Chemical Regulations in the United States: An Overview

Several regulations in the United States restrict chemicals in consumer products. Some substances are banned, while others are subject to limits. In other cases, there are reporting and testing requirements.

The chemical regulations that do apply depend on various factors, including the product type, age group, or even which US states you sell in.

In this guide, we cover the CPSIA, TSCA, California Proposition 65 and other regulations that set compliance requirements for chemicals in consumer products.

Consumer Product Safety Improvement Act (CPSIA)

While the CPSIA covers children’s products in general, it also includes provisions that restrict certain substances that are deemed to be hazardous. Below we provide some examples of parts that restrict specific substances.

16 CFR Part 1307 – Prohibition of Children’s Toys and Child Care Articles Containing Specified Phthalates

It restricts certain phthalates (DEHP, DBP, BBP, DINP, DIBP, DPENP, DHEXP, DCHP) to a maximum of 0.1% in children’s toys and childcare articles.

16 CFR Part 1303 – Ban of Lead-Containing Paint and Certain Consumer Products Bearing Lead-Containing Paint

a. It bans lead in paint in children’s products and furniture article

b. It restricts lead in paint and surface coating materials to 0.009% in other consumer products.

ASTM standards

Note that the CPSIA also incorporates standards that may contain additional substance restrictions. For instance, 16 CFR Part 1250 incorporates ASTM F963-23 by reference, thereby mandating compliance with its requirements. In turn, ASTM F963-23 restricts substances such as lead, cadmium, and others.

How can I comply with the CPSIA requirements?

Third-party lab testing is mandatory for all children’s products. This testing process also covers mandatory substance tests. Notice that only CPSC-accepted labs can issue valid test reports.

The issued test report is then the basis for your Children’s Product Certificate (CPC).

Toxic Substances Control Act (TSCA)

The TSCA has a very broad scope and, although it mainly regulates substances and mixtures, it restrictions some substances in consumer products, such as PFAS and PCBs. Below we list some examples of parts under the TSCA that restrict substances in consumer products.

40 CFR Part 751 – Regulation of Certain Chemical Substances and Mixtures Under Section 6 of the Toxic Substances Control Act

It restricts several types of substances articles, such as:

• 2,4,6-TTBP < 0.3% by weight
• PCTP < 1% by weight
• DecaBDE – prohibited
• PIP(3:1) – prohibited
• HCBD – prohibited

40 CFR Part 770 – Formaldehyde Standards for Composite Wood Products

It restricts the formaldehyde emissions in:

• Hardwood plywood to 0.05 ppm
• Medium-density fiberboard to 0.11 ppm
• Thin medium-density fiberboard to 0.13 ppm
• Particleboard to 0.09 ppm

40 CFR Part 705 – Reporting and Recordkeeping Requirements for Certain Per- and Polyfluoroalkyl Substances

Although it doesn’t limit any substances, it requires certain companies to submit reports to the EPA regarding PFAS and PFAS-containing products.

How can I comply with the TSCA requirements?

Labs can test materials to verify the content of PFAS, formaldehyde, and other substances restricted under the TSCA.

21 CFR – FDA: Food Contact Materials

While the FDA covers a wide range of products, here we focus on a few examples of provisions that restrict specific substances in different types of food contact materials (FCM).

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

It covers adhesives and components of coatings as indirect food additives. This part generally lists substances permitted for use in adhesives and components of coatings, as well as their specific usage conditions.

For example, ammonium silico-fluoride can be used as a bonding agent for aluminum foil, but it should not exceed 1% by weight of the finished adhesives.

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

It covers paper and paperboard components as indirect food additives. It generally lists various substances that can be used as components of paper and paperboard and their usage restrictions.

For instance, alkyl ketene dimers can be used as adjuvants in paper and paperboard, so long as the substance does not exceed 0.4% by weight of the paper and paperboard FCM.

21 CFR Part 177 – Indirect Food Additives: Polymers

It applies to polymers as indirect food additives. In general, this part lists substances allowed in polymers and the specific conditions under which these substances can be used.

For example, maleic acid can be used in cellophane packaging in a concentration lower than 1%.

How can I comply with the FDA requirements for food contact materials?

You will need to submit the food contact product or material to a testing company for lab testing. The sample will be subjected to migration testing, for the sake of verifying that the material is compliant.

21 CFR – FDA: Cosmetics

The FDA covers cosmetic products and also lists prohibited and restricted substances. We list below a few examples of such substances.

a. Bithionol – prohibited in cosmetics, as it might result in photocontact sensitization.

b. Chloroform – prohibited in cosmetics, as it is cancer-causing and harmful.

c. Hexachlorophene – restricted to 0.1% in cosmetics, as it is toxic. Prohibited in cosmetics for mucous membranes.

d. Mercury compounds – restricted to 65 ppm (if there are no alternatives) and 1 ppm (if it occurs in trace amounts), as it is bioaccumulative.

How can I comply with FDA requirements for cosmetics?

Third-party testing is required to verify the substance content in cosmetics products. Notice that cosmetics products are also subject to labeling requirements.

Federal Hazardous Substances Act (FHSA)

The FHSA sets labeling requirements for consumer products that contain hazardous substances and also provides restrictions for several substances in specific products. Here are some examples:

a. Lead – restricted to 0.06% of the total weight of the metal-cored wicks for candles.

b. Sodium and potassium hydroxide – restricted to 10% by weight in liquid drain cleaners.

c. Carbon tetrachloride – banned in fire extinguishers exceeding 10 ppm.

Model Toxics in Packaging Legislation

Many states in the US have adopted the Model Toxics in Packaging Legislation, which sets restrictions for several substances in packaging materials. Below we list and explain six substances and their restrictions regarding packaging.

The legislation prohibits the intentional introduction of the following substances into packaging or packaging materials:

• Lead
• Mercury
• Cadmium
• Hexavalent chromium
• PFAS
• Phthalates

It also restricts the following heavy metals to 100 ppm if they are incidentally introduced into packaging materials:

• Lead
• Mercury
• Cadmium
• Hexavalent chromium

California Proposition 65

California Proposition 65 currently restricts the use of around 900 substances in consumer products in California. You must either ensure that your products do not contain those substances at levels exceeding certain limits, or provide warnings on your substance-containing products.

Here we list a few examples of substances and their restrictions:

• Acetaldehyde – NRSL of 90 µg/day
• Di-n-butyl Phthalate (DBP) – MADL of 8.7 µg/day
• BPA – MADL of 3 µg/day
• Methanol – MADL of 47,000 µg/day (inhalation)
• Styrene oxide – NRSL of 4 µg/day
• Thiourea – NRSL of 10 µg/day

We explain what NRSLs (No Significant Risk Levels) and MADLs (Maximum Allowable Dose Levels) are in this guide.

How can I comply with California Proposition 65 requirements?

Third-party lab testing is required to verify compliance with California Proposition 65. You are normally not required to test for all of the more than 800 substances covered. Qualified testing companies can help you assess which substances under California Proposition 65 are relevant to your product and materials.

RoHS

Several states in the US have RoHS regulations that restrict the use of some substances in electronic products. They restrict some – or all – of the following substances:

• Cadmium – 0.01%
• Lead – 0.1%
• Mercury – 0.1%
• Chromium VI – 0.1%
• PBB – 0.1%
• PBDE – 0.1%
• DEHP – 0.1%
• BBP – 0.1%
• DBP – 0.1%
• DIBP – 0.1%

Note that the restricted substances may vary according to the state.

How can I comply with RoHS requirements?

You can either submit the components for lab testing or obtain RoHS test reports from your supplier. RoHS is widely known among suppliers in Asia and Europe. However, don’t expect suppliers to be aware of RoHS limits in the United States. Instead, they tend to follow the RoHS Directive substance limits in the European Union.

FAQ

How can we determine which chemical restrictions apply to a certain product?

This largely depends on the following factors:

• Product type
• Age group
• Materials

Some regulations, such as California Proposition 65, apply to companies selling in a certain US state.

What happens if a product contains restricted chemicals above the limits?

In some cases, selling products that contain substances above the set limits is prohibited. In other words, if the level of a certain chemical exceeds the limit, even if by a small margin, then that product cannot be sold.

That said, some regulations only require that you report the chemical, or that you affix a warning label.