Migration from food packaging inks Issues & some solutions

Legislation – Plastics• Plastics Directive 2002/72/EC• only applies to materials made exclusively ofplastics• lists do not include substances only used in themanufacture of packaging inks• Regenerated Cellulose Film Directive 2007/42/EC• Printed surfaces must not contact the foodstuffs• No specific legislation for packaging inks4

Legislation – What about GMP ?• 2023/2006/EC elaborates GMP requirements for1935/2004 (Food Contact Materials)• Responsibility to observe GMP in the supply chain• Separate Annex mentions printing inks:•“Processes involving the application of printing inksto the non-food contact side of a material or article”• Legal opinion – concerns the applicationprocesses, i.e. formulated (= press side mixing/adhesive interactions), applied (= printing), handledand stored to avoid set-off and through migration• Not a specific obligation on ink manufacturers5

Legislation – Relevance of 1935/2004/EC ?• “On materials and articles intended to comeinto contact with food”• No mention of inks in 89/109/EEC• Printing inks first mentioned in 1935/2004/ECin Annex I• Legal opinion considers this refers only tothose inks intended for food contact‣ i.e. for printing on the food contact surface• Does not apply to packaging inks per se but doesapply to the ‘finished’ packaging once printed6

Terminology• Printing inks are supplied in a wet state• Inks have to be printed onto a substrate• Inks have to be dried• Easily transferred‣ Touch it and you get covered in ink• Not accurate to talk about migration from ink• Should strictly refer to migration from print orbetter still - printed articles7

Process - 1InkSubstrateFountPrinting pressDryingPrinted substrateCleanersStorage8

Process - 2Printed substratePackaging manufactureFoodPackaged foodFurther processingCooking in packagingStorageConsumption9

Variables influencing migration from printThe ink manufacturer cannot ensure complianceof the packaging• Too many variables outside our control:• substrate selection• barrier properties• surface treatment• print design• ink coverage• film weight• press type & speed• drying conditions• ambient temperature• packaging design• lamination adhesiveand conditions• effects of other layers• nature of packagedfoodstuff• storage conditions(time, temperature)• humidity etc, etc11

Substrate effects on migration from printPE PET PE OPP PE PE OPP OPP PET PET Al foilOPPDEHADBPDCHPDPOPNETSA12

Variables – Unexpected contaminationPotential sources of contamination• Press washes and cleaning agents• Fountain solution• Substrate - especially if recycled content• Leaching from press rollers & ink train• Storage pallets• Adjacent storage• Vehicle and Fork Lift Truck emissions• Atmospheric contaminants13

Ink manufacturers response• General duty of care and product stewardship• Responsibility in the Supply Chain from GMP• Withdrawal of supply for certain applications• Active R&D programmes ongoing many years• Availability of next generation Low Migrationproducts (e.g. Irocart LMQ, Suncure ULM, etc)• Cost issues – marketplace reluctance• Best practice guidance14

Low Migration Printing – Best PracticeBest Practices for theproduction of packaging forfood and sensitive products• Brochure available• Details all parts of theprocess that affect packagingproduction• Check lists and guidance• References to additionalinformation15

Low migration ink strategies• Higher purity raw materials• Increase molecular weight• Polymeric additives• Reactive / curable additives• Increase functionality / crosslink density• Select likely migrants with– high limits or minimal restrictions– known toxicity and good toxicological data sets16

Effect of Molecular WeightExtractablesMWt17

Joint Industry Task Force – PIJITF activities• Set up following ITX issue• Concern about possibility of a repeat• 4 WGs set up for different packaging types• Assessment of packaging, substrates, volumes,food types, consumption, etc to prioritise• Identification of worst case / highest potential• Commercial packaging samples from stores• Extensive analytical studies18

PIJITF activities – Flexible packaging WG• 100 samples of commercial food packaging• 65 different additives considered• Plasticisers all migrating below SML / limit• 2 highest migrating => revision of formulationguidelines & new maximum addition limit• All other additives migrating below 0.01 mg/kg• No exceedances of appropriate migration limitsNB considered to be highest risk samples19

PIJITF activities – Paper & Board WG• Similar approach to Flexibles• Very poor response from sample providers– Mainly secondary packaging• Significant migration from standard (not lowmigration) products– Distillates, fatty acid esters– Photoinitiators, acrylate monomers• Excessive mineral oil from recycled board20

Ongoing issues• Petroleum distillate / hydrocarbons• Use of recycled board• Packaging minimisation• Design process – who is designing for safety ?• High temperature applications• Lack of migration testing & capabilities• Emerging tox data (not all will be favourable)• Cost issues• Is packaging safety a priority ?21

Summary• Legislation lacking or unclear for packaging inks• Ink makers want to do the right thing• Migration depends upon many variables• Low migration products are available‣ But poor uptake• Still a number of issues & concerns22

Conclusions• Need greater responsibility by all players in thesupply chain• Better design process to include safety• Make food packaging safety a priority• Better enforcement ?• More food packaging scares ?23