Canadian Printing Ink Manufacturers' Association

STATEMENT ON PRINTING INKS AND FOOD PACKAGING Members of the C.P.I.M.A. regularly receive inquiries about the suitability of a variety of ink types for food packaging applications. The purpose of this statement is to clarify many of the issues that arise, including those concerning regulatory bodies both in Canada and the United States. From the onset, it is essential to distinguish between package designs where the ink is intended to come into direct food contact and those where direct food contact between the printing ink film and the foodstuff is neither intended nor expected. An example of inks with no direct food contact is the printing on plastic tubs for yogurt and margarine. INKS FOR DIRECT FOOD CONTACT There are four agencies in North America that have regulations affecting the use of printing inks for food packaging applications. In Canada, both Health Canada (Health Protection Branch) and the Canadian Food Inspection Agency deal with food packaging issues. The Canadian Food Inspection Agency (CFIA) enforces packaging requirements with respect to federally regulated packaging facilities. Health Canada sets standards and evaluates food packaging with respect to the standard. Although it is not mandatory, the Health Protection Branch recommends that food packaging companies obtain a letter of non-objection for any packaging that may have direct contact with food. This letter can only be obtained after properly designed extraction tests have been made using the materials that represent the foodstuff that is to be packaged. If such extraction tests are not done, then Health Canada, to the best of our knowledge, will assume a worst-case scenario in which the majority of the ink components are assumed to migrate into the food in significant quantities. In addition, they will request toxicological data as described under the section below on "no direct food contact". The regulatory body in the United States is the Food and Drug Administration (F.D.A.). The F.D.A. does not approve specific products (i.e. printing inks) for direct or indirect contact with food. Their sole concern is with materials that may become, either by default or design, food additives. They also rely on either properly designed extraction studies or expert testimony, before determining the food additive status of a printing ink. The other agency in the United States is the Department of Agriculture (U.S.D.A.) The U.S.D.A. regulates the packaging materials used primarily for meat and poultry products. It is important to note that the U.S.D.A. stresses that the responsibility for providing guarantees to food packers rests with the converters who provide the finished packaging material. If direct contact between the foodstuff and the printing ink is intended, then the U.S.D.A. follows the same food additive regulations as the F.D.A. NO DIRECT FOOD CONTACT In Canada, when "no direct food contact" with the ink film is intended, there is no need for a food packager to obtain a letter of non-objection from Health Canada, provided the following requirements are met: The package design should incorporate a functional barrier between the foodstuff and the final ink film; The inks must be properly and completely dried or cured after printing, such that the print does not set-off or mark during the stacking or nesting of the packages prior to filling with food. The CFIA can review inks used at federally regulated packaging facilities and approve these inks for "no direct food contact". One of the areas that is considered is the presence of heavy metals in the ink. There are instances, however, when the food packager may wish to obtain a non-objection status from Health Canada, to be assured of the suitability of the package design. For non-objection status to be obtained, the Bureau of Chemical Safety of Health Canada requires that the printing ink manufacturer submit in complete confidence, a full breakdown of every ingredient in the ink formulation together with all known toxicological data on these materials. In addition, details of the specific food, the package design and the life expectancy of the package will be required before they will consider issuing a letter of non-objection. A letter of non-objection status does not absolve the packager from liability should there be a failure in package design leading to the contamination of the food product. Owing to the need for Health Canada to fully research every raw material used in a printing ink formulation for which a non-objection status is being requested, it may be months from the initial application before a letter of non-objection may be issued. In some cases, the process has been known to take years to complete. The previously mentioned functional barrier concept for "no direct food contact" is also recognized by the F.D.A. and the U.S.D.A. CONCLUSION The issue of "direct food contact" and "no direct food contact" of printing ink for food packaging application refers to the toxicological properties of a printing ink. Of equal importance in some applications, are the odour and taint properties of the printing ink being used. There is not necessarily any direct relationship between toxicological, odour and taint properties. The latter should be determined independently for a given package design and product. The C.P.I.M.A. does not recommend printing inks for direct contact with food. Reviewed: February 2004

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