If you have any questions or comments, please send them to connect@tracegains.com. We look forward to hearing from you. Meeting Description: Food packaging is an important element to the safety of food and its ingredients, as they travel through the supply chain and on to the consumer. How can you protect yourself, your brand, your customers, and the end consumer from adverse impacts? What are best practices you should be paying attention to in manufacturing and purchasing of packaging materials and components? -How can you proactively monitor and manage your suppliers? -Debra Krug-Reyes of ConAgra will discuss the need for food safety programs at packaging suppliers. -George Gansner of IFS will then talk about the role and importance of the Global Food Safety Initiative (GFSI) and International Featured Standards. This webinar will reveal the history of the IFS PACsecure standard, focus on the benefits of certification to the supplier and customer, as well as review the tools available in support of certification which include HACCP implementation workbooks designed specifically for the sector for which it applies (glass, metal, rigid plastic, flexible plastic, and paper – corrugated, paper board, etc.). About the IFS PACsecure standard: Since 2003, IFS has built its presence around the world as a leading standard in the food supply chain, and in 2013, IFS PACsecure was added to the family of GFSI benchmarked certifications. This standard for primary and secondary packaging materials was developed to provide packaging converters the opportunity to certify their systems and products with a HACCP-based approach, using risk-based methodology. Developed jointly by the food and packaging industry in North America with the guidance of the Packaging Consortium, the IFS PACsecure standard is now globally viable and meets GFSI customer requirements.

1. What’s new in GFSI: IFS PACsecure

2. Q&A

3. Today’s Presenters
Debra Krug-Reyes
•Principal in the Food Safety and Quality Auditing Group
ConAgra Foods
GeorgeGansner
•Director, Global Marketing and Business Development; Manager - Americas
International Featured Standards (IFS)

4. Food Safety and Packaging: What do CPGs Expect of Suppliers?
Debra Krug-Reyes
Food Safety and Quality Auditing
ConAgra Foods, Inc.
August 14, 2014

5. Agenda
Current Status
Typical Expectations from CPG/Food Companies
Product Recalls
Risk-Based Preventive Programs
6

6. Necessary mindset
If your product touches food at some point in the downstream supply chain, you are a part of the Food Industry.
Treat Food Packaging (Human andPet) with the same food safety rigor as food–look at potential risks from design to consumption

7. The Federal Food, Drug and Cosmetic Act
The FDA regulates Food Contact Materials based on the premise that they are potential Food Additives
Section 210(s) of the Act:
A Food Additive: “Any substance the intended use of which results in or may be reasonably expected to result … in its becoming a component of food”
Any substances which then become part of a food by being transferred from the packaging are considered “Indirect Food Additives”
Conclusion: Packaging Materials are potential Food Additives
8

8. Typical Expectations for Packaging Supplier Approval
Supplier survey / risk assessment
Site Audit:
3rdparty; GFSI or other Food Safety certification;
CPG internally developed audit
Typical assessments:
GMPs, Employee Practices, Training
HACCP/Food Safety Risk/Hazard Assessment
Controls in place to eliminate identified risks–CCPs or prerequisites
Supply chain management/approval process
Raw material regulatory approvals
Chemical migration testing
9

9. FOOD SAFETY Continues to be Big News
10

10. 0
100
200
300
400
500
600
700
800
900
1000
E. coli
Listeria
Salmonella
ForeignMaterial
Packaging- Not Labeling
UndeclaredIngred/ ALLERGENS
U.S. 2011
U.S. 2012
U.S. 2013
U.S. Food Recalls –2011-2013
11
Source: Food Industry Report , Vol. 24, 25, 26 No. 4 April 2012, April 2013, April 2014

11. Canada Food Recalls 2011-2012
Source: Food Industry Report, Vol. 24 and 25, No. 4, April 2012 and April 2013
0
50
100
150
200
250
300
E. coli
Listeria
Salmonella
ForeignMaterial
Packaging- NotLabeling
UndeclaredIngred/ ALLERGENS
Canada 2011
Canada 2012
12

12. Impact of Recall Indirect Costs
Product Reputation
LOSS OF CONSUMER CONFIDENCEin the brand, the product category, the company, the food industry
Other brands and other companies are affected
Product Recovery
Disposal Costs
Analytical Costs
Shelf-space
13

13. Top Food Safety Related Issues Associated with Packaging
Undeclared/Unlabeled Allergens /Misbranding
Wrong food or wrong package
Mixed labeled packaging materials–Packaging Supplier or Food Plant errors (e.g., labels, cartons, film, lids, cups,…)
Human errors–multiple potential sources–Murphy’ Law
Incorrect Label Printing
Copy review errors
Prior print versions re-appear
Printing changed or lost
Chemical Migration
Migration into product(e.g., film, pallets, ink…)
May be “Perceived” food safety issues–odors, taste
Social Media Communication (e.g., BPA)
14

14. People with food allergies
DEPEND ON CORRECT LABELS
It’s the LAW
15

15. 16
Reaction to MILK
Reaction to PEANUTS
Normal
Food Allergies can lead to serious reactions–potentially fatal

16. Hostess Recalls Chocolate Mini Muffins– Mislabeled/Unlabeled Allergen
Banana Nut muffins packaged in the wrong bag--bag was labeled as “Chocolate Chip”, walnutspresent in the muffins not listed on the label–
Unlabeled Allergenand Misbranded Product
October 1, 2010 –Consumer Reports Food Safety Alert
17

17. OM Wieners with Cheese in
Classic Wieners Package–
Not labeled as containing cheeseUNLABELED MILK ALLERGEN
Fox NewsApril 20, 18

18. 19

19. 20

20. 21

21. Pro-active packaging suppliers preventmixed labeling
Controls to prevent mislabeling:
Implement strict controls at points where human error could occur
Changeover/Line Clearance checklists
Print copy reviews
Electronic Vision Systems
Rework controls
Employee training and reinforcement
Joint Responsibility:
Controls at both the packaging supplier AND the food plant
22

22. Non-Label Related Issues
Less frequent
Larger amount of product implicated
Huge financial impact
23

23. Chemical Migration
Migration into product
Sources–film, ink, pallets, …..
Perceived or real risk?
Social Media (e.g., BPA)
News reports
24

24. Kellogg’s Recall 28MM Boxes of Cereal– Cereal box liners imparted bad taste and odor to the food
Associated with nausea and vomiting in some consumers.The source was identified as higher than normal levels of a chemical (2-Methyl Naphthalene)in the liners
June 2010
25

25. Johnson & Johnson Recalls Over 60MM Bottles of Pain Relievers Due to Musty Odor (3 Recalls)
The odor was caused by trace amounts of a chemical (tribromoanisole(TBA)) formed as a by-product of mold growth on high-moisture
wooden pallets
In addition to causing an unpleasant odor, TBA has been associated with temporary and non- serious gastrointestinal symptoms.
Jan -Oct 2010
26

26. Supplier approval programs (resin and other materials)
Letters of Guarantee/Certificate of Conformance
Chemical Migration testing
Audits of incoming materials
Consider end use of packages (e.g., direct product contact, microwave, hot fill, pH of the food,…)
Packaging supplier and customer must work closely to understand the interaction of the package with the food–consider foreseeable use
Pro-active programsprevent potential chemical migration
27

27. Other Considerations
CONSUMER PERCEIVED food safety/consumer hazards
FORESEEABLE USEof the material
28

28. Perceived Food Safety Risk
29

29. Consider foreseeable use
in the packaging risk analysis
30

30. Who’s Responsible for Safety of Packaging Materials?
Joint Responsibility
Packaging Supplier and CPG Manufacturer
31

31. Joint Responsibilities
Sound Quality Management Systems
Risk Analysis–what “could” happen if….
Controls to prevent incidents
Secondary checks/controls
Prevent potential for human error
Use of technology (e.g., vision systems)
Learn from prior mistakes–yours and others
Remember Murphy’s Law
32

32. Pro-active food safety programs at packaging suppliers and food manufacturers can preventpotential issues
33

33. Prerequisites & Basics for HACCP/Food Safety Programs
34
HACCP/ Food Safety
GMP
Sanitation, Sanitary Design, Maintenance
Process Control
Microbiological Chemical & Physical Control
Specifications
Training
Environmental Monitoring
Supplier Control
Product Traceability & Recall

34. Food Safety Across the Supply Chain
HACCP/Food Safety Programsidentify potential hazards/risks and controlsthat can be implemented to preventpotential hazards
The HACCP approach is a proven food safety program accepted worldwide–the ultimate goals:
Protect consumers
Prevent / Eliminate Recalls
35

35. GFSI–Global Food Safety Initiative
Vision: Safe Food for Consumers Everywhere
Mission:Driving continuous improvement in food safety to strengthen consumer confidence worldwide
A strong HACCP/Food Safety programincluding strong prerequisite programsare essential components of the Global Food Safety Initiative
36

36. Food Safety is everyone’s responsibility
37

37. 38

38. 39
Blank area for graphics
Thanks to sister CPG companies and the Food Safety Alliance for Packaging (Technical Committee of IoPP) that contributed content to portions of this presentation.

39. IFS PACsecure
Whatisthat?
TraceGains Webinar | August 14, 2014

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Introduction
The IFS PACsecure Standard -in a nutshell
For manufacturers and converters of
packaging materials
To ensure quality and safety of
packaging materials
Food and non-food materials
Meets GFSI requirements
Roll out in North America and Europe

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Introduction
Origin oftheStandard
Safety standards for manufacturers ofpackaging material
(Packaging Association of Canada -PAC)
Prerequisite Program
HACCP-plans and workbooks for hazard identification

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Introduction
Origin oftheStandard
PACsecure: development by working group of North America’s largest packaging and food manufacturers
IFS PACsecure is GFSI Benchmarked
IFS PACsecure: CooperationofIFS andPAC todeveloptheStandard andmeetGFSI requirements

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Introduction
Structured asIFS Food
Part 1
(Audit protocol)
Part 2
(Requirements)
Part 3
(AB, CB & Auditors)
Part 4
(Report)
•Annex 1 –different IFS Standards
•Annex 2 –Certification process
•Annex 3 –Productscopes
•Annex 1 -Glossary
•Annex 1 –Productscopes
•Annex 1 -Report coverpage
•Annex 2 -Audit report
•Annex 3 -Action plan
•Annex 4 -Certificate

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Part 1: Audit protocol
The Standard applies to manufacturers of different packaging materials
Withoutfoodcontact
Withfoodcontact
e.g. PE foil for vegetables, tin plate cans for beverages, paper packaging for flour…
e.g. technicalproducts
>> Scope oftheaudit
>> Productscopes
Flex pack.
Rigid
plastic
Paper
Metal
Glass
Other natural
mat.
>> Processing linesshallbeoperatingduringtheaudit

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Part 1: Audit protocol
>> Scope oftheaudit
IFS PACsecure product scopes
Examples
1. Flexiblepackaging
Blown film extrusionof PE films for cheese wrapping
2. Rigidplastic
thermoforming of PP trays for readymeals
3. Paper
Papermaking, manufacturingof corrugated cardboard
4. Metal
Drawingof two-piece alucans for soft drinks
5. Glass
Blow-blowing of glass containers
6. Other natural materials
Materials to be considered as “other natural materials” are,e.g.wood, clay, cork, jute, textiles, banana leaves
Multi-component
The main component of multi component packaging materials (e.g. drink cartons) has to be mentioned in the scope of the audit on the report.

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Part 1: Audit protocol
>> Typesofaudits
Initial audit
Follow upaudit
Renewalaudit
•First audit for the company against the IFS PACsecure
•All requirements shall be audited (complete company audit)
•Required when Major and final score ≥75%
•Auditor focuses on implementation of corrective action related to Major
•Performed on-site, by the same auditor
•If failure, a complete new audit necessary
•Any full audit after the initial audit
•All requirements to be audited
•Check corrective action plan from previous audit
•Companies are responsible for maintaining their certification

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Part 1: Audit protocol
>> Typesofaudits
Extension audit
•Between two audits, in case of new products or processes
•CB shall decide risk based if audit is necessary, which requirements are applicable
•In general, extension audit necessary when risk assessment or product scopes or technologies are different

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Part 1: Audit protocol
Influencing factors
Size ofthesite
Scope oftheaudit
>> Minimum auditduration: 2 days(exceptionspossible)
Type ofproduction
Numberofproductionlines
Numberofpersonnel
Numberofnon-conformitiesofpreviousaudit

49. •all members shall be approved IFS PACsecure auditors
•lead auditor and co-auditor(s) shall be identified
•auditor’s profile shall comply with the activities of the audited factory
•2 hours of the audit duration are not shareable (for common tasks, e.g. opening and closing meeting, discussion about audit findings)
•audit time schedule shall indicate which auditor did which part of the audit
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Part 1: Audit protocol
>> Audit team

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Part 1: Audit protocol
>> Scoring system-deviations
Result
Explanation
Points
A
Full compliance
20
B
Almost full compliance
15
C
Small partoftherequirementhasbeenmet
5
D
Requirement has not been implemented
-20

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Part 1: Audit protocol
>> Scoring system-Major
•May be given to any requirement (except KO)
•Meaning: substantial failure to meet the requirement (including product safety/legal issues or if it might lead to a serious health hazard)
•Substracts15 % of score
>> Scoring system-KO
•KO-requirements may be scored with A (20pts), B (15pts) or D (-50 %)
•“D” leads to non-certification or suspension of certificate

52. Part 1: Audit protocol
>> Conditionsforawardingthecertificate
Non conformity
Status
Action of the auditee
Certificate
At least 1 KO scored with D
Not approved
send completed action plan
scheduling of a new initial audit, not earlier than 6 weeks after
NO
> 1 Major
and/or
total score <75%
Not approved
send completed action plan
scheduling of a new initial audit, not earlier than 6 weeks after
NO
Max 1 Major and total score is
≥75%
Not approved unless further actions taken and validated after follow up
send action plan within 2 weeks after receiving preliminary report
Follow-up audit max 6 months after the audit date
Foundationlevel
(if Major NC solved)
Total score ≥75% and <95%
Approved for IFS PACsecure foundation
send action plan within 2 weeks after receiving preliminary report
Foundationlevel
Total score ≥95%
Approved for IFS PAC secure higher level
send action plan within 2 weeks after receiving preliminary report
Higherlevel

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Part 2: List ofauditrequirements
1 checklist
9 KO requirements
>> Key facts
References to the original PACsecure standard in the checklist
Examplequestionsofauditorsin thechecklist
Examples for KO and Major in checklist
Additional HACCP plansandworkbooksavailablebyPAC

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Part 2: List ofauditrequirements
>> Structureofthechecklist, example: trainings
No
Requirement
PAC secure- rqmnt
PAC secure-No
Whattocheck?
Whatshouldbeasked?
ExampleforKO/Major
3.3.4
The contentsoftrainingand/orinstructionshallbereviewedandupdatedregularlyandtakeintoaccountcompany‘sspecificissues, packagingmaterial safety, packagingmaterial relatedlegal requirementsandproduct/processmodifications.
D 1.2.1–4
4, 5
–How are training contents reviewed?
<review test>
–When are training contents reviewed?
–When was the latest training content update done?
–What was the content of the latest update?
<audit results>
–specific issues: non- conformities, failures
During the on-site audit evidence was given that employees did not act according to knowledge trans- mitted in the training sessions and this lead to a product safety risk.

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Part 2: List ofauditrequirements
>> Content
•Corporate structure, Management review…
1. Senior Management Responsibility
•Documentation, Recordkeeping, Riskassessment…
2. Quality andPackagingMaterialSafetyManagement System
•Personnelhygiene, Training, Stafffacilities, Working conditions…
3. ResourceManagement

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Part 2: List ofauditrequirements
>> Content
•Legallyrequireddocumentation, Specifications, Formula/ Configurations, Purchasing, Productionandstorageareas, Cleaning, Waste, Foreignmaterial, Pests, Maintenance, Traceability…
4. PlanningandProductionProcess
•Internal audits, Calibration, Productanalysis, Complaints, Correctiveactions…
5. Measurements, Analysis, Improvements
•Site security, Personell andvisitors…
6. PackagingMaterial Defense/Food Defense andExternalInspections

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Part 2: List ofauditrequirements
>> 9 KO requirements–4 ofthemin chapter4 (productionprocess)
Senior Management responsibility(1.2.4)
Personnelhygiene(3.2.1.2)
Specifcationsforrawmaterials(4.2.1.2)
Compilancewithcustomeragreements(4.2.2.1)
Procedurestoavoidforeignmaterial (4.12.1)
Traceabilitysystem(4.18.1)
Internal audits(5.1.1)
Procedureforwithdrawal/recall(5.9.2)
Correctiveactions(5.11.2)

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Part 2: List ofauditrequirements
>> SupportingdocumentsbyPAC >> example: CP determination

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Part 2: List ofauditrequirements
>> SupportingdocumentsbyPAC >> example: CP determination

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Part 3: RequirementsforCBs andauditors
>> Auditor requirements
IFS PACsecure
IFS Food
IFS HPC scope3
PACsecure
otherpack- stds.
poduct/ process-audit training
poduct/ process-audit training
otherpack- stds.

61. Key question: is the audited company capable of supplying safe products that comply with the agreed specifications?
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Part 3: RequirementsforCBs andauditors
>> Audit objectivesandprinciples
•An audit should check the capability of a company to use its systems and processes to realize a safe, legal and conform product
•During the audit, the auditor uses objective evidence on site to check whether safe, legal and conformant products are actually produced and delivered
•The aim is, in a given audit situation, to reach equivalent results regardless of who the auditor is

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Part 4: Reporting andIFS Audit Portal
>> Audit portalanddatabase–wheretheauditsarestored
•Uploadreports
•Manage companies
•Compare reports
•…
CBs
•Access to ownaudit data
•Unlockretailers
•Createsubaccounts
•…
Suppliers
•Searchfor suppliers
•E-mail notif. in case of certificatesuspension
•…
Retailers
User groups

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Update
Audit status
>> 23 sitescertified, somealreadytwice
AustriaandGermany, e.g.:
Canada andUSA, e.g.:

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Status
News
•GFSI-recognizedsinceDecember2013
GFSI benchmark
•Working groupcreatestrainingmaterials
•McDonald‘s Europe acceptsIFS PACsecure
Rollout in Europe
•English, German, ItalianandSpanishalreadyavailable
•French andPortugueseareworkedon
Translation oftheStandard

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Conclusion
Review
•Standard forpackagingmaterial manufacturers
What?
•Flexible & rigid plastics, paper, metalglass, othernaturalmaterials
Scope?
•Safety& qualityformanufacturers
•Reductionoffaultsandcosts
•MeetGFSI requirements
Objectives?
•Independent assessment
•Riskbased
•Flexibilityofimplementation
Benefits?

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Conclusion
Benefits
•IFS PACsecure offersupto1 yeartoclosedeviations
•More flexible requirements
•Trulyrisk-basedrequirements
•Guideline includedin thechecklist
comparedto
BRC IoP
•Check ofcompliancewithcustomerrequirements
•IFS PACsecure displaysthedegreeoffulfillment(scoringsystemwithpercentage)
•Comparableregardlessoflanguage
•Harmonizedauditreport, comparabletotheotherIFS Standards
comparedto
ISO 22000 + PAS223

67. IFS PACsecure, Version 1 | Neckarsulm | 11.06.2013
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IFS PACsecure, Version 1
Benefits
•IFS PACsecure-Anforderungen prüfen Sicherheit und Qualität von Herstellern und berücksichtigen Kundenanforderungen. So können z.B. Lieferantenaudits reduziert werden
Hohes IFS-Anforderungsniveau
•Der IFS PACsecure-Standard wird durch die GFSI geprüft –dabei werden Qualität und Belastbarkeit der Anforderungen untersucht.
GFSI-Benchmark
•Trotz vieler Gemeinsamkeiten unterscheidet sich IFS PACsecure vom BRC-IoP- Standard. IFS PACsecure fragt z.B. nach:
•Überprüfung der Mitarbeiterverantwortlichkeiten
•Hygieneregeln auch für Besucher und Dienstleiter
•Ständige Verfügbarkeit von Spezifikationen und gesetzl. geforderter Dokumente
•Erfüllung von Kundenanforderungen
•…
Unterschiede zu BRC-IoP
Thankyou
for your attention
George Gansner
IFS Managementgansner@ifs-certification.com
314-686-4610

69. Documentation —Turning Static Data Into Information
Typical
24/7 Detection& Compliance
Automation
TraceGains
Dynamic Information
AutomaticScorecarding
Difficult to search, analyze, andtake action
Instant eNotification
Alerts
No More Spreadsheets: Documents to Data
Static Data
COAs
Supplier Documents
Finished Goods Quality
Machine Maint.
Receiving
Receiving Inspections
Lab Results
Auto. P.O. Acknowl.
Plant Floor Feedback
Finished Goods QA
COA
ActionForm™

70. TraceGains Automation Solves Many Problems
GFSI
Labeling
FSMA
Audits

71. Q&ARajan Gupta
rajan.gupta@ tracegains.comGeorge Gansner
gansner@ifs-certification.comDebra Krug-Reyes
deb.krug-reyes
@conagrafoods.com