FAQ

1. What is migration? FAQ

2. What is migration? Migration = Transfer of substances from the packaging to the packed food product. The concentration of migrants is stated in mg/6dm2 of packaging or mg/kg (ppb) of foodstuff packed.These traces may not always be detected in organoleptic testing (odour and taste tests) or when consumed but may be found by sensitive chemical analysis. Potential migrants are e.g.: • Plasticizers from plastics or inks • Monomers from plastics or coatings • Solvents, washes & cleaning chemicals, oils and greases • Low molecular weight components from substrates or adhesives etc. • Low molecular ink additives (e.g. photoinitiators) • Hydrocarbon distillates or mineral oils from conventional inks

3. Main methods of migration Set-off migration • Through migration = Migration from the printed side through the substrate onto the unprinted side. • Set-off migration = Migration from the printed side to the unprinted side of another sheet in a stack or roll Ink Substrate Food contact surface Through migration Food

4. Migration - FAQ • What is migration? It is the transfer of substances from the packaging to the packed food product. These traces may not always be detected in organoleptic testing (odour and taste tests) or when consumed but may be found by sensitive chemical analysis. • How does migration occur? Migration can occur by three different mechanisms: - Penetration through the substrate - “Set off” transfer onto the reverse side in the stack - Vapour phase transfer (only in case of metal decoration)

5. Migration – FAQ • How do you measure migration and in what units? • Migration is measured by accredited laboratories using sophisticated measuring cells and highly sensitive chromatography or mass spectroscopy equipment. • Measuring migration from printed packaging is a much more complex task than assessing impact on odour or taint. • Migration is measured by determining the identify of, and amount of, materials that transfer from the packaging material sample ideally into a control sample of the actual food itself. • In practice, analysis of food samples is difficult and so food simulants are used to mimic the nature of the food itself. Different models are possible (area of print, weight of food simulant, contact time and temperature) and the results are often quoted in parts per billion (ppb); actually micro grams per kg of food. The migration models for different food stuffs are set out in EC regulation and are normally quoted from migration tests using the following model: 600 cm2 of print, 1kg of food, 10 days at 40°C. Note: these are subject to periodic review and updating.

6. Migration – FAQ • North American legislation • FDA regulates the materials which can be used in items (packaging) which will come into contact with food. • The base assumption is that any materials used in food contact applications will become part of the food unless documented testing proves otherwise. • The FDA provides a list of approved materials in title 21 CFR (Code of Food regulations). • Inks and coatings that do not have direct food contact are not regulated, as long as there is a “functional barrier” between food contact side and the ink or coating, and the inks and coatings do not migrate to the food contact side during various steps in the process. • It is the responsibility of the packaging manufacturer to determine if the construction meets the definition of a functional barrier.

7. Migration – FAQ • What level of migration is acceptable? The determination of an “acceptable” maximum level of migration is based on the toxicological profile of the migrant material and in some cases the availability and expert assessment of the toxicological data. In all cases of migration the migrates must be identified in order to carry out a risk assessment. The below data are used in Europe and agreed among leading end users and food safety organisations. Note: migration testing can take some weeks to complete due to sample preparation times before and after the period in the migration cell

8. Migration – FAQ • Is migration time dependant? Yes, migration is a time dependant phenomenon, basically the longer potentially “migratable” components are in the proximity of the packaged goods the greater the risk of migration although there will ultimately be a dynamic equilibrium established between the migrant level in the food and in the packaging. • What migrates? The following is a non-exhaustive list of typical potential migrates: • Plasticizers from plastics or inks • Monomers from plastics or coatings • Solvents, washes & cleaning chemicals, oils and greases • Low molecular weight components from substrates or adhesives etc. • Low molecular ink additives (e.g. photo initiators) • Hydrocarbon distillates or mineral oils from conventional inks • Why measure migration? To be sure that packaging complies with regulations. Measurements undertaken by an accredited laboratory of fully commercial and representative production packaging may be required. Depending on the result of a risk assessment from package design to the filling line, migration testing at an appropriate frequency may form part of the necessary production protocol and specification. A first stop may be the establishment of a relationship (mutual understanding of requirements) with a local or regional competent, accredited laboratory.

9. Migration – FAQ • What are “low migration” products? Low migration products for use in low migration printing are consumables specifically formulated and tested for this application. Essentially they are made from materials that under normal or foreseeable conditions of use do not migrate – when correctly applied in the intended application – at a level which would prevent migratables from the finished package being above the currently accepted limits. • Does Flint Group offer Low Migration(LM) Inks for all applications? Flint Group Narrow Web offers Low Migration inks in UV Flexo – Flexocure ANCORA We can offer Low migration technology for many other print applications ( sheetfed offset, flexo & gravure SB) • Can Flint Group ensure that once printed with Flint Group inks there won’t be any migration? No. The responsibility for the compliance of the packaging does not lie with one individual member of the packaging chain. A co-operation between all partners along the packaging chain is important to reduce the overall risk of migration and Flint Group plays an active role to assist in this matter.

10. Summary • The responsibility for the compliance of the packaging does not lie with only one individual member of the packaging chain. • There shall be no unacceptable change in the quality, odour or taste of the foodstuff • There shall be no use or migration of carcinogenic, mutagenic or reprotoxic substances (CMR substances) • The migration of substances evaluated for food contact shall remain below defined limits (according to SML or < 10ppb) • There shall be no adulteration of the foodstuff. • Packaging Inks for food packaging are not covered by any specific legislation. • Ultimate responsibility is with “person placing pack on market” – but we all have to work together.