Phthalate Regulations in the United States: An Overview

Phthalates are a group of chemicals used to improve certain material characteristics in plastics. However, phthalates may cause infertility, obesity, and cancer. It’s therefore not surprising that these substances are subject to increasingly strict regulations – especially when it comes to infant and children’s products.

That said, phthalates regulations also cover food packaging, kitchen utensils, and other products. Keep reading, and learn what importers and manufacturers must know about US phthalates restrictions and lab testing.

What are phthalates?

Phthalates are a group of chemicals that are often added to plastics, rubber, coating materials, and adhesives to enhance the flexibility, transparency, and longevity of these products. In other words, they help to improve the overall quality of the materials.

Some scientific research has found that exposure to phthalates may result in detrimental effects to the human body, such as the following:

• Endocrine disruption
• Harm to child growth and neurodevelopment
• Negative impact on reproductive systems in adolescents and young children
• Endometriosis
• Diabetes
• Decreased testosterone
• Breast or uterine cancer

For this reason, several federal agencies such as the CPSC and the FDA regulate the level of phthalates in consumer products.

Examples

Here, we list some of the most common phthalates that are restricted in consumer products:

• DINP
• DCHP
• DIDP
• DEHP
• DPENP
• DHEXP
• DBP
• BBP
• DEP
• DIBP

Are phthalates banned in the United States?

The CPSIA prohibits the import and sale of children’s toys and childcare products that contain more than 0.1% of certain phthalates, including the following:

• DEHP
• DBP
• BBP

The FDA also limits the use of phthalates in certain consumer products, such as food contact materials. Several states, like California, New York, and Vermont, have adopted their own phthalates restrictions.

Which products and materials may contain phthalates?

Phthalates are mainly found in plastic products or products that contain plastic components. Here are some examples of categories of consumer products that might contain phthalates:

• Food packaging
• Kitchen utensils
• Toys
• Medical devices
• Electronic products
• Curtains

As an example, phthalates are often added to PVC used for manufacturing food packaging to soften the material and increase its durability. Phthalates may also act as components of adhesives and sealants. Further, they are widely used in medical devices like blood bags, tubing, catheters, and disposable gloves to increase pliability and comfort.

They may also be used in coatings used on non-plastic products, such as leather goods.

CPSIA: Children’s Products

The Consumer Product Safety Improvement Act (CPSIA) regulates children’s products that are imported, manufactured, and sold in the United States. It also establishes safety standards and rules, which might include substance restrictions on phthalates, heavy metals, and other dangerous substances.

Product scope

The CPSIA covers a wide range of products intended for children aged 12 and younger. Here, we list several examples of regulated products that may contain phthalates:

• Children’s toys
• Children’s clothing and general wearing apparel
• Frame child carriers
• High chairs
• Pacifiers
• Soft infant and toddler carriers

16 CFR Part 1307 – Prohibition of children’s toys and child care articles containing specified phthalates

16 CFR Part 1307 bans children’s toys and child care articles containing specified phthalates above a certain amount. Specifically, it restricts the use of the following phthalates to a maximum of 0.1% by weight:

• DEHP
• DBP
• BBP
• DINP
• DIBP
• DPENP
• DHEXP
• DCHP

This prohibition does not include inaccessible component parts of covered products.

Inaccessible component parts are defined as parts that are not physically exposed via casings or coverings, and do not become exposed due to the product’s expected use and abuse (e.g., aging, breaking, or mouthing).

ASTM Standards

Some ASTM standards that cover children’s products may also restrict phthalates. The CPSIA might incorporate by reference several of those standards, and as such, render compliance with those standards mandatory.

For example, ASTM F-963 – Standard Consumer Safety Specification for Toy Safety was updated to reflect the phthalates restrictions set by 16 CFR Part 1307. You can learn more about this topic on the ASTM’s website.

FDA 21 CFR: Food Contact Materials

FDA 21 CFR regulates food, drugs, cosmetics and food contact materials within the United States.

Phthalates deauthorization

The FDA deauthorized the use of 25 plasticizers via an amendment to the following food additive regulations:

• 21 CFR Part 175
• 21 CFR Part 176
• 21 CFR Part 177
• 21 CFR Part 178

The deauthorization, by way of the FDA’s final rule on plasticizers in food contact materials, covers the following ortho-phthalates:

• Dimethyl phthalate
• Diphenyl phthalate
• Methyl phthalyl ethyl glycolate
• Diethyl phthalate
• Diphenylguanidine phthalate
• Ethyl carbethoxymethyl phthalate
• Diisobutyl phthalate
• Butyl benzyl phthalate
• Di-n-butyl phthalate
• Butyl carbobutoxymethyl phthalate
• Dihexyl phthalate
• Di(butoxyethyl) phthalate
• Dimethylcyclohexyl phthalate
• Diisooctyl phthalate
• Dioctyl phthalate
• Butyloctyl phthalate
• Di(2-ethylhexyl) hexahydrophthalate
• Amyl decyl phthalate
• Butyl decyl phthalate
• Decyl octyl phthalate
• Didecyl phthalate
• Dodecyl phthalate
• Dihydroabietyl phthalate
• Castor oil phthalate, hydrogenated
• Castor oil phthalate with adipic acid and fumaric acid-diethylene glycol

21 CFR Part 175 – Indirect Food Additives: Adhesives and Components of Coatings

21 CFR Part 175 regulates indirect food additives in adhesives and components of coatings used in food contact materials.

21 CFR Part 175.105 contains a table listing substances that are permitted for use in adhesives. The table includes the following phthalates:

• Dicyclohexyl phthalate
• Di(2-ethylhexyl)phthalate
• Diisodecyl phthalate
• Diallyl phthalate

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

21 CFR Part 176 covers the use of indirect food additives in components of paper and paperboard. It allows the use of some phthalates for specific usages, including:

a. Dicyclohexyl phthalate, which can be used as a component of paper and paperboard that is in contact with aqueous and fatty foods.

b. Diallyl phthalate, which can be used as a component of paper and paperboard that is in contact with aqueous and fatty foods, as well as dry food.

c. Di-(2-ethylhexyl) phthalate, which can be used as a defoaming agent in the manufacture of paper and paperboard.

21 CFR Part 177 – Indirect Food Additives: Polymers

21 CFR Part 177 covers polymers that are used as indirect food additives. Here are a few examples of polymers covered by this part, and the phthalates that can be used in these materials:

a. Rigid acrylic plastics – Di-(2-ethylhexyl) phthalate.

b. Cellophane – Dicyclohexyl phthalate and Di-(2-ethylhexyl) phthalate.

c. Food container closures with sealing gaskets – Di-2-ethylhexyl terephthalate and Diisodecyl phthalate.

Note that the use of some phthalates is subjected to limitations. For example, the amount of Di-(2-ethylhexyl) phthalate must limited to less than 5% by weight, alone or in combination with other phthalates.

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

21 CFR Part 178 covers adjuvants, production aids, and sanitizers, which may contain phthalates.

For instance, 21 CFR Part 178.3740 covers plasticizers in polymeric substances, and specifies two types of phthalates and their restrictions:

a. Dicyclohexyl phthalate – The FDA permits its use alone or with other phthalates in plastic PVA or PVC sheets in food contact materials, which must contain “no more than” 10% by weight of the total phthalates.

b. Diisononyl phthalate – The FDA states that this phthalate can be used “at levels not exceeding” 43% by weight of allowed vinyl chloride homopolymers or copolymers used in food contact materials.

Another example is 21 CFR Part 178.3910, which covers surface lubricants used to make metallic products. This part lists the following two permitted phthalates:

• Di(2-ethylhexyl)phthalate
• Diisodecyl phthalate

State Regulations

Some states in the US have developed their own regulations limiting the use of phthalates in consumer products to protect public health.

Note that this list is not comprehensive; however, you can find more regulations that limit the use of phthalates on the Safer States’ website.

California Proposition 65

California Proposition 65 restricts the use of more than 900 kinds of toxic chemical substances used in consumer products. It requires products manufactured, imported, or sold in California to conform to the chemical restriction requirements so that such products do not pose harm to the users.

The proposition restricts the following phthalates as they can cause birth defects, brain damage, reproductive harm, or cancers to consumers:

• BBP – MADL 1,200 μg/day (oral)
• DBP – MADL 8.7 μg/day
• DEHP – NSRL 310 μg/day (adult), MADL 4,200 μg/day (intravenous)
• DIDP – MADL 2,200 μg/day
• DINP – NSRL 146 μg/day
• DnHP – MADL 2,200 μg/day

You can find the definitions of “Maximum Allowable Dose Level (MADL) and “No Significant Risk Level (NSRL)” in this article.

Model Toxics in Packaging Legislation

The Toxics in Packaging Clearinghouse (TPCH) established the Model Toxics in Packaging Legislation to reduce the usage of four heavy metals in packaging or packaging materials sold in the US.

In 2021, the TPCH updated the Legislation to prohibit the intentional introduction of phthalates and PFAS during the manufacturing and distribution of packaging and packaging materials.

So far, 19 states have toxics in packaging requirements, which are based on the model legislation. Here, we list several states that have such legislations:

• California
• Connecticut
• New Hampshire
• Minnesota
• New York
• Rhode Island
• Washington

Vermont Bans on Phthalates in Children’s Products

The state of Vermont prohibits the manufacturing and marketing of food packaging and children’s products containing “chemicals of high concern”, which include some types of phthalates.

Specifically, the Vermont’s Department of Health’s Chemicals of High Concern In Children’s Products Rule lists the following phthalates as chemicals of high concern:

• DCHP
• DEP
• DBP
• DPP
• DIBP
• DMEP
• DnOP
• DIDP
• DINP
• DnHP
• BBP
• DEHP
• TBPH

Chemicals such as the above phthalates are added to the list if research has proven that the chemical harms the human body.

Maine’s Act To Protect the Environment and Public Health by Further Reducing Toxic Chemicals in Packaging

Maine forbids the sale of food packaging that contains phthalates. In particular, the following substances and materials should not contain any amount of phthalates:

• Printing materials on the packaging
• Ink
• Dyes
• Pigments
• Adhesives
• Stabilizers
• Coatings
• Plasticizers
• Any other additives

New York’s ban on phthalates in children’s products

On January 9, 2023, New York enacted a bill prohibiting the manufacture, importation, or sale of children’s toys or childcare products containing concentrations over 0.1% of the following phthalates:

• DEHP
• DBP
• BBP
• DINP
• DIDP
• DNOP

This ban will take effect on January 9, 2025, and violators of this bill must pay a fine of at least USD 10,000 per day.

Phthalate Lab Testing

Lab testing is often necessary to prove a product’s compliance with regulations that restrict phthalates. This in practice means that importers and manufacturers must ensure that their phthalate-containing products comply with regulations such as California Proposition 65, CPSIA, and FDA 21 CFR.

When their products pass testing, they receive a test report that proves the products’ compliance with relevant substance restrictions, including phthalates.

Test methods

There are different test methods to assess the content of phthalates in consumer products. For example, the CPSC approves the usage of the test method “CPSC-CH-C1001-09.4 – Standard Operating Procedure for Determination of Phthalates” to assess compliance with the ban on children’s toys and childcare articles containing specific phthalates.

The CPSC also accepts the usage of the following two ASTM standard test methods:

a. ASTM D7823 – Standard Test Method for Determination of Low Level Phthalates in Poly (Vinyl Chloride) Plastics by Thermal Desorption—Gas Chromatography/Mass Spectrometry.

b. ASTM D8133 – Standard Test Method for Determination of Low Level Phthalates in Poly (Vinyl Chloride) Plastics by Solvent Extraction—Gas Chromatography/Mass Spectrometry.

Testing companies

Here we list several labs that are accepted by the CPSC to test children’s products against the phthalates limitations set by 16 CFR Part 1307:

• Bureau Veritas
• Eurofins
• Intertek
• QIMA
• Bay Area Compliance Laboratories Corp
• TÜV SÜD

Compliance Risks

Plastics used to manufacture everything from watch straps to toys and food packaging contains, to this day, excessive amounts of phthalates.

In fact, excessive phthalate content is one of the most common reasons for forced product recalls – and failed lab tests. Keep in mind that products manufactured in Asia are not necessarily made with US phthalate regulations in mind.

It’s therefore risky to buy products that are manufactured for other markets or work with suppliers that don’t have experience procuring compliant materials.