Title: Recent developments in the risk assessment of chemicals in food and their potential impact on the safety assessment of substances used in food contact materials
Abstract: EFSA JournalVolume 14, Issue 1 4357 OpinionOpen Access Recent developments in the risk assessment of chemicals in food and their potential impact on the safety assessment of substances used in food contact materials EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF), EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF)Search for more papers by this author EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF), EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF)Search for more papers by this author First published: 28 January 2016 https://doi.org/10.2903/j.efsa.2016.4357Citations: 52 Panel members: Claudia Bolognesi, Laurence Castle, Jean-Pierre Cravedi, Karl-Heinz Engel, Paul Fowler, Roland Franz, Konrad Grob, Rainer Gürtler, Trine Husøy, Sirpa Kärenlampi, Wim Mennes, Maria Rosaria Milana, André Penninks, Vittorio Silano, Andrew Smith, Maria de Fátima Tavares Poças, Christina Tlustos, Detlef Wölfle, Holger Zorn and Corina-Aurelia Zugravu. Correspondence: [email protected] Acknowledgement: The Panel wishes to thank the members of the Working Group on Food Contact Materials: Claudia Bolognesi, Laurence Castle, Jean-Pierre Cravedi, Roland Franz, Konrad Grob, Martine Kolf-Clauw, Eugenia Lampi, Maria Rosaria Milana, Maria de Fátima Tavares Poças, Kettil Svensson and Detlef Wölfe. The CEF Panel also wishes to thank the former members of the CEF Panel, Ricardo Crebelli, Jean Claude Lhuguenot, Catherine Leclercq and Iona Pratt, and EFSA staff, Eric Barthélémy and Dimitrios Spyropoulos, for the preparatory work on this scientific opinion. Adoption date: 2 December 2015 Published date: 28 January 2016 Question number: EFSA-Q-2011-00107 On request from: EFSA AboutPDF ToolsExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Abstract This Opinion describes recent developments in the safety assessment of chemicals in food and explores their potential impact on EFSA evaluation of food contact materials (FCM). It is not intended to be a guidance document. The draft opinion was subject to a public consultation and this final Opinion takes into account the scientific comments received. The Opinion will provide the European Commission with the scientific basis for a discussion among risk managers on possible implications for risk management. One major area to revisit is the estimation of consumer exposure. Four food consumption categories could be set. They are approximately 9, 5, 3 and 1.2 times higher than the current SCF default scenario, i.e. 17 g/kg bw per day, and so using them would afford a higher level of protection, particularly for infants and toddlers. Special exposure scenarios might be used if consumption were lower. The amount of toxicity data needed should be related to the expected human exposure. The tiered approach of the SCF is updated. For substances used in FCM, genotoxicity testing is always required, even if their migration leads to a low exposure. Beyond this, three threshold levels of human exposure, namely 1.5, 30 and 80 μg/kg bw per day, are proposed as triggers for the requirement for additional toxicity data. Regarding the identification and evaluation of migrating substances, experience has shown that more focus is needed on the finished materials and articles. Considering the non-intentionally added substances (NIAS), such as impurities of the substance along with reaction and degradation products including oligomers, the same approach as is used for authorised substances could, in principle, be applied for their toxicological assessment, as the same degree of safety should be warranted for all migrating substances. However, non-testing methods could have increased importance for the assessment of genotoxicity of NIAS. References Barlow S, 1994. The role of the Scientific Committee on Food in evaluating plastics for packaging. Food Additives and Contaminants, 11, 249– 259. Barlow S, Kozianowski G, Wuertzen G and Schlatter J (2001). Threshold of toxicological concern for chemical substances present in the diet. Food and Chemical Toxicology 39: 893– 905. Bott J, Störmer A and Franz R, 2014a. A model study into the migration potential of nanoparticles from plastics nanocomposites for food contact. Food Packaging and Shelf Life 2(2) 73– 80 (2014). DOI:10.1016/j.fpsl.2014.08.001 Bott J, Störmer A and Franz R, 2014b. A Comprehensive Study into the Migration Potential of Nano Silver Particles from Food Contact Polyolefins. In: MA Benvenuto, S Ahuja, TV Duncan, G Noonan, E Roberts-Kirchhoff (Eds.), 2014. Chemistry of Food and Food Contact Materials: From Production to Plate. ACS Symposium Series 1159: 51– 70; American Chemical Society: Washington, DC, 2014. DOI:10.1021/bk-2014-1159.ch005 Bott J, Stoermer A and Franz R, 2014c. Investigation into the migration of nanoparticles from plastic packaging materials containing carbon black into foodstuffs. Food Additives and Contaminants. Vol. 31 (10), 1769– 1782 (2014). DOI:10.1080/19440049.2014.952786 Cramer GM, Ford RA and Hall RL, 1978. Estimation of toxic hazard - a decision tree approach. Food and Cosmetic Toxicology 16: 255– 276. EC (European Commission), 2001. Guidance of the Scientific Committee on Food (SCF) for the presentation of an application for safety assessment of a substance to be used in food contact materials prior to its authorisation. SCF/CS/PLEN/GEN/100 Final. 19 December 2001. ECHA (European Chemicals Agency), 2008. Guidance on information requirements and chemical safety assessment: guidance for the implementation of REACH. European Chemicals Agency, Helsinki. ECHA (European Chemicals Agency), 2013a. Grouping of substances and read-across approach. Part 1: Introductory note. Available on line: http://echa.europa.eu/documents/10162/13628/read_across_introductory_note_en.pdf ECHA (European Chemicals Agency), 2013b. Grouping of substances and read-across approach. Part 2 Example 1 - Analogue approach: similarity based on breakdown products. Available on line: http://echa.europa.eu/documents/10162/13628/read_across_introductory_note_en.pdf ECHA (European Chemicals Agency), 2015. Read-Across Assessment Framework (RAAF). Available online: http://echa.europa.eu/documents/10162/13628/raaf_en.pdf EFSA (European Food Safety Authority), 2005. Opinion of the Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food on a request from the Commission related to Semicarbazide in food. The EFSA Journal 2005, 219, 36 pp. doi:10.2903/j.efsa.2005.219 EFSA (European Food Safety Authority), 2006. Guidance of the Scientific Committee on a request from EFSA related to uncertainties in dietary exposure assessment. The EFSA Journal 2006, 438, 54 pp. doi:10.2903/j.efsa.2007.438 EFSA (European Food Safety Authority), 2009. Guidance of the Scientific Committee on a request from EFSA on the use of the benchmark dose approach in risk assessment. The EFSA Journal 2009, 1150, 72 pp. doi:10.2903/j.efsa.2009.1150 EFSA (European Food Safety Authority), 2011a. EFSA Comprehensive European Food Consumption Database. Available online: http://www.efsa.europa.eu/en/food-consumption/comprehensive-database EFSA (European Food Safety Authority), 2011b. Overview of the procedures currently used at EFSA for the assessment of dietary exposure to different chemical substances. EFSA Journal 2011; 9(12): 2490, 33 pp. doi:10.2903/j.efsa.2011.2490 EFSA (European Food Safety Authority), 2012. EFSA Scientific Colloquium Summary Report 17: Low-dose-response in toxicology and risk assessment. doi:10.2805/20634. Available online: http://www.efsa.europa.eu/sites/default/files/corporate_publications/files/353e.pdf EFSA (European Food Safety Authority), 2015a. Guidance on uncertainty in EFSA Scientific Assessment (draft submitted to public consultation on 18 June 2015). Available online: http://www.efsa.europa.eu/en/consultations/call/150618 EFSA (European Food Safety Authority), 2015b. Scientific opinion on recent developments in the risk assessment of chemicals in food and their potential impact on the safety assessment of substances used in food contact materials (draft submitted to public consultation on 7 July 2015). Available online: http://www.efsa.europa.eu/en/consultations/call/150707 EFSA (European Food Safety Authority), 2015c. Call for proposals—GP/EFSA/AFSCO/2015/01: New approaches in identifying and characterizing microbiological and chemical hazards. Available online: http://www.efsa.europa.eu/en/art36grants/article36/gpefsaafsco201501.htm?utm_source=newsletter&utm_medium=email&utm_campaign=20141112&utm_content=call EFSA Scientific Committee, 2011a. Scientific Opinion on guidance on the risk assessment of the application of nanoscience and nanotechnologies in the food and feed chain. EFSA Journal 2011; 9(5): 2140, 36 pp. doi:10.2903/j.efsa.2011.2140 EFSA Scientific Committee, 2011b. Scientific Opinion on genotoxicity testing strategies applicable to food and feed safety assessment. EFSA Journal 2011; 9(9): 2379, 68 pp. doi:10.2903/j.efsa.2011.2379 EFSA Scientific Committee, 2012. Scientific Opinion on exploring options for providing advice about possible human health risks based on the concept of Threshold of Toxicological Concern (TTC). EFSA Journal 2012; 10(7): 2750, 103 pp. doi:10.2903/j.efsa.2012.2750 EFSA Scientific Committee, 2013. Scientific Opinion on the hazard assessment of endocrine disruptors: scientific criteria for identification of endocrine disruptors and appropriateness of existing test methods for assessing effects mediated by these substances on human health and the environment. EFSA Journal 2013; 11(3): 3132. 84 pp. doi:10.2903/j.efsa.2013.3132 FAO/WHO (Food and Agriculture Organization of the United Nations and World Health Organization), 2009. Principles and methods for the risk assessment of chemicals in food (environmental health criteria; 240. WHO, Geneva. Foster E, Mathers JC and Adamson AJ, 2010. Packaged food intake by British children aged 0 to 6 years. Food Additives and Contaminants: Part A, 27, 380– 388. International Life Sciences Institute (ILSI), 2015. Guidance on best practices on the risk assessment of non intentional added substances (NIAS) in food contact materials and articles. ILSI Europe Report Series 2015, ISBN: 9789078637424. DOI: D/2015/10.996/39 Koster S, Rennen M, Leeman W, Houben G, Muilwijk B, van Acker F and Krul L (2014). A novel safety assessment strategy for non-intentionally added substances (NIAS) in carton food contact materials. Food Addit. Contam. 2014, Part A 31(3), 422– 443. Kroes R, Renwick AG, Cheeseman M, Kleiner J, Mangelsdorf I, Piersma A, Schilter B, Schlatter J, van Schothorst F, Vos JG and Würtzen G, 2004. Structure-based thresholds of toxicological concern (TTC): guidance for application to substances present at low levels in the diet. Food and Cosmetics Toxicology, 42, 65– 83. Munro IC, 1990. Safety assessment procedures for indirect food additives: an overview. Regulatory Toxicology and Pharmacology, 12, 2– 12. Munro IC, Ford RA, Kennepohl E and Sprenger JG, 1996. Correlation of structural class with no observed effect levels: a proposal for establishing a threshold of concern. Food and Chemical Toxicology, 34, 829– 867. Ntim SA, Thomas TA, Begley TH and Noonan GO (2015): Characterisation and potential migration of silver nanoparticles from commercially available polymeric food contact materials, Food Additives & Contaminants: Part A, doi:10.1080/19440049.2015.1029994 OECD (Organisation for Economic Cooperation and Development), 2012. Conceptual Framework for Testing and Assessment of Endocrine Disrupters, as included in the Guidance Document 150 (Annex 1.4), published in the OECD Series on Testing and Assessment in August 2012. OECD, Paris. OECD (Organisation for Economic Cooperation and Development), 2014. Guidance on Grouping of Chemicals, Second Edition. ENV/JM/MONO(2014)4. Second edition Series on Testing and Assessment No. 194. Available online: http://www.oecd.org/officialdocuments/publicdisplaydocumentpdf/?cote=env/jm/mono%282014%294&doclanguage=en Pinalli R, Croera C, Theobald A and Feigenbaum A, 2011. Threshold of toxicological concern approach for the risk assessment of substances used for the manufacture of plastic food contact materials. Trends in Food Science & Technology, 22, 523– 534. Poças MF, Oliveira JC, Pinto HJ, Zacarias ME and Hogg T, 2009. Characterization of patterns of food packaging usage in Portuguese homes. Food Additives and Contaminants, 26, 1314– 1324. Rennen M, Koster S, Krul C and Houben G. Application of the threshold of toxicological concern (TTC) concept to the safety assessment of chemically complex food matrices. Food and Chemical Toxicology 2011, 49: 933– 940. Rulis AM, 1986. De minimis and the threshold of regulation. In: Food Protection Technology, Proceedings of the Conference for Food Protection, Ed. CW Felix. Lewis Publishing Inc., Chelsea, MI, USA, 29– 37. Rulis AM, 1989. Establishing a threshold of regulation. In: Risk Assessment in Setting National Priorities. Eds JJ Bonin and DE Stevenson. Plenum Publishing Corporation, New York, NY, USA, 271– 278. Rulis AM, 1992. Threshold of regulation: options for handling minimal risk situations. In: Food Safety Assessment. Eds Finley JW, Robinson SF and Armstrong DJ. American Chemical Society Symposium Series, 484, 132– 139. US FDA (United States Food and Drug Administration), 1995. Federal Register—Food additives; threshold of regulation for substances used in food-contact articles. Final rule. Federal Regulation 60(136), 36582– 36594. US FDA, Silver Spring, MD, USA. VKM (Norwegian Scientific Committee for Food Safety), 2009. Evaluation of the EU exposure model for migration from food contact materials (FCM). Opinion of the Panel on Food Additives, Flavourings, Processing Aids, Materials in Contact with Food and Cosmetics of the Norwegian Scientific Committee for Food Safety. VKM, 06/406-5 final. VKM, Oslo. WHO (World Health Organization), 2003. Domestic water quantity, service level and health. WHO/SDE/WSH/3.02. WHO, Geneva, Switzerland. Available online: http://www.who.int/water_sanitation_health/diseases/WSH03.02.pdf WHO (World Health Organization), 2012. Guidance for immunotoxicity risk assessment for chemicals. IPCS harmonization project document; no 10. WHO, Geneva, Switzerland. Citing Literature Volume14, Issue1January 20164357 This article also appears in:Foods for infants and young children ReferencesRelatedInformation