Food Contact Material Regulations – North America

Finally, the FDA also has regulations affecting the use of BPA in FCM. Under 21 CFR 175.300 – Resinous and Polymeric Coatings, epoxy resins derived from BPA and epichlorohydrin are prohibited from being used in packaging for powdered and liquid infant formula. In 21 CFR.1580 – Polycarbonate resins, these materials are prohibited in infant feeding bottles (baby bottles) and spill-proof cups, including their closures and lids, designed to help train babies and toddlers to drink from cups (sippy cups).

BPA is also regulated on a local level by several jurisdictions. Several places completely prohibit the use of BPA in containers to be filled with food or liquid for infants and young children: Chicago, Delaware, Maine, Maryland, Massachusetts, Minnesota, Multnomah County, New York, Nevada, Vermont, Washington, Washington D.C. and Wisconsin.

Connecticut and Vermont regulate BPA in reusable food and beverage containers, whereas Washington State prohibits its presence in certain sports bottles and further regulates the application of bisphenol-based epoxy linings in food and drink cans.

California also imposes strict restrictions on BPA and other bisphenols in juvenile feeding, sucking and teething products, with the practical quantitation limits (PQLs) to be determined by the Department of Toxic Substances Control (DTSC).  

California Prop 65 is the “Safe Drinking Water and Toxic Enforcement Act of 1986” and requires the state to maintain a list of chemicals known to cause cancer, birth defects and other reproductive harm. Prop 65 is unusual in that it achieves many of its aims by consent decree or settlement agreements – an agreement between named parties that is not legally binding on parties not named. It is advisable, however, for non-named stakeholders to remain aware of settlement agreements in order to avoid future legal complications.

Substances found in FCMs, such as BPA, cadmium, lead, 4,4’-methylenedianiline (4,4’-MDA), PFOA, PFOS and/or phthalates, have been the subject of a number of settlement agreements. FCMs named in the settlements include bibs, ceramic ware, cookware, dispensers, espresso machines, fast food packaging, food containers, glassware, kitchen utensils, paper straws, pet items, polycarbonate dishware and tableware.

Over the years, per- and polyfluoroalkyl substances (PFAS) in FCMs and other consumer goods have increasingly been regulated across the US due to their toxic effects and negative impacts on the environment. This diverse family of synthetic chemicals, which include perfluorooctanoic acid (PFOA) and perfluorooctane sulfonic acid (PFOS), are chemically inert and resistant to high temperatures with properties to repel water, grease oil and/or dirt.

The use of PFAS in FCMs and other articles is regulated by several jurisdictions across the US, including California, Colorado, Connecticut, Hawaii, San Francisco, Santa Rosa, Maine, Maryland, Minnesota, New Hampshire, New Jersey, New Mexico, New York, Oregon, Rhode Island, Vermont and Washington.

Finally, as with BPA/bisphenols and PFAS regulations, stakeholders need to be aware that articles containing Food Contact Substances (FCS) need to also comply with other applicable rules and standards for consumer products. These include the Consumer Product Safety Improvement Safety Act of 2008 (CPSIA) and localized reporting rules in Maine, Minnesota, Oregon, Vermont and Washington.

Without a single set of regulations on permissible limits and reporting covering FCMs in the US, compliance can be difficult. Differences between local and national laws mean that a product, which may be compliant with the federal government, may not be compliant in some states. Manufacturers and suppliers need to focus not only on national laws, but also local laws such as Minnesota’s 325E.3892 on the prohibition of lead and cadmium and Washington’s 70A.565 RCW ‘Cookware containing lead.’ In addition, they must remain aware of recent California Prop 65 settlement agreements, to protect themselves against possible costly legal cases.

SGS has the expertise to help manufacturers and suppliers of FCM achieve compliance with markets around the globe. Our technical experts have extensive experience of testing materials and articles for many markets. We offer the full range of FCM testing, including migration tests, along with expert advice on emerging regulations, compliance issues and documentation review. Our experience can ensure your products meet the appropriate territorial regulations for food contact materials and help pave the way for compliance.

Learn more about food contact testing services >

Food contact materials in Canada are regulated under the Canada Consumer Product Safety Act (CCPSA), federal legislation that protects human health and safety and prohibits bisphenol A (BPA) in polycarbonate baby bottles. Beyond specific chemical and product requirements, the CCPSA also prohibits any consumer product that is a danger to human health or safety, acting as a general safety backstop.

Regulations made under the CCPSA affecting food contact materials include:

• Consumer Products Containing Lead Regulations (SOR/2018-83)
• Glazed Ceramics and Glassware Regulations (SOR/2016-175)
• Infant Feeding Bottle Nipples Regulations (SOR/2016-180)
• Kettles Regulations (SOR/2016-181)
• Phthalates Regulations (SOR/2016-188)
• Surface Coating Materials Regulations (SOR/2016-193)

Because these rules apply nationally and sit within one piece of legislation, manufacture and supply of food contact materials to Canada is comparatively straightforward to navigate.

The Federal Food, Drug and Cosmetic Act (FFDCA) is the key legislation covering food contact materials in the USA, administered by the Food and Drug Administration (FDA). Regulations are principally found in Title 21 of the Code of Federal Regulations, with most regulated indirect food additives and polymers covered in 21 CFR 174 to 179.

Manufacturers can demonstrate compliance in several ways:

• Meeting the criteria for Generally Recognized as Safe (GRAS)
• Qualifying for a Threshold of Regulation (TOR) exemption, where possible migration falls below regulatory thresholds
• Obtaining an effective Food Contact Substance Notification (FCN)
• Relying on a Prior Sanction letter issued by the FDA or US Department of Agriculture before 1958, for example within 21 CFR 181