Plastic Product Regulations and Safety Standards in the United States

Plastic products and materials are subject to substance restrictions, labeling, certification, and lab testing requirements in the United States. That said, the specific requirements depend on factors such as product type, age group, and usage. Many US states also have their own regulations that apply to plastic products.

In this guide, we take a look at product compliance requirements applicable to plastic toys, kitchen appliances, packaging materials, electronic components, and more.

Consumer Product Safety Improvement Act (CPSIA)

The Consumer Product Safety Improvement Act (CPSIA) covers safety requirements for toys and other children’s products, such as substance limitation, testing, and labeling requirements.

The CPSIA defines a children’s product as any product generally sold to children aged 12 years or younger. Here we list examples of covered products:

• Plastic toys
• Plastic children’s supplies
• Plastic part in children’s clothes
• Plastic children’s jewelry

Requirements

The CPSIA generally requires that children’s products, including the ones made or that contain plastic, should comply with applicable safety rules, and be tested by a CPSC-accepted accredited laboratory.

Here we summarize the requirements that are applicable for plastic children’s products:

a. Labeling requirements (e.g CPSIA Tracking Label)

b. Documentation requirements (e.g Children’s Product Certificate)

c. Product Registration Card (applicable for infant or toddler products)

d. Lab testing (e.g test against relevant ASTM standards)

Restricted Substances

The CPSIA sets substance restrictions for children’s products. For example, products that contain an excessive amount of phthalates are prohibited.

Phthalates are chemical plasticizers that are often used for plastic softening. Here are three types of phthalates that might be found in your plastic products, and their limitations:

• di-(2-Ethylhexyl) phthalate (DEHP)< 0.1% by weight
• dibutyl phthalate (DBP) < 0.1% by weight
• Benzyl butyl phthalate (BBP) < 0.1% by weight

Other substances, such as heavy metals, might also be restricted. For instance, the amount of lead contained in the products should be lower than 0.01% by weight.

Lab Testing

Importers and manufacturers of plastic children’s products should ensure that their products are compliant with relevant standards, such as ASTM F-963 for toys.

CPSIA requires that the compliance tests must be performed by a CPSC-approved third-party testing company. You can find the list of CPSC-accepted labs here.

21 CFR (FDA)

21 Code of Federal Regulations set out the requirements for the sale of food, drugs, cosmetics, and food contact materials (FCM), including food-contact plastics such as plastic food packaging and kitchen utensils. Plastics can also be found inside vacuum bottles, lids, and many other food contact materials.

Product Scope

Here are some examples of the FCM that might contain plastic:

• Food packaging
• Electrical kitchen appliances
• Plastic kitchen bowls
• Plastic kitchen chopping board

Restricted Substances

21 CFR sets out the safety requirements for FCMs, including substances restrictions. Here are some restricted substances under the 21 CFR:

• Polypropylene glycol dibenzoate < 20% by weight
• Propylene glycol dibenzoate < 20% by weight
• Diethyl phthalate (DEP) – Can be only used as a preservative

21 CFR Part 175: Adhesives and Components of Coatings

21 CFR Part 175 restricts adhesives and components of coatings that might be added in plastic products, such as:

• Propylene glycol dibenzoate < 20% by weight
• p-tert-Butylpyrocatechol – Can only be used as a polymerization control agent
• Diisodecyl phthalate (DIDP) – Can only be used as a plasticizer

21 CFR Part 177: Polymers

21 CFR Part 177 restricts polymers used as indirect food additives. It provides a list of restricted substances and their limitation, such as:

• Styrene Copolymer < 0.008% by weight
• Dodecyl Mercaptan < 0.05% by weight
• Di(2-Ethylhexyl) phthalate (DEHP) < 0.3% by weight
• Dimethyl phthalate (DMP) – Can only be used as polymerization catalyst aid

Lab Testing

FCM importers and manufacturers must ensure that their plastic products are safe to use and compliant with relevant restrictions. Therefore, they should arrange lab testing in accordance with 21 CFR to assess the substance contents in their products. Testing companies such as SGS and Intertek can provide such testing services.

Toxic Substances Control Act (TSCA)

The TSCA regulates the manufacture and sale of certain toxic chemicals in order to protect the public from potential harm. The act covers a wide range of topics such as water treatment chemicals, substances registration, and the restriction of certain substances in consumer products.

40 CFR Part 751 – Regulation of Certain Chemical Substances and Mixtures Under Section 6 of the Toxic Substances Control Act sets out restrictions for Persistent, Bioaccumulative, and Toxic (PBT) in consumer products, including plastic products.

Product Scope

PBT are commonly used as plasticizers or fire retardants in plastic products. Here we list some examples of covered products:

• Plastic containers
• Plastic toys
• Plastic cases
• Plastic electronic components

Besides PBT, the TSCA also regulates other substances in consumer products, such as mercury and PCB on electronics products, and formaldehyde in wood composite materials.

Restricted Substances

Here we list some examples of restricted chemicals that might be used in plastic products:

• Decabromodiphenyl ether (DecaBDE) – prohibited
• Isopropylated phosphate (PIP) – prohibited
• Hexachlorobutadiene (HCBD) – prohibited
• 2,4,6-Tris(tert-butyl)phenol (2,4,6-TTBP) < 0.3% by weight
• Pentachlorothiophenol (PCTP) < 1% by weight

Lab Testing

Plastic products’ importers or manufacturers should conduct lab testing to assess if their products contain restricted substances above the allowed limits. A third-party lab testing company such as SGS or Intertek can perform such tests.

California Proposition 65

California Proposition 65 sets out substance restrictions and warning requirements for most consumer products sold in California, including plastic products. In particular, California Proposition 65 requires a warning label if the product contains or might contain an excessive amount of restricted substances.

Product Scope

California Proposition 65 applies to most consumer products sold in California. Below we list some examples of covered products that might contain plastic:

• Jewelry and accessories
• Watches
• Toys
• Electronics
• Furniture
• Stationery accessories

Restricted Substances

California Proposition 65 regulates substances that can cause health issues to consumers, for example, cancer or reproductive issues. It defines the No Significant Risk Level (NSRL) as the daily intake level that might lead to at most the 0.001% risk of cancer. Here we list some NSRL fo substances that might be found in plastic products:

• DEHP < 310 μg/day
• DINP < 146 μg/day
• Chromium Hexavalent < 0.001 μg/day

California Proposition 65 also defines the Maximum Allowable Dose Levels (MADL) as the daily level of exposure that has no observable reproductivity damaging effect (if multiplied by 1,000). Here we list some MADL fo substances that might be found in plastic products:

• DIDP < 2020 μg/day
• DBP < 8.7 μg/day

Importers and manufacturers should refer to the restricted substances list and ensure that their plastic products do not contain excessive levels of these substances. Otherwise, they shall apply a warning label to their products.

Warning Labels

California Proposition 65 requires that importers or manufacturers should notify consumers if the products contain or might contain harmful substances above the prescribed levels by affixing a warning label.

Here is an overview of the information that should be contained in the label:

• Warning symbol
• Warning statements
• Hazard’s description (e.g. Carcinogens and reproductive toxins)

Lab Testing

Third-party lab testing is the only way to ensure your products do not contain restricted substances above the level set by California Proposition 65 compliant. Importers and manufacturers should contact a reputable testing company before they sell their plastic products in California.

RoHS

The Restriction of Hazardous Substances (RoHS) Directive is originally an EU Directive that restricts heavy metals and other hazardous substances in electronic products, which may also include plastic parts and casing. In the United States, many states adopted some of the substance limitations set by the EU RoHS Directive.

Product Scope

RoHS applies to electronic products, including their components such as wires, coatings, and plastic parts. Here are some examples of products that fall under the scope of RoHS US state regulations:

• Video displays
• Computers
• Computer periphericals

Restricted Substances

The EU RoHS Directive provides the maximum concentration value for 4 heavy metals, 2 flame retardants, and 4 phthalates that might commonly used in electronic products, as follows:

• Lead < 0.1% by weight
• Mecury < 0.1% by weight
• Hexavalent Chromium < 0.1% by weight
• Cadmium < 0.01% by weight
• Polybrominated biphenyls (PBB) < 0.1% by weight
• Polybrominated diphenyl ethers (PBDE) < 0.1% by weight
• Bis(2-Ethylhexyl) phthalate (DEHP) < 0.1% by weight
• Benzyl butyl phthalate (BBP) < 0.1% by weight
• Dibutyl phthalate (DBP) < 0.1% by weight
• Diisobutyl phthalate (DIBP) < 0.1% by weight

Most of the US states that adopted the RoHS decided to only restrict some of the substances covered by the EU RoHS Directive. Below, we present the RoHS requirements in different states.

California RoHS Law

The California RoHS Law requires covered electronic devices sold in the states to meet the restrictions set by EU RoHS for the following substances:

• Lead
• Mercury
• Hexavalent Chromium
• Cadmium

The list of covered devices includes:

• Cathode ray tubes (CRTs) and devices containing ray tubes
• Computer monitors containing CRTs
• Laptop and desktop computer containing LCD
• Televisions containing CRTs, LDC or plasma screens
• Portable DVD players with LCD screens

New Jersey – Electronic Waste Management Act

The New Jersey’s Electronic Waste Management Act prohibits the sales of covered electronic devices that do not comply with the limitations of the heavy metal set out by the EU RoHS:

• Lead
• Mercury
• Hexavalent Chromium
• Cadmium

Covered devices include computers and televisions.

The act also requires registration and reporting with the state authorities. Manufacturers should provide information such as company details, brand and device type, and a compliance statement.

Illinois – Electronic Products Recycling and Reuse Act

Illinois’ Electronic Products Recycling and Reuse Act covers products such as:

• Computers
• Computer monitors
• Printers
• Televisions
• Electronic keyboards

It requires importers and manufacturers of electronic devices to apply for the Electronics Manufacturer Registration if the products exceed the concentration values set out by the EU RoHS, for the following substances:

• Lead
• Mercury
• Hexavalent Chromium
• Cadmium
• PBB
• PBDE

Indiana E-Waste Law

The Indiana E-Waste Law (IC 13-20.5) requires any video display devices sold to households to comply with the EU RoHS restrictions for the following substances:

• Lead
• Mercury
• Hexavalent Chromium
• Cadmium
• PBB
• PBDE

Also, importers and manufacturers should disclose whether their products exceed the maximum allowed concentration of restricted substances by registering to the Indiana Department of Environmental Management’s Re-TRAC reporting system.

Minnesota – Waste Management

The Minnesota Statute – Waste Management requires importers and manufacturers of video display devices to register on the Pollution Control Agency Website and disclose whether their products comply with the EU RoHS restrictions for the following substances:

• Lead
• Mercury
• Hexavalent Chromium
• Cadmium
• PBB
• PBDE

New York – Electronic Equipment Recycling And Reuse Act

New York’s Electronic Equipment Recycling And Reuse Act states that manufacturers of covered devices should register with the NYS department. Also, manufacturers should ensure that their products do not exceed the EU RoHS limitation for the following substances:

• Lead
• Mercury
• Hexavalent Chromium
• Cadmium
• PBB
• PBDE

Covered devices include small electronic equipment, televisions, and computers.

Rhode Island – Electronic Waste Prevention, Reuse, and Recycling Act

The Rhode Island’s Electronic Waste Prevention, Reuse, and Recycling Act requires that manufacturers of covered electronic devices should register with the Rhode Island Department, and comply with the restrictions set by the EU RoHS for the following substances:

• Lead
• Mercury
• Hexavalent Chromium
• Cadmium
• PBB
• PBDE

Covered products include:

• Computers
• Computer monitors
• Printers
• Televisions

Wisconsin – Electronic Waste Recycling

The Wisconsin Statute Chapter 287.17 – Electronic Waste Recycling prohibits the sale of covered electronic devices that are not compliant with the substance restrictions set out by the EU RoHS Directive.

Manufacturers should also register with the Wisconsin Department of Resources and confirm whether their products are in compliance with the EU RoHS substance restrictions, before starting to sell their products.

Covered devices include:

• Televisions
• Printers
• Computer monitors
• Computer accessories

Lab Testing

Third-party lab testing is the only safe way to assess product compliance with the RoHS substance restrictions. Reputable testing companies such as TÜV SÜD or QIMA offer RoHS testing services.

Model Toxics in Packaging Legislation

The Model Toxics in Packaging Legislation aims to reduce the concentration of heavy metals such as lead and cadmium in packaging and packaging components. The legislation is adopted by certain states such as:

• California
• New York
• Iowa
• Minnesota

Plastic packaging importers and manufacturers should comply with the Toxics in Packaging Laws before selling their products in states that apply the legislation.

Product Scope

The legislation is applicable for all packaging and its components. Here are some examples of covered products:

• Plastic wraps
• Plastic bags
• Plastic containers
• Plastic boxes

Restricted Substances

The legislation sets out the limitation on four heavy metals in packaging as below:

• Lead < 0.01% by weight
• Mercury < 0.01% by weight
• Cadmium < 0.01% by weight
• Hexavalent chromium < 0.01% by weight

Documentation

Manufacturers and suppliers of packaging and packaging components are required to issue a certificate of compliance. Here is an overview of the information that must be included in the certificate of compliance:

• Company letterhead
• Company name and address
• Compliance statement
• Representative signature

You can find a certificate sample on this website.

Lab Testing

The certificate of compliance relies on the result of relevant lab testing. As such, it is important to arrange testing in accordance with the Model Toxics in Packaging Legislation substance restrictions.