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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 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

Federal BPA laws

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.

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 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 Food contact bottles or cups for children 3 years of age or younger ≤ 0.1 ppb
City of Chicago
(Illinois)
§7-28-637
BPA-Free Kids Ordinance
Food contact containers for children under the age of 3 Prohibited
Connecticut Public Act 09-103
‘An Act Concerning Banning Bisphenol A in Children’s Products and Food Products’
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 bottle or cup to be filled with food or beverage for children under 4 years of age Prohibited
US Illinois Public Act 97-1101 ‘Toxin-Free Toddler Act’ Empty bottles or cups to be filled with food or liquid intended for children under 3 Prohibited
Maine Chapter 882
‘Regulation of Bisphenol A in Children’s Products’
Reusable food or beverage containers 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
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 Nevada Revised Statutes 597.985 and 597.990
‘Knowing manufacturing, sale or distribution of certain products containing bisphenol A’
Food contact bottles or cups for children under the age of 4 Prohibited
Containers containing baby food for children under the age of 4
Containers containing infant formula
New York State Environment Conservation Laws
§37-0501 to 37-0511
‘Bisphenol A’
Food contact materials and articles for children under 3 years old, including pacifiers Prohibited
Vermont 18 V.S.A. §1512
‘Bisphenol A’
Reusable food or beverage containers Prohibited
Plastic containers, jars or cans containing infant formula or baby food Prohibited
Washington RCW 70.280
‘Bisphenol A-Restrictions on sale’
Food and beverage containers for children up to the age of 3 Prohibited
Sports water bottles (≤ 64 ounces) Prohibited
Washington DC Code of District of Columbia
§8-108.01
‘Restrictions on bisphenol A’
Food contact containers for children under the age of 4 Prohibited
Wisconsin W.S.A 100.335
‘Child’s containers containing bisphenol A’
Baby bottles or spill-proof cups for children up to the age of 3 Prohibited
(Label required if BPA-free)

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:

Substance Scope Reformulation/Prop 65 Warning
BPA Polycarbonate dishware BPA-free otherwise warning
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
Washington (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.

Learn more about food contact testing services >