Food additives and packaging

314 Pages·2014·14.44 MB·English

by  Komolprasert

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
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Standard for Information Sciences—Permanence of Paper for Printed Library Materials,
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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
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
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
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