1. Printing Safe Food Packaging
Zagreb, May 2016
We assume responsibility for safe products

2. The 4 elements for safe food packaging
Agenda
The 4 elements for safe food packaging
Migration : Examples - Mechanisms
Regulations
Risk assessment - Migration testing
UV Low Migration systems
Siegwerk solutions : SICURA NUTRI systems

3. The 4 elements for safe food packaging
Agenda
The 4 elements for safe food packaging
Migration : Examples - Mechanisms
Regulations
Risk assessment - Migration testing
UV Low Migration systems
Siegwerk solutions : SICURA NUTRI systems 3

4. Example Press Articles
Your and our continuous challenge is to produce safe and compliant products
Example Press Articles
High risk regarding food
contamination &
compliance 4

5. Four Elements to Safe Production
Siegwerk offers superior product safety with inks, processes, guidance & support
Four Elements to Safe Production
Safe products
Systematic processes
Product safety guidance
Proactive safety work 5

6. ! Migration Mechanisms Set-off Diffusion Benefits
Safe products – Siegwerk ensures low migration for whatever applications
Migration Mechanisms
Set-off
Diffusion
Substrate
Packaging structure
Ink
Ink
Migration via diffusion into packaged good
Set-off migration
SB, WB, UV or vegetable oil-based inks with best low migration standards
Information on all relevant migrants and support for risk evaluation
Safe inks reflecting the printing, conversion and end-use of whatever packaging
Benefits
Influencing parameters
Packaging structure
Printing & Converting process
Ink/ varnishes composition Associated risks to be evaluated in each case
Volume/surface ratio
Packaged good
Storage conditions ! 6

7. Shrink Sleeves PP, PE or PS & Shrink Sleeves PET
Concrete examples: Food packaging
Shrink Sleeves PP, PE or PS & Shrink Sleeves PET
In-Mould Labels & Self-adhesive Labels on Cups
PS&R recommendations
Depending on storage time and thickness of bottles there is a high risk of direct migration
Possible set-off due to storage in stack. Low but existing migration risk depending on cup thickness
A question often asked: For which job do i need a Low Migration system
Answer is simple: when there is a risk of migration :
-by set off?
-by diffusion
Low migration inks and varnishes
Low migration inks and varnishes 7

8. Raw Material Introduction Process
Systematic processes – Our material introduction process excludes unwanted substances
Raw Material Introduction Process
Sample request
Lab tests
Global HSE approval
Business approval
New raw material
Checklist for Approval
Exclusion criteria (e.g., carcinogenics, mutagenics, reprotoxics, toxics)
Defined purity standards and full understanding on existing impurities
Compliance with chemical registration
Full understanding of chemical composition for food packaging
Benefits
Compliant inks via highest standards in material testing and selection
Reduced claim risk since raw materials checked for impurities
Reliability based on profound analytical know-how also for critical compounds 10

9. Siegwerk Information on Relevant Migrants
Product safety guidance – We share all information on critical ingredients
Siegwerk Information on Relevant Migrants
Statement of composition (SoC)
Detailed information on potential migrants
Available for all Siegwerk products
Benefits
Full transparency on potential migrants to produce compliant food packaging
Excellent basis to perform worst-case calculations
Supporting information to prepare declaration of conformity 11

10. 12

11. The 4 elements for safe food packaging
Agenda
The 4 elements for safe food packaging
Migration : Examples - Mechanisms
Regulations
Risk assessment - Migration testing
UV Low Migration systems
Siegwerk solutions : SICURA NUTRI systems 11

12. What happened, when Benzophenone from Sleeves migrated...
The Migration Risk Labels – Sleeves
2009:
What happened, when Benzophenone from Sleeves migrated...
... The HDPE bottle was not a barrier

13. What happened, when ITX migrated....
The Migration Risk - Primary with barrer but with set-off risk
2006:
What happened, when ITX migrated.... PE
Ink
Board
Alu PE PE
Food
Ink
Board
Alu PE

14. Migration – thresholds for migrating substances are extremely low and often difficult to measure
Visual overview on migration limits – example dilution of sugar
*as in various ww legislation
Specific migration limits for evaluated* substances: some ppm down to ppb
Sugar cube (2.5 g) dissolved in
Threshold non-eva- luated substances/ no concern 10/50 ppb
0.25 liter cup
2.5 liter bottle
2,500 liter truck
2.5 million l tank ship
10 gram per kilogram (1%)
1 gram per kilogram (1‰)
1 milligram per kilogram (1ppm)
1 microgram per kilogram (1ppb)
Examples for values
Alcohol in drinks
Alcohol in blood
Nitrate in water
Heavy metal in water

15. The 4 elements for safe food packaging
Agenda
The 4 elements for safe food packaging
Migration : Examples - Mechanisms
Regulations
Risk assessment - Migration testing
UV Low Migration systems
Siegwerk solutions : SICURA NUTRI systems 15

16. Regional regulations: European food safety regulations overview
Ensuring compliance – a complex challenge
Regional regulations: European food safety regulations overview
Basic principles (Article 3):
No risky migration
No change in food composition
No deterioration of food
EU-Framework Regulation
(EU) No 1935/2004
GMP
(EU) No 2023/2006
Regenerated Cellulose Film
2007/42/EC
Ceramics
84/500/EEC
Plastic Materials
(EU) No 10/2011
Elastomers and Rubbers
Active and Intel-ligent Materials EC/450/2009
Positive lists
Migration limits:
a) SML-Value (Specific Migration Limit) in ppm (mg/kg) = based on 1 kg Foodstuff/simulant
b) Overall Migration limit of 10 mg/dm² resp. 60 mg/kg foodstuff/simulant
c) Calculation basis: 1 kg/6 dm² resp. “as is” Food:Surface ratio
Union Guidelines on Reg. (EU) No 10/2011 on plastic materials and articles intended to come into contact with food
Union Guidance on Reg. (EU) No 10/2011 … as regards information in the supply chain

17. What are the permissible migration thresholds?
… they depend on documentation of toxicological data, and of subsequent toxicological expertise by the European Food Safety Authority EFSA
Threshold
(ppb)
Evaluated substances
Specific
Migration
Limit (SML)
90 days
Feeding
Study
--> X ppb
Most UV standard PIs have to meet 10 ppb 50
in vitro
Genotoxicity
tests
Non evaluated substances
X = depends on NOAEL
(No Observed Adverse Effect Level) 10
tox data
not existing 17

18. Complex value chain – responsibilities have to be shared
Ensuring compliance – a complex challenge
Complex value chain – responsibilities have to be shared 6.
Final validation 1.
Packaging specifications
Food industry
Siegwerk
proactively as- sumes responsibility by understanding
the needs of
each partner in
the chain
Converter 5.
Process validation 2.
Packaging conception
Ink manu-facturer 4.
Advice on how to
use ink 3.
Ink develop- ment & supply
Food Safety

19. The 4 elements for safe food packaging
Agenda
The 4 elements for safe food packaging
Migration : Examples - Mechanisms
Regulations
Risk assessment – Migration testing
UV Low Migration systems
Siegwerk solutions : SICURA NUTRI systems 19

20. Direct injection of simulant
Risk assessment – Migration testing
Exposure Simulation with a liquid simulant
Immersion
1-side exposure in stainless steel cells
Various packaging directly filled with simulant
In Mould Labels
Sleeves on
PEHD bottle
PES cups
Direct injection of simulant
LC/MS State-of-the-art quantification
(specific identification, sensitivity)
Official or ‘in-house’ methods

21. The 4 elements for safe food packaging
Agenda
The 4 elements for safe food packaging
Migration : Examples - Mechanisms
Regulations
Risk assessment – Migration testing
UV Low Migration systems
Siegwerk solutions : SICURA NUTRI systems 21

22. . Principles of UV formulation MONOMERS OLIGOMERS PHOTOINITIATORS
Viscosity, adhesion
flexibility, reactivity
OLIGOMERS
Pigment wetting, flexibility, adhesion,
chemical & mechanical resistance
PHOTOINITIATORS
Reactivity
UV INK
PIGMENTS
Shade .
ADDITIVES
Slip, levelling, stability

23. P-P UV Curing: Photo-polymerization - Initiation Pigment Oligomer
Photoinitiator
Pigment
Monomer

24. UV Curing: Photo-polymerization - Propagation
P.P.

25. UV Curing: Photo-polymerization - Propagation
P P
P P
P P
P P
P P
P P

26. UV Curing: Photo-polymerization - Propagation
P P
P P
P P
P P
P P
P P

27. UV Curing: Photo-polymerization - Terminaison
P P

28. A 3D network that offers high resistances (mechanical & chemical)
UV Curing : a 3D Curing mechanism
P P
P P
P P
P P
P P
P P
P P
P P
P P
P P
A 3D network that offers high resistances (mechanical & chemical)
But with ‘’standard’’ UV systems, low molecular residual photoinitiators &
monomers are not trapped in the network: RISK OF MIGRATION

29. + Using a standard UV ink for food packaging, is like …
UV Curing : a 3D Curing mechanism
Using a standard UV ink for food packaging, is like …
…to try to catch very small fishes
…with a very lousy net
Non LM System +

30. What is a Low Migration System?
MONOMERS
High purity grade
High molecular weight
High functionnality
Calibrated molecular weight distribution
OLIGOMERS
High purity grade
Low viscosity (to limit use of monomers)
PHOTOINITIATORS
High purity grade
Low intrinseque odor
High molecular weight
Low migration ability
High reactivity
SICURA LM
ADDITIVES
Purity
PIGMENTS
High purity.
SUPPORT
Food packaging printing guidelines
Product Safety & Analytical support

31. LM vs Non LM systems : The fisherman story

32. LM vs Non LM systems : The fisherman story+
LM System +

33. The 4 elements for safe food packaging
Agenda
The 4 elements for safe food packaging
Migration : Examples - Mechanisms
Regulations
Risk assessment – Migration testing
UV Low Migration systems
Siegwerk solutions : SICURA NUTRI systems

34. Nestlé New Standard Abstract 21st. Feb.2014
Sicura Nutriflex 10 – Compliance that convinces
Regulatory Compliance 1
Regulatory Compliance
EuPIA
Guidelines
Regulation (EC)
N° 2023/2006
SWISS ordinance ²
Regulation (EC)
N° 1935/2004¹
Good Manufacturing
Practices
Nestlé New Standard Abstract 21st. Feb.2014
French Law of 24th Dec. 2012
Plastics Regulation
(EU)
N° 10/2011
BPA free
BPA free

35. is one of the lowest migration system in its category
Sicura Nutriflex 10 – Technology that convinces 2
State of the art composition:
The MxPy Matrix is a tool developed by Siegwerk technology team to characterise semi-quantitatively the formulation profile of UV inks or varnishes dedicated for food packaging application
Migration
Molecular Weight
Molecular
Weight
Benchmark vs competition
Sicura Nutriflex 10
is one of the lowest migration system in its category

36. Sicura Nutriflex 10 – Printing better, faster & safer

37. Sicura NUTRI systems : Developed and manufactured following a strict & dedicated process
Our raw material introduction process excludes unwanted substances
Strongly supported by a skilled and well equipped analytical lab
Manufactured in a Dedicated Production Site
New raw material
Sample
request
Lab tests
Global HSE approval
Business approval
A risk assessment of supplied raw materials is performed to determine potential non consistencies of raw materials with SIEGWERK‘s specifications
Organoleptic properties checked thanks to two sensory panels, on routine basis but also during the product development
Checking of cross-contamination risks during production through appropriate protocol of analysis
Checklist for Approval
Exclusion criteria (e.g., carcinogenics, mutagenics, reprotoxics, toxics)
Defined purity standards and full understanding on existing impurities
Compliance with chemical registration
Full understanding of chemical composition for food packaging
Manufactured in a our production facility of Aarberg (Switzerland) dedicated to UV inks & varnishes for packaging printing
Good Manufacturing Practices (GMP) in place*
ISO 9001:2008 and ISO 14001:2004 certified
Experienced Management and Staff
LCMS in QC lab to check purity of LM product
Each batch of UV LM product produced in Aarberg is tested in purity.
Migration testing: Recognized expertise of Annemasse GAN lab
Round robin test made among 19 different labs (ink manufacturer, industry,..) ; Siegwerk analytical lab in the top 3 for accuracy and repeatability

38. TAKE AWAY
SICURA Nutriflex 10
► process & bases
SICURA Nutriflex 10

39. Thank you! Hvala! Contact person: Marc Larvor
Head of Technical Marketing
Business Unit Sheetfed/Narrow Web
Mobile: +33 (0)
Mail:

40. SICURA Flex LM OPV UV varnishes
UV Low migration systems – The SICURA product portfolio
SICURA Litho Nutriboard Paper & Board
► process & bases
SICURA Litho Nutriplast Plastics Plastics
► process & bases
SICURA Nutriflex 10
► process & bases
SICURA Nutriflex 20
► process & bases
SICURA Flex LM OPV UV varnishes
►gloss, matt, dry offset