Printing, Packaging, and Protecting Food Tom Dunn, Flexpacknology LLC packaging safety & solutions℠ February 6, 2015, 1
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Printing, Packaging, and Protecting Food
Tom Dunn, Flexpacknology LLCpackaging safety & solutions℠
February 6, 2015,
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THOMAS DUNN: BACKGROUNDFlexible Packaging Association / Printpack Inc
BA; MS Yale
Flexible Packaging Product Development & Regulatory Compliance (35 yrs)... Processes:
flexo, gravure, adhesive & extrusion laminations, metalizing, barrier & cohesive coating
Products:Salted snacks, confectionery, RTE cereal, processed meat, thermally sterilized foods
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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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PRINTING, PACKAGING, AND PROTECTING FOOD- AN OverviewA 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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PRINTING, PACKAGING, AND PROTECTING FOOD- LEARNING OBJECTIVES
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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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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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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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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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INKS ON FOOD PACKAGING: HAACP-BASED RISK ASSESSMENT
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.
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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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How does HACCP process proceed?HACCP PRELIMINARY STEPS
1. Assemble HACCP Team2. Describe Product3. Identify Intended Use4. Construct Flow Diagram5. Verify Flow Diagram
HACCP PRINCIPLES
6. Conduct a hazard analysis7. Identify control points/critical control points (CP/CCPs)8. Establish critical limits for each CCP9. Establish CCP monitoring requirements10. Establish corrective actions11. Validate that HACCP system works as intended12. Establish record keeping procedures
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Process Flow Diagram
Receiving In-Plant Transfers
Add value• Step 1• Step 2…• Step n
Shipping
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Hazard AnalysisSTEP Biological Chemical Physical
Receiving
transfers
VA Step 1
VA Step 2…
VA Step n
Shipping
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Control & Critical Control Points STEP Biological Chemical Physical
Receiving
Transfers
VA Step 1
VA Step 2…
VA Step n
Shipping
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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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INKS ON FOOD PACKAGINGREPRESENT RISKS
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.
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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
* www.repubblica.it (1 March 2009)
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Motive, means, and opportunity
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Murphy’s Law
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Research Continues
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 boxesMOAH: Mineral Oil-Aromatic Hydrocarbons b: piled packsDIPN: Diisopropyl Naphthalenes C: free standing packs
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GMPS FOR FORMULATING FOOD PACKAGING INKS
Use of good practices while manufacturing inks can greatly mitigate the potential chemical contamination risk to food from printed packaging materials
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Good practices-Farm to Fork
Agricultural
Manufacturing
Storage-Distribution
Merchandising
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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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PRIMARY PRODUCTION ENVIRONMENTAL HYGIENE HYGIENIC PRODUCTION OF FOOD SOURCES HANDLING, STORAGE AND TRANSPORT CLEANING, MAINTENANCE & PERSONNEL HYGIENE AT
PRODUCTIONESTABLISHMENT: DESIGN AND FACILITIES
LOCATIONPREMISES 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 RECORDSRECALL 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
GENERAL PRINCIPLES OF FOOD HYGIENECODEX FOOD HYGIENE (BASIC TEXTS); 4th edition; 2009
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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.”
• European Printing Ink Association
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EuPIA Good Manufacturing Practices for the Production of Packaging
Inks non-food-contact surfaces of food packaging
QUALITY MANAGEMENT SYSTEMEU requirement!
PERSONNEL AND TRAINING All levels trained /Committed
FORMULATIONCritical Control Point
RAW MATERIAL CONTROLSSpecifications/CoAs/FIFO inventory
PRODUCTIONMfg. instructions/Controls/Calibrate/ QC tests
QUALITY CONTROLSample, test, adjust, approve, calibrate
PRODUCT INFORMATIONTrade name, CoA, Composition,
PACKAGINGPerformance/ legal requirements
STORAGEPrevent deterioration, contamination
DELIVERYClean, clearly labeled
TRACEABILITYDelivery-Batch reference levels
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EuPIA Formulation Control
• EuPIA Guideline on Printing Inks (2011)• Exclusion Criteria:• “CMR”• “Toxic” or “Very toxic”• Sb, As, Cd, Cr(VI),Pb, Hg, Se colorants/compounds • REACH “SVHC”
• Purity requirements• MW 1000 Dalton• Migration considerations
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EuPIA Formulation Decision Tree
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GMPS FOR PRINTING WITH FOOD PACKAGING INKS
Use of good practices while printing packaging materials can mitigate remaining potential chemical contamination risk to food from printed packaging.
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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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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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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 analysis 2
1 4.7.1 General requirements2 4.7.4 Chemical contamination
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Hazard AnalysisInk 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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Printers’ CCP Management
1. Use ink meeting EuPIA selection criteria2. Print with on target/in control drying/curing
process3. Validate Migration levels4. Verify drying/curing process in process• Rub resistance• Solvent resistance• etc.
5. Prepare Corrective Action Plan
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PRINTING, PACKAGING, AND PROTECTING FOOD- SUMMARY•A HAACP-based risk assessment
process reveals packaging hazardsBest practice for food chain safety
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PRINTING, PACKAGING, AND PROTECTING FOOD- SUMMARY
• Food packaging inks primarily represent chemical riskMigration to and set-off onto contact side
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PRINTING, PACKAGING, AND PROTECTING FOOD- SUMMARY• Formulating food packaging inks
requires using GMPsMW, heavy metal, toxicity, genotoxicity
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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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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
