3. THOMAS DUNN: CURRENT
Product development; expert witness; food safety; HACCP/GMP gap analysis
Life time Achievement Awards:
• Polymers & Laminations Division (Tech. Assn. Pulp and Paper Industry)
• Food Packaging Division (Inst. Food technologists)
• Packaging Hall of Fame (Packaging Machinery Manufacturers Inst.)
Author:
MANUFACTURING FLEXIBLE PACKAGING: Materials, Machinery, and Techniques (Elsevier, 2015)
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4. PRINTING, PACKAGING, AND PROTECTING
FOOD- AN Overview
A proactive response to the market recall of millions of Euros worth of
packaged goods now mitigates what was an underrated risk to packaged
foods. This webinar reviews new expectations that the response
established for food packaging manufacturers and the procedures that
they should follow to assure food safety.
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6. PRINTING, PACKAGING, AND PROTECTING
FOOD- LEARNING OBJECTIVES
•Place food packaging inks in context of
HAACP-based risk assessment process
•Recognize risks represented by food
packaging inks
•Understand GMPs for formulating
food packaging inks
•Understand GMPs for printing with
food packaging inks
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7. PRINTING, PACKAGING, AND PROTECTING
FOOD- LEARNING OBJECTIVES
•Place food packaging inks in context of
HAACP-based risk assessment process
•Recognize risks represented by food
packaging inks
•Understand GMPs for formulating
food packaging inks
•Understand GMPs for printing with
food packaging inks
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8. PRINTING, PACKAGING, AND PROTECTING
FOOD- LEARNING OBJECTIVES
•Place food packaging inks in context of
HAACP-based risk assessment process
•Recognize risks represented by food
packaging inks
•Understand GMPs for formulating
food packaging inks
•Understand GMPs for printing with
food packaging inks
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9. PRINTING, PACKAGING, AND PROTECTING
FOOD- LEARNING OBJECTIVES
•Place food packaging inks in context of
HAACP-based risk assessment process
•Recognize risks represented by food
packaging inks
•Understand GMPs for formulating
food packaging inks
•Understand GMPs for printing with
food packaging inks
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10. INKS ON FOOD PACKAGING:
HAACP-BASED RISK ASSESSMENT
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The HACCP-process systematically reveals significant food hazards from biological,
chemical, and physical contamination. It identifies what hazards must be mitigated
and how to do so dependably.
11. What is HACCP?
• Hazard Analysis/Critical Control Point
> Prevent hazards rather than test for their presence
in finished products
> Identify biological, chemical, and physical hazards
in food supply chain that cause unsafe food
products
> Design, implement, verify measurements to
reduce hazards to a safe level.
- Critical Control Points
- Prerequisite programs
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12. How does HACCP process proceed?
HACCP PRELIMINARY STEPS
1. Assemble HACCP Team
2. Describe Product
3. Identify Intended Use
4. Construct Flow Diagram
5. Verify Flow Diagram
HACCP PRINCIPLES
6. Conduct a hazard analysis
7. Identify control points/critical control points (CP/CCPs)
8. Establish critical limits for each CCP
9. Establish CCP monitoring requirements
10. Establish corrective actions
11. Validate that HACCP system works as intended
12. Establish record keeping procedures
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15. Control & Critical Control Points
STEP Biological Chemical Physical
Receiving
Transfers
VA Step 1
VA Step 2…
VA Step n
Shipping
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16. Mitigating Risks
• Control Points
• GMPs (PRPs)
• Critical Control Points
• Establish control limits
• Choose monitoring method
• Validate and verify
• Management System for CPs and CCPs
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17. INKS ON FOOD PACKAGING
REPRESENT RISKS
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Ink chemistry is typically the most complex in packaging systems. Its interactions
with other packaging materials has caused product adulteration and significant
market disruption. The HACCP-process confirms that inks used for printed
packaging materials may present a significant chemical food contamination risk.
18. Packaging: guilty as charged
• November, 2005 – March, 2009*
– Italy seizes 30 million liters of children’s milk with traces of
a chemical used in manufacturing packaging inks
– Precautionary withdrawals in France, Spain and Portugal
– Food Processor and packager ordered to pay damages, and
legal costs, to the parents of two
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* www.repubblica.it (1 March 2009)
21. Research Continues
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Valeria Guazzotti, et al.; Migration kinetics of mineral oil hydrocarbons from recycled
paperboard to dry food: monitoring of two real cases. Food Packaging and Shelf Life.
11/2014; 3:9-18
MOSH: Mineral Oil-Saturated Hydrocarbons a: inside boxes
MOAH: Mineral Oil-Aromatic Hydrocarbons b: piled packs
DIPN: Diisopropyl Naphthalenes C: free standing packs
22. GMPS FOR FORMULATING
FOOD PACKAGING INKS
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Use of good practices while manufacturing inks can greatly mitigate the potential
chemical contamination risk to food from printed packaging materials
23. Good practices-Farm to Fork
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Agricultural
Manufacturing
Storage-Distribution
Merchandising
24. GFSA:
Codex General Standard for Food Additives
Good Manufacturing Practices (GMP) for food additives:
• All food additives subject to the provisions of this Standard
shall be used under conditions of good manufacturing
practice, which include the following:
– the quantity of the additive added to food shall be limited to the
lowest possible level necessary to accomplish its desired effect;
– the quantity of the additive that becomes a component of food
as a result of its use in the manufacturing, processing or
packaging of a food and which is not intended to accomplish any
physical, or other technical effect in the food itself, is reduced to
the extent reasonably possible; and,
– the additive is prepared and handled in the same way as a food
ingredient.
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25. PRIMARY PRODUCTION
ENVIRONMENTAL HYGIENE
HYGIENIC PRODUCTION OF FOOD SOURCES
HANDLING, STORAGE AND TRANSPORT
CLEANING, MAINTENANCE & PERSONNEL HYGIENE AT
PRODUCTION
ESTABLISHMENT: DESIGN AND FACILITIES
LOCATION
PREMISES AND ROOMS
EQUIPMENT
FACILITIES
CONTROL OF OPERATION
CONTROL OF FOOD HAZARDS
KEY ASPECTS OF HYGIENE CONTROL SYSTEMS
INCOMING MATERIAL REQUIREMENTS
PACKAGING
WATER
MANAGEMENT AND SUPERVISION
DOCUMENTATION AND RECORDS
RECALL PROCEDURES
ESTABLISHMENT: MAINTENANCE AND SANITATION
MAINTENANCE AND CLEANING
CLEANING PROGRAMMES
PEST CONTROL SYSTEMS
WASTE MANAGEMENT
MONITORING EFFECTIVENESS
ESTABLISHMENT: PERSONAL HYGIENE
HEALTH STATUS
ILLNESS AND INJURIES
PERSONAL CLEANLINESS
PERSONAL BEHAVIOUR
VISITORS
TRANSPORTATION
GENERAL
REQUIREMENTS
USE AND MAINTENANCE
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GENERAL PRINCIPLES OF FOOD HYGIENE
CODEX FOOD HYGIENE (BASIC TEXTS); 4th edition; 2009
26. EuPIA* Compliance Strategy
“In summary it can be concluded that the ink manufacturer does not have an
independent responsibility for the formulation and application of the inks,
but this remains ultimately with the downstream partners.
To allow shared and final responsibilities to be met there needs to be
cooperation between ink manufacturer and the rest of the supply chain.
The cooperation between ink manufacturer and converter is best managed by
requirement specifications, e.g. by detailed information about the substrate,
type of food packed, printing and converting process parameters, storage and
treatment conditions.
When provided with this information the ink manufacturer is enabled to
formulate inks that comply with the Regulation, if they are correctly used.”
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•European Printing Ink Association
27. EuPIA
Good Manufacturing Practices for the Production of Packaging
Inks non-food-contact surfaces of food packaging
QUALITY MANAGEMENT SYSTEM
EU requirement!
PERSONNEL AND TRAINING
All levels trained /Committed
FORMULATION
Critical Control Point
RAW MATERIAL CONTROLS
Specifications/CoAs/FIFO inventory
PRODUCTION
Mfg. instructions/Controls/Calibrate/ QC
tests
QUALITY CONTROL
Sample, test, adjust, approve, calibrate
PRODUCT INFORMATION
Trade name, CoA, Composition,
PACKAGING
Performance/ legal requirements
STORAGE
Prevent deterioration, contamination
DELIVERY
Clean, clearly labeled
TRACEABILITY
Delivery-Batch reference levels
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30. GMPS FOR PRINTING WITH
FOOD PACKAGING INKS
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Use of good practices while printing packaging materials can mitigate remaining
potential chemical contamination risk to food from printed packaging.
31. Safe Inks used safely safe packaging
• EU system evolved quickly to protect food supply
• Member States
• Scientific community
• Industry groups
• US law unchanged:
• If no migration into food, the US FDA has no regulatory
authority
• If migration into food, migrant must have clearance for
food type/use.
• GMP use is mandatory for manufacturing food packaging
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32. Safe packaging by safely printing ink
• Global priority on the integrity of the food
supply chain:
• consensus standards for safe manufacture of food
packaging generated
• ISO Technical Specification (ISO/TS 22002-4):
Prerequisite programs on food safety—Part 4: Food packaging manufacturing
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33. ISO/TS 22002-4 on printing!
• A hazard analysis shall be carried out. If applicable,
measures to prevent microbiological, physical and
chemical contamination shall be implemented 1.
• Chemical contamination from ink migration applies:
Printed and coated materials shall be handled and stored in their intermediate
and finished states in such a manner that transfer of substances to the food
contact side via set-off or other mechanism is reduced to a safe level
appropriate for these materials as defined by hazard analysis2
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1 4.7.1 General requirements
2 4.7.4 Chemical contamination
34. Hazard Analysis
Ink migration / offset
• EuPIA guidelines describe “safe inks”
• German Printing Ordinance in 2016?
• a positive list of evaluated substances
• Overall migration limit of 10 mg/dm2
• Specific migration limits
• Non-evaluated substances limited to detectable
level of 10 ppb.
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35. Printers’ CCP Management
1. Use ink meeting EuPIA selection criteria
2. Print with on target/in control drying/curing
process
3. Validate Migration levels
4. Verify drying/curing process in process
• Rub resistance
• Solvent resistance
• etc.
5. Prepare Corrective Action Plan
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36. PRINTING, PACKAGING, AND PROTECTING
FOOD- SUMMARY
•A HAACP-based risk assessment
process reveals packaging hazards
Best practice for food chain safety
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37. PRINTING, PACKAGING, AND PROTECTING
FOOD- SUMMARY
•Food packaging inks primarily represent
chemical risk
Migration to and set-off onto contact side
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38. PRINTING, PACKAGING, AND PROTECTING
FOOD- SUMMARY
•Formulating food packaging inks
requires using GMPs
MW, heavy metal, toxicity, genotoxicity
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39. PRINTING, PACKAGING, AND PROTECTING
FOOD- Summary
•Printing with food packaging inks
requires GMP use
ISO GMP-PRP and CP approach available
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40. PRINTING, PACKAGING, AND PROTECTING
FOOD- Summary
•A HAACP-based risk assessment
process reveals packaging hazards
•Food packaging inks primarily represent
chemical risks
•Formulating food packaging inks
requires using GMPs
•Printing with food packaging inks
requires GMP use
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