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Flexo Sustainable : Year End 2011
line with good manufacturing practice in the production of suitable printed food packaging. As a result, the packaging industry has a first class reputation for the production of high quality and safe food packaging. ASSUMPTIONS IN AMERICA In the United States, the Food and Drug Administration (FDA) has regulations regarding various components of food packaging, however, the key difference between North America and Europe is that the industry is self-regulating within the Code of Federal Regulations (CFR) guidelines. It is up to the converter to assure that the finished package is within the FDA guidelines for the intended use. FDA guidelines categorize inks and coatings as direct con- tact (expected to be in contact with the food product), indirect contact (expected to come into contact with the food product in normal use) and incidental contact (NOT expected to come into contact with the food product in normal use). Most printed packaging is used under the "incidental contact" definition and/or where there is a barrier. For much of the industry, the assumption is made that the substrate is a barrier, and this has been assumed to be correct due to the lack of issues that have arisen over the years. The reality is that very few people check to make sure that this is true. Even with a substrate that is an effective barrier, there can still be transfer of materials to the reverse side dur- ing manufacturing where web printed products are rewound or sheet products are stacked. At this time, the options appear to be coalescing into some rough guidelines in Europe that are compatible with U.S. FDA guidelines. The general approach holds that, if the pack- age and packaging materials migrate to the product with a contamination of less than 10 parts per billion (ppb), the level is "acceptable" as long as it is not toxic. Certainly, if the material noticeably alters the food, it is not fit for use even at these low levels. To achieve this level, it is necessary to utilize materials that are low migration. There is a level from 10 ppb to 50 ppb, where the concern about the migratory item is acceptable if proper toxicology data exists to support that conclusion. Again, the material must be fit for use and not alter the food product. Over the 50 ppb migratory level, a full toxicological evalu- ation would have to exist or be performed to validate use as appropriate. In the U.S., this would require petitioning the FDA relative to the particular use by filing a food additive petition or through a Food Contact Notification (FCN). Again, this applies to any ink, coating or adhesive used in packaging and is not specific to any chemistry type or printing process. The easiest way to look at this is as a decision tree during the package design. The first question would be, "Is this for a food or a non-food application?" If it is a non-food or non- sensitive application, any ink/coating/ adhesive that meets the performance requirements should be acceptable. If it is for food or a sensitive application, the question would be, "Is this a primary or outer wrap?" Primary packaging typically requires low-migration prod- ucts to ensure there will not be an issue. If it is outer wrap and there is an effective barrier (for the chemistry in question), then standard materials can be used. If there is not a barrier, then low-migration inks are recommended to provide the lowest possible risk. Inks that are not low-migration can be used, but it is highly recommended that proper testing be implemented to ensure that the use does not compromise the package. About the Author: Anthony Bean is a manager of energy curing ink at Sun Chemical and can be reached at 973-727-1258 or Tony.Bean@sunchemical.com. For many years, Sun Chemical has worked on understanding the factors affecting migration and has developed a complete portfolio of low migration inks and coatings to support the packaging chain across a range of print processes and technologies, including the SunCure®, SunBeam®, SolarFlexTM and SunPakTM product lines. The company 's "Low Migration Best Practice Guide," updated in May 2011, reflects the current packaging market situation as it stands today including the impact of the new Swiss Ordinance legislation and reach. For a copy of the guide, please contact firstname.lastname@example.org. Different levels of packaging, depicted in this corn flakes box, serve as barriers against migration. 12 Sustainable FLEXO YEAR-END 2011 www.flexomag.com