The issue of food safety requires collaboration throughout the supply chain. H.B. Fuller is proud to be an active player in the development and application of the Guidance of Food Contact Status Declaration for Adhesives. Alexandra Ross, product regulatory specialist, and Elizabeth Staab, marketing manager, packaging solutions, have examined the role of current legislation, providing insight about how the guidance from the Association of European Adhesives and Sealants Industry (FEICA) helps both the adhesive manufacturer and user. They have also reviewed the step-by-step raw material and adhesive evaluation process, which ensures adhesives used for food packaging are safe. Over 70 delegates used the webinar to benefit from the knowledge of our experts who help customers make the right decision and ensure food safety compliance. Learn more about our packaging solutions @ www.hbfuller.com/packaging-solutions.

1. Ensuring Food Safety
How to assess
adhesives used in
food contact packaging?
May 6, 2014
Alexandra Ross
Elizabeth Staab

2. ©2014 H.B. Fuller Company
Welcome
2
Alexandra Ross
Product Regulatory Specialist
Elizabeth Staab
Marketing Manager
Packaging Solutions

3. ©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

4. ©2014 H.B. Fuller Company
Megatrends
4
Demographic
changes
Lifestyle Sustainability

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Industry Megatrends
5
Demographic
Changes

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Industry Megatrends
6
Lifestyle

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Industry Megatrends
7
Sustainability

8. Monitoring the Risk from
Packaging Adhesives
8

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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

10. ©2014 H.B. Fuller Company
Food Contact Regulation & Control
10
Migratio
n
Monitoring
&
Control
Kind and
amount of
substances
Packaging
Construction
Barrier of
the
packaging
Surface /
Volume
Ratio
Contact time
and
Temperature
Type of
food

11. ©2014 H.B. Fuller Company
What is the Risk of Adhesives?
11
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

12. ©2014 H.B. Fuller Company
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)

13. ©2014 H.B. Fuller Company
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
14
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

15. Compliance Status
15
Information
in the
Supply Chain
a. Regulation (EU) No 1935/2004
Traceability & 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..)
©2014 H.B. Fuller Company

16. Rejection List FEICA
16
Examples
of Rejected
Substances
Substances classified as CMR
Regulation (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 Derivatives
Regulation (EC) No 1895/2005
Substances that deplete the ozone layer
Regulation (EC) No 1005/2009
Dimethylfumarate
Regulation (EU) No 412/2012
PBB & PBDE
Directive 2011/65/EU (ROHS)
©2014 H.B. Fuller Company

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Raw Material Evaluation
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Source: FEICA Food Contact Guidance
&

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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

19. ©2014 H.B. Fuller Company
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

20. Adhesive Assessment
for Final Food
Contact Application
20

21. ©2014 H.B. Fuller Company
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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Evaluation of Packaging
22
Source: FEICA Food Contact Guidance

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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)

24. ©2014 H.B. Fuller Company
Barrier and Migration Risks
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BARRIER+
-
EVOH – Laminates
PET
PVDC / PVC
PA
PE
Corrugated Board
Carton
Paper
Barrier Properties of Packaging Materials
Could represent an absolute barrierGLASS, METAL, ALUFILM

25. ©2014 H.B. Fuller Company
Evaluation of Migration Potential - Test
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Source: FEICA Food Contact Guidance

26. ©2014 H.B. Fuller Company
Typical Adhesive Applications
26
Application Adhesive Barrier Migration Risk
Corrugated
Hotmelt
Water-based - Low, secondary
packaging
Carton
Folding Box
Hotmelt
Water-based - Low
Flexible packaging
Laminated films
Isocyanate-based +/- Medium
Bottle-Labeling
Water-based
Hotmelt + Very low

27. ©2014 H.B. Fuller Company
32 cm
22 cm
Calculation Example 1 – Snack Food
27
• Structure of laminate: OPP printed / met. OPP
• Food: 150 g (dry)
• Adhesive: Reactive, solventless; 0,28 g per bag
Package
• Identity: PM-Ref: 68320
• SML= 6 mg/kg
Stabilizer
A
• 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

28. ©2014 H.B. Fuller Company
Calculation Example 2 – Cereals
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• Packaging: Carton & Inliner
• Food: 375 g (dry)
• Adhesive: Hotmelt; 1 g / box
Package
• 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 place
Results

29. ©2014 H.B. Fuller Company
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

30. This presentation is for informational purposes only and does not constitute an offer by H.B. Fuller to sell or a warranty of any kind.
Thank you
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