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

Volumn 9, Issue 7, 2011, Pages

[No Author Info available]

Author keywords

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

Indexed keywords

EID: 84873675417     PISSN: None     EISSN: 18314732     Source Type: Journal    
DOI: 10.2903/j.efsa.2011.2184     Document Type: Article

References (35)

1. Allen B and Blakistone B, 1994. Assessing reclamation processes for plastics recycling, 208th American Chemical Society National Meeting. Washington DC, August 25, 1994, 418–434.
2. AFSSA (Agence Francaise de Securite Sanitaire des Aliments), 2006. Evaluation sanitaire des «matériaux en poly(éthylène téréphtalate) recyclés utilisés en tant que matériaux au contact des denrées alimentaires et de l'eau de boisson», available through: www.contactalimentaire.com/fileadmin/ImageFichier_Archive/contact_alimentaire/Fichiers_Documents/Avis_AFSSA-CSHPF/avis_du_27-11-2006rap.pdf
3. Barlow SM, Kozianowski G, Würtzen G, Schlatter J, 2001. Threshold of toxicological concern for chemical substances present in the diet. Report of a workshop held on 5–6 October 1999 in Paris, France Organised by the ILSI Europe Threshold of Toxicological Concern Task Force. Food and Chemical Toxicology 39 (2001) 893–905.
4. Bayer F, Myers D and Gage M, 1994. Consideration of poly(ethylene terephthalate) recycling for food use, 208th American Chemical Society National Meeting. Washington DC, August 25, 1994, 152–160.
5. Bayer F, 2002. Polyethylene terephthalate recycling for food-contact applications: testing, safety and technologies: a global perspective. Food Additives and Contaminants, Vol. 19, Supplement, 111–134.
6. Begley TH, McNeal TP, Biles JE and Paquette KE, 2002. Evaluating the potential for recycling all PET bottles into new food packaging, Food Additives and Contaminants Vol 19, Supplement, 135–143.
7. Begley T, Castle L, Feigenbaum A, Franz R, Hinrichs K, Lickly T, Mercea P, Milana M-R, O'Brien T, Rebre S, Rijk R and Piringer O, 2005. “Evaluation of migration models that might be used in support of regulations for food-contact plastics”, Food Additives and Contaminants, Vol 22, (1): 73–90 (2005).
8. Cheeseman MA, Machuga EJ, Bailey AB, 1999. A tiered approach to threshold of regulation. Food and Chemical Toxicology 37, 387–412.
9. Demertzis PG, Johansson F, Lievens C and Franz R, 1997. Studies on the development of a quick inertness test procedure for multi-use PET containers – Sorption behaviour of bottle wall strips, Packaging Technology and Science Vol 10, 45–58.
10. EC (European Commission), 2001. Guidelines of the Scientific Committee of Food for the presentation of an application for safety assessment of a substance to be used in food contact materials prior to its authorisation. ec.europa.eu/food/fs/sc/scf/out82_en.pdf.
11. EC (European Commission), 2006. Regulation No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), Annex XVII. eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=iJ:L:2006:396:0001:0849:EN:PDF.
12. EC (European Commission), 2008. Regulation (EC) No 282/2008 of the Commission of 27 March 2008 on recycled plastic materials intended to come into contact with foods. eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=iJ:L:2008:086:0009:0018:EN:PDF
13. EC (European Commission), 2010. Applicability of generally recognised diffusion models for the estimation of specific migration in support of EU Directive 2002/72/EC. C. Simoneau Ed., JRC Scientific and Technical Report EUR 24514 EN 2010, Ispra, (VA) Italy, October 2010.
14. EC (European Commission), 2011. Regulation (EC) No 10/2011 of the Commission of 14 January 2011 on plastic materials and articles intended to come into contact with food. eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=iJ:L:2011:012:0001:0089:EN:PDF.
15. EFSA (European Food Safety Authority), 2008. 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. doi:10.2903/j.efsa.2008.717. www.efsa.europa.eu/en/efsajournal/doc/717.pdf.
16. EFSA (European Food Safety Authority), 2011. Use of the EFSA Comprehensive European Food Consumption Database in Exposure Assessment. EFSA Journal 2011;9(3):2097. [34 pp.] doi:10.2903/j.efsa.2011.2097. Available online: www.efsa.europa.eu/efsajournal.htm.
17. Federal Register, 1995. Food additives; threshold of regulation for substances used in food-contact articles. Final rule. Fed. Reg. 60 (136), 36582–36594.
18. FDA (Food and Drug Administration), 2006. Guidance for Industry: Use of Recycled Plastics in Food Packaging: Chemistry Considerations. www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodIngredientsandPackaging/ucm120762.htm.
19. Foster E, Mathers JC, Adamson AJ, 2010. Packaged food intake by British children aged 0 to 6 years. Food Additives and Contaminants: Part A, 27 (3) 380–388.
20. Franz R and Welle F 1999. Post consumer poly(ethylene terephthalate) for direct food contact applications. Deutsche Lebensmittel-Rundschau 95, 424–427.
21. Franz R and Welle F, 2003. Recycling Packaging Materials. Chapt. 23, pp. 497–518. In: R. Ahvenainen (ed.): Novel Food Packaging Techniques – Woodhead Publishing Ltd., Cambridge, 2003.
22. Franz R, Bayer F and Welle F, 2004a: Guidance and Criteria for Safe Recycling of Post-Consumer Polyethylene Terephthalate into New Food Packaging Applications. Report EUR 21155 - Luxembourg: Office for Official Publications of the European Communities ISBN 92-894-6776-2; cpf.jrc.it/files/eu_report21155_rpet_guide.pdf.
23. Franz R, Mauer A and Welle F, 2004b. European Survey on Post-consumer Poly(ethylene terephthalate) Materials to Determine Contamination Levels and Maximum Consumer Exposure from Food Packages Made from Recycled PET. Food Additives and Contaminants 21 (3), 265–286 (2004).
24. Franz R and Welle F, 2008. Migration measurement and modelling from poly(ethylene terephthalate) (PET) into softdrinks and fruit juices in comparison with food simulants. Food Additives and Contaminants 25(8), 1033–1046 (2008).
25. Komolprasert V, and Lawson AR, 1995. Residual contaminants in recycled poly(ethylene terephthalate): Effects of washing and drying. ACS Symposium Series No. 609 (Washington, DC: American Chemical Society), pp. 435±444.
26. Kroes R et al., 2004. Structure-based thresholds of toxicological concern (TTC): guidance for applicationto substances present at low levels in the diet. Fd. Cosmet. Toxicol., 42: 65–83.
27. Munro, I.C., 1990. Safety assessment procedures for indirect food additives: an overview. Regul. Toxicol. Pharmacol. 12, 2–12.
28. Pennarun PY, Saillard P, Feigenbaum A and Dole P, 2005. Experimental Direct Evaluation of Functional Barriers in PET Recycled Bottles: Comparison of Migration Behaviour of Mono- and Multilayers, Packaging Technology and Science; 18: 107–123.
29. Piringer O and Hinrichs K, 2001. Evaluation of migration models. Final Report of the EU-project contract no. SMT-CT98-7513, Brussels.
30. PlasticsEurope, 2010. Letter dated 8 July 2010 with the ref “Polyethylene terephthalate (PET) packaging resins sold in Europe” on compliance of PET packaging resins sold by European manufacturers of PET packaging resin with Directive 2002/72/EC.
31. Rulis A. M., 1986. De minimis and the threshold of regulation. In Food Protection Technology, Proceedings of the Conference for Food Protection, Ed. Felix, C.W. Lewis Publishing Inc, Chelsea, Michigan. Pp. 29–37.
32. Rulis A. M., 1989. Establishing a Threshold of regulation. In: Risk Assessment in Setting National Priorities, Eds Bonin, J.J., Stevenson, D.E. Plenum Publishing Corporation, New York. Pp. 271–278.
33. Rulis, A M., 1992. Threshold of regulation: options for handling minimal risk situations. In: Finley, J.W., Robinson, S.F., Armstrong, D.J. (Eds.), Food Safety Assessment. American Chemical Society Symposium Series, vol. 484, pp. 132–139.
34. Welle F and Franz R, 2008, SiOx layer as functional barrier in polyethylene terephthalate (PET) bottles against potentialcontaminants from post-consumer recycled PET, Food Additives and Contaminants, July 2008, Vol. 25, No. 6, 788–794.
35. WHO (World Health Organisation), 2003. Domestic water quantity, service level and health. Geneva, World Health Organization (WHO/SDE/WSH/3.02); www.who.int/water_sanitation_health/diseases/WSH03.02.pdf.