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Printing Safe Food Packaging. We assume responsibility for safe products. 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.
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Printing Safe Food Packaging We assume responsibility for safe products
Agenda • The 4 elements for safefood packaging • Migration : Examples - Mechanisms • Regulations • Riskassessment - Migration testing • UV Low Migration systems • Siegwerk solutions : SICURA NUTRI systems
Agenda • The 4 elements for safefood packaging • Migration : Examples - Mechanisms • Regulations • Riskassessment - Migration testing • UV Low Migration systems • Siegwerk solutions : SICURA NUTRI systems 3
Your and our continuous challenge is to produce safe and compliant products Example Press Articles High risk regarding food contamination & compliance 4
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
Safe products – Siegwerk ensures low migration for whatever applications Influencing parameters Migration Mechanisms • Packaging structure • Printing & Converting process • Ink/ varnishes composition Associated risks to be evaluated in each case • Volume/surface ratio • Packaged good • Storage conditions • Set-off • Diffusion Substrate Packaging structure Ink Ink Migration via diffusioninto packaged good Set-off migration Benefits • 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 • ! 6
Concrete examples: Food packaging In-Mould Labels & Self-adhesive Labels on Cups Shrink Sleeves PP, PE or PS & Shrink Sleeves PET 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 Low migration inks and varnishes Low migration inks and varnishes 7
Systematic processes – Our material introduction process excludes unwanted substances Raw Material Introduction Process New raw material Labtests Global HSEapproval Businessapproval Sample request • 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
Product safety guidance – We share all information on critical ingredients Siegwerk Information on Relevant Migrants • Detailed information onpotential migrants • Available for all Siegwerkproducts • Statement of composition (SoC) 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
Agenda • The 4 elements for safefood packaging • Migration : Examples - Mechanisms • Regulations • Riskassessment - Migration testing • UV Low Migration systems • Siegwerk solutions : SICURA NUTRI systems 11
The Migration Risk Labels – Sleeves 2009: What happened, when Benzophenone from Sleeves migrated... ... The HDPE bottle was not a barrier
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 migrationlimits – exampledilutionofsugar *as in various ww legislation • Specific migration limits for evaluated* substances: some ppmdown to ppb • Sugar cube (2.5 g) dissolved in • Threshold non-eva- luated substances/ no concern 10/50 ppb 2.5 literbottle 2.5 million ltank ship • 0.25 litercup 2,500 litertruck • 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
Agenda • The 4 elements for safefood packaging • Migration : Examples - Mechanisms • Regulations • Riskassessment - Migration testing • UV Low Migration systems • Siegwerk solutions : SICURA NUTRI systems 15
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) Evaluatedsubstances 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 evaluatedsubstances X = depends on NOAEL (No Observed Adverse Effect Level) 10 tox data not existing 17
Ensuring compliance – a complex challenge Complex value chain – responsibilities have to be shared Siegwerk proactively as-sumes responsibility by understanding the needs of each partner in the chain 1. Packaging specifications 6. Final validation Food industry 2. Packaging conception 5. Process validation • Converter Ink manu-facturer 4. Advice onhow to use ink 3. Ink develop-ment & supply Food Safety
Agenda • The 4 elements for safefood packaging • Migration : Examples - Mechanisms • Regulations • Riskassessment – Migration testing • UV Low Migration systems • Siegwerk solutions : SICURA NUTRI systems 19
Sleeves on PEHD bottle PES cups In Mould Labels • Risk assessment – Migration testing Exposure Simulation with a liquid simulant 1-side exposure in stainless steel cells Immersion Various packaging directly filled with simulant Direct injection of simulant LC/MS State-of-the-art quantification (specific identification, sensitivity) Official or ‘in-house’ methods
Agenda • The 4 elements for safefood packaging • Migration : Examples - Mechanisms • Regulations • Riskassessment – Migration testing • UV Low Migration systems • Siegwerk solutions : SICURA NUTRI systems 21
Principles of UV formulation MONOMERS Viscosity, adhesion flexibility, reactivity OLIGOMERS Pigment wetting, flexibility, adhesion, chemical& mechanicalresistance PHOTOINITIATORS Reactivity UV INK PIGMENTS Shade . ADDITIVES Slip, levelling, stability
P-P P-P P-P P-P P-P P-P • UV Curing: Photo-polymerization - Initiation Pigment Oligomer Monomer Photoinitiator
P.P. P.P. P.P. P.P. P.P. P.P. • UV Curing: Photo-polymerization - Propagation
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
P P P P P P P P P P P P • UV Curing: Photo-polymerization - Terminaison
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
UV Curing : a 3D Curing mechanism Non LM System Using a standard UV ink for food packaging, is like … …with a very lousy net …to try to catch very small fishes +
What is a Low Migration System? • MONOMERS • High puritygrade • High molecularweight • High functionnality • Calibratedmolecularweight distribution • OLIGOMERS • High puritygrade • Lowviscosity(to limit use of monomers) • PHOTOINITIATORS • High puritygrade • Lowintrinsequeodor • High molecularweight • Low migration ability • High reactivity SICURA LM PIGMENTS High purity. ADDITIVES Purity • SUPPORT • Food packaging printing guidelines • Product Safety & Analytical support
LM vs Non LM systems : The fisherman story Non LM System + LM System +
Agenda • The 4 elements for safefood packaging • Migration : Examples - Mechanisms • Regulations • Riskassessment – Migration testing • UV Low Migration systems • Siegwerk solutions : SICURA NUTRI systems
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
Sicura Nutriflex 10 – Technology that convinces • State of the art composition: 2 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 Benchmark vs competition SicuraNutriflex 10 is one of the lowest migration system in itscategory Migration Molecular Weight MolecularWeight Migration
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 Global HSE approval Businessapproval Lab tests New raw material Sample request • 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
SICURA Nutriflex 10 • TAKE AWAY ► 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 Litho Nutriboard Paper & Board SICURA Litho Nutriplast PlasticsPlastics SICURA Nutriflex 10 SICURA Nutriflex 20 SICURA Flex LM OPV UV varnishes • UV Low migration systems – The SICURA product portfolio ► process & bases ► process & bases ► process & bases ► process & bases ►gloss, matt, dry offset