Scientific Opinion on the safety evaluation of the process, PP crates CHEP, used to recycle plastic for use as food contact materials 1

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1 SCIENTIFIC OPINION Scientific Opinion on the safety evaluation of the process, PP crates CHEP, used to recycle plastic for use as food contact materials 1 EFSA Panel on food contact materials, enzymes, flavourings and processing aids (CEF) 2, 3 European Food Safety Authority (EFSA), Parma, Italy ABSTRACT The scientific opinion of EFSA deals with the risk assessment of the recycling process PP crates CHEP with the Ref. No. RECYC003 for which the CEF Panel concluded that there is no safety concern for the consumer if the process is run in a product loop which is in a closed and controlled chain under the conditions described by the applicant and the recycled polypropylene is used for manufacturing polypropylene crates intended to be used in contact with whole fruits and vegetables and pre-packed meat. European Food Safety Authority, 2010 KEY WORDS PP crates CHEP ; Ref. No. RECYC003; Food contact materials, Plastic, Polypropylene, Recycling, Process, Safety evaluation. 1 On request from the Ministry of Health, Welfare and Sport, The Netherlands, Question No EFSA-Q adopted on 25 November Panel members: 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. Correspondence: cef-unit@efsa.europa.eu 3 Acknowledgement: The European Food Safety Authority wishes to thank Laurence Castle, Nathalie Gontard, Eugenia Lampi, Maria Rosaria Milana and Karla Pfaff for their contribution to the draft opinion. Suggested citation: EFSA Panel on food contact materials, enzymes, flavourings and processing aids (CEF); Scientific Opinion on the safety evaluation of the process, PP crates CHEP, used to recycle plastic for use as food contact materials. EFSA Journal 2010;8(12):1929. [11 pp.] doi: /j.efsa Available online: European Food Safety Authority,

2 Recycling process PP crates CHEP SUMMARY Within the task of evaluating processes to recycle plastic materials into materials and articles intended to be used in contact with food according to the Regulation (EC) No.282/2008 of the Commission of 27 March 2008 on recycled plastic materials intended to come into contact with foods, the CEF Panel received a request from a competent Member State Authority for safety evaluation of a recycling process following a corresponding application from the industry. The request received and the outcome of the safety evaluation is summarised below: The Ministry of Health, Welfare and Sport, The Netherlands, requested the evaluation of the plastic recycling process PP crates CHEP with the European Commission reference number (REF. No.) RECYC003, for recycling damaged food contact re-usable polypropylene crates from a product loop which is run in a closed and controlled chain in order to produce recycled polypropylene flakes. In the process pre-cleaned crates are ground into flakes, washed and dried. The flakes may be blended with virgin polypropylene or used up to 100% to manufacture recycled polypropylene crates intended to be used for long term storage of whole fruits and vegetables and of pre-packed meat at room temperature or below. The dossier was submitted on behalf of CHEP UK Ltd, United Kingdom. The CEF Panel concluded that there is no safety concern for the consumer if the process is run in a product loop which is in a closed and controlled chain under the conditions described by the applicant and used for manufacturing PP crates intended to be used in contact with whole fruits and vegetables and pre-packed meat, as requested by the applicant. The Panel recommends that it should be verified periodically, as part of the good manufacturing practice (GMP) in the meaning of the Regulation (EC) 2023/2006, that input originates from materials and articles that have been manufactured in accordance with Community legislation on food contact materials and articles (Reg. (EC) No. 282/2008, art. 4b). Specifications for input (crates used within a product loop which is in a closed and controlled chain) as well as the cleaning of the crates during their service life should be kept under control to ensure that the process is run under the evaluated conditions. 2

3 TABLE OF CONTENTS Abstract... 1 Key words... 1 Summary... 2 Table of Contents... 3 Background as provided by the legislation... 4 Terms of reference as provided by the legislation... 4 Assessment Introduction General information Description of the process Data on comparative testing of virgin and recycled polypropylene Compliance with the relevant provisions on food contact materials and articles Process analysis and evaluation by the applicant Discussion... 8 Conclusions... 9 Recommendations... 9 Documentation provided to EFSA... 9 References... 9 Abbreviations

4 BACKGROUND AS PROVIDED BY THE LEGISLATION According to the Regulation No. (EC) 282/2008 of the Commission of 27 March 2008 on recycled plastic materials intended to come into contact with foods (art. 3), recycled plastic materials and articles shall only be placed on the market if they contain recycled plastic obtained only from an authorised recycling process. Before a recycling process is authorised, EFSA s opinion on its safety is required. This procedure for authorisation laid down in articles 9 and 10 of the Regulation No. (EC) 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 4 applies for the authorisation of recycling processes. According to this procedure the industry submits applications to the Member States competent Authorities which in their turn transmit the applications to the EFSA for their evaluation. The application is supported by a technical dossier submitted by the industry following the EFSA guidelines on submission of a dossier 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 (EFSA, 2008). In this case, EFSA received an application from the Ministry of Health, Welfare and Sport, The Netherlands, requesting the evaluation of the plastic recycling process PP crates CHEP with the European Commission reference number (REF. No.) RECYC003. TERMS OF REFERENCE AS PROVIDED BY THE LEGISLATION The EFSA is required by Article 5 of Regulation No (EC) 282/2008 of the Commission of 27 March 2008 on recycled plastic materials intended to come into contact with foods to carry out risk assessments on the risks originating from the migration of substances from food contact recycled plastic materials and articles into foods and to deliver a scientific opinion on the recycling process used to manufacture recycled plastic materials and articles before their authorisation and inclusion in a positive list. 4 This Regulation replaces Directive 89/109/EEC of 21 December 1988, OJ L 40, , P.38 4

5 ASSESSMENT 1. Introduction The European Food Safety Authority was asked by the Ministry of Health, Welfare and Sport, The Netherlands, to evaluate the safety of the recycling process PP crates CHEP with REF. No. RECYC003. The request has been registered in the EFSA s register of received questions under the number EFSA-Q The dossier was submitted on behalf of the company CHEP UK Ltd, United Kingdom. The dossier submitted for evaluation followed the EFSA 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, 2008). 2. General information According to the applicant, the recycling process PP crates CHEP is used to recycle cleaned damaged food contact re-usable polypropylene crates (RPC) which have been used in a product loop which is in a closed and controlled chain in order to produce recycled polypropylene flakes. These flakes (also called regrind) may be blended with virgin polypropylene or be used up to 100% to manufacture recycled polypropylene crates intended to be used for long term storage of whole fruits and vegetables and of prepacked meat at room temperature or below. The closed product loop process for recycled polypropylene crates is in the implementation phase. The process is not yet authorized by any European Member State or by U.S. FDA. 3. Description of the process According to the applicant, the input of the recycling process is cleaned damaged RPC which have been used in a European product loop for the packaging of whole fruits and vegetables and of pre-packed meat products. Crates are ground into flakes from which metal parts are removed before and after grinding. Flakes are further washed, centrifuged, sieved and finally dried. Recycled flakes are intended to be used with or without blending with virgin PP to manufacture new recycled PP crates by injection moulding. The applicant is the supplier of the input material and is also customer/owner of the new recycled crates. However, grinding and injection moulding, are performed by two other companies that are part of the loop Input According to the applicant, the input of the recycling process consists of damaged pre-washed RPC that have been used in a closed loop of growers, distributors and retailers for packaging, transport and storage and display of whole fruits and vegetables as well as pre-packed meat. In this loop, crates are frequently cleaned in a 2-step washing procedure: 5

6 a. washing at increasing pressure with a strong alkaline detergent at 50 C, rinsing with heated-up water, b. disinfection using a disinfectant based on hydrogen peroxide and peroxyacetic acid, washing with potable water and drying with high-pressure air at 50 C. According to the applicant, the reusable crates are made of polypropylene that complies with the Directive 2002/72/EC relating to plastic materials and articles intended to come into contact with foodstuffs (EC, 2002). 3.2 Steps of the process The process includes the following steps: 1. At the end of the service life (e.g. because of damages), the RPC pre-cleaned as described above (input) are ground into flakes. Metal parts are removed before and after grinding by means of a metal detector, a magnet and a separator. 2. The regrind is washed with potable water in order to remove potential adhering contamination. Water and fines are removed by centrifugation. Small particles (diameter lower than 2.5 mm) are removed through a sieve. The regrind is then dried with heated air (50 60 C) in a cyclone. 3. Dry regrind is packed in new and clean food grade big bags for storage and transport to the injection moulder. 3.3 Output The following technical specifications for the PP flakes have been established by the applicant: melt flow index, tensile modulus, density, charpy impact strength notched. Recycled flakes are used pure or blended at any ratio with virgin PP to manufacture new recycled crates by injection moulding which are then re-introduced in the product loop. 4. Data on comparative testing of virgin and recycled polypropylene In order to assess the effect of the repeated reprocessing of crates (grinding and injection moulding) on the formation of degradation products, migration tests have been performed to compare migratable components present in virgin and multiple reprocessed crates. According to the applicant, the service life of the crates is 10 years or longer and it is very unlikely that the crates be recycled more than 3 times. Following a protocol proposed by Coulier et al. [1], migration from a five times reprocessed PP material versus a virgin PP material was tested by total immersion into iso-octane for 2 days at 20 C. The following parameters were tested: - overall migration, - migration of the fraction with a molecular weight below 1000 Da with Size Exclusion Chromatography/Evaporative Light-Scattering Detector (ELSD) and Ultraviolet (UV), - migration of semi-volatile substances with Gas Chromatography/Mass Spectrometry (GC/MS), 6

7 - migration of anti-oxidants and light stabilizers with High Performance Liquid Chromatography/UV or ELSD; in addition to isooctane, this test was also done in 15% ethanol for 10 days at 40 C, - volatile compounds present at the surface of the crates by Thermal Desorption/GC/MS. There was no significant difference in the overall migration and in the migration of the low molecular weight fraction (below 1000 Da) of the recycled and virgin material. Migration of semi-volatile substances into iso-octane was observed. The peaks in the chromatograms that were increased for the recycled material have been examined and identified as far as possible. The identified substances were degradation products of stabilizers and of a plasticizer. The differences for the substances detected between recycled and virgin material were in the range of µg/dm². Migration of anti-oxidants and stabilizers into iso-octane was not influenced by the reprocessing and was far below existing specific limits. Specific migration in 15% ethanol was not detectable in all cases. Volatile compounds showed a decrease in the recycled compared to the virgin material. 5. Compliance with the relevant provisions on food contact materials and articles According to the applicant, the pre-washed reusable polypropylene crates used as input material for the recycling process are made of polypropylene that complies with Directive 2002/72/EC (EC, 2002). As demonstrated by comparative testing, there are only minor differences between virgin PP and five times reprocessed PP material. 6. Process analysis and evaluation by the applicant The applicant presented a process analysis in which the following steps are addressed: - Handling of the crates in the loop controlled by a quality system that ensures the cleanness of the crates before use or before recycling. The use within the product loop in a closed and controlled chain ensures that the input originates from materials manufactured according to the Directive 2002/72/EC and avoids chemical contamination e.g. by misuse of the crates. The risk involved with this part of the chain is considered negligible by the applicant. - Washing procedure during regular use in the loop and before the recycling The critical points are controlled by the HACCP system. In case of failure any remaining residue will be removed in the washing step of the regrind (step 2). The risk involved with this part of the process is considered negligible by the applicant. - Regrinding and washing during the recycling Washing is performed with drinking water. The risk involved with this part of the process is considered negligible by the applicant. - Injection moulding Recycled as well as virgin polypropylene has been tested for the potential formation of degradation products by injection moulding. Migration tests have been performed to compare migratable components present in virgin and multiple reprocessed crates (cf. chapter 4). The migration (into iso-octane for 2 days at 20 C) of volatile, non-volatile and semi-volatile compounds is not significantly different for virgin and five times reprocessed polypropylene. It was demonstrated that the differences in the semi-volatile substances migrated into isooctane between five times reprocessed and virgin material were in the range of µg/dm² plastic due to degradation products of additives. Therefore the risk from this step of the process is considered negligible by the applicant. 7

8 According to the applicant, two aspects ensure the safety of the recycling process. 1. Firstly the input originates from a product loop in a closed and controlled chain in which crates are frequently cleaned. The life cycle of crates excludes any significant contamination with substances that may form a risk to human health. 2. Secondly the grinding and the subsequent washing of the regrind will remove potential contamination due to intermediate storage of the crates (steps 1-2). 7. Discussion The Panel considers that this process is in the scope of Art. 4 c) i) of the Regulation (EC) No. 282/2008, i.e. a process for which the plastic input originates from a product loop which is in a closed and controlled chain ensuring that only materials and articles which have been intended for food contact are used and any contamination can be ruled out. The data presented by the applicant allow identifying the process, its input, output and intended uses of final articles. The recycling process is part of a European product loop of growers, distribution centres and retailers and cleaner. Within the loop, the crates are used for long term storage of whole fruits, vegetables and pre-packed meat at cooled or at room temperature. At the end of their service life (e.g. because of damages), pre-cleaned crates (input) are recycled. In the recycling process the crates are ground into flakes, which are subsequently sorted, washed and dried. These flakes are used up to 100% to manufacture new recycled crates by injection moulding. The Panel considers that injection moulding is part of the recycling process. Considering the high temperatures used in the further processing of the flakes (injection moulding at ºC), the possibility of contamination by microorganisms can be discounted. Therefore this evaluation focuses on the chemical safety of the final product. The Panel noted that the cleaning of the crates during their service life includes a 2-step washing procedure at increasing pressure with a strong alkaline detergent at 50 C, rinsing with heated-up water, disinfection using a disinfectant based on hydrogen peroxide and peroxyacetic acid, washing with potable water and drying with high-pressure air at 50 C. The Panel considers the input material (crates used within product loop in a closed and controlled chain) and the cleaning of the crates during their service life as critical process steps. The closed loop process is run under a quality assurance system. In addition, the washing of the crates during their service life is controlled by a HACCP system. The grinding of flakes and the washing of the regrind (to remove potential surface contamination due to intermediate storage of the input material) do not introduce additional contamination into the recyclate. The Panel concluded that these steps are of no safety concern. The recycled PP flakes are characterised by the following technical specifications established by the applicant: melt flow index, tensile modulus, density, charpy impact strength notched. The Panel noted that the technical specifications are mainly related to the required mechanical properties of the material. The manufacture of new crates from the regrind by injection moulding is not different from processes using virgin polypropylene. In addition, regarding the changes of the polypropylene by repeated reprocessing, the applicant did a comparative testing of virgin and five times reprocessed material. Testing included overall migration, migration of the fraction with a molecular weight of less than 1000 Da, volatile compounds present at the surface of the crates, migration of semi-volatile substances into isooctane, migration of additives (anti-oxidants, UV- and light stabilizers). Testing was focused on the detection of differences in the migratable substances present in virgin and recycled crates. The analytical methods are well described including calibration, recovery data and sample chromatograms. The tests 8

9 demonstrated negligible differences not considered of a safety concern for the intended use of the final product. The Panel noted that the whole product loop is run under a quality assurance system. For the washing step during the service life of the crates, a HACCP system is in place. A corresponding control plan with critical points, critical parameters and relevant monitoring procedures was provided. These parameters should be adequately monitored and kept under control according to Regulation (EC) 2023/2006 on good manufacturing practice (GMP) for materials and articles intended to come into contact with food (EC, 2003). CONCLUSIONS Taking into account the above, the Panel concludes that the input of the process PP crates CHEP originates from a product loop which is in a closed and controlled chain ensuring that only materials and articles which have been intended for food contact are used and that any contamination can be ruled out when run under the conditions described by the applicant. The recycling process PP crates CHEP is therefore able to produce recycled PP suitable for manufacturing PP crates intended to be used in contact with whole fruits and vegetables and pre-packed meat as requested by the applicant. RECOMMENDATIONS The Panel recommends that it should be verified periodically, as part of the good manufacturing practice (GMP) in the meaning of the Regulation (EC) 2023/2006, that input originates from materials and articles that have been manufactured in accordance with Community legislation on food contact materials and articles (Reg. (EC) No. 282/2008, art. 4b). Specifications for input (crates used within a product loop which is in a closed and controlled chain) as well as the cleaning of the crates during their service life should be kept under control to ensure that the process is run under the evaluated conditions. DOCUMENTATION PROVIDED TO EFSA Dossier PP crates CHEP. Dated: April 23, Submitted on behalf of CHEP UK Ltd. REFERENCES L. Coulier, H. Hub, R. Rijk, Analytical protocol to study the food safety of (multiple-)recycled high-densitiy polyethylene (HDPE) and polypropylene (PP) crates: Influence of recycling on the migration and formation of degradation products, Polymer degradation and stability, 92, EFSA (European Food Safety Authority), Opinion of the Scientific Panel on food additives, flavourings, processing aids and materials in contact with food (AFC) on Guidelines on submission of a dossier 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. The EFSA Journal (2008) EC (European Commission), 2008, Commission regulation (EC) No 282/2008 on recycled plastic materials and articles intended to come into contact with foods, 9

10 EC (European Commission), 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 EC (European Commission), Commission regulation (EC) 2023/2006 on good manufacturing practice (GMP) for materials and articles intended to come into contact with food; EC (European Commission), Commission Directive 2002/72/EC, relating to plastic materials and articles intended to come into contact with foodstuffs; 10

11 ABBREVIATIONS CEF Da EC EFSA GC/MS GMP HACCP HPLC PP REF No RPC SEC/ELSD US FDA UV Scientific Panel on food contact materials, enzymes, flavourings and processing aids Dalton European Commission European food safety authority Gas chromatography coupled to mass spectrometry Good manufacturing practice Hazard Analysis Critical Control Point Liquid chromatography high pressure Polypropylene Reference Number Re-usable polypropylene crates Size exclusion chromatography coupled with evaporative light scattering detection United State Food and Drug Agency Ultra-violet 11