h.b. fuller on food safety may 6 2014
TRANSCRIPT
Ensuring Food SafetyHow to assess adhesives used in food contact packaging?
May 6, 2014
Alexandra RossElizabeth Staab
©2014 H.B. Fuller Company
Welcome
2
Alexandra RossProduct Regulatory Specialist
Elizabeth StaabMarketing Manager
Packaging Solutions
©2014 H.B. Fuller Company
Agenda
3
1. Megatrends influence Packaging
1. Megatrends influence Packaging
2. Monitoring the Risk from Packaging Adhesives
3. Adhesive Assessment for Final Food Contact Application
4. Questions & Answers
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Food Contact Regulation & Control
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Migration
Monitoring&
Control
Kind and amount of
substances
Packaging Construction
Barrier of the
packaging
Surface / Volume Ratio
Contact time and
Temperature
Type of food
©2014 H.B. Fuller Company
Food Contact Regulation & Control
10
Migration
Monitoring&
Control
Kind and amount of
substances
Packaging Construction
Barrier of the
packaging
Surface / Volume Ratio
Contact time and
Temperature
Type of food
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What is the Risk of Adhesives?
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Possible migration into food should not endanger human health
(Article 3, Regulation (EC) No 1935/2004)
Hazard: Toxicity
Exposure: Effective amount
Risk = Hazard x Exposure
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FEICA Food Contact Guidance
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Safe food in safe packaging by using safe adhesives
Guidance of a Food Contact Status
Declaration for Adhesives(issued February 2013)
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Raw Material and Adhesive Related Evaluation
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Raw Material Data Gathering
Raw Material Evaluation
Adhesive Related Evaluation
Source: FEICA Food Contact Guidance
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Raw Material Data Gathering
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Requested Information from RM Supplier
1.Date
2. Identification of Raw Material Supplier
3. Chemical Identification
4. Compliance Status
5. Compliance with Rejection List FEICA
Source: FEICA Food Contact Guidance
Compliance Status
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Information in the Supply Chain
a. Regulation (EU) No 1935/2004Traceability & Article 3
b. Regulation (EC) No 2023/2006
GMP
c. Regulation (EU) No 10/2011 (Plastics Regulation):
Substances on Union List
Non-authorized substances
Dual use additives
d. Other: EU Member States Legislations or Recommendations
e. Non-EU Legislations:FDA Sections (e.g. 175.105, 175.300, 176.170, 176.180, etc..)
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Rejection List FEICA
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Examples of Rejected Substances
Substances classified as CMRRegulation (EC) No 1272/2008
Substances containing heavy metals > 100 ppm Council Directive 94/62/EC
Phthalates According to Annex XVII of Regulation (EC) No 1907/2006
Epoxy DerivativesRegulation (EC) No 1895/2005
Substances that deplete the ozone layerRegulation (EC) No 1005/2009
DimethylfumarateRegulation (EU) No 412/2012
PBB & PBDE Directive 2011/65/EU (ROHS)
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©2014 H.B. Fuller Company
Toolbox for Raw Material Evaluation
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Food Contact Status Declaration
Adequate information
Comp. A
Comp. B
Comp. C
Comp. D
Comp. E
Comp. F
Plastics Regulation (EU) No 10/2011
BfR Recommendation (e.g. XIV, XXV)
FDA 175.105
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Food Contact Status Declaration by Adhesive Supplier
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Adhesive Supplier Information
Product Information
Product Compliance
Adhesive Supplier Recommendations
Assessment of Suitability by DU
Source: FEICA Food Contact Guidance
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Adhesive Evaluation by Downstream User
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Source: FEICA Food Contact Guidance
Evaluation of Packaging
Evaluation of Migration
Potential
Migration Modeling / Test
Worst-Case Approach
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Barrier Properties of Packaging Materials
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Functional Barrier (Definition according to Regulation (EU) No 10/2011):
A barrier consisting of one or more layers of any type of material which ensures that the
final material or article complies with Article 3 of Regulation (EC) No 1935/2004 and with
the provisions of this Regulation.
Barrier against permeation of: Oxygen
Water vapor
Carbon dioxyde
Nitrogen
Acting as a barrier against migration of substances (functional barrier)
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Barrier and Migration Risks
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BA
RR
IER
+-
EVOH – Laminates
PET
PVDC / PVC
PA
PE
Corrugated Board
Carton
Paper
Barrier Properties of Packaging Materials
Could represent an absolute barrierGLASS, METAL, ALUFILM
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Evaluation of Migration Potential - Test
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Source: FEICA Food Contact Guidance
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Typical Adhesive Applications
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Application Adhesive Barrier Migration Risk
CorrugatedHotmelt
Water-based - Low, secondary
packaging
Carton
Folding Box
Hotmelt
Water-based - Low
Flexible packaging
Laminated filmsIsocyanate-based +/- Medium
Bottle-LabelingWater-based
Hotmelt + Very low
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32 cm
22 cm
Calculation Example 1 – Snack Food
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• Structure of laminate: OPP printed / met. OPP
• Food: 150 g (dry)
• Adhesive: Reactive, solventless; 0,28 g per bagPackage
• Identity: PM-Ref: 68320
• SML= 6 mg/kg
StabilizerA
• 1 kg food = 6,66 bags
• 0,28 g adhesive x 6,66 = 1,866 g / kg food
• Stabilizer A = 0,00186 g / kg food
Calculation
• 1,86 mg is far below SML of 6 mg / kg• Calculation means 100% migrates
• Assumed, no barrier in place
Results
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Calculation Example 2 – Cereals
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• Packaging: Carton & Inliner
• Food: 375 g (dry)
• Adhesive: Hotmelt; 1 g / boxPackage
• Identity: PM-Ref: 93120
• SML(T) = 5 mg / kg
Stabilizer B
• 1 kg Cereals = 2,66 boxes
• Adhesive = 2,66 g / kg food
• Stabilizer B = 0,00266 g / kg food Calculation
• 2,6 mg is far below SML of 5 mg / kg• Calculation means 100% migrates
• Assumed, no barrier in placeResults
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Key Learnings
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RM• Evaluation of Raw Materials Used
Barrier• Barrier Properties of Packaging Material
Adhesive• Evaluation of Adhesive by Manufacturer & Downstream User
Test• Migration Test if Required