The purpose of the regulation is to address infant sleep products not already covered by a sleep product regulation and to reduce deaths associated with known infant sleep hazards, including, but not limited to, fall hazards, asphyxiation and suffocation, obstruction of nose and mouth by bedding, and inclined sleep surfaces. In response to incident data compiled by CPSC, the regulation addresses: (1) fall hazards, (2) asphyxiation and suffocation, and (3) obstruction of nose and mouth by bedding.
The regulation was originally published at 86 FR 33022 and codified at 16 C.F.R. part 1236. The regulation incorporates by reference ASTM F3118, and 16 C.F.R. § 1236.2 identifies the latest Commission-accepted version of ASTM F3118 that is mandatory as well as any modifications.
Read-only copies of ASTM standards that are incorporated by reference can be viewed at ASTM’s electronic Reading Room.
More information is available on our infant sleep products business guidance page.
An “infant sleep product” is a “product marketed or intended to provide a sleeping accommodation for an infant up to 5 months of age” that is not already covered under one of the following regulations:
- 16 CFR part 1218 - Safety Standard for Bassinets and Cradles
- 16 CFR part 1219 - Safety Standard for Full-Size Baby Cribs
- 16 CFR part 1220 - Safety Standard for Non-Full-Size Baby Cribs
- 16 CFR part 1221 - Safety Standard for Play Yards
- 16 CFR part 1222 - Safety Standard for Bedside Sleepers
Examples of infant sleep products include in-bed sleepers, baby boxes, compact/travel bassinets, baby nests, and infant travel tents. Additionally, if a product name implies the product is for use as an infant sleep product (such as use of the terms “bed,” “bassinet,” or “crib”), and the product is not already subject to one of CPSC’s other mandatory standards for infant sleep, then the product meets the definition of an infant sleep product and is subject to 16 C.F.R. part 1236.
Infant sleep products not already subject to one of the five mandatory standards for sleep products listed above must comply with the requirements for bassinets and cradles, codified at 16 C.F.R. part 1218, including meeting the definition of a “bassinet/cradle” See our bassinets and cradles business guidance page for more information on how to comply with that standard.
Yes. There are general requirements for child care articles and durable infant or toddler products that apply:
- Small parts: Products intended for children under 3 years of age must not contain small parts or liberate small parts after use and abuse testing.
- Lead in paint and similar surface coatings: Children’s products must not bear paint and/or similar surface coatings that contain more than 0.009 percent (90 ppm) lead.
- Total lead content: Children’s products must not contain greater than 100 ppm (0.01 percent) of total lead content in any accessible component part.
- Phthalates: Children’s toys and child care articles as defined per 16 C.F.R. § 1307.2 must not contain greater than 0.1 percent (1000 ppm) of any regulated phthalate in any accessible plasticized component part.
- Third-party testing: Children’s products must be tested for compliance with applicable safety rules by a third-party, CPSC-accepted laboratory.
- Certification: Domestic manufacturers or importers of children’s products must generate a Children’s Product Certificate (CPC) certifying compliance with the applicable safety rules and ensures that a CPC accompanies the distribution of the product.
- Labeling: Children’s products must bear distinguishing, permanent marks on the product and any packaging (tracking label) that allow consumers to ascertain certain information. Durable infant or toddler products are required to have product markings in addition to the tracking label. This chart summarizes the specific labeling and registration requirements that durable infant and toddler products must meet.
- Registration form: Durable infant or toddler products must have a product registration form (also known as registration card) permanently attached to the product. There must also be an option to register via a website or, in the absence of a website, via email.
In determining whether products meet the definition of an infant sleep product, firms should consider relevant factors set forth in the regulation, such as marketing and advertising, labeling, product design, and consumer usage (including potential for misuse).
Products that were intended for infant (0 – 5 months of age) sleep, based on the product’s design, may not be labeled and marketed as not intended for infant sleep solely to avoid meeting the requirements of the regulation. The product must also be designed in such a way that indicates it is not intended for infant sleep.
The “infant loungers” category of products encompasses a broad range of products.
In determining whether products meet the definition of an infant sleep product, firms should consider relevant factors set forth in the regulation, such as marketing and advertising, labeling, product design, and consumer usage (including potential for misuse).
If part of the product’s marketing or advertising includes “bassinet”, then it must comply with the requirements for bassinets at 16 C.F.R. part 1218. For more information, visit our bassinets and cradles business guidance page.
If the product only references a space to sleep and not specifically marketed as a bassinet or travel bassinet, then it must comply with the requirements for infant sleep products.
It depends on the intended use, marketing, and design of the tent. An after-market product may be subject to the requirements for infant sleep products in certain circumstances if it provides sleeping accommodation and is marketed and intended for infants up to 5 months of age.
Crib wedges, sleep positioners, and sleep wedge pillows are out of scope of the regulation for infant sleep products. These products fall within the scope of the Infant Support Cushion Rule and are considered infant support cushions.
A product marketed or intended for infant sleep with an advertised age range that includes infants up to 5 months of age, is within the scope of the regulation for infant sleep products. An infant sleep product advertised for infants 0-6 months or 0-9 months could be within the scope of the regulation, as well as an infant sleep product advertised for infants 3-12 months, 0+, or a product advertised for “newborns” or “all infants.”
Multiuse products with different use modes must meet the applicable regulation for each use while in that mode, as specified in many CPSC regulations for children’s products. The product’s marketing, instruction manuals, and labeling must be clear and contain all required warnings on the product and in the instructions that are applicable to each intended use. If any intended use is marketed for sleep for infants up to 5 months, then the product, in that mode, is required to comply with regulation for infant sleep products if it is not already subject to one of CPSC’s mandatory standards for sleep products (full-size baby cribs, non-full-size baby cribs, play yards, bedside sleepers, and bassinets and cradles).
Any product advertised for “attended” or “supervised” sleep must still comply with the infant sleep product regulation if not already subject to one of CPSC’s mandatory standards for sleep products (full-size baby cribs, non-full-size baby cribs, play yards, bedside sleepers, and bassinets and cradles).
A product that includes references to sleep, snooze, dream, nap, etc. in the product name, description, or instructions suggests to caregivers that the product is intended for sleep. In addition, advertising or marketing with pictures of sleeping children, animals, or other similar figures could also convey to caregivers that the product is intended for sleep.
It depends on the specifics of the product. In determining whether products meet the definition of an infant sleep product, firms should consider relevant factors set forth in the regulation, such as marketing and advertising, labeling, product design, and consumer usage (including potential for misuse).
A “bassinet/cradle” is defined at ASTM F2194-13 as “a small bed designed primarily to provide sleeping accommodations for infants, supported by free standing legs, a stationary frame/stand, a wheeled base, a rocking base, or which can swing relative to a stationary base.” Neither the definition nor the rest of the ASTM standard for bassinets specify a minimum height for the legs or frame/stand/base. The requirements to have “free standing legs or a stationary frame/stand/wheeled or rocking base” and to be raised off the floor is intended to discourage or prevent use of the product on other, less stable, surfaces, such as elevated surfaces or soft surfaces (e.g., couches and adult beds).
See our bassinet and cradle business guidance page for more information.
Unless marketed or intended for infant sleep, carriages and strollers are not within the scope of the regulation for infant sleep products. Carriages and strollers must comply with 16 C.F.R. part 1227; however, carriages and strollers and their accessories would be within the scope of the regulation for infant sleep products if they are marketed or intended to provide sleeping accommodation for an infant up to 5 months of age. Some carriage and stroller accessories, such as hand-held infant carriers, also need to comply with the requirements for hand-held infant carriers per 16 C.F.R. part 1225.
Baby boxes marketed or intended for infant sleep for 0 to 5 months likely would not comply with the regulation for infant sleep products since they typically are not able to meet the requirements for bassinets and cradles per 16 C.F.R. part 1218.