EFSA plastics pre-dossier & compliance with agricultural standards

D1.5 – EFSA plastics pre-dossier & compliance with agricultural standards July 2025 Authors: Pedro López (CETEC) Ref. Ares(2025)6160281 - 29/07/2025 A2C – Deliverable D1.5V2.0 Page 2 І67 1 Technical references Project Acronym Agro2Circular Project Title TERRITORIAL CIRCULAR SYSTEMIC SOLUTION FOR THE UPCYCLING OF RESIDUES FROM THE AGRIFOOD SECTOR Project Coordinator Coordinator Name: Fuensanta Monzó Sánchez PARTNER NAME [email protected] Project Duration October 2021 – March 2025 (42 months) Deliverable No. D1.5 D5 Dissemination level* PU Work Package WP1.A2C Specifications, Residues Management and Data Integration System Task T1.2.1 - Plastics food contact assesment & compliance with agriculture standards Lead beneficiary 1 (CETEC) Contributing beneficiary/ies GWC (Salvador Navarro), CETEC(Pedro López) Due date of deliverable 30 September 2024 Actual submission date 25 March 2025 * PU = Public PP = Restricted to other programme participants (including the Commission Services) RE = Restricted to a group specified by the consortium (including the Commission Services) A2C – Deliverable D1.5V2.0 Page 3 І67 CO = Confidential, only for members of the consortium (including the Commission Services) Document history V Date Comments v0.1 28/03/2025 First draft of document v0.2 31/03/2025 Revised version based on the comments of Fuensanta Monzó (CETEC) v1.0 25/03/2025 First final version, approved by the WP leader and the project coordinator, (will be) submitted to EC. v2.0 28/07/2025 Second final version, approved by the WP leader and the project coordinator, (will be) submitted to EC. Document Distribution Log Version Date Distributed to v0.1 28/03/2025 Fuensanta Monzó (CETEC) V0.2 31/03/2025 Fuensanta Monzó (CETEC) V2.0 28/07/2025 Fuensanta Monzó (CETEC) Verification and approval Name Date Verification Final Draft by WP leader Jaime OrtízCETEC 28/07/2025 Approval Final Deliverable by coordinator Fuensanta Monzó - CETEC 28/07/2025 Disclaimer and acknowledgement A2C – Deliverable D1.5V2.0 Page 4 І67 This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 101036838 Disclaimer This document reflects only the views of the author(s) the European Research Executive Agency (REA) is not responsible for any use that may be made of the information it contains. Whilst efforts have been made to ensure the accuracy and completeness of this document, the A2C consortium shall not be liable for any errors or omissions, however caused. A2C – Deliverable D1.5V2.0 Page 5 І67 2 Table of contents 1 Technical references ................................................................... 2 2 Table of contents ......................................................................... 5 2.1List of Figures............................................................................................................ 7 2.2 List of Tables. ........................................................................................................... 8 3 List of abbreviations ..................................................................... 9 4 Executive summary <abstract> ................................................. 10 5 Introduction ................................................................................ 13 5.1 Fundamental Regulatory Framework. ............................................................. 15 5.2 Other Relevant EFSA Guidelines and Documents ......................................... 19 5.3 A Step-by-Step Guide to Safety Assessment Documentation ....................... 20 6 Compliance with agriculture standards. ..................................... 27 Description of the process used for the recycling of agricultural plastic. .............. 27 6.1 First treatment and extrusion. .......................................................................... 27 6.2 DECONTAMINATION PROCESS ....................................................................... 34 7 Assessment of the decontamination process in samples from the refreshing process by means of NIAS test. .................................... 40 7.1 Assessment of samples decontaminated by the refreshing process. .......... 40 7.2 Volatile organic compounds assessment. ...................................................... 41 A2C – Deliverable D1.5V2.0 Page 6 І67 7.3 Semi-volatile organic compounds assessment. ............................................. 42 8 Assessment of decontamination process in samples from degassing process by means of NIAS test. .................................... 44 8.1 Assessment of samples decontaminated by the refreshing process. .......... 44 8.2 Volatile organic compounds assessment. ...................................................... 45 8.3 Semi-volatile organic compounds assessment. ............................................. 46 9 Main recommendations to GWC to meet and prepare EFSA dossier in agricultural plastic. ......................................................... 49 10 Collection of the plastic wastes from food packaging. ............... 51 10.1 Aseptic bags from Agrotransformados. .......................................................... 51 10.2 Aseptic bags from Laboratories Almond S.L. .................................................... 55 10.3 Aseptic bags from Citromil SL. ........................................................................ 56 10.4 Summary of the aseptic bag types. ................................................................. 56 11 Description of the recycling process: pretreatment and preliminary decontamination & mechanical recycling of multilayers structures.58 12 Conclusions. .............................................................................. 61 13 Bibliography ............................................................................... 64 A2C – Deliverable D1.5V2.0 Page 7 І67 2.1List of Figures. Figure 1 Stages of the agricultural plastic recycling process. ............................................ 27 Figure 2 The way in which it packages the plastic material collected from the field (bales). ................................................................................................................................... 28 Figure 3 Pre-treatment of the latter. ................................................................................... 29 Figure 4 Opening and shredding of bales. ......................................................................... 29 Figure 5 Appearance of the recycled plastic after shredding and washing. ....................... 30 Figure 6 Water treatment plant at the GWC facility. ........................................................... 31 Figure 7 Different parts of the final decontamination process undergone by grinded and washed plastics in the Intarema TVEPlus Extruder. ................................................... 32 Figure 8 Stalinger refreshing technology. .......................................................................... 34 Figure 9 Process recoSTAR .............................................................................................. 35 Figure 10 Erema refreshing technnology .......................................................................... 36 Figure 11 Plastic Pre-treatment and preliminary decontamination system in GWC for the multilayer aseptic bag waste. ...................................................................................... 58 A2C – Deliverable D1.5V2.0 Page 8 І67 2.2 List of Tables. Table 1 Comparative table of Key regulatory documents. ................................................. 17 Table 2 Agrotransformados aseptic bag type 1 ......................................................... 51 Table 3 Agrotransformados aseptic bag type 2 ......................................................... 52 Table 4 Agrotransformados aseptic bag type 3 ......................................................... 52 Table 5: Agrotransformados aseptic bag type 4 ....................................................... 53 Table 6 Agrotransformados aseptic bag type 5 ......................................................... 53 Table 7 Agrotransformados aseptic bag type 6 ......................................................... 54 Table 8 Agrotransformados aseptic bag type 7 ......................................................... 54 Table 9 Agrotransformados aseptic bag type 8 ......................................................... 55 Table 10 Citromil aseptic bag. ........................................................................................... 56 Table 11 Different types of aseptic bag structures ................................................... 57 A2C – Deliverable D1.5V2.0 Page 9 І67 3 List of abbreviations SML (Specific migration limit) NIAS Non Intentional Added Substances EFSA European food safety authority. C.M.S.S Compliance monitoring summary sheet FCM food contact materials PET polyethylene terephthalate GMP Good manufacturing practices DoC Declaration of conformity QAS Quality assurance system A2C – Deliverable D1.5V2.0 Page 16 І67 It includes a list of authorized monomers, additives and polymer production aids 12. The regulation also emphasizes the importance of migration testing and the establishment of Specific Migration Limits (SMLs) and an overall Migration Limit (GML) to ensure that excessive transfer of substances to food does not occur9 . Although primarily focused on new plastics, Regulation (EU) No. 10/2011 is relevant for recycled plastics, as these must meet similar safety standards with respect to migration of substances into food 3. The regulation most directly relevant to the development of this guide is Regulation (EU) 2022/1616 on recycled plastic materials and articles intended to come into contact with food1. This regulation, which entered into force on October 10, 2022 and repealed Regulation (EC) No. 282/2008, aims to increase recycled content in food packaging while ensuring a high level of human health protection 5. It sets out key requirements, including the need for EFSA authorization for recycling processes(excluding closed loop recycling), appropriate recycling technologies(mechanical PET recycling and closed and controlled chain recycling) and the concept of novel technologies 2. It also mentions the requirements for compliance testing (specific and overall migration, heavy metals, primary aromatic amines) 5. In addition, it establishes a Union Register for authorized technologies, recyclers, processes, schemes and decontamination facilities 1. Finally, it details the requirements for labeling and the Declaration of Conformity (DoC) 17. Regulation (EU) 2022/1616 is the most current and directly applicable regulation for this guide, as it replaces the previous framework 5. Regulation Scope Key requirements Chronology and status.. Regulation (EC) No. 1935/2004 All materials and articles intended to come into contact with food. General principles safety, inertia, no transfer of components on In force A2C – Deliverable D1.5V2.0 Page 17 І67 quantities dangerous . Regulation (EU) No 10/2011 Plastic materials and articles intended for contact with food Composition requirements detailed, migration limits, EU list of authorized substances In force with amendments Regulation (EU) No 2022/1616 Recycled plastic materials and articles intended to come into contact with foodstuffs. EFSA for recycling processes (except in closed loop), suitable recycling technologies, decontamination, Union Registration, labeling, DoC In force, since October 2022. Repeals Regulation (EC) Nº 282/2008 Regulation (EU) No 28/02/2008 Materials and objects of recycled plastic intended to come in contact with food. Authorization of recycling processes, incoming quality control of the input, guarantee of absence of contamination Repealed on October, 10 , 2022. Table 1 Comparative table of Key regulatory documents. The EFSA scientific opinion published in 2011 (EFSA Journal 2011;9(7):2184) provided criteria for the safety assessment of a mechanical recycling process to produce recycled polyethylene terephthalate (PET) for mechanical recycling process to produce recycled polyethylene terephthalate (PET) intended for use in food contact materials and articles 21. A2C – Deliverable D1.5V2.0 Page 18 І67 This opinion focused specifically on the safety assessment of recycling processes mechanical recycling of PET intended for food contact 1. At its essence, the 2011 opinion was based on the principle of evaluating the cleanup efficiency of a recycling technology or process through challenge tests using surrogate contaminants 21. The demonstrated efficiency was then applied to a baseline contamination level for post-consumer PET 28. This approach aimed to determine whether a recycling process could reduce the levels of contamination to a point where migration to food would not pose a risk to human health. EFSA established several key criteria for assessing the safety of PET recycling processes in its 2011 opinion. One of the important criteria was the quality of the input material 21. The opinion specified that the material from input should originate primarily from PET containers that have been in contact with food, with a limit on the proportion of PET from non-food applications (e.g., no more than 5%) 21. The quality of the input material was considered to significantly influence the potential types and levels of contamination that might be present. Another crucial factor was the decontamination efficiency of the recycling process 22. The opinion highlighted the need to identify the critical steps in the recycling process that were responsible for ensuring effective decontamination. Examples of such critical steps included preheating, decontamination in a polymerization reactor in a continuous solid-state polymerization (SSP) reactor, drying and crystallization, and extrusion22. Also emphasized the importance of controlling the operating parameters (such as temperature, pressure and residence time) in these critical residence time) at these critical stages to ensure consistent performance 22. EFSA also took into account the intended use of the recycled plastic21. The opinion recognized that the end-use application of the recycled material (e.g., the type of food it would come into contact with, contact conditions and the type of food with which it would come into contact, contact conditions and temperature) could influence the decontamination temperature) could influence the necessary decontamination requirements. The 2011 decision detailed the challenge test methodology that applicants were required to use to demonstrate the decontamination effectiveness of their recycling process 21.that A2C – Deliverable D1.5V2.0 Page 19 І67 applicants were to use to demonstrate the decontamination effectiveness of their recycling process 21. This methodology involved the introduction of specific surrogate contaminants into the input material prior to the recycling process and the measurement of their measurement of their reduction through the process. These surrogates were selected to represent different classes of possible contaminants that could be found in post-consumer PET. In addition, the scientific opinion introduced the concept of a reference contamination level of 3 mg/kg PET for contaminants resulting from possible misuse 27. The decontamination efficiency obtained from the challenge test was applied to this reference level applied to this reference level. The opinion compared the residual concentration of the surrogates in recycled PET (Cres) with a modeled concentration (Cmod) 28. Cmod was calculated using generally recognized conservative migration models to ensure that the related dietary exposure did not exceed a threshold of toxicological concern (TTC) value of 0.0025 μg/kg body weight per day for substances with structural alerts of concern for potential genotoxicity28. EFSA also considered a default exposure scenario of an infant consuming water from a 100% recycled PET bottle 28. 5.2 Other Relevant EFSA Guidelines and Documents In addition to the 2011 scientific opinion, EFSA has published other guidelines and scientific opinions that are relevant to the safety assessment of recycling processes for plastics intended for contact with food. It is essential to consider these supplemental documents to gain a full understanding of EFSA's requirements. A key document is the 2024 Scientific Guidance on the criteria for the evaluation of safety claims for mechanical recycling processes for PET used in food and beverage packaging 1. This updated guide refines and expands on the criteria described in the 2011 opinion, taking into account the new regulatory framework established by Regulation (EU) 2022/1616 3. The 2024 guidance emphasizes the need to provide detailed information on the collection, preprocessing, decontamination; post-processing and intended use of recycled PET 31.This guide represents the latest information from EFSA on the evaluation of PET recycling processes under the new regulation 1. A2C – Deliverable D1.5V2.0 Page 20 І67 There are also other EFSA scientific opinions on specific recycling processes and technologies that can provide valuable examples of how EFSA applies its assessment criteria in practice. These include opinions on technologies such as Starlinger Decon 29 technology and Starlinger IV+ 22. Examination of these opinions can provide information on the level of detail and type of information EFSA expects in a safety assessment. In addition, EFSA has published general guidelines on recycling processes for recycled plastics intended to come into contact with food 1. These guidelines are essential reading for the completion of technical dossiers related to applications for authorization 3. They provide additional requirements that go beyond the regulations themselves and offer practical advice for the preparation of authorization applications 3. To understand the application procedures and requirements for safety assessments, it is necessary to consult both Regulation (EU) 2022/1616 and EFSA guidance on the application process 3. The general process involves the submission of a complete technical dossier to the competent authority of a member state, which then forwards it to EFSA for scientific evaluation 3. The dossier should include detailed information on the recycling process, input material characterization, decontamination efficiency data, (supported by challenge test data), the characterization of the recycled plastic, the intended use and demonstration of compliance with relevant regulations 22. Thorough preparation of the application dossier is essential for a successful safety assessment by EFSA 22 5.3 A Step-by-Step Guide to Safety Assessment Documentation The development of a generic document for safety evaluations of food contact plastic recycling processes for plastics intended for food contact requires a systematic approach, following the identified steps and elaborating on the details provided by EFSA. Steps 1 and 2: Comprehensive guidance on locating and identifying all relevant scientific opinions, guidelines and normative documents. A2C – Deliverable D1.5V2.0 Page 21 І67 The crucial first step in developing your guidance is to ensure that you have access to all relevant EFSA and European Commission documents. The EFSA website (www.efsa.europa.eu) and the European Commission website are the primary sources for these publications 1. It is recommended to use specific keywords such as "plastic recycling", "food contact materials", "safety assessment" and the specific regulation numbers (e.g. 1935/2004,2022/1616, 10/2011) when searching these websites. It is important to identify both general MCA regulations and specific documents related to recycled plastics. A comprehensive search strategy will ensure that your guide is based on the most complete and up-to-date information available. Steps 3 and 4: Methodical approach to analyze the 2011 opinion and other documents to extract key criteria, processes and complementary information. Once you have collected the relevant documents, the next step is to analyze them systematically to extract key information. A structured approach to reading and note-taking is suggested, focusing on identifying basic principles, definitions, requirements and assessment methodologies. The creation of summaries or concept maps can be useful to visualize the relationships between different concepts and regulations. It is important to distinguish between the requirements for different types of recycling technologies (e.g., recycling mechanical PET vs. novel technologies) 2. A thorough analysis will ensure that all relevant information is captured and understood, forming a solid basis for your guidance. Step 5: Detailed explanation of the information and steps that EFSA considers necessary for a safety assessment of a plastics recycling process. Based on the analysis of EFSA's guidelines and regulations, your guidance should provide a complete list of information required in an application dossier. This information includes 22: ● Detailed description of the recycling process, including all steps, equipment and operating parameters. A2C – Deliverable D1.5V2.0 Page 22 І67 ● Characterization of the input material, detailing its origin, type and the Quality control measures applied. ● Challenge test data demonstrating the decontamination efficiency of the process for relevant surrogate contaminants. ● Characterization of the recycled plastic, including its properties and intended uses. ● Information on the intended food contact application, specifying food types and contact conditions. ● Demonstration of compliance with all relevant regulations for food contact materials. ● Analysis and evaluation of the process, including identification of critical control points. ● Operating parameters of critical steps. ● Self-assessment of the safety and efficacy of the process. Providing this detailed checklist will act as a practical checklist for those using your guide to prepare safety assessments. Step 6: Structuring a generic safety assessment document: outline of essential sections and elements based on EFSA requirements. To ensure that your guidance is practical and easy to use, you should propose a clear structure for a generic safety assessment document. This structure could mirror that of an EFSA application or a full technical report. ● Executive Summary: A brief summary of the recycling process and its safety. ● Introduction: Setting the context and objectives of the assessment. ● Description of the Recycling Process: A detailed flow chart and a description of each stage of the process. A2C – Deliverable D1.5V2.0 Page 23 І67 ● Characterization of the Input Material: Details on the origin, type and quality control of incoming plastic. ● Decontamination Efficiency: Presentation of the methodology and the results of the challenge tests results. ● Characterization of Recycled Plastic: Description of the properties and ● Intended Application: Specification and properties of the output material. ● Intended Application: Specification of the food types and contact conditions for which the product is intended. Contact conditions for which the recycled plastic is intended. ● Regulatory Compliance: Demonstration of compliance with. Regulation (EU) 2022/1616 and other relevant regulations. ● Process Control and Quality Assurance: Description of the quality management system and monitoring procedures Quality Management System and monitoring procedures. ● Safety Assessment and Conclusion: Summary of the findings and conclusion on the safety of the process. ● Appendices: Inclusion of raw data, test reports and other supporting documentation. A well-defined structure will ensure that the safety assessment document is comprehensive, logical, and easy to follow for both the user and the regulatory authorities. Step 7: Review examples of EFSA safety assessments of specific recycling processes and technologies specific recycling processes. A2C – Deliverable D1.5V2.0 Page 24 І67 The guide should encourage users to study publicly available EFSA opinions on authorized recycling processes publicly available EFSA opinions on authorized recycling processes. These examples, such as those Starlinger, VACUREMA, and PETUK SSP mentioned in 21, can provide valuable information on the level of detail and type of information EFSA expects in a safety assessment. The analysis of these practical examples can help users to better understand the expectations and standards for safety assessments. Step 8: Identification and understanding of any updates or amendments of the 2011 scientific opinion, particularly in light of Regulation (EU) 2022/1616 and the 2024 guidance. Finally, it is crucial that your guidance emphasizes the importance of taking into account the 2024 Scientific Guidance as the most up-to-date information on EFSA's on PET recycling 1. Your guidance should highlight any significant changes in evaluation criteria or application requirements compared to the 2011 opinion. It is essential to reiterate that the new regulatory framework of Regulation (EU) 2022/1616 takes precedence. Keeping up to date with the latest guidelines and regulations will ensure the accuracy and relevance of your safety assessment guidance. Incorporation of Decontamination Efficiency and Challenge Test Data. A critical component of any safety assessment of plastics recycling processes is the demonstration of decontamination efficiency. Your guide should provide practical guidance on how to present and interpret challenge test data for this purpose. It is important to explain the need to select appropriate surrogate contaminants that represent a range of potential hazards 27. The guidance should detail the need to describe the experimental design of the challenge test, including the initial concentration of the surrogates and the analytical methods used for their detection. It should also provide guidance on how to calculate and present the decontamination efficiency, e.g., in percent reduction 27. A key aspect of EFSA's evaluation is the comparison of the residual concentration of the surrogates (Cres) with the modeled residual concentration of the surrogates (Cres) with the modeled concentration (Cmod) based on its criteria 28. The guide A2C – Deliverable D1.5V2.0 Page 25 І67 should explain how to perform this comparison and its importance in demonstrating the safety of the process. In addition, it is critical to the need for robust analytical methods with appropriate limits of detection and quantification 33. A clear and scientifically sound presentation of challenge test data is essential to demonstrate the efficacy of the decontamination process to EFSA. Addressing Novel Technologies and the Union's Registry The regulatory framework recognizes different types of recycling technologies, and its guidance should address the assessment and permitting pathways for novel technologies2. It is important to explain that recycling technologies other than mechanical PET recycling and closed-loop recycling are classified as “Novel Technology” 5. The guidance should highlight the requirement for a complex new technology It should also mention that EFSA must provide opinions on whether novel recycling technologies are suitable to be used as the basis for recycling processes 18. Understanding the specific pathway for novel technologies is crucial to ensure that your guidance is complete. In addition, the guide should explain the importance of the European Union Register of Authorized Processes 1. Regulation (EU) 2022/1616 establishes this register for novel technologies, recyclers, recycling processes, recycling schemes and decontamination facilities. The main purpose of this registry is to provide information to users of recycled plastic and to competent authorities for compliance verification. The guidance should highlight how this registry promotes transparency and facilitates traceability in the recycled plastics supply chain. Compliance and Best Practices Assurance Maintaining the safety and quality of recycled plastics intended for food contact requires compliance with Good Manufacturing Practices (GMP). Your guidance should emphasize that the production of recycled plastics must comply with GMP as described in Regulation (EC) No. 2023/2006 1 GMPs ensure that the correct input material, equipment and operating conditions are used during production 2. Your guide should also mention the importance of quality assurance systems and traceability from input to final product to final product 33. GMP A2C – Deliverable D1.5V2.0 Page 32 І67 Figure 7 Different parts of the final decontamination process undergone by grinded and washed plastics in the Intarema TVEPlus Extruder. • Initial degassing in the EREMA Preconditioning Unit takes place through preheating and predrying the material (2). • The optimum screw design – tuned to the material to be processed – enables reverse degassing in the Preconditioning Unit (3-6), thus relieving the degassing zone of the extruder. • Gas inclusions in the melt are removed in the extruder degassing zone (7). Only thoroughly melted, filtered and homogenised material can pass the degassing zone of the extruder. Furthermore, high filtration performance is achieved thanks to reduced shearing upstream of the melt filter which is crucial specially for the disinfection of agricultural film waste due to its high amount of soil impurities According to this mechanism, the melting procedure takes place with minimum shearing effect. This prevents any further size reduction of disturbing contaminants prior to filtration and enhances filtration efficiency. A2C – Deliverable D1.5V2.0 Page 33 І67 In order to assess effectiveness when it comes to contaminant removal by this extruder, several analyses have been performed over the resulting material. A2C – Deliverable D1.5V2.0 Page 34 І67 6.2 DECONTAMINATION PROCESS Refreshing technology. Starlinger refreshing technology is based upon the same processes since both brands rely on a two steps process with a first degassing one in a high vacuum extruder, the INTAREMA® TVEplus® and the recoSTAR® Direct respectively , and a subsequent thermal physical cleaning process designed to eliminate odours caused by low volatile, high molecular substances by keeping the pellets at the temperature required for fast and deep cleansing discharge of such volatile materials. . Figure 8 Stalinger refreshing technology. The STALINGER system employs three stages of odour reduction in its line RecoSTAR: feeder preparation by heating and homogenisation of the material, degassing and odour extraction and homogenisation of the material, degassing and odour extraction. A2C – Deliverable D1.5V2.0 Page 35 І67 Figure 9 Process recoSTAR The following process steps are carried out in the recoSTAR universal recycling line: 1. Material feeding via cyclone for sidewall strips. 2. and/or by roller feeder 3. and/or by conveyor belt with/without metal detector 4. Material crushing in the single-shaft mill 5. feeding to the single-screw extruder 6. Degassing of the melt to remove volatile impurities 7. Filtration of the melt without backwash filter 8. Melt filtration with back-flushing filter 9. Filtration of the melt with rotating filter 10. Melt filtration with high-performance backflushing filter 11. Water ring pelletiser 12. Underwater pelletising machine 13. Yarn pelletising machine 14. Storage silo A2C – Deliverable D1.5V2.0 Page 36 І67 Figure 10 Erema refreshing technnology EREMA has its Intrarema system to carry out this process using similar technology. The large-volume preconditioning unit guarantees a long residence time of the material at high temperature. In combination with the Air Flush technology, which washes the plastic with a continuous stream of hot air, and the subsequent degassing, highly volatile odorous substances are removed prior to extrusion. The application time of this technology was 22 hours. The results obtained in both processes are very similar, other than technical aspects led GWC to decide in favour of Stalinger's technology. A2C – Deliverable D1.5V2.0 Page 37 І67 Water-soluble extracting agent method. A second possibility to decontaminate our plastics once they have been shredded and extruded into pellets is to carry out another treatment based on a different method of decontamination is to perform another treatment based on the removal of contaminants by means of using a water-soluble extracting agent. The procedure for the decontamination of recycled plastic consists of the following stages: 1 Separation and shredding of the plastic: separation can be carried out using identification techniques such as NIR (near infrared spectroscopy) or X-ray fluorescence. While shredding is carried out by a blade crusher, a mill or cryogenic shredder to reduce the size of the material to flake or dust. 2. Washing (with or without surfactant, oxidizing agents can also be used to remove impurities) rinsing and drying. (mechanically). 3. Decontamination where the contaminants and additives present in the recycled plastic are removed. 4. Water recovery and extracting agent recovery systems to be recirculated and reused, making the process sustainable. Water recovery can be carried out by ultra-nitration and flocculation-decantation, or by crystallization and flocculation-decantation. Meanwhile solvent recovery is carried out employing ultrafiltration membranes and subsequent filtering. The decontamination stage is carried out independently from the conventional recycling process so that its input can be plastic already recycled from other recyclers. Therefore, it is a system for improving the quality of the recycled product (upgrading). A2C – Deliverable D1.5V2.0 Page 38 І67 Figure 10 Schematic diagram of the extractor’s decontamination and recovery unit. This technology improves the quality of recycled plastics regardless of their origin, whether post-industrial or post-consumer. Therefore, it solves, to a certain extent, the problem of recycling domestic plastic waste, increasing its recyclability. • A recycled material free of organic contaminants is obtained, increasing the added value of the product. • By increasing the quality of recycled plastic, the range of new opportunities for these materials will expand because they can be used in many applications (e.g., packaging in the cosmetics, hygiene, and food sectors). • It removes a broader range of organic compounds, from the most volatile to the heaviest. • It is a sustainable procedure, as it allows recirculation and reuse of both water and the extracting agent • By working at atmospheric pressure, the technology is simple and easy to implement. A2C – Deliverable D1.5V2.0 Page 39 І67 • The decontamination module can act as an independent module for the recycling process. In this case, the input to the process would be the recycled pellets, and it can become a system for improving the quality of the product already recycled by other companies. • The decontamination stage can be carried out before or after regranulation. • Only nontoxic agents are used in the process. A2C – Deliverable D1.5V2.0 Page 40 І67 7 Assessment of the decontamination process in samples from the refreshing process by means of NIAS test. Samples collected from both processes were collected and tested for the detection of the following substances that have not been intentionally added. The evaluation was carried out by dividing the test in three categories: metals and elements, volatile organic compounds and semi-volatile organic compounds according to the regulation EU 10/2011. The analyses performed are qualitative, showing only those compounds identified above the instrumental detection limit of the equipment. In case the risk obtained is medium/ high, it means that it will have to consider performing a specific analysis to accurately quantify the compound. The interpretation and the risk indicated as low (L), medium (M) or high (H), has been established according to the results obtained in relation to the regulation studied. 7.1 Assessment of samples decontaminated by the refreshing process. Tested elements. Result mg/kg Interpretation Risk Lithium ND UE 10/2011 L Beryllium ND UE 10/2011 L Boron ND UE 10/2011 L Sodium 12 UE 10/2011 L Magnesium 45 UE 10/2011 L Aluminum 4.3 UE 10/2011 L Phosphorus ND UE 10/2011 L Sulfur ND UE 10/2011 L Potassium 1.4 UE 10/2011 L Calcium 94 UE 10/2011 L Scandium ND UE 10/2011 L Titanium ND UE 10/2011 L Vanadium ND UE 10/2011 L Chrome ND UE 10/2011 L Manganese ND UE 10/2011 L Iron 3.78 UE 10/2011 L Cobalt ND UE 10/2011 L Nickel ND UE 10/2011 L A2C – Deliverable D1.5V2.0 Page 41 І67 Copper ND UE 10/2011 L Zinc 6.1 UE 10/2011 L Germanium ND UE 10/2011 L Arsenic ND UE 10/2011 L Selenium ND UE 10/2011 L Strontium ND UE 10/2011 L Molybdenum ND UE 10/2011 L Palladium ND UE 10/2011 L Cadmium ND UE 10/2011 L Lead ND UE 10/2011 L Antimony ND UE 10/2011 L Cesium ND UE 10/2011 L Bario ND UE 10/2011 L Lanthanum ND UE 10/2011 L Europium ND UE 10/2011 L Gadolinium ND UE 10/2011 L Terbium ND UE 10/2011 L Silver ND UE 10/2011 L Thallium ND UE 10/2011 L Lead ND UE 10/2011 L Bismuth ND UE 10/2011 L 7.2 Volatile organic compounds assessment. Tested compounds Result mg/kg Interpretation Risk Isopropyl myristate [100-27-0] 5.5 UE 10/2011(non SML) estimated toxicity L Ethyl palmitate [628-97-7] 0.25 UE 10/2011(non SML) estimated toxicity L Isopropyl palmitate [142-91-6] 1.3 UE 10/2011(non SML) estimated toxicity L Tris(2-4-di-tert-butylphenyl) phosphate [95906-11-9] (Irgafos 168) 24 UE 10/2011(non SML) estimated toxicity no data L Sum of alkanes 4.5 UE 10/2011(non SML) estimated toxicity no data L A2C – Deliverable D1.5V2.0 Page 48 І67 The surface to volume ratio (S/V) used by the laboratory to express the results was 0.6 dm2 in 100 ml of simulant. The customer must verify the conformity of this ratio with the one used in his product. - ND: Not Detected indicates that the compound, although measured, cannot be qualitatively detected above the detection limit. - The analyses performed are qualitative, showing only those compounds identified above the instrumental detection limit of the equipment. In case the risk obtained is medium/high, this means that the client will have to consider a specific analysis to accurately quantify the compound. - The interpretation and the risk indicated as low (L), medium (M) or high (H), has been established according to the results obtained in relation to the regulation studied, as well as the theoretical toxicity level of the compound. In conclusion, we can say that in the evaluation of metals, both methods show identical results. For the evaluation of volatile organic compounds, the elimination of these compounds by the refreshing process is more efficient, since in the extraction method there was one component that appeared at a high level (2-(5-Chloro-2-benzotriazolyl)-6-tert-butylp-cresol. Finally, in the case of semi-volatile organic compounds, another substance was detected at high levels. Confident of the efficiency shown for the decontamination of agricultural plastic, GWC preferred to use this method also in another production line for food plasti A2C – Deliverable D1.5V2.0 Page 49 І67 9 Main recommendations to GWC to meet and prepare EFSA dossier in agricultural plastic. 1. Prepare a flow-chart diagram with relevant key steps and a short written description. 2. Contaminant evaluation plan for the different batches received 2.1. Wastes management operators of the plastic input should ensure: 2.1.1. The plastic waste originated only from municipal waste, food retail or other food businesses if it was only intended and used for food contact with food. 2.1.2. Plastic waste originates only from plastic materials and articles manufactured in accordance with Regulation (EU) 10/2011( on plastic materials and articles intended to come into contact with food). 2.1.3. The plastic waste is subject to separate collection. Plastic waste shall be considered as collected separately. 2.1.4. Levels of Materials that are different for the plastic for which the decontamination process is intended, should be reduced to the requirements for the plastic input provided by the recycler. 2.2. The plastic waste shall be controlled through collection and preprocessing by means of quality assurance systems which: 2.2.1. ensure the conditions and requirements are met. 2.2.2. ensure traceability of each batch up to the point of the first sorting of collected plastic waste; and 2.2.3. be certified by an independent third party 3. Requirements for the decontamination process: Quarterly contaminant evaluation plan for the different batches received, which should include NIAS. 4. Inputs and output of the applied contamination process shall meet the specifications by means of characterization of the materials indicating their main mechanical properties such as tensile strength, bending, mass flow rate, oxidation induction time. DSC,... 5. The decontamination installation shall meet: 5.1. Located at a single recycling facility. 5.2. Its configuration and operation corresponds to that of the recycling process it applies. It is operated as described in the compliance monitoring summary sheet A2C – Deliverable D1.5V2.0 Page 50 І67 5.3. A repository of records used to record information on the quality of individual batches as defined in section 4.1 of the C.M.S.S. A2C – Deliverable D1.5V2.0 Page 51 І67 10 Collection of the plastic wastes from food packaging. Through a series of visits and surveys to agri-food partners that use aseptic bags, technical information and samples of aseptic bags have been collected. The partners involved in this task have been Agrotransformados SA (MCT), Laboratorios Almond SL (ALM) and Citromil SL (CITROMIL). In the following sections, we are going to describe the collected technical information and the aseptic bags characterization made by CETEC when technical information is not available. 10.1 Aseptic bags from Agrotransformados. Agrotransformados S.A. meets the requirements set out in the IFS FOOD Version 6.1., Nov. 2017 and other associated normative documents. The company Agrotransformados SA uses several kinds of aseptic bags that come from various suppliers. The first one is a multilayer laminated sheet with an Oxygen Transmission (cm3O2/m2/d) < 0,01: Composition Outer Cover PE40 Aluminum9 PA15 PE55 Inner lining, Product contact layer LLDPE50 Table 2 Agrotransformados aseptic bag type 1 A2C – Deliverable D1.5V2.0 Page 52 І67 The second one is a multilayer structure with an Oxygen Transmission (cm3O2/m2/d) < 0,05: Composition Outer cover PE40 Metallized PET12 PE50 Inner lining, Product contact layer PE115 Table 3 Agrotransformados aseptic bag type 2 The third one is also a multilayer structure, High Barrier Type with an Oxygen Transmission (cm3O2/m2/d) < 0,02: The fourth one is a multilayer structure with an Oxygen Transmission (cm3O2/m2/d) < 0,01: Composition Outer Cover PE30 Composition Outer Cover PE45 Metallized PET12 PE45 Inner lining, Product contact layer PE EVOH PA PE Table 4 Agrotransformados aseptic bag type 3 A2C – Deliverable D1.5V2.0 Page 53 І67 Aluminum7 PA15 PE45 Inner lining, Product contact layer PE50 PE50 Table 5: Agrotransformados aseptic bag type 4 The fifth one is a multilayer structure with an Oxygen Transmission (cm3O2/m2/d) < 0,06: Composition Outer Cover LLDPE38 Metallized PET12 LLDPE38 Inner Lining LLDPE EVOH LLDPE Inner lining, Product contact layer LLDPE50 Table 6 Agrotransformados aseptic bag type 5 The sixth one is a multilayer structure with an Oxygen Transmission (cm3O2/m2/d) = 0,38: Composition Outer Cover PE20 A2C – Deliverable D1.5V2.0 Page 54 І67 Metallized PET12 PE53 Inner lining, Product contact layer PE45,7 EVOH7,6 PE45,7 Table 7 Agrotransformados aseptic bag type 6 The seventh one is a multilayer structure with an Oxygen Transmission (cm3O2/m2/d) < 1: Composition Outer Cover PE Metallized PET PE Inner lining, Product contact layer LLDPE65 LLDPE65 Table 8 Agrotransformados aseptic bag type 7 The eighth one is a multilayer structure with an Oxygen Transmission (cm3O2/m2/d) < 0,1: Table 8: Agrotransformados aseptic bag type 8 Composition Outer Cover PE38 Metallized PET12 PE38 Inner lining LLDPE30 LLDPE30 A2C – Deliverable D1.5V2.0 Page 55 І67 Table 9 Agrotransformados aseptic bag type 8 10.2 Aseptic bags from Laboratories Almond S.L. Laboratorios Almond SL meets the requirements set out in the IFS FOOD Version 6.1., Nov. 2017 and other associated normative documents. The aseptic bag used by the company is a multilayer structure made of three layers, composed of the following materials2: Composition Outer Cover LLDPE PET Aluminum LLDPE Inner lining LDPE EVOH LDPE Inner lining, Product contact layer LLDPE 2due to lack of technical sheet, the composition have been determined by CETEC laboratory In addition, this aseptic bag complies with the global migration tests and with the specific migration tests of heavy metals according to the Commission Regulation (EU) No 10/2011 of 14 January 2011 and hence Article 3 of European Regulation No. 1935/2004. And also comply with the content of heavy metals according to European Directive 94/62/EC - Total Lead, Cadmium, Mercury and Hexavalent Chromium content. Inner lining, Product contact layer LLDPE30 A2C – Deliverable D1.5V2.0 Page 56 І67 10.3 Aseptic bags from Citromil SL. Citromil SL meets the requirements set out in the IFS FOOD Version 7., Oct. 2020 and other associated normative documents. The aseptic bag used by the company is a multilayer structure made of two layers, composed of the following materials and an Oxygen Transmission (cm3O2/m2/d) < 0,02: Composition External layer LDPE45 Metallized PET12 LDPE45 Internal layer PE EVOH PA PE Table 10 Citromil aseptic bag. 10.4 Summary of the aseptic bag types. 1 2 3 4 5 6 7 8 9 OTR (cm3O2/m2/d) <0,01 <0,05 <0,02 <0,01 <0,06 0,38 <1 <1 <1 Outer cover PE40 PE40 PE45 PE30 LLDPE38 PE20 PE LLDPE38 PE40 Aluminum9 Metallized PET12 Metallized PET12 Aluminum7 Metallized PET12 Metallized PET12 Metallized PET Metallized PET12 Metallized PET12 PA15 PE50 PE45 PA15 LLDPE38 PE53 PE LLDPE38 PE50 PE55 PE45 Inner lining LLDPE LLDPE30 A2C – Deliverable D1.5V2.0 Page 57 І67 EVOH LLDPE30 LLDPE Inner lining, Product contact layer LLDPE50 PE115 PE PE50 LLDPE50 PE45,7 LLDPE65 LLDPE EVOH PE50 EVOH7,6 LLDPE65 LLDPE50 PA PE45,7 LLDPE50 PE Table 11 Different types of aseptic bag structures The different types of aseptic bags have been summarized in Table 9. 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