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Food Contact Material Regulations – USA

The Federal Food, Drug and Cosmetic Act (FFDCA) is the key piece of legislation covering food contact materials (FCM) in the US. 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 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.

JurisdictionCitationScopeBPA Requirement
Federal21 CFR 175.300 Resinous and Polymeric CoatingsEpoxy resins derived from BPA and epichlorohydrin as coatings in packaging for powdered and liquid infant formulaProhibited
CaliforniaHealth and Safety Code Division 104, Part 3, Chapter 12Bottles 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 3Prohibited
Connecticut
General Statutes Title 21A
Consumer Protection § 21a-12b. Reusable Food and Beverage containers Containing Bisphenol A: Prohibition; Enforcement
Reusable food or beverage containersProhibited
Jars, cans or plastic containers containing infant formula or baby foodProhibited
DelawareChapter 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 containersProhibited
Infant formula packaging containing intentionally added BPAProhibited
Baby food packaging containing intentionally added BPAProhibited
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 yearsProhibited
Infant formula in containers≤ 0.5 ppb
Containers for infant formula≤ 0.5 ppb
Massachusetts105 CMR 650.020
‘Listing of banned hazardous substances’
Reusable food and beverage containers for children up to the age of 3Prohibited
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 oldProhibited
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 3Prohibited
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 containersProhibited
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 4Prohibited
Containers with intentionally added BPA containing baby food or infant formula for children under the age of 4
New York StateEnvironment 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 cupsProhibited
Vermont

18 V.S.A. §1512
‘Bisphenol A’

Reusable food or beverage containers, including baby bottles, spill-proof cups, sports bottles, and thermosesProhibited
Plastic containers or jars containing infant formula or baby foodProhibited
Infant formula or baby food stored in a canProhibited
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 youngerProhibited
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 4Prohibited
Medically essential products in facilities licensed to provide medical careMay be used if approved by Food and Drug Administration (FDA)
WisconsinW.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 youngerProhibited
(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.

JurisdictionCitationScopeUnless otherwise indicated, PFAS Requirement
CaliforniaChapter 12.5 ‘Juvenile Products’ (commencing with Section 108945) to Part 3 of Division 104 of the Health and Safety Code, relating to product safetyJuvenile productsProhibited 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 fibersProhibited 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 FranciscoEnvironmental Code, Chapter 16 ‘Food Service and Packaging Waste Reduction Ordinance’Single-use food service wareProhibited
California – Santa RosaChapter 9-30 to City Code ‘Zero Waste Food Ware’Food ware and/or food ware accessories in food facilitiesProhibited
ColoradoHB 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 productsProhibited if intentionally added
In handle of cookware or any cookware surface that comes into contact with food, foodstuffs or beveragesList the presence of intentionally added PFAS on product label, including on the product listing for online sales
CookwareUnless 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
ConnecticutTitle 22a ‘Environmental Protection’ Chapters 446d Sec 22a-255g to 22a-255mFood PackagingProhibited
Maine
32 MRSA § 1731 ‘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’

ProductsProduct manufacturer to submit notification if product contains intentionally added PFAS
Carpets, rugs or fabric treatmentsProhibited
ProductsProhibited
MarylandArticle – 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 carpetsProhibited
Minnesota325F.075 ‘Food Packaging; PFAS’Food packagesProhibited
New York StateEnvironmental 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 fibersProhibited
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
WashingtonESHB 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) 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:

SubstanceScopeReformulation/PROP 65 Warning
BPAPolycarbonate dishwareBPA-free otherwise warning
LeadPizza cutters
Pastry brushes
Basting brushes
≤ 40 ppm
4,4’-MDANylon cooking utensils≤ 200 mg/kg and
≤ 10 μg/L in 3% acetic acid
PhthalatesKitchen 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.

JurisdictionScope/SubstanceCitation
FederalChildren’s productsCPSIA
MaineChildren’s products
(Priority chemicals, PCs)
Title 38, Chapter 16-D: Toxic chemicals in children’s products
OregonChildren’s products
(High priority chemicals of concern for children’s health, HPCCCHs)
ORS § 431A.253 to § 431A.280
New York Suffolk CountyChildren’s products containing cadmiumChapter 704: Retail Sales; Article VI, § 704-40 to § 704-47
VermontChildren’s products18 V.S.A. Chapter 38A: ‘Chemicals of High Concern to Children’
WashingtonChildren’s products
(Chemicals of high concern to children, CHCCs)
RCW Chapter 70.240: Children’s Safe Products Act, CSPA
VariousBPARefer 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.

Learn more about food contact testing services >

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