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Food Additives and Packaging 1162 ACS SYMPOSIUM SERIES Food Additives and Packaging Vanee Komolprasert, Editor Division of Food Contact Notifications Office of Food Additive Safety U.S. Food and Drug Administration College Park, Maryland Petra Turowski, Editor Division of Food Contact Notifications Office of Food Additive Safety U.S. Food and Drug Administration College Park, Maryland Sponsored by the ACSDivisionofAgriculturalandFoodChemistry,Inc. AmericanChemicalSociety,Washington,DC DistributedinprintbyOxfordUniversityPress LibraryofCongressCataloging-in-PublicationData Foodadditivesandpackaging/VaneeKomolprasert,editor,DivisionofFoodContact Notifications,OfficeofFoodAdditiveSafety,U.S.FoodandDrugAdministration, CollegePark,Maryland;PetraTurowski,editor,DivisionofFoodContactNotifications, OfficeofFoodAdditiveSafety,U.S.FoodandDrugAdministration, CollegePark,Maryland;sponsoredbytheACSDivisionofAgriculturalandFood Chemistry,Inc.AmericanChemicalSociety,WashingtonDC. pagescm.-- (ACSsymposiumseries;1162) Includesbibliographicalreferences. ISBN978-0-8412-3024-8(permanentpaper) 1. Foodadditives.2. Food--Packaging. I.Komolprasert,Vanee.II.Turowski,Petra. TX553.A3F56852014 664′.06--dc23 2014024666 ThepaperusedinthispublicationmeetstheminimumrequirementsofAmericanNational Standard for Information Sciences—Permanence of Paper for Printed Library Materials, ANSIZ39.48n1984. Copyright©2014AmericanChemicalSociety DistributedinprintbyOxfordUniversityPress AllRightsReserved. ReprographiccopyingbeyondthatpermittedbySections107or108 oftheU.S.CopyrightActisallowedforinternaluseonly,providedthataper-chapterfeeof $40.25plus$0.75perpageispaidtotheCopyrightClearanceCenter,Inc.,222Rosewood Drive,Danvers,MA01923,USA.Republicationorreproductionforsaleofpagesinthis bookispermittedonlyunderlicensefromACS.Directtheseandotherpermissionrequests toACSCopyrightOffice,PublicationsDivision,115516thStreet,N.W.,Washington,DC 20036. Thecitationoftradenamesand/ornamesofmanufacturersinthispublicationisnottobe construedasanendorsementorasapprovalbyACSofthecommercialproductsorservices referenced herein; nor should the mere reference herein to any drawing, specification, chemicalprocess, orotherdataberegardedasalicenseorasaconveyanceofanyright or permission to the holder, reader, or any other person or corporation, to manufacture, reproduce,use,orsellanypatentedinventionorcopyrightedworkthatmayinanywaybe relatedthereto. Registerednames,trademarks,etc.,usedinthispublication,evenwithout specificindicationthereof,arenottobeconsideredunprotectedbylaw. PRINTEDINTHEUNITEDSTATESOFAMERICA Foreword The ACS Symposium Series was first published in 1974 to provide a mechanism for publishing symposia quickly in book form. The purpose of the series is to publish timely, comprehensive books developed from the ACS sponsoredsymposiabasedoncurrentscientificresearch. Occasionally,booksare developed from symposia sponsored by other organizations when the topic is of keeninteresttothechemistryaudience. Beforeagreeingtopublishabook,theproposedtableofcontentsisreviewed forappropriateandcomprehensivecoverageandforinteresttotheaudience. Some papersmaybeexcludedtobetterfocusthebook;othersmaybeaddedtoprovide comprehensiveness. When appropriate, overview or introductory chapters are added. Draftsofchaptersarepeer-reviewedpriortofinalacceptanceorrejection, andmanuscriptsarepreparedincamera-readyformat. As a rule, only original research papers and original review papers are included in the volumes. Verbatim reproductions of previous published papers arenotaccepted. ACSBooksDepartment Editors’ Biographies Dr. Vanee Komolprasert Dr. VaneeKomolpraserthasbeenaconsumersafetyofficerforovernineyears attheOfficeofFoodAdditiveSafety,U.S.FoodandDrugAdministration,College Park, MD. She manages the multidisciplinary review of pre-market notification submissionsforthesafeuseofnewfoodcontactsubstancesandfoodpackaging. She also provides professional service to representatives of the regulated food packagingandfoodprocessingindustry. BeforejoiningOFAS,shewasaresearch scientist for 14 years at FDA in Chicago, IL, investigating several high-priority projects on food packaging safety. She has published 30 peer-reviewed articles and book chapters. She has a Ph.D. in agricultural engineering, a Professional Engineer(P.E.)licenseinchemicalengineering,anM.S.inpackaging,andaB.S. infoodtechnology. Dr. Petra Turowski Dr. Petra Turowski has been a chemist, consumer safety officer, and team leader at the U.S. Food and Drug Administration over a period of 14 years, working in the Center for Food Safety and Applied Nutrition’s Offices of Food Additive Safety; Nutrition, Labeling, and Dietary Supplements; and PremarketApproval. SheservesasteamleaderfortheDivisionofFoodContact Notification’sCommitteeforGlobalHarmonizationandDataSharing–Europe. She has worked on or overseen hundreds of submissions and petitions from the industry, including Food Contact Notifications, Pre-notification Consultations, and New Dietary Ingredient Applications. Before joining FDA, Petra was an assistant professor of chemistry at Smith College and an adjunct assistant professor in the molecular and cellular biology program at the University of Massachusetts at Amherst for seven years. She was a Teaching Fellow at AmherstCollege,haswrittenmanypublications,receivednumerousawardsand fellowships, and holds Ph.D. and S.B. degrees from the Massachusetts Institute ofTechnologyandtheUniversityofCaliforniaatBerkeley,respectively. ©2014AmericanChemicalSociety Preface ThisACSSymposiumSeriesbookevolvedfromtheACSsymposium“Food Additives and Packaging,” sponsored by the Division of Agricultural and Food Chemistry (AGFD) at the 245th ACS National Meeting & Exposition in New Orleans, LA, April 7–11, 2013. There had not been such a large meeting of scientists, regulators, and legal representatives of the industry in this field or an ACSSymposiumrelatedtothistopicforatleast10years. ThethemeoftheSpring 2013ACSMeeting,“FoodandEnergy,”wasperfect. Thepurposeinorganizingthisbookwastobroadenthereaders’understanding of the rules and regulations governing the use of food additives and food packagingmaterialsintheU.S.andglobally. Furthermore,thebookinvestigates novel materials and applications related to food additives and food packaging materialsandexploresconcerns,issues,andcurrenteventsinthefield. Thebook particularly highlights global regulations, research, development, applications, and evaluation of food additives and food packaging materials. These areas are dynamic,constantlychanging,andexpectedtoattracttheinterestofabroadand diversereadership. When consumers think of food additives, they usually think of chemicals directly added to food, like preservatives, food colorings and flavorings, and sugar substitutes. However, the term “food additive” is legally defined to cover anysubstanceswhichmaybecomecomponentsoffood. Theterm“foodcontact substances” (FCS) is used in the U.S. to include components of packaging materials,andmaterialsusedintheprocessing,handling,andstorageoffood. This Symposium Series book is divided into two parts: Part I on Global Regulations and Part II on Research and Development, Applications, and Evaluations. Thisbookcontains19timelychapterswrittenbyglobalauthorities inthefieldsoffoodadditives,foodprocessingaids,andfoodpackagingmaterials, whicharedesignedtoattracttheinterestofabroad,diversereadership. Part I of this book highlights how food additives and packaging materials are classified and regulated in different parts of the world and addresses some of the scientific, legal, and practical issues related to these regulations from the perspective representatives. Part I contains monographs on general aspects of regulatory processes in various countries (U.S., EU, Thailand and Japan) and specificaspects,suchasGRASsubstances,coloradditives,enzymes,flavorings, safetyassessments,andtheNationalEnvironmentalPolicyAct(NEPA). Part II presents some current topics related to the research, development, applications, and evaluation of food additives and food packaging materials. Part II contains monographs on applying regulatory knowledge for packaging complianceandevaluatingfoodpackagingforpre-packagedirradiatedfood,and ix on various emerging technologies, such as a control release packaging system and high pressure processing that can improve the appearance, texture, taste, or shelf-lifeoffood;italsoincludesmonographsthatdiscussotheraspects,suchas bisphenolA,PETpackagingmaterials,nanomaterials,andbiomaterials. The audience for this book includes food scientists, packaging scientists, researchers,regulators,governmentofficials,regulatorystaffinthefoodindustry and personnel at law offices interested in obtaining updates on food additive and food packaging material regulations, as well as the emerging research and development,applications,andevaluation. Itwillalsointerestfoodtechnologists andengineersdesigningfoodpackages,polymerchemists,andpolymerengineers developingnewpackagingmaterials. WewouldliketothanktheauthorsofthechaptersandAshlieCarlson,Arlene Furman, TimMarney, andBobHausermanfromtheACSBooksdepartmentfor their incredible patience when we missed nearly every deadline. It has been a pleasureandjoytoworkwithyouall. WealsothankAllanBaileyfromtheDivisionofFoodContactNotification, U.S.FDA,forhisinvaluableinputtothisbook. VaneeKomolprasert DivisionofFoodContactNotifications OfficeofFoodAdditiveSafety U.S.FoodandDrugAdministration CollegePark, Maryland [email protected](e-mail) PetraTurowski DivisionofFoodContactNotifications OfficeofFoodAdditiveSafety U.S.FoodandDrugAdministration CollegePark, Maryland [email protected](e-mail) x Chapter 1 Global Regulation of Food Additives Mitchell Cheeseman* Regulatory&IndustryAffairsDepartment,Steptoe&JohnsonLLP, 1330ConnecticutAvenue,N.W.,Washington,DC20036 *E-mail: [email protected]. This chapter compares and contrasts the common elements of the major national and international processes for the safety assessment and regulation of food additives. The chapter describes the general approach to safety assessment and the limited ways in which the major regulatory processes differ. ThechapterfocusesontheU.S.andE.U.regulatoryapproaches but also discusses the processes used by the FAO/WHO Joint ExpertCommitteeofFoodAdditivesandtheCodexCommittee onFoodAdditives. Background FoodadditiveregulationisanareaofprominencesincethebeginningofU.S. food safety laws over 100 years ago. Although the U.S. Pure Food and Drugs Act of 1906 did not provide for premarket approval of these ingredients it did acknowledge concerns for chemicals in food and established the beginnings of FDA’s regulation of food colors. The regulation of food additives globally has beenledformanydecadesbythethreemostrobustanddistinctsafetyassessment programs currently in place as well as their predecessor organizations. This “big three” include the Joint FAO/WHO Expert Committee on Food Additives (JECFA), the European Union Scientific Committee on Food; more recently the European Food Safety Authority (EFSA) and the United States Food and Drug Administration(FDA). However, the efforts of the Codex Alimentarius Commission’s (Codex) WorkingGroupontheGeneralStandardforFoodAdditives(GSFA)overthepast two decades as well as recent incidents regarding the safety of food ingredients worldwide as well as trade considerations have increased awareness amongst othernationsoftheneedforconsistentregulationinthisarea. Asaresultmany ©2014AmericanChemicalSociety more nations have begun to move toward a more robust premarket clearance and listing program for food additives. In most cases the assessment process in nationswithlessdevelopedregulatoryprogramsreliesinonewayoranotheron the previous reviews by JECFA and/or EFSA and/or FDA. However, this is not universally true and fully independent requirements for premarket review and listing certainly do exist, (e.g., in Canada, Australia and New Zealand, Japan and in China). Still even these more fully developed systems as a well as most evolvingsystemsfollowandremainhighlycompatiblewiththethreemostrobust programsmentionedabove. Asaresult, thischapterdiscussesthe‘bigthree”in somedetailasabasisforunderstandingalleffortsworldwide. Thus,thisisnotan indepthtreatmentofanyreviewsystembutismeantasanoverviewofthemajor features,pointsofsimilarityandpointsofdifference. Althoughmanyevolvingsystemsfollowthethreelongstandingprogramsthey arealsobeginningtotakeintoaccountcertainculturaldifferenceswhichmayor may not be completely compatible with the other major standards. It may well bethattheGSFAwillovertimeconstituteapointofunificationamongallthese nationalstandards. United States Regulation of Food Additives/Ingredients The US program is easily the most complex of existing national programs. InlargepartthiscomplexityderivesfromhowU.S.lawdefinesa“foodadditive” (1). This definition is unique from other national definitions and from the definition used by EFSA, Codex and the GSFA in some significant ways. First of all, the U.S. definition specifically includes so-called “indirect additives” and excludes so-called “color additives.” As a result, the U.S. is unique in regulating components of food contact materials as “indirect” food additives and in regulating food colors separately from other food ingredients/additives. The U.S. regulatory framework also exempts from the food additive definition those substances authorized for use by FDA or the United States Department of Agriculture prior to September 6, 1958. The U.S. regulatory framework also stands apart from most other food additive regulatory frameworks by including processingaidsunderthefoodadditiveprovisionsofthelaw. Mostothersystems applyonlyageneralsafetystandardtoprocessingaidsandtomostfoodcontact substancesaswell. However,thebiggestdifferencebyfarbetweentheU.S.frameworkandother existing regulatory frameworks for food additives is the existence of the unique exemption from premarket approval requirements for uses of food ingredients that are generally recognized as safe by qualified experts. This provision was introducedintotheU.S.lawwhenFDAwasgrantedpremarketapprovalauthority asacommonsensemeasuretoavoidrequiringsubstanceswhoseuseinfoodwas already widely recognized as safe to undergo extensive safety testing or to use limitedFederalresourcesforpremarketreview. Theso-calledGRASexemption permits safety to be based on either common use in food prior to 1958 or on scientificproceduressimilartootherfoodingredients. Asapracticalmatter,this meansthatGRASusesoffoodsubstancesdonotrequirepremarketauthorization 4
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