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 support 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 support manufacturers of pottery and silver-plated hollowware, 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 hollowware for lead
Federal Laws on BPA and Polycarbonate Resins
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).
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, more than 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.
| Jurisdiction | Citation | Scope | BPA Requirement |
|---|---|---|---|
| Federal | 21 CFR 175.300 Resinous and Polymeric Coatings | Epoxy resins derived from BPA and epichlorohydrin as coatings in packaging for powdered and liquid infant formula | Prohibited |
| California | Health and Safety Code Division 104, Part 3, Chapter 12 | Bottles or cups designed or intended to be filled with liquid, food, or beverage intended primarily for consumption from that bottle or cup by children three years of age or younger | ≤ 0.1 ppb |
| City of Chicago (Illinois) | §7-28-637 BPA-Free Kids Ordinance | Containers designed to be filled with food or liquid for children under the age of 3 | Prohibited |
| Connecticut | General Statutes Title 21A Consumer Protection § 21a-12b. Reusable Food and Beverage containers Containing Bisphenol A: Prohibition; Enforcement | Reusable food or beverage containers | Prohibited |
| Jars, cans or plastic containers containing infant formula or baby food | Prohibited | ||
| Delaware | Chapter 25, Title 6, §2509 ‘Products for Young Children, Prohibition of Bisphenol A’ | Empty bottles or cups to be filled with food or beverage for children under 4 years of age | Prohibited |
| Maine | Chapter 882 ‘Regulation of Bisphenol A in Children’s Products’ | Reusable food or beverage containers | Prohibited |
| Infant formula packaging containing intentionally added BPA | Prohibited | ||
| Baby food packaging containing intentionally added BPA | Prohibited | ||
| Maryland | Title 24, Subtitle 3, §24-304 ‘Childcare Articles Containing Bisphenol A Prohibited’ | Empty bottles or cups to be filled with food or liquid for a child under the age of 4 years | Prohibited |
| Infant formula in containers | ≤ 0.5 ppb | ||
| Containers for infant formula | ≤ 0.5 ppb | ||
| Massachusetts | 105 CMR 650.020 ‘Listing of banned hazardous substances’ | Reusable food and beverage containers for children up to the age of 3 | Prohibited |
| Minnesota | Chapter 325F.173 ‘Bisphenol A in certain children’s products’ | Empty bottles or cups to be filled with food or liquid for children under 3 years old | Prohibited |
| Chapter 325F. 174 ‘Bisphenol A in children’s food containers’ | Containers containing infant formula, baby food, or toddler food for children under the age of 3 | Prohibited | |
| Multnomah County (Oregon State) | Board of Health Order No. 2011-129 ‘Restricting the Sale of all Reusable Containers and Reusable Infant and Child Beverage Containers containing Bisphenol A’ | Reusable beverage containers | Prohibited |
| Nevada | Revised Statutes 597.985 and 597.990 ‘Knowing manufacturing, sale or distribution of certain products containing bisphenol A’ | Bottles or cups containing intentionally added BPA if these are designed or intended to be filled with liquid or food intended primarily for consumption by a child under the age of 4 | Prohibited |
| Containers with intentionally added BPA containing baby food or infant formula for children under the age of 4 | |||
| New York State | Environment Conservation Laws §37-0501 to 37-0511 ‘Bisphenol A’ (Bisphenol A-Free Children and Babies Act) | Pacifiers and unfilled beverage containers to be used by children under 3 years old, including pacifiers, baby bottles, baby bottle liners and cups, cup lids, straws and sippy cups | Prohibited |
| Vermont | 18 V.S.A. §1512 ‘Bisphenol A’ | Reusable food or beverage containers, including baby bottles, spill-proof cups, sports bottles, and thermoses | Prohibited |
| Plastic containers or jars containing infant formula or baby food | Prohibited | ||
| Infant formula or baby food stored in a can | Prohibited | ||
| Washington | RCW 70.280 ‘Bisphenol A-Restrictions on sale’ | Empty bottles, cups, or other containers designed or intended to be filled with any liquid, food, or beverage primarily for consumption by children 3 years of age or younger | Prohibited |
| Sports water bottles (≤ 64 ounces) | Prohibited | ||
| Washington DC | Code of District of Columbia §8-108.01 ‘Restrictions on bisphenol A’ | Empty bottles, cups, or other containers to be filled with liquid or food for consumption by a child under the age of 4 | Prohibited |
| Medically essential products in facilities licensed to provide medical care | May be used if approved by Food and Drug Administration (FDA) | ||
| Wisconsin | W.S.A 100.335 ‘Child’s containers containing bisphenol A’ | Empty baby bottles or spill-proof cups primarily intended by for use by a child 3 years of age or younger | Prohibited (Label required if BPA-free) |
Local PFAS Laws
Over the years, per- and polyfluoroalkyl substances (PFAS) in FCM 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 FCM and other consumer goods is regulated by several jurisdictions across the US. For example, California and New York outlaw PFAS in food packaging made mostly of paper, paperboard or derived from plant fibers. Connecticut, Minnesota and Vermont forbid PFAS in food packaging. Maine became the first state to prohibit PFAS in products, including FCM, under its ‘Products Containing PFAS’ law.
| Jurisdiction | Citation | Scope | Unless otherwise indicated, PFAS Requirement |
|---|---|---|---|
| California | Chapter 12.5 ‘Juvenile Products’ (commencing with Section 108945) to Part 3 of Division 104 of the Health and Safety Code, relating to product safety | Juvenile products | Prohibited if either intentionally added that has a functional or technical effect, or ≥ 100 ppm (as total organic fluorine) |
| California | Chapter 15 ‘Chemicals of Concern in Food Packaging and Cookware’ (commencing with Section 109000) to Part 3 of Division 104 of the Health and Safety Code, relating to product safety | Food packaging substantially made of paper, paperboard, or derived from plant fibers | Prohibited if either intentionally added that has a functional or technical effect, or ≥ 100 ppm (as total organic fluorine) |
| In handle of cookware or any cookware surface that comes into contact with food, foodstuffs or beverages | Posting of information on internet website for cookware listing for online sales if contains designated list of chemicals (DTSC) | ||
| List their presence on product label | |||
| California – San Francisco | Environmental Code, Chapter 16 ‘Food Service and Packaging Waste Reduction Ordinance’ | Single-use food service ware | Prohibited |
| California – Santa Rosa | Chapter 9-30 to City Code ‘Zero Waste Food Ware’ | Food ware and/or food ware accessories in food facilities | Prohibited |
| Colorado | HB 22-1345 ‘Concerning Measures to Increase Protections from PFAS Chemicals’ | Carpet and rugs, cosmetics, fabric treatments, food packaging derived from plant fibers, indoor and outdoor textile furnishings, indoor and outdoor upholstered furniture, juvenile products, and oil and gas products | Prohibited if intentionally added |
| In handle of cookware or any cookware surface that comes into contact with food, foodstuffs or beverages | List the presence of intentionally added PFAS on product label, including on the product listing for online sales | ||
| Cookware | Unless no individual PFAS is intentionally added, manufacturers (include importers or first domestic distributors by statute) must not make a claim that the cookware is free of any PFAS on cookware package | ||
| Hawaii | Act 152 (HB 1644, 2022) Food Packaging; Firefighting Foam; Perfluoroalkyl and Polyfluoroalkyl Substances; Ban; Fines; Department of Health | Food packaging comprised, in substantial part, of paper, paperboard, or other materials originally derived from plant fibers: food boats, pizza boxes, plates, wraps and liners | Prohibited |
| Connecticut | Title 22a ‘Environmental Protection’ Chapters 446d Sec 22a-255g to 22a-255m | Food Packaging | Prohibited |
| Maine | Title 32, Chapter 26-A ‘Reduction of Toxics in Packaging’ | Food packages, including disposable food service gloves | Prohibited* *Prohibition by rule, and only becomes operative if safer alternatives are available, otherwise 2 years from date on which Dept. of Environmental Protection (DEP) determines a safer alternative is available, whichever is later |
| Phthalates prohibited | |||
| Maine | 38 MRSA § 1614 ‘Products Containing PFAS’ | Products | Product manufacturer to submit notification if product contains intentionally added PFAS |
| Carpets, rugs or fabric treatments | Prohibited | ||
| Products | Prohibited | ||
| Maryland | Article – Environment Section 6 Subtitle 16 ‘PFAS Chemicals’ (SB 273, Chapter 139, 2022, cross-filed HB 275, Chapter 138, 2022) | Food packages or food packaging substantially composed of paper, paperboard, or other materials derived from plant-fibers; Plastic disposable gloves used in commercial or institutional food service; Rugs and carpets | Prohibited |
| Minnesota | 325F.075 ‘Food Packaging; PFAS’ | Food packages | Prohibited |
| HF 2310 (Chapter, 2023) | Products | Manufacturer (includes importer or first domestic distributor) to submit notification if product contains intentionally added PFAS (effective January 1, 2026) | |
| Products | Prohibited if intentionally added, unless the commissioner has determined that the use of PFAS is unavoidable (effective January 1, 2032) | ||
| New York State | Environmental Conservation Law § 37-0209 ‘Prohibition on the Use of Perfluoroalkyl and polyfluoroalkyl Substances in Food Packaging’ | Food packaging made, in substantial part, from paper, paperboard or other materials derived from plant fibers | Prohibited |
| Vermont | 18 V.S.A Chapter 33A ‘Chemicals of Concern in Food Packaging’ | Food Packaging | Prohibited |
| Phthalates prohibited | |||
| Dept. of Health (DOH) may adopt rules for prohibition of bisphenols | |||
| Washington | ESHB 2658 (2018) Food Packaging - Perfluorinated Chemicals | Food packaging, made in substantial part, of paper, paperboard, or other materials originally derived from plant fibers: bags and sleeves, bowls, closed containers, flat service ware, food boats, open-top containers, pizza boxes, plates, and wraps and liners | Prohibited |
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 complications.
Substances found in FCM, such as BPA, cadmium, lead, 4,4’-methylenedianiline (4,4’-MDA), PFOA and/or phthalates, have been the subject of a number of settlement agreements. FCM named in the settlements include bibs, ceramic ware, espresso machines, faucets, glassware, kitchen gadgets and accessories, nylon cooking utensils and polycarbonate dishware.
For guidance, settlement agreements include:
| Substance | Scope | Reformulation/PROP 65 Warning |
|---|---|---|
| BPA | Polycarbonate dishware | BPA-free otherwise warning |
| Lead | Pizza cutters Pastry brushes Basting brushes | ≤ 40 ppm |
| 4,4’-MDA | Nylon cooking utensils | ≤ 200 mg/kg and ≤ 10 μg/L in 3% acetic acid |
| Phthalates | Kitchen accessories | ≤ 1000 ppm each of BBP, DBP, DEHP, DIDP, DINP and DnHP |
US Regulations: Other Laws
Finally, as with BPA 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, Oregon, Vermont and Washington.
| Jurisdiction | Scope/Substance | Citation |
|---|---|---|
| Federal | Children’s products | CPSIA |
| Maine | Children’s products (Priority chemicals, PCs) | Title 38, Chapter 16-D: Toxic chemicals in children’s products |
| Oregon | Children’s products (High priority chemicals of concern for children’s health, HPCCCHs) | ORS § 431A.253 to § 431A.280 |
| New York Suffolk County | Children’s products containing cadmium | Chapter 704: Retail Sales; Article VI, § 704-40 to § 704-47 |
| Vermont | Children’s products | 18 V.S.A. Chapter 38A: ‘Chemicals of High Concern to Children’ |
| Washington | Children’s products (Chemicals of high concern to children, CHCCs) | RCW Chapter 70.240: Children’s Safe Products Act, CSPA |
| Various | BPA | Refer to Local BPA Laws section |
Without a single set of regulations on permissible limits and reporting covering FCM 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 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.
Food Contact Material Testing
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.
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