44 | l&l Migration danger? As more label converters move into flexible packaging, who is responsible for checking that migrationcompliant inks are being specified? Steve Fisher, managing director, Mirage Inks, argues that the food industry needs to get more closely involved Labels&Labeling
With all the (justifiable) attention paid by retailers to ‘green’ packaging issues, why do we not see a similar degree of enthusiasm when selecting a migration-compliant ink system for food packaging? Harmful chemicals or other raw materials used within ink formulations intended for food packaging may, under certain circumstances, pass through substrates – including PET bottles – directly into the food or beverage. The same can be said of print in a reel where the printed side remains in contact with the food side (back transfer). How many companies are aware of this, or care whether they are compliant with EU migration regulations? This situation has not been helped by exaggerated claims from within my industry, which have added to a general confusion surrounding what you are and are not permitted to use. I recently read an article espousing the benefits of a particular ink system. Only six of the 2,500 words made reference to ‘odor and migration being challenges’. For European users, it would have been of greater value had it confirmed that the ink system was – or was not – compliant with EU legislation. In Italy in 2004 European Food Safety Authority (EFSA) officials discovered unacceptable levels of itx (isopropylthioxanthone) in powdered infant milk that had been contaminated by UV ink on the package. The product was withdrawn shortly afterwards at a huge financial cost. But five years later the migration status of itx remains unclear, despite the availability of known toxicological data. The European Printing Ink Association (EUPIA) states that levels up to 50ppb are acceptable, while a Council of Europe policy statement lists itx as a non-evaluated substance with a migration limit of 10ppb when used on the non-food contact surface. Some food organizations have stated that they will not accept the presence of any itx in their products while allowing other components to be used where there is no toxicological data available. Confused? The EU has very clear guidelines on migration, but it looks like Switzerland, a non-EU country, will be the first to enact the EU’s guidelines into legislation. In the absence of harmonized European legislation, the Swiss regulations could well become a European, if not worldwide reference, and it can be anticipated that major brand-owners will request compliance with Swiss law. It should no longer be sufficient to claim an ink system has ‘low migration’, which could be way above the 10ppb figure stated in EU legislation. Far better, in my view, to specify migration levels ‘below 10ppb’, or ‘between 10ppb and 50ppb’ where toxicological data is available and therefore compliant with EU legislation. It could also be considered deliberately misleading to claim migration levels below 10ppb when aluminum foil is used as the reference substrate, since we all know it is an exceptional natural barrier in its own right. Our own industry representatives must accept a lot of the blame for tolerating or actively promoting ink systems for use within the EU without reference to EU compliance. Why isn’t the food industry, including retailers, more vociferous and demanding on the subject of migration? After all, it is reasonable to expect them to be concerned at the prospect of their product being tainted or contaminated. What steps and initiatives are they taking with suppliers to identify and eradicate the problem? I am cynically inclined to think that use of non-compliant products is seen as a risk worth taking given the very long odds against our own Food Standards Agency paying a flying visit to test packaging on supermarket shelves and insisting on a product recall. Especially as the packaging, in most cases, is very price sensitive. Towards a global standard? How many of us are aware of the differences between US and European legislation concerning inks deemed suitable for food packaging? The FDA’s system of Food Contact Notification (FCN) for a Food Contact Substance (FCS) is based on exposure and the cumulative estimated daily intake of a particular substance. In general, for a cumulative exposure of > 0.5 ppb but < 50 ppb to be acceptable, two mutagenicity tests are required to establish its safety under the FCN program. This differs significantly from the EU, where a migration level of up to 50ppb requires three mutagenicity tests. The REACH approach, by contrast, is more hazard-based, and in many ways not as rigorous as the procedures applied to food and pharmaceutical products. For the future, I would like to see the food industry playing a more pivotal and responsible role in the establishment of common global migration standards. I do not profess to know how widespread migration issues are, but I would guess it is more significant than is commonly thought. For forty or so raw materials we have used during the last two years formulating our range of free radical UV inks, there is no toxicological data available. Many raw material suppliers have stated this is because the components are not intended for food packaging. A 2004 study by the School of Health and Life Sciences, King’s College London investigated the transfer of substances from secondary packaging into food, and highlighted the presence of several different types of free radical photo-initiator in the packaging with the potential to migrate at a rate exceeding Tolerable Daily Intake values into both the packaging and the food products themselves. Clearly there is a need for regulation. It remains to be seen whether my industry has the commitment to support regulation for fear of offending organizations with an interest in suppressing migration issues to protect their markets.
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