Products and materials containing formaldehyde are subject to various regulations in the United States. Selling products that contain this substance above the set limits can result in a recall, or trigger other requirements. This limit depends on the product, materials, or the US state you sell in.
This guide serves as an introduction to formaldehyde requirements in the United States for various products and materials. We also explain what formaldehyde is, and which products and materials are more likely to contain this substance.
Content Overview
FREE CONSULTATION CALL (US, EU & UK)
- Request a free 30-minute call with Ivan Malloci to learn how we can help you with:
- Find product requirements
- Certification and labeling
- Lab testing
What is formaldehyde?
Per the Environmental Protection Agency (EPA), formaldehyde is a colorless gas, that is flammable at room temperature and has a strong odor. Formaldehyde might cause harm to human health when you are exposed to it, for example, via the airways. The substance may irritate the throat, skin, nose, and eyes.
California’s Proposition 65 fact sheet states that adhesives used in manufacturing building materials and household products can contain formaldehyde. Formaldehyde may also be passed from mother to baby during pregnancy.
Is formaldehyde banned in the United States?
Several US state or national regulations and standards regulate the content and emission limits of formaldehyde in certain products. For instance, 40 CFR Part 770 (TSCA) sets a formaldehyde emission limit of 0.09 ppm in particleboards.
Here are some regulations that regulate the usage of formaldehyde:
a. 40 CFR Part 770 – Formaldehyde Standards for Composite Wood Products (TSCA)
b. 21 CFR Part 175 – Indirect Food Additives: Adhesives and Components of Coatings
c. 21 CFR Part 177 – Indirect Food Additives: Polymers
d. 16 CFR Part 1500 – Hazardous Substances and Articles: Administration and Enforcement Regulations
Which products and materials may contain formaldehyde?
Here are some examples of products that may contain formaldehyde:
- Hardwood plywood
- Particleboard
- Medium-density fiberboard
- Products that contain glues, paints, and coatings
- Products that contain preservatives (e.g.cosmetics)
- Upholstery furniture
- Paper products
- Hair smoothing products
- Fertilizers
- Pesticides
40 CFR Part 770 – Formaldehyde Standards for Composite Wood Products (TSCA)
40 CFR Part 770 sets formaldehyde emission standards, as well as other requirements regarding the import, manufacture, distribution, and sale of the following products:
- Composite wood products
- Component parts containing composite wood products
- Finished goods containing composite wood products
Substance restrictions
40 CFR Part 770 specifies the emission limits of formaldehyde for specific materials:
- Hardwood plywood – 0.05 parts per million (ppm)
- Medium-density fiberboard – 0.11 ppm
- Thin medium-density fiberboard – 0.13 ppm
- Particleboard – 0.09 ppm
It requires products to undergo testing to determine their formaldehyde emission limits using the following test methods:
a. ASTM E1333-14 Standard Test Method for Determining Formaldehyde Concentrations in Air and Emission Rates from Wood Products Using a Large Chamber
b. ASTM D6007-14 Standard Test Method For Determining Formaldehyde Concentrations In Air From Wood Products Using A Small-Scale Chamber
Certification
Importers and manufacturers of composite wood products must apply for, and consequently obtain, a certification by providing information that includes:
- The panel producer’s and quality control manager’s contact details
- A copy of the panel producer’s quality control manual
- Information about the product
- Information about the resin system that is used in producing the panel
- Valid reports of tests conducted per ASTM E1333-14 or ASTM D6007-14
This certification would demonstrate that the composite wood products comply with the requirements regarding the formaldehyde emission standards.
Labeling
Imported, sold, or supplied panels for sale in the United States must bear labels carrying the following information:
- Panel producer’s name (or number)
- Lot number
- EPA TSCA Title VI TPC (third-party certifier) number
- Statement that the product is TSCA Title VI certified
Panels manufactured per 40 CFR Part 770.17 must additionally carry a label stating that those panels were made with no-added formaldehyde-based resins.
Panels manufactured per 40 CFR Part 770.18 must also be labeled but with a statement indicating they were made with ultra low-emitting formaldehyde resins.
The label may come in the form of a stamp, tag, or sticker.
40 CFR Part 721 – Significant New Uses of Chemical Substances (TSCA)
40 CFR Part 721 sets reporting requirements for when you intend to manufacture or process formaldehyde for commercial uses, as a significant new use. According to the EPA, a “significant new use” means that chemical substances and mixtures are used in a new way. In this case, it is required to submit a notice before “significant new use” occurs.
We were not able to find substance restrictions or other requirements.
Food Contact Materials: 21 CFR (FDA)
This section lists some requirements concerning formaldehyde from 21 CFR Parts 175 and 177. Note, however, that more provisions and requirements for formaldehyde might exist for food contact materials.
21 CFR Part 175 – Indirect Food Additives: Adhesives and Components of Coatings
Adhesives
21 CFR Part 175 allows the safe use of formaldehyde in adhesives, but only when you adhere to the conditions established in Subpart B – Substances for Use Only as Components of Adhesives.
An example of a condition for formaldehyde substances includes tri(nonylphenyl) phosphite-formaldehyde resins, which can only be used as a stabilizer.
Components of Coatings
21 CFR Part 175 permits the use of formaldehyde in components of coatings, such as acrylate ester copolymer coatings and resinous coatings. Note that this permission applies only within the conditions set by Subpart C – Substances for Use as Components of Coatings.
For instance, when formaldehyde is used in acrylate ester copolymer coatings, it must not exceed the amount necessary to accomplish the intended technical effect.
Another example includes 3-(Aminomethyl)-3,5,5-trimethylcyclohexylamine reacted with phenol and formaldehyde with a ratio of 2.6:1.0:2.0. This can only be used in coatings meant for repeated contact with the following types of foods, at temperatures not exceeding 88 °C (190 °F):
- Nonacid aqueous products
- Acidic aqueous products
- Aqueous, acid or nonacid that contain fat
- Dairy products
- Low-moisture fats and oils
- Alcoholic and nonalcoholic beverages
- Bakery products
- Dry solids
21 CFR Part 177 – Indirect Food Additives: Polymers
21 CFR Part 177 allows the usage of formaldehyde and its resins in polymers, so long as said usage adheres to the conditions set out in this part.
For instance, only a maximum of 0.15% of the condensation polymer of toluene sulfonamide and formaldehyde may be used as an adjuvant in acrylonitrile/styrene copolymer as a component of packaging materials.
Another example is melamine formaldehyde, which can only be used as the basic polymer in cellophane as a food packaging material.
Cosmetic Products
The FDA acknowledges that products such as nail polishes, nail hardeners, and hair straightening products may contain formaldehyde.
We could not find any specific information regarding the restriction of formaldehyde in these products.
Regardless, you must still list the ingredients that are present in your product, including formaldehyde. You must also include a warning statement indicating the potential health hazard that might happen during the product’s use.
16 CFR Part 1500 – Hazardous Substances and Articles: Administration and Enforcement Regulations
16 CFR Part 1500 is under the Federal Hazardous Substances Act, and it lists formaldehyde – and products containing 1% or more of formaldehyde – as a “strong sensitizer” substance that may potentially cause hypersensitivity.
Products that contain at least 1% or more of formaldehyde – or that contain other strong sensitizers and hazardous substances – must carry a cautionary label that includes the following:
- Signal word “Caution” or “Warning”
- Affirmative statement “May Produce Allergic Reaction by Skin Contact”
Note that we have taken the information regarding the cautionary labeling of strong sensitizer substances from the CPSC Staff’s Strong Sensitizer Guidance Document .
40 CFR Chapter I Subchapter E – Pesticide Programs (FIFRA)
The EPA considers some products that contain formaldehyde to be pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).
Examples of pesticides that may contain formaldehyde include:
- Disinfectants (i.e. for egg hatcheries)
- Preservatives (i.e. for household laundry products)
- Industrial gas used to prevent microbial contamination
FIFRA requires pesticides to comply with requirements such as:
- Registration
- Labeling
- Packaging
- Certification
- Substance restrictions
- Lab testing
State Regulations
While there are several state regulations that are relevant to formaldehyde usage, this section lists just a few examples.
| Title | Description |
| California Proposition 65 | California Proposition 65 restricts the safe harbor levels of formaldehyde as a cancer-causing gas to a No Significant Risk Level (NSRL) of 40 µg/day. |
| California Airborne Toxic Control Measures | The California Air Resources Board (CARB) has established 17 CCR Part 93120, which is an Airborne Toxic Control Measure that aims to reduce the formaldehyde emissions from composite wood products that are made, sold, and supplied in California, such as:
|
| Minnesota: Bans on Formaldehyde for Children Products | Minnesota restricts the use of formaldehyde in children’s personal care products and some ingestible products, because formaldehyde may be hazardous to children in high amounts. |
Lab Testing
You generally must have your product tested to prove that your product complies with the technical requirements of various regulations and standards. For instance, these tests can help ensure that your products don’t contain formaldehyde excess amounts.
Here are some examples of methods used to test products against formaldehyde levels:
a. Using a desiccator to determine formaldehyde levels in wood (ASTM D5582-14)
b. Using a chamber to determine formaldehyde concentrations in air (ASTM D6007-14)
Here are some companies that offer to test products for formaldehyde:
- Intertek
- QIMA
- UL
- SGS
- TÜV Rheinland
Compliance risks
Products made for other countries and markets without strict formaldehyde regulations may contain excessive amounts of the substance. In fact, it’s not uncommon that manufacturers in low-cost manufacturing countries are unaware of the formaldehyde contents in their materials.
Our recommendation is to always request a supplier’s existing lab test reports – to assess if they have a track record of manufacturing and exporting formaldehyde-free products.
Such test reports can, for example, correspond to the following:
a. 40 CFR Part 770 – Formaldehyde Standards for Composite Wood Products (TSCA)
b. 21 CFR Part 175 – Indirect Food Additives: Adhesives and Components of Coatings
c. California Proposition 65
Either one of these would at least provide an indication of a compliance track record.
That said, you also need third-party lab testing to verify that your products are compliant with all applicable formaldehyde restrictions.
Thank you for this article.
We are consumers. Our question is, is there a way that this can be stopped? What is it that we can do to keep this from happening? It is causing a lot of people to be sick, and seems unnecessary. What can be done to get companies to stop this, or is this something that we just have to tolerate? What would be the steps that one would have to take to get the industry to stop the use of this?
My husband broke out in a severe rash while serving in Viet Nam. The doctor diagnosed it as a reaction to the beer served there. He advised him never to drink the beer as it had high levels of formaldehyde in it. He has stage 3b kidney disease. Could the gradual deterioration of the kidneys be caused by his initial exposure to the formaldehyde?
Hello Jean,
You need to contact a medical professional. This is not our area. We only provide information about product compliance requirements.
Does a company have to be certified to use formaldehyde, iam in Canada ,
It is illegal to manufacture or import composite wood products in the United States if they contain excessive amounts of formaldehyde. This major improvement to consumer safety is the result of a lawsuit filed in October 2017.