SGS Helps Companies Comply with North American Regulations for Food Contact Materials

Top Quote North America has a complex web of regulations covering food contact materials and articles. SGS helps manufacturers understand the best way to achieve compliance. End Quote
  • (1888PressRelease) October 13, 2017 - Food Contact Materials and Articles (FCM) are regulated in different ways in Canada and the US. Within the US, they can also be regulated on a federal, state and municipal level. This can make it difficult for economic suppliers of FCM to ensure they are providing compliant products to all markets.

    In Canada, FCM are governed by the Canada Consumer Product Safety Act (CCPSA). This piece of federal legislation is responsible for protecting human health and safety and, in relation to FCM, it contains general safety requirements to safeguard the public from hazards posed by consumer products. Enshrined within it are regulations regarding certain chemicals and/or consumer products, including specific safety and performance requirements. CCPSA also prohibits the use of bisphenol A (BPA) in polycarbonate baby bottles.

    Manufacturers of consumer products containing Food Contact Substances (FCS) need to be aware of Appendix C of the CCPSA, which contains:
    • Asbestos Products Regulations (SOR/2016-164)
    • 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)

    Manufacturers and suppliers of FCM to Canada will find it comparatively simple as this one piece of legislation applies to the whole country. In the US, however, stakeholders need to consider both federal and local regulations to remain compliant.

    On a Federal level, the main piece of legislation covering FCM is the Federal Food, Drug and Cosmetic Act (FFDCA), administered by the Food and Drug Administration (FDA).

    Regulations pertaining to FCM can principally be found in Title 21 of the Code of Federal Regulations (CFR). The majority of regulated indirect food additives and polymers can be found in 21 CFR 174 to 179:
    • 174 – General
    • 175 – Adhesives and components of coatings
    • 176 – Paper and paperboard components
    • 177 – Polymers
    • 178 – Adjuvants, production aids and sanitizers
    • 179 – Irradiation in the production, processing and handling of food

    To help manufacturers of FCM, 21 CFR also contains:
    • 180 – Food additives permitted in food or in contact with food on an interim basis pending additional study
    • 182 – Substances recognized as safe
    • 184 – Direct food substances affirmed as generally recognized as safe
    • 186 – Indirect food substances affirmed as generally recognized as safe

    One way to ensure compliance is to meet the criteria for Generally Recognized as Safe (GRAS). The law does, however, also allow Threshold of Regulations (TOR) exemptions, when any possible migration is below regulation thresholds, and an effective Food Contact Substance Notification (FCN). Finally, the FDA will also exempt any substance that is the subject of a Prior Sanction letter, issued by either the FDA or US Department of Agriculture prior to 1958. This may be in the form of, for example, a private letter, or contained within 21 CFR 181.

    To help manufacturers of pottery and silver-plated hollow-ware, the FDA has published compliance policy guides in relation to leachable cadmium and/or lead. They are:
    • CPG Sec 545.400: Pottery (ceramics) for cadmium
    • CPG Sec 545.450: Pottery (ceramics) for lead
    • CPG Sec 545.500: Silver-plated hollow-ware for lead

    BPA in FCM
    The FDA regulates the use of BPA in FCM via 21 CFR 175.300 – Resinous and Polymeric Coatings. This prohibits the use of epoxy resins derived from BPA and epichlorohydrin from being used in packaging for powdered and liquid infant formula.

    BPA is also regulated, on a local level, by legislation that prohibits its use in certain consumer products. The City of Chicago, for example, under its ‘BPA-Free Kids Ordinance’, BPA is forbidden in food contact containers for children under the age of three. In the state of Vermont, it is prohibited from reusable food or beverage containers, and plastic containers, jars or cans containing infant formula or baby food. In total, 15 jurisdictions within the USA have prohibitions on the use of BPA in some FCM. This includes Maryland, which bans the use of BPA in empty bottles or cups that will be filled with food or liquid for a child under the age of four.

    The same Maryland regulation, ‘Childcare Articles Containing Bisphenol A Prohibited’, does allow the use of BPA in some items, but with severe restrictions. Manufacturers are restricted to less than or equal to 0.5 ppb in containers with or for the use of infant formula.
    California also imposes strict restrictions on BPA but does not completely ban it. Its Health and Safety Code allows a maximum of 0.1 ppb of BPA in food contact bottles or cups for children aged three or less.

    California Proposition 65
    Companies doing business in California must also consider California Proposition 65 (Prop 65), the “Safe Drinking Water and Toxic Enforcement Act of 1986”. This is a unique piece of legislation that achieves 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 to avoid future legal complications.

    Substances such as BPA, cadmium, lead, 4,4’-methylenedianiline (4,4’-MDA) and/or phthalates, have often been the subject of settlement agreements. FCM named in the settlements include ceramic ware, espresso machines, faucets, glassware, kitchen gadgets and accessories, nylon cooking utensils and polycarbonate dishware.

    For guidance, settlement agreements include:
    • 4,4’-MDA in nylon cooking utensils – restricted to ≤ 200 mg/kg and ≤ 10 μg/L in 3% acetic acid3
    • Phthalates in kitchen accessories – restricted to ≤ 1000 ppm each of BBP, DBP, DEHP, DIDP, DINP and DnHP4

    Finally, as with BPA regulations, stakeholders need to also be aware that substances contained within FCM will also need to comply with other relevant rules and standards for consumer products. These include the Consumer Product Safety Improvement Safety Act of 2008 (CPSIA) and localized reporting rules in Maine, Oregon, Vermont and Washington.

    The complexity of FCM regulations in North America mean that a product may be compliant in one territory but non-compliant in another. Manufacturers need to check their FCM against the latest requirements of the target market to ensure compliance. Working with certification experts, such as SGS, can help stakeholders understand and comply with the right regulations for the target market.

    SGS Food Contact Testing Services
    SGS has the expertise to help manufacturers and suppliers of FCM achieve compliance with markets around the globe. They offer the full range of FCM testing, including migration tests, along with expert advice on emerging regulations, compliance issues and documentation review. SGS’s experience helps ensure products meet the appropriate territorial regulations for food contact materials and help pave the way for compliance. Learn more about SGS’s Food Contact Testing Services >> [link to:]

    For further information contact:
    Hing Wo Tsang Ph.D
    Global Information and Innovation Manager
    Email: ( @ ) sgs dot com

    About SGS
    SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 90,000 employees, SGS operates a network of over 2,000 offices and laboratories around the world.

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