Food Contact Materials Regulations in the United States: An Overview

Food contact materials comprise products and packaging that are meant to come into contact with food or drinks. This includes cookware, cutlery, and food containers. While the main focus of food contact materials regulations is the restrictions of substances that are deemed to be dangerous (e.g. heavy metals), other requirements might also apply – such as labeling.

In this guide, we summarize various food contact material regulations in the United States, including substance restrictions, labeling, documentation, and testing requirements.

21 CFR Part 1 – General Enforcement Regulations

This part includes provisions for food, food contact materials, cosmetics, drugs, and other products that are regulated by the FDA.

In this section, we only focus on requirements that are relevant to food contact materials.

Product scope

21 CFR Part 1 covers food contact substances, which are defined as any substance meant to be used as part of the materials used to hold, manufacture, package, or transport food.

ACE submission

An ACE filer, that is, a person authorized to submit an electronic import entry for products that are regulated by the FDA should submit data elements regarding FDA-regulated articles to the Automated Commercial Environment (ACE) or other CBP-authorized EDI systems.

The data that should be submitted is specified in 21 CFR Part 1.72:

a. Product information:

• FDA Country of Production
• FDA Product Code, which must match the description in the invoice
• Full Intended Use Code

b. Importer information (e.g. phone number and email address)

You can find more information in this guide.

Documentation

Importers and manufacturers are also required to maintain records regarding whether the food enters or is being offered for interstate commerce.

Companies that import and manufacture food contact materials in products other than the finished food contact containers are excluded from these requirements.

However, if the FDA reasonably believes that a food article, or exposure to such, can cause negative health consequences or death to humans or animals, it may request to access any maintained records.

21 CFR Part 109 – Unavoidable Contaminants In Food For Human Consumption And Food-Packaging Material

21 CFR Part 109 contains provisions for unavoidable food contaminants and substance restrictions. It also has labeling and documentation requirements.

Product scope

This part covers added or naturally occurring poisonous or deleterious substances in both foods for human consumption and food contact materials.

Substance restrictions

This part restricts the use of polychlorinated biphenyls (PCBs) and regulates substances in ornamental and decorative ceramicware.

Restrictions on PCBs

The temporary tolerance for PCBs in paper food packaging material meant for, or used with, human food, animal feed and components thereof, is 10 parts per million (ppm).

This tolerance does not apply to paper food packaging that uses a functional barrier to prevent PCBs from migrating from the packaging to the food therein.

Additionally, companies must ensure that new equipment or machinery used for manufacturing food-packaging materials do not contain or use PCBs.

Restrictions on ornamental and decorative ceramicware

The usage of ornamental and decorative ceramicware to hold, prepare, or serve food may result in lead leaching into the food.

In order to avoid this issue, such products should be regulated as food contact materials, unless they bear an obvious label stating that they should not be used for food-handling purposes.

Labeling

Ornamental and decorative ceramicware should bear one of the following messages either on an obvious stick-on label or as molded, fired, or painted on the exterior of the base:

a. “Not for Food Use. May Poison Food”

b. “Not for Food Use. Glaze contains lead. Food Use May Result in Lead Poisoning”

c. “Not for Food Use – Food Consumed from this Vessel May be Harmful”

The product may bear an additional non-food statement (e.g., “For Decorative Purposes Only”) or a symbol at least 2.54 centimeters (1 inch) in diameter to indicate such.

Documentation

The following documentation might be required for functional barriers:

• Test results
• Description of the barrier’s composition
• A specific definition of the barrier

21 CFR Part 174 – Indirect Food Additives: General

21 CFR Part 174 covers provisions and requirements regarding indirect food additive substances and their substance restrictions.

Product scope

This part covers indirect food additive substances that are used in products that are meant to be in contact with food.

Note that food additive substances that migrate into food at negligible levels are exempted if the substance:

a. Is shown to not be carcinogenic to humans and animals.

b. Does not present health or safety concerns at below 0.5 parts per billion (ppb).

c. Does not have a technical effect on the food it migrates to.

d. Does not significantly or negatively impact the environment.

Good Manufacturing Practice

Good manufacturing practice requires the quantity of migratory food additive substances that might end up in food to:

a. Not exceed, if no limits are specified, reasonable amounts necessary to achieve the desired physical or technical effect in the food contact product.

b. Not exceed prescribed substance limitations.

c. Not physically or technically affect the food, except if permitted by provisions set in 21 CFR Parts 170–189.

Part 174.5 also notes that components of food contact substances should be pure enough for their intended use.

21 CFR Part 175 – Indirect Food Additives: Adhesives And Components Of Coatings

21 CFR Part 175 contains requirements about adhesives and coating components as indirect food additive substances.

Product scope

Subpart B covers substances that are for use “only” as components of adhesives and pressure-sensitive adhesives, such as:

• Acetone
• Ethylene glycol
• Japan wax
• Octyl alcohol
• Terpineol
• Zinc acetate

Subpart C covers substances that are for use as components of coatings, such as:

• Acrylate ester copolymer coating
• Paraffin (synthetic)
• Resinous and polymeric coatings
• Zinc-silicon dioxide matrix coatings

Substance restrictions

21 CFR Part 175 sets restrictions for various substances, as explained below.

Restrictions on optional substances in adhesives

Optional substances used in formulating adhesives are subject to prescribed limitations and might include:

a. Substances that are generally recognized as safe (GRAS) for usage in food or food packaging.

b. Substances that prior sanctions or approvals permit for use in adhesives.

c. Permitted flavoring substances that are volatilized from the adhesives.

d. Approved color additives for usage in food.

e. Substances permitted by, and meet the requirements of, other relevant regulations.

f. Substances listed under Subpart B that meet the requirements of relevant regulations.

Restrictions on pressure-sensitive adhesives

This part provides substance restrictions for pressure-sensitive adhesives that might be used as the food contact surface of labels and tapes for certain foodstuffs. Here, we list three examples of substances and their restrictions:

a. 4-[[4, 6-Bis(octylthio)-s-triazin-2-yl]amino]-2,6-di-tert-butylphenol as a stabilizer should not exceed 1.5% by weight of the finished adhesive.

b. 2,2′-(2,5-Thiophenediyl)-bis(5-tert-butylbenzoxazole) as an optical brightener should not exceed 0.05% by weight of the finished adhesive.

c. 2-Hydroxy-1-[4-(2-hydroxyethoxy) phenyl]-2-methyl-1-propanone as a photoinitiator should not exceed 5% by weight of the finished adhesive.

Restrictions on components of coatings

Here we list a few coating substances and their restrictions from 21 CFR Subchapter B Subpart C:

a. Paraffin (synthetic) – Oil content should not exceed 2.5% of the coating substance.

b. Siloxanes and silicones – Platinum content of the coating to not exceed 150 ppm.

c. Packaging for powdered and liquid infant formula – Epoxy resins derived from 4,4′-Isopropylidenediphenol (Bisphenol A, BPA) reacting with epichlorohydrin are prohibited from use as coatings.

Labeling

Finished adhesive containers should carry a label with the following statement: “Food-packaging adhesive”.

21 CFR Part 176 – Indirect Food Additives: Paper And Paperboard Components

21 CFR Part 176 contains requirements for indirect food additive substances, specifically as components of paper and paperboard.

Product scope

This part covers substances for use as components of paper and paperboard, such as the following:

• Alkyl ketene dimers
• Defoaming agents used in coatings
• Slimicides
• Sodium nitrate-urea complex

Substance restrictions

21 CFR Part 176 sets various substance restrictions. We provide the restrictions for the substances listed above, as examples:

a. Alkyl ketene dimers – Hydrolysis products dialkyl ketones should not exceed 0.4% by weight of the paper or paperboard.

b. Defoaming agents used in coatings – Formaldehyde should only be used as a defoamer preservative.

c. Slimicides – 1,2-Benzisothiazolin-3-one is a slime-control substance permitted at 0.06 lb per ton of dry-weight fiber.

d. Sodium nitrate-urea complex – Should not exceed 15% by weight of the finished paper.

Labeling

This part sets labeling requirements for the food additive Chromium (Cr III) complex of N-ethyl-N-heptadecylfluoro-octane sulfonyl glycine when used as a paper component for dry food packaging.

The food additive label should contain sufficient directions for its usage to ensure compliance with requirements such as:

a. The food additive should not exceed 0.5% by weight of the paper.

b. The paper’s food-contact surface is overcoated with a resinous coating at least 1/3 mil thick.

Additionally, slimicides should include a label that provides sufficient usage directions.

Documentation

This part specifies record-keeping requirements for components of paper and paperboard that are in contact with aqueous and fatty foods.

Specifically, the information from manufacturing records should determine if the food-contact surface of the paper or paperboard contains substances that:

a. Are GRAS in food and for its intended use in paper and paperboard used in food packaging.

b. Are approved or sanctioned for use.

c. May be used safely without extractive limitations.

21 CFR Part 177 – Indirect Food Additives: Polymers

21 CFR Part 177 contains provisions for polymers used as indirect food additive substances in single and repeated-use food contact surfaces.

Product scope

Subpart B covers substances for use as basic components of both single and repeated-use food contact surfaces, such as:

• Cellophane
• Fluorocarbon resins
• Nylon resins
• Polyurethane resins

Subpart C covers substances that are only for use as components of products meant for repeated use, such as:

• Resin-bonded filters
• Polyamide-imide resins
• Textiles and textile fibers
• Mineral-reinforced nylon resins

Substance restrictions

This part sets restrictions for many types of substances that might be found in polymers. Here, we list some examples:

a. Cellophane might contain n-Butyl acetate only up to 0.1% by weight of the finished packaging cellophane.

b. Polyurethane resins might contain Dibutyltin diacetate, only for use as a catalyst to achieve the intended physical or technical effect in the resin.

c. Textiles and textile fibers might contain borax as an adjuvant substance, only as a preservative.

d. Infant feeding bottles (baby bottles), spill-proof cups, and their closures and lids can’t contain polycarbonate resins

Labeling

This part requires microporous polymeric filters to have labels that include sufficient pre-use treatment directions, such as using a minimum of 2 gallons of potable, 180 °F, water to wash the filter before its first contact with food.

It also requires ultra-filtration membranes to have labeling that includes sufficient pre-use treatment directions, such as conditioning and washing the membrane with a minimum of 8 gallons of potable water before its first use in food contact.

Good Manufacturing Practice

Per good manufacturing practice, the quantity of indirect food additives such as polymers should not:

a. Exceed a reasonably required amount necessary to achieve the desired physical or technical effect in the product.

b. Exceed prescribed limitations.

c. Be meant to physically or technically alter the food, except where permitted in this part.

Polymers used as indirect food additives in food contact products should be suitably pure for their intended use.

21 CFR Part 178 – Indirect Food Additives: Adjuvants, Production Aids, And Sanitizers

21 CFR Part 178 contains provisions for adjuvants, production aids, and sanitizers as indirect food additive substances.

Product scope

Subpart B covers substances used to control microorganism growth, such as hydrogen peroxide solutions.

Subpart C covers antioxidants and stabilizers, such as those for polymers, and organotin stabilizers in vinyl chloride plastics.

Subpart D covers certain adjuvants and production aids, such as animal glue, mineral oil, and petrolatum.

Substance restrictions

We provide here a few examples of covered substances and their restrictions:

a. Hydrogen peroxide solutions should not contain more than 35% of hydrogen peroxide.

b. Antioxidants for polymers should not contain pentaerythritol and its stearate ester in a total amount that exceeds 0.4% by weight of the polymers.

c. Animal glue should contain formaldehyde only if used as a preservative.

Labeling

Sanitizing agents for use on food-processing equipment and utensils, and food-contact products, should bear labeling that adheres to FIFRA’s labeling requirements.

Industrial starch-modified should bear the name “industrial starch-modified” in the food-additive container. The label of the food additive container of industrial starch modified that is limited to usage conditions should bear a statement of the limited use.

Good Manufacturing Practice

Colorants used for polymers as a production aid should be used according to good manufacturing practices. The colorants’ use levels should not exceed the reasonably necessary amount to achieve the desired coloring effect.

21 CFR Part 179 – Irradiation In The Production, Processing And Handling Of Food

21 CFR Part 179 contains requirements for irradiation in the production, processing, and handling of food.

Product scope

Subpart B covers radiation and radiation sources, such as that used for:

• Inspecting food
• Inspecting packaged food
• Controlling food processing
• Treating food
• Heating food
• Etching food

Subpart C covers packaging materials used during the irradiation of prepackaged food.

Substance restrictions

Here we list some examples of substance restrictions set by this part for packaging materials used for irradiated food:

a. The amount of amides of erucic, linoleic, oleic, palmitic, and stearic acid in polyethylene film should not be higher than 1% by weight.

b. The amount of propylene, noncrystalline in polyethylene film should not be higher than 2% by weight.

c. Stearates of aluminum, calcium, magnesium, potassium, and sodium in polyethylene film should not be higher than 1% by weight.

Radiation limits

Packaging materials that may be irradiated with gamma, electron beam, or X-radiation, should not exceed certain kilograys. Here we list some examples of covered packaging materials and their restrictions:

a. Glassine paper – Radiation should not exceed 10 kilograys.

b. Ethylene-vinyl acetate packaging materials – Radiation should not exceed 30 kilograys.

c. Polyethylene film containing BHA – Radiation should not exceed 60 kilograys.

Labeling

Retail packages of irradiated foods should bear a conspicuously-placed logo with either of the following statements, as well as information mandated by other regulations:

• “Treated with radiation”
• “Treated by irradiation”

Irradiated foods that are not packaged should still bear the required logo and statement on:

• The bulk container
• The counter sign
• A card

On the other hand, labels of irradiated food should bear either of the following statements when shipped for further processing, labeling, or packing:

a. “Treated with radiation – do not irradiate again.”

b. “Treated by irradiation – do not irradiate again.”

Good Manufacturing Practice

Packaging materials that are subject to irradiation related to the processing and radiation treatment of prepackaged food should adhere to good manufacturing practice.

21 CFR Part 182 – Substances Generally Recognized As Safe

21 CFR Part 182 contains requirements regarding substances that are generally recognized as safe (GRAS).

Product scope

This part covers substances that are GRAS and that:

a. Migrate from cotton fabrics used in dry food packaging.

b. Migrate to food from paper and paperboard food contact articles.

c. Are added directly to food.

Substance restrictions

21 CFR Part 182 Subpart B lists a number of specific substances that are affirmed as GRAS.

While Subpart A lists substances that are GRAS, it does not specify substance restrictions. As such, manufacturers should ensure that they adhere to good manufacturing practices.

Good manufacturing practice

Good manufacturing practice applies to substances that are GRAS, in that:

a. The amount of substance added to the food should not exceed a reasonably necessary amount to achieve the desired nutritional, physical, or technical effect on the food.

b. The amount of GRAS substances that become a part of food, but that was not intended for it to be so, should be reduced as much as possible.

c. The GRAS substance is of an acceptable food grade, and as such, is prepared and handled as a food ingredient.

21 CFR Part 186 – Indirect Food Substances Affirmed As Generally Recognized As Safe

21 CFR Part 186 contains provisions for various indirectly-added food substances that are affirmed as GRAS.

Product scope

Subpart B specifies multiple substances that are affirmed as GRAS, including:

• Sulfamic acid
• Ferric oxide
• Japan wax
• Pulp
• Sodium sulfate

Substance restrictions

While for some of the substances listed in Subpart B, there are specific restrictions, for some it is sufficient to follow good manufacture practices. Here we provide some examples.

a. Sulfamic acid – No limitations, excluding the ones set by the good manufacturing practice.

b. Ferric oxide – No limitations, excluding the ones set by the good manufacturing practice.

c. Sodium chlorite – It can be at levels from 125 to 250 ppm as a slimicide in paper and paperboard used as food contact material.

21 CFR Part 189 – Substances Prohibited From Use In Human Food

21 CFR Part 189 contains provisions for substances that are banned from direct and indirect addition to human food.

Product scope

This part covers substances that are banned from indirect addition to human food through food-contact surfaces.

Additionally, it covers substances that are prohibited from direct addition in or use as human food.

Substance restrictions

Here we list some examples of substances that are prohibited in food contact materials:

• Flectol H
• Lead solders
• 4,4′-Methylenebis (2-chloroanaline)
• Tin-coated lead foil capsules for wine bottles

You can find the complete list in Subpart D of this part.

21 CFR – Other parts

Note that, in some cases, the following parts of 21 CFR might also be relevant for food contact materials:

a. 21 CFR Part 170 – Food Additives

b. 21 CFR Part 171 – Food Additive Petitions

c. 21 CFR Part 180 – Food Additives Permitted in Food or in Contact with Food on an Interim Basis Pending Additional Study

d. 21 CFR Part 181 – Prior-Sanctioned Food Ingredients

Bisphenol A (BPA) Regulations

BPA is a kind of chemical substance that is widely used in making polycarbonate plastics and epoxy resins since the 1960s. Polycarbonate plastics can be used as the material to make food and beverage containers, such as water bottles, baby bottles, and plastic containers.

BPA can potentially affect the metabolic and cardiovascular systems, as well as the mammary and prostate glands in the human body, and besides being regulated at the Federal level by the FDA, it is also regulated by several US states. For example:

a. California: The Health and Safety Code Division restricts the level of BPA to a maximum of 0.1 ppb, for bottles intended to be used by children less than 3 years old.

b. New York State: The Environment Conservation Laws prohibit the use of Bisphenol A for FCM products marketed for children under 3 years old.

c. Washington, DC: The Code of the District of Columbia prohibits the use of Bisphenol A for FCM products marketed for children under 4 years old.

ASTM Standards

ASTM standards are voluntary unless they are incorporated by reference by one or more regulations. However, you can still use such standards for ensuring product compliance and quality, during the manufacturing process.

Examples

a. ASTM F2643-15 – Standard Specification for Powered Pot, Pan and Utensil Washing Sinks

b. ASTM F1047-17 – Standard Specification for Frying and Braising Pans, Tilting Type

c. ASTM F1640-16 – Standard Guide for Selection and Use of Contact Materials for Foods to Be Irradiated

d. ASTM C1607-12 – Standard Test Method for Determination of “Microwave Safe for Reheating” for Ceramicware

You can find more standards in the official ASTM’s website.

Lab Testing

You generally need to have your food-contact products lab tested to ensure that they don’t contain prohibited substances, or substances that exceed the weight by weight or migration limits. Other types of testing might also be necessary.

When your products pass the testing, you receive a test report that proves your product’s compliance with one or more regulations.

Test methods

Here are several examples of test methods that are incorporated by reference under 21 CFR Parts 175-179:

a. ASTM D938–71 (Reapproved 1981) – Standard Test Method for Congealing Point of Petroleum Waxes, Including Petrolatum

b. ASTM D611–82 – Standard Test Methods for Aniline Point and Mixed Aniline Point of Petroleum Products and Hydrocarbon Solvents

c. ASTM D1238–82, condition E – Standard Test Method for Flow Rates of Thermoplastics by Extrusion Plastometer

d. ASTM D1386–78 – Standard Test Method for Saponification Number (Empirical) of Synthetic and Natural Waxes

e. ASTM D1243–79, method A – Standard Test Method for Dilute Solution Viscosity of Vinyl Chloride Polymers

Test labs

Here we list a few test labs that offer testing services for food contact materials against FDA’s requirements:

• Intertek
• SGS
• Bureau Veritas
• Eurofins
• UL Solutions