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FLEXO Magazine : June 2008
PLANTS & PROCESSES Don't Be Mis-Lead Understanding Ink/Lead Compliance By Greg Cansler R ecent media reports have alerted u.s. consumers that toys, jewelry and various other goods imported from overseas are toxic with high lead concentrations. This has caused American consumers to question which products are safe for their families. Many industries are now fearful of getting caught in the dragnet that their products are toxic with lead. Not immune are companies in the flexographic printing industry. To ensure product safety, flexographic printers are questioning more than ever whether lead is in their products and, if so, what are the implications? To date, there are no u.s. regulations that require inks or print- ed material to be 100-percent lead free. u.s. government agencies realized decades ago that the total avoidance of lead in many instances is impossible, and that certain concentrations should be tolerated. THE LEAD BAN Beginning in the 1970s, various government agencies passed legislation to regulate and reduce the use of lead in consumer products because of its extreme toxicity to humans and the en- vironment. Those laws and others that have followed affect how products are regulated in the flexographic printing industry. Under 16 CPR 1303, the u.s. Consumer Product Safety Commission, in an effort to prevent child poisoning, banned any paint or similar surface-coating materials for consumer use that contain lead or lead compounds in which the lead content (cal- culated as lead metal) is in excess of 0.06 percent of the weight (600ppm) of the total nonvolatile content of the paint or the weight of the dried paint film. Printing inks and pigments that become bonded to the surface of a product are not considered paint or similar surface coating materials. The Toxics in Packaging Clearinghouse (TPCH) was formed in 1992 to promote the Model Toxics in Packaging Legislation. This model legislation was originally drafted by the Source Reduction Council of CONEG (Coalition of Northeastern Governors) in 1989. It was developed in an effort to reduce the amount of lead, hexavalent chromium, mercury and cadmium entering the waste stream as components of packaging and packaging sold or distributed throughout the u.s. According to the legislation, companies are not permitted to sell or distribute any package or packaging component to which any of the four metals has been intentionally introduced. Packaging components may include coat- ings, inks and labels. The law further requires that the incidental presence of the combined metals be gradually reduced to 100ppm. - Incidental presence is defined as the presence of one of the four regulated metals as an unintended or undesired component of the final package. The FDA includes lead on its list of poisonous and deleterious substances. FDA has reviewed several direct human food ingre- dients (Le., food dyes) and has determined them to be "generally recognized as safe" when used in accordance with current good manufacturing practices. Some of these ingredients contain lead concentrations that range from 0.1 to 10ppm. It is important to recognize that these regulations apply to a broad range of industries. There are no regulations concern- ing lead that are specific to anyone type of printing application, substrate, or process. It is also important to understand that these regulations address lead at tolerance levels and not as allowable safe concentrations. ACCEPTABLE LEVELS Even though printed products are not required to be 100-per- cent lead free, it should be the intention of the printing industry to minimize lead concentrations in its products. To do so, printers should evaluate their products. There are various methods to ap- proach this situation. One method that flexographic printers use in evaluating their products is to contact their suppliers to determine if the prod- ucts being used are lead compliant. For instance, printers have begun contacting ink suppliers to request lead-free ink certifica- tions. The rational is that if the inks are lead free, then so are the printed products. This is wishful thinking. It has been known for some time that chemicals, such as inks and coatings, may contain detectable concentrations of lead impurities. Inks and other chemicals may have low-lead concentrations, but to state that they are lead free is misleading. The term lead free is inappropriately used to describe inks with lead concentra- tions that are below detection limits Le. non-detect. In my eight years of being involved with regulatory compliance, no laboratory analysis report has ever said "lead free" or "zero lead" when con- JUNE 2008 www.flexography.org FLEXO