. 12 In accordance with Art. 9 and 20 of Regulation (EC) No 1935/2004, the parameters were provided to EFSA by the applicant and made available to the Member States and the European Commission (see Appendix C). 13 Technical dossier, section ‘Determination of the decontamination efficiency of the recycling process’ and Appendix E. 14 Technical dossier, section ‘Table of operating parameters’. ==== Refs References EFSA (European Food Safety Authority) , 2008. Guidelines for the submission of an application for safety evaluation by the EFSA of a recycling process to produce recycled plastics intended to be used for manufacture of materials and articles in contact with food, prior to its authorisation. EFSA Journal 2008;6(7):717, 12 pp. 10.2903/j.efsa.2008.717 EFSA (European Food Safety Authority) , 2009. Guidance of the Scientific Committee on transparency in the scientific aspects of risk assessments carried out by EFSA. Part 2: general principles. EFSA Journal 2009;7(5):1051, 22 pp. 10.2903/j.efsa.2009.1051 EFSA (European Food Safety Authority) , 2021. Administrative guidance for the preparation of applications on recycling processes to produce recycled plastics intended to be used for manufacture of materials and articles in contact with food. EFSA Journal 2021;18(3):EN‐6512, 30 pp. 10.2903/sp.efsa.2021.EN-6512 EFSA CEF Panel (EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) , 2011. 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 Journal 2011;9(7):2184, 25 pp. 10.2903/j.efsa.2011.2184 FDA (Food and Drug Administration) , 2006. Guidance for Industry: Use of Recycled Plastics in Food Packaging: Chemistry Considerations. Available online: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-use-recycled-plastics-food-packaging-chemistry-considerations