Home' FLEXO Magazine : December 2014 Contents ASSOCIATION HAPPENINGS
How useful was the newest version of Flexographic Image Reproduc-
tion Specifications & Tolerances (FIRST)? So useful that it jumped
from version 4.1 to 5.0 in October. FIRST 5.0 brought with it:
• An opening chapter detailing FIRST methodology, information
previously located in the “Print” section
• Substantial additions to the chapter on “Implementation &
Communication,” with particular focus on the “Optimization,”
“Press Fingerprint,” “Process Control,” “Press Characterization”
and “Process Improvement” sections
• Heavy refinement to the design chapter, removing obsolete
terminology and references
• Covering prepress best practices for vignettes, gradations, and
transparency and effects, along with various screening options
• A top to bottom rewrite of the “Print” chapter, bringing the ma-
terial in sync with its sister publication, Flexography: Principles
& Practices 6.0, and adding a section titled “Optimizing The
Process Color Gamut.” The significance of this addition cannot
be understated, as it spells out the “right” way to print, rather
than several accepted “different” methods
• Information pertaining to creative briefs, style guides, QR codes,
datamatrix codes and snap tags
Another “five”: The fifth entry in the FLEXOGRAPHY 101 booklet
series, covering plate making, was released. It covers different plate
types, photopolymer plate properties, technologies related to imaging
masks and various plate making procedures.
The number of FIRST certifications continued to grow over the
course of the year. As of the end of 2014, there were 380 Press Opera-
tor certifications, 56 Prepress Operator certifications, 322 Implemen-
tation Specialist certifications and two Company certifications.
The FQC continued its pursuit of standards, conducting studies and
trials through the year. The group’s efforts were highlighted in a ses-
sion at Forum and in quarterly articles for FLEXO® magazine.
Navigating FDA Compliance
Mitzi Ng Clark
icrowaveable retort pouches. Stand
up zipbags. Singleser ving stickpacks.
These representjust a few examples of
flexiblepackaging uses foundinthe
U.S . markettoday.As demandfor flexible packag-
ing continues its momentum inthefood sector, it is
imperative that manufacturers have afundamental
understanding ofthe way in which flexiblefoodpack-
aging is regulatedintheU.S.
AGENCIES & ACTS
Adiscussionof theU.S. regulatoryframeworkforflexiblefoodpack-
aging mustbeginwithanunderstanding ofthegovernmentagency
acomponentorotherwiseaffecting thecharacteristicsof any
packaging... or holding food...”1
discussedlateron. Byvirtueofitsdefinition, theterm“foodadditive”
Sincefoodadditiveclearancesaregeneric,anyone mayrely onthem.
cAct,§ 201(s),21U.S .C .§321(s).
OEC Graphics’FUSION.Thiscustomized packagingmanagement
teammembersreal-timeaccesstofiles,images, proofs, press
OEC Graphics, Inc.
Oshkosh | Appleton | Chicago | Atlanta | California | Carolinas
20 FLEXO | AUGUST 2014
UndertheFCNprogram, theAgencyisrequiredby lawtoclearthe
EXCEPTIONS TO THE RULES
AsfortheTOR exemption, FDA canexempt afoodcontactsubstance
• Theintendeduseofthesubstance resultsindietaryexposuresof
lessthan 0.5 ppb
Iftheintendeduseofthesubstanceis not thesubjectof oneofFDA’s
tion.Asmentionedabove,substancesthatare not reasonablyantici-
patedtobecomecomponentsof foodare notfoodadditivesunderthe
Act and,asa result,are notsubject toFDApremarketclearance.This
exemption, knownasthe“no migration”exemption, is supportedby
caselawandhasbeenusedby industryformany yearstosubstantiate
subjectof lettersissuedbyFDAortheU.S.Department ofAgriculture
GRAS substancesisnotexhaustive.4Thus, manufacturersarefreeto
rizationor noticeby FDA.
thesubjectofarelevant regulatory clearanceorexemption, thepack-
regulation. Theregulationisfoundat21C.F.R.§ 174.5and requiresa
About the Author: Mitzi Ng Clark isa
partner at thelaw offices of Keller and
Heckman LLP. Shepractices in the area
of foodanddrug law, with anemphasis
administeredby the FDAand otherfederal
in compliance and good manufacturing
ofproductsandpackaging. Inaddition, she counsels clients ona broad
EuropeanUnion, the Pacific Rim andLatin America.
3 Seesupra note1.
4 21C.F.R.182.1 .
22 FLEXO | AUGUST 2014
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“There are myriad materials that
can be used in flexible packaging
for food. Manufacturers along the
supply chain will best maximize
their opportunities in this growing
market by ensuring that their
materials comply with FDA’s food
contact regulatory scheme.
Flexographic Image Reproduction Specifications & Tolerances
22 FLEXO | DECEMBER 2014
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