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

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

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

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

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

! 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

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

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

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

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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

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

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

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

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

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

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

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

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

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

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

. 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

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

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

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

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

UV Curing: Photo-polymerization - Terminaison P P

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

+ 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 +

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

LM vs Non LM systems : The fisherman story

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

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

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 817.023.21² Regulation (EC) N° 1935/2004¹ Good Manufacturing Practices Nestlé New Standard Abstract 21st. Feb.2014 French Law 2012-1442 of 24th Dec. 2012 Plastics Regulation (EU) N° 10/2011 BPA free BPA free

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

Sicura Nutriflex 10 – Printing better, faster & safer

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

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

Thank you! Hvala! Contact person: Marc Larvor Head of Technical Marketing Business Unit Sheetfed/Narrow Web Mobile: +33 (0)607325351 Mail: marc.larvor@siegwerk.com

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