Recently we reviewed the complexities involved in achieving compliance with legislation relating to Food Contact Materials and Articles (FCM) in Europe1. The problem is no less confusing when we look at North America. There is no single set of rules covering Canada and the United States and, for manufacturers and suppliers of FCM to the US, the issue becomes even more confusing when you look at how different pieces of legislation, on a federal, state and municipal level, impact upon FCM.
Canada Consumer Product Safety Act
FCM are governed by the Canada Consumer Product Safety Act (CCPSA), a piece of federal legislation responsible for protecting human health and safety. In effect, it contains general safety requirements to safeguard the public from hazards posed by consumer products. It has regulations regarding certain chemicals and/or consumer products, via specific safety and performance requirements, and it 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 these rules apply to the whole country and they are enshrined in one piece of legislation. In the United States, however, stakeholders need to consider both federal and local regulations to remain compliant.
US Regulations: Federal
The Federal Food, Drug and Cosmetic Act (FFDCA) is the key piece of legislation covering FCM in the US, at a federal level. It is 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
Meeting the criteria for Generally Recognized as Safe (GRAS) is one way to ensure compliance but the law does also allow Threshold of Regulations (TOR) exemptions, when any possible migration is below regulation thresholds, and an effective Food Contact Substance Notification (FCN).
In addition, 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 also 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
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.
US Regulations: Local BPA Laws
BPA is also regulated on a local level by several jurisdictions. Several places completely prohibit the use of BPA in certain consumer products. For example, the City of Chicago forbids its use in food contact containers for children under the age of three, under its ‘BPA-Free Kids Ordinance’, and the state of Vermont prohibits it in 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, which 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 other 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.
US Regulations: California Proposition 65
California Proposition 65 (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 complications2.
Substances found in FCM, such as BPA, cadmium, lead, 4,4’-methylenedianiline (4,4’-MDA) and/or phthalates, have been the subject of a number 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
US Regulations: Other Laws
Finally, as with BPA regulations, stakeholders need to be aware that articles containing 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, Oregon, Vermont and Washington.
Without a single set of regulations on permissible limits and reporting covering FCM in North America, compliance can be difficult. Differences between local and national laws mean that a product, which may be compliant in one state, may not be compliant in some cities. Manufacturers and suppliers need to focus not only on national laws, the CCPSA and FFDCA, but also local laws such as Wisconsin’s W.S.A 100.335 – ‘Child’s containers containing bisphenol A’. In addition, they must remain aware of recent California Prop 65 settlement agreements, to protect themselves against possible costly legal cases.
SGS Solutions: Food Contact Testing
SGS has the expertise to help manufacturers and suppliers of FCM achieve compliance with markets around the globe. We 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 can ensure your 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.
HingWo Tsang, Ph.D.
Global Information and Innovation Manager
SGS Hong Kong Limited
t: +852 2774 7420
1 Complexity in Food Contact Material Regulations: A European Perspective
2 California Proposition 65 Settlement Update
3 California Proposition 65: 4, 4’-Mda in Nylon Cooking Utensils
4 California Proposition 65 Reformulation of Phthalates in Consumer Products – Part 1