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FLEXO Magazine : April 2013
<10ppb 10–50ppb >50 ppb No Effect Level Required for toxicologically unevaluated substances or substances where not enough data exists to judge toxicity. Evaluate test result Acceptable for substances for which three mutagenicity tests exist and are all negative (i.e . absence of genotoxicity). Full evaluation needed At this level of migration, the full toxicological profile must be evaluated. The migrant may be an approved food additive or otherwise non-toxic. This decision must be made by a competent regulatory and scientific person(s). To meet your target compliance requirements, migration studies should be performed by an accredited inde- pendent laboratory. Depending on risk assessment, ongoing migration testing should be performed to ensure compli- ance over time. MIGRATION & COMPLIANCE Ultimate determination of compliance with migration regulations can only be assured with the testing of the complete package, as it will go to market. Here are some guidelines for consideration. MINIMIZING RISK When inks and coatings are separat- ed from the packaged food, by one or more layers of material, the suitability of those inks and coatings is determined by the barrier properties and the extrac- tion properties of the packaged food. Given that there is a wide array of combinations of food types, packaging materials, and inks and coatings, there is a lack of clarity on the permeability of various combinations of plastic contain- ers and film substrates. To be sure a packaging material acts as a functional barrier, migration tests with the final packaging construction are recommend- ed. Containers such as pre-formed metal cans and glass bottles are considered low to no risk for migration. Low migration inks are recommended when it comes to UV/EB and conventional sheetfed printing, especially if thin film substrates or paper material with weak barrier properties are used as the pri- mary packaging material. Low migration inks should be tested under standard- ized conditions to prove that they do not migrate above defined acceptable limits. Because these tests cannot simulate all possible food/substrate combinations, there cannot be 100 percent safety assur- ance without a suitable risk assessment. www.flexography.org april 2013 FLEXO 23 Committed to increasing your productivity and profitability Contacts Xymid, LLC • 5141 Craig Rath Blvd. • Midlothian, VA 23112 fax 804-744 -5331 • flexoprintsleeves.com UltraFlex Thin Sleeves DuraRound Thick Sleeves AccuMount Bridge Mandrels ProTek Anilox Covers Crystal Bray Customer Ser vice Rep. ph. 804-744-5229 firstname.lastname@example.org Jeff Moore Regional Sales Manager ph. 704-948-4648 email@example.com