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FLEXO Magazine : November 2011
brand owners outside of Switzerland expect inks and coat- ings to comply with these requirements. At the start of 2011 the German Authorities also declared their intention to implement their own National Ordinance on inks for food packaging. Both sets of legislation are fully anticipated to form the basis of European-wide legislation in coming years. ROLE & RESPONSIBILITIES According to the UK Food Standards Agency, “The pack- aging designer, manufacturer and the food manufacturer that distributes the product are responsible for ensuring the requirements of the regulations are met AND for ensuring appropriate selection of materials for the intended end use of the packaging. ” The reason for this delineation is that the ink manufacturer does not control the selection of inks and coatings for each print specification nor the press production and environmen- tal conditions. Simply printing with low migration inks and coatings does not ensure compliant packaging; appropriate good manu- facturing printing protocols also have to be adhered to. It is strongly advised that the industry adhere to all published guidelines and regulations covering food packaging and to use only appropriately selected inks and other consumables. CHOICES & NECESSITIES Printing compliant food packaging is often seen as a minefield of complex legislative decisions, however the brand owner, print specifier and print converter have some simple choices to make. A risk assessment should always be completed at the initial stage of the packaging concept design, starting with the package designer and the brand owner. If a migration risk is an- ticipated, then the package either needs to be tested to prove its migration perfor- mance and appropriate steps taken to reduce the risk, or low migration inks and coatings should be used to avoid any worries. • If the testing route is chosen, and it is proven that appropri- ate barrier perfor- mance is provided by the substrate, then the designer has a choice of using standard inks and coatings or “intermediate” migration solutions. • If unacceptable migration is present, then it becomes nec- essary to either design in a functional or absolute barrier to migration or use low migration inks and coatings. The economics of the choices a printer needs to make with regard to migration, however, pose another challenge com- pletely. Weighing up which route is the most cost effective can be complex, but the bottom line is that the whole of the pack- aging supply chain, from brand owner to packer filler, needs to work together to ensure safe packaging for the consumer. By and large, printing and converting companies are expert in selecting appropriate procedures and practices in 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 An example of food packaging that would typically need the use of low-migration inks. 34 FLEXO november 2011 www.flexography.org FLX_November11.indd 34 11/8/11 3:53 PM